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6,697 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria - Part A:
- Moderately severe (≤2% FVIII) hemophilia A
- <3 Years of age at the time of informed consent
- Caregiver (parent or legal guardian) has provided written informed consent
- ≤2 EDs to pdFVIII, rFVIII, or a single dose of FFP, Cryoprecipitate or PRBCs.
- Adequate hematologic function (HgB >8 g/dL and platelet count >100,000 µL)
- Adequate hepatic function (total bilirubin ≤1.5x ULN and both AST/ALT ≤3x ULN at
screening (excluding known Gilbert's)
- Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)
- Negative test for inhibitor (<0.6 BU/mL) with a 72-hour washout within 4 weeks of
enrollment
- No documented FVIII inhibitor since birth *Participants will be encouraged to
co-enroll in the ATHN 8 Study
Inclusion Criteria - Part B
- Moderately severe (≤2% FVIII) hemophilia A
- <21 Years of age at the time of informed consent
- Documented on 2 occasions a persistent low (>0.6 BU/mL) or high titer inhibitor (>5
BU/mL) with a 72-hour washout within 8 weeks of enrollment after either the first time
ITI or after single attempt of <6 months of continuous 3x/week factor ITI
- Caregiver and/or participant provided written informed consent
- Adequate hematologic function (HgB >8 g/dL and platelet count >100,000 µL)
- Adequate hepatic function (total bilirubin ≤1.5x ULN and both AST/ALT ≤3x ULN at
screening (excluding known Gilbert's)
- Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)
Exclusion Criteria - Part A and B
- Inherited or acquired bleeding disorder other than severe hemophilia A (participants
with previous documentation of low von Willebrand factor (vWF) defined as vWF antigen
and vWF ristocetin cofactor both between 40-50 will be permitted)
- Previous or current treatment for thromboembolic disease or signs of thromboembolic
disease
- Conditions that may increase risk of bleeding or thrombosis. Will not require or
request a thrombophilia evaluation
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the HEMLIBRA® injection (with the exception of rituximab)
- Known HIV infection with CD4 count <200 cells/µL within 24 weeks prior to screening.
Testing not required if can demonstrate negative testing in mother prior to pregnancy
- Use of systemic immunomodulators at enrollment or planned use during the study
- Participants who are at high risk for thrombotic microangiopathy (TMA) (for example,
have a previous medical or family history of TMA), in the investigator's judgment
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study, may pose additional risk, or would, in the
opinion of the investigator, preclude the participant's safe participation in and
completion of the study
- Planned surgery (excluding minor procedures or central line placement) during the
study
- Receipt of HEMLIBRA® as part of a prior investigational study; an investigational drug
to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
administration; a non-hemophilia-related investigational drug concurrently, within
last 30 days or 5 half-lives, whichever is shorter
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Emicizumab PUPs and Nuwiq ITI Study | NCT04030052 | Contradiction |
6,426 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Main Inclusion Criteria:
- Healthy patients with rosacea
- Males and females ≥18 years of age
- 10 to 40 papules and pustules and ≤2 nodules
- Score of 2 to 4 on the IGA
- Presence of telangiectasia
- Moderate to severe erythema
Main Exclusion Criteria:
- Use of topical acne treatments or topical or systemic antibiotics
- Use of systemic retinoids within 90 days of baseline
- Use of an investigational drug within 90 days of baseline
- Pregnant or nursing women
- Women of childbearing potential not using an adequate form of contraception
- Change in method of contraception within 4 months of baseline
- Known hypersensitivity to tetracyclines
- Surgeries that bypass or exclude the duodenum or achlorhydria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea | NCT00126399 | Entailment |
4,969 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria
- Men and women age 22 years or older
- A diagnosis of ET as confirmed from clinical history and examination by a neurologist
or neurosurgeon specialized in movement disorder
- Have had an inadequate response to one or two oral doses of medication, per local
standards. An inadequate medication trial is defined as a therapeutic dose of each
medication and poor response to drug, or the development of side effects as the
medication dose is titrated.
- Able to communicate sensations during the ExAblate TcMRgFUS treatment
Exclusion criteria:
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP > 100 on medication)
- Subjects with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease
- Patient with severely impaired renal function
- History of abnormal bleeding and/or coagulopathy
- History of immunocompromise including those who are HIV positive.
- History of intracranial hemorrhage
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Subjects with uncontrolled symptoms and signs of increased intracranial pressure
(e.g., headache, nausea, vomiting, lethargy, papilledema).
- Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (can be up to 4 hrs of total table time.)
- Are participating or have participated in another clinical trial in the last 30 days
- Significant claustrophobia that cannot be managed with mild medication.
- Presence of any other neurodegenerative disease such as Parkinson-plus syndromes
suspected on neurological examination.
- Presence of significant cognitive impairment
- Subjects with life-threatening systemic disease
- Subjects with a history of seizures within the past year
- Subjects with presence or history of psychosis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 99 Years | A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor | NCT03253991 | Entailment |
2,706 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- All reducible inguinal hernias will be included in the study
Exclusion Criteria:
- Irreducible hernia after anesthesia
- Obstructed and strangulated hernias
- Pediatric hernias
- Associated other hernias like ventral hernias
- Unfit for spinal anesthesia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 85 Years | Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair | NCT01117337 | Entailment |
747 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- The patient experiences pain and limitations of the great toe dorsiflexion at the
MTP-I joint.
- The patient has a clinically and radiographically verified arthritis in the MTP-I
joint indicating the need for surgical treatment.
- The patient reads, understands and is able to complete the study questionnaires in
Swedish.
- The patient has received written and oral information regarding the study and has
signed the informed consent form.
Exclusion criteria:
- The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM =
0°).
- The patient has previously received surgical treatment affecting the anatomy of the
MTP-I joint.
- The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is
seriously ill.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Artelon Metatarsophalangeal (MTP) Spacer | NCT01028469 | Contradiction |
1,263 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | - INCLUSION CRITERIA:
Patients with histologically or cytologically proven primary small cell or non-small cell
lung cancers, advanced esophageal cancer, or pleural mesotheliomas are eligible for
evaluation. In addition, patients with cancers of nonthoracic origin with metastases to the
lungs or pleura are eligible for evaluation.
Patients with intracranial metastases which have been treated by surgery or radiation
therapy may be eligible for study provided there is no evidence of active disease and no
requirement for anticonvulsant therapy or steroids following treatment.
Patients with prior Decitabine or Depsipeptide exposure are eligible for study provided
they have not experienced dose limiting toxicity at the dose of DAC or DP that they are
scheduled to receive.
Patients with prior or current celecoxib exposure are eligible for study provided that it
has been intermittent, or of short term duration (less than 1 month).
Patients must have had no chemotherapy, biologic therapy, celecoxib exposure, or radiation
therapy for their malignancy within 30 days prior to treatment. Patients may have received
localized radiation therapy to non-target lesions provided that the radiotherapy is
completed 14 days prior to commencing therapy, and the patients has recovered from any
toxicity.
Patients must have an ECOG performance status of 0-2.
Patients must have adequate pulmonary reserve evidenced by FEV1 and DLCO greater than the
30% predicted, and pCO2 less than 50 mm Hg and pO2 greater than 60 mm Hg on room air ABG.
Patients must be 18 years of age or older due to the unknown effects of demethylating
agents and HDAC inhibitors during childhood and adolescent development.
Patients must have a platelet count greater than 100, 000, an ANC equal to or greater than
1500 without transfusion or cytokine support, a normal PT, and adequate hepatic function as
evidenced by a total bilirubin of less than 1.5 x upper limits of normal. Serum creatinine
less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70
ml/min/1.73m(2).
All patients will have cardiology consultation. Subsequent evaluation will consist of
stress/redistribution thallium, 24th ambulatory EKG monitoring, ECHO, cardiac MR, or
coronary angiography as indicated.
Patients must be aware of the neoplastic nature of his/her illness, the experimental nature
of the therapy, alternative treatments, potential benefits, and risks. The patient must be
willing to sign an informed consent, and undergo tumor biopsies to evaluate target gene
expression prior to, and after, decitabine/depsipeptide treatment.
EXCLUSION CRITERIA:
Patients with primary and metastatic cancers involving the lungs or pleura which cannot be
readily biopsied by endoscopic or percutaneous fine needle aspiration techniques will be
excluded.
Patients with untreated limited stage SCLC, and operable NSCLC or operable esophageal
cancer will be excluded.
Patients who have received three or more systemic cytotoxic treatment regimens will be
excluded due to possible cumulative marrow suppression.
Patients with active intracranial and leptomeningeal metastases as well as those requiring
anticonvulsant medications will be excluded.
Patients with life expectancy less than three months will be excluded.
Patients with pulmonary embolism, or deep venous thrombosis, or prosthetic heart valves
requiring anticoagulation will be excluded.
Cardiac exclusion criteria, patients with known cardiac abnormalities such as:
-Uncontrolled arrhythmias
History of serious ventricular arrhythmias not controlled by coronary artery bypass
surgery.
Patients with a history of sustained VT, VF, Toursades de Pointes, or cardiac arrest who do
not have an automatic implantable cardioverter defibrillator in place
Congenital Long QT syndrome or QTc greater than 480 msec
Patients with Mobitz II second degree block who do not have a pacemaker
Patients with any cardiac arrhythmia requiring anti-arrhythmic medication other than a beta
blocker or calcium channel blocker
Patients in whom digitalis cannot be discontinued
- Decompensated heart failure (NYHA Class II or IV)
- LVEF less than 50% by MUGA scan or echocardiogram
- Hypertrophic or restrictive cardiomyopathy from prior treatment of other causes and
patients with left ventricular hypertrophy
- Uncontrolled hypertension (i.e greater than or equal to 160/95)
- Myocardial infarction within one year of study
- Clinical significant active myocardial ischemia on the basis of nuclear imaging or
angiography
- History of coronary artery disease (e.g. angina Canadian Class II-Iv or positive
stress imaging study)
- Patients with other cardiac disease may be excluded at the discretion of the PI
following consultation with cardiology
Co-medication causing QTc prolongation unless a 5 half-life washout period has elapsed
between discontinuing the drug and entering this study.
Pregnant patients and lactating mothers will be excluded due to the unknown, potentially
harmful effects of demethylating agents and HDAC inhibitors on fetal and early childhood
development.
Patients with active infections will be excluded.
Patients with HIV infection will be excluded due to the potential risk of opportunistic
infection during DAC/DP-induced myelosuppression and potentially deleterious activation of
viral gene expression.
Patients should not be using hydrochlorothiazide diuretics if entered on this protocol.
Therefore, patients who must use hydrochlorothiazide diuretics will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies | NCT00037817 | Entailment |
1,885 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular,
mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by
endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC
Cancer Staging Manual Seventh Edition Expected curative resection through distal
subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG
(Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology)
score class I, II, or III Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding Severe mental disorder History of previous
upper abdominal surgery (except laparoscopic cholecystectomy) History of previous
gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged
or bulky regional lymph node diameter over 3cm by preoperative imaging History of
other malignant disease within past five years History of previous neoadjuvant
chemotherapy or radiotherapy History of unstable angina or myocardial infarction
within past six months History of cerebrovascular accident within past six months
History of continuous systematic administration of corticosteroids within one month
Requirement of simultaneous surgery for other disease Emergency surgery due to
complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50%
of predicted values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 74 Years | Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer | NCT02219854 | Entailment |
4,573 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Women in good overall health with no chronic medical conditions that result in
periodic exacerbations that require significant medical care
- Women between 18 and 35 years inclusive at the screening visit
- BMI< 32 kg/m²
- Regular menstrual cycles between 21 and 35 days when not using hormonal contraception.
- Subjects postpartum or post-abortal must have one normal menstrual cycle (2
menses) prior to enrollment.
- Subjects previously using Intra-Uterine Device (IUD) or taking hormonal
contraception (or any other hormonal treatment, except an injectable treatment)
need to have at least one menstrual cycle (2 menses) without the treatment before
screening.
- Subject previously using an injectable (DMPA), must have had their last injection
at least 9 months before screening.
- Women not at risk of pregnancy: not sexually active, or willing to protect all acts of
intercourse with condoms, or have a sterile partner or have undergone previous tubal
ligation (including validated Essure), or be in a same sex relationship.
- Women able to give informed consent form to participate in the study and in the
opinion of the investigator able to follow all study requirements, use the study
medication and record the requested information appropriately
- Intact uterus and both ovaries
- At least one progesterone concentration > 3 ng/mL (>10 nmol/L) during the luteal phase
of the screening period
Exclusion Criteria:
- Pregnant as confirmed by positive high-sensitivity urine pregnancy test at enrollment
visit
- Trying to conceive or desire to conceive in the next 3 months
- Currently breastfeeding, or within the last 2 months
- Known Polycystic Ovarian Syndrome (PCOS)
- Cancer (or past history of any carcinoma or sarcoma)
- Known abnormal thyroid status, if in clinical judgment of the investigator it cannot
be controlled during the study
- Known hypersensitivity to the ingredients of the test active substances or its
excipients
- Current acute liver disease and/or benign liver tumors
- Have vaginal or cervical infection including clinical evidence of bacterial vaginosis
- Evidence of abnormal cervical lesion
- History of excisional or ablative treatment procedure on cervix (ie. Loop
Electrosurgical Excision Procedure (LEEP), Cryotherapy, Cold Knife Cone)
- Undiagnosed abnormal uterine bleeding
- Prior malabsorptive-type bariatric surgery
- Known or suspected alcoholism or illicit drug abuse
- Use of any hormonal contraception or IUD other than the study medication during the
study (including ulipristal acetate for emergency contraception in the past 5 days)
- Use of any medications that can interfere with the metabolism of progestin-based
contraceptives (e.g CYP3A4 enzymes inducers or inhibitors, etc)
- Unstable diabetes mellitus
- Current participation in any other trial of an investigational medicine or
participation in the past two months (or within 5 elimination half-lives for chemical
entities or 2 elimination half-lives for antibodies, whichever is the longer) before
screening
- Abnormalities in laboratory results or TVUS performed at screening visit recognized as
clinically significant by the investigator
- Conditions not suitable for frequent TVUS examinations, (e.g. virgo intacta)
- In custody or submitted to an institution due to a judicial order
- Relative or household member of the investigator's or sponsor's staff
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill | NCT03585712 | Contradiction |
2,789 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Adult patients with hernia defect that requires laparoscopic measurement
Exclusion Criteria:
- Minors
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Laparoscopic Measuring Device Study | NCT03234855 | Entailment |
3,608 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- all menstruating women regardless of age
- Women with heavy periods as measured by pictorial blood assessment chart
- Women diagnosed with a bleeding disorder
Exclusion Criteria:
- Acquired defective color vision
- Factor VIII, Factor IX, FactorXI levels >250%
- An inherited thrombophilic defect detected because of a positive family or personal
history of thrombosis
- Current use of oral contraceptives
Female
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 60 Years | The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders | NCT00697385 | Entailment |
3,384 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Body weight: =<50.0kg, <80.0kg
- Body mass index: =<17.6, <26.4
- Healthy as judged by investigator or caregiver from subjective and objective symptoms
and physical examination data
Exclusion Criteria:
- Attending another clinical trial within 120 days before the study
- Blood donation within 90 days (400ml) or 30 days (200ml) before the study
- Receiving any drugs within 7 days before the study
- History of allergy to drugs
- Having GI disorders
- History or complication of liver diseases
- History or complication of heart disease
- History or complication of respiratory diseases
- History or complication of renal diseases
- History or complication of cerebrovascular diseases
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 44 Years | A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers | NCT01115985 | Contradiction |
6,111 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Provide written informed consent for the trial;
2. Age 65 years or older;
3. In the opinion of the investigator, subject has the cognitive ability to provide
accurate information to study site personnel and to follow instructions, or subject
has a caregiver who can provide accurate information and ensure subject's compliance
with instructions;
4. Presentation with at least two of the following symptoms of acute respiratory illness:
1. nasal congestion
2. chest congestion
3. shortness of breath
4. cough
5. body ache
6. fever (≥100.4 ºF)
Exclusion Criteria:
1. Subject is currently taking antibiotics or has taken antibiotics within the previous
30 days.
2. Subject is currently taking antivirals or has taken antivirals within the previous 30
days.
3. Subject has been hospitalized within the previous 30 days.
4. Severity of illness (according to the Investigator) requires immediate hospitalization
or referral to specialty care.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| TEM-PCR™ Prospective Clinical Utility Study | NCT04248361 | Contradiction |
3,198 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | - INCLUSION CRITERIA:
Up to 25 patients may be enrolled in this study to obtain at least 20 patients to complete
the study and to allow for an estimated up to 20% early attrition rate. Eligible patients
will have primary SS diagnosed according to the American-European Consensus Group Sjogren's
Syndrome Classification Criteria. Subjects will be chosen based on their potential capacity
to reverse the inflammatory process and at least partially recover the exocrine function in
the salivary and lacrimal glands, as indicated in the inclusion criteria by requiring a
minimal level of salivary flow as a marker of functional gland tissue. Pre-screening, which
would include ophthalmologic evaluation, standard laboratory tests, and minor salivary
gland biopsy, will be performed under the natural history protocol, and eligible patients
will be offered to sign the informed consent for this protocol.
Age at entry at least 18 years
Must give written informed consent prior to entry in the protocol.
Must fulfill at least 4 of the 6 following criteria for Primary SS as defined by the
American-European Consensus Group Sjogren's Syndrome Classification Criteria, including
either item IV or VI, or fulfill 3 of the 4 objective criteria (III, IV, V, VI) [53] :
Ocular symptoms (at least one):
Dry eyes greater than 3 months
Foreign body sensation in the eyes
Use of artificial tears greater than 3x/day
Oral symptoms (at least one):
Dry mouth greater than 3 months
Swollen salivary glands
Need liquids to swallow dry foods
Ocular signs (at least one):
Schirmer test (without anesthesia) less than or equal to 5 mm/5 min
Positive vital dye staining (van Bijsterveld greater than or equal to 4)
Histopathology: Minor salivary gland biopsy showing focal lymphocyte sialoadenitis (focus
score greater than or equal to 1 per 4 mm(2))
Oral signs (at least one):
Unstimulated whole salivary flow (less than or equal to 1.5 ml in 15 min)
Abnormal parotid sialography
Abnormal salivary scintigraphy
Autoantibodies (at least one):
Anti-SSA or Anti-SSB
One or more of the following:
Serum ANA level greater than or equal to 1EU
Serum Anti-SSA level greater than or equal to 20EU
Serum Anti-SSB level greater than or equal to 20EU
Serum RF level greater than or equal to 20 IU/ml
One or more of the following:
ESR greater than 25 mm/hr for men; ESR greater than 42 mm/hr for women
Serum IgG level greater than or equal to 1750 mg/dl
Serum CRP level greater than or equal to 0.8 mg/dl
Stimulated salivary flow of at least 0.1 ml/min.
Minor salivary gland biopsy with a focus score of greater than or equal to 4 within at most
12 months prior to the study enrollment.
Score of 3 or more on Oxford scale in at least one eye at the study entry.
Negative age- and gender- appropriate malignancy screening for breast, cervical, colorectal
cancer for women; and prostate and colorectal cancer for men. Specifically:
- All women: pelvic exam with Papanicolaou smear within one year of study entry.
- Women age 40 and older: mammogram within 1 year of study entry,
- Both genders age 50 and older; stool screening for occult blood within one year, or
flexible sigmoidoscopy or colonoscopy within five years
- Men age 50 and older: rectal examination or prostate specific antigen testing
EXCLUSION CRITERIA:
Past head and neck irradiation.
Hepatitis B, C, HIV, or HTLV infection.
History of lymphoma or monoclonal gammopathy of unknown significance (MGUS).
Sarcoidosis.
Graft-versus-host disease.
Women of childbearing potential are required to have a negative pregnancy test at
screening.
Women of childbearing potential and fertile men who are not practicing or who are unwilling
to practice birth control during and for a period of three months after the completion of
the study.
Any therapy with human or murine antibodies or any experimental therapy within 3 months.
Therapy with cyclophosphamide, pulse methylprednisolone or IVIg, azathioprine,
mycophenolate mofetil, oral cyclosporine or methotrexate within 4 weeks of first study
treatment.
History of rituximab therapy.
Prednisone dose greater than or equal to 10 mg/day.
Allergy to murine or human antibodies.
History of anaphylaxis.
Serum creatinine greater than 2.0 mg/dl.
History of any malignancy.
Active infection that requires the use of intravenous antibiotics and does not resolve
within 1 week of Day 1.
Any active viral infection that does not resolve within 10 days prior to Day 1.
WBC less than 2000/microL or ANC less than 1500/microL or Hgb less than 9.0 g/dL or
platelets less than 150,000/microL or absolute lymphocyte count less than or equal to
500/microL.
ALT and/or AST greater than 1.5x upper limit of normal (ULN) or alkaline phosphatase
greater than 1.5x ULN.
Significant concurrent medical condition that, in the opinion of the Principal
Investigator, could affect the patient's ability to tolerate or complete the study.
Live vaccines within 12 weeks of first treatment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Pilot Study of Raptiva to Treat Sjogren's Syndrome | NCT00344448 | Entailment |
4,847 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or
ACTH independent etiologies including:
- Cushing's Disease that (more than one may apply)
- has recurred after primary pituitary surgery
- has persisted despite pituitary surgery (failed pituitary surgery)
- has been treated with radiation therapy to the pituitary
- is not treatable with surgery
- exists in subjects who are not candidates for or who refuse surgery
- Ectopic ACTH
- Ectopic CRF secretion
- Adrenal adenoma
- Adrenal carcinoma
- Adrenal autonomy
2. Have documented biochemical evidence of endogenous hypercortisolemia which includes
elevated urinary free cortisol.
3. Require medical treatment of hypercortisolemia.
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
- Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
- Have an acute or unstable medical problem, which could be aggravated by mifepristone
treatment.
- Taking medications within 14 days of the baseline visit (Day 1) that a) have a large
first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin
and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or
unwilling to use medically acceptable, non-hormonal methods of contraception during
the study.
- Have received investigational treatment (drug, biological agent or device) within 30
days of Screening
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia
(exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or
therapeutic use of ACTH
- Have Pseudo-Cushing's syndrome.
- Postmenopausal women with an intact uterus who have experienced unexplained vaginal
bleeding within 12 months of Screening are excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome | NCT01371565 | Contradiction |
2,698 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Male patients
- >18 yrs
Exclusion Criteria:
- Research protection
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair | NCT01086007 | Entailment |
5,627 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Parents or legally authorized representatives must give signed informed consent before
any trial-related activities
- IGF-1 SDS of ≤ -1 for age and gender
- Short stature, as defined by a height SDS of ≤ -2 for age and gender
- Chronological age ≥ 5 years
- Bone age ≤ 11 years in boys and ≤ 9 years in girls
- GH sufficiency, defined as a maximal stimulated GH response of greater than or equal
to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a
prior GH stimulation test may satisfy this requirement).
- Prepubertal status
- Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to
the 5th percentile for age and gender
Exclusion Criteria:
- Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response
greater than or equal to 10 ng/mL)
- Prior or current use of medications with the potential to alter growth patterns
including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase
inhibitors, androgens and estrogens
- Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations
- Current use of medications for attention deficit disorder
- A chronic health condition that requires anti-inflammatory steroids or daily
medication unless approved by the Medical Monitor
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency | NCT00572156 | Contradiction |
2,285 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Male
2. Age 4 to 7 years
3. Ambulant independently. Subjects may use a wheelchair occasionally, but only for long
distances
4. Diagnosis of DMD confirmed by at least one of the following:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical DMD OR
- Gene deletion test positive (missing one or more exons) in the central rod domain
(exons 25-60) of dystrophin, where reading frame can be predicted as
'out-of-frame',
- and clinical picture consistent with typical DMD.
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication, or other mutation resulting in a stop codon mutation) that can be
definitely associated with DMD, with a typical clinical picture of DMD.
5. Positive family history of DMD confirmed by one of the criteria listed above in a
sibling or maternal uncle, and clinical picture typical of DMD.
6. Glucocorticosteroid - naïve (i.e. has not been treated with prednisone or Deflazacort
within 1 year before onset of the study)
7. Has not participated in other therapeutic research protocol within the last 6 months.
8. Evidence of muscle weakness by MRC score or clinical functional evaluation
9. Ability to provide reproducible repeat QMT bicep score of either the right or left arm
within 15% of first assessment score.
Exclusion Criteria:
1. Symptomatic DMD carrier
2. Use of any medication, nutritional supplement or herb for treatment of DMD within the
last 3 months.
3. Symptomatic cardiomyopathy or ventricular arrhythmias
4. History of significant concomitant illness, impairment of blood clotting ability (as
evidenced by increased PT/PTT or bleeding time over the upper limit of normal (ULN)),
recent cerebral or retinal hemorrhage, bleeding diathesis, gastric ulcer, hypotension
or significant impairment of renal or hepatic function (defined as serum creatinine
and GGT respectively, greater than 1.5 times normal upper limit for age and gender).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Pentoxifylline in Duchenne Muscular Dystrophy | NCT00102453 | Contradiction |
1,758 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Able to read, comprehend, and complete the consent form
2. Aged ≥18
3. Clinically fit for endoscopy
4. Referred for endoscopy via any clinical pathway
Exclusion Criteria:
1. Known upper GI conditions with or without ongoing endoscopic monitoring including
Barrett's oesophagus, oesophageal dysplasia, gastric ulcers, duodenal polyps or any
established upper GI malignancy
2. Previous oesophagectomy, gastrectomy for malignant disease
3. OGD performed within last 3 years of study initiation
4. Oesophageal stricture precluding completion of diagnostic endoscopic examination
5. Coagulopathy or anticoagulant/antiplatelet therapy for high risk conditions making non
possible to discontinue the medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study | NCT04843397 | Contradiction |
5,211 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- 55 years of age or older
- independent living within the city of Sault Ste. Marie, Ontario, Canada
- capable of providing informed consent
Exclusion Criteria:
- not at risk for falls
- unable to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study | NCT00465387 | Entailment |
536 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Natural cycles, in which a frozen-thawed day 3 embryo is replaced.
- Signed informed consent.
- Regular cycle (i.e. between 26 and 35 days)
- Normal transvaginal ultrasound at screening, without evidence of clinically
significant abnormality consistent with finding adequate for ART with respect to
uterus and adnexa.
- Embryos frozen by vitrification.
- Single or dual embryo transfer.
Exclusion Criteria:
- Known allergic reactions to progesterone products.
- Intake of experimental drug within 30 days prior to study start.
- Contraindication for pregnancy.
- Embryos of women above 39 years of age at the time of embryo freezing.
- Recipients of oocyte donation cycles
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak? | NCT02145819 | Contradiction |
6,704 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male subjects with congenital haemophilia A or B and inhibitors with spontaneous
bleeds which require on-demand treatment
- Subjects prescribed NovoSeven® as the first line or recommended bypass agent
- History of on average at least 4 bleeds of any type over a 3 month period
- Subject or caregiver able and willing to complete daily journal for 3 months
- Informed consent obtained from all subjects or legal representative
Male
No healthy subjects accepted to join the trial.
| Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX | NCT00710619 | Contradiction |
5,826 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male and female patients between the ages of 18 and 65;
- Between 5'4" and 6'2"
- Body Mass Index<32
- Willing and able to provide written informed consent;
- Understands the clinical study requirements and is able to comply with the follow-up
schedule set forth in the protocol;
- Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal
symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus,
sore throat, throat clearing);
- Presents with Reflux Symptom Index (RSI) > 13;
- Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;
- Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.
Exclusion Criteria:
- Currently being treated with another investigational medical device and/or drug;
- Currently receiving treatment for sleep apnea with continuous positive airway pressure
(CPAP);
- Female patients who are of child-bearing potential and not using an acceptable method
of birth control, or is pregnant or breast-feeding;
- Suspected esophageal cancer;
- Confirmed nasopharyngeal cancer;
- Previously undergone Nissen Fundoplication;
- Hiatal hernia > 4 cm
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Sleep Position May Reduce Acid Reflux Symptoms at Night | NCT02320968 | Contradiction |
4,767 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion criteria:
- Normal Kidney function (last checked within 6 months). Serum creatinine levels 1.5
mg/dL or below for females, 2.0 mg/dL for males.
- An audiogram within the past 6 months
- Mayo Clinic patients who live in Phoenix area
Exclusion criteria:
- Any participant with decreased kidney function within past 6 months, over 1.5 mg/dL
for females and over 2.0 mg/dL for males.
- Current treatment with Lithium
- Tinnitus rating with 0, 1, or 2 on the 0-10 Tinnitus scale
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Trial of Magnesium Dependent Tinnitus | NCT01273883 | Entailment |
1,329 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion criteria:
- Women aged 20-45 years in 28 to 32 weeks of pregnancy
- Positive HBsAg and HBeAg
- Serum viral load above 6 log10 IU/mL
Exclusion criteria:
- Major systemic disease of the mother or fetus
- Positive anti-HIV or anti-HCV
- Under treatment of antiviral therapy
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the
fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus | NCT03695029 | Contradiction |
2,790 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Male sex
- Age > 18 years
- Primary inguinal hernia
- Unilateral hernia
- Elective surgery
Exclusion Criteria:
- Recurrent inguinal hernia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes | NCT04806828 | Entailment |
4,088 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- 1. Health status: Healthy, or those with sleep-wake disorders
Exclusion Criteria:
1. Pregnancy
2. Currently smoking
3. Any respiratory disorder other than associated with Sleep/Wake Disorder or
well-controlled asthma
4. Habitual use of medications known to affect respiratory function (e.g. opioids,
benzodiazepines, etc).
5. Use of medication known to affect pulse pressure (Beta Blockers)
6. Atrial Fibrillation
7. Tattoos located on wrist
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | PSG Validation Study of Zensorium Biosensing Wearable Device | NCT04200495 | Entailment |
3,993 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Screening Inclusion Criteria
1. Subject is 40-75 years old, with a Body Mass Index (BMI) ≤ 40 kg/m2.
2. Subject has Kellgren-Lawrence (K-L) severity grade I, II or III in the index knee
as determined by X-ray. Contralateral knee: K-L severity grade 0, I or II.
3. Subject has had at least two signs and at least two symptoms of OA disease (based
on the European League Against Rheumatism (EULAR) recommendations for diagnosing
knee OA) in the index knee for at least 6 months despite conservative treatment
(weight reduction, physical therapy, pain medications, etc.). The EULAR signs and
symptoms are as follows:
- Signs: crepitus, restricted movement and bony enlargement
- Symptoms: persistent knee pain, limited morning stiffness and reduced
function
4. Subject must be willing to abstain from other IA treatments of the knee for the
duration of the study.
5. Subject is willing to discontinue all analgesics including NSAIDs, except
acetaminophen/paracetamol, at least seven days before the treatment injection and
through the completion of the study.
6. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0
grams per day per the package insert) for the treatment of joint pain for the
duration of the study. At least forty eight hours prior to the Baseline Visit and
each follow-up visit, the subject is willing to discontinue use of
acetaminophen/paracetamol.
7. Subject is willing to maintain a stable dose of oral glucosamine and/or
chondroitin sulfate products throughout the study, if taken prior to signing the
informed consent form (ICF).
8. Subject is able to understand and comply with the requirements of the study and
voluntarily provides consent.
Exclusion Criteria:
- 1. Subject received an IA injection of Hyaluronic Acid (HA) and/or steroid in either
knee within 6 months of signing the informed consent form (ICF). A subject will be
excluded if they are planning to receive an HA or steroid injection (other than the
study injection) in either knee during the course of this study.
2. Subject had an arthroscopy of either knee within 3 months of signing the ICF.
3. Subject had an open surgical procedure of either knee or hip or any surgery of the
spine within 12 months of signing ICF. Subject plans to have knee, hip or spine
surgery within the study period.
4. Subject has intra-articular trauma to the index knee. Subject has concurrent
multi-system or multi-limb trauma.
5. Subject has evidence or medical history of the following diseases in the index
knee: septic arthritis; inflammatory joint disease; history of Reiter's syndrome;
gout; chondrocalcinosis associated with recurrent episodes of acute synovitis of the
knee consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone;
ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of
Wilson disease; heritable disorders or collagen gene mutations.
6. Subject has a history of cartilage repair surgery in the index knee within 3 years
of signing the ICF.
7. Subject has a history of ACL repair, reconstruction or injury in the index knee
within 3 years of signing the ICF.
8. Subject has X-ray findings of acute fractures, severe bone loss, avascular
necrosis, severe bone or joint deformity in the index knee.
9. Subject has significant varus or valgus deformity greater than 10 degrees in either
knee.
10. Subject has a clinically apparent tense effusion of the index knee. 11. Subject
has knee instability in either knee per the Investigator's assessment.
12. Subject requires consistent use of an assistive device (e.g. wheelchair, walker,
etc.) Occasional use of a cane is acceptable.
13. Subject has medical condition(s) which could affect study assessments or may
adversely affect the safety and/or success of the study treatment. This includes but
is not limited to the following: a. Peripheral neuropathy severe enough to interfere
with evaluation of the subject, b. Vascular insufficiency severe enough to interfere
with evaluation of the subject, c. Active fibromyalgia, d. Hemiparesis involving
either lower extremity, e. Immunocompromised or immunosuppressive disorder or
receiving medications to treat immunosuppressive disorders, f. Systemic bleeding
disorder(s), g. Current malignancy or treatment within the last 5 years, except for
non-melanoma skin cancer, h. Significant psychiatric disorder, i. Active drug and/or
alcohol abuse within the past year, j. Uncontrolled diabetes with a screening HbA1c of
>7%.
14. Subject is taking medications at the time the subjects signs the ICF which could
interfere with the treatment procedure, healing and/or assessments. This includes but
is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet
treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular
protection is allowed if a stable regimen is maintained for the duration of the study.
15. Subject is receiving treatment using electromagnetic stimulation and/or low
intensity ultrasound in the index knee at the time of signing the ICF, within 3 months
of signing the ICF or plans to receive treatment any time during the study period.
16. Subjects who had an oral, intramuscular, intravenous, rectal suppository or
topical (excluded in index knee only) corticosteroid within 30 days of signing the ICF
are excluded. Topical corticosteroid use at any site other than the index knee is
allowed.
17. Subject has a pre-treatment contraindication to IA injections or aspiration of the
index knee, including cutaneous infection in the injection site area, active IA
infection (as suggested by moderate or marked effusion), knee deformity or condition
which, in the opinion of the Investigator could jeopardize the sterility or delivery
of the IA injection.
18. Subjects with a history of hypersensitivity to any of the ingredients in the
hyaluronan or previous hypersensitivity to the administration of corticosteroids or an
inability to tolerate acetaminophen/paracetamol.
19. Subject has any contraindication to the receipt of a corticosteroid. 20. Subject
is receiving or in litigation for worker's compensation. 21. Subject is a woman who is
pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential
who refuses to use effective contraception during the course of the study.
22. Subject was involved in any other research study involving an investigational
product, or a new application of an approved product, within 60 days of signing the
ICF.
Baseline Inclusion Criteria
1. Subject has a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
pain-sub-score ≥ 40 mm and ≤ 90 mm in the affected knee and ≤ 30 mm in the contralateral
knee on a 100 mm Visual Analog Scale (VAS) scale.
Baseline Exclusion Criteria
1. Subject has a decrease of ≥ 20 mm in the WOMAC pain-sub-score (average of 5 pain
scales) from Screening to Baseline in the index knee on a 100 mm Visual Analog Scale
(VAS) scale.
2. Subject has a synovial fluid aspirate volume > 20 mL in the index knee.
3. Subject has a contraindication to continue with the study treatment injection based on
the visual appearance of the synovial fluid aspirate unless the fluid is examined
microscopically prior to injection with no clinically significant findings (e.g.
bacteria, crystals or blood).
4. Subject has range of motion of less than 100° flexion in either knee.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide | NCT03191903 | Entailment |
861 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)
- Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology
criteria
- Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2)
obtained within 1 year of enrollment
- At least one of the following: age >50, morning stiffness <30 minutes in duration,
crepitus, and OA of the knee must involve the index tibiofemoral joint and must have
present for at least 6 months
- Patients who meet at least one of the following: unwilling to take non-opiate pain
medications, or for whom non-opiate pain medications have failed, or are candidates
for or seeking invasive interventions such as intraarticular injections, knee
arthroplasty, or total knee surgery
- Pain levels as required by the protocol at Screening and Baseline
Exclusion Criteria:
- Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any
other disease that in the Investigator's opinion would interfere with the assessment
of pain and other symptoms of OA
- Patients with regional pain syndromes suggestive of fibromyalgia or regional pain
caused by lumbar or cervical compressions with radiculopathy or at risk of developing
radiculopathy.
- Diagnosis or history of fibromyalgia
- Planned surgical procedure during the duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee | NCT00669409 | Entailment |
1,449 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Male and female outpatients of at least 50 years of age.
- Female patients must be either post-menopausal for one year, surgically sterile, or
using effective contraceptive methods such as barrier method with spermicide or
intra-uterine device. Oral contraceptives use is not allowed 4 weeks prior screening
and throughout the duration of the study. Patients on hormonal replacement therapy are
allowed if they have been on a stable dose for at least 6 months.
- Primary osteoarthritis of the hand, hip or knee according to American College of
Rheumatology (ACR) criteria or osteoarthritis of the spine. One joint will be
identified as the target joint and will be evaluated throughout the duration of the
trial.
- Is expected to need non-steroidal anti-inflammatory drugs (NSAID) or simple analgesic
therapy for osteoarthritis for at least the next 6 weeks.
- Controlled hypertension with mean sitting systolic blood pressure (MSSBP) <140 mmHg
and mean sitting diastolic blood pressure (MSDBP) <90 mmHg (mean of 3 cuff blood
pressure measurements). Patients must have taken the same fixed dose of
antihypertensive medication(s) on a regular basis for at least 3 consecutive months
prior to screening and are not expected to adjust their antihypertensive medication(s)
during the study. Regular wake-up times which are expected to continue for the
duration of the trial.
Exclusion Criteria:
- History of hypersensitivity to any of the study drugs or to drugs with similar
chemical structures.
- Patients who have any known allergic-type reactions after taking acetylsalicylic acid
or NSAIDs which may include (but are not limited to) history of asthma, acute
rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type
reactions
- History of malignancy of any organ system, treated or untreated, within the past 5
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5 mIU/ml).
- History of cardiac and cerebral thrombotic/ ischemic diseases and/ or events as listed
below:
angina pectoris (of any severity) or other evidence of coronary heart disease; myocardial
infarction; coronary heart disease with ECG-evidence of silent myocardial infarction;
coronary artery bypass grafting (CABG) or percutaneous coronary intervention (any PCI
procedure); clinically significant carotid artery stenosis or history of carotid
endarterectomy; congestive heart failure, NYHA class II - IV; second or third degree heart
block in the absence of permanent pacing and all potentially life-threatening arrhythmia or
symptomatic arrhythmia; clinically significant valvular heart disease; cerebrovascular
disease; peripheral arterial disease
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Effects of Lumiracoxib and Ibuprofen on Blood Pressure and Urinary Eicosanoid Excretion in Osteoarthritis Patients With Controlled Hypertension | NCT00419796 | Entailment |
1,166 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Patients who will undergo pleuroscopy with biopsy
Exclusion Criteria:
- Patients with known malignant pleural effusion
- Inability or unwillingness to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy | NCT03868579 | Contradiction |
1,103 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | INLUSION CRITERIA
Patients with a family history of hypertrophic cardiomyopathy are eligible.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Family Studies of Inherited Heart Disease | NCT00001225 | Entailment |
4,937 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Confirmed essential tremor by NIH criteria
- Significant functional activity limitation due to ET
- Patients who have failed, are inadequately treated or cannot tolerate alternative
treatments for ET as well as treatment naïve patients who have considered but declined
alternative treatment
Exclusion Criteria:
- Patients adequately controlled without side effects on a current ET treatment
- Pregnant patients or patients who may become pregnant during the study
- Patients with other medical conditions that may cause tremor, such as Parkinson's
disease or active hyperthyroidism
- Patients taking medications that might produce tremor or interfere with the evaluation
of tremor such as CNS-stimulants or beta-blockers
- Patients who must take medications that alter liver metabolism as well as patients
with liver disease or coagulation disorders
- Patients with seizure disorders
- Patients with a history of allergy or hypersensitivity reaction to barbiturates or
other related medications, such as phenobarbital or phenytoin
- Patient with significant general medical or clinical laboratory abnormalities
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Study of T2000 in Essential Tremor | NCT00321087 | Entailment |
593 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- gestational sac size <12 mm or no visible sac (with positive pregnancy test) day of
surgical abortion
- no medical contraindications to outpatient abortion at study site
Exclusion Criteria:
- not able to consent
- suspected ectopic pregnancy (pelvic mass, unilateral pain, or detection on
ultrasound), suspected molar pregnancy, or no sac and vaginal bleeding suspicious for
completed spontaneous abortion
- failed medication abortion
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion | NCT01085825 | Entailment |
4,045 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Participant must be >= 18 years of age inclusive, at the time of signing the informed
consent.
- Clinical diagnosis of OA in the index knee by American College of Rheumatology
criteria.
- Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2,
3, or 4 on standing anterior-posterior X-ray of the index knee.
- Osteoarthritis pain in the index knee unresponsive (ie, the participant still
experiences pain) to conservative therapy for >=6 months preceding Screening, defined
as history indicating that:
1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or
participant is unable to take acetaminophen/paracetamol chronically/long term
because of contraindication or inability to tolerate; AND
2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including
cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided
sufficient pain relief or participant is unable to take NSAIDs because of
contraindication or inability to tolerate.
- Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at
Screening AND Day 1 AND a minimum pain score of 4 on either of the individual WOMAC
NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing
stairs at Screening AND Day 1.
- Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at
Screening and Day 1.
- Body mass index of >=18 to <=39.0 kg/m2
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.
- Current non-pharmacologic treatment regimen for knee OA must be stable for at least 2
weeks before Day 1 and remain stable throughout the study. Participant must be willing
to abstain from starting a new or changing their non-pharmacologic treatment regimen
for the duration of the study.
- Willing to stop treatment with oral and topical NSAIDs, opioids, and all other
systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from
2 weeks before Day 1 to end of study.
- Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are
prohibited) as rescue therapy if required.
- Female subjects of childbearing potential and Male subjects must agree to comply with
protocol specified contraceptive requirements
Exclusion Criteria:
- Documented or reported history of increased bleeding in the absence of anticoagulant
or antiplatelet drugs or prior history of major bleeding episode in the presence of
anticoagulant or antiplatelet therapy.
- History of idiopathic or immune-mediated thrombocytopenia including history of or
laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4
[ie, PF4]).
- Currently active or recent history (within preceding 12 months) of a gastric or
duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy, or other moderate to severe pain that may confound assessments or
self-evaluation of the pain associated with osteoarthritis. Participants with a
present (current) history of sciatica are not eligible for participation. Participants
with a history of sciatica who have been asymptomatic for >=3 months and who have no
evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are
eligible for participation.
- History of other disease that may involve the index joint, including inflammatory
joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg,
ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related
arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint
diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
- History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of
osteoporosis and a minimally traumatic or atraumatic fracture).
- History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a
similar chemical or pharmacological class.
- Current clinically significant medical conditions, medical history, physical findings,
or laboratory abnormality that, in the Investigator's opinion, makes the participant
unsuitable for the study. Chronic medical conditions will be allowed at the discretion
of the Investigator but must be stable without necessitating medication changes within
30 days before Day 1.
- Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the participant will comply
with the protocol or complete the study per protocol.
- Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin <=100
mg/day.
- Previous treatment with PPS in any form.
- Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory
systemic therapy as follows:
1. Chronic use of corticosteroids: >=15 mg/day of oral prednisolone or equivalent
daily,
2. Intermittent corticosteroids: >=40 mg/day of oral prednisolone or equivalent for
1 or more short courses of >3 days.
- Use of bisphosphonates within 12 weeks before Day 1.
- Use of denosumab and iloprost within 12 weeks before Day 1.
- Use of a knee brace on the index knee within 2 weeks before Day 1.
- Systemic steroids administered intravenously, intramuscularly, and orally for OA or
other indications within 2 weeks before Day 1.
- Intra-articular injections to the index knee: steroids within 12 weeks; hyaluronic
acid or any other intra-articular injections within 24 weeks before Day 1.
- Use of vitamins and dietary supplements known to alter haemostasis within 2 weeks
before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin,
evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed
extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric,
vitamins C and E, vitamin K.
- Participation in another clinical trial or administration of any IP or experimental
product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
- Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets
<150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST] or alanine
aminotransferase [ALT]) >=2 × ULN at Screening.
- Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection
(detectable virus or diagnosis of AIDS); participants with HIV infection must be on
chronic suppressive antiviral medication.
- Radiographic evidence of any of the following conditions in any Screening radiograph:
excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg,
rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg,
Paget's disease, metastatic calcifications), primary or metastatic tumour lesions,
stress, or traumatic fracture.
- Radiographic evidence of any of the following conditions at Screening:
1. subchondral insufficiency fractures
2. spontaneous osteonecrosis of the knee
3. osteonecrosis
4. pathologic fracture
- Any clinically significant abnormalities on clinical chemistry, haematology,
urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as
judged by the Investigator (at Screening).
- Resting, supine blood pressure (BP) >=160 mmHg in systolic pressure or >=100 mmHg in
diastolic pressure at Screening. If a participant is found to have uncontrolled and/or
untreated significant hypertension at Screening and anti-hypertensive treatment is
initiated, assessment for study eligibility should be deferred until BP and
antihypertensive medication have been stable for at least 1 month. For participants
with previously diagnosed hypertension, antihypertensive medications must be stable
for at least 1 month before Screening.
- Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting
little or no self-care).
- Major surgery or anticipated surgery during the study.
- Currently hospitalized or any planned hospitalizations during the study.
- Plan for total knee reconstruction in affected knee(s) during the study.
- Knee surgery or trauma to the index knee within 1 year before Day 1.
- A history of drug or alcohol abuse and/or dependence within the 12 months before
Screening that, in the opinion of the investigator, may affect participant ability to
comply with study requirements.
- Contraindication to MRI scans.
- An employee of the Sponsor, clinical research organisations or research site personnel
directly affiliated with this study or their immediate family members defined as a
spouse, parent, sibling, or child, whether biological or legally adopted.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium Versus Placebo in Participants With Knee Osteoarthritis Pain | NCT04809376 | Entailment |
3,353 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
Adults with normal hearing
- Veteran status
- Age between 20 and 79 years
- All puretone thresholds at 25 dB HL or lower
Adults with sensory neural hearing loss
- Veteran status
- Age between 20 and 79 years
- Average hearing thresholds between 26 and 55 dB HL
Adults with middle ear disorders
- Veteran status
- Adult between 20 and 89 years
- Diagnosis of middle ear disorder
Exclusion Criteria:
- Draining ear
- Sensory neural hearing loss greater than 55 dB HL
- Cerumen impaction of ear canal
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 89 Years | Wide Frequency Band Test of Hearing in Veterans | NCT02019888 | Contradiction |
4,950 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Diagnosis of ET by a Movement Disorder Neurologist
- Stable dose of tremor medication for a period of at least 6 weeks prior to screening
- Tremor in the arms
- Tremor(s) is/are moderately severe (amplitude of at least 1cm)
Exclusion Criteria:
- Significant non-ET related abnormal findings on neurological exam
- Tremor at rest, or other features suggestive of Parkinson disease
- Diagnosis of dementia
- Pregnant or nursing
- Childbearing potential and unable or unwilling to use contraception during course of
the trial
- On medications known to interact with the study drug
- Current or prior history of alcohol or substance abuse
- Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as
Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin,
carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver
enzymes (within the past 7 days).
- Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit
containing products.
- Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly
protein-bound
- Do not wish to take a cannabis-derived agent
- Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners
- Allergy or sensitivity to cannabis
- Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks
or plan to use it during this research study.
- Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder,
schizophrenia, schizoaffective disorder, or other major psychiatric disorder)
- Current or prior history of suicidal thoughts and/or behavior
- Active medical problem affecting the immune system, liver, gastrointestinal tract,
lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood
clotting disorder
- Current infection
- Reduced kidney function (GFR <60)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Trial of Cannabis for Essential Tremor | NCT03805750 | Entailment |
870 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- 50 to 80 years old
- Study Subjects must be willing to sign Informed Consent to participate in the study
- In the past month, at least seven consecutive days in the squat, standing, walking or
going up and down the stairs, the most serious degree of visual analogy of the knee
pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not
painful is 0)
- Morning joint stiffness is less than 30 minutes
- X-ray：Grade 1-3 radiographic OA as defined by the K-L classification
Exclusion Criteria:
- Knee instability
- The knee joint is obviously deformed (> 5 degree valgus or varus deviation on X-ray)
- Clinical diagnosed as Pes tendinitis, Chondromalacia
- Taking NSAIDs or steroids (including oral and injection) within one week
- Using anticoagulant drugs for a long time
- Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time
(PT value) is less than 11 seconds or greater than 16 seconds
- Leukemia, sepsis, platelet dysfunction or other blood related diseases
- tumors, infections or the trauma before the same site
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial | NCT03734900 | Entailment |
2,567 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- Consent of the patient or legal guardian;
- Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous
papules on healthy skin, different sizes, itchy and fleeting
- Children aged between 2 and 11 years and 11 months (up to 30 kg);
Exclusion Criteria:
- Participation in clinical trial in 30 days prior to study entry;
- Patients with history of hypersensitivity to desloratadine or prednisolone or with
corticosteroids use contraindications ;
- Patients with any clinically significant disease other than cutaneous rash including
hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune
disorders;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients diagnosed with other dermatoses
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 11 Years | Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment | NCT01529242 | Entailment |
6,253 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- healthy Caucasian origin
- male or female
- age between 18 and 55 years
- accepting not to participate in another COVID-19 vaccine study until the end of the
study
- volunteers who do not plan to get a child in the next one year; the volunteer and the
partner should use a reliable form of contraception (abstinence, condom, birth control
implant, birth control pills used or IUD used by the partner) during the study for at
least 1 year
- female participants of childbearing potential (defined as any female who has
experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at
least 12 consecutive months) must agree to be heterosexually inactive through 12
months after the first vaccination OR agree to consistently use any of the described
methods of contraception from through 12 months after the first vaccination.
- male subjects agree to refrain from sperm donation from the time of first vaccination
until 3 months after last vaccination
- participants must refrain from blood or plasma donation from the time of first
vaccination until 3 months after last vaccination
- the outcome of the following examinations should be clinically insignificant: medical
and surgical history (hypo-, hypertension, allergy, other diseases, major surgery,
micturition, defecation, sleep, illness within the last 4 weeks prior to the start of
the trial);
- life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special
diet, drug abuse) should be normal/acceptable
- body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ECG should
be normal/acceptable.
- physical examination (general state and abnormal findings per system:
endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose,
throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital,
musculoskeletal, Lymph nodes, skin, and neurological/psychiatric) should be
normal/acceptable
- laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride,
total protein, albumin, glucose, creatinine, BUN, uric acid, total bilirubin, direct
and indirect bilirubin, lipid panel (total cholesterol, triglyceride, HDL, LDL), AST,
ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Leukocytes, platelet count,
prothrombin time (PT) and activated partial thromboplastin time (aPTT); HBsAg, HIV-Ab,
HCV-Ab; urine examination: urine color, appearance, specific gravity, pH, protein,
glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if
erythrocytes or leucocytes are out of the limits ) should be normal/acceptable.
- antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
- drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine,
opioids, barbiturates)
- normal body weight in relation to height and age according to
- BMI = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2)
- Informed consent given in written form according to section 15.3.
- agree not to participate in another vaccine clinical trial until the end of the study.
- agree to remain in the study area for the entire duration of the study.
Exclusion Criteria:
- women with a positive blood (β-HCG) pregnancy test
- lactating women
- history of COVID-19 infection or showing COVID-19 infection symptoms
- having had contact to people with known COVID-19 infection in the last 14 days
- having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having
aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
- positive real time RT-PCR COVID-19 test.
- leukemia or neoplasm in history.
- persons with autoimmune diseases
- allergic diathesis or any clinically significant allergic disease (i.e. asthma)
- any condition that might impair the immune response
- recent or current immunosuppressive medication
- any other vaccine application 30 days before the first dose
- presence or a history of clinically significant cardiovascular, renal, hepatic,
pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological,
psychiatric or other major diseases;
- disruption of platelets or other blood clotting disorders, which may cause
contraindications to intramuscular administration
- clinically significant illness within 4 weeks before the start of the study.
Especially any acute or chronic illness seizures.
- any regular intake or administration of any prescribed systemic or topical medication
within 2 weeks prior to the start of the study; in the case of intake or
administration of any prescribed systemic or topical medication within 4 weeks before
the start of the study because of an insignificant illness, this should be stated in
the CRF.
- intake or administration of OTC medication (including herbal remedies) which may have
an effect on the study according to the investigator within 2 weeks prior to the start
of the study
- volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any
other investigational drug within 4 weeks prior to the first study product
administration
- concomitant intake or administration of any systemic or topical drugs (including
herbal remedies) on the application days
- treatment with any investigational drug (i.e., drug not yet approved) in the last 4
weeks before beginning of the trial
- medication with drugs known to alter organs or systems such as barbiturates,
phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks)
- donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any
amount within the last month (4 weeks)
- supine blood pressure, after resting for 5 min, higher than 140/90 or lower than
100/60 mmHg
- supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min
- supine respiratory rate, after resting for 5 min, outside the range of 15 - 18
breathings / min
- any clinically significant abnormality of the ECG (12 leads) recorded in rest
- laboratory values (appendix 5) outside normal range with clinical relevance at entry
examination
- alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of
alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine
or 50 ml of spirits) or recovered alcoholics
- caffeine abuse i.e. regular use of more than 750 mg/day caffeine
- alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke,
chocolate) and fruit-juice from 24 hours prior to each application until the end of
hospitalization
- grapefruit products from 7 days prior to the first application until the end of
hospitalization
- smoking of more than 10 cigarettes or equivalent per day, no smoking allowed during
hospitalization in the clinical unit
- vegetarian or any special diet due to any reason
- knowledge to have any type of parenterally transmitted hepatitis or carrier of the
HBsAg (HBsAg test positive)
- HIV-Ab test positive
- Test on anti-HCV antibodies positive
- positive drug screen or history of drug abuse (amphetamines, cannabinoids,
benzodiazepines, cocaine, opioids, barbiturates)
- legal incapacity and/or other circumstances rendering the subject unable to understand
the nature, scope and possible consequences of the study
- evidence of an uncooperative attitude.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo | NCT04838080 | Contradiction |
6,594 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males age 18-75 years, inclusive
- Established hemophilia B with ≥3 hemorrhages per year requiring treatment with
exogenous FIX OR use of FIX prophylaxis because of history of frequent bleeding
episodes
- Plasma FIX activity ≤2% (<1% for first cohort; then per protocol)
- Negative for active Hepatitis C virus (HCV), defined as Hepatitis C virus antibody
negative and negative (undetectable) PCR test for plasma Hepatitis C virus ribonucleic
acid (RNA) OR if Hepatitis C virus antibody positive must have ≥2 consecutive negative
(undetectable) PCR tests for plasma HCV RNA at least 3 months apart, and negative at
screening
Exclusion Criteria:
- Family history of inhibitor to FIX protein or personal laboratory evidence of having
developed inhibitors to FIX protein at any time (>0.6 Bethesda Units on any single
test)
- Documented prior allergic reaction to any FIX product
- Detectable AAV8 neutralizing antibodies
- Markers of hepatic inflammation or overt or occult cirrhosis as evidenced by one or
more of the following:
- Platelet count <175,000/μL
- Albumin ≤3.5 g/dL
- Total bilirubin >1.5 x ULN and direct bilirubin ≥0.5 mg/dL
- Alkaline phosphatase >2.0 x ULN
- ALT or AST >2.0 x ULN (except for subjects who are HIV infected)
- Liver biopsy in the past indicating moderate or severe fibrosis (Metavir staging
of 2 or greater)
- History of ascites, varices, variceal hemorrhage or hepatic encephalopathy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B | NCT01687608 | Contradiction |
4,971 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Patients with clinically diagnosed ET who have had placement of VIM DBS and are
willing to undergo a baseline programming visit and 12-week follow-up assessment
2. At least initial benefit from VIM DBS as judged by patient report and clinician exam
3. VIM DBS placement no less than three months from entry into study
4. Patients must demonstrate ability to use patient programmer to switch between group
settings on a weekly basis
5. Ability to wear wrist monitor for 2 week intervals, twice during the study 6. Patients
with the following IPG types: Activa PC, SC or RC
Exclusion Criteria:
1. Atypical tremor disorder including but not limited to tremor due to multiple
sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome
2. DBS placement complicated by infection, hemorrhage or stroke
3. Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or
previous DBS surgery resulting in explantation and reimplantation
4. Known incorrect or poor lead placement
5. Inability to change group settings on a weekly basis at least 75% of the time
6. Inability to tolerate 12-week period without additional programming changes, including
voltage stimulation adjustment
7. Inability to tolerate 12-week period without adjustment of anti-tremor medications,
including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines
8. Battery voltage < or equal to 2.70V
9. Patient with the following IPG types: Soletra, Kinetra or Itrel
10. Inability to tolerate two group settings due to side effects or lack of efficacy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients | NCT02947841 | Entailment |
1,057 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of
arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic
ECGs and/or Holter monitoring.
Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording
and uploading a test ECG recording at the office visit.
Exclusion Criteria:
1. Patients <18 years of age.
2. Patients with a myocardial infarction (MI) within the last three months, and/or known
history of sustained VT/VF.
3. Patients with NYHA class IV heart failure.
4. Patients with unstable angina.
5. Patients with syncope as the presenting symptom.
6. Patients unable to or unwilling to use the device.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Validation of an iPhone-based Event Recorder for Arrhythmia Detection | NCT02005172 | Contradiction |
713 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age >45
- Ability to make follow-up visits over the 6 month protocol
- Ability to give informed consent
- Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on
visual analogue scale with symptoms present greater then 6 months.
Exclusion Criteria:
- Recent trauma to the hand or wrist or fractures eeen on radiographs
- Eaton grade 1, or 4 joints affected
- Metabolic bone disease
- Recent systemic or localized infection (within last 2 weeks)
- History of rheumatologic disease
- Allergies to injected solutions
- Thumb carpo-metacarpal joint injections in the prior 6 months.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
| Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis | NCT00685880 | Contradiction |
402 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Surgically confirmed endometriosis
- History of menstrual cycles between 26 and 32 days
- Otherwise in good health
- Age 18-40 years, inclusive
- Subject had pain graded at Screening and Day 1 according to a scale suggested by
Biberoglu and Berhman5 in at least one of the following categories:
1. moderate or severe pelvic pain not related to menstruation, OR
2. moderate or severe dysmenorrhea, OR
3. moderate or severe pelvic tenderness elicited on pelvic examination accompanied
by non-menstrual pelvic pain.
- Subject agrees to double barrier method of contraception
Exclusion Criteria:
- Any abnormal lab or procedure result the study-doctor considers important
- History of undiagnosed uterine bleeding or gynecological disorder
- Severe reaction(s) to hormone therapy
- History of osteoporosis or other metabolic bone disease
- Subject currently breast feeding
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis | NCT00160446 | Contradiction |
259 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria
- General good health
- Sexually active, at risk for pregnancy, and desiring contraception
- Low-risk for HIV or STD infection
- Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior
to study entry
- Expect to have same sexual partner for duration of the study
- Normal cyclic menses with a usual length of 21 to 35 days
- Documented history of at least two spontaneous, normal menstrual cycles since
delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
- Willing to accept a risk of pregnancy
- Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per
week for a period of 6 months
- Willing to be fitted with a diaphragm and use the diaphragm with test product during
all acts of heterosexual vaginal intercourse for the duration of the study
- Willing to only use the test product with diaphragm as the sole method of
contraception over the course of the study (with the exception of emergency
contraceptive pills when indicated)
- Capable of using the product and diaphragm properly
- Willing to keep a diary to record coital information, product use information,
information about the use of other vaginal products, and sign and symptom data for
self and partner
- Agree not to participate in any other clinical trials during the course of the study
- Written informed consent to participate in the trial
Participant's Sexual Partner Must Not Be/Have
- Infertile
- Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to
study entry
- HIV infected
- More than one sexual partner in the 4 months prior to study entry
- Engaged in homosexual intercourse
- Shared injection drug needles in the 6 months prior to study entry
- Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex
Exclusion Criteria
- Pregnant or desire to become pregnant during the course of the study
- History of infertility or conditions that may lead to infertility
- Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex
- History of toxic shock syndrome (TSS)
- Two or more urinary tract infections (UTIs) in the 12 months prior to study entry
- Current suspected or diagnosed urinary tract infection or vaginitis
- Contraindications to pregnancy (medical condition or chronic use of medications
contraindicated for pregnancy)
- Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy
- More than one sexual partner in the 4 months prior to study entry
- Shared injection drug needles in the 6 months prior to study entry
- HIV infected or suspected HIV infection
- Genital herpes simplex virus (HSV) infection with the first occurrence (initial
episode) within 3 months prior to study entry or have clinical evidence of HSV on exam
- Sexually transmitted diseases (STDs) in the 3 months prior to study entry
- Lactating or breastfeeding
- Abnormal vaginal bleeding or spotting in the month prior to study entry
- Lower abdominal or pelvic pain in the month prior to study entry
- Abnormal finding on pelvic examination which, in the view of the study investigator,
precludes participation in study
- Vaginal or cervical irritation, including vaginal or cervical epithelial disruption,
ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema
- Vaginal or cervical biopsy or surgery in the 3 months prior to study entry
- Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to
study entry
- Depo-Provera injection in the 10 months prior to study
- Vaginal or cervical abnormality that would interfere with the proper placement and
retention of test product and diaphragm
- Abnormal Pap smear in the 12 months prior to study entry
- Consume (on average) greater than 2 to 3 alcoholic beverages per day
- Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry
- Investigational drug or device use in the month prior to study entry
- Previously participated in or completed this study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effectiveness of BufferGel as a Vaginal Contraceptive | NCT00065858 | Contradiction |
4,834 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Pediatrics (age≤21 years) at time Korlym initiation
- Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare
provider
- Received at least one dose of Korlym
- Availability of pre-treatment (baseline) and follow-up data
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome | NCT03379363 | Contradiction |
3,305 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Participants must have a gestational age at birth between 36-42 weeks and birth weight
greater than or equal to 2500 gms.
Participants must have normal growth and development as assessed by general pediatric
examination and growth charts, obtained historically from family and/or pediatrician.
Participants must have a normal visual system by ophthalmic examination.
Participants must be between the post-conceptual ages of 40 weeks and 70 weeks of age
inclusive.
Participants must be able to undergo a complete opthalmic evaluation.
Participants must be able to undergo standard eye movement recording.
Participants must not have any eye diseases.
Participants must not have any neurologic disease, developmental delay, congenital genetic
syndromes, congenital organ malformations, malformation syndromes or metabolic diseases.
Participants must not be on any systemic or ocular medications.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Development of the Eye Motor System During the First 7 Months of Life in Infants With and Without a Family History of Cross-Eye | NCT00001143 | Contradiction |
5,132 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- We will include elderly women 65 years and older if they reside in a nursing home or
an assisted living facility and have a known history of osteoporosis, as determined by
history of an adult fragility fracture or bone mineral density criteria for
osteoporosis (T-score -2.5 at the total hip, femoral neck or spine) or low bone mass
(T-score < -2.0 at the total hip, femoral neck or spine, consistent with the National
Osteoporosis Foundation Treatment guidelines). If a participant's spine and or hip are
not evaluable (due to surgery, calcifications, artifact in the scan area, scoliosis,
etc.), they may be included in the study with a T-score of ≤ -2.0 at the forearm.
- Elders will be chosen without consideration of ethnic or racial background. We chose
frail, institutionalized women because 70-85% of them have osteoporosis and this age
group is substantially under-treated.
- We will include all who qualify, if they are able to weight bear or assist with
transfer to chair, to endure that the results have maximum generalizability to the
nursing home population as a whole.
Exclusion Criteria:
- Children will be excluded because they are not frail, institutionalized elders.
- Men will be excluded because they do not become postmenopausal and are less likely to
become osteoporotic.
- We will exclude institutionalized women with subacute illnesses who are not expected
to survive or who will be discharged in less than 2 years.
- We will also exclude patient with a contraindication to bisphosphonate, such as
hypocalcemia, allergy, pervious adverse event (excluding gastrointestinal disorders),
or currently on an oral bisphosphonate.
- We will exclude patients with a calculated creatinine clearance of < 30 ml/mm.
- We will exclude women scheduled for or in need of a tooth extraction as this procedure
has been associated with osteonecrosis of the jaw in patients with cancer given
multiple coursed of high dose intravenous bisphosphonates.
- We will screen for these conditions by detailed history, physical exam (including
dental exam), chart review, and baseline laboratory analyses, including
BUN/creatinine, liver function tests, TSH, calcium, PTH, 25-hydroxyvitamin D, alkaline
phosphatase and baseline calculated creatinine clearance. Participants with vitamin D
levels < 20 ng/ml will be treated with vitamin D 50,000 IU/wk for 8 weeks in addition
to calcium. Vitamin D will be rechecked and the patient will be enrolled if the
vitamin D level is > 20 ng/ml.
- Patients will be allowed to continue on certain medications known to affect bone and
mineral metabolism (e.g. glucocorticoids, anticonvulsants) because their use is common
in this population. (In our facilities, 2.9% of patients use glucocorticoids and 7.2%
use anti-epileptic drugs.) In addition, women who have been treated in the past or
present with osteoporosis agents, such as estrogen/progesterone, raloxifene, and
calcitonin, will be allowed to participate and continue on these therapies if
prescribed by their physician. However, if patients are currently on or have been on
bisphosphonates for greater than 1 year in the previous 2 years prior to enrollment,
they will be excluded as some bisphosphonates are long acting.
- Patients will be allowed to wear hip pads if prescribed by their physician. If they
are on parathyroid hormone, they may participate, but will be told that monotherapy
with parathyroid hormone is more beneficial than combination therapy with parathyroid
hormone and alendronate, as we have previously demonstrated.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Zoledronic Acid for Osteoporosis in the Elderly | NCT00558012 | Contradiction |
1,826 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- healthy subjects and gastric cancer patients documented by endoscopy.
Exclusion Criteria:
- the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks
prior to the study
- coexistence of two kinds of gastroduodenal lesions
- coexistence of severe systemic diseases
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Proteiomic Fingerprints of Gastric Juice | NCT00834236 | Entailment |
2,664 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patient 18 years old and above
- Patient has given consent
- Patient is able to fill in questionnaire on his\her own, unaided (exceptions are
patients who are unable to fill in the questionnaire for technical reasons, e.g. can
not write due to the surgery (e.g. their arm in a cast) or unable to see the text
(e.g. spectacles not available); patient is in department, available for interview.
- Patient is capable of participating in the CPSP incidence study (i.e. capable to fill
the questionnaires on the website at 6 and 12 months after surgery).
- Time of data collection immediately after surgery is POD1 and 24±12 hrs after surgery.
- Patient has not undergone repeat surgery (same organ) during current hospitalization.
- Patient has undergone a surgery included in the appendix 1 list below:
List of surgeries to be included:
Surgery without preoperative pain
1. Thoracotomy for lung cancer
2. Breast surgery for cancer
3. Inguinal hernia repair (laparoscopic)
4. Hysterectomy (laparoscopic)
5. Hysterectomy (open)
6. Hysterectomy (vaginal)
7. Colectomy (laparoscopic)
8. Colectomy (open)
9. Thyroidectomy
10. C section
11. High gastric bypass
12. Laparoscopy
13. Prostatectomy
Surgery with potential preoperative pain
1. Cholecystectomy (laparoscopic)
2. Cholecystectomy (open)
3. Total knee arthroplasty
4. Knee arthroscopy
5. Total hip arthroplasty
6. Extracorporeal circulation auxiliary to open heart surgery
7. Spinal surgery
8. Hip arthrotomy
Exclusion Criteria:
- patient not fulfilling at least one of the inclusion criteria mentioned above
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study | NCT01467102 | Entailment |
719 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- symptomatic advanced unilateral knee or hip osteoarthritis (Kellgren-Lawrence grade 3
or 4) that is inadequately controlled with conservative management including physical
therapy, bracing and/or oral anti-inflammatory medications
- completed an intake assessment by a Hip and Knee Clinic of the Alberta Bone and Joint
Health Institute with the musculoskeletal physician and have been deemed to be a
candidate for a knee or hip arthroplasty
Exclusion Criteria:
- unable to provide informed consent
- have religious or other objections to the use of blood or blood products
- will not be available for the projected 1 year follow up period
- at the time of treatment have a systemic infection or a localized infection at the
area of injection
- have thrombocytopenia or are on antiplatelet, anti-inflammatory or statin medications
that cannot be stopped for 1 week prior to and for 1 month following the treatment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 95 Years | BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty | NCT03908827 | Contradiction |
6,481 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria:
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or
Sjogren's syndrome.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea | NCT02095158 | Entailment |
4,716 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Women ages 18-45 and able to give voluntary written informed consent;
- Regular menstrual periods of 24-35 days in length;
- Body mass index 18.5 to 30 kg/m2;
- No past or present DSM-IV psychiatric or substance dependence diagnosis by structured
diagnostic interview (SCID-NP); no substance abuse history within the previous 2
years;
- Absence of mood symptoms across the menstrual cycle during one month of prospective
daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based
on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has
been used in numerous studies to confirm the presence or absence of significant
premenstrual mood and behavioral difficulties;
- Must be willing and able to participate in at least three of the four challenge
paradigms.
Exclusion Criteria:
- Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
- Family history of first degree relative with an Axis I psychiatric or substance
dependence disorder (excepting alcohol and nicotine) (per subject report);
- Current treatment with psychoactive medication;
- Diabetes controlled by means other than diet;
- Use of steroid contraceptives (any method involving hormones) within the previous 4
months;
- Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on
any particular occasion; must be willing to abstain from alcohol consumption for 48
hours prior to each 1H-MRS scan;
- Implanted metallic devices.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women | NCT00676026 | Entailment |
1,915 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the
gastric or gastroesophageal junction.
- Previous first-treatment with chemotherapy or radiation therapy failed. Ability to
take medications orally. With measurable lesions. Patients must have a performance
status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Without serious system dysfunction and could tolerate chemotherapy. With normal
marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood
transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of
≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a
creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min
(Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase
(ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- Life expectancy ≥3 months. With normal electrocardiogram results and no history of
congestive heart failure.
- Without bleeding and thrombosis disease. With normal coagulation function: activated
partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
- Female subjects of child-bearing potential must agree to use contraceptive measures
starting 1 week before the administration of the first dose of apatinib until 8 weeks
after discontinuing study drug. Male subjects must agree to use contraceptive measures
during the study and 8 weeks after last dose of study drug With written informed
consent signed voluntarily by patients themselves or their supervisors witted by
doctors.
- With good compliance and agree to accept follow-up of disease progression and adverse
events.
Exclusion Criteria:
- Patients with a history of another neoplastic disease within the past three years,
excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
nonmetastatic prostate cancer.
- Patients with brain or central nervous system metastases, including leptomeningeal
disease.
- Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound,
ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina,
New York Heart Association (NYHA) grade II or greater, congestive heart failure,
history of myocardial infarction within 6 months Evidence of bleeding diathesis or
coagulopathy.
- History of a stroke or CVA within 6 months. Clinically significant peripheral vascular
disease. Inability to comply with study and/or follow-up procedures. Patients with any
other medical condition or reason, in that investigator's opinion, makes the patient
unstable to participate in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma | NCT03788174 | Entailment |
2,245 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedure.
3. Has a history or presence of gout defined as having one or more of the American
Rheumatism Association (ARA) criteria for the diagnosis of gout:
1. A tophus proven to contain urate crystals by chemical or polarized light
microscopic means, AND/OR;
2. Characteristic urate crystals in the joint fluid, AND/OR;
3. History of at least 6 of the following clinical, laboratory, and x-ray phenomena:
i. more than one attack of acute arthritis, ii. maximum inflammation developed within
1 day, iii. monoarticular arthritis, iv. redness observed over joints, v. first
metatarsophalangeal joint painful or swollen, vi. unilateral first metatarsophalangeal
joint attack, vii. unilateral tarsal joint attack, viii. tophus (proven or suspected),
ix. Hyperuricemia, x. asymmetric swelling within a joint on x-ray, xi. subcortical
cysts without erosions on x-ray, xii. joint fluid culture negative for organisms
during attack.
4. Is male or female at least 18 years of age, inclusive.
5. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent throughout the duration of the study.
6. Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
7. Has an estimated Glomerular Filtration Rate (eGRF) [Modification of Diet in Renal
Disease (MDRD)] ≥30 mL/min and <60 mL/min at Screening visit (Day -21 for participants
on urate lowering therapy (ULT) and Day -4 for participants not on ULT) or at the
retest visit.
8. Has at least one gout flare within 12 months prior to Screening visit.
Exclusion Criteria:
1. Has received any investigational compound within 30 days prior to Screening.
2. Is an immediate family member, study site employee, or is in a dependant relationship
with a study site employee who is involved in conduct of this study (eg, spouse,
parent, child, sibling) or may consent under duress.
3. Is breastfeeding or pregnant.
4. Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
5. Has a history of xanthinuria.
6. Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day
1/Randomization Visit.
7. Has a known hypersensitivity to febuxostat or any components of their formulation; has
a known hypersensitivity to naproxen, any other nonsteroidal anti-inflammatory drug
(NSAID), aspirin, lansoprazole, colchicine or any components in their formulation.
8. Has active peptic ulcer disease.
9. Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years
prior to the Screening Visit.
10. Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >2 x
the upper limit of normal (ULN).
11. Has rheumatoid arthritis which requires treatment.
12. Has a significant medical condition and/or conditions that would interfere with the
treatment, safety, or compliance with the protocol.
13. Has experienced either a myocardial infarction (MI), stroke, hospitalized unstable
angina, cardiac or cerebrovascular revascularization procedure or hospitalized
transient ischemic attack (TIA).
14. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse within 5 years prior to the Screening visit. Participant consumes >14 alcoholic
beverages/week.
15. Has participated in another investigational study within the 30 days prior to the
Screening Visit.
16. Has a known history of infection with hepatitis B, hepatitis C, or human
immunodeficiency virus.
17. Is required to take excluded medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment | NCT02128490 | Entailment |
2,401 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Established clinical diagnosis of DMD and documented dystrophin gene mutation
predictive of DMD phenotype
- Confirmed absence of dystrophin as determined by muscle biopsy (ambulatory patients)
- Anti-AAV9 antibodies below protocol-specified thresholds
- Stable cardiac and pulmonary function
- Adolescents: non-ambulatory by protocol-specified criteria
- Children: ambulatory by protocol-specified criteria
- Stable daily dose (or equivalent) of oral corticosteroids ≥ 12 wks
Exclusion Criteria:
- Prior or ongoing medical condition or physical examination, ECG or laboratory findings
that could adversely affect subject safety, compromise completion of treatment and
follow-up, or impair assessment of study results
- Abnormal liver function
- Abnormal renal function
- Clinically significant coagulation abnormalities
- Impaired cardiovascular function based on cardiac MRI or ECHO
- Impaired respiratory function based on FVC % predicted or need for daytime ventilatory
support
- Significant spinal deformity or presence of spinal rods
- Body mass index ≥ 95th percentile for age
- Exposure to another investigational drug within 3 months or 5 half-lives prior to
screening
- Exposure to drugs affecting dystrophin or utrophin expression within 6 months prior to
screening
Additional inclusion/exclusion criteria may apply. Patients over 30 kg will not be eligible
for treatment at this time. A weight limit of ≤ 18 kg will be implemented for the next two
patients to be dosed.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 17 Years | Microdystrophin Gene Transfer Study in Adolescents and Children With DMD | NCT03368742 | Entailment |
2,120 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- infertile men with previously abnormal semen analyses.
- Control group: fertile adult males
Exclusion Criteria:
- Proxceed use within 3 months of the start of study.
- Vitamin E supplements with > 45 IU daily
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Vitamin E and Male Infertility | NCT00178516 | Entailment |
3,099 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- for the patients: Clinical diagnosis of intellectual disbility
- for the unaffected sibs: to be aged at least 3 years
- informed consent
Exclusion Criteria:
- absence of informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Research and Characterization of New Genes Involved in Intellectual Disability | NCT01867554 | Entailment |
360 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Healthy sexually active women who have ever used an FC and using condoms (male or
female) as their current method of contraception.
2. Be 18 to 40 years at enrolment (inclusive).
3. Have a negative urine pregnancy test at enrolment visit.
4. Is HIV negative
5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using
hormonal contraception.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for
a period of 6 months.
10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary
method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and
details of condom use and any condom failures.
13. Be willing to state that, to her best knowledge, her sexual partner:
- Has not had a vasectomy or been previously diagnosed as infertile.
- Is HIV negative
- Has no known history of allergy or sensitivity to natural rubber latex,
water-based or silicone lubricants
- Does not want her to become pregnant in the next 7 months
14. Agree to have fingerprint identity check
15. Be willing to give written informed consent to participate in the trial.
16. Intend to stay in the area for the next 6-7 months
17. Be willing to be randomized
Exclusion Criteria:
1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone
lubricants
2. Have evidence of sexually transmitted infections on syndromic assessment and / or
vaginal examination
3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
4. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
6. Be in a monogamous relationship of less than 4 months with their partner.
7. Have any contraindications to pregnancy (medical condition) or regularly use
medications that are unsafe to use in pregnancy
8. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
9. HIV positive.
10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or
Nur-Isterate in the last 4 months prior to enrolment
16. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
17. Have taken an investigational drug or used an investigational device within the past
30 days.
18. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom | NCT04233632 | Contradiction |
2,867 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. diagnosis of ALS
2. first clinical weakness within past 3 years
3. slow vital capacity >= 60% of predicted within 1 month of treatment
4. may be on stable dose of riluzole for at least 30 days, or otherwise agree to not
initiate riluzole for duration of the trial
5. may be on stable dose of edaravone for at least 30 days, otherwise agree to not
initiate edaravone for duration of the trial
6. can travel to Stony Brook to receive medical care
7. must have a monitor who can be contacted at regular intervals to report on subject's
clinical/psychiatric status
Exclusion Criteria:
1. use of tracheostomy or mechanical ventilation within last 3 months
2. hepatic insufficiency or abnormal liver function
3. renal insufficiency
4. clinically significant psychiatric disorder
5. active malignancy
6. history of HIV, clinically significant chronic hepatitis, or other active infection
7. history of stomach or intestinal surgery or condition that could interfere with
absorption, distribution, metabolism or secretion of study drug
8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be
instructed to refrain from alcohol during the study)
9. use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs
known to interact strongly with perampanel.
10. pregnancy or lactation
11. clinically significant medical condition (other than ALS) that would pose a risk to
the subject if they were to participate
12. know hypersensitivity to perampanel
13. currently participating, or has participated in a study with an investigation or
marketed compound within 3 months of entry
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS) | NCT03020797 | Entailment |
369 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive.
- Women not intending to become pregnant for 13 months.
- Intact uterus and both ovaries.
- Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal
contraception; if postpartum or postabortal, history of regular menstrual cycles of
21-35 days in length and at least one cycle (2 menses) with a cycle length consistent
with her past cycles.
- Sexually active (currently) and willing to discontinue current contraceptive method to
participate in the study.
- In the opinion of the investigator, able to comply with the protocol, e.g. live within
the study site catchment area or within a reasonable distance from the site.
- Do not meet any of the exclusion criteria.
- Signed informed consent prior to entry into the trial.
Exclusion Criteria:
- Known hypersensitivity to estrogens or progestins.
- Known hypersensitivity to silicone rubber.
- Known or suspected pregnancy.
- History of infertility of >1.0 year in woman or her male partner.
- History of vasectomy or sterility in male partner; tubal ligation (sterilization) in
women
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed
at screening with Chlamydia or gonorrhea may be included in the trial following
treatment; partner treatment is also recommended. Investigators should make a
determination if subjects are at high risk for reinfection, e.g. multiple sex
partners, untreated partner, and whether such subjects can be included.)
- History of pelvic inflammatory disease since last pregnancy episode.
- History of toxic shock syndrome.
- Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative
may participate provided there is follow up for this finding per standard of care).
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a
vaginal ring.
- Women planning to undergo major surgery.
- Smoking in women who are 35 years and over or will be 35 years during the course of
the trial; Women < 35 years who smoke 15 cigarettes or more must be evaluated by the
PI for inclusion based on risk factors that would increase their risk for CVD, e.g.
lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
- Breastfeeding.
- Current or past thrombophlebitis or thromboembolic disorders.
- History of venous thrombosis or embolism in a first-degree relative <55 years of age
suggesting familial defect in blood coagulation system, which in the opinion of the
principal investigator, suggests use of a hormonal contraceptive could pose a
significant risk.
- Cerebrovascular or cardiovascular disease.
- History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- Past history of any other carcinoma unless in remission for more than 5 years.
- Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive.
- Headaches with focal neurological symptoms.
- Severe constipation.
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
- Benign or malignant liver tumors; active liver disease.
- Diastolic blood pressure (BP) ³85 mm Hg and/or systolic BP ³135 mm Hg after 5-10
minutes rest.
- Known or suspected alcoholism or drug abuse.
- Abnormal serum chemistry values according to the physician's judgment.
- Participation in another clinical trial within last 30 days.
- Weight >95 kg or >209 lbs.
- Use of liver enzyme inducers on a regular basis.
- Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months
before initiation of treatment. Use of Depo-Proveraâ [depo-medroxyprogesterone (DMPA)]
unless suspended 6 months before treatment.
- Current use of implanted hormonal contraceptives, including Mirenaâ [progestin
containing intrauterine system (IUS)], Jadelleâ, Norplantâ or Implanonâ (subjects
using any of these methods who request removal for reasons unrelated to the purpose of
enrollment in this study may be considered for participation).
- Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons
unrelated to the purpose of enrollment in this study may be considered for
participation.
- Known HIV infection.
- Women at high risk of contracting HIV, e.g. women with multiple sex partners who need
to use condoms consistently, injection drug users. If women enrolled in the study do
use condoms to protect against STIs, they should be instructed that this occasional
use should be with non-N-9 containing condoms and they should record condom use in
their diaries. Women found to have an STI at screening will be treated prior to
inclusion in the study (with the exception of those infected with HIV).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring | NCT00455156 | Contradiction |
311 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help
pregnancy (biochemical or non-pregnant)
- age ≤36 years old
- normal histopathological stage (+5-7)
- endometrial NK cell <4.5%
- 0 endometrial CD138 positive cell
- natural cycle frozen embryo transfer
- frozen blastocysts (≥4BC) embryos ≥ 1
Exclusion Criteria:
- Scar uterus (diverticulum or incision false lumen after cesarean section)
- intrauterine adhesions
- untreated hydrosalpinx
- adenomyosis (endometrial displacement)
- endometritis
- uterine fibroids compress the endometrium
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 36 Years | Effect of Intrauterine Injection of HCG on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients | NCT03682614 | Contradiction |
6,455 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Healthy, male and nonpregnant female subjects, 18 years of age or older.
2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment
grading scale at baseline
3. Subjects with the presence of telangiectasia at Baseline
4. Subjects with the presence of facial erythema associated with their rosacea at
Baseline
Exclusion Criteria:
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea
3. Standard exclusion criteria.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel | NCT02576847 | Entailment |
6,571 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | INCLUSION CRITERIA
- Provision of informed consent
- Age: 18 years or older
- Subjects with a single-rooted tooth indicated for extraction bounded by stable,
natural teeth
- Tooth planned for extraction must have a dehiscence defect in the surrounding bone,
observed clinically and/or radiographically, that affects at least 50% of the bone
height
- Subjects must be interested in replacing the tooth with a single implant-supported
fixed restoration
- Subjects must be able and willing to follow instructions related to the study
procedures
- Subjects must have read, understood and signed an informed consent form
EXCLUSION CRITERIA
- Mandibular incisors
- Subjects with a history of organ failure (e.g. liver, kidney)
- Subjects with severe hematologic disorders, such as hemophilia or leukemia
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as
osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone
metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or
chronic intake of glucocorticoids
- Pregnant women (as indicated by positive serum HCG test) or nursing mothers
- Subjects with conditions that would result in compromised healing (e.g. poorly
controlled diabetes, active heavy tobacco use [>10 cigs/day])
- Subjects who, at the discretion of the investigators, would be unsuitable candidates
for the study due to safety, psychological or practical reasons (e.g. known allergies
to any product used for the study, limited mouth opening, etc.)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Treatment of Post-Extraction Dehisced Socket - A Case Series Study | NCT02980211 | Contradiction |
791 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence
grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review,
and/or pre-op MRI
2. Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging
of CMC OA as diagnosed by X-ray and physical examination
3. Study Subjects must be willing to voluntarily give written Informed Consent to
participate in the study and sign the Health Insurance Portability and Accountability
Act (HIPAA) authorization before any study procedures are performed
4. Subjects with ASA grade I, II, or III
5. Males and females 25-85 years old
6. Subjects must have continued pain in their targeted/treatment joint despite
conservative therapies for at least 3 months
Exclusion Criteria:
1. Subjects that are allergic to lidocaine, epinephrine or valium
2. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be
stopped as follows prior to injection; Thrombolytics and anti-platelet medication
including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for
3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta®
(rivaroxaban) for 24 hours
3. Subjects with systemic immunosuppressant use within six (6) weeks from screening and
subjects with HIV/viral hepatitis
4. Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
5. Women that are pregnant or planning to become pregnant during the study
6. Subjects on long term use of oral steroids
7. History of any chemotherapy or radiation therapy on the targeted/treatment joint or
adipose harvest site
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 85 Years | Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints | NCT03166410 | Entailment |
4,719 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Eumenorrheic females
- Age 18-45 years old
- BMI of 18.5-34.99 kg/m2
Exclusion Criteria:
- Practice exercise more than 2 days/week in the last 3 months.
- Cardiovascular, metabolic, pulmonary or muscular-skeletal condition
- Taking medications that affect metabolism (e.g. oral contraceptives)
- Irregular menstrual cycles
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Resistance Training and Sex Hormone Concentrations During the Menstrual Cycle | NCT04163380 | Entailment |
4,815 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study
C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from
mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically
acceptable methods of contraception during the study.
- Are able to provide written informed consent
- Are able to return to the investigative site to complete the study evaluations
outlined in the protocol.
- Will not use systemic estrogens during the study.
Exclusion Criteria:
- Have an acute or unstable medical problem, which could be aggravated by mifepristone
treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first
pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic
margin; and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or
unwilling to use medically acceptable, non-hormonal methods of contraception during
the study.
- Have received investigational treatment (drug, biological agent or device) other than
CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone
or eplerenone is allowed to control hypokalemia.
- Postmenopausal women with a history of endometrial hyperplasia with atypia or
pathological features consistent with endometrial carcinoma.
- Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved
after induction of menstrual bleeding with progesterone.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Any woman with an intact uterus who has a hemorrhagic disorder or is being treated
with an anticoagulant (e.g. warfarin, heparin).
- Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
- Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome | NCT00936741 | Contradiction |
3,136 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Age greater or equal to 18 y/o
- Patients presenting to academic referral center for DES
- Diagnosis of mild to moderate DES with meibomian gland dysfunction and ocular rosacea,
based on evaluation of meibomian glands (MG), MG secretions, and other factors
- Facial rosacea
- Patients must not have started any new medications within the past 1 month
- Patients should not be using warm compresses or lid scrubs more than 1-2 times in the
previous 2 weeks
- Symptomatic changes in DES
Exclusion Criteria:
- Age < 18
- History of inflammatory DES (e.g. Sjogren's, rheumatoid arthritis, Stevens-Johnson
syndrome, ocular cicatricial pemphigoid)
- History of trauma-induced ocular surface disease (thermal burns, chemical burns)
- Severe DES
- Pregnant women
- H/o seizures
- Significant unprotected sun exposure or use of tanning beds or creams in treated area
(must be discontinued at least 2 weeks prior to treatment, during treatment course,
and 2 weeks after last treatment)
- Use of Accutane, anti-coagulants, or St. John's Wort
- Active infections/immunosuppression
- Herpes 1 or 2 within the treatment area
- Patients who have undergone LASIK surgery within the past 12 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome | NCT01917539 | Contradiction |
826 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Participants with sustention of chronic pain associated with OA or LBP for at least 3
months
- Participants whose pain cannot be controlled sufficiently with at least 14-day
continuous treatment with identical oral NSAIDs at a usual maximum dose during 3
months prior to this study
- Outpatients
- Ambulatory participants without need for any supportive device or assistance during
daily life
Exclusion Criteria:
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which acetaminophen is contraindicated
- Participants with history of convulsion or the possibility of convulsive seizure
- Participants with concurrent, previous, or possible alcohol dependence, drug
dependence, or narcotic addiction
- Pregnant participants or those who may be pregnant, lactating mothers, and
participants who wish pregnancy during the study period
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain | NCT00736853 | Entailment |
5,023 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Patients with essential tremor defined criteria Consensus statement of the movement
Disorder Society on Classical Essential Tremor (1998), with trembling of the upper
limbs causing functional impairment justifying surgical therapy.
- Man or woman aged 20 to 85 years.
- Patient having an absolute contraindication against or on Deep Brain Stimulation (DBS)
of the VIM.
- Patient who received a first effective unilateral thalamotomy on tremor with a
satisfactory clinical outcome (no cognitive impairment, lack of postural disorder
Musculoskeletal severe lack of dysarthria). The first effective thalamotomy will be
characterized by an improved score of tremor ≥ 45% and improved functional gene ≥ 50%.
- Patient who received a first unilateral thalamotomy with satisfactory radiological
evolution. Unsatisfactory radiological evolution will be characterized by a contrast
uptake> 350 mm3 one year with edema on T2 and Flair sequences extended beyond the
internal capsule.
- Patient requiring contralateral treatment because of the severity of the tremor and
functional impairment.
- Patient affiliated to a social protection scheme.
- Patient who understood and signed the informed consent form (signature of a third
person possible when the patient is unable to read and / or write but in a state to
give consent).
Exclusion Criteria:
- Patient with against-indication for performing a brain MRI (pacemaker, intracranial
metallic objects etc.)
- Patient with an against-indication to radiosurgical treatment (prior treatment with
cerebral radiotherapy)
- Pregnant or lactating women
- Women of childbearing potential unless
1. surgical sterilization
2. use of effective contraception (intrauterine device or method more hormonal
barrier method), and requiring to present a test pregnancy by assaying the
negative serum with chorionic gonadotrope hormon (CGH) when selecting and accept
to remain under the current form of contraception for the duration of the study
(in women past menopause should be amenorrheic for at least 12 months to be
considered as no longer able to bear a child).
- simultaneous participation in another clinical trial or exclusion period of a previous
clinical trial.
- vulnerable persons: minors, protected adults (guardianship) and Major unable to
consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 Years | Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor | NCT02827955 | Entailment |
2,968 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- A clinical diagnosis of definite, probably or laboratory supported probably ALS,
either sporadic or familial ALS according to a modified El Escorial criteria
- Willing and able to give informed consent
- FVC greater than or equal to 50% predicted
- Evidence of abnormality in upper and/or lower extremity motor function (clinical
evidence of muscle atrophy and weakness in an upper and/or lower extremity). The
patient should have at least 4 or 8 testable upper extremity muscle groups.
- Subjects may take riluzole. Riluzole must have been at stable doses for at least
thirty days prior to baseline visit.
- If woman of childbearing age, must be non-lactating and surgically sterile or using an
effective method of birth control (double barrier or oral contraceptive) and have a
negative pregnancy test
- Disease duration less than five years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS] | NCT00005674 | Entailment |
478 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Women aged 18-49 years.
2. Women with history of recurrent miscarriage(two or more consecutive miscarriages)
3. Women with history of previous deliveries.
Exclusion Criteria:
1. Pregnant women
2. Women with medical disease (e.g. DM, thyroid disorders, hypertension, systemic lupus
erythematosus, antiphospholipid antibody syndrome).
3. Women with known uterine anomalies.
4. Obesity (BMI >30%).
5. Women on anticoagulant medications or antiplatelet medications.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Use of Platelet Indices for Prediction of Recurrent Miscarriage | NCT03710226 | Contradiction |
1,672 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Must be at least 18 years of age
2. Male or Female
3. Must provide written informed consent prior to the performance of any study-related
procedures.
Exclusion Criteria:
1. Subjects who in the opinion of the study staff are too agitated, distressed or who are
otherwise unable to cooperate with study procedures
2. Subjects with bigeminy, trigeminy, isolated ventricular premature beat (VPD) or atrial
fibrillation or any other condition, in the opinion of the study staff that can result
in a significantly irregular heath rhythm.
3. Subjects with signs or recent history of inflammation or infection of the wrists or at
the reference clinical test site.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method | NCT03452280 | Entailment |
6,098 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Eligible patients are infants under 4 years of age with genetic disorders undergoing
developmental surveillance in the NICU GraDS program.
Exclusion Criteria:
- Children 4 years of age or older will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 4 Years | Application of a Systematic Developmental Assessment to a Novel Population: Infants With Rare Genetic Disorders | NCT03967743 | Entailment |
1,631 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Individuals who consent to participate in the study
- Residents in the study area
- Older than 6 months of age (or weighing more than 5Kg)
- Women in the second or third trimester who are not on IPTp
Exclusion Criteria:
- Individuals who do not consent to participate in the study
- Younger than 6 months of age (or weighing more than 5Kg)
- Women in the first trimester of pregnancy
- Severely ill individuals
- Individuals on contra-indicated medication
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| Mass Drug Administrations of DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique | NCT02914145 | Entailment |
4,499 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
Participants were required to meet the following criteria:
- Healthy adult females between 18 and 40 years old for eumerroheic and oral
contraceptive groups or under 60 years old for postmenopausal women.
- Presenting with healthy iron parameters (serum ferritin >20μg/l, haemoglobin >115 μg/l
and transferrin saturation >16%).
- Performing endurance training between 5 and 12 h per week (study I) or experienced in
resistance training performing at least 1 h session two times per week during a
minimum of a year (study II).
Exclusion Criteria:
The exclusion criteria included:
- Irregular menstrual cycles.
- Any existing disease and/or metabolic or hormonal disorder.
- Any musculoskeletal injury in the last six months prior to the beginning of the
project.
- Any surgery interventions (e.g. ovariectomy) or other medical conditions that would be
exacerbated by an eccentric resistance exercise protocol.
- Regular use of medication or dietary supplements that could affect the results (e.g.
nonsteroidal anti-inflammatory drugs).
- Taking medication that alters vascular function (e.g. tricyclic antidepressants,
α-blockers, β-blockers, etc.).
- Pregnancies in the year preceding.
- Smoking.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise | NCT04458662 | Contradiction |
1,217 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Pleural effusion
- Hospital admission
- No previous pleural procedure
- Age > 18 years
- No previous chemoradiotherapy
- No antibiotic therapy during previous trimester
- All history, chest X-ray, and pleural and blood cell counts and biochemistry entry
data obtained within 4 hours after admission
Exclusion Criteria:
- No diagnosis at one month post-admission
- No informed consent provided
- Age < 18 years
- History, chest X-ray, or pleural and blood cell counts and biochemistry entry data
obtained later than 4 hours after admission
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Using Pleural Effusions to Diagnose Cancer | NCT03319472 | Entailment |
5,111 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean
(T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
- Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean,
but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1
to L4) or total hip.
Exclusion Criteria:
1. Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score
<-3.5) at the lumbar spine (L1 to L4) or total hip.
2. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture
between T4 and L4 inclusive.
3. Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures
between T4 and L4 inclusive, OR
- Osteopenia patients (T-score <-1 and >-2.5) who have two or more vertebral
fragility fractures between T4 and L4 inclusive.
4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs
around them precluding the assessment of BMD.
5. Patients who have secondary causes of osteoporosis or other disorders of bone and
mineral metabolism.
6. Other exclusion criteria as specified in the study protocol.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 75 Years | Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis | NCT00532337 | Contradiction |
6,989 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- For the 3 groups of patients : colonoscopy planned by a gastroenterologist in the
context ot the usual medical follow-up of the patient
For patients with Alzheimer's disease :
- Patient with early to moderate Alzheimer disease (continuum of patients with mild
cognitive impairment due to Alzheimer's disease and patients diagnosed with probable
Alzheimer's disease) according to the National Institute of Aging-Alzheimer's
Association (NIA AA) criteria
- Mini-Mental State Examination (MMSE) score ≥18;
- Has one informant or care partner;
- No parkinsonian syndrome
- No sign of lewy Body dementia
For patients with Parkinson's disease:
- patients with Parkinson Disease according to the United Kingdom Parkinson's Disease
Society Brain Bank (UKPDSBB) criteria
- No dementia sign or cognitive deficit associated to Alzheimer's disease
For patients without neurodegenerative disease:
- No history or current neurological/degenerative condition (e.g, lewy body dementia,
Parkinson's disease, Parkinsonian syndrome, Alzheimer's disease,…)
- No memory complaint with a Mac Nair score ≤15
- MMSE score ≥28 ;
- Patient at risk of colic cancer with a colonoscopy scheduled
Exclusion Criteria:
For the 3 groups of patients : :
- History of colonic disorder ((e.g inflammatory condition, adenocarcinoma)
- contra-indications to colonoscopy
For patients with Alzheimer's disease and for patients with Parkinson's disease:
- Any neurological/neurodegenerative condition different from the group to which it belongs
(e.g other than Alzheimer's disease for Alzheimer's disease group or other than Parkinson's
disease for Parkinson's disease group….)
For patients without neurodegenerative disease:
- Any neurological/neurodegenerative condition (e.g lewy body dementia, Parkinsonian
syndrome, Parkinson's disease, Alzheimer's disease..)..
- functional colopathy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Exploration of the Enteric Nervous System in Alzheimer Disease | NCT03472183 | Entailment |
4,424 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Age between 18 and 65 years.
- Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3
months of evolution.
- Pain when palpating the lateral epicondyle area.
- Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or
Mill's
- Have the capacity to perform all clinical tests, understand the study process, and
obtain informed consent.
Exclusion Criteria:
- Previous history of direct trauma, fractures, joint instability, surgery or rheumatic
alterations of the lateral epicondyle area.
- Full elbow extension limited.
- Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative
pathology in the cervical spine, exacerbated pain increase with neck movements or
cervical compression.
- Symptoms compatible with entrapment of the posterior interosseous nerve.
- NSAID intake the week before the intervention;
- Have received treatment with infiltration in the last year;
- Have received physiotherapy treatment during the last month.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy | NCT03572803 | Contradiction |
2,229 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- 4.1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout,
synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.
4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of
18-85yrs.
Exclusion Criteria:
- 4.2.1 Current or history of disease or disorders of the liver, kidneys,
gastrointestinal system, or cardiovascular system.
4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal
clinically accepted ranges. Blood test must be performed in the last 7 days.
4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area
of pain where the compound cream and transdermal patch would be applied.
4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.
4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or
alcohol use or dependence that, in the opinion of the site investigator, would interfere
with adherence to study requirements.
4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject
either completes therapy or is clinically stable on therapy, in the opinion of the site
investigator, for at least 14 days prior to study entry.
4.2.8 Inability or unwillingness of subject to give written informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Prospective Analgesic Compound Efficacy (PACE) Study | NCT02403687 | Entailment |
6,317 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed case of Covid-19
Exclusion Criteria:
- Cases not reported
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Forecast Number of Covid-19 Cases Worldwide | NCT04460274 | Entailment |
682 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Homozygous for C282Y mutation in HFE (hemochromatosis) gene
- Written informed consent
- Age 18-65 y
- Not pregnant or lactating
- Body weight < 75 kg
- Body mass index (BMI) between 18.5 and 25 kg/m2
- No acute illness/infection (self-reported)
- No metabolic or gastrointestinal disorders, eating disorders or food allergy to the
ingredients of the test meal (self-reported)
- No scheduled phlebotomy throughout the study period
- The last phlebotomy will be at least 4 weeks prior first test meal administration
- No use of medications affecting iron absorption or metabolism during the study
- No intake of mineral/vitamin supplements 2 weeks before the first study day and during
the study
- Participation in any other clinical study within the last 30 days
- Expected to comply with study protocol
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement | NCT03990181 | Entailment |
4,794 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Unilateral Meniere's Disease
- 2 vertigo episodes of at least 20 minutes
- Fluctuating hearing by subjective history and/or audiometric documentation.
Audiometric documentation is defined as affected ear pure-tone average change from an
audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
- Less than 45 dB 4-frequency pure-tone average in the affected ear
- Tinnitus and/or aural fullness
- Willing to undergo the clinical trial procedures
- Signed informed consent
Exclusion Criteria:
- Acute or chronic middle ear disease in either ear
- Only hearing ear
- 4-frequency pure-tone average > 45 dB in either ear
- Known allergy to famciclovir or any of the ingredients in the formulation
- Taking oral steroids or receiving IT steroids at time of enrollment. If the subject
has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of
treatment in the study
- Must not have had previous inner ear surgery
- History of immunodeficiency diseases such as HIV
- History of renal insufficiency or other kidney diseases
- A female of child-bearing potential who is pregnant
- History of noncompliance to medical regimens
- Unwilling to or unable to comply with the protocol, including scheduling study
evaluations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Famvir for Treatment of Hearing in Unilateral Meniere's Disease | NCT01526408 | Entailment |
763 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Women over 18 diagnosis of CMC joint OA in their dominan hand.
- State 1-2 according to the American College of Rheumatology.
- Pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual
analog scale (VAS)
- Ability to read or understand the patient information sheets.
- Ability to sign a consent form will be included in the study
Exclusion Criteria:
- Neurologic disorder affecting the upper limb
- Previous treatment for their hand problem in the last 6 months including an
intra-articular joint injection to wrist, fingers, or thumb
- Had fractures or a significant hand injury or previous surgery to the wrist, thumb or
hand
- Finger tenosynovitis.
- Dupuytren disease.
- Psychological treatment.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment | NCT03270488 | Contradiction |
619 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Patients with a PUL
2. Patients with mild or no symptoms
3. Patients willing to be randomized
4. First hCG value <10,000 IU/L
5. Patients with an interval between two hCG measurements of 44-56 h
Exclusion Criteria:
1. Hemodynamically unstable patients
2. Hemoperitoneum
3. Patients not managed as outpatients during the course of the initial two hCG
measurements
4. Non-understanding of the oral or written study information
Female
No healthy subjects accepted to join the trial.
| Management of Pregnancies of Unknown Location (PUL) | NCT03461835 | Entailment |
2,413 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Age 5-20 years
- Duchenne muscular dystrophy documented by written report of stop codon mutation
analysis of the dystrophin gene.
- Subject is capable of cooperating for efficacy and safety testing
- Absent dystrophin on muscle biopsy
- Subjects may be untreated, taking prednisone or comparable corticosteroids
- Subjects taking corticosteroids must be on the same dose for at least 3 months (90
days) prior to the start of the study.
Exclusion Criteria:
- Known allergy to any aminoglycoside or sulfate compounds
- Current use of potential nephrotoxic or ototoxic drug
- Current use of corticosteroids has not been stable for 3 months (90) days
- Known mutation at nucleotide 1555 in 12S rRNA gene of mitochondrial DNA (predisposes
to aminoglycoside hearing loss and commercially available via Athena Diagnostics Lab).
This DNA testing (Hearing susceptibility test) will be made available through funding
from this grant.
- Inability to hear within the range of 0 to 25 dB in any hearing frequency by pure tone
audiometry
- Cystatin C equal to or > 1.4mg/L
- Other medical condition that would impede the conduct of study (e.g., congestive heart
failure)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 20 Years | Six Month Study of Gentamicin in Duchenne Muscular Dystrophy With Stop Codons | NCT00451074 | Entailment |
5,810 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | - INCLUSION CRITERIA:
Patients with white, red, or white and red lesions in the oral cavity and oropharynx as
identified by the participating dentist.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 110 Years | Biomarkers for Oral Cancer | NCT00341497 | Entailment |
4,955 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Main Inclusion Criteria:
- Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as
follows:
- Bilateral postural tremor with or without kinetic tremor, involving hands and
forearms, that is visible and persistent.
- It is to be noted that:
- Tremor of other body parts may be present in addition to upper limb tremor.
- Bilateral tremor may be asymmetric.
- Tremor is reported by patient to be persistent, although the amplitude may
fluctuate.
- First onset of essential tremor at least 6 months before screening with stability of
the tremor symptoms over 4 weeks and in the opinion of the investigator definite
diagnosis of essential tremor.
- Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level,
corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories
(scale part C, items 16-23) in the limb to be treated between of 2 or higher.
- Visible tremor at wrist level in at least one of the four positions/tasks used in
kinematic assessments
- Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a
treatment of up to three joints of the selected upper limb (wrist treatment
mandatory).
- Stable concomitant anti-tremor medication and no clinically relevant findings in
routine laboratory examinations.
Main Exclusion Criteria:
- Any neurological signs abnormal for the subject's age, other than the tremor itself
and Froment's maneuver.
- Exposure to the following tremorogenic drugs: Lithium, Valproic acid, Amiodarone,
typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or
potentially tremorogenic drugs is allowed only if, in the opinion of the investigator,
this will not interfere with the study drug evaluation. In these cases, a stable
medication should be reached 4 weeks before screening and intended for the time during
the study drug evaluation.
- Trauma to the central nervous system or the nerves of the target limb within the three
months preceding the onset of tremor.
- Evidence of psychogenic origins of tremor.
- Life habits (e.g. smoking, alcohol or substance abuse) prejudicial to study
participation.
- Prior surgery to treat tremor
- Recent (16 weeks) treatment with any Botulinum toxin product for any reason.
- Relevant recent or planned surgery or other specified relevant treatments and/or
concomitant disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Botulinum Toxin A to Treat Arm Tremor | NCT02207946 | Entailment |
4,237 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- the diagnostic criteria based on the consensus of Chinese experts and the guidelines
for noncystic fibrosis bronchiectasis issued by the British Thoracic Society in 2010;
- male or female, aged 18-70 years;
- being in the stable stage, and no acute exacerbation of bronchiectasis within the past
three weeks;
- frequency of acute exacerbation of bronchiectasis ≤ 3 times every year;
- signed informed consent for participation.
Exclusion Criteria:
- having developed respiratory failure with estimated survival time less than one year;
- having hemoptysis as a comorbidity;
- having complications by active tuberculosis;
- being pregnant or with severe heart, liver,and kidney dysfunctions;
- participating in other pharmacological clinical trials within the past 3 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials | NCT03147443 | Contradiction |
5,824 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/or
regurgitation occurs once a week or more.
- Esophagitis stage A-B according to Los Angeles classification,
- Major symptom should be gastroesophageal reflux disease (GERD) in presence of
overlapping symptoms,
- Age range should be 18-70 years,
- BMI should be 18-33 kg/m2,
- Presence of sufficient gastric acidity: Cases which intragastric ph > 4 value is under
25% according to dual multichannel intraluminal impedance-pH MII monitoring performed
before study initiation,
- Pathologic intraesophageal acid exposure; DeMeester score > 14.75 and/or ph < 4 value
> 4% (according to at 21 hour measurement at least),
- Helicobacter pylori should be negative according to biopsy in gastrointestinal system
(GIS) endoscopy performed in last 12 months before study initiation; if biopsy not
performed in endoscopy, stool antigen test or urease breath test should be performed
and Helicobacter pylori should be negative.
Exclusion Criteria:
- Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed in
last 12 months before study initiation, all types of gastrointestinal system (GIS)
pathology such as Barret stricture, stomach channel obstruction, malignity,
gastrointestinal system (GIS) bleeding and cases with > 3 cm Hiatus hernia.
- Presence of severe chronic comorbid diseases; uncontrolled or insulin-dependent
diabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomatic
and are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1
cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellison
syndrome, primary esophagus motility disorders, pancreatitis, inflammatory bowel
disease, chronic liver disease, severe liver disease, uncontrolled renal impairment,
presence of cancer except non-melanoma skin cancer, heart failure, cerebrovascular
disease, epilepsy,
- Major psychiatric disease,
- Alcoholism or cases take narcotics,
- Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroid
function tests, liver enzymes,
- Malabsorption that may affect drug absorption,
- Immunosuppressive and cortisone taking cases,
- Pregnancy or positive pregnancy test and lactating women,
- Cases taking all types of drugs which may affect gastrointestinal system motility or
acid release,
- Cases undergo abdominal operation; hysterectomy, abdominal hernia operation,
caesarean, appendectomies may be included but all types of cholecystectomy will be
excluded.
- Cases taking a proton pomp inhibitor (PPI) and H2 blocker for last seven days and
prokinetic drug for last three days,
- Condition that taking drugs need stomach acid for optimal absorption; such as
ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic
agents.
- Cases who must take prostaglandin analogs,
- Cases who must take non-steroidal anti-inflammatory drug (NSAID) during study,
- Cases taking antidepressants,
- Cases who refuse to sign informed consent,
- Hypersensitivity to study drug.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity | NCT02689999 | Contradiction |
7 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Documented hypothalamic or pituitary hormone deficiency
- Testosterone deficiency, defined as total serum testosterone less than 250 ng/dL at
two 8 AM readings
- Growth hormone deficiency, defined by either of the following:
- For subjects who have thyroxine and cortisol deficiencies, either a subnormal
age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
- For subjects who do not have thyroxine and cortisol deficiencies, either a subnormal
age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
- Duration of testosterone and growth hormone deficiencies of two years or more
- Replacement of cortisol and/or thyroxine deficiencies
- Able to give informed consent
Exclusion Criteria:
- Current testosterone treatment or treatment during the two years prior to study entry
- Current growth hormone treatment or treatment during the three years prior to study
entry
- Use of other prescription or over-the-counter androgens (androstenedione, DHEA),
estrogens, or antiandrogens (spironolactone, ketoconazole)
- Diseases that could influence bone, such as hyperparathyroidism
- Medications that could influence bone, such as anticonvulsants or glucocorticoids
(prednisone greater than 20 mg/day for longer than 2 weeks/year). Calcium and
over-the-counter vitamin D supplements are allowed.
- Cancer that could limit life expectancy to fewer than 5 years
- Neuromuscular disease or history of stroke with residual neurological defect
- Severe or uncontrolled psychiatric illness or dementia
- Noncancerous enlargement of the prostate gland (American Urological Association
symptom score greater than 21)
- Prostate cancer by history, prostate nodule on digital rectal exam (DRE), or prostate
specific antigen (PSA) greater than 4
- Current alcohol or drug dependence
- Heart failure (New York class III or IV)
- Unstable angina
- Myocardial infarction within 3 months of study entry
- Liver disease (ALT greater than 3 x normal)
- Renal disease (serum creatinine greater than 2.5 mg/dl)
- Diabetes mellitus (glycosolated hemoglobin greater than 8.0%)
- Hypertension (systolic BP greater than 160 or diastolic BP greater than 100 mm Hg)
- Hematocrit greater than 48%
- Weight greater than 300 pounds
- Poor quality scan at baseline even when repeated
- Untreated, severe, obstructive sleep apnea (Epworth sleepiness score greater than 10)
- Unable to undergo an MRI because of a cardiac pacemaker or ferrometallic objects in
the body
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Will Testosterone and Growth Hormone Improve Bone Structure? | NCT00080483 | Contradiction |
6,295 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Men or women ≥ 18 years of age on the day of inclusion (no upper limit).
2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to dosing:
Feeling hot or feverish, cough, sore throat, low energy or tiredness, headache, muscle
or body aches, chills or shivering, and shortness of breath.
3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid
antigen test).
4. Understand and agree to comply with the planned study procedures.
5. The patient or legally authorized representative give signed informed consent.
Exclusion Criteria:
1. Requiring hospitalization at time of screening, or at time of study drug
administration.
2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen
partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300,
respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute.
3. Known allergies to any of the components used in the formulation of the ensovibep or
placebo.
4. Suspected or proven serious, active bacterial, fungal, viral, or other infection
(besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk
when taking intervention.
5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion
of the investigator, should preclude participation in this study.
6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered
life-threatening within 29 days of dosing.
7. Prior or concurrent use of any medication for treatment of COVID-19, including
antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic
therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and
nonsteroidal anti-inflammatories [NSAIDs]) are permitted. Prior vaccination for
COVID-19 is permitted.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 | NCT04828161 | Entailment |
4,617 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Patients presenting for hysterectomy for any benign indication including but not
limited to abnormal uterine bleeding, menorrhagia, uterine fibroids, adenomyosis,
pelvic pain, dysmenorrhea, pelvic organ prolapse or endometriosis.
2. Age ≥ 18 years
3. Pre-operative hemoglobin >8 g/dl
4. Willing to have IV tranexamic acid or a placebo prior to hysterectomy
5. Ability to understand and the willingness to sign a written informed consent.
6. Can be previously treated with Depo-Lupron, Depo-Provera, Oral Contraceptive pills,
Mirena IUD, endometrial ablation, myomectomy, oral progestins
7. Hysterectomy in combination with the following procedures is permitted:
unilateral/bilateral salpingectomy or oophorectomy, ovarian cystectomy,
fulguration/excision of endometriosis, appendectomy, sacrocolpopexy,
anterior/posterior repair, uterosacral vault suspension, retropubic midurethral sling
and cystoscopy
Exclusion Criteria:
1. Patients with known or suspected endometrial/ovarian/cervical cancer.
2. Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
3. Patients currently undergoing treatment for any type of cancer.
4. Patients with known bleeding/clotting disorders or a history of thromboembolism
(including deep venous thrombosis or pulmonary embolism)
5. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to tranexamic acid.
6. Any procedures which occur in combination with other elective surgical procedures
(such as abdominoplasty, breast augmentation, etc) which are not included in the
previously mentioned inclusion criteria above will be excluded from data analysis.
7. Uncontrolled current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, subarachnoid hemorrhage, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements.
8. Patients with acquired defective color vision
9. Patients with known renal failure and/or Cr > 5 within the last 6 months
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| IV Tranexamic Acid Prior to Hysterectomy | NCT02911831 | Entailment |
2,510 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Female and male infants aged 3-12 months.
2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka Criteria.
3. Patients with moderate to severe atopic dermatitis (IGA ≥3)
4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at
baseline.
5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
6. The patient's parents are able to apply the study product twice a day (each morning
and evening) for a consecutive period of 63 days.
7. Patients who have completed the tolerability patch test without any adverse effects
after 72 hours.
Exclusion Criteria:
1. Any clinically significant controlled or uncontrolled medical condition that would, in
the opinion of the investigator, put the patient at undue risk or interfere with
interpretation of study results.
2. Clinically significant impairment of renal or hepatic function.
3. Clinically significant immunodeficiency.
4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or
evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle cream
(including the tolerability patch test performed at the Screening Visit) or
intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).
7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior
to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and
inhaled corticosteroids for stable medical conditions are allowed.
8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline),
or 5 half-lives (whichever is longer).
9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0
Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources
between screening and follow-up visits.
10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of
treatment/Day 0 Visit (Baseline), including but not limited to topical
corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach
baths.
11. Use of topical products containing ceramides 2 weeks prior to Day 0.
12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or
infection with human immunodeficiency virus).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 12 Months | Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis | NCT03676933 | Contradiction |
1,036 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Elective primary unilateral total knee arthroplasty
- Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in
the affected joint
- Patients of surgeons who have agreed to participate in the study
- Age > 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1-3
- Regional anesthesia
- Epidural patient-controlled analgesia (PCA) for postoperative pain
- Adductor canal block for postoperative pain
Exclusion Criteria:
- Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
- Use of general anesthesia
- History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
- Preoperative oral steroid use in the past 6 months
- Intra-articular steroid injection within one month of scheduled surgery in affected
joint
- Non-English speakers
- Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid
arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I
diabetes)
- Peri-articular injections or infusions for postoperative pain
- Diagnosis of crystalline arthropathy
- Diagnosis of osteonecrosis
- Active infection or use of antibiotics
- Pregnant women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis | NCT02626533 | Entailment |
3,577 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Physician members of the International Gynecologic Oncologists Society or the Society
of Gynecologic Oncologists
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Interest in Spirituality and Oncology: Is It An International Phenomenon? | NCT00429117 | Entailment |
1,427 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- outpatients who have esophagus symptoms.
Exclusion Criteria:
- known or suspected complex history of gastrointestinal obstruction, stenosis or
fistula.
- dysphagia or delayed gastric emptying.
- known or suspected possibility of active bleeding of digestive tract.
- a history of abdominal operation.
- pacemaker implantation and gastrointestinal pacemaker users.
- patients who are allergic to simethicone or pronase.
- pregnant women,mental patients.
- other circumstances that doctors consider inappropriate for the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach | NCT03457909 | Contradiction |
1,748 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age greater than 18 years old
- New onset of hematemesis, melena or hematochezia
- Able to sign consent
- Hemodynamically stable (that is, blood pressure >100/60 or pulse <110 at the time of
consent)
- Emergency Department must plan to admit patient to the hospital or Clinical Decision
Unit
- If patients have pacemakers and/or implantable cardioverter defibrillator (ICD), they
will be placed on telemetry
Exclusion Criteria:
- adults unable to consent
- individuals who are not yet adults (infants, children, teenagers)
- pregnant women
- prisoners
- prior history of gastroparesis
- prior history of gastric or small bowel surgery
- prior history of inflammatory bowel disease
- concern for infectious colitis
- evidence of dysphagia at the time of presentation
- presence of small amounts of bright red blood per rectum
- allergy to metoclopramide or erythromycin
- code status of do not resuscitate/do not intubate (DNR/DNI) or comfort measures only
(CMO)
- prior history of abdominal radiation
- abdominal pain suggesting an acute abdomen or obstruction.
- patients who cannot undergo surgery
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding | NCT03955055 | Contradiction |
4,939 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- I1. Sufficiently conversant in the English language to satisfy I3.
- I2. Able and willing to comply with all study requirements.
- I3. Able and willing to provide written informed consent to participate (including by
parent or legal guardian if under 16 years old).
Exclusion Criteria:
- There are no exclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 3 Years old.
| Vital Sign Comparison Between Lifelight and Standard of Care - Development | NCT04003662 | Entailment |
Subsets and Splits