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1,279 | 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:
- Signed informed consent
- Male or female subjects ≥ 18 years of age
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
- Patients with advanced malignant epithelioid mesothelioma or advanced recurrent serous
ovarian cancer, who have exhausted available therapeutic options; in addition, in the
dose expansion part of the study, patients with metastatic pancreatic adenocarcinoma,
who have exhausted available therapeutic options
- Availability of fresh or archival tumor tissue samples
- Adequate bone marrow, liver and renal function, as assessed by pre-defined laboratory
requirements (within 28 days before start of study drug treatment)
- A negative serum pregnancy test in women of childbearing potential (WOCBP) performed
within 7 days before the start of study drug administration. Women and men of
reproductive potential must agree to use highly effective methods of contraception,
when sexually active.
Exclusion Criteria:
- Impaired cardiac function, clinically significant cardiac disease or cardiac
arrhythmias
- Pericarditis (any CTCAE grade) or pericardial effusion (CTCAE Grade ≥ 2)
- Left Ventricular Ejection Fraction (LVEF) < 50% (as measured at screening by
echocardiogram).
- History of anaphylactic reactions to monoclonal antibody therapy
- History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia
(t-AML) or with features suggestive of MDS/AML
- Infections of CTCAE (Common Terminology Criteria for Adverse Events) version 5.0 Grade
2 not responding to therapy or active clinically serious infections of CTCAE Grade >2;
known human immunodeficiency virus (HIV) infection; active hepatitis B virus (HBV) or
hepatitis C virus (HCV)infection requiring treatment. Patients with chronic HBV or HCV
infection are eligible at the investigator's discretion provided that the disease is
stable and sufficiently controlled under treatment
- Known brain, spinal or meningeal metastases
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.
| First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin | NCT03507452 | Entailment |
6,210 | 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:
- Medical doctor, Nurse ,Respiratory therapist or nurse assistant who work in the
emergency room, general covid ward or intensive care unit
- Age : between 18-70 years
- RT-PCR and serology tests for SARS-CoV-2 negative at baseline evaluation
- Direct care of patients in the emergency room, general Covid wards or intensive care
unit
- Informed consent signed
Exclusion Criteria:
- Two or more of the following : Body temperature higher than 38 Celsius, Cough of
recent onset (in the previous 10 days), Dyspnea, Odinophagia, Malaise, fatigue, Acute
diarrheal disease.
- History of COVID-19 confirmed by RT-PCR or IgG antibodies
- Family member with suspected or confirmed COVID 19
- Cohabitating with a suspected or confirmed case of COVID-19
- Hepatitis B anti-surface antigen antibodies lower than 10mU/ml at baseline evaluation
- Acute or chronic Hepatitis B
- Confirmed diagnosis of HIV infection either by clinical history or ELISA inmunassay at
baseline evaluation
- Use of TDF/FTC in the last three months for other clinical conditions
- ALT or AST higher than 2 times the upper reference limit
- Serum hemoglobin <11g/dl or neutropenia<1.000cell/mm3
- Renal dysfunction defined as eGFR lower than 60ml/min (using the CKDEPI formula) or
history of Chronic kidney disease Known hypersensitivity to TDF/FTC Serum phosphorus
level <2.5mg/dl
- Diagnosed osteopenia or osteoporosis
- History of pathological fractures
- Pregnancy, lactation or pregnancy desire during the period of the study
- Being a participant in another Clinical trial of prevention for COVID-19
- Use of any of the following drugs: Cidofovir, Celecoxib, Diclofenac, Ibuprofen,
Metadon, Naproxen, Nimesulide, Piroxicam, Amiodarone, Quinine, Amikacin, Cephalexin,
Clarithromycin, Gentamicin, Piperacillin / Tazobazorcin, Flucomycin, Flucomycin,
Sulfadiazine, Vancomycin , Ganciclovir, Ledipasvir / Sofosbuvir, Sofosbuvir /
Velpatasvir, Furosemide, Hydralazine, Sacubitril, Verapamil, Interferon, Hydroxyurea,
Dolutegravir / Lamivudine Abacavir, Didanosine, Lamivudine, Atazanavir / cobicistat,
Atazanavir / ritonavir, Darunavir / ritonavir, Darunavir / cobicistat, Indinavir,
Interferon, Hydroxyurea, Cyclosporine, Mycophenolate, Sirolimus, Tacrolimus,
Acetazolamide Orlistat, Probenecid, Pyridostigmine, Sevelamer, Zoledronic acid.
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 70 Years | Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia | NCT04519125 | Contradiction |
502 | 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. History of 2 or more unexplained recurrent miscarriage.
2. Child bearing period (18-35 years old).
3. Non pregnant state.
4. Regular menstrual cycles for the previous three months before the study.
5. No hormonal contraception or intrauterine device.
6. impaired uterine artery blood flow (PI >2.02) (Mansour et al., 2018).
Exclusion Criteria:
- 1-Having any possible causes of abortion: anatomical, genetic, endocrinological,
infectious, or immunological.
2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic
lupus).
3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia,
thyrotoxicosis … etc.).
4- Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery
disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history
of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss | NCT04718233 | Contradiction |
90 | 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. | - Healthy Men Ages 18-80
- All ethnicities eligible
- Men with indeterminate erectile dysfunction eligible with normal serum gonadotropin,
total testosterone, prolactin and TSH concentrations and documented integrity of the
neurovascular, cardiovascular, hepatorenal systems
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men | NCT00431197 | Contradiction |
6,547 | 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 patients less than 6 years of age with moderately severe to severe hemophilia A
(FVIII less than or equal to 2%).
- Treatment history of less than 50 exposure days to prior recombinant or plasma-derived
FVIII replacement products.
- Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable
antiviral regimen at the time of enrollment in the study.
Exclusion Criteria:
- Presence of any bleeding disorder in addition to hemophilia A.
- Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening.
- Treated with immunomodulatory therapy during the screening period
- Treatment history of more than 5 exposure days (ED) to Xyntha.
- Known hypersensitivity to hamster protein.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 5 Years | Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age | NCT00759655 | Contradiction |
1,158 | 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:
1. Patients with recurrent pleural effusion of unknown origin after a first pleural tap
according to BTS guidelines.
2. Indication for thoracoscopy according to BTS guidelines.
3. Patients accept further investigation according to Danish and BTS guidelines.
4. Have received oral and written consent and agreed.
5. At the time of inclusion, above 18 years of age.
Exclusion Criteria:
1. Female patients: pregnancy or breastfeeding.
2. Lack of language comprehension.
3. Legally incompetent patients.
4. Life expectancy less than 3 month.
5. Contraindications to pleural tissue sampling.
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.
| Rational Approach to a Unilateral Pleural Effusion2 | NCT02834455 | Contradiction |
4,757 | 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:
- Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or
satisfy criteria with a duration of <3 months
- Vertigo symptom scale (VSS-SF) >12
Exclusion Criteria:
- Cognitive dysfunction that is so pronounced that it will make participation difficult
- Unable to read, understand Norwegian
- Severe medical or psychiatric illness (including substance abuse) that reduces the
patient's ability to follow the VR program
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 | Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness | NCT04458376 | Entailment |
5,995 | 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:
- Ability to provide informed consent, preferably in writing or, failing that, orally in
front of a witness, before any study procedure is performed.
- Male and female patients aged 18 to 75 years old (inclusive).
- Patients with symptoms of functional dyspepsia (according to the Rome IV criteria) of
moderate severity (VAS score between 30 mm and 70 mm) and/or bothersome heartburn
within 2 and 14 days prior to the screening/baseline visit.
o According to the current Rome IV diagnostic criteria, functional dyspepsia is
defined as one or more of the following symptoms: postprandial fullness (classified as
postprandial distress syndrome), early satiation (inability to finish a normal sized
meal, also classified as postprandial distress syndrome), and epigastric pain or
burning (classified as epigastric pain syndrome).
- Ability of the patients (according to the investigator's opinion) to comprehend the
full nature and purpose of the study including possible risks and side effects.
- Patients who agree not to alter their diet in any way for the duration of the trial
and to maintain it at steady state.
- Patients who agree not to make any major lifestyle changes during the trial.
- Willingness to comply with all the study procedures and schedule.
- Chronic therapies (if not related to the gastroenterological pathologies object of the
study, according to the opinion of the investigator) are allowed, if the regimen is
maintained stable during the whole study.
Exclusion Criteria:
- Declines or unable to provide informed consent.
- Disease or health condition
- Patient presenting at least one of the following symptoms or conditions at screening:
anemia, chronic gastrointestinal bleeding, progressive unintentional weight loss,
epigastric mass, anorexia, persistent or recurrent vomiting, dysphagia or odynophagia,
porphyria, hypophosphatemia, and/or cachexia.
- Patients presenting with at least of the following gastrointestinal conditions at
screening: erosive GERD, Barrett's oesophagus or oesophageal stricture, active or
healing gastroduodenal ulcer (except scars), history of gastric, duodenal or
esophageal surgery, symptomatic gallstone, and/or other gastrointestinal disease such
as gastroenteritis, inflammatory bowel disease, celiac disease and/or colorectal
cancer.
- Patients with known malignancy disease, infectious disease or severe heart or
pulmonary disease.
- Patients with known severe liver or kidney disease (AST/SGOT, ALT/SGPT >2 upper limits
of normal, serum creatinine >1.5 mg/dl).
- Patients with mental or metabolic disorders and any other disease that according to
the physician can compromise the patient´s safety and/or patient´s study compliance.
- Treatments
- Patients receiving any treatment (pharmacological or medical device) for heartburn or
dyspeptic symptoms within the last 14 days prior to randomization.
- Patients receiving any drugs that could affect symptoms or study evaluation such
antacids, PPIs, H2RAs, prokinetics, and/or gastric mucosal protectants at baseline
and/or taken within the last 14 days prior to randomization.
- Patients receiving any drugs that could affect symptoms or the study as antibiotics,
NSAIDs, anticholinergics and/or cholinergic agents.
Note: Patients will be asked to avoid any drugs of the above mentioned since the beginning
of the study (baseline visit) until the end of the study.
- Patients under triple therapy or eradication therapy against Helicobacter pylori.
- Patients planned for long-term new therapies with anti-anxiety agents,
glucocorticosteroids and anti-inflammatory agents during study period.
- Known hypersensitive or intolerance to any components of the study medical devices.
- Previous intake of any of the study medical devices.
- Other general conditions
- Patients who are unable to understand or are unwilling to sign an informed consent
form.
- Unable or unwilling to complete all required screening and/or follow-up assessments.
- Unable to understand and complete self-administered scales/questionnaires planned to
be used in the study.
- Participation in interventional research studies of investigational medicinal or
device products (ongoing or terminated less than 30 days before screening)
- Patients with active alcohol or drug addiction or any other condition that, in the
investigator's opinion, would interfere with their ability to comply with the study
requirements.
- Patients with any concurrent condition that, in the investigator's opinion, would
jeopardize the safety of the patient or compliance with the protocol.
- Pregnant or nursing (lactating) women;
- Women of childbearing potential and sexually active: they must be willing to use at
least one acceptable effective contraceptive measure (- progestogen-only oral hormonal
contraception, where inhibition of ovulation is not the primary mode of action , -
male or female condom with or without spermicide, - cap, diaphragm or sponge with
spermicide). Pregnancy test will be performed at screening and at the final/premature
withdrawal visit. The use of contraception in male patients is not required.
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 | Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn. | NCT03531372 | Entailment |
4,100 | 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:
• Adolescents (≥14 years old) and adults with a diagnosis of narcolepsy according to ICSD-3
criteria at their first ("incident") or with established diagnosis ("prevalent" subjects),
able to provide consent
Exclusion Criteria:
- inability to read, write, or using a tablet;
- major psychiatric disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
| TElemedicine for NARcolepsy | NCT04316286 | Entailment |
6,456 | 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 for subjects:
- Aged 18 and older
- Subjects that meet one of the following criteria:
- Healthy subjects without an inflammatory facial rash or an inflammatory eye
condition
- Subjects diagnosed with ocular rosacea or cutaneous rosacea (papulopustular or
erythematotelangiectatic) by either a board-certified dermatologist or
ophthalmologist
Exclusion Criteria
- Those who are prisoners or cognitively impaired.
- Those who have had any change to their hormonal birth control regimen in the last 4
weeks
- Systemic antibiotic use in the last four weeks
- Allergy or known intolerance to tetracyclines
- Those who wear contact lenses
- Autoimmune disease such as lupus, dermatomyositis that has cutaneous involvement
- Those who are pregnant or may become pregnant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Lipidome and Microbiome Profile of the Eye in Rosacea | NCT03655197 | Entailment |
1,944 | 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:
- Have signed the informed consent and can comply with the visit and related procedures
stipulated in the program
- Age ≥18 years old and ≤75 years old
- D2 radical resection was performed within 21-60 days before the beginning of the first
cycle of chemotherapy in this clinical study
- Preoperative neoadjuvant chemotherapy was not performed and Gastric and
gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma,
mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were
confirmed by postoperative pathological staging. Note: the presence of distant
metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone
metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be
performed
- Postoperative ECOG score was 0 or 1
- Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil
absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and
hemoglobin ≥ 90 g/L
- Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic
transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of
normal value
- Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR>45 ml/min
- Serum albumin ≥ 25 g/L (2.5g /dL)
- INR or PT ≤ 1.5 times ULN
- Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA
virus quantitative detection, only < the upper limit of the normal detection value can
be included in the group, and should long-term use of anti-hepatitis b drugs
- Tumor specimens can be provided for consultation (if the patient's surgical specimen
comes from another hospital), protein and gene testing
Exclusion Criteria:
- Postoperative wound healing is poor and chemotherapy is not appropriate to start
- Recurrent patients or suspected peritoneal metastases after radical surgery
- Known DPD enzyme deficiency
- Allergy to, or history of severe allergy to, or contraindication to any of the
experimental drugs or its excipients
- Patients who are expected to require major surgery during the study period
- Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or
CT-confirmed active pneumonia
- Tested positive for HIV
- Active hepatitis b or c
- Only liquid diet was allowed after the operation, with BMI <18kg/m2
- Uncontrolled pain
- A history of antitumor drug therapy other than radical surgery
- Severe infection in the active stage or with poor clinical control
- Use of hormones is contraindicated
- Severe cardiovascular disease, myocardial infection or cerebrovascular accident,
arrhythmia, unstable angina pectoris within 3 months before the trial
- Uncontrollable increase in blood pressure or blood sugar
- A history of other malignancies within 5 years, except for carcinoma in situ of the
cervix, non-melanoma skin cancer, or stage I uterine cancer
- Distant metastases are known
- Peripheral neuropathy ≥ NCI CTCAE grade 2
- Serum albumin < 2.5 g/dL
- Chronic enteritis
- Any other disease for which there is evidence of a need to limit the use of
experimental drugs
- Participate in additional trials up to 30 days before the trial or plan to participate
in additional trials while the trial is ongoing
- Receive other experimental drugs up to 28 days before the start of the trial
- Women who are pregnant or nursing, or who plan to become pregnant within five months
of the end of treatment. Women of childbearing age should receive a blood/urine
pregnancy test 7 days before the start of the trial
- Clinically significant active bleeding
- Patients who have trouble swallowing tablets
- Previous allogeneic bone marrow transplant or organ transplant
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 Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer | NCT04351867 | Entailment |
4,014 | 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:
- symptomatic early knee OA
- full weight-bearing status
- have elected to receive PRP treatment
- Male veterans
- Female veterans or non-veterans
Exclusion Criteria:
- inflammatory arthritis, gout or recurrent pseudogout
- symptomatic OA of other lower extremity joints
- BMI >35 kg/m2
- use of walking, orthopedic, or prosthetic assistive device
- severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or
above56
- inability to have MRI
- pregnant or intending to become pregnant during the study
- predominantly patellofemoral disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Precision Assessment of Platelet Rich Plasma for Joint Preservation | NCT03460236 | Entailment |
1,451 | 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:
- who have dysphagia symptoms and verified deglutition disorder by video fluoro
swallowing study
Exclusion Criteria:
- who reject the checkup their deglutition function by high resolution manometry
- who reject apply "Synchronized Electrical Stimulator"
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device | NCT02718963 | Entailment |
4,293 | 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:
- Healthy volunteers
Exclusion Criteria:
- Use of regular medication except the oral contraceptive pill
- Current smokers
- Significant occupation exposure to air pollution
- Intercurrent illness
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 50 Years | Woodsmoke Exposure and Cardiovascular Function | NCT01488500 | Entailment |
2,010 | 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:
- Patient consent
- Adequate tissue including adequate tumour burden
- Diagnosis of adenocarcinoma in this biopsy
Exclusion Criteria:
- No patient consent
- Inadequate tissue or block not present in archive
- No adenocarcinoma in biopsy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Retrospective Validations Microsatellite Instability (MSI) Testing v Mismatch Repair (MMR) in Gastric Adenocarcinoma | NCT04232020 | Entailment |
4,022 | 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:
1. Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
2. Symptomatic daily during the last month.
3. Symptomatic for more than one year.
4. Able to walk up and down a flight of 10 stairs with or without walking aids.
5. Able to walk 3 stairs up and down without walking aids.
6. Understand Norwegian orally and in writing.
7. Body mass index below 35.
Exclusion Criteria:
1. Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than
osteoarthritis of the knee which can negatively affect the walking ability, balance or
pain.
2. Body mass index above or equal to 35.
3. Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
4. Chronic generalized pain (American College of Rheumatology Criteria, 2010).
5. Inability to understand Norwegian language.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 70 Years | Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis | NCT03113149 | Entailment |
6,344 | 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:
- 3 days or less with clinical COVID-19 symptoms (fever, cough, sour throat, headache,
body ache, anosmia, diarrhoea, vomiting).
- sign inform consent.
- >50% risk developing a severe clinical presentation of COVID-19 according to risk
calculator
Exclusion Criteria:
- COVID-19 negative test
- known pregnancy
- chronic use of steroid medication
- deep vein thrombosis in the last 6 months
- extended anticoagulation in the last 3 months.
- known allergy to sulodexide.
- severe symptoms that warrant hospital care at initial screening
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 80 Years | Suloexide in the Treatment of Early Stages of COVID-19 | NCT04483830 | Entailment |
3,598 | 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:
1. Menstruating females with menorrhagia or menometrorrhagia referred to hematology or
gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular
periods with heavy menstrual bleeding with a PBAC score greater than 100;
menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals.
2. PBAC Score greater than 100 for 2 consecutive cycles
3. Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12
months prior to study participation.
4. Normal external genitalia examination within 6 months prior to study participation.
5. Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study
participation.
6. Negative urine or serum pregnancy test within 4 weeks prior to study participation.
Exclusion Criteria:
1. Presence of intra uterine device.
2. Presence of a diagnosed bleeding disorder based on the standard work-up including
complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen,
von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation.
3. Intake of medications with increased risk of bleeding
4. Taking herbal products.
5. Sexually active status.
6. Body weight less than 40 kg.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study | NCT01428713 | Contradiction |
783 | 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:
- Clinical diagnosis of Osteoarthritis Disease
Exclusion Criteria:
- Others Disease orthopedics
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Postural Analysis in Patients With Knee Osteoarthritis | NCT01031576 | Entailment |
4,371 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Being either male or female
- Being from 5 to 80 years of age
- Being considered normal weight, overweight, or obese based on specified BMI ranges
- Having a bodyweight of less than 440 pounds
- Being willing to comply with the study procedures
Exclusion Criteria:
- Having metal-containing objects in your body
- Being pregnant or attempting to become pregnant
- Being claustrophobic
- Having medical implants such as a pacemaker or metal joint replacements
- Being a professional athlete or someone with severe oedema or dehydration
- Having a body weight greater than 440 pounds
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 80 Years | Tanita BIA System Validation | NCT02118675 | Entailment |
4,423 | 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:
Invitations to participate in the study will be extended to male and female patients, 18
years and above, referred to the Orthopaedic Departments who receive a diagnosis of Lateral
Epicondyle Tendinosis (with or without degenerative changes) with symptoms present for > 3
months, whose symptoms and clinical evaluation warrant the prescription of a peri-tendinous
injection to relieve symptoms and who are competent to give informed consent.
Exclusion Criteria:
- Absence of tenderness at the lateral epicondyle.
- Congenital or traumatic bio-mechanical deformities of Elbow complex.
- Previous Corticosteroidal, Local Anaesthetic, PRP or Hyaluronic Acid injections to
target elbow within the last three months.
- Known hypersensitivity to PRP, Hyaluronic acid or any excipients associated with any
of the prescribed injections.
- Known contraindication to any treatments constituting normal/appropriate therapy in
the view of the Consulting clinician including local infection
- Ipsilateral arm pathology severe enough to cause confusion of localised pain
perception.
- Pregnant or lactating women
- Pain score less than 4/10
- Patients commenced on medication for the treatment of anxiety or depression within the
last 6 weeks
- Previous involved in research in last 12 months
- Any progressive, degenerative neuromuscular disorder
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 | Comparing Injection Treatments for Tennis Elbow | NCT03984955 | Contradiction |
1,397 | 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:
- Post-menopausal females aged greater 55 years
- Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the
previous 3 months and expected to continue on this treatment for the duration of the
study
- Willing to abstain from alcohol for 24 hours before each dose and until the end of
each study day
- Willing to abstain from smoking for 24 hours before each dose and until the end of
each study day
Exclusion Criteria:
- History of drug hypersensitivity
- Suffers from dysphagia, achalasia, or other conditions or medications affecting upper
gastrointestinal motility
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 75 Years | Upper GI Handling of Branded vs. Generic Alendronate | NCT00400530 | Contradiction |
4,130 | 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:
- Adult male or female same or older than age of 40
- Severity of acute exacerbation of Chronic obstructive pulmonary disease(COPD) must
suit oral administration treatment
- Diagnosed as COPD before receiving written informed consent and outcome measure of
spirometry testing confirmed as [Ratio of Forced Expiratory Volume in 1 second(FEV1)
to Forced Vital Capacity(FVC)](FEV1/FVC) < 0.7
- Subject showing following signs and symptoms:
(i)Purulent Sputum or Sputum level is increased (ii)Difficulty in breathing is
increased
- Female subjects who might be pregnant must do pregnancy test and results should be
negative before randomization is done. She must receive written informed consent form
(NOTE: Subject who has used single hormone contraception for pregnancy control or has
not been more than 1 year after Tubule ligation and menopause are excluded from the
study)
- Subject who can agree and sign written informed consent form approved by Institutional
Review Board(IRB) before participating in study and follow study requirements
Exclusion Criteria:
- Subject who administered excess daily dose of antimicrobial/antibiotics in past 72
hours before receiving written consent
- Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving
written consent
- Diagnosed to have infectious diseases or such diseases results in complications before
receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess,
Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema,
Asthma)
- Have kidney or liver diseases who correspond following criteria:
(i) Creatinine Clearance(CCr) < 50 mL/min (ii) Blood Urea Nitrogen(BUN) ≥ 30 mg/dl
(iii) Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 3 x Upper
Limit Normal(ULN) (iv) Total bilirubin > 2 x ULN (v) Alkaline Phosphatase(ALP) > 2 x
ULN.
- Organic gastrointestinal disorder having abnormal absorption problem condition in past
6 months before receiving written consent (NOTE: Active Crohn's disease, active
ulcerative colitis)
- Diagnosed to have neutropenia where absolute neutrophil count is < 1,000cells/mm3
(NOTE: Even though subject neutrophil count is < 1,000cells/mm3, if it is acute
infection, subject maybe possible to participate)
- Chronic Hepatitis B carrier
- Have proof that subject is Hepatitis C carrier or have Hepatitis C antibody
- Immunodeficiency diseases such as HIV positive, AIDS, Bone marrow transplant or
leukemia
- Have medical history of hypersensitive reaction to antibiotics of fluoroquinolones
- Have medical history of seizure or administration of anti-seizure drug in past 1 year
before receiving written consent (NOTE: Epilepsy, Convulsions, Myasthenia gravis)
- Medical history of ventricular arrhythmia
- Medical history of QTc prolongation or currently administering drug that delays QTc
interval (NOTE: QTc prolongation means QTc interval > 450 msec)
- Complex infections or diseases that can effect study assessment or need long-term
antibiotic treatment exceeding 7 days
- Subject who has participated in Clinical trials or Bioequivalence test in past 30 days
before receiving written consent
- Clinically significant by observations considered as unsuitable based on medical
judgement by investigators where current condition can effect quality of safety or
data
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.
| A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg | NCT01658020 | Contradiction |
5,434 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Males and females 18 years of age or older
- Confirmed VWD by 2 of 4 VWD coagulation tests abnormal
- A past bleeding history
- No hormone, oral contraceptive, estrogen use in past 8 weeks
- Willingness to have blood drawn
- Willingness to sign informed consent
Exclusion Criteria:
- Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia
- Use of estrogens, hormones, oral contraceptives in past 8 weeks
- Use of immunomodulatory or experimental drugs or diuretics
- Pregnant or lactating women
- Past cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial
flutter), hypertension, MI, stroke, or thrombosis
- Past allergic reaction to Neumega or DDAVP
- Surgery within the past 8 weeks
- Inability to comply with study protocol requirements
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin, or NSAIDs
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma, and plasma derivatives
containing FVIII, VWF within 5 days of study
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.
| Phase II Study of IL-11 (Neumega) in Von Willebrand Disease | NCT00151125 | Entailment |
3,677 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Patients with suspected CES
- Minimum age 18 years.
- Both sexes
- Able to provide informed consent for their data to be included in the study
Exclusion Criteria:
- Patients with pre-existing urinary tract pathologies (neuropathic bladder, urologic
pathologies or surgery, history of urinary incontinence.)
- Under age of 18 years.
- Patients with urinary catheter for whatever reason.
- Prisoners.
- Patients unable to provide informed consent for themselves.
- Previous spinal surgery
- Patients with urinary tract infections
- Patients with pre-existing neurological conditions affecting:
- Central nervous system such as multiple sclerosis
- Peripheral nervous system such as diabetic neuropathy, B12 deficiencies, thyroid
abnormalities
- Autonomic nervous system such as multiple system atrophy.
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.
| Post-void Bladder Scanning in Acute Cauda Equina Syndrome | NCT02806167 | Entailment |
4,735 | 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:
- Must be female
- Aged 18 to 50 years, with regular menstrual cycles.
- Healthy volunteers and women with von Willebrand's disorder are both being recruited.
Exclusion Criteria:
- Pregnancy
- Use of hormonal therapy including birth control pills
- Use of hemostatic agents such as DDAVP or anti-platelet agents.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Changes in Bleeding and Clotting During the Menstrual Cycle | NCT00480545 | Entailment |
4,902 | 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:
- Participant has been implanted with the DBS for ET
- Participant has significant voice tremor as determined by our
laryngology/speech-language pathology team
Exclusion Criteria:
- Participant does not have history of aphasia or other speech/language deficits
- Participant does not have history of stroke or multiple sclerosis
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 | Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres? | NCT02960243 | Contradiction |
6,666 | 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 (PTPs):
- Chinese participants with severe hemophilia A (defined as Factor VIII (FVIII): C < 1%
with one- stage clotting assay documented at the time of screening)
- Currently receiving on-demand or any type of prophylaxis treatment regimen with any
FVIII product
- For participants < 12 years of age, ≥ 50 exposure days (ED); for participants ≥ 12 to
65 years of age, ≥ 150 ED with any FVIII product
- No current evidence of inhibitor
- No history of FVIII inhibitor formation
- Signed informed consent
Part B (PUPs/MTPs):
- Participants must be <6 years of age at the time of their parent or legal
representative's signature of informed consent on the participant's behalf
- Chinese participants with severe hemophilia A (defined as Factor VIII (FVIII): C < 1%
with one- stage clotting assay documented at the time of screening)
- PUPs must have no previous exposure to any FVIII product. MTPs must have no more than
1 ED with any purified FVIII concentrate or 3 exposures with FFP or cryoprecipitate.
- MTPs must have no current evidence of inhibitor antibody as measured by the
Nijmegen-modified Bethesda assay (<0.6 BU/mL) in 2 consecutive samples and must have
absence of clinical signs or symptoms of decreased response to FVIII administration.
Testing for the 2 negative samples must be performed by the central laboratory at
least 1 week but not more than 2 weeks apart. Participants may not receive FVIII
product within 72 hours prior to the collection of samples for inhibitor testing.
- PUPs and MTPs must observe a 6-month washout period if they have received subcutaneous
factor substitution therapy (emicizumab).
- PUPs may be included if they will receive their first FVIII dose with KOVALTRY for
treatment of first bleed and agree to start prophylaxis as part of their care. MTPs
may be included if they agree to start prophylaxis as part of their care.
Exclusion Criteria:
Part A (PTPs):
- Any other bleeding disease that is different from hemophilia A (e.g. von Willebrand
disease, hemophilia B)
- Platelet count < 100 000/mm^3
- Impaired renal function (serum creatinine > 2.0 mg/dL) or active liver disease
(alanine aminotransferase/aspartate aminotransferase [ALT/AST] > 5x ULN)
- Human immunodeficiency virus (HIV) positive with an absolute CD4 lymphocyte cell count
< 250 cells/μL
- Known hypersensitivity to the active substance, mouse or hamster protein
- Receiving chemotherapy, immune modulatory drugs other than anti-retroviral
chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (> 14 days)
within the last 3 months.
- Requiring any pre-medication to tolerate FVIII infusions (e.g. antihistamines)
- Currently participating in another investigational drug study, or having previously
participated in a clinical study involving an investigational drug within 30 days of
signing informed consent or participated in completed interventional clinical studies
with BAY81-8973 (Kovaltry)
- Planned major surgery, defined as surgery with respiratory assistance and/or general
anesthesia
Part B (PUPs/MTPs):
- Any other bleeding disease that is different from hemophilia A (e.g. von Willebrand
disease, hemophilia B)
- Platelet count < 100 000/mm^3
- Impaired renal function (serum creatinine >2× upper limit of normal [ULN]) or active
liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >5×
ULN) based on screening laboratory assessments
- MTPs with history of FVIII inhibitor formation
- Known hypersensitivity to the active substance, mouse or hamster protein
- First treatment with KOVALTRY for high risk bleeding situations (e.g., surgery,
intracranial bleed) or requiring intensive or prolonged treatment
- Receiving chemotherapy, immune modulatory drugs other than anti-retroviral
chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (> 14 days)
within the last 3 months.
- Requiring any pre-medication to tolerate FVIII infusions (e.g. antihistamines)
- Currently participating in another investigational drug study, or having previously
participated in a clinical study involving an investigational drug within 30 days of
signing informed consent or participated in completed interventional clinical studies
with BAY 81-8973 (Kovaltry)
- Planned major surgery, defined as surgery with respiratory assistance and/or general
anesthesia
- Unable to tolerate volume of blood draws required for study participation
Male
No healthy subjects accepted to join the trial.
Subject must be at most 65 Years | A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A | NCT04565236 | Contradiction |
5,122 | 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:
- aged ≥ 65
- Functional Ambulation Category (FAC) score ≥ 3
- able to walk for ≥ 10 meters
- living in the community
- Montreal Cognitive Assessment-5-minute protocol score ≥ the 16th percentile of the age
and education adjusted cutoff score (i.e., being cognitively intact)
- can communicate effectively in Cantonese.
Exclusion Criteria:
- on prescription anti-osteoporotic medications
- have uncorrected vision or hearing impairment
- have an unstable condition or terminal disease that is unlikely to resolve and may
preclude the planned assessments (e.g. malignant arrhythmias).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults | NCT04709393 | Contradiction |
4,731 | 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. | Key Inclusion Criteria:
- Healthy male and female subjects between 18 to 65 years of age.
- Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
- Physical examination and vital signs are within normal range or slightly abnormal.
Key Exclusion Criteria:
- History or current liver disease, or liver injuries.
- A positive HBsAg, HCV Ab and/or HIV Ab.
- Platelet count <150,000/mcL
- INR> 1.2
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 | Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects | NCT04679129 | Entailment |
6,941 | 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
- Subjects aged 60 or over
- Subjects with Alzheimer's disease, according to the NINCDS/ADRDA diagnostic criteria
71
- MMSE > 18
- Subjects with at least one VRF (whether treated or not): arterial hypertension
(defined as SBP/DBP ≥ 140/90 mmHg in at least three different consultations or, for
ambulatory measurements, > 130/80 mmHg with a Holter recorder or > 135/85 mmHg with a
self-measurement device), type 2 diabetes (defined as a glycaemia value over 1.26 g/l
(7 mmol/l) after an 8-hour fast (confirmed on two occasions), dyslipidaemia (defined
as an LDL cholesterol level > 1.6 g/l or 1.3 or 1 g/l, depending on the patient's risk
level)
- Subjects having agreed to participate in the study (provision of informed consent).
- Subjects accompanied by a person likely to provide information on the patient (during
the visit or over the phone).
Exclusion criteria
- Any other disease that might interfere with the evaluation of cognitive disorders.
- No formal education or a poor understanding of French (interfering with administration
of the neuropsychological tests).
- Major physical problems likely to interfere with administration of the tests (poor
eyesight, hearing, etc.).
- Non-Alzheimer's dementia (isolated vascular dementia, Lewy body dementia,
frontotemporal dementia, etc.)
- Psychotropic drugs likely to modify the patient's non-stabilized cognitive state.
- Patients with a history of cardiovascular events can be included (randomization will
be balanced in terms of this criterion).
- Participation in a therapeutic clinical trial 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 60 Years old.
| Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease | NCT01423396 | Entailment |
5,770 | 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:
- 1. Male or female patients aged ≥18 years old with severe primary RAS resistant to
colchicine prescribed at a dose of 1mg/day or more for at least 3 months, or
intolerant to colchicine
Severity of primary oral aphtous ulcer is defined by the presence of at least one of the
following criteria:
i) - At least one giant oral ulcer (≥ 1cm in diameter) confirmed by the investigator during
the month preceding inclusion and/or, ii) - Multiple simultaneous oral ulcers ( ≥4),
including herpetiform ulcers confirmed by the investigator during the month preceding
inclusion and/or, iii) - Continuous evolution of oral ulcers, some lesions healing, as
newly appearing oral ulcers develop within the month before inclusion and/or, iv) - Oral
ulcers occurring at least 7 days each month during the previous 3 months and/or v) - Major
pain related to oral ulcers interfering with eating, speaking, or swallowing
- In all cases, patients must have at least one oral ulcer on the date of inclusion
2. Patient having read and understood the information letter and signed the Informed
Consent Form 3. For women who are not postmenopausal and who do not plan on having children
anymore: agreement to remain abstinent or use two adequate methods of contraception 4.
Patient able to comply with the study protocol, in the investigator's judgment 5. Patient
affiliated with, or beneficiary of a social security (health insurance) category
Exclusion Criteria:
1. Patient has any significant medical condition, significant laboratory abnormality, or
psychiatric illness that would prevent the subject from participating in the study.
2. Patient has secondary RAS (e.g., celiac disease, Crohn's disease, ulcerative colitis,
relapsing polychondritis, PFAPFA, AIDS…).
3. Depression and suicidal ideation
4. Co-medication with a cytochrome P450 3A4 (CYP3A4) enzyme inducer ( especially,
rifampicin and most anti-epileptic drugs (e.g. carbamazepine, phenytoin)
5. Severely underweight patient (BMI < 18.5 kg/m2)
6. Patient cannot be followed regularly.
7. Patient has any other inflammatory oral disease, which confounds the ability to
interpret data from the study (ie, lichen planus, auto immune bullous diseases with
oral involvement),
8. Patient has any medical condition that requires systemic treatment which may confound
the ability to interpret data from the study (ie, lupus erythematosus, rheumatoid
arthritis...)
9. Patient is currently enrolled in any other therapeutic trial.
10. Other than RAS, subject has any clinically significant (as determined by the
Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,
renal, hematologic, immunologic disease, or other major disease that is currently
uncontrolled.
11. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative
disease within the past 5 years, except for treated (ie, cured) basal cell or squamous
cell carcinomas, in situ cervix carcinoma, or any situation in which the oncologist in
charge of the patient considers that oncologic risk allows the use of apremilast.
12. Patient with positive blood test for HIV.
13. Any bacterial infections requiring treatment with oral or injectable antibiotics, or
significant viral or fungal infections, within 4 weeks of Screening. Any treatment for
such infections must have been completed and the infection cured, at least 4 weeks
prior to Screening and no new or recurrent infections prior to the Baseline Visit.
14. Patient has received a live vaccine within 3 months of baseline or plans to do so
during study.
15. Patient is a pregnant or breastfeeding (lactating) woman or intending to become
pregnant during the study; Women who are not postmenopausal (≥ 12 months of
non-therapy-induced amenorrhea) or surgically sterile must have a negative result from
a serum pregnancy test within 1 week prior to randomization.
16. Patient has used systemic therapy which may potentially be effective in RAS within
four weeks prior to randomization (including, but not limited to corticosteroids,
azathioprine, levamisole, thalidomide).
17. Patient has used biologic therapy including anti TNF within 5 pharmacokinetic
half-lives.
18. Prior treatment with apremilast, or participation in a clinical study, involving
apremilast.
19. Patient has any condition including the presence of laboratory abnormalities, which
places the subject at unacceptable risk if he/she were to participate in the study.
20. Galactose intolerance, lactase deficiency or glucose/galactose malabsorption
21. Patient is deemed unreliable or for any reason not able to comply with the protocol
22. Patient with alcohol dependency
23. Male patient intending to conceive a child with his partner
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.
| Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis | NCT04227314 | Contradiction |
1,007 | 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:
- Able and willing to give informed consent and to comply with the study protocol and
follow-up instructions.
- Symptomatic OA of the knee, as defined by the American College of Rheumatology's
Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are
bilateral, then the knee identified by the subject as more symptomatic will serve as
the index knee.
- Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while
walking on a flat surface (corresponding to question 1 of the visual analog format of
the WOMAC.
- Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren
and Lawrence (K-L) grading scale.
- Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or
the presence of medial bone cyst, sclerosis, or osteophyte.
Exclusion Criteria:
- Inability or unwillingness to wear study shoes for at least 6 hours/day for 6
days/week
- Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
- Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm
at these sites (WOMAC).
- > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the
mechanical axis (hip-knee angle).
- Predominant lateral compartment OA, defined as narrowing of the lateral joint space in
excess of the narrowing of the medial joint space in either the index or the
contralateral knee.
- Concurrent systemic inflammatory arthropathy,
- Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous
3 months or history of fracture of either lower extremity within 6 months of study
entry.
- Intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia,
plantar fasciitis, peripheral neuropathy, or any foot condition that may be
exacerbated by particular footwear.
- Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan
derivatives within 4 months.
- Pregnant subjects will be excluded because of the X-rays required.
- Any medical condition that, in the opinion of the PI, would render the subject unable
to complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Effects of Specialized Footwear in Osteoarthritis | NCT01597830 | Entailment |
4,558 | 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:
- Willing to provide informed consent
- Willing to take COCs and follow all study requirements
- Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
- Last menstrual period (LMP) <35 days before study entry
- Has body mass index of 18-30
- Negative urine pregnancy test as enrollment
- Documented HIV-1 infection
- On nevirapine-containing ART for at least three months (ART group only)
- CD4 cell count of greater than or equal to 350 (for non-ARV group only)
- Currently sexually active and plans to stay sexually active for the next 6 months
Exclusion Criteria:
- Medical contraindications to COC use
- Recent pregnancy (within 3 months)
- Has breastfed in last 3 months
- Last pregnancy was ectpoic
- Has been sterilized
- Has had any of the following conditions since last pregnancy, or since menarche if
never pregnant:
Pelvic Inflammatory disease Diagnosis of infertility
- Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has
had no menses since last injection regardless of its timing)
- has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin
implants or intrauterine systems, progestin-only contraceptive pills,
medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study
entry
- Has an acute infection or other opportunistic diseases requiring therapy within 14
days before enrollment
- Has active drug or alcohol use that, in the opinion of the investigator, would
interfere with adherence to study requirements
- Has taken any prohibited medication within 30 days before study entry
- Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
- Has any condition (social or medical) which in the opinion of the investigator would
make study participation unsafe or complicate data interpretation
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs) | NCT00829114 | Contradiction |
5,600 | 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:
- Adolescents between 13 and 19 years old.
- Obese or overweight according to the IOTF.
- No physical or medical impediment for performing physical activity.
- No risk for eating disorders (SCOFF questionnaire).
- Report less than 20 minutes of physical activity per day.
- Have an active Facebook account and use it more than 20 minutes per day.
- Low-risk in the Gatehouse Bullying Scale.
Exclusion Criteria:
- Physical or medical impediment for performing physical activity.
- Answer "yes" at least twice on the SCOFF questionnaire.
- Report more than 20 minutes of exercise per day.
- Not having an active Facebook account or using it less than 20 minutes per day.
- "High Risk" on the Gatehouse Bullying Scale.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 19 Years | Use of Facebook as a Motivating Factor in a Weight-reduction Program for Obese and Overweight Adolescents | NCT01819376 | Contradiction |
3,931 | 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:
- Individuals diagnosed with knee osteoarthritis II-III level according to the results
of radiological evaluation by Kellgren and Lawrence
- Individuals aged between 40 and 65 years
- Individuals who have pain in his/her either of the knees in 3 month period and who
have a VAS score of 3 or more
- Individuals who can walk 10 meters independently (with or without ancillary device)
Exclusion Criteria:
- Individuals with Body Mass Index 35 and above
- Individuals with a history of surgery or injury involving the lower limb within the
last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
- Individuals who received hyaluronic acid or corticosteroid injections in the last year
- People with severe eyesight, hearing disabilities Individuals with neurological
deficit or disorder
- Individuals with regular exercise habits in the last 6 months
- Individuals with inflammatory rheumatic diseases.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | The Validity, Reliability and Responsiveness of the Fullerton Advanced Balance Scale in Osteoarthritis | NCT03728387 | Entailment |
4,087 | 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. Patients diagnosed with narcolepsy type 1 or type 2 based on the International
Classification of Sleep Disorders, third edition (ICSD-3) criteria for at least 6
months - diagnosis for at least 6 months will ensure that initial fluctuations due to
likely starting on new drug regimen are relatively stable.
2. Eligibility screened and agreement of the participant's treating clinician in
Narcolepsy out-patient clinic of St. James's Hospital that he/she can participate - to
ensure that as per General Data Protection Regulation guidelines that the treating
clinician eligibility screens rather than the physiotherapy study researcher.
3. Patients aged ≥18 to <65 years at the time of obtaining informed consent - as patients
>18 years will not been seen in this centre, and patients >65 years may have
age-related changes in cardiovascular fitness and physical activity which may be
difficult to separate from those pertaining to narcolepsy diagnosis.
4. Able to understand English - as questionnaires will necessitate a sufficient level of
English for completion.
Exclusion Criteria:
1. Patients with sleep disorders other than narcolepsy (e.g., moderate to severe sleep
apnea syndrome, moderate to severe periodic limb movement disorder) - so results are
not diluted by including conditions other than narcolepsy.
2. Any medical contraindication to exercise of moderate intensity and short duration
including but not limited to cardiovascular or respiratory conditions, morbid obesity,
and severe osteoarthritis of the lower extremities - as these conditions would
preclude ability to conduct physical test battery.
3. Confirmed pregnancy - people with an advanced pregnancy may score differently on
physical functioning/performance tests, people with a confirmed pregnancy will be
excluded from study participation to limit bias.
4. Dementia or significant cognitive impairment or psychiatric illness that would
preclude ability to participate in study.
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 | 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy' | NCT04419792 | Entailment |
6,189 | 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:
- Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test
or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of
the following two criteria:
1. Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen
saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
2. Requiring invasive mechanical ventilation.
Exclusion Criteria:
- Patients with a viral infection other than COVID-19
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 90 Years | Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia | NCT04381858 | Contradiction |
3,280 | 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:
- aged of 18 years or more
- Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Exclusion Criteria:
- secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
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 ASSESS National Multi-center Prospective Cohort | NCT03040583 | Entailment |
1,315 | 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. | - ELIGIBILITY CRITERIA FOR ALL PARTICIPANTS:
All study participants must be of self-described African or African American ancestry. They
will be at least 18 years old and must be able to provide informed, written consent for
participation.
INCLUSION CRITERIA:
Inclusion Criteria for Sickle Cell Patients
1. Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S
beta + thalassemia by electrophoresis is required).
2. If taking chronic analgesics (NSAID, acetaminophen) or opioids, study subjects should
be on a stable dose for 4 weeks prior to recruitment.
Inclusion Criteria for Control Subjects
1. Hemoglobin AA genotype by HPLC or hemoglobin electrophoresis.
2. General good health defined as the absence of untreated major medical conditions (e.g.
uncontrolled systemic hypertension, etc.).
EXCLUSION CRITERIA:
Exclusion Criteria for Sickle Cell Patients
1. History of severe vaso-occlusive pain crisis resulting in either evaluation in an
emergency department or admission to a hospital during the two weeks prior to study
enrollment.
2. Acute pain at the time of enrollment defined as spontaneous recent onset pain with a
self rated score of 6 or higher on a scale of 0-10. (This is acute pain not the pain
that subjects function at on a daily basis.)
Exclusion Criteria for Control Subjects
1. Acute pain or injury at enrollment or a recent history of chronic pain (daily pain
reported for at least 6 months) in the past 3 years.
2. Major medical/psychiatric illness known to cause pain.
3. Sickle cell trait.
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 99 Years | Genetics and Pain Severity in Sickle Cell Disease | NCT01441141 | Contradiction |
3,445 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study | NCT02521922 | Entailment |
4,938 | 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 alcohol-responsive Essential Tremor
- Limb involvement should be a prominent feature of the Essential tremor
- Patients must be willing and able to safely stop and remain off any medications used
to treat essential tremor for at least 4 half-lives
- Patients must be willing to abstain from ethanol and caffeine intake for at least 48
hours prior to starting the study hospitalization until study termination
- Patients must be willing and able to fast for periods of up to 12 hours during the
study
EXCLUSION CRITERIA:
- Patients with abnormalities other than tremor on neurological exam
- Patients with active or past alcohol abuse or dependence
- Patients with acute or chronic severe medical conditions such as renal failure,
hepatic failure or lung disease
- Patients taking primidone
- Patients on other acute or chronic medications that influence hepatic metabolism or
central nervous system (CNS) function and cannot be temporarily discontinued for the
length of the study
- Patients who do not wish to take a potentially intoxicating drug
- Patients with abnormalities on their baseline screening laboratory tests
- Women who are pregnant or lactating
- Patients younger than age 21
- The presence of cognitive impairment preventing informed consent or cooperation during
the study
- People of Far East Asian or Native American descent, who may possess variant alleles
of the genes for alcohol metabolism, i.e., alcohol dehydrogenase and aldehyde
dehydrogenase, resulting in altered (slower) metabolism and potentially increased
sensitivity to alcohols and their metabolites
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.
| Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor | NCT00102596 | Entailment |
4,213 | 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:
- Age between 18-45 years old;
- Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the
range of 19~28kg/m2
- Healthy men or women based on history, physical examination, laboratory examination
and ECG.
- Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral
ovariectomy or hysterectomy); or are willing to use at least one of the following
contraceptive methods within 30 days of the first administration of the study drug
until the last administration: I Male partner vas deferens ligation; II. Non-hormonal
contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges,
septa, vaginal ring containing sizing gel or cream.
- Male subjects should be surgically sterilized; or are willing to use at least one of
the following contraceptive methods within 30 days from the first administration of
the study to the last administration: I. Female partners abstinence during the study
period (including no donation): II. Compounds use hormonal contraceptives (oral,
vaginal, parenteral or transdermal); III. Subjects and / or their female partners use
non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes,
intrauterine devices, Fine gel or cream of the vaginal ring.
- If female, the pregnancy test result should be negative during the screening period.
- Voluntary to sign the informed consent.
Exclusion Criteria:
- History or presence of cardiovascular disease, respiratory disease, endocrine and
metabolic system disease, urinary system, digestive system, hematological system
diseases, nervous system or Psychiatric diseases, and acute or chronic infectious
disease and malignant tumor.
- A history of drug or food allergy.
- Positive test in any of the HBsAg、HCV Ab、HIV Ab and Syphilis Ab.
- Any of the AST、ALT、ALP、TBIL and DBIL exceed the upper limits of normal, or other
laboratory test results exceeding the normal range and judged by the investigator to
be clinically significant.
- History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other
surgeries that could disturb gastrointestinal motility and PH absorption.
- Female who were during pregnancy, breastfeeding, period and unwilling to take reliable
birth control method.
- Female partners were fertile and unwilling to take reliable contraceptive measures.
- Others as specified in the detailed 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 45 Years | Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China | NCT03288636 | Contradiction |
6,116 | 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. Age at least 18 years
2. Ability and willingness of participant or Legally Authorized Representative (LAR) to
give written informed consent.
3. Laboratory confirmed diagnosis of infection with SARS-CoV-2 by PCR
4. Hospitalized for COVID-19 with one or more respiratory or gastrointestinal (GI)
symptoms:
- COVID-19 associated respiratory symptoms include but are not limited to: cough,
shortness of breath, difficulty breathing, or sore throat
- COVID-19 associated GI symptoms include but are not limited to: loss of taste,
loss of sense of smell, diarrhea, nausea, or vomiting,
Note: Respiratory and GI symptoms other than those listed above, must be noted as
acceptable and signed by study PI or designee.
Exclusion Criteria:
1. Receipt of pooled immunoglobulin in past 30 days
2. Current or prior enrollment in a SARS-CoV-2 antibody or T-cell therapeutic study.
Note: Patients enrolled on other randomized controlled trials of pharmaceutical and/or
non-pharmaceutical interventions for COVID and meeting eligibility criteria will not
be excluded, as determined by study PI (or designee) on a case-by-case basis and as
allowed by eligibility criteria of the other trials.
3. Contraindication to transfusion or history of prior reactions to transfusion blood
products. This may include religious or cultural objections to receiving blood
products and transfusions.
4. ABO-compatible titered plasma is not available
5. > 10 days from noted COVID-related subjective or objective fever at randomization.
Patients without subjective or objective fever, > 10 days from symptom onset as
determined by study PI.
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 99 Years | COVID-19 Antibody Plasma Research Study in Hospitalized Patients | NCT04524507 | Contradiction |
5,493 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Patients suspected of temporal arteritis and referred by their physicians to biopsy of
a temporal artery.
Exclusion Criteria:
- Pregnancy; age > 80 or < 18; unable to answer study questions
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 | Diagnostic Study of Temporal Arteritis | NCT01130857 | Contradiction |
6,406 | 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. - Probable COVID-19 based on presence of at least 5 of the following symptoms of acute
onset within the prior 4 days: fever, cough, sore throat, fatigue, episodic chest pain
or shortness of breath with exercise, muscle or body aches, headache, loss of smell or
taste, stuffy or runny nose, chills or shivering, feeling hot or feverish, nausea,
diarrhea
2. - Subjects must signify that they have contacted a doctor about their current
symptoms.
3. - Subject gives informed consent for study and is willing to take the treatments and
complete the scheduled evaluations.
4. - Subject has acquired a study partner who has agreed to complete the follow-up forms
for the subject if the subject unable or has been hospitalized.
Exclusion Criteria:
1. - Constant rather than episodic trouble breathing, Persistent pain or pressure in the
chest, New confusion, Inability to wake or stay awake, Bluish lips or face, or any
other severe symptom [symptoms CDC urges immediate medical care for].
2. - Known sensitivity or intolerance to famotidine or another acid-blocking drug.
3. - Lack of access to the internet at home.
4. - Using tizanidine (Zanaflex® , a muscle relaxant), dasatinib (Sprycel®, a drug for
leukemia), cefditoren (Pivoxil®, an antibiotic), or fosamprenavir or delavirdine
(drugs for HIV) [Drug exclusions are per US label for Pepcid].
5. - Significant heart or kidney disease in the last 3 months according to subject's
primary doctor
6. - Pregnant women
7. - Taking any investigational medications to treat COVID-19, famotidine, anti-viral
drugs or corticosteroids and not stopping them within 48 hours before starting study
treatment.
NOTE: patients are allowed to take over-the-counter agents for temporary relief of symptoms
such as antipyretics and analgesics (aspirin, ibuprofen etc), cough remedies,
anti-diarrheals, etc.
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.
| Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19) | NCT04565392 | Entailment |
3,890 | 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:
- Is male or female ≥ 40 years of age
- If a participant in the previous MEL3-12-02 study, completed the study and did not
discontinue for lack of efficacy or safety
- Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for
OA pain
- If female and of childbearing potential, is nonlactating and nonpregnant
Exclusion Criteria:
- History of allergic reaction or clinically significant intolerance to acetaminophen,
aspirin, or any NSAIDs, including meloxicam
- Requires continuous use of opioid or opioid combination products to control OA pain of
the knee or hip
- Clinically significant unstable cardiac, respiratory, neurological, immunological,
hematological, or renal disease
- Significant difficulties swallowing capsules or unable to tolerate oral medication
- Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device,
or therapy within 30 days before Screening
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.
| Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip | NCT01801735 | Entailment |
4,789 | 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:
- Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus
throughout much of the waking day.
- Subject is able to use the electronic diary to complete their daily tinnitus ratings
- Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural
hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear
injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear
barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
- Subject is willing to comply with the protocol and attend all study visits.
Exclusion Criteria:
- Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury,
or tinnitus resulting from a tumor or stroke.
- Subject is pregnant or lactating.
- Subject has other clinically significant illness, medical condition or medical history
at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely
reduce the safety of study participation or compliance with study procedures.
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 | OTO-313 in Subjects With Subjective Tinnitus | NCT03918109 | Entailment |
5,388 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Employee or dependent of an intervention or control employer
Exclusion criteria:
- Not continuously enrolled in health plan and therefore some claims may be missing
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 99 Years | The Effect of Financial Incentives on Utilization of Low-cost Providers | NCT02249156 | Entailment |
4,527 | 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:
- Body Mass Index between 20-30 Kg/m2
- regular menstrual cycles
- sedentary lifestyle (physical activity not more than 30 minutes per day three times a
week)
Exclusion Criteria:
- Fasting blood sugar greater than 110 mg/dL
- Systolic Blood Pressure greater than 140 mmHg
- Diastolic Blood Pressure greater than 90 mmHg
- Fasting triglycerides greater than 120 mg/dL
- Documented or self-reported chronic disorders such as arthritis, or other inflammatory
diseases
- Women who are Post-menopausal or Peri-menopausal
- Pre-menopausal women who are pregnant, uni/multiparous, taking oral contraceptives, or
who have menstrual cycles lasting less than 20 days or greater than 45 days,
polycystic ovary syndrome (PCOS), amenorrhea, eumenorrhoea, or polymenorrhoea.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Menstrual Cycle Hormones and Eating Behavior | NCT01407692 | Contradiction |
1,791 | 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:
- Apparently healthy; no medical conditions that might affect the study measurements (as
determined by the study physician)
- No use of medication that would interfere with the study measurements (as determined
by the study physician)
- No use of antibiotics in the 3 months before the study or during the study
- No reported participation in another nutritional or biomedical trial 3 months before
the study or during the study
- Being used to eating 3 meals daily
- BMI: 20 - 35 kg m-2
- No reported participation in night shift work 2 weeks prior to the study or during the
study
- Not taking part in strenuous exercise ≤10 hours/week
- Not consuming more than 21 alcoholic test meals in a typical week
- Not presently a smoker
- No reported weight loss or gain of more than 10 % of bodyweight for 6 months before
the study
- No eating disorder
- No MRI contraindications; i.e absence of metal implants, infusion pumps and
pacemakers, as assessed by a MRI safety screening questionnaire
Exclusion criteria:
- High or very high restrained eater
- Use of any medically- or self-prescribed diet for the duration of the study
- Allergies or food intolerances
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | MRI Study of Stomach Volumes and Satiety | NCT01690182 | Contradiction |
4,120 | 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:
- All Non obstructive Azoospermic Patients.
- Azoospermic Patients due to Administration of Chemo/Radiotherapy.
Exclusion Criteria:
- Patients with Testicular Cancer.
- Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 50 Years | MSCs For Treatment of Azoospermic Patients | NCT02025270 | Contradiction |
230 | 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-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular
menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to
hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries
according to transvaginal ultrasonography during past 6 months prior to study and
compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less
than 8 IU/l All women showed no recognizable endometriosis according to symptoms and
clinical examination in transvaginal ultrasonography or diagnostic laparoscopy.
7-7-All women have a history of unexplained infertility 8-Normal ovulatory function
and normal semen analysis according to the World Health Organization criteria .
Exclusion Criteria:
- Patients with other ovulation disorders such as hypo and hypergonadotropic,
hypogonadism, hyperprolactinemia.
2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous
history of systemic diseases such as endocrine and metabolic disorders.
6- Previous history of inappropriate ovarian response to stimulation with
gonadotropins (poor responders).
7-Prior history of more than 3 unsucce
Female
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle | NCT04539613 | Contradiction |
4,656 | 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:
Premenopausal women aged 30 - 50 years old scheduled for vaginal, abdominal or laparoscopic
total hysterectomy one or more of the following clinical symptoms:
- bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea),
- chronic pelvic pain,
- dysmenorrhoea,
- or dyspareunia junction zone definable
Exclusion Criteria:
- postmenopausal women,
- pregnancy
- gynecological cancer
- GnRH analog therapy or systemic hormone therapy in the last three months prior to
hysterectomy
- junctional zone not identifiable
Female
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis | NCT02197923 | Entailment |
6,965 | 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 Alzheimer patient group:
- Signed Informed Consent.
- Male or female subject, between 55 and 85 years inclusive.
- Specific clinical phenotype of AD: Presence of an early and significant episodic
memory impairment (isolated or associated with other cognitive or behavioural changes
that are suggestive of a dementia syndrome) that includes the following:
- Gradual and progressive change in memory function reported by patient or
informant over more than 6 months.
- Objective evidence of an amnesic syndrome of hippocampal type, based on
significantly impaired performance on an episodic memory test with established
specificity for mild to moderate AD.
- Cognitive tests including MMSE score 12 ≤ MMSE ≤ 25 for mild to moderate AD (measured
in the last 3 months), b) Scores of other tests routinely practiced at the hospital
for measurement of memory and cognition shall be compatible with mild to moderate AD.
- Neuroimaging compatible with a diagnosis of mild to moderate AD.
- Cerebrospinal fluid (CSF) biomarkers showing at least 2 positive levels out of the 3
biomarkers: CSF Aβ1-42 and tau (Phosphorylated-Tau and/or Total-Tau). CSF collection
and data being only retrospective.
Inclusion Criteria for healthy controls:
- Signed Informed Consent.
- Male or female subject, between 55 and 85 years inclusive.
- Normal clinical and cognitive scores as measured using standard neuropsychological
tests.
- Normal scores in other neuropsychological tests routinely practiced at the hospital
for measurement of memory and cognition.
- No abnormal neuroimaging findings in at least structural MRI.
Exclusion Criteria:
- Any subject who did not sign the informed consent form.
- Any chronic neurodegenerative disease (vascular dementia, Parkinson's disease,
Creutzfeldt Jacob, Huntington's disease, etc.), acute neurodegenerative disease
(stroke), history or presence of clinically relevant psychiatric history
(schizophrenia, psychosis), some chronic inflammatory diseases that impact blood cells
(e.g. anemia of inflammation and chronic disease) and some cancers (that impact blood
cells: e.g. leukemia), major sensory deficits that could interfere with cognitive
assessment (visual and auditory), epilepsy.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice
a month).
- Blood donation, any volume, within 2 months before inclusion.
- Neutropenia (Neutrophils < 1500/mm3).
- Thrombocytopenia (platelets: < 100,000/mm3, rule out EDTA-induced
pseudothrombocytopenia).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 85 Years | ADDIA Chronobiological Study | NCT02973971 | Entailment |
1,696 | 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:
- Adults over 18, capable of informed consent
Exclusion Criteria:
- History of arrhythmia. Has implanted pacemaker or defibrillator, right
wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right
hand or wrist, or with any metallic objects that cannot be removed from the right hand
or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute
or more than 100 per minute, resting respiratory rate greater than 25 per minute,
diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the
study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Sensory Effects of Rapidly-Changing Magnetic Fields | NCT01632800 | Entailment |
1,637 | 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:
- be an amateur practitioner of the Crossfit modality with at least 6 months of regular
sports practice (at least 4 times a week)
- between 18-40 years old
- agree to participate in the study and sign the informed consent form (ICF).
Exclusion Criteria:
- active wrist/ arm injury or pain on the day of the test (pain score greater than 3 in
10 for both shoulder, forearm, wrist and / or hand on the VAS pain scale)
- history of wrist injury (especially fracture or ligament injury)
- previous wrist surgery
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 40 Years | Influence of Wrist Taping on Handgrip Strength in Crossfit Athletes | NCT04780906 | Entailment |
845 | 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:
- Hand OA
- Age over 40
- Visual analogic scale (VAS) for pain at rest between 3-8cm
- Signed informed consent term
Exclusion Criteria:
- Change in the use of oral corticosteroid or nonsteroidal antiinflammatory (NSAID) in
the last 30 days
- Change in drugs for OA in the last two months
- IAI in this joints in the last three months
- Any change in treatment for OA in the hands in the last two months
- Suspicion of local and or systemic infection, and pregnancy
- Hands X-ray suggesting arthropathy of the interphalanges of other etiology
- Serious coagulation disorder
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.
| Corticosteroid Intra-articular Injection in Hands Osteoarthritis | NCT02102620 | Entailment |
475 | 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:
- Age 18-50 years, inclusive
- General good health (by volunteer history and investigator judgment)
- Currently having regular menstrual cycles of 21 - 35 days by volunteer report
- Protected from pregnancy, meaning one of the following: Sexually abstinent and
planning to remain abstinent for the duration of the study; In a monogamous
heterosexual relationship for at least four months with a partner who is not known to
be HIV positive and has no known risks for sexually transmitted infections (STIs) and:
Couple is using condoms and is willing to use non-spermicidally lubricated condoms
throughout the study or One partner is sterilized; or in a monogamous same-sex
relationship for at least four months with a partner who is not known to be HIV
positive and has no known risks for STIs.
- Willing to abstain from vaginal activity and vaginal product use as required in the
protocol
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy examination
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within two calendar months from the last pregnancy outcome.
Note: If recently pregnant must have had at least two spontaneous menses since
pregnancy outcome
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 6 months
- Current use of copper intrauterine device (IUD)
- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study products
- Symptomatic reproductive tract infection (RTI)
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial (device, drug, or vaginal trial)
within the last 30 days or planned participation in any other investigational trial
during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
- Abnormal finding on physical examination or a social or medical condition which, in
the opinion of the investigator, would make participation in the study unsafe or would
complicate interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products | NCT02534779 | Contradiction |
6,419 | 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:
- Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by
the treating physician.
- Subjects must have visible telangiectasia on the side of the face.
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the
sun.
- Subject willing to have photographs taken and used in presentations or publications.
Exclusion Criteria:
- Subjects must not have had a previous laser treatment, deep chemical peel in the
intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6
months of their inclusion into this study or have ever taken gold therapy.
- Subjects must not have a history of keloid formation.
- Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of
hyper-pigmentation).
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white
patches appear).
- Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30
while exposed to the sun.
- Subject not willing to have photographs taken and used in presentations, publications
and marketing material
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 70 Years | EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA | NCT03211585 | Entailment |
6,787 | 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 18 to <65 years old with severe hemophilia A or B with or without
inhibitors to FVIII or FIX.
- Subjects is willing and able to comply with the mandatory washout periods prior to
screening and prior to dosing and through 48 hours post dosing. At screening this
includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes
a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours
through 48 hours post dosing.
- Subjects must agree and commit to using a a highly effective method of birth control
from the time of screening through four weeks after study drug administration.
Exclusion Criteria:
- Presence of a bleeding disorder in addition to hemophilia A or B.
- Regular, concomitant therapy with immunomodulating drugs (eg, intravenous
immunoglobulin, and routine systemic corticosteroids).
- History of coronary artery disease, thrombolic disease or diagnosis of prothrombic
disorder.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 64 Years | Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia | NCT01439971 | Entailment |
176 | 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:
Low testosterone
Exclusion Criteria:
- Normal testosterone levels
- Elevated Prostatic Specific Antigen (PSA)
- History of breast or prostate cancer
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men | NCT02082197 | Entailment |
3,788 | 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:
Patient must be willing and able to give informed consent for participation in the study
- Age 18-80 years
- Knee Pain
- WOMAC Pain Subscale ≥ 5 during screening
- Mean Visual Analogue Scale (VAS) ≥ 5 during 1 week of screening.
- Fulfilment of the clinical criteria of the American College of Rheumatology for knee
OA 13
- X-ray or MRI confirmation of knee osteoarthritis
All medications or interventions for pain due to knee osteoarthritis must have been stable
for two weeks prior to screening and patient is willing to maintain a stable regimen
throughout the study.
Exclusion Criteria:
Exclusion Criteria:
- Current mood disorder (dysthymia, bipolar mood disorder)
- Major Depression > 12 months (Beck Depression Inventory Score ≥ 18)
- History of a psychoactive substance use disorder within the preceding 12 months
- Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension,
renal insufficiency)
- Glaucoma
- Acute myocardial infarction
- Uncontrolled hypertension
- History of convulsion
- Pregnancy; women of childbearing age will be required to use contraceptives during the
duration of the study. Furthermore a pregnancy test will be performed prior to the
beginning of the study and once a month during the study period.
- Breast feeding
- Participation in a clinical trial in the 3 weeks preceding the study
- Allergy to study medication
- Recent intra-articular corticosteroid or hyaluronic acid injection in the knee joint.
Patients must be willing to abstain from such interventions during the entire study
- Use of the following medication:
- opioids except for tramadol,
- benzodiazepines other than indicated at low doses for sleep disorders
- NSAID
- Corticosteroids
- Impaired kidney function (Creatinine > 1.5mg/dl)
- Patient has significantly impaired hepatic function defined as any of the following:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper
limit of normal (ULN).
- ALT or AST >3 × ULN and (total bilirubin [TBL] >2 × ULN or international
normalized ratio [INR] >1.5).
- ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting, right upper
quadrant pain or tenderness, fever, rash,and/or eosinophilia (>5%).
- Patient is currently using or has in the past used recreational or medicinal cannabis
or synthetic cannabinoid based medications within 3 months prior to study entry
- Patient is unwilling to abstain from using recreational or medicinal cannabis, or
synthetic cannabinoid based medications during the study
- Patients who are not able to understand the study measures and are not able to
complete pain assessment forms.
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 | Efficacy of Cannabidiol in Knee Osteoarthritis | NCT04607603 | Entailment |
3,586 | 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:
- Healthy male or female subjects between the ages of 18 and 55 years
- Negative urine pregnancy test on Day1 for females of childbearing potential
- Weight within +/- 20 percent of ideal weight according to the Metropolitan Life Height
and Weight chart
- Willing and able to cooperate with the investigator and his/her staff
- Written informed consent in accordance with GCP (Good Clinical Practice) and local
legislation
Exclusion Criteria:
- Any finding, medical condition or dietary restriction that, in the investigator's
opinion, may interfere with optimal participation in the study or produce a
significant risk to the subject
- In the opinion of the investigator, the subject has any disease or condition that may
result in altered absorption, excess accumulation, or impaired metabolism or excretion
of the trial medications
- A known or suspected hypersensitivity to any of the trial medications or their
excipients or any other NSAIDs (Non-Steroid Anti-Inflammatory Drug)
- A history of gastrointestinal ulcer, perforation or bleeding
- A history of cerebrovascular bleeding or any other bleeding disorder
- Women of childbearing potential not using adequate contraception (e.g, intrauterine
device, contraceptive pills, Depo-Provera® implant, barrier device) for at least 3
months prior to, and for the duration of trial participation. It should be noted that
NSAIDs may interfere with the effectiveness of intrauterine devices
- History of bronchial asthma
- Use of any medications that might influence the results of the trial
- Use of anticoagulants, including warfarin, heparin, ticlopidine, clopidogrel or
aspirin
- Any laboratory value outside the normal range that is considered clinically
significant by the investigator. In addition, subjects with the following specific
laboratory values will not be allowed:
- A serum creatinine concentration at baseline > 1.5 mg/dl
- SGOT (serum glutamic-oxaloacetic transaminase) or SGPT (serum glutamic-pyruvic
transaminase) liver enzymes results at baseline > 1.5 times the upper limit of
normal
- A hemoglobin concentration < 10.5 g/dl
- A white cell count < 3500/mm³
- A platelet < 100,000/mm³ or a documented abnormal bleeding time, platelet
aggregation, thromboxane B2 synthesis, thromboplastin time (PT) or activated
partial thromboplastin time (APTT)
- Inability to refrain from smoking on testing days
- Participation in another trial with an investigational drug within 30 days of entering
the trial
- Subjects with increased keloid formation
- Previous surgery of the gastrointestinal tract (except appendectomy)
- Participation in excessive physical activities (≤ 5 days prior to administration)
- Current drug or alcohol abuse
- Small or difficult to locate arm veins that would impair the clinician's ability to
draw blood samples
- Homeopathic medication
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 | Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects | NCT02183155 | Contradiction |
4,333 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
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 60 Years | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Contradiction |
1,474 | 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:
1. Male and female patients between 20 to 80 years old
2. Patients with at least one condition below
- Systolic blood pressure is 140mmHg or higher, or diastolic pressure is 90mmHg or
higher, and 2 or more cardiovascular risk factor, and low-density lipoprotein
cholesterol is 130mg/dL or higher.
- Systolic blood pressure is 140mmHg or higher, or diastolic pressure is 90mmHg or
higher, and 0 or 1 cardiovascular risk factor, and low-density lipoprotein
cholesterol is 160mg/dL or higher.
- Patients with medication for hypertension, and (a) symptomatic coronary artery
disease, stroke, peripheral artery disease regardless of low density lipoprotein
cholesterol level, or (b) diabetes mellitus, carotid artery stenosis of 50% or
higher, aortic aneurysm with low density lipoprotein cholesterol 100mg/dL or
higher, or (c) more than 2 cardiovascular risk factor with low density
lipoprotein cholesterol 130mg/dL or higher, or (d) 0 or 1 cardiovascular risk
factor with low density lipoprotein cholesterol 160mg/dL or higher
- Patients with medication for dyslipidemia, and systolic blood pressure is 140mmHg
or higher or diastolic blood pressure is 90mmHg or higher
- Patients with medication for hypertension and dyslipidemia
3. Patients who can understand the provided information, and sign the consent form
Exclusion Criteria:
1. Systolic blood pressure is 180mmHg or higher, or diastolic blood pressure is 100mmHg
or higher
2. Patient with endocrinologic or metabolic disorder which could affect serum lipid or
lipoprotein
- Uncontrolled diabetes mellitus (HbA1c result at baseline evaluation is 9% or higher,
or fasting glucose is 160mg/dL or higher
3. Severe cardiologic disorder (heart failure with NYHA class 3 or 4, heart attack in 6
months, myocardial infarction, heart surgery, percutaneous coronary intervention,
unstable angina) or coronary artery bypass surgery in 3 months
4. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or
other clinically significant cardiac arrhythmia judged by the researcher
5. Patient with genetic disease such as galactose intolerance, Lapp lactase deficiency,
or glucose-galactose malabsorption
6. Patient with psychotic disease, or drug or alcohol addiction
7. Patient with severe liver cirrhosis, renal failure, or heart failure
8. Patient with systemic infectious disease
9. Patient who had systemic steroid (intravenous, intramuscular, or per oral) within 2
months before screening, or planned to
10. Patient in pregnancy, lactation, or childbearing age without proper contraceptive
measure
11. Patient who attended other clinical trial 1 month before screening
12. Patient who seems to be inappropriate to be in clinical trial judged by researcher
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 80 Years | Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia | NCT04061824 | Entailment |
5,331 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass
index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
- Women of child bearing potential with intact ovarian function by medical history and
history of regular menstrual cycles must have been on a stable regimen of combination
oral contraceptives containing EE and progestin (28 day regimen) without evidence of
breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1
Exclusion Criteria:
- Any significant acute or chronic medical illness
Other protocol defined exclusion criteria could apply.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI) | NCT02480881 | Contradiction |
2,872 | 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:
- ALS diagnosed as possible, laboratory-supported probable, probable, or definite as
defined by revised El Escorial criteria
- Age 18 years or older
- Exhibits bulbar dysfunction manifested by dysarthria and/or dysphagia, according to PI
judgment, exhibits a score of 55 or above on the CNS-Bulbar Function Scale
- Capable of providing informed consent and following trial procedures
- Geographic accessibility to the site
- Women must not be able to become pregnant for the duration of the study and must be
willing to be on two contraceptive therapies
- Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the
screening visit
- Must be able to swallow capsules throughout the course of the study, according to PI
judgment
- Subjects must not have taken riluzole for at least 30 days or be on a 50mg BID dose of
riluzole for at least 30 days prior to randomization (subjects how have never taken
riluzole are permitted in the study)
- Subjects taking anti-sialorrhea medication(s) must be on a stable dose for at least 30
days prior to randomization (anti-sialorrhea naïve subjects are permitted in the
study)
- Must be able to safely swallow at least 30 milliliters (mLs) of water for the water
swallowing test
Exclusion Criteria:
- Prior use of Nuedexta®
- Current use of dextromethorphan, quinidine, quinine, mefloquine or opioids
- History of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or
other hypersensitivity reactions
- History of known sensitivity or intolerability to dextromethorphan
- Use of an mono amine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI
- Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de
pointes, or heart failure
- Complete atrioventricular (AV) block without implanted pacemaker, or subjects at high
risk of complete AV block
- Concomitant use with drugs that both prolong QT interval and are metabolized by
cytochrome P 2D6 (CYP2D6) (i.e., thioridazine or pimozide)
- Exposure to any other experimental agent (off-label use or investigational) within 30
days prior to Baseline Visit
- Invasive ventilator dependence, such as tracheostomy
- Any history of either substance abuse within the past year, unstable psychiatric
disease, cognitive impairment, or dementia, according to PI judgment
- Placement and/or usage of feeding tube
- Pregnant women or women currently breastfeeding
- Unable to turn diaphragm pacing device off during swallowing tests
- Salivatory Botox within 90 days (3 months) of screening
- Salivatory radiation within 180 days (6 months) of screening
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.
| Clinical Trial Nuedexta in Subjects With ALS | NCT01806857 | Entailment |
1,207 | 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:
1. > 18 years of age
2. Recurrent pleural effusion due malignancy Malignant pleural effusions are defined as
either Fluid in the context of histocytologically confirmed pleural malignancy, or
pleural fluid in the context of histocytologically confirmed malignancy elsewhere,
with no other clear cause for the effusion.
3. 1 or more therapeutic procedures for pleural fluid drainage prior to enrolment.
4. Written informed consent
5. Ability to comply with study procedures and ability to operate the device
6. Expected survival of more than 3 months after device insertion
Exclusion Criteria:
1. Haemothorax
2. Purulent pleural effusion
3. Significant pleural fluid septation or loculation on thoracic ultrasound or
cross-sectional imaging
4. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of
the device.
5. Pregnant females or females anticipating pregnancy during study period.
6. Patients currently enrolled in another interventional clinical study
7. Concurrently implanted with any other Active Implantable Medical Device, including,
but not limited to cardiac pacemaker or cardioverter defibrillator.
8. Major comorbidity which, in the opinion of the principal investigator, is likely to
significantly decrease life expectancy, increase anaesthetic risk, or lead to device
removal (e.g. moderate to severe congestive heart failure, significant valvular heart
disease, persistent immunosuppression, etc.)
9. Other contraindication to general anaesthesia
10. Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection
or malignant involvement over proposed insertion site)
11. Significant renal impairment, as determined by the principal investigator
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.
| Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy. | NCT01952327 | Entailment |
5,619 | 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:
- Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on
the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
- Pubertal: breast development at least M2 for girls and at least 4 ml of testicular
volume for boys
- Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys
- Signed informed consent
Exclusion Criteria:
- Adopted children ( different genetic background, lack of data on birth parameters and
parents)
- Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al
(see appendix)
- Chronic use of glucocorticoids
- Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
- Known GH deficiency
- Chronic infectious disease
- Active rheumatic disease
- Previously diagnosed or currently suspected malignancy
- Sex steroid therapy
- Diabetes mellitus
- Renal insufficiency (serum creatinine > 1.5 mg/dl)
- Hepatic disease ( liver test > 4 fold upper limit of normality)
- Current congestive heart failure
- Inability to follow the study protocol
- Treatment with a non registered drug during the last 30 days before the moment of
inclusion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 15 Years | A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height | NCT00840944 | Contradiction |
1,979 | 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:
- Biopsy proven adenocarcinoma of the stomach
- Treated with palliative intent
- At least one index symptom such as bleeding, obstruction or pain
- No prior abdominal radiotherapy
- Not on chemotherapy
Exclusion Criteria:
- Patients treated with radical intent
- Previous abdominal radiotherapy
- Patients on chemotherapy
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.
| Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial | NCT01341756 | Entailment |
3,585 | 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:
- Bleeding patients.
Exclusion Criteria:
- Coagulation defects, and those on anti-platelet drugs.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Platelet Glycoproteins in Inherited Thrombocytopathy: Association With Aggregation Studies and Bleeding Severity | NCT03648190 | Contradiction |
1,954 | 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. Age≥18 years;
2. Pathologically diagnosed with advanced gastric adenocarcinoma (including
gastroesophageal junction) with measurable metastases outside the stomach (≥10mm on
spiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors
1.1);
3. Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction
adenocarcinoma;
4. Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin,
paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacy
assessment is SD, PR or CR. No more than 28 days from the starting day of last cycle
of chemotherapy;
5. Eastern Cooperative Oncology Group（ECOG）performance status 0 or 1;
6. Blood routine test and Biochemical tests:
- Hemoglobin ≥ 80g / L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
- Platelet count≥ 90 × 109 / L;
- Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upper
limit of normal (ULN); liver metastases, if any, the ALT and AST<5 × ULN;
- Serum total bilirubin≤1.5 × ULN;
- Serum creatinine≤1.5 × ULN;
- Serum albumin≥30g/L;
7. Life expectancy more than 3 months;
8. Voluntarily join the study and sign the Informed Consent Form for the study;
9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
within 7 days before enrolment and the test result must be negative. They shall take
appropriate methods for contraception during the study until the 8th week post the
last administration of study drug. For men, (previous surgical sterilization
accepted), shall agree to take appropriate methods of contraception during the study
until the 8th week post the last administration of study drug.
Exclusion Criteria:
1. Patients with a known history of allergic reactions and/or hypersensitivity attributed
to apatinib or its accessories;
2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg
and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary
heart disease greater than ClassⅠ; Ⅰ-level arrhythmia (including QT interval
prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiac
dysfunction; Patients with positive urinary protein;
3. Factors that could have an effect on oral medication (such as inability to swallow,
chronic diarrhea and intestinal obstruction);
4. Subjects with high gastrointestinal bleeding risk, including the following conditions:
local active ulcer lesions with positive fecal occult blood test (++); history of
black stool, or haematemesis in the past 2 months;primary lesion in stomach with
positive fecal occult blood test (+) should be evaluated by endoscopy and other
potential massive haemorrhage conditions evaluated by the investigator;
5. Abnormal Coagulation (international normalized ratio>1.5, activated partial
thromboplastin time>1.5 UNL), with tendency of bleeding;
6. Associated with central nervous system (CNS) metastases;
7. Pregnant or lactating women;
8. Suffering from other malignancies within 5 years;
9. History of uncontrolled psychotropic drug abuse or mental disorders;
10. Participated in other clinical study within 4 weeks;
11. Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;
12. Concomitant disease conditions judged by investigator that may seriously affect
subject's safety or affect the study completion;
13. Other cases that the researcher found ineligible
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.
| Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer | NCT02537171 | Entailment |
332 | 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:
- 3- On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at
least 2 of the following should be present:
- Advanced maternal age (≥ 40 years old) or any other risk factor
- A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional
protocol)
- An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or
anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml NB: In the absence of advanced maternal
age or abnormal ORT, two previous episodes of poor ovarian response after maximal
stimulation patients are also considered poor responders according to ESHRE consensus.
- Presence and Adequate visualization of both ovaries
- Uterine cavity within normal anatomy
Exclusion Criteria:
Any factor which may affect reproductive outcome other than that the patient is a poor
responder will be excluded from the study, like:
1. Severe male factor .
2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
3. Immunological disorder (eg: SLE, APS, … etc)
4. Thyroid or adrenal dysfunction
5. Neoplasia (especially: hypothalamic, pit, ovarian)
6. Women diagnosed with PCOS according to Rotterdam criteria
7. Hydrosalpinx that hasn't been surgically removed or ligated. 8 . Untreated
hyperprolactinemia 9 . Abnormal bleeding disorder
10.Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist)
12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3
or 4 14.Ovarian cyst> 10 cm.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol | NCT03484611 | Contradiction |
4,724 | 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:
- Signed informed consent before any trial related activities
- Female of 18 - 50 years of age
- Subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal
ultrasonography (or transrectal ultrasonography for unmarried subjects)
- Presence of moderate or severe pain as shown by VAS score of at least 4 on at least
one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual
pelvic pain, dysuria, dyschezia
- Occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration
prior to screening
Exclusion Criteria:
- Pregnancy
- Patients with infertility who are willing to be pregnant
- Using hormonal contraception or other forms of hormonal therapy within the last 30
days
- Being under therapy with systemic corticosteroids on a chronic or regular basis within
the last 90 days
- History or presence of suspected malignancy abnormalities
- History of surgical treatment for endometriosis within 3 months prior to screening
- History of hysterectomy or oophorectomy
- Presence of clinical signs of sexually transmitted disease
- Presence of unexplained uterine or cervical bleeding
- Impaired liver function: serum ALT > 2.5 times upper limit of normal
- Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
- Known or suspected allergy to similar products
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis | NCT01942122 | Entailment |
75 | 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:
- Male
- In good health
- Aged 18-35
Exclusion Criteria:
- Female
- Known carcinoma of the breast or prostate
- Known sensitivity to alcohol or soy products
- Preexisting cardiac, renal, or hepatic diseases
- Obesity
- Chronic lung diseases
- Cancer
- Use of anticoagulants
- Use of insulin or a history of diabetes
- Use of corticosteroids
- High levels of physical contact with women or children
- Preexisting liver problems
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance | NCT01408498 | Contradiction |
4,648 | 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:
- Patient who undergo laparoscopic assisted vaginal hysterectomy due to following
gynecologic disease
1. uterine leiomyoma
2. uterine adenomyosis
3. Endometrial hyperplasia
4. cervical intraepithelial neoplasia including carcinoma in situ and FIGO stage IA1
cancer
5. Dysfunctional uterine bleeding
6. Other benign gynecologic disease requiring hysterectomy
- American Society of Anesthesiologists Physical Status classification I-II
- Patient who have signed an written informed consent
Exclusion Criteria:
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Patient who requiring further procedure excluding hysterectomy, unilateral or
bilateral salpingooophorectomy / salpingectomy / oophorectomy
- Patient who undergoes subtotal hysterectomy
- Patient who have other pain source excluding gynecologic disease
- Pregnancy and lactating woman
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease | NCT01679548 | Entailment |
3,846 | 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:
- Men and women diagnosed with primary or secondary osteoarthritis of the
knees,classified as grades I to IV Kelgreen and Lawrence (KL), ie, any degree of knee
osteoarthritis
Exclusion Criteria:
- Patients who have psychiatric or neurological disorders, whose symptoms during the
evaluation to the school are related or significantly interfere in the functions of
attention, memory, logical reasoning, understanding and interaction with the group in
order to undermine the assimilation of the guidelines given
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Project Osteoarthritis: Recovering Quality of Life Through Education | NCT01572051 | Entailment |
4,736 | 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 with benign conditions such as uterine fibroids, menorrhagia, adenomyosis,
pelvic pain, abnormal uterine bleeding
Exclusion Criteria:
- None
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? | NCT02192606 | Entailment |
14 | 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:
- Men age 18 through 69 years old
- Men who are distressed by their low libido as defined by SDI-2, and SCI-M
questionnaires. (Appendices A,C)
- Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of
9 or less. (Appendix D)
- Men with good erectile function as defined by IIEF greater than 22
- Men with normal testosterone and liver function values (may be on testosterone
therapy)
- Men who are satisfied in their relationship or with their partners
- Men or their female partners must be willing to use one form of contraception
throughout the study and 30 days after final study visit.
- Willing to give informed consent
Exclusion Criteria:
- Hypogonadal patients (less than 350 ng/dL)
- IIEF-EF less than 22
- CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is
prohibited for the duration of the trial, and if such medication becomes necessary,
flibanserin treatment must be suspended until 2 weeks after the last dose of the
CYP3A4 inhibitor
- Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
- Men with normal to high libido
- Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.
- Men who are stressed or fatigued as determined by the PI
- Men with partners who have low libido as determined by the PI
- Men with pre-existing conditions that might predispose to hypertension
- Men who are not willing to meet the requirements for drinking alcohol during their
participation in the study
- Men who are taking digoxin
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years | Hypoactive Sexual Desire Disorder in Males (10-18-40-13) | NCT04002661 | Contradiction |
2,469 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG
statement on sarcoidosis (AJRCCM 1999)
Exclusion Criteria:
- A history of neurosarcoidosis
- Undergoing structured exercise training at the time of enrollment or in the preceding
6 months
- Current participation in a pharmacological study
- Cardiovascular abnormalities on the ECG during baseline peak exercise test
- A 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination
with a 'normal' quadriceps peak torque or distance walked in 6 minutes
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Exercise Training in Sarcoidosis (EXTRAS Study) | NCT00099424 | Entailment |
4,112 | 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:
- Adult subjects with COPD, 40 - 75 years of age
- All subjects must have a diagnosis of COPD and must have airway obstruction with a
post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of
predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70%
- Subjects must be current or ex-smokers with a smoking history of more than 10
pack-years
- Subjects must be able to perform technically acceptable pulmonary function tests
during the study period as required in the protocol
- Subjects must be able to produce an sufficient amount of sputum during sputum
induction at screening
Exclusion Criteria:
- Subjects with a significant respiratory disease other than COPD.
- Exacerbation within 8 weeks prior to screening
- Subjects with more than 1 COPD exacerbation within 12 months prior to screening
- Subjects must have an FEV1 of at least one Liter
- Subjects with a history or physician's diagnosis of asthma. If a patient has a total
blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify
that the increased eosinophil count is related to a non-asthmatic condition.
- Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to
inactive constituents of the inhalation powder
- Subjects with known hypersensitivity of the bronchial system to inhalation of
nebulized drugs or saline solution
- Subjects with a history of cystic fibrosis
- Subjects with clinically evident bronchiectasis
- Subjects taking any:
- Oral beta-adrenergic drugs or non cardioselective beta blockers,
- Oral glucocorticoids,
- Antihistamines or antileukotrienes prescribed for asthma,
- Oral cromolyn sodium or oral nedocromil sodium,
- Concomitant inhalative therapy with antibiotics and / or concomitant systemic
therapy with fluoroquinolones
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder | NCT01168895 | Contradiction |
4,547 | 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:
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 21-40 years of age
- BMI > 18, < 30
- Serum P4 > 9 ng/ml on single sample collected between days 18-25 of self-reported
menstrual cycle
- Flexible schedule allowing morning blood draws on less than 48 hour notice
- In good general health
- Commit to remain on stable diet during study period (no changes to normal dietary
habits)
- Commit to using non-hormonal contraceptive methods during study period except those
prescribed in the experimental protocol
- No objections to taking study drugs
Exclusion Criteria:
- Oral contraceptive use or other hormone supplement within the preceding 2 months
- Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera®)
- Contraindications to study drugs
- Current or past pregnancy within the previous 6 months or currently trying to conceive
- Desiring to conceive in the next 8 months
- Breastfeeding in the past 2 months
- Diagnosed Diabetes or Metabolic Syndrome
- Current or previous use of cholesterol lowering drugs within the preceding 12 months
- Diagnosed Polycystic Ovary Syndrome
- History of, or self-reported, substance abuse
- Smoker
- Previous infertility treatment excluding male factor issues
- Use of an investigational drug within the past 2 months
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Relationship Between the Menstrual Cycle and Heart Disease in Women | NCT01546454 | Contradiction |
307 | 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:
- Age >/= 18 years
- Female gender
- >/= Stage II pelvic organ prolapse
- Clinical diagnosis of pelvic organ prolapse and desiring non-surgical management with
pessary
- Ability to provide informed consent and complete all study requirements
Exclusion Criteria:
- Life expectancy < 12 months
- Current pregnancy
- Patients will undergo a urine pregnancy test
- Already using vaginal estrogen
- Limited manual dexterity
- History of vaginal erosion with prior pessary use
- All patients with a past or present diagnosis of Breast cancer
- Patients with any pathology of the female reproductive organs
- Patients with undiagnosed abnormal genital bleeding
- Patients with known or suspected estrogen-dependent neoplasia
- Active deep vein thrombosis, pulmonary embolism or history of these conditions
- Active or recent (within last year) arterial thromboembolic disease
- Patients with liver dysfunction or disease
- Patients with known hypersensitivity to Estrace's ingredients
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vaginal Creams to Reduce Vaginal Erosion in Pessary Users | NCT02316249 | Contradiction |
2,335 | 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:
For non-ambulant patients:
1. Children and teenagers aged between 5 and 18 years with DMD, who have lost the ability
to walk 10 meters with no support
2. The diagnosis of DMD must be documented by genetic testing. If a muscle biopsy is
available, it should contain less than 10% of revertant fibres
3. Patients should have deletions amenable of skipping of exons 51 or 53 or 45 or 44 or
46 or 50 or 52
4. Patients should be capable of sitting upright in a wheelchair for at least an hour
5. Patients should be stable from a respiratory point of view. Artificial ventilation
with either Bipap or tracheostomy is not a contraindication to the study.
6. Informed consent signed by a parent/legal guardian (or by the patient if 16 years of
age).
7. In France, a subject will be eligible for inclusion in this study only if either
affiliated to, or a beneficiary of, a social security category.
For ambulant patients:
1. Ambulant children from 5 years old and teenagers with DMD, and potential candidates
for future genetic therapies with antisense oligomer (AO) exon skipping
2. The diagnosis of DMD must be documented by MLPA or a standard genetic test for the
disorder, genotypically confirmed to have an out-of-frame deletion(s) that could be
corrected by skipping exon 51 or 53 or 45 or 44 or 46 or 50 or 52
3. If a muscle biopsy is available less than 10% revertant fibres
4. Ability to walk independently for at least 75 meters in 6 minutes at recruitment.
5. Patients should receive the standard of care for DMD as recommended by the NorthStar
UK and TREAT-NMD (i.e.: on glucocorticoids treatment)
6. Sufficiently preserved pulmonary function (FVC >30%) and absence of symptoms of
cardiac failure
7. Informed consent signed by a parent/legal guardian (or by the patient if 16 years of
age)
8. In France, a subject will be eligible for inclusion in this study only if either
affiliated to, or a beneficiary of, a social security category.
For healthy volunteers and disease controls:
1. Participant are able to provide informed consent/assent for taking blood samples
and/or performing limb MRI and/or physiotherapy assessment of the upper limb function
2. Participants have a neuromuscular disease that is not Duchenne Muscular Dystrophy or
are a healthy volunteer with no neuromuscular disease
3. Able to have a blood sample taken
Exclusion Criteria:
For non-ambulant patients:
1. Patients who are currently involved in interventional clinical trials aimed at
restoring dystrophin will be excluded, as their data could not be used to establish
natural history of the disease (participation in a previous interventional clinical
trial prior to 6 months from being recruited in the study is not an exclusion
criterion)
2. Patients with severe intellectual impairment, who would be unable to cooperate with
examination
3. Patients/families the investigators anticipate may have emotional/ psychological
problems if recruited into a natural history study
4. Symptomatic cardiac failure
5. Recent (< 6 months) upper limb surgery or trauma
6. Anticipated surgery for anytime during the duration of the study
7. None of the current treatments for DMD are exclusion criteria
8. For the MRI sub-study, patients with metal/metallic surgically inserted equipment
incompatible with MRI scan will be excluded as well as patients suffering from
claustrophobia.
For ambulant patients:
1. Patients who are currently involved in interventional clinical trials aimed at
restoring dystrophin will be excluded, as their data could not be used to establish
natural history of the disease (participation in a previous interventional clinical
trial prior to 6 months from being recruited in the study is not an exclusion
criterion)
2. Patients with severe intellectual impairment, who would be unable to cooperate with
examination
3. Patients/families the investigators anticipate may have emotional/ psychological
problems if recruited into a natural history study
4. Recent surgery or anticipated for anytime during the duration of the study
5. For the MRI sub-study, patients with metal/metallic surgically inserted equipment
incompatible with MRI scan will be excluded as well as patients suffering from
claustrophobia.
For healthy volunteers and disease controls
1. Patients who are currently involved in interventional clinical trials aimed at
restoring dystrophin will be excluded, as their data could not be used to establish
natural history of the disease (participation in a previous interventional clinical
trial prior to 6 months from being recruited in the study is not an exclusion
criterion)
2. Patients with severe intellectual impairment, who would be unable to cooperate with
examination
3. Patients/families the investigators anticipate may have emotional/ psychological
problems if recruited into a natural history study
4. For the MRI sub-study, patients with metal/metallic surgically inserted equipment
incompatible with MRI scan will be excluded as well as patients suffering from
claustrophobia
Male
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 18 Years | Outcome Measures in Duchenne Muscular Dystrophy: A Natural History Study | NCT02780492 | Entailment |
5,123 | 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:
- Females
- Postmenopausal women
- Outpatients screened for osteoporosis
- Women > 45 years
- Women < 45 years under menopause
- Women obtained their consent to be measured
Exclusion Criteria:
- Premenopausal females
- Women without any symptom of menopause
- Women not obtained their consent to be measured
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 90 Years | Osteoporosis Screening Trial | NCT01677637 | Contradiction |
2,549 | 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:
- Diagnosis of AD by physician at birth-15 years old
- Diagnosed by physician by Hanifin and Rajka criteria: itching, dry skin, chronic
dermatitis : at face, extensor area (infant), flexor area (children and adult), with
or with out history of atopy in family
- Follow at allergy clinic once a year or can ask current symptom via telephone
interview.
- Evaluate severity of the disease by SCORAD (Scoring Atopic Dermatitis )
Exclusion Criteria:
- Onset of atopic dermatitis more than 15 years old.
- Other disease: skin, cardiovascular, liver disease, endocrine, neurology, ect
- Not complete data collection in case record form in out patient record.
- Cannot be reach current symptom of patient.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 15 Years | The Natural History of Atopic Disease in Thai Children and Association With Atopic March | NCT02532920 | Entailment |
5,488 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Decreased visual acuity (BVA) <5 days, regardless of degree of severity, abrupt onset
in the context of newly diagnosed or suspected Horton's disease at this loss of visual
acuity
- Able to sign the consent
- Affiliated to the social security system
- Already under conventional treatment of Horton's disease or the: requiring:
Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of
the referring physician for its vasculitis and + - immunosuppressive or biotherapy if
necessary.
Exclusion Criteria:
- Underlying hepatocellular insufficiency known
- Patient under guardianship or curator
- Hypersensitivity to the active substance or to any of the excipients
- Moderate to severe hepatic insufficiency corresponding to class B or C of the
Child-Pugh classification
- Any other ophthalmological pathology explaining the sudden drop in vision: retinal
detachment, retinal hemorrhage, posterior uveitis, nonarteritic arterial occlusion,
cortical stroke
- Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or
alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal
before start of treatment
- Patient under treatment with cyclosporine A, antiretrovirals, glibenclamide or
Rifampicin.
- Pregnant or lactating women
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.
| Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | NCT03841734 | Contradiction |
5,336 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
1. Voluntarily signed the informed consent as applicable to participate in the study, age
18-55, inclusive, male: female=1:1;
2. Body mass index between 18.5-26 kg/m², inclusive, with a body weight ≥50 kg (male),
≥45 kg (female);
3. Considered "healthy" by the investigator. Healthy status is defined by absence of
evidence of any active or chronic disease following a detailed medical and surgical
history, as well as a complete physical examination including vital signs, 12-lead
ECG, X-ray examination, infectious disease examination, peripheral blood cell count,
platelet aggregation and coagulation function, blood chemistry, urine routine and
stool routine ( include occult blood);
4. An understanding, ability, and willingness to fully comply with study procedures and
restrictions.
Exclusion Criteria:
1. History of any hematological, digestive system, respiratory, cardiovascular, renal,
neurological, psychiatric disease, metabolic disorders or tumor, which could affect
the action, absorption, or disposition of the investigational product, or clinical or
laboratory assessments;
2. History of abnormal bleeding or coagulation disorders (e.g. easy bruising, gum
bleeding, prolonged bleeding after tooth extraction, joint hemorrhage; anemia in
recent 1 year caused by menorrhagia, postpartum hemorrhage, vitamin K deficiency,
haemorrhagic diseases caused by acquired coagulation factor antibodies, trauma or
post-operative bleeding, etc.);
3. Pregnant or lactating female during screening period; subjects and their partners did
not agree to take effective contraceptive measures (such as intrauterine devices,
contraceptives or condoms) throughout the study period and within 30 days after the
end of the visit period;
4. History of allergic to therapeutic or diagnostic protein products, allergic to two or
more drugs and/or non-drug factors; suffering from allergic diseases;
5. History of surgery within six months before signing the informed consent; Willing to
undergo surgery within two weeks after the end of the trial (including cosmetic
surgery, dental surgery, oral surgery, etc.);
6. Participated an investigational product in recent 3 months;
7. Current use of any prescription or over-the-counter (herbal, vitamins, or healthcare
products). Current use is defined as use within 14 days or PK equivalent of 5
half-lives, whichever is longer;
8. History of Bleeding or donated more than 400ml blood 3 months before screening period,
or plan to denote blood within 1 month after the trial;
9. Consume more tobacco or alcohol (≥14 units of alcohol per week: one standard unit
contains 14g of alcohol, equals to 360ml of beer, 45ml of 40% liquor or 150ml of wine;
smokers with more than 5 cigarettes per day.);
10. Consume excessive caffeine-containing beverages, foods that may affect drug metabolism
within four weeks before signing informed consent: coffee (≥1100 mL per day), tea
(≥2200 mL per day), cola (≥2200 mL per day), energy drinks (≥1100 mL per day),
chocolate (≥510 g per day);
11. Positive HIV, HBsAg, Hepatitis C virus, Tubercle Bacillus antibody screen;
12. Researchers believe that there are other factors that are not suitable for
participating in the experiment.
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 50 Years | A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects | NCT04235933 | Contradiction |
4,463 | 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 18 to 65 years
- confirmed lateral epicondylitis
- had not received any treatment prior to enrolment
Exclusion Criteria:
- symptoms lasting less than 6 weeks
- history of acute trauma, fracture, and/or surgery within 12 months
- patients who had received corticosteroid injection, physiotherapy, splint or casting
during the past 6 months
- bilateral involvement and history of cervical disk herniation, radiculopathy or
abnormal electrophysiologic study
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 | Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis | NCT01986465 | Contradiction |
224 | 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:
- Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
- Total testosterone levels < 300 ng/dL at two qualification visits
- Patients in good general health
Exclusion Criteria:
- Allergy to sesame or testosterone products
- BMI ≥ 40 kg/m2
- Hematocrit ≥ 52%
- History or current evidence of breast or prostate cancer
- Elevated prostate-specific antigen (PSA) for age.
- Abnormal digital rectal examination (DRE)
- Unstable psychiatric illnesses
- Obstructive uropathy of prostatic origin
- Poorly controlled diabetes
- Congestive heart failure
- Within 6 months of screening, myocardial infarction (MI), unstable angina leading to
hospitalization, percutaneous coronary intervention, coronary artery bypass graft,
uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid
revascularization, endovascular procedure, or surgical intervention for peripheral
vascular disease.
- History or current treatment of thromboembolic disease.
- Use of adrenocorticotropic hormone (ACTH) or oral/depot corticosteroids within 6 weeks
of screening.
- History of severe, untreated sleep apnea
- Subjects with any clinically significant medical condition which, in the opinion of
the investigator, would make the subject an unsuitable candidate for enrollment in the
study
- Positive serology for HIV, hepatitis B or hepatitis C
- Current evidence of drug or alcohol abuse.
- Skin conditions in injection site that could confound injection site assessments.
- Administration of other investigational compounds within one month of screening or 5
half-lives of the investigational compound, whichever is longer).
- Use of estrogen, gonadotropin-releasing hormone (GnRH) or growth hormone within 12
months of screening.
- Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other
substances/supplements know to affect the pharmacokinetics (PK) of testosterone
enanthate
- Considered or scheduled surgical or dental procedures associated with blood loss ≥500
mL during study.
- Donation of plasma or blood within 56 days of screening or history of donation of > 50
mL of blood or plasma within 3 months of screening.
- Donation of plasma or blood during study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism | NCT02504541 | Entailment |
914 | 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:
- Ages 45 and older
Joint pain inclusion will be considered with a mild [Mild pain (0-44)] to moderate pain
level [Moderate pain (45-74 mm)] (Hawker, Mian, Kendzerska, & French, 2011) not completely
relieved by medications.
Measured decreased range of motion by 20% (back, shoulder, knee and hip) and hip abduction
wide enough to straddle a horse without discomfort.
Written physician's or advanced practice registered nurse's (APRN) clearance to ride a
horse.
Ability to read and understand English as evidenced by the capacity to follow verbal and
written directions at the screening interview.
Exclusion Criteria:
Self-reported: fear of horses.
Self reported allergies to horses.
Self reported osteoporosis.
Inability to abduct hips wide enough to straddle a horse comfortably.
Lack of transportation to the Therapeutic Riding Center.
Horse riding for the previous six months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Horses and Education as Arthritis Therapy | NCT03141853 | Entailment |
6,153 | 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 healthcare workers
Exclusion Criteria:
- Healthy healthcare workers' refusal.
- Pregnancy and lactation.
- Confirmed acute cases of SARS-CoV-2 Infection
- Having a history of SARS-CoV-2 infection in the past 3 months.
- Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose,
pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14
days before vaccination.
- History of allergy to any vaccines
- Previous vaccination within the last 30 days
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Safety and Immunogenicity of Inactivated Vaccine Against COVID-19 Infection | NCT04756271 | Contradiction |
4,529 | 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. Informed consent: signed written informed consent before inclusion in the study;
2. Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;
3. Body Mass Index: 18.5-30 kg/m2 inclusive;
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89
mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position;
5. Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months
before the screening visit;
6. Menstrual cycle: history of a normal menstrual cycle before combined oral
contraceptive pill use;
7. hCG: endogenous hCG levels <1.2 IU/L at screening and Day -1, Period 1;
8. Pituitary down-regulation: Luteinizing hormone (LH) <5 IU/L; Follicle stimulating
hormone (FSH) <4 IU/L at Day -1, Period 1;
9. Papanicolaou smear (PAP) test: negative or not clinically significant PAP test results
within 12 months before the screening visit or at screening;
10. Full comprehension: ability to comprehend the full nature and purpose of the study,
including possible risks and side effects; ability to co-operate with the investigator
and to comply with the requirements of the entire study;
11. Additional contraception: study participants with an active sexual life must be using
one additional contraceptive method, as follows:
1. A male sexual partner who agrees to use a male condom with spermicide
2. A sterile sexual partner.
Exclusion Criteria:
1. Contraindications: any contraindications to combined oral contraceptive pill or
gonadotropins;
2. Electrocardiogram 12-leads (supine position): clinically significant abnormalities;
3. Physical findings: clinically significant abnormal physical findings which could
interfere with the objectives of the study;
4. Laboratory analyses: clinically significant abnormal laboratory values indicative of
physical illness;
5. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or
formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in
general, which the investigator considers may affect the outcome of the study;
6. Diseases: relevant history of cardiovascular, pulmonary, hepatic, renal,
haematological, gastrointestinal, immunological, dermatological, endocrine,
genitourinary (e.g. polycystic ovary disease, ovarian cysts, primary ovarian failure,
early menopause or abnormal bleeding of undetermined origin), malignant neoplasia,
neurological or psychiatric diseases that could interfere with the aim of the study;
7. Medications: treatment with gonadotropin preparations within 6 months prior to
screening; other medications, including over the counter medications and herbal
remedies, for 2 weeks before the start of the study;
8. Investigative drug studies: participation in the evaluation of any investigational
product for 3 months before this study. The 3-month interval is calculated as the time
between the first calendar day of the month that follows the last visit of the
previous study and the first day of the present study;
9. Blood donation: blood donations for 3 months before this study;
10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day defined
according to the United Stated Department of Agriculture (USDA) Dietary Guidelines
2015-2020; 17), caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10
cigarettes/day);
11. Drug test: positive result at the drug test at screening or day -1, Period 1;
12. Alcohol test: positive alcohol breath test on day -1;
13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits
in the 4 weeks before this study; vegetarians;
14. Pregnancy: positive or missing pregnancy test at screening or at day -1 of each
period; pregnant or lactating women.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation | NCT03735030 | Contradiction |
2,697 | 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:
- healthy males, who are not taking Tamsulosin regularly who are undergoing elective
inguinal hernia repair (laparoscopic, open, and robotic assisted)
Exclusion Criteria:
- Patients who are already taking tamsulosin, terazosin (alpha blocker treatement for
BPH) , finasteride, dutasteride ( both 5 alpha reductase inhibitors), sulfa allergy,
and lactose allergy
Male
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
| Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair | NCT02958878 | Entailment |
3,705 | 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:
- Age 50-85
- Diagnosed with Knee Osteoarthritis by a physician or by ACR clinical criteria
Exclusion Criteria:
- sensory dysfunction due to injury (i.e. known nerve damage)
- neurological diagnosis affecting sensory or motor function (e.g. stroke, Parkinson's
Disease, multiple sclerosisetc.)
Healthy Volunteers eligibility criteria:
- Age 50-85
- Do not possess knee osteoarthritis diagnosis
- do not have knee pain
- do not have a history major knee trauma or lower extremity trauma or surgery
- do not have any other pain condition
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 85 Years | Pain Phenotypes in Knee Osteoarthritis | NCT02664896 | Contradiction |
2,349 | 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. Boys aged between 5 and 16 years inclusive.
2. Duchenne muscular dystrophy resulting from a mutation correctable by treatment with
PRO044.
3. Life expectancy of at least 6 months.
4. No previous treatment with investigational medicinal treatment within 6 months prior
to the start of the (pre)-screening for the study.
5. No previous treatment with idebenone within 6 months prior to the start of the
(pre)-screening for the study.
6. Willing and able to adhere to the study visit schedule and other protocol
requirements.
7. Written informed consent signed (by parent(s)/legal guardian and/or the patient,
according to the local regulations).
8. Glucocorticosteroids use which is stable for at least 2 months prior first drug
administration.
Exclusion Criteria:
1. Aberrant RNA splicing and/or aberrant response to PRO044, detected by in vitro PRO044
assay during pre-screening.
2. Known presence of dystrophin in ≥ 5% of fibers in a pre-study diagnostic muscle
biopsy.
3. Severe muscle abnormalities defined as increased signal intensity in >50% of the
tibialis anterior muscle at MRI.
4. FEV1 and/or FVC < 60% of predicted.
5. Current or history of liver or renal disease.
6. Acute illness within 4 weeks prior to treatment (Day 1) which may interfere with the
measurements.
7. Severe mental retardation which in the opinion of the investigator prohibits
participation in this study.
8. Severe cardiac myopathy which in the opinion of the investigator prohibits
participation in this study.
9. Need for mechanical ventilation.
10. Creatinine concentration above 1.5 times the upper limit of normal (age corrected).
11. Serum ASAT and/or ALAT concentration(s) which suggest hepatic impairment.
12. Use of anticoagulants, antithrombotics or antiplatelet agents.
13. Use of idebenone.
14. Use of any investigational product within 6 months prior to the start of the
(pre)-screening for the study.
15. Subject has donated blood less than 90 days before the start of the (pre)-screening
for the study.
16. Current or history of drug and/or alcohol abuse.
17. Participation in another trial with an investigational product.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 16 Years | Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD) | NCT01037309 | Entailment |
6,564 | 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:
- Patients with hemophilia A who have been treated with factor VIII on demand or on
prophylaxis and who have developed inhibitors to factor VIII
- ≤ 2 years from the time of first inhibitor detection.
- High-responding inhibitors (historical peak > 5 BU/mL)and known anamnestic response in
case of negative inhibitor titre.
- Candidates to start daily ITI with FVIII doses ranging from 50 IU/Kg/day to 200
IU/Kg/day
- Maximal two bleedings in the same joint within the last 6 months before entering the
study or maximal six joint bleeds in the same joint within 2 years
- Adequate venous access for daily infusion and capable (caregiver) of reconstituting
and injecting the study drug
- Informed consent by parents or legal guardians.
Exclusion Criteria:
- ITI already started
- Known or suspected hypersensitivity to the active substance or to any of the
excipients of the study drug
- Administration of any investigational product within 30 days prior to randomisation
- Other coagulation disorders than congenital hemophilia A.
- Family history of thrombosis at an early age (< 40 years), known thrombophilia, any
previous thrombosis including catheter-related deep vein thrombosis, previous neonatal
thrombosis.
- Known pseudo tumours
- Known severe liver disease
- Platelet count < 50,000 platelets/µL at screening
- Surgery within one month or planned major and/or orthopaedic surgery.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 8 Years | rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors | NCT01105546 | Contradiction |
6,215 | 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:
- Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect
clinical symptoms)
- Call into office within the first 7 days of illness
- Have any of the following high risk conditions:
- Age >60
- HTN, CAD, or chronic heart disease
- Diabetes
- Chronic kidney disease
- Chronic lung disease
- Active or recent chemotherapy for malignancy
- Organ transplant
- Taking Immune-suppressing medications
- HIV with CD4 <200 cells/mm3
- Experiencing at least one of the following high risk symptoms:
- Severe cough
- Fever 100.0F or greater
- Diarrhea
- Shortness of Breath
- Hypoxia
Exclusion Criteria:
• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be
offered HCQ
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 99 Years | Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore | NCT04350450 | Contradiction |
4,841 | 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:
- Aged 18 years old or over
- Patient with a diagnosed Cushing's disease according to the French "protocole national
de diagnostic et de soins (PNDS)"
- Patient who underwent a MRI pituitary for diagnostic purposes
- Patient who have undergone catheterization of the lower petrosal sinuses (if MRI does
not detect pituitary adenoma) and have a result in favor of a central secretion of
ACTH
- Patient having an indication of surgical excision of the adenoma
- Patient with a micro-adenoma (less than 1 cm in diameter) if the tumor is visualized
on MRI
- Patient for which informed and written consent to participate has been obtained.
Exclusion Criteria:
- - Patient participating in another study
- Patient with a pituitary macro-adenoma with visual impairment
- Patient with ACTH-dependent Cushing's syndrome secondary to ectopic ACTH secretion
- Patient with recurrence and / or history of pituitary adenoma excision
- Patient with a contraindication to pituitary surgery or general anesthesia
- Pregnant woman, breastfeeding or old enough to have children but without effective
recognized contraception
- Contra-indication to the realization of an MRI: permanently fixed metal parts
(pacemaker, cerebral clip, cephalic end piercing, cochlear implant, pin or screw for
recent bone fracture, dental equipment, metal splinters), claustrophobia
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.
| Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease | NCT03346954 | Contradiction |
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