id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
5,791 | 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. Not having an active disease
2. Be between the ages of 18 and 45
3. Not using antibiotics in the last two weeks
4. Do not use inhaler treatments
5. Not to have an oral or salivary gland disease
6. One week after menstrual bleeding in female cases
7. At least 10 pack years (P / Y) cigarette story in the case group
Exclusion Criteria:
1. Being an active disease
2. <18 years and> 45 years old
3. Having used antibiotics in the last two weeks
4. Use inhaler treatments
5. Oral and salivary gland disease
6. One week after menstrual bleeding in female cases
7. Being in the luteal phase
8. Menstrual irregularity
9. Being pregnant
10. Taking hormonal treatment
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 | Effect of Oral pH Changes on Smoking Desire | NCT04032236 | Contradiction |
634 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Patients with hemochromatosis, aged > 30 years, C282Y- homozygote, with serum-ferritin
=/> 1000 µg/L
- Patients aged > 18 years with verified low-risk or intermediate-1 risk of
myelodysplastic syndrome, with normal cytogenetics and serum-ferritin > 1500 µg/L, or
with a transfusion history of =/> red- blood-cell-transfusions.
Exclusion Criteria:
- Previous or current venesection
- MDS patients eligible for hematopoietic stem cell transplantation
- Subject complies with one or more of the following standard exclusion criteria for MRI
examination;
- If the patient has a pacemaker.
- If the patient has a neurostimulator
- If the patient has a "aneurismeclips"
- If the patient has a foreign object in the eye. If yes, what object.
- If the patient has a cochlea-/earimplant.
- If the patient has a V/P shunt.
- If the patient is claustrophobic.
- If the patient has an artificial heart valve.
- If the patient has known renal failure, eGFR <30.
- If the patient has or will have a liver transplantation.
- Other: metal prostheses, metal implant
- Presence of inflammation (CRP ≥ 5 mg/L)
- Presence of proteinuria or creatinine > 2 x UNL (Upper Normal Limit)
- Estimated glomerular filtration rate (GFR) < 60 mL/min
- ALAT, ASAT, GT or ALP > 2 x ULN ( Upper Normal Limit)
- ALAT > 90 U/L for women, ALAT > 140 U/L for men
- ASAT > 70 U/L for women, ASAT > 90 U/L for men
- ALP > 210 U/L for women and men
- GT > 90 U/L for women ≤ 40 years, GT > 150 U/L for women > 40 years
- GT > 160 U/L for men ≤ 40 years, GT > 230 U/L for men > 40 years
- Acute or chronic hepatitis
- Patients with chronic liver disease Child Pugh Class B and C
- Chronic skin disease with rash
- Estimated survival < 6 months
- Prior or concomitant treatment with other iron chelator therapies within 6 weeks of
screening
- History of non-compliance to medical regimens, or considered potentially unreliable
and/or not cooperative
- Uncontrolled diabetes, defined as glycolated hemoglobin (HbAlc) > 8.5%
- Presence of cataracts or hearing loss disease
- Presence of a surgical or medical condition which might significantly alter
absorption, distribution, metabolism or excretion of study drug
- Planned in-hospital surgeries during the course of the study
- Subjects who are pregnant, breast-feeding, or intending to become pregnant
- Hypersensitivity to the active substance or the excipients in drug product
- Any other reason why, in the opinion of the investigator, the patient should not
participate (e.g. serious heart disease, infection, cancer, etc).
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 80 Years | Treatment of Iron Overload With Deferasirox (Exjade) in Hereditary Hemochromatosis and Myelodysplastic Syndrome | NCT01892644 | Contradiction |
957 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Written informed consent (IRB/IEC specific) has been obtained prior to initiation of
any protocol required procedures.
2. Male or female between 40 and 75 years of age. Females of childbearing potential must
have a negative urine pregnancy test at screening.
3. Body weight >40 kg and <150 kg with a body mass index (BMI) between 19-40 kg/m2
inclusive.
4. Idiopathic osteoarthritic knee pain diagnosed in accordance with the American College
of Rheumatology modified clinical classification criteria (Altman et al, 1986) and
verified radiologically as Kellgren-Lawrence grade I, II or III (Kellgren and
Lawrence, 1957) at the index knee. The clinical diagnosis of OA will be confirmed by
the ACR clinical and radiographic criteria for classification of idiopathic OA based
upon the following criteria (index knee):
1. Knee pain for at least 14 days per month for the 3 months before study entry.
2. Osteophytes (with radiographic evidence).
3. And at least 1 of the following 3 conditions: Age >50, or morning stiffness <30
minutes, or crepitus.
4. X-ray images of the knee joints are available confirming OA. X-ray images older
than12 months cannot be used. New photos are needed to confirm the diagnostic
criteria for OA.
5. For the index knee, the average of the worst daily pain score over the last 14 days
prior to day 0 must be 4.0 to 9.0. The 14-day average score will be derived from worst
daily pain scores recorded in a diary for the index knee.
6. Discontinued use of all analgesic medications (including over-the-counter analgesics/
Non-Steroidal Anti-Inflammatory Drug at least 3 days prior to visit 2 (subjects are
allowed limited use of analgesic medications).
7. Have agreed to maintain the same activity level throughout the course of the study.
Exclusion Criteria:
1. Have a history of recurrent seizures other than febrile seizures.
2. Have a history of frequent and/or severe allergic reactions with multiple medications.
3. Have a current or recent history, as determined by the investigator or his delegates,
of severe, progressive, and/or uncontrolled renal, hepatic, hematological,
gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric or cerebral
disease which could interfere with the subject's participation in the study.
4. At screening, have an abnormality in the 12-lead ECG that, in the opinion of the
investigator, increases the risks associated with participation in the study. In
addition, subjects with following findings will be excluded:
1. Confirmed Bazett's corrected QT (QTcB) interval > 450 msec for men and > 470 msec
for women at screening. If QTcB is prolonged a second ECG will be taken to
confirm the finding; (additional ECGs may be performed if required),
2. Bundle branch blocks and other conduction abnormalities other than mild first
degree atrio-ventricular block, left anterior hemi block due to left axis
deviation and right bundle branch block of benign origin i.e. not caused by other
cardiac disease,
3. Irregular rhythms other than sinus arrhythmia or occasional supraventricular or
ventricular ectopic beats,
4. History of unexplained syncope,
5. Family history of unexplained sudden death or sudden death due to long QT
syndrome,
6. T-wave configurations are not of sufficient quality for assessing QT interval
determination, as assessed by the investigator.
5. Have an alanine aminotransaminase > 2.5 times Upper Limit of Normal (ULN) at
screening, based on reference ranges of the local laboratory. Moderate or greater
hepatic impairment.
6. Have prior renal transplant, current renal dialysis or severe renal insufficiency
(determined by a derived glomerular filtration rate using Cockcroft Gault formula of
≤30 ml/min/1,73m² calculated by the local lab), or serum creatinine laboratory value
>1.5 times ULN, based on the reference ranges of the local laboratory.
7. Have active peptic ulcer or gastrointestinal bleeding.
8. Have known inflammatory intestinal disease.
9. Subject with ischemic heart disease, peripheral arterial disease and/or
cerebrovascular disease.
10. Subject with congestive heart failure (NYHA II-IV).
11. Subject with uncontrolled arterial hypertension (>160/90).
12. Subject with diabetes mellitus and documented atherosclerosis.
13. History of bronchospasms, acute rhinitis, nasal polyps, angioneurotic edema, urticaria
or other type of allergic reaction after having used acetylic acid or NSAID, inclusive
COX-2 inhibitors.
14. Is allergic to the active ingredient of etoricoxib or one or more of the excipients.
15. Pregnant female, breast feeding or planning a pregnancy during the study period.
Females of child-bearing potential, not using a reliable means of contraception.
16. Subject with an active malignancy of any type or a history of malignancy within the
last 5 years (except basal cell carcinoma of the skin that has been excised prior to
study start).
17. Are taking any excluded medications (analgesic medications) that cannot be
discontinued during the screening period (3 days prior to visit 2).
18. Subject in treatment with anticoagulants (with the exception of acetylsalicylic acid),
methotrexate or rifampicin or antihypertensives (with the exception of
Ca+-antagonists).
19. Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at Visit 1.
20. Have a history of substance abuse or dependence within the past year, excluding
nicotine and caffeine.
21. Subject at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and
persistent or recurrent chest infections and subjects who are permanently bed ridden
or wheelchair bound).
22. Subject with a history of, or suspected, demyelinating disease of the central nervous
system (e.g. multiple sclerosis or optic neuritis).
23. Have an autoimmune disorder (not including psoriasis).
24. Subject that do not fully understand the EPM procedures according to investigator
experience.
25. Investigator site personnel directly affiliated with this study and/or their immediate
family cannot participate. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
26. Subject diagnosed with any condition suggestive of a secondary cause of knee OA
including but not limited to knee trauma, septic arthritis, inflammatory joint
disease, articular fracture, major dysplasia or congenital abnormality, ochronosis,
acromegaly, hemochromatosis, Wilson's disease, or primary osteochondromatosis.
27. History of surgery (including arthroscopy) in the index knee within 3 months prior to
visit 1 or already planned surgery of the index knee at any time.
28. History of significant prior injury to the index knee within 12 months prior to visit
1.
29. Subject diagnosed with Kellgren and Lawrence grade IV at the index knee.
30. Use of lower extremity assistive devices other than a knee brace or 'shoe lift'. Use
of a cane in the hand opposite to the index knee is acceptable.
31. History of prior synovial fluid analysis showing a White Blood Cell count ≥ 2000 mm3
that is indicative of a diagnosis other than OA at the index knee.
32. Have a confounding painful condition that may interfere with assessment of the index
knee joint. (Knee pain should be the predominant pain. Mild OA of the hands is
allowed, for instance).
33. History of any other musculoskeletal or arthritic condition that may affect the
interpretation of clinical efficacy and/or safety data or otherwise contraindicates
participation in this clinical study (i.e., currently symptomatic fractures or any
concurrent rheumatic disease such as but not limited to fibromyalgia, rheumatoid
arthritis, gout, pseudo-gout or Paget's disease and Reiter's syndrome are excluded).
34. Have used corticosteroids prior to baseline:
1. Intra-articular injection of steroids into the index knee or into any other site
than the index knee within the previous 3 months,
2. Intra-muscular corticosteroid injections within the previous 3 months,
3. Oral corticosteroids within the previous 1 month.
35. Have initiated or changed their established physiotherapy program within the last 14
day prior to visit 3.
36. Have not recorded a minimum of 10 days of diary data of the last 14 days immediately
preceding visit 3.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Single Center 2-way Crossover Study to Investigate the Mechanism of Action of Etoricoxib in Subjects With Osteoarthritis Knee Pain | NCT01619150 | Entailment |
5,355 | 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:
- Participants are female and have a uterus
- Participants are between the ages of 18 and 51 years at the time of consent
- Participants have heavy menstrual bleeding as evidenced by their symptoms of
subjective increased bleeding volume and desire to seek treatment
- The symptom of heavy menstrual bleeding has been present for most of the last 6 months
- Participants have regular menstrual cycles between 24 -38 days in length
Exclusion Criteria:
- Participants who are pregnant or have a positive urine β-hCG
- Participants whose bleeding is coming from a cervical, vaginal, urinary or
gastrointestinal source
- Participants who are found to have or who have a previous diagnosis of uterine or
cervical polyps, adenomyosis, or leiomyomas (fibroids)
- Participants who are found to have or who have had endometrial hyperplasia, cervical
dysplasia or malignancy of any of the vulva, cervix, endometrium, breast or ovaries.
- Participants who have ovulatory dysfunction as defined by menstrual cycles that are
irregular in frequency and regularity and are often punctuated with periods of
amenorrhea
- Participants who are found to have or who have been diagnosed with a coagulopathy
- Participants who have a current genitourinary infection
- Participants who are desirous of becoming pregnant within the next four months
- Participants who have untreated or inadequately treated thyroid disease
- Participants who have a contraindication to either treatment including
hypersensitivity
- Participants who are breastfeeding
- Participants with mild, moderate or severe hepatic impairment
- Participants with moderate or severe renal impairment
- Participants with severe asthma not controlled with oral glucocorticoids
- Participants with active disease, or history of deep vein thrombosis (DVT), pulmonary
embolism (PE), cerebral thrombosis or with family history of thromboembolic disease
- Patients with subarachnoid hemorrhage
- Patients with acquired disturbances of colour vision
- Participants who are already on hormone based treatment including, progesterone only
pills, combined oral contraceptive pill (COCP), Intrauterine System (IUS)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 51 Years | Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding | NCT03027973 | Contradiction |
1,768 | 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:
- FD diagnosis by ROME IV criteria (one or more of bothersome symptoms like postprandial
fullness, early satiation, epigastric pain, and epigastric burning. It must include
criteria for postprandial distress syndrome and epigastric pain syndrome for the last
3 months with symptom onset at least 6 months before diagnosis and no evidence of
structural disease, including upper endoscopy).
- No organic disease on upper gastrointestinal endoscopy and ultrasound.
- Currently, not on any active therapy during the last two months.
- No previous history of Helicobacter pylori eradication.
- No antibiotic therapy within the last month.
- Not received proton pump inhibitors for a minimum of 4 weeks prior to study
enrollment.
Exclusion Criteria:
- Presence of alarm symptoms such as GI bleeding, unexplained iron deficiency anemia,
unintentional weight loss, palpable abdominal mass, family history of colon or stomach
cancer or symptom onset ≥50 years of age and not yet screened for colon cancer, or
sudden/acute onset of a new change in bowel habit)
- No proper informed consent.
- Endoscopic treatment for gastroesophageal reflux.
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 | Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment | NCT04302402 | Contradiction |
6,230 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- · Confirmed diagnosis of COVID-19 infection using a positive RT-PCR or a positive IgG
antibody test prior to or during hospitalization or,
· With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19
infection and:
- elevated D-dimer and/or
- positive imaging results showing unilateral or bilateral pneumonia or ground-glass
opacity in lungs · The subject or legal authorized representative able to read and
sign an informed consent document including authorization permitting release of
personal health information approved by the investigator's Institutional Review Board
(IRB).
Exclusion Criteria:
Subjects will be excluded from entry if ANY of the criteria listed below are met:
- Less than 3 years of age
- Subject is pregnant
- Active treatment for cancer
- History of long-term use of immunosuppressive agents
- History of severe chronic respiratory disease and requirement for long-term oxygen
therapy
- Patients undergoing hemodialysis or peritoneal dialysis
- Patients on full dose anticoagulant at the time of enrollment
- Any condition unsuitable for the study as determined by investigators
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
| The Evaluation of Hemostasis in Hospitalized COVID-19 Patients | NCT04493307 | Contradiction |
5,864 | 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:
- 19≤ age ≤ 75
- Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
- Patients experienced heartburn or acid regurgitation within 7 days of screening day
- Patients understood the consents and purpose of this trial and signed consent form
Exclusion Criteria:
- Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder
or signs of gastrointestinal bleeding
- Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more
than normal upper range)
- Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59
mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
- Uncontrolled diabetes mellitus
- Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2
weeks
- Before screening EGD, a patient who has taken drugs containing following list within 1
weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents,
salicylates(except 100mg a day for prevention of cardiovascular disease), steroids,
propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin
analogs, antacids of aluminum/magnesium)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 75 Years | Efficacy and Safety of HIP1601 Capsule | NCT04080726 | Contradiction |
3,852 | 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. Patients suffered from chronic unilateral knee pain for more than 4 months and with
roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence
Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA)
will be recruited.
2. The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm
thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound
guidance.
3. Small volume of SF will be aspirated first and sent for SF analysis. SF showing
evidences of crystals suggesting possible gouty arthritis and infection will not be
included in this study.
4. Patient has previously received oral NSAIDs and physical modality treatments but
WITHOUT any obvious improvements in knee pain and function.
The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in
communication with the synovial cavity of the knee joint. This is to prevent the aspiration
of isolated cystic lesion at the supra-patellar region.
Exclusion Criteria:
1. Total obliteration of knee joint as shown on the roentgenogram images. Patient has
systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of
the knee joint (varus >5°, valgus >5°), hematological diseases (coagulopathy), severe
cardiovascular diseases, infections, and immune-depression.
2. Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before
blood harvest
3. Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than
150,000/mm3.
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 85 Years | High Frequency Intensive Autologous PRP Injection and Genicular Nerve Blocks in Treating Knee Osteoarthritis | NCT04088045 | Entailment |
5,745 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- patients diagnosed with Behcet's Disease according to International Criteria for BD.
- patients with active oral ulcers.
- patients free from any visible oral lesions other than the oral ulcers of BD.
- patients who agreed to take the supplied interventions.
- patients who will agree to participate in the study.
- patients who will accept to sign the informed consent.
Exclusion Criteria:
- patients not physically able to participate in survey or clinical oral examination.
- patients with organ or life-threatening disease.
- patients with history of a severe or chronic medical condition including tuberculosis,
hepatitis and human immunodeficiency virus.
- patients under immunosuppressive drugs.
- patients with organ transplantation.
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 60 Years | Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease | NCT03771768 | Contradiction |
4,713 | 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:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
5,966 | 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:
- Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious
complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
Exclusion Criteria:
- Patients who had previous anti-reflux surgery, previous open abdominal surgery, if
parents declined to participate into study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Month old.
Subject must be at most 21 Years | Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children | NCT01027975 | Contradiction |
6,171 | 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. Male and female hospitalized patients between 45 and 80 years of age at time of
consent.
2. Clinical and laboratory diagnosis of COVID-19 infection. Patients must be positive for
the SARS-CoV-2 by Real-Time Reverse Transcriptase (RT)-PCR
Diagnostic Panel as well as two of the following three symptoms:
- Fever (oral temperature ≥ 100.4 °F [> 38 °C]) with or without chills
- Dyspnea or difficulty breathing (≤ 2 on mMRC dyspnea scale)
- Nonproductive cough
3. Patients must present with moderate to severe illness as defined below:
- Moderate illness: Patients who have evidence of lower respiratory disease by
clinical assessment or imaging and an oxygen saturation (SpO2) > 93% on room air
at sea level
- Severe illness: Patients who have a respiratory frequency > 30 breaths per minute
(bpm), SpO2 ≤ 93% on room air at sea level, ratio of arterial partial pressure of
oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300, or lung infiltrates >
50%.
4. APACHE II score < 20
5. Therapies which have been shown to be beneficial and are included in standard COVID-19
treatment guidelines (e.g. those of WHO or NIH) are permitted
6. Sexually active women of child-bearing potential (WCBP) must be using a medically
acceptable method of birth control throughout the study and for at least 1 day
following the end of study, and have a negative urine pregnancy test at the Screening
visit. A WCBP is defined as a female who is biologically capable of becoming pregnant.
A medically acceptable method of birth control includes intrauterine devices in place
for at least 3 months, surgical sterilization, or the implant. In patients who are not
sexually active, abstinence is an acceptable form of birth control and urine will be
tested per protocol. Women who are of nonchild-bearing potential, i.e.,
post-menopause, must have this condition captured in their medical history. Pregnant
women and nursing mothers are excluded from this study.
7. Patient or LAR is available and willing to give written informed consent, after being
properly informed of the nature and risks of the study and prior to engaging in any
study-related procedures.
Exclusion Criteria:
1. Known sensitivity, allergy, or previous exposure to LSALT peptide.
2. Exposure to any investigational drug or device <90 days prior to entry into study.
3. Treatment with immunomodulators or immunosuppressant drugs, including but not limited
to IL-6 inhibitors, TNF inhibitors, anti-IL-1 immunomodulators, and JAK inhibitors
within five half-lives or 30 days (whichever is longer) prior to randomization and
throughout the study period. However, should any of these treatments become
standard-of-care and incorporated into clinical treatment guidelines (e.g. those of
WHO or NIH), the treatment is permitted.
4. Anticipated transfer to another hospital or medical center within 72 hours, which is
not a study site.
5. Uncontrolled of poorly treated active hepatitis B (HBV), hepatitis C (HepC), or HIV
infection. Those subjects who are positive for HBV, HepC, or HIV but are
well-controlled with low viral loads are allowed to participate in this study:
- HBV low viral load defined as <20,000 IU/mL
- HepC low viral load defined as <800,000 IU/mL
- HIV low viral load defined as <5000 copies/mL
6. Participation in another drug or device study at any time during this study, for
example:
- Ulinastatin 200,000 IU or greater
- High dose intravenous Vitamin C
- Budesonide and formoterol
- Bevacizumab to prevent ARDS
- Dornase alfa to reduce hypoxemia in ventilated trauma patients.
7. As indicated in the inclusion criteria, pregnant female patients are excluded from
study. Further, female patients who are nursing are excluded from study.
8. Has any medical condition considered to be clinically significant and could
potentially affect patient safety or study outcome, including but not limited to:
- Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30
mL/min/1.73 m2 or hemodialysis)
- End-stage malignancy undergoing treatment
- Immunocompromised patients or those with medical/surgical conditions (e.g., solid
organ transplantation) which require chronic immunosuppression
- Chronic hematologic disease which, in the opinion of the PI, prohibits the
patient from entering into study
- Acute liver injury with AST and/or ALT levels greater than 3x ULN
- History of coagulopathy within the last year as defined by abnormal ACT, aPTT,
and/or PT/INR values at least 2-fold outside normal limits, and/or
- End-stage lung disease, acute lung injury, severe chronic obstructive pulmonary
disease (COPD), or mechanical ventilation.
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 80 Years | LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) | NCT04402957 | Contradiction |
1,157 | 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:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB (with pleural effusion) or IV disease
- Measurable disease
- At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT
scan
- The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses that are not confirmed and followed by imaging techniques
- Blood and tissue blocks available
- Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous
nodules) to provide core needle biopsy tissue before and during study treatment
- No known brain metastases
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
- Creatinine ≤ 1.5 times ULN
- Serum fasting cholesterol ≤ 350 mg/dL
- Serum fasting triglycerides ≤ 400 mg/dL
- HIV negative
- No uncontrolled infection
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or non-invasive carcinomas
- No concurrent severe underlying disease that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
treatment
- No prior biologic therapy
- No prior gene therapy
- No prior immunotherapy
- No concurrent immunotherapy
- No concurrent prophylactic growth factors to support neutrophil count
- No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
- No other concurrent chemotherapy
- No concurrent dexamethasone (10 mg IV)
- No prior radiotherapy to 30% or more of bone marrow
- Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful
pre-existing bony metastasis) allowed
- No other concurrent investigational therapy
- No concurrent immunosuppressive therapy
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.
| CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer | NCT00079235 | Contradiction |
903 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Participants aged 40 years or older and diagnosed with mild or moderate knee
osteoarthritis(KOA) are eligible to participate in the study
- The following criteria are used for diagnosis of KOA:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as
demonstrated in X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times)
and white blood cell count < 2000/mm3;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. If a patient
meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is
confirmed.
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
- diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors
or rheumatism of the knee joint and rheumatoid arthritis;
- present sprain or trauma in the lower limb;
- unable to walk properly due to foot deformity or pain;
- present with mental disorders;
- present with comorbidities including severe cardiovascular disease, liver or kidney
impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
- females who are pregnant or lactating;
- using physiotherapy treatments for osteoarthritis knee pain;
- have used intra-articular injection of glucocorticoid or viscosupplementation in the
past six months;
- received knee-replacement surgery;
- diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic
classification) or late clinical stage of KOA;
- have a swollen knee or positive result of floating patella test; or'
- are participating or have participated in the other clinical trials.
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.
| Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points | NCT03299439 | Entailment |
1,841 | 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. locally advanced (>T1) and/or nodal positive (N+) histologically proven adenocarcinoma
of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases
(M0) and without infiltration of adjacent structures and organs
2. no previous surgical resection
3. no previous cytostatic chemotherapy
4. Age > 18 years (female and male)
5. ECOG ≤ 2
6. surgical resectability
7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
8. Leucocytes > 3.000/µl
9. Platelets > 100.000/µl
10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance > 50 ml/min
11. written informed consent.
12. Ejection fraction > 50% in echocardiography before start of therapy
Exclusion Criteria:
1. distant metastases or infiltration of adjacent structures or organs and all primarily
not resectable stages
2. relapse
3. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin.
Epirubicin and Docetaxel
4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin,
Cisplatin, Epirubicin or Docetaxel
5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
6. malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the
cervix uteri, adequately treated skin basal cell carcinoma)
7. severe non-surgical accompanying disease or acute infection
8. peripheral polyneuropathy > NCI Grad II
9. severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
10. chronic inflammable gastro-intestinal disease
11. inclusion in another clinical trial
12. pregnancy or lactation
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.
| 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer | NCT01216644 | Entailment |
121 | 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:
- Diagnosed with hypogonadotropic hypogonadism, either congenital or acquired
- Have low circulating levels of testosterone
- Have low circulating levels of gonadotropins (follicle stimulating hormone [FSH];
luteinizing hormone)
- Presence of both scrotal testes
- Have azoospermia (no measurable level of sperm)
- Adequate replacement of other pituitary hormones
- Good general physical and mental health
Exclusion Criteria:
- Primary hypogonadism, such as Klinefelter's syndrome
- History of unilateral or bilateral cryptorchidism (maldescended testes)
- History or presence of testicular pathology of clinical importance (e.g.,
epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy,
occlusive azoospermia, etc), and/or vasectomy
- Treated with FSH, hCG or gonadotropin-releasing hormone (GnRH) within previous 3
months or for more than 1 month within previous 6 months
- Proven spermatogenesis with hCG treatment alone
- Previous unsuccessful attempt with hCG in combination with human menopausal
gonadotropin (hMG)/FSH to achieve spermatogenesis
- Required a dose of hCG of more than 6000 international units (IU) per week in a
previous attempt to normalize T levels
- Untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or
hypothalamic tumor that is likely to progress during the study
- History or presence (known or suspected) of testicular, prostatic or breast cancer
- Prostate pathology of clinical importance
- Past or present oncologic treatment (chemo/radiotherapy)
- Diabetes mellitus
- Clinically significant, untreated hyperprolactinaemia
- Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
- Tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- User of recreational or illicit drugs or has had a recent history (within the past
year) of drug abuse or dependence, or increased alcohol consumption
- Allergy/sensitivity to gonadotropins or its/their excipients
- Has received within previous 1 month or plans to use: Hormonal preparations other than
the study medication, drugs that are known to impair testicular function, agents known
to affect sex hormone secretion and/or drugs that are known or suspected to be
teratogenic
- Used any investigational drugs within three months or actively participating in
another study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937) | NCT01709331 | Contradiction |
5,614 | 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:
- Before starting treatment, according to the medical history, clinical symptoms and
signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- According to the height statistical data of Chinese children's physique development in
nine cities in 2005, height is lower than the third percentile of growth curve of
normal children with the same age and gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH stimulation test with two different mechanisms affirms that GH peak concentration
of patients' plasma <10.0ng/ml.
- Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than
his/her chronological age (CA).
- Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- Receive no prior GH treatment within 6 months.
- Sign informed consent.
Exclusion Criteria:
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
value, Cr> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
(HBsAg) or hepatitis B e antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or
general infection and immune deficiency.
- Potential tumor patients (family history).
- Diabetic.
- Abnormal growth and development, such as Turner syndrome, constitutional delay of
growth and puberty, Laron syndrome, growth hormone receptor deficiency, girls of
growth retardation without excluding abnormal chromosome.
- Subjects took part in other clinical trial study within 3 months.
- Other conditions which in the opinion of the investigator preclude enrollment into the
study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
| Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | NCT02314676 | Contradiction |
484 | 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:
For All Females:
- Ages 18-45 years of age
- Able to provide written informed consent
- Normal Pap smear at screening or documentation of such within six months prior
- Regular monthly menses or amenorrhea due to hormonal contraceptive use
- Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
- Able/willing to complete Study Diary
- Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
- Agree to apply assigned study gel as required per protocol
- Agree to abstain from the following activities from at least 48 hours prior to
enrollment through the Day 14 visit:
- Insertion of fingers/objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels
- Participating in other vaginal microbicide or contraceptive studies
Additional Inclusion Criteria for Stage 1:
- HIV-uninfected
- In a monogamous sexually active relationship with one male partner throughout the
study
- Report having vaginal intercourse only with that partner at least two times per week
- Agree to use study-provided male condoms for each act of vaginal intercourse while
taking part in the study
- Agree to inform male partner about participation
Additional Inclusion Criteria for Stage 2:
- HIV-infected
- Sexually abstinent or agree to abstain from sexual intercourse while taking part in
the study
- Under regular medical care for HIV management
- CD4+ lymphocyte count > 200/mm3 for the last 6 months
- HIV viral load > 4.0 log10 copies/ml at screening
- Documentation of prior HIV genotype with one or more mutations conferring resistance
to a non-nucleoside reverse transcriptase inhibitor (NNRTI)
- Not currently on antiretrovirals
- Willing to provide study staff with access to medical records related to their HIV
infection
Inclusion Criteria for Male Partners:
- Ages 18 years or older
- Able to give written informed consent
- Male sexual partners of HIV-uninfected women taking part in Stage 1 of the study
Exclusion Criteria:
Exclusion Criteria for All Females:
- Are post-menopausal
- Have had a hysterectomy
- Clinically significant chronic medical condition (other than HIV) that is considered
progressive.
- History of malignancy, with the exception of basal cell or squamous cell skin cancer
- Pregnant or planning to become pregnant in the next three months
- Currently breastfeeding
- History of sensitivity or allergy to latex or any compound used in this study
- Have received antibiotics in the 14 days prior to enrollment
- Have used a spermicide or spermicidally lubricated condom within 7 days prior to
enrollment
- Have been using a hormonal contraceptive method for less than 3 months prior to
enrollment
- Have participated in other microbicide or contraceptive studies in the past three
months
- Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for
Grading the Severity of Adult Adverse Events at screening
- Have a positive bacterial urine culture
- Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal,
cervical and/or perineal ulcer or lesions or abnormal Pap smear)
- In the three months prior to enrollment have had any of the following:
- An abnormal Pap smear
- A pregnancy
- An abortion
- An intrauterine device (IUD)
- Breakthrough menstrual bleeding
- Vaginal bleeding during or following vaginal intercourse
- Gynecologic surgery
- Signs consistent with a sexually transmitted disease (STD)
- Signs of genital trauma
- Signs of genital tract infection other than asymptomatic bacterial vaginosis (BV)
- In the six months prior to enrollment have had any of the following:
- History of treatment for or a diagnosis with a new STD
- Exchanged sex for money, drugs or gifts
- Protected (with condoms) penile-vaginal or penile-anal sexual contact with more
than 4 partners
- Unprotected (without condoms) penile-vaginal or penile-anal sexual contact with
more than 1 partner
- A male sexual partner who was diagnosed or treated for an STD (other than HIV)
- A male sexual partner who has injected drugs
- Are currently using, or in the last year have used intravenous drugs (except for
therapeutic use), crack or other recreational drugs
- Are currently abusing, or in the last year have abused alcohol.
- Any other condition that, in the opinion of the investigator, might interfere with the
evaluation of the study objectives
Additional Exclusion Criteria for Stage 1:
- Unprotected (without condoms) or protected (with condoms) penile-vaginal or
penile-anal sexual contact with an HIV-infected partner in the past 6 months
- Unwilling to use study-provided male condoms while on study
Additional Exclusion Criteria for Stage 2:
- NNRTI mutations in plasma and/or genital secretions at screening
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 | Study of UC-781 Vaginal Microbicide | NCT00132444 | Contradiction |
3,826 | 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:
Knee Osteoarthritis Subjects
1. Male or female 18-60 years of age
2. Confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings
3. Unilateral chronic knee pain >4 months
4. Imaging findings consistent with mild-moderate generalized cartilage degeneration (MRI
chondropathy or radiographic changes)
5. Failed non-invasive modalities of treatment
6. Subjects must have the ability to understand and the willingness to sign a written
informed consent document
7. For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per
year during the treatment period. A woman is considered to be of childbearing
potential if she is postmenarcheal, has not reached a postmenopausal state (<12
continuous months of amenorrhea with no identified cause other than menopause), and
has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples
of contraceptive methods with a failure rate of <1% per year include bilateral tubal
ligation, male sterilization, hormonal contraceptive that inhibit ovulation,
hormone-releasing intrauterine devices, and copper intrauterine devices. The
reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Period
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
withdrawal are not acceptable methods of contraception
Focal Chondral Defect Subjects
Inclusion Criteria:
1. Male or female 18-60 year of age
2. Knee pain and/or effusion
3. Inability to continue or difficulty in participation in recreational or professional
sport
4. MRI with Outerbridge Grade 4 focal chondral defect
5. Subjects must have the ability to understand and the willingness to sign a written
informed consent document
6. For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per
year during the treatment period. A woman is considered to be of childbearing
potential if she is postmenarcheal, has not reached a postmenopausal state (<12
continuous months of amenorrhea with no identified cause other than menopause), and
has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples
of contraceptive methods with a failure rate of <1% per year include bilateral tubal
ligation, male sterilization, hormonal contraceptive that inhibit ovulation,
hormone-releasing intrauterine devices, and copper intrauterine devices. The
reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Period
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
1. Radiographic findings consistent with Kellgren-Lawrence Stage 4 disease
2. Focal chondral defect
3. Major axial deviation (>5 degrees varus or valgus)
4. Concomitant ligamentous or meniscal injury
5. BMI > 40 as defined by NIH Clinical Guidelines Body Mass Index
6. Women who are pregnant, breastfeeding or unwilling to practice birth control during
participation in the study
7. Concurrent participation in another investigational trial involving systemic
administration of agents (within the previous 30 days), or have received prior
intra-articular injection of any form
• Or plans to participate in any other allogeneic stem cell therapy trial during the
2-year follow-up period
8. Symptomatic active cardiac or respiratory disease that requires scheduled use of
medication
9. Neurologic disorder including, but not limited to epilepsy, Parkinson's disease,
dementia, cerebrovascular disease, tumor of the nervous system, and amyotrophic
lateral sclerosis.
10. Psychiatric disorder including, but not limited to schizophrenia, bipolar disorder,
personality disorder, depression, anxiety, or any other mental illness that would
prevent the completion of the study
11. Current immunosuppression from medication or disease
12. History of systemic malignancy
13. History of infection with hepatitis B, C, or HIV
14. History of inflammatory arthropathy
15. History of prior local knee infection
16. Major surgeries, other than diagnostic surgery within 4 weeks
17. Contraindication to MRI:
- Indwelling medical devices such as pacemakers, aneurysm clips, etc.
- Indwelling metal from any other cause (trauma, etc.). To be excluded with history
and/or radiographs, as necessary
18. Screening hematology with white blood cell count < 4.5 x 109 cells/L, hematocrit <30%,
and platelets <150 x 109 platelets/L
19. Have a known history of hypersensitivity or anaphylactic reaction to Dimethyl
sulfoxide (DMSO)
20. Have been treated in the last 6 months before enrollment for alcohol and/or drug abuse
in an inpatient substance abuse program
21. Subject unlikely to complete the study as determined by the Investigator
22. Subjects must have normal marrow function, and be clinically stable with no
significant changes in health status within 2 weeks prior to cell collection that the
PI/Sub-Investigator deems relevant to exclude from participation. (See below for
details of the cell collection procedure)
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 | Impact of Mesenchymal Stem Cells in Knee Osteoarthritis | NCT03477942 | Entailment |
951 | 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 and radiographic diagnosis of osteoarthritis of the hand.
- Hand symptoms such as pain, aching and stiffness present across the prior six months.
- Willingness to use only Tylenol to relieve hand symptoms during the study.
- Primary spoken language is English.
Exclusion Criteria:
- Current use of narcotics, opiates, morphine, steroids.
- Previous surgery to the hand.
- Infection or wound in the hand.
- Involvement in litigation, worker's compensation claim or receiving disability
benefits because of osteoarthritis of the hand.
- Participation in a research study during the prior 90 days.
- Pregnant or lactating.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of the Use of Laser Light to Treat Osteoarthritis of the Hand. | NCT00254111 | Entailment |
535 | 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:
- women with thin endometrium
Exclusion Criteria:
- serum positive hepatitis B and C women
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium | NCT03166345 | Contradiction |
2,785 | 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:
- Patients scheduled for elective, inguinal hernia repair
- 18 years or older
- Male gender
- ASA physical classification system 1-3
- Informed consent
Exclusion Criteria:
- Patients with recurrent hernia, except patients operated in childhood without mesh
application.
- Patients with bilateral hernia
- Patients with chronic pain
- Patients in anticoagulation therapy
- Previous major surgery in lower abdomen
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation | NCT02467140 | Entailment |
3,026 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. A diagnosis of moderate IDD
2. Mobility independence
3. No secondary diagnosis of autism, nor sensory disabilities such as blindness or
deafness
4. Students had been studying at the school for at least one year prior to data
collection.
Exclusion Criteria:
-
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 21 Years | Collaborative Consultation for Participation Among Students With IDD | NCT02797639 | Entailment |
6,492 | 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 who had provided written informed consent to participate in the study.
- Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to
severe facial rosacea, defined as the presence of: i. At least twelve and not more
than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with
a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii.
Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND
iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.
- Subject willing to minimize external factors that might trigger rosacea flare-ups as
recommended per protocol and patient instructional guide (e.g., spicy foods, thermally
hot foods and drinks, hot environments, prolonged sun exposure, strong winds and
alcoholic beverages).
- Non-nursing, female subjects of child bearing potential, who are using an acceptable
form of birth control: total abstinence, oral (birth control pills), intravaginal:
(e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or
transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD);
double-barrier (diaphragm or condom with spermicidal gel or foam); for two months
prior to study enrollment or a vasectomized partner. All female subjects of child
bearing potential must have undergone an in-office urine pregnancy test, with a
negative result, prior to being randomized to receive study drug. In addition, women
of childbearing potential must have agreed to a have urine pregnancy test at Day 42
and at the end of the study (Day 84). Females not of childbearing potential due to
menopause must have been postmenopausal for at least one year. Male subjects must be
willing to not attempt to conceive a child during the participation in the study.
Females utilizing oral contraception must be willing to utilize an appropriate
secondary form of contraception during the study.
- Subjects who use the same brand of soap, make-up, hair products, or shaving
lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit
and agree not to change these product brand/types during the study, with the exception
of using the study approved cleanser and moisturizer with sunscreen provided by the
sponsor.
- Male subjects who are willing to shave, if applicable, at approximately the same time
every day.
- Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or
excessive exposure to the sun for the duration of the study.
Exclusion Criteria:
- Presence of any skin condition on the face that would interfere with the diagnosis or
assessment of rosacea as determined by the Investigator.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
with diagnosis or assessment of rosacea. Patients also must not grow excess facial
hair during the study (i.e. they need to be free of excess facial hair for follow-up
visits).
- History of hypersensitivity or allergy to minocycline, any other tetracycline or any
other component of the formulation, or known reactions to cleansers, including Ponds
Cold Cream, and moisturizer with sunscreen.
- Subjects using, or planning use of concomitant treatments within 30 days prior to
Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery,
intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray,
IPL, laser therapy or UV therapy).
- Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin)
or therapeutic vitamin A supplements of greater than 10,000 International Units/day
(multivitamins are allowed).
- Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol,
Depogen, birth control pills), for less than 2 months prior to the Baseline Visit.
(Subjects using estrogens for 2 months or more are not excluded unless the subject
expected to change dose, drug, or discontinue estrogen use during the study).
- Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2)
systemic antibiotics known to have an impact on the severity of facial rosacea (e.g.,
containing tetracycline and its derivatives, erythromycin and its derivatives,
sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids.
- Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2)
topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole,
azelaic acid, erythromycin, ivermectin, sulfur based topical products).
- Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than
5 nodules or sinus tracts.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.
- Subjects with underlying diseases or other dermatological conditions, such as; atopic
dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of
interfering topical or systemic therapy or may have interfered with the rosacea
diagnosis.
- Subjects using an investigational drug or participating in an investigational study
within 30 days of the Baseline Visit. Use of an investigational drug and/or
participation in another investigational study prohibited during this study.
- Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol
or drug abuse with in the past year.
- Medical history of immunodeficiency or other significant ongoing medical condition or
disease as determined by the 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.
| Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea | NCT03263273 | Entailment |
3,386 | 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:
1. Controlled Type n Diabetes Mellitus (HbAlc <9%)
2. Baseline levels ofLDL-C >100 mg/dL
3. HDL-C <40 mg/dL
4. Triglycerides :::200mg/dL and :::500mg/dL
5. ALT and AST levels :::30%above the ULN with no active liver disease and CK :::50%above
the ULN
6. Alcohol consumption <2 drinks per day and with a maximum intake of <10 drinks per week
7. Patients who are currently treated with pioglitazone (15 to 45 fig/day), rosiglitazone
(2 to 8 fig/day), or metformin (500 mg to 2500 fig/day) as monotherapy or in
combination with insulin or sulfonylureas must have been on a stable dose of these
anti-diabetic agents for the previous 3 months
8. Patients on warfarin or warfarin-like anticoagulants must agree to have their INRJPT
levels drawn per standard of care by the local lab for adjustment of anticoagulant
dosage
j. The patient understands the requirements of the study, and voluntarily agrees to
participate in the study and provides informed consent
Exclusion Criteria:
1. Uncontrolled Type n Diabetes Mellitus (HbAlc >9%);
2. Known history of CAD
3. Known history of myopathy or rhabdomyolysis
4. Known history of intolerance to statins or fibric acid derivatives
5. The use of lipid lowering agents or treatments therapy including bile acid
sequestrants, HMG-Co-A reductase inhibitors, fish oil, nicotinic acid (doses >200
mg/day) or niacin taken within 6 weeks prior to the eligibility for randomization
visit or 8 weeks prior to the eligibility visit, if the patient is on fibrates
6. Serum creatinine> 1.5 mg/elL. If serum creatinine is between 1.2 and 1.49 mg/elL, the
calculated creatinine clearance using the Crockcroft/Gault [Crockcroft, 1976 #124]
formula must be >50 ml/min to be included in this study
Formula for Males:
CrCI= (140-age [years])x (body weight [kg]) (72) x (serum Cr [mg/elL])
Formula for Females:
CrCI=(140-age [years]) x (body weight [kg]) x 0.85 (72) x (serum Cr [mg/dL]) g. Active
liver disease including viral hepatitis (hepatitis B or C) as determined by positive
antibodies to core and surface antigen for hepatitis B, and positive antibodies for
hepatitis C h. Uncontrolled hypertension (treated or untreated) with systolic blood
pressure >160 mmHg or diastolic blood pressure >100 mmHg i. Proteinuria as defined by >0.5
mg albumin per mg creatinine (if dipstick> 1+) or history of nephrotic syndrome j.
Secondary hypercholesteremia due to hypothyroidism (TSH >6~U/mL) or nephrotic syndrome;
Patients with a history of hypothyroidism, who are on a stable dose of thyroxine with
normalized plasma thyroxine and TSH may be included k. Diagnosis of homozygous familial
hypercholesteremia, or Types I or V hyperlipidemia 1. The concomitant use of cyclosporine;
systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazadone, or HIV
protease inhibitors are excluded. The concomitant use of systemic (pO or IV)
glucocorticoids, and verapamil (other calcium channel blockers are acceptable), or the
consumption oflarge amounts of grapefruitjuice (> 1 quart) are excluded. m. Known
hypersensitivity to any component of HMG-CoA reductase inhibitors or fibrates including
history of elevated liver or muscle function tests, jaundice, or hepatotoxicity or myopathy
associated with these treatments n. History of partial ileal bypass o. Treatment with any
other investigational drug within the previous 30 days Currently using illicit drugs;
history of drug or alcohol abuse within the past 5 years Type 1 diabetes mellitus,
hyperlipidemicpancreatitis or known presence of cholelithiasis (gallstones); Any therapy or
condition that would pose a risk to the patient or make it difficult for the patient to
comply with requirements of the study s. Participation in any other studies involving
investigational or marketed products within 30 prior to entryin the study. .
1. Pregnantand/orlactatingwomen,andwomenof childbearingpotentialnot usingacceptablemeansof
contraception.Womenof childbearingpotentialmustbe usingadequatemeasuresof contraception(as
determinedby the investigator)to avoidpregnancyandshouldbe highlyunlikelyto
conceiveduringthe study period. Womenof childbearingpotentialmusthavea
negativepregnancytest at the timeof initialscreening.
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.
| Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study | NCT00309712 | Contradiction |
1,984 | 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:
- presenting for upper endoscopy for gastric indications
- gastric indications include upper abdominal pain dyspepsia abnormal gastric imaging
iron deficiency anemia gastric ulcer management of GI blood loss without active
bleeding reflux weight loss.
Exclusion Criteria:
- Subjects who are incarcerated, younger than 18, or unable to give informed consent
will be excluded.
- Patients who have evidence of active gastrointestinal bleeding will be excluded
- Patients taking anti-thrombotic agents including clopidogrel, ticlopidine, coumadin,
heparin, enoxaparin, and direct II or Xa inhibitors
- Patients with INR >1.5, platelet count <75,000
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.
| Narrow Band Imaging for Gastric Neoplasia | NCT02197351 | Entailment |
3,327 | 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:
1. Adult aged 18-65 years.
2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or
more at any frequency) by standard audiometric measures for >6 months.
3. Documented medical history consistent with hearing loss being caused by noise exposure
or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to
screening required).
4. Female subjects must be of non-childbearing potential or will need to utilize two
methods of highly effective contraception during the study participation (e.g.
hormonal contraception or an intrauterine device and condoms) or remain abstinent.
Male subjects should use condoms with spermicide during the course of the study or
remain abstinent. Subjects should not donate sperm or ova during the study period.
Exclusion Criteria:
1. Perforation of tympanic membrane or other tympanic membrane disorders that would
interfere with the delivery and safety assessment of an intratympanic medication or
reasonably be suspected to affect tympanic membrane healing after injection in either
ear. This includes a current tympanostomy tubes.
2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the
ear to be injected.
4. Active chronic middle ear disease or a history of major middle ear surgery, as an
adult, in the ear to be injected.
5. Subject has had an intratympanic injection in either ear within 6 months of the
screening visit.
6. History of clinically significant vestibular symptoms at the discretion of the
investigator.
7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid
arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
8. History of head or neck radiation treatment or exposure.
9. History of substance abuse within 2 years of the Screening Visit.
10. Positive urine pregnancy test or breast-feeding.
11. Any known factor, condition or disease that, in the view of the investigator, might
interfere with treatment compliance, study conduct or interpretation of the results
such as psychiatric disease or suicidal tendencies.
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 | FX-322 in Sensorineural Hearing Loss | NCT03616223 | Contradiction |
2,235 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Signed Informed consent
- Patient meeting the American College of Rheumatology/ European League Against
Rheumatism (ACR/EULAR) 2015 gout classification criteria
- History of ≥1 self-reported flares of gouty arthritis within 12 months
- Current ongoing flare of gouty arthritis characterized by pain intensity
- Currently tender and swollen joint
- Onset of current flare within 4 days
- Intolerant, unresponsive, contraindicated or not appropriate for treatment with NSAIDs
and colchicine (both treatment options)
- If on urate-lowering therapy, on a stable dose and regimen
- Women of childbearing potential willing to use adequate contraception
Inclusion criteria for treatment of subsequent flare(s)
- Current flare of gouty arthritis characterized by pain intensity
- Currently tender and swollen joint
- Women of childbearing potential willing to use adequate contraception
Exclusion Criteria:
- Use of specified pain relief medications or biologics (including glucocorticoids,
narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor
necrosis factor inhibitors) within specified periods prior to randomization
- Contraindication to triamcinolone
- Polyarticular gouty arthritis involving more than 4 joints
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- History of malignancy within the past 5 years. Exceptions are basal cell skin cancer,
carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy.
- Known hypersensitivity to Escherichia coli-derived proteins, Kineret® (anakinra),
Kenalog® (triamcinolone acetonide) or any components of the products.
- Known presence or suspicion of active or recurrent bacterial, fungal or viral
infections, including tuberculosis, or HIV infection or hepatitis B or C infection
- Presence of severe renal function impairment chronic kidney disease (CKD) stages 4 and
5
- Presence of neutropenia
- Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic,
gastrointestinal, central nervous system or hepatic disease
- History of myocardial infarction, unstable angina, cerebrovascular events, or coronary
artery bypass grafting, New York Heart Association (NYHA) class III or IV heart
failure within the previous 3 months
- Patients who have undergone major surgery within 2 weeks, or have an unhealed
operation wound/s
- Presence of any medical or psychological condition or laboratory result that in the
opinion of the investigator might create risk to the patients or to the study.
- Earlier or current treatment with anakinra
- Pregnant or lactating women
- History of >12 flares overall in the 6 months prior to randomization
Exclusion criteria for treatment of subsequent flare(s):
- Known presence or suspicion of active or recurrent bacterial, fungal or viral
infections, including tuberculosis, or HIV infection or hepatitis B or C infection.
- Presence of severe renal function impairment CKD stages 4 and 5
- Presence of neutropenia
- History of myocardial infarction, unstable angina, cerebrovascular events, or coronary
artery bypass grafting, NYHA class III or IV heart failure within the previous 3
months
- Patients who have undergone major surgery within 2 weeks or have an unhealed operation
wound/s.
- Pregnant or lactating women.
- Presence of any condition or laboratory result that in the opinion of the investigator
makes the patient not appropriate for treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis | NCT03002974 | Entailment |
6,229 | 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. Ages 18-75
2. Must be able to read and write in English or Spanish
3. Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in
both nostrils
4. Must be one of the following:
- Currently experiencing a Fever of 100﮲ Fahrenheit and above or self-reports
having fever within the past 48 hours, and experiencing at least one (1)
additional associated CDC COVID-19 symptom:
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
- Previously tested positive for COVID-19 in past 14 days, and experiencing at
least one (1) additional associated CDC COVID-19 symptom
- Currently experiencing at least three (3) additional associated CDC COVID-19
symptoms so long as at least at least one (1) symptom is either: cough, shortness
of breath, and/or new loss of taste or smell.
Exclusion Criteria:
1. Currently suffering from nasal trauma such as a nosebleed
2. Received a nasal rinse/wash/aspirates for standard of care testing
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion | NCT04720794 | Contradiction |
3,142 | 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:
- Patients with type 2 diabetes mellitus suffering from xerostomia.
- Patients aged between 35 and 50 years old.
- Glycated hemoglobin less than 7% (28) .
- Duration of diabetes mellitus not less than 4 years and not more than 8 years.
Exclusion Criteria:
- Patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs.
- Patients with any systemic disease reported to produce hyposalivation (sjogren's
syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8).
- Patients receiving chemo-therapy and radio-therapy.
- Mouth breathers.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Malic Acid in Treatment of Xerostomia | NCT04756986 | Contradiction |
1,825 | 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 to75 years old;
2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the
gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥
10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
3. Failure of prior therapy (during or after treatment) in patients who have received at
least two prior chemotherapy regimens;
4. ECOG PS of 0-2;
5. Major organ function has to meet the following criteria:
For results of blood routine test (without blood transfusion within 14 days):
- HB ≥ 90g / L
- ANC ≥ 1.5 × 109 / L
- PLT ≥ 80 × 109 / L
Biochemical tests results:
- Bilirubin <1.25 times the upper limit of normal (ULN)
- ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN
- Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault
formula)
6. An expected survival of ≥ 3 months;
7. Patient received apatinib treatment regimen at investigators' discretion;
8. Patient has to 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. 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 ClassII; II-level arrhythmia (including QT interval
prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac
dysfunction;
2. Factors that could have an effect on oral medication (such as inability to swallow,
chronic diarrhea and intestinal obstruction);
3. 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 vomiting blood in the past 3 months;unresected primary lesion in
stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with
massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy
result;
4. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
5. Associated with CNS (central nervous system) metastases;
6. Pregnant or lactating women;
7. Other conditions regimented at investigators' discretion.
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 | Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer | NCT02426034 | Entailment |
3,736 | 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:
- Patients of either sex with primary osteoarthritis of one or both knees fulfilling
diagnostic criteria for osteoarthritis knee laid down by American College of
Rheumatology.
- Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least
2 and chronic pain in the knee joint for more than 3 months.
Exclusion Criteria:
- The patients with secondary osteoarthritis of knees
- Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- Patients on steroids
- Disease modifying drugs, e.g. methotrexate and azathioprine
- Patients with recent trauma in the area of acupuncture
- History of intra articular injection of steroid within last two months
- Patients missing two or more sessions of electro-acupuncture consecutively were
excluded from the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK) | NCT02299713 | Contradiction |
4,084 | 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:
- Patients that have a scheduled office visit with their primary care physician.
- Patients have to be Kaiser Permanente members
Exclusion Criteria:
- Non-English speaking patients unable to understand English to complete the surveys.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Validating the Use of a Subjectively Reported Sleep Vital Sign | NCT03018912 | Entailment |
5,622 | 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:
- Girls 10 through 14 years of age who are in good general health and have a BMI in the
85th to 95th percentile or greater than the 95th percentile
- Availability of a parent or guardian to ensure the child attends all monthly clinic
visits and who will be available to attend the monthly educational sessions if the
child is assigned to the intervention group
Exclusion Criteria:
- Cardiac or pulmonary conditions such as cystic fibrosis, congenital heart disease, or
other conditions that would impair ability to do fitness testing
- Physical challenges such as deformities that would impair ability to perform physical
activities
- Use of medications such as corticosteroids, seizure medication, or other central
nervous system (CNS) medications that would interfere with daily physical activity
Female
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 14 Years | Mood and Behavior Changes Among Overweight Adolescent Females | NCT00127374 | Contradiction |
4,021 | 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. Primary osteoarthritis of the knee
2. Radiologic evidence of OA of the knee
3. On stable pain therapy with an oral or topical NSAID or acetaminophen
4. Experience a "moderate flare" of pain following washout of stable pain therapy
5. Able to read and understand English or Spanish to answer pain assessment questions
without any explanation
6. If female, surgically sterile or non-pregnant
7. Except for OA, in reasonably good general health
8. Written informed consent
Exclusion Criteria:
1. Secondary OA of the study knee
2. History of pseudo gout or inflammatory flare-ups
3. Participation would conflict with contraindications, warnings or precautions as stated
in the prescribing information for oral or topical diclofenac
4. Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
5. Any malignancy within the previous 3 years, except local therapy for superficial skin
cancer not on the study knee
6. Known sensitivity to the use of oral or topical diclofenac, aspirin [acetylsalicylic
acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol
7. Ongoing abnormality that could confound interpretation of the safety results (eg,
anemia, unresponsive gastrointestinal [GI] reflux, etc.)
8. Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the
last 6 months
9. Uncontrolled diabetes
10. Screening laboratory test results of serum creatinine ≥ 1.5 times upper limit of
normal; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
gamma-glutamyltransferase (GGT) ≥ 3 times upper limit of normal; and hemoglobin less
than or equal to lower limit of normal
11. Documented alcohol or drug abuse within 1 year
12. If female, breast-feeding
13. Major surgery or previous damage to the study knee at any time, or minor knee surgery
to the study knee within 1 year
14. Requires oral or intra-muscular corticosteroids, or received an intra articular
corticosteroid injection into the study knee within the past 90 days, or into any
other joint within the past 30 days, or currently applying topical corticosteroids
onto the study knee
15. Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the
study knee in the past 6 months
16. On prior stable therapy (ie, more than 3 days per week for the previous month) with an
opioid analgesic prior to the screening visit will be excluded.
17. Recently started taking a sedative hypnotic medication for insomnia
18. Taking anti-depressants
19. Not willing to discontinue prohibited medications/therapies
20. Cannot tolerate acetaminophen
21. Re-entering study after dropping out or withdrawn from study
22. Used another investigational drug within the previous 30 days
23. On or currently applying for disability benefits on the basis of knee OA
24. History of fibromyalgia
25. Other painful or disabling conditions affecting the knee or leg, or disabling
condition of the hands (used to apply the study drug)
26. Skin disorder with current involvement on the hands (used to apply the study drug) or
the knee(s) (application site)
27. Referred to an orthopedic surgeon for consideration of, or been advised to have, knee
replacement or knee reconstruction surgery
28. Radiologic evidence of OA of the knee advanced to the point that all cartilage has
been eroded (ie, bone on bone)
29. Recently started using a cane within the past 30 days
30. History of chronic headaches that may require more than occasional use of rescue
medication for headaches
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 85 Years | Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis | NCT01119898 | Entailment |
1,445 | 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:
- Patients with post-acute dysphagia (lesion occurring at least six weeks prior,
approximately),
- remaining in inpatient care for at least one month after the first moment of data
collection,
- 18 years of age or older,
- receiving regular visits from their family members or caregivers.
Exclusion Criteria:
- Failing to meet inclusion criteria
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.
| Poster on Dysphagia-specific Food Procedures: Usability and Impact | NCT03820791 | Contradiction |
3,555 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with
normal adrenal function and normal glucose regulation
- Age ≥ 18 years
- Ability to comply with the study protocol
- Capability to perform spiroergometry
Exclusion Criteria:
- Any contraindication for performing spiroergometry according to the guidelines of the
German Cardiac Society:
- acute myocardial infarction
- instable angina pectoris
- symptomatic arrhythmia
- severe and symptomatic stenosis of the aortic valve
- decompensated heart failure
- acute pulmonary embolism
- Acute myocarditis
- Acute pericarditis
- Acute aortic dissection
- main coronary artery disease
- valvulopathies
- electrolyte disturbance
- arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110 mm
Hg)
- Tachyarrhythmia or Bradyarrhythmia
- Hypertrophic cardiomyopathy and other forms of obstructive heart disease
- second or third degree atrioventricular block
- Fever
- Diabetes mellitus Type 2
- Diseases or medication influencing the endogenous levels of plasma catecholamines(e.
g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
- Glucocorticoid-pharmacotherapy
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 | Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I | NCT01452893 | Entailment |
2,723 | 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:
- surgeon determined need for inguinal hernia repair
Exclusion Criteria:
- < 18 years of age
- > 99 years of age
- medical indication for open repair
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 | Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial | NCT03133533 | Entailment |
3,039 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Subject has Fragile X syndrome with a molecular genetic confirmation of the full FMR1
mutation (>200 CGG repeats) or the other loss of function mutations of the FMR1 gene
(SNVs and deletions of the gene).
- Subject is a male or non-pregnant, non-lactating female age 6 to 25 years, inclusive.
- Subjects who are capable of becoming pregnant must use an acceptable method of birth
control for the duration of the study. Acceptable forms of birth control include
abstinence (only for subjects who are not sexually active), intrauterine devices in
place for at least 3 months, oral contraceptives, surgical sterilization, or adequate
barrier methods.
- Subject must have a caregiver (parent, guardian, or other legally authorized
representative) who is willing to participate in the whole study.
- Subject and caregiver are able to attend the clinic regularly and reliably.
- Subject and/or subject's caregiver is able to understand, read, write and speak
English or French fluently to complete study-related materials.
- For subjects who are not their own legal guardian, subject's caregiver is able to
understand and sign an informed consent to participate in the study.
- The use of concomitant medication must be stable, in terms of dose and dosing regimen,
for at least 4 weeks prior to Screening and must remain stable during the period
between first visit (Screening) and the commencement of the study; every effort should
be made to maintain stable regimens of allowed concomitant medications from the time
of commencement of double-blind study medication until the last study assessment.
- Behavioral/educational treatments must be stable for 4 weeks prior to first visit
(Screening) and must remain stable during the period between Screening and the
commencement of randomized double-blind study medication.
- Overall IQ, as assessed at Screening on the Leiter-III, is not higher than 79, and
subject must speak at least occasional 3-word phrases.
Exclusion Criteria:
- Families that are not cooperative and will not follow through with the demands of this
study.
- Subject has a life-threatening medical problem or other major systemic illness that
compromises health or safety and/or would interfere with this study.
- Age younger than 6 or older than 25 years.
- History of intolerable adverse events with metformin.
- Current or recent metformin treatment (within the past 4-months).
- BMI inferior to 2 standard deviations below the mean for age using the World Health
Organization scale.
- Serum creatinine > 1.4 mg/dl (female) or > 1.5 mg/dl (male).
- History of metabolic acidosis or a condition with lactic acidosis.
- Severe Vitamin B12 deficiency.
- Pregnancy at screening or unwillingness to use acceptable method of birth control, if
applicable.
- IQ higher than 79 on the Leiter-III at Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 25 Years | A Trial of Metformin in Individuals With Fragile X Syndrome (Met) | NCT03862950 | Entailment |
2,584 | 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:
- occult inguinal or ventral hernia diagnosed in laparoscopic surgery
Exclusion Criteria:
- clinically diagnosed inguinal or ventral hernia
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 100 Years | Follow-up of Symptomless Inguinal and Ventral Hernias | NCT04683367 | Contradiction |
5,841 | 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:
- Subject must be at least 18 years of age and at least the minimum Age of Majority
according to applicable State or Country Law and must be less than 75 years of age,
with a life expectancy > 3 years
- Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia
and laparoscopic surgery
- Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than
6 months (regurgitation or heartburn which is defined as a burning epigastic or
substernal pain which responds to acid neutralization or suppression)
- Patient requires daily proton pump inhibitor or other anti-reflux drug therapy
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for ≥
4.5% of the time Note: Subjects shall have discontinued any GERD medications for at
least 7 days prior to testing.
- Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy
demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on
proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement
when comparing their on PPI and off PPI GERD-HRQL score
- GERD symptoms, in absence of PPI therapy (minimum 7 days)
- If the subject is of child bearing potential must have a negative pregnancy test
within one week prior to implant and must agree to use effective means of birth
control during the course of the study
- Subject is willing and able to cooperate with follow-up examinations
- Subject has been informed of the study procedures and the treatment and has signed an
informed consent form
Exclusion Criteria:
- The procedure is an emergency procedure
- Currently being treated with another investigational drug or investigational device
- History of gastroesophageal surgery, anti-reflux procedures, or
gastroesophageal/gastric cancer
- Any previous endoscopic anti-reflux intervention for GERD
- Suspected or confirmed esophageal or gastric cancer
- Any size hiatal hernia >3cm as determined by endoscopy
- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences
- Esophagitis - Grade C or D (LA Classification)
- Body Mass Index (BMI)>35
- Symptoms of dysphagia more than once per week within the last 3 months.
- Diagnosed with Scleroderma
- Diagnosed with an esophageal motility disorder such as but not limited to Achalasia,
Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES
- Subject has a history of or known esophageal stricture or gross esophageal anatomic
abnormalities (Schatzki's ring, obstructive lesions, etc.)
- Subject has esophageal or gastric varices
- Subject has history of or known Barrett's esophagus
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, or plans to become pregnant during the course of the study
- Medical illness (i.e. congestive heart failure) that may cause the subject to be
non-compliant with or able to meet the protocol requirements or is associated with
limited life expectancy (i.e. less than 3 years)
- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that
exhibit depression that are on appropriate medication(s) are allowable.
- Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials
- Subject has an electrical implant or metallic, abdominal implants
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 | LINX Reflux Management System Clinical Study Protocol | NCT00776997 | Contradiction |
1,939 | 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. Patients with histologically documented gastric carcinoma (diffuse/intestinal
histotype) eligibile for R0.
1. Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
2. Urgent presentation: perforation without purulent generalized peritonitis
3. Positive cytology of peritoneal fluid (if previously obtained)
2. Age ≥ 18 years and ≤75 years.
3. Written informed consent.
Exclusion Criteria:
1. Gastroesophageal Junction (GEJ) cancer
2. Distant metastatic disease (even if limited and completely resected)
3. Peritoneal carcinomatosis
4. History of tumor diagnosed in the 3 years before entering the study, except for
topical and healed pathologies that do not need further treatment (e.g. non-melanoma
skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or
cervix).
5. Psychological, family or social conditions which may negatively affect the treatment
and follow-up protocol.
6. Poor general conditions (ECOG > 2).
7. Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically
significant cardiovascular disease: cerebral vascular accident/stroke (< 6 months
prior to enrolment), unstable angina, congestive heart failure (New York Heart
Association Classification Class > II) or serious uncontrolled cardiac Arrhythmia
requiring medication
8. Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance
<60 mL / min).
9. Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin > 1.5 upper
limit of normal).
10. Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm 3,
platelets <100000 / mm3).
11. Impaired pulmonary function (presence of COPD or other pulmonary restrictive
conditions with FEV1 <50% or DLCO <40% of normal age value).
12. History or presence of other disease, metabolic dysfunction, or clinical laboratory
finding giving reasonable suspicion of a disease or condition that contraindicates use
of HIPEC or chemotherapy or patient at high risk from treatment complications.
13. Pregnancy.
14. Krukenberg tumor
15. Refusal to join the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study | NCT03917173 | Entailment |
5,189 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. Fully informed, understood, voluntary participate, and the patient himself or guardian
agree to sign the written informed consent and patient be able to comply with the
protocol;
2. Aged from 50 years to 85 years, inclusive;
3. Spontaneous amenorrhea time ≥ 2 years, or bilateral oophorectomy≥ 2 years. If the
status of bilateral ovariectomies is unknown, the menopause status should be confirmed
by follicle stimulating hormone(FSH) level≥ 40IU/L;
4. Based on the results of dual energy X-ray absorptiometry, BMD of lumbar spine(L1~L4),
femoral neck or total hip: -4.0<T-Score≤-2.5；
5. There must be at least one of the following risk factors:
- History of osteoporotic fracture;
- Father's and mother's hip fracture history, or both parents';
- Low body mass index(≤19kg/m^2);
- Patient's age was equal or greater than 70 years old;
- Current smoker;
- CTX1 was one standard deviation higher than that of healthy premenopausal women
within screening period(ie, CTX1>0.43ng/mL);
6. Ability to act independently.
Exclusion Criteria:
1. Suffering from the following diseases known to affect calcium or bone metabolism:
- Various metabolic bone diseases, such as osteogenesis imperfecta and
osteomalacia;
- Paget's osteopathy;
- Cushing's syndrome;
- Hyperprolactinemia;
- Hypopituitarism;
- Acromegaly;
- History of hyperparathyroidism or hypoparathyroidism;
- History of hyperthyroidism or hypothyroidism(hypothyroidism patients can be
included: only receiving stable thyroid hormone replacement therapy, if the
thyroid stimulating hormone(TSH) level is normal, or 5.5μIU/mL<TSH≤10.0μIU/mL,
and free thyroxine(FT4) is in normal range can be included);
- Malabsorption syndrome or various gastrointestinal diseases associated with
malabsorption, such as Crohn's disease and chronic pancreatitis;
- Abnormal level of blood calcium: the current diagnosis of hypocalcemia or
hypercalcemia or albumin corrected serum calcium levels are not within the
laboratory normal range(calcium supplements should not be used for at least 8
hours prior to serum calcium testing);
- Vitamin D deficiency: 25 hydroxyvitamin D concentration<20ng/mL. Allowed to
retest after oral vitamin D2 soft capsules in the screening period. If the
concentration of 25 hydroxyvitamin D is more than or equal to 20ng/mL， it can be
selected;
- Other diseases such as rheumatoid arthritis, gout, multiple myeloma, etc;
2. Medical history of two or more vertebrae fractures;
3. Malignant tumor(excluding skin basal cell carcinoma or squamous cell carcinoma,
cervical carcinoma in situ or breast ductal carcinoma in situ) in recent 5 years;
4. Severe renal function damage(creatinine clearance rate<30mL/min), or dialysis, urinary
calculi or chronic cystitis;
5. Suffering from the following liver or biliary diseases:
- Liver cirrhosis;
- Biliary abnormalities(except for Gilbert syndrome or asymptomatic gallstones);
- Positive hepatitis C virus antibody(HCV-Ab) and the titer of HCV-RNA exceeded the
upper limit of norma;
- Positive hepatitis B suface antigen(HBsAg) and peripheral blood HBV-DNA titer
≥1000 capies[CPS]/mL or 200IU/mL;
- Unstable liver disease: defined as liver ascites, hepatic encephalopathy,
coagulopathy, hypoalbuminemia, varicosis in esophagus or stomach fundus or
persistent hepatic jaundice;
6. Liver transaminase: aspartate aminotransferase≥2.0×upper limit of norma value(ULN),
alanine aminotransferase≥2.0ULN, alkaline phosphatase≥1.5ULN or total
bilirubin≥1.5ULN;
7. Suffering from the following oral diseases:
- Osteomyelitis or osteonecrosis of the jaw, previously or currently;
- Actue dental or mandibular disease requiring stomatological surgery;
- Planned invasive dental surgery during the trial period;
- Dental or stomatological surgery have not healed;
8. Conditions which can influence bone mineral density determination by dual energy X-ray
absorptiometry:
- Less than two lumbar vertebrae can be measured;
- Height, weight or waistline may hinder accurate measurement;
- Other conditions that may affect bone density testing
9. Received anti-osteoporosis drugs or those drugs may affect bone metabolism:
- Use of injectable bisphosphonates, fluoride or strontium within 2 years before
screening;
- Use of oral bisphosphonates: more than 2 years, or more than 3 months but less
than 2 years and discontinued from last dosage less than 1 year, simultaneously;
- Usage of any drugs which may affect bone metabolism within 6 weeks before
screening: parathyroid hormone or parathyroid hormone analogue(such as
teriparatide); assimilative hormone or testosterone; glucocorticoid(equivalent to
prednisone>5mg/day for more than 10 days); systemic hormone replacement therapy;
selective estrogen receptor regulator(such as reloxifene); tibolone; calcitonin;
active vitamin D and ite analogues, other bone active drugs include
anticonvulsant drugs(except benzodiazepines) and he[arin; long-term systemic use
of ketoconazole, androgen, adrenocorticotropic hormone, cinacalcet, aluminum,
lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone
agonist;
- Patients who have received RANKL inhibitors previously;
10. Positive HIV antibody;
11. Known alcoholism or drug abuse(during 12 months before screening), because alcohol or
drug abuse may interfere with subject's understanding or finish of trial;
12. Known allergy to test drug, reference drug or basic drug and its excipients;
13. Participate in interventionary clinical study(drug or device) within one month before
screening;
14. Other serious, acute or chronic diseases, mental disorders or laboratory
abnormalities, which are judged by investigator to be unsuitable to participate this
study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . | NCT04591275 | Entailment |
5,687 | 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:
All participants participating in GeNeSIS must be enrolled in the core study. Participants
for whom written consent to release information is provided may enter the core study if
they meet any of the following inclusion guidelines:
- Treatment with Humatrope for improvement of growth.
- No treatment with somatropin in participants with a history of neoplasia or in those
with any SHOX deficiency-related disorder.
Exclusion Criteria:
- Participants with closed epiphyses are not eligible for GeNeSIS entry. However,
participants may remain in the study if epiphyseal closure occurs during study
participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Observational Study of Somatropin Treatment in Children | NCT01088412 | Entailment |
4,308 | 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:
CF patients:
- Patient's written informed consent obtained prior to any study-related procedure;
- Male or female patient ≥ 18 years old with a confirmed historical diagnosis of cystic
fibrosis;
- Ability to provide a spontaneous sputum sample at screening;
- Non- or ex-smokers who smoked < 10 pack years and stopped smoking > 1 year before
screening visit;
- Patient in stable clinical condition and free from exacerbation for at least 4 weeks
prior to screening and/or prior to randomisation;
- Patient on stable concomitant treatment regimen within 4 weeks prior to screening
and/or prior to randomisation;
- Patient with pre-bronchodilator FEV1 ≥ 50% of predicted normal at screening and/or
prior to randomisation;
- Vital signs within normal limits at screening and prior to randomisation;
NCFB patients:
- Patient's written informed consent obtained prior to any study-related procedure;
- Male or female patient ≥ 18 years old with a diagnosis of Bronchiectasis confirmed by
a historical Chest CT;
- Presence of clinically significant symptoms related to Bronchiectasis, such as daily
cough that occurs over months or years, daily production of large amount of sputum,
shortness of breath, wheezing chest pain;
- Ability to provide a spontaneous sputum sample at screening;
- Non- or ex-smokers who smoked < 10 pack years and stopped smoking > 1 year before
screening visit;
- Patients in stable clinical condition and free from exacerbation since at least 4
weeks before screening and/or prior to randomisation;
- Patients on stable concomitant treatment regimen within 4 weeks prior to screening
and/or prior to randomisation
- Patient with pre- bronchodilator FEV1 ≥ 50% of predicted normal at screening and/or
prior randomization visit;
- Vital signs within normal limits at screening and prior to randomisation
EXCLUSION CRITERIA CF Patients
- Patient with BMI ≤ 17
- History of a clinically meaningful unstable or uncontrolled chronic comorbidity in the
opinion of the Investigator;
- Unstable pulmonary status or symptomatic respiratory tract infection and related
changes in therapy for pulmonary disease as per Investigator's judgment within 4 weeks
before screening or prior to randomisation;
- Abnormal and clinically significant 12-lead ECG at screening or prior to
randomisation;
- History of asthma based on objective evidence;
- History of malignancy, solid organ/haematological transplantation;
- Patient with evidence of active Nontuberculous Mycobacteria (NTM) and Tuberculous
Mycobacteria (TM) infection or related bronchiectasis in the past 12 months;
- Patient with a positive test for active Allergic Bronchopulmonary Aspergillosis (ABPA)
infection confirmed at screening or patient withABPA related bronchiectasis.
- Pregnant or lactating women.
- Patient on non-steroidal anti-inflammatory drugs (NSAIDs) within 4 weeks prior to
screening or prior to randomization visit.
- Patient on cystic fibrosis transmembrane conductance regulator (CFTR) modulators and
correctors if not on stable treatment regimen for at least 3 months prior to screening
or prior to randomization.
- Positive HIV1 or HIV2 serology at screening; Positive results from the Hepatitis
serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening
(i.e. positive HB surface antigen (HBsAg), HB core antibody (anti-HBc), HC antibody);
NCFB Patients
- Patient with BMI ≤ 17
- History of a clinically meaningful unstable or uncontrolled chronic comorbidity in the
opinion of the Investigator;
- Unstable pulmonary status or symptomatic respiratory tract infection and related
changes in therapy for pulmonary disease as per Investigator's judgment within 4 weeks
before screening or prior to randomisation.
- Abnormal and clinically significant 12-lead ECG at screening or prior to randomisation
that results in active medical problem which may impact the safety of the patients as
per Investigator's judgment.
- History of malignancy, solid organ/haematological transplantation;
- Known diagnosis of cystic fibrosis. A negative sweat test is required at screening
(sweat chloride should be < 40 mmol/L);
- History of asthma based on objective evidence of the condition;
- Patient with primary diagnosis of COPD in the opinion of theInvestigator;
- Patient with rheumatoid factor positivity;
- Patient with evidence of active Nontuberculous Mycobacteria (NTM) and Tuberculous
Mycobacteria (TM) infection or related bronchiectasis in the past 12 months;
- Patient with a positive test for active Allergic Bronchopulmonary Aspergillosis (ABPA)
infection confirmed at screening or patient with ABPA related bronchiectasis;
- Patient with Connective Tissue Disease (CTD) related bronchiectasis;
- Diagnosis of common variable immunodeficiency (CVID);
- Patient on any antibiotics (except for stable macrolides treatment),oral, inhaled and
IV, within 4 weeks prior to screening or prior to randomisation;
- Patient on oral corticosteroids within 4 weeks prior to screening visit or prior to
randomization.
- Patient on non-steroidal anti-inflammatory drugs (NSAIDs) within 4 weeks prior to
screening or randomization visit.
- Patient on Carbocysteine and Mannitol treatment within 4 weeks before the screening or
randomization visit.
- Patient with traction bronchiectasis;
- Patient with any condition that prevent them to use inhaledantibiotics (including
patients who previously experienced adverse reaction to inhaled antibiotics;
- Patient treated with monoclonal antibodies (mAb);
- Pregnant or lactating women.
- Positive HIV1 or HIV2 serology at screening; Positive results from the Hepatitis
serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening
(i.e. positive HB surface antigen (HBsAg), HBcore antibody (anti-HBc), HC antibody).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis | NCT04010799 | Entailment |
6,816 | 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 (12-60 yr. old) with severe HA under FVIII concentrates prophylaxis will be
selected at the Haemostasis and Thrombosis Center of the Fondazione Policlinico
Universitario "A. Gemelli", IRCCS, Rome, Italy (FPG) and at the satellite site at the
Department of Cellular Biotechnology and Haemathology, Policlinico Umberto I, Sapienza
University of Rome, Italy (UNSA_SS).
Exclusion Criteria:
- All patients with malignant tumors, or treated with anticoagulant / antiplatelet
agents, and suffering from other congenital coagulation disorders (von disease
Willebrand disease, other congenital deficiency of coagulation factors) or severe
thrombocytopenia (<30,000 Plt /μL).
Patients who would have undergone a severe bleed or surgery during the past 3 months before
enrolment.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 60 Years | PHYSICAL ACTIVITY AND FVIII CLEARANCE: RELEVANCE FOR PERSONALIZED THERAPY IN SEVERE HAEMOPHILIA A (PHYSEMO) | NCT04303936 | Entailment |
1,382 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Hard or firm stools for 2 or less per week
- Age are from newborn to 3 years old
Exclusion Criteria:
- Children>3 years of age
- Patients presented severe inflammation or malnutrition, unconsciousness or perforation
of intestine
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 3 Years | A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study | NCT02216994 | Entailment |
394 | 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. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the
American Fertility Society (AFS) classification of uterine adhesions;
- 2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
- 3. Having a clear desire to fertility;
- 4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV,
Hepatitis B or C, syphilis and psychiatric pathology;
- 5. Serum β-hCG is negative;
- 6. Be willing to complete the study and sign the consent form.
Exclusion Criteria:
- 1. Having a history of malignant tumor;
- 2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine
malformations;
- 3. Hysteroscopic adhesiolysis more than 3 times in the past;
- 4. Absence of peripheral vein access.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Human Amniotic Epithelial Cells for Asherman's Syndrome | NCT03223454 | Contradiction |
3,277 | 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:
- ability to understand and provide informed consent
- general good health male and female adults, were 20 years or older
- no pregnant woman
- had six caines-free maxillary anterior teeth without restorations on the labial
surfaces
Exclusion Criteria:
- had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)
- evidence of fracture or major cracks on tooth
- were pregnant or nursing
- had tooth sensitivity
- smokers
- had teeth shade A1, A2
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE | NCT00978861 | Entailment |
941 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- symptomatic knee osteoarthritis according to the American College of Rheumatology
criteria for the classification and reporting of OA of the knee joint,
- predominance of self-reported pain over the medial aspect of the knee,
- radiographic evidence of medial compartment knee osteoarthritis with an Ahlbäck score
of grade I or greater,
- and radiographic evidence of lateral compartment with Ahlbäck classification grade 0.
Exclusion Criteria:
- any previous surgery or severe trauma in the affected limb.
- inflammatory joint disease or tumors in the affected limb.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| The Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis | NCT03147495 | Entailment |
762 | 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:
- MMSE>21
- Chronic knee pain (VAS score>5)
- Right dominant
- Unilateral knee pain
Exclusion Criteria:
- Pain characteristics such as the presence of a rheumatologic disease other than knee
osteoarthritis, lumbar radiculopathy, systemic inflammatory disease, diabetic
neuropathy, problems similar to knee osteoarthritis,
- Hearing or vision problems,
- Injection therapy involving the knee region within the last 6 months,
- Surgical operation involving the knee region
- Psychiatric problems and anti-depressant usage
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 | Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis | NCT03792165 | Contradiction |
3,682 | 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:
- The patient (or his/her guardian/parent/person-of-trust) was correctly informed about
the study
- A participating ER doctor has requested an imaging exam for the patient during one of
the trial observation periods (ie the "before" period or the "after" period).
Exclusion Criteria:
- The patient is under judicial protection
- The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the
study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays | NCT01785368 | Entailment |
5,626 | 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:
Girls with Turner syndrome will qualify to participate in this study if they meet the
following criteria:
Karyotype diagnosis compatible with Turner syndrome.
No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no
treatment with either of these agents in the preceding 3 months.
Chronological age of 10.0 to 14.9 years.
Bone age less than or equal to 12 years.
EXCLUSION CRITERIA:
Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
Y component in peripheral karyotype.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 14 Years | The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome | NCT00001343 | Contradiction |
5,045 | 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 must be ≥ 18 years
- The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder
neurologist;
- The patient previously underwent a GK thalamotomy (> 12 months ago);
- The tremor on the untreated side negatively impacts the patients' quality of life;
- The patient wants treatment of the contralateral side.
Exclusion Criteria:
- Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2
falls/months, wheelchair, walker, cane use);
- Clinically relevant speech impairment (e.g. impairment of intelligibility);
- Inability to comply with the follow-up schedule;
- Refusal of the treating physician.
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.
| Bilateral Essential Tremor Treatment With Gamma Knife | NCT04748640 | Entailment |
4,323 | 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:
- Ability to produce semen sample
Exclusion Criteria:
- Cognitive impairment
- Inadequate language skills for informed consent
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility | NCT02932865 | Entailment |
3,467 | 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:
1. Signed informed consent
2. Males or females aged 18 to 75 years. Female patients must be non-fertile. To be
considered as non-fertile, females must fulfil the following:
- Non-nursing and non-pregnant 12 months prior to enrolment
- Not of child bearing potential ie, either documented irreversible surgically
sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal
ligation) or post-menopausal. Post-menopausal is defined as serum
follicle-stimulating hormone (FSH) levels in the post-menopausal range combined
with amenorrhea for more than 1 year in a woman above 50 years of age, or
amenorrhea for more than 2 years below 50 years of age
3. Patients with hypercholesterolemia treated with stable doses of the below listed lipid
lowering medication for at least 3 months prior to randomization
- Atorvastatin not more than 20 mg/day or
- Simvastatin not more than 40 mg/day
4. LDL-cholesterol > 3.0 mmol/L (Week -1)
5. Subject able and willing to comply with all study requirements
6. At randomization, diet as instructed by the investigator during the last 4 weeks prior
to randomization and willingness to follow these instructions throughout the study
Exclusion Criteria:
1. Cholesterol lowering agents other than the defined statins
2. History of somatic or psychiatric disease/condition, which may interfere with the
objectives of the study as judged by the investigator
3. Clinically significant illness or clinically relevant trauma within 2 weeks before the
administration of the investigational product as judged by the investigator
4. Chronic (> 3 months) pain condition requiring daily medication with pain killers
5. Glycosylated haemoglobin (HbA1c) > 7.0%
6. Diabetes requiring medication other than metformin
7. Clinically abnormal physical findings and laboratory values as judged by the
investigator and abnormal resting ECG, eg, QTc interval > 450 msec
8. Body Mass Index of ≥ 40 kg/m2
9. Resent history (< 3 month) of stroke or transient ischemic attacks
10. History of seizure disorder, except febrile convulsions
11. A current diagnosis of cancer, unless in remission
12. Blood pressure (BP) of > 160/95 mm Hg
13. History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia
and atrial fibrillation
14. Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or
percutaneous coronary intervention < 6 month before randomization
15. Congestive heart failure New York Heart Association Class > 2
16. Unstable or severe angina pectoris or peripheral artery disease
17. Known thyroid disease or thyroid biomarkers (TSH, T3, free T3, T4, free T4) outside
reference range for normal at enrolment and at baseline
18. Positive urine pregnancy test in women at enrolment
19. Use of thyroid replacement therapy and hormone replacement therapy (including
contraceptive pills) for last 3 months before randomization
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 | LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin | NCT00593047 | Entailment |
5,656 | 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:
Subjects will qualify for the overweight group for the dose-establishing studies 1 and 2
and main study) if they meet the following criteria:
1. Good general health.
2. Age greater than or equal to 7 and less than 15 years.
3. Tanner stage I, II or III for the breast among girls and testes less than10 mL for
boys based upon an examination by a trained physician or nurse practitioner.
4. Weight > 30 kg.
5. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and
HgbA1C less than or equal to 6.4%.
6. Females who are age 10 or greater must have a negative pregnancy test.
7. Body mass index greater than or eqaul to 95th percentile determined by Centers for
Disease Control age and sex specific data (given that most pathology of obesity does
not usually emerge until children cross the 95th percentile).
8. No evidence of growth failure as defined as height > 5th percentile.
Subjects will qualify for the non-overweight control group (for the main study only) if
they meet the following criteria:
1. Recommended by a pediatric endocrinologist to undergo GH stimulation testing to
establish the diagnosis of GH-deficiency.
2. Good general health.
3. Age greater than or equal to 7 and less than15 years.
4. Tanner stage I, II or III for the breast among girls and testes less than 10 mL for
boys based upon an examination by a trained physician or nurse practitioner.
5. Weight > 30 kg.
6. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and
HgbA1C less than or equal to 6.4%.
7. Females who are age 10 or greater must have a negative pregnancy test.
8. Height < 5th percentile.
9. BMI between the 5th and 85th percentiles determined by Centers for Disease Control age
and sex specific data.
10. Birth weight and length not consistent with small for gestational age (SGA) criteria
or a history of intrauterine growth restriction (IUGR) based on recall history.
EXCLUSION CRITERIA (for the dose-establishing sutides 1 and 2, and the main study):
Subjects will be excluded if they have any of the following:
1. Baseline creatinine greater than or equal to 1.0 mg/dl.
2. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or
decreased perfusion.
3. Hepatic disease with elevated liver function tests (ALT or AST)greater than or equal
to 1.5 the upper limits of normal.
4. Pregnancy.
5. Evidence for impaired glucose tolerance or Type 2 diabetes, including fasting plasma
glucose greater than or equal to 100 mg/dL, 2 hour post-dextrose glucose greater than
or equal to 140 mg/dL, or HgbA1C > 6.4%.
6. Presence of other endocrinologic disorders leading to obesity (e.g. Cushing Syndrome).
7. Any disorder that is known to affect GH secretion (e.g. untreated hypothyroidism) or
use of any medication known to affect GH levels (including glucocorticoids and GH
itself).
8. Any other disorder that is known to affect stature including skeletal dysplasias.
9. Recent use (within two years) of anorexiant medications, stimulant medications, or
other medications felt to impact growth.
10. Individuals who have, or whose parent or guardians have, current substance abuse or a
psychiatric disorder or other condition that, in the opinion of the investigators,
would impede competence or compliance or possibly hinder completion of the study.
11. Individuals receiving medical treatment other than diet for hypertension or
dyslipidemia.
12. Individuals with evidence of precocious puberty as defined as palpable breast tissue
noted in females before the age of 7, testicular size greater than or equal to 4cc in
males before the age of 9, or bone age advancement more than 2 SD for chronologic age.
13. Individuals receiving androgen or estrogen hormone therapy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 14 Years | Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children | NCT01237041 | Contradiction |
2,700 | 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:
- 50 patients selected and operated by the PI.
Exclusion Criteria:
- patients under the age of 18
- pregnancy
- BMI > 35
- recurrent groin hernia
- no Informed Consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Robotic Utility for Surgical Treatment of Groin Hernias | NCT02975401 | Entailment |
2,546 | 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:
- Children aged 6-36 months
- diagnosis of Atopic Dermatitis according to SCORAD index
Exclusion Criteria
- Age < 6 months
- age > 36 months,
- skin infections,
- ichthyosis,
- food allergies,
- other allergic diseases,
- chronic systemic diseases,
- congenital cardiac defects,
- active tuberculosis,
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
- celiac disease,
- cystic fibrosis,
- metabolic diseases,
- malignancy,
- chronic pulmonary diseases,
- malformations of the gastrointestinal and/or respiratory tract,
- administration of prebiotics/ probiotics/symbiotic/systemic immunomodulators during
the 4 weeks before enrolment,
- treatments with topical immunomodulators (Tacrolimus or Pimecrolimus) over the three
months prior to enrolment;
- use of corticosteroids or calcineurin antagonists or phototherapy in the previous 4
weeks,
- use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
- investigator's uncertainty about the willingness or ability of the subject to comply
with the protocol requirements;
- participation in any other studies involving investigational or marketed products
concomitantly or within two weeks prior to entry into the study;
- hypersensitivity to components contained in study product.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 36 Months | Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis | NCT03863418 | Entailment |
2,630 | 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:
- elective repair for a primary unilateral inguinal hernia OR
- elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
Exclusion Criteria:
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device | NCT01622712 | Entailment |
2,294 | 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:
- diagnosis of DMD.
Exclusion Criteria:
- presence disorders in cognitive function that would prevent comprehension of the
experimental instruction.
Male
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 34 Years | Analysis of a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy | NCT02891434 | Contradiction |
1,411 | 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. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on
selected arms after run-in period
2. Lipid levels measured after run-in period were:
- Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
- Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 →
fasting LDL-C ≥ 130mg / dL
- Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or
10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C
≥ 100 mg / dL
Exclusion Criteria:
1. Patients whose blood pressures measured at Visit 2 were:
- Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
2. Patients who had lipid levels measured at Visit 2
- Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or
TG ≥ 500 mg / dL
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet | NCT03583905 | Contradiction |
3,884 | 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:
- Ages 30-60
- Knee pain
- Radiographically confirmed knee osteoarthritis
Exclusion Criteria:
- Medical conditions contraindicating moderate aerobic exercise as determined through
prescreening questions, ie: heart condition, asthma, history of stroke.
- Inability to exercise via treadmill or exercise cycle
- Contraindication to radiography
- Pregnancy
- History of recent joint injection (steroid, synvisc, etc.) within 6 weeks of study
- History of previous joint arthroplasty
- History of inflammatory joint disease
- Inability to sign informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 60 Years | Reaching Exercise Goals: Comparison of Exercise Means in Patients With Knee Osteoarthritis | NCT01359124 | Entailment |
5,872 | 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:
1. Any patient deemed a candidate for Sleeve Gastrectomy.
2. Age 18 years or older.
3. Body Mass Index equal or greater to 40 without comorbidities OR Body Mass Index equal
or greater than 35 with at least one obesity co-morbidity.
Exclusion Criteria:
1. The presence of one or more of the following will be reason for exclusion:
1. Daily Proton Pump Inhibitor or H2 blocker use for typical GERD symptoms during
Screening day to Surgery day
2. GERD Health Related Quality of Life (HRQL) questionnaire score greater than or
equal to 15.
2. Hiatal hernia greater than 2cm by either preoperative endoscopy or Upper
gastrointestinal (UGI) within one year of evaluation for bariatric surgery.
3. The Los Angeles classification of the severity of reflux esophagitis: C,D
4. Barrett's esophagus
5. Dysphagia with poor esophageal function measured by motility testing.
6. Does not meet National Institute of Health's weight loss surgery criteria.
7. Inability to commit to no pregnancy for 18 months post operatively.
8. Gastroparesis as defined by 4 hour nuclear emptying study.
9. Previous bariatric surgery.
10. Eosinophilia esophagitis.
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.
| Hiatal Interrogation in Sleeve Gastrectomy | NCT03527810 | Contradiction |
3,998 | 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:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory
drugs (NSAIDs)
Exclusion Criteria:
none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee | NCT02183129 | Entailment |
3,325 | 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:
Aims 1 and 2:
- Adult English speaking patients who are experienced users of Bone Anchored Implants
(BAIs) for the indication of either single sided deafness or conductive hearing loss.
- Experienced will be defined as greater than 6 months of device use and no intermittent
function of the device within 2 weeks of enrollment.
- Subjects will be limited to those who have normal hearing by bone conduction defined
as a pure tone average of 25 dBHL or better at 500, 1000, 2000, & 3000 Hz in at least
one ear.
Aim 3:
- English speaking children 5 to 17 years of age and their primary guardian who present
to the clinic for treatment by BAI on a headband device for the indications of single
sided deafness or conductive hearing loss.
- Subjects will be limited to those who have no prior use of a BAI or bone conduction
hearing device, normal hearing by bone conduction defined as a pure tone average of 25
dBHL or better at 500, 1000, 2000, & 3000 Hz in at least one ear. For those children
where this cannot be definitively established, children will be included who display
clinical signs of normal bone conduction hearing beyond a reasonable doubt and may
include such evidence as (but not limited to): auditory brainstem response, speech
awareness thresholds, visual reinforcement audiometry, conditioning play audiometry,
CT scans, etc.)
Aim 3 a & b:
- Pediatric bilateral or unilateral conductive hearing loss patients who are between the
ages of 2 and 17 years of age
- Pediatric participants who are currently managed by the University of Miami with a
bone conduction device attached to a softband.
Exclusion Criteria:
Aims 1 & 2:
- Non-English speakers
- Participants reporting allergies to adhesives or highly reactive skin.
Aim 3:
- Pediatric participants who are non-English speakers.
- Children who have previous experience with a BAI or bone conduction hearing device
will not be included for study.
- Pediatric participants reporting allergies to adhesives or highly reactive skin.
Aims 3a & 3b:
- Pediatric participants who are non-English speakers.
- Pediatric participants reporting allergies to adhesives or highly reactive skin.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Adhear Bone Conduction System | NCT03533686 | Contradiction |
4,886 | 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:
- ≥ 18 years of age.
- Has a documented diagnosis of ACTH-dependent, endogenous Cushing's syndrome and is
scheduled for curative surgery.
- Must be able to comprehend and sign an approved Informed Consent Form (ICF) and other
applicable study enrollment documents.
Exclusion Criteria:
- Plans for pre-operative and/or intra-operative use of glucocorticoid ("steroid
cover").
- Use any of the following treatments for Cushing's syndrome, as specified:
- 4 weeks prior to first specimen collection and/or during the study period.
- Adrenostatic medications (metyrapone, ketoconazole, fluconazole,
aminoglutethimide, LCI699 or etomidate etc).
- Short-acting somatostatin analogs (octreotide, pasireotide).
- 6 weeks prior to first specimen collection and/or during the study period.
o Mifepristone.
- 8 weeks prior to first specimen collection and/or during the study period.
o Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin
antagonists (cyproheptadine, ketanserin, retanserin), dopamine agonists
(bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and
somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR,
lanreotide).
- Concomitant use of the following due to their potential to stimulate the expression of
FKBP5:
- Testosterone or other steroid hormone analogues.
- Oral contraceptives or hormonal replacement therapy.
- History of illness that the Principal Investigator (PI) considers could interfere with
or affect the conduct, results, and/or completion of the clinical trial.
- Pregnancy or breastfeeding.
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.
| Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery | NCT02922257 | Entailment |
1,956 | 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:
- Participants must have unresectable or metastatic solid malignancy that is
histologically or cytologically confirmed to be one of the tumor types listed below:
- CRC
- Gastric adenocarcinoma
- GEJ adenocarcinoma
- Esophageal adenocarcinoma
- Cholangiocarcinoma
- Gallbladder carcinoma
- Participants must be candidates to receive an oxaliplatin-based regimen as part of
their standard-of-care treatment.
- Participants in phase 1b cohorts or in Cohort 2B can be receiving an oxaliplatin-based
regimen
- For phase 1b cohorts utilizing FOLFOX: up to 2 cycles of FOLFOX (≤85 mg/m2
oxaliplatin per 2-week cycle) may have been received prior to Cycle 1 Day 1 of
study treatment
- For phase 1b cohorts utilizing CAPOX: up to 2 cycles of FOLFOX (≤85 mg/m2
oxaliplatin per 2-week cycle) or one cycle of CAPOX (≤130 mg/m2 oxaliplatin per
3-week cycle) may have been received prior to Cycle 1 Day 1 of study treatment.
- For all phase 1b cohorts: if subject has received oxaliplatin in prior cycles at
higher doses than those listed above, there must be a minimum of 28 days off
treatment prior to Cycle 1 Day 1 of treatment in this study.
- For Cohort 2B prior to the first dose of study treatment:
- Subjects may have received up to 1 cycle of FOLFOX (≤85 mg/m2 oxaliplatin
per 2-week cycle) prior to Cycle 1 Day 1 but may not have received prior
oxaliplatin for metastatic disease
- Oxaliplatin received in an adjuvant setting is permitted if >6 months prior
to Cycle 1 Day 1
- At least 21 days must have elapsed from prior systemic anticancer therapy
(including hormonal and biologic therapy but excluding 1 cycle of FOLFOX),
non-central nervous system radiation, and treatment with other experimental
agents
- HER2+ disease, as determined by laboratory testing based on one of the following:
- For CRC, cholangiocarcinoma, and gallbladder carcinoma:
- HER2 amplification or overexpression from fresh or archival tumor tissue
utilizing one of the following Clinical Laboratory Improvement Amendments
(CLIA) certified or International Organization for Standardization (ISO)
tests:
- HER2 overexpression (3+ immunohistochemistry [IHC])
- HER2 (ERBB2) amplification by in situ hybridization assay (fluorescence
in situ hybridization [FISH] or chromogenic in situ hybridization
signal ratio ≥2.0 or gene copy number >6)
- HER2 (ERBB2) amplification by next generation sequencing (NGS) assay
- HER2 amplification in a CLIA certified blood-based NGS assay
- Gastric, GEJ, and esophageal adenocarcinomas must use the following criteria:
- HER2+ overexpression (IHC3+) by an FDA approved assay, from a newly obtained
biopsy or surgical specimen, evaluated following the package insert's
interpretational manual for gastric adenocarcinoma. IHC2+ is eligible if the
tumor is HER2 amplified by an FDA approved in situ hybridization assay
- Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as
determined by the investigator
- Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the
investigator
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Exclusion Criteria:
- History of known hypersensitivity to oxaliplatin, fluoropyrimidines, leucovorin,
trastuzumab, or compounds chemically or biologically similar to tucatinib, except for
Grade 1 or 2 infusion related reactions to oxaliplatin or trastuzumab that were
successfully managed, or known allergy to any of the excipients in the study drugs
- Treatment with oxaliplatin dose in excess of the limitations specified in the
inclusion criteria
There are additional inclusion criteria. The study center will determine if criteria for
participations are met.
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.
| Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers | NCT04430738 | Entailment |
5,566 | 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:
- To be included in the short stature group, subjects must have had short stature,
defined height less than -2 SD for gender and age or an abnormal growth velocity for
gender and age).
- To be included in the failure-to-thrive group, subjects must have had poor weight
gain, defined as weight less than -2 SD for gender and age or an abnormal weight
velocity for gender and age.
- Patients in both groups will be evaluated for the presence of chronic gastrointestinal
symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or
recurrent symptoms. Patients who were affected in both weight and height will be
stratified by which measurement was more severely affected, with poor weight gain
being the primary problem in the "failure-to-thrive" grouping (Group 2) and "poor
linear growth" being the primary problem in the short stature group (Group 1).
- Patients who have had chronic gastrointestinal symptoms, defined as symptoms of
gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal
stature and growth, will be analyzed separately (Group 3).
Exclusion Criteria:
- Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior
to presentation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 21 Years | Ghrelin Levels in Children With Poor Growth | NCT01070173 | Contradiction |
6,746 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males or females >= 18 years of age.
- A diagnosis of hemophilia A, moderate (FVIII:C 0.01-0.04 U/ml) or mild (FVIII:C >=
0.05 U/ml); or a diagnosis of VWD, defined by a low VWF:RCo and past bleeding history.
- For those with VWD, an inability to use DDAVP due to i) unresponsiveness defined as
VWF:RCo or FVIII:C level lower than 50 IU/dl or less than a 3-fold increase after 0.3
microgram/kg DDAVP; ii) allergic reactions or seizures; or iii) a contraindication to
DDAVP.
- Willingness to have blood drawn.
- Willingness to sign informed consent.
Exclusion Criteria:
- Presence of other bleeding disorders, acquired Von Willebrand disease, primary
thrombocytopenia.
- Use of immunomodulatory or experimental drugs, or diuretics.
- Pregnant or lactating women.
- Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
atrial flutter), hypertension, MI, stroke, or thrombosis.
- Past allergic reaction to Neumega.
- 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 substantial quantities of FVIII and/or VWF within five days of study.
- Baseline safety and/or hematology lab values outside the normal limits and/or an EKG
indicating an arrhythmia.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of IL-11 in DDAVP Unresponsive | NCT00994929 | Contradiction |
6,337 | 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:
- The participant is a patient at TUKHS or has agreed to participate in a study approved
by the KUMC Human Research Protection Program (HRPP).
- The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR.
- Patient is 18 years of age or older.
Exclusion Criteria:
- Participant declines to participate (living patients only)
- Participant or healthcare surrogate is unable to provide informed consent (living
patients only)
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| COVID-19 Biorepository | NCT04568148 | Entailment |
3,574 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Clinical diagnosis of Erythema migrans
- Over the age of 18
- Signing an concent form after information in writing
Exclusion Criteria:
- Allergic to any of the three drugs in the study
- Under the age of 18
- Pregnancy
- Dementia or known drug abuse
- Antibiotic treatment last 14 days
- Concommitant Chemotherapy or immunomodulating therapy
- Concommitant use of medicine with potential interaction (defined in protocol)
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.
| Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice | NCT01368341 | Entailment |
5,308 | 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:
- History of fragility fracture OR
- High risk for fractures OR
- Very low BMD (T-score ≤ -2.5) OR
- Failed or intolerant to bisphosphonates
- Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25-hydroxyvitamin D
[25(OH)D] must be within acceptable normal limits
Exclusion Criteria:
- History of skeletal irradiation
- Those at increased risk for osteosarcoma
- Diagnosis of Paget's disease
- History of primary hyperparathyroidism
- Significant renal impairment
- Vitamin D deficiency
- On steroids or have other causes of secondary osteoporosis
Female
No healthy subjects accepted to join the trial.
| Teriparatide (PTH) and Bone Strength in Postmenopausal Women | NCT01155245 | Entailment |
3,139 | 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:
- Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's
syndrome.
- Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing,
a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of
sufficient intensity for the patient to seek therapy.
- Females of childbearing potential must not be at risk for pregnancy during the study.
Females not of childbearing potential include postmenopausal and women who have been
surgically sterilized.
- Patients must not be in an acute phase of illness.
Exclusion Criteria:
- Patients who have clinically significant reduction kidney function. cardiovascular
abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the
presence of enlarged salivary glands; physical closure of the salivary gland or known
surgical procedure on the lacrimal punctum.
- Patients with diagnoses of a current gastrointestinal (GI) disease that would be
exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder,
acute iritis, narrow angle glaucoma, or retinal disease as determined by medical
history and physical examination.
- Patients who are otherwise judged inappropriate for inclusion in the study by the
investigator
- Patients who have received any experimental drugs or devices or participated in any
clinical trial within 30 days prior to screening including participation in a previous
NGX267 clinical trial.
- Patients who are allergic to compounds that are similar to NGX267.
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.
Subject must be at most 55 Years | Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome | NCT00637793 | Contradiction |
3,805 | 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:
- - Both gender (female and male) patients
- Age between 40 - 60
- Knee osteoarthritis Grade I & II on Kellgren and Lawrence (K/L) criteria
- Prediagnosed case of knee OA as per the American College of Rheumatology (ACR).
Exclusion Criteria:
- Known skin allergies
- Sensory-motor dysfunction of lower extremity
- Severe joint deformity of lower extremity
- Post Traumatic Arthritis
- Constitutional Symptoms (Fever, Malaise, Weight Loss and high blood pressure)
- Knee Intraarticular injection in past 3 months
- Acute low back pain
- History of spinal surgery
- Subject using assistive devices for ambulation i.e. cane, walkers, sticks
- Refused to give consent
- Body Mass Index > 30 kg/m2
- Received physiotherapy treatment in the past 3 months
- Visual Analogue Scale <4
- Patellofemoral joint arthritis will be excluded
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Mulligan Manual Therapy and Trunk Stabilization Exercises Versus Isometric Knee Strengthening on Knee Osteoarthritis | NCT04099017 | Entailment |
6,567 | 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:
- Aged 6 to 18 years
- Participants do not perform regular physical activity and sports.
- For hemophilia group who developed hemophilic arthropathy in at least one of the lower
limb joints due to severe hemophilia (total lower limb hemophilia joint health score
≥3).
- For hemophilia group patients to be receiving prophylaxis but have no major bleeding
that could affect the musculoskeletal system in the past two weeks
Exclusion Criteria:
- Have any auditory and visual impairment
- Undergo any orthopedic injuries including lower limb
- Have any neurological or cognitive disorders
Male
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 18 Years | Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health | NCT04406519 | Contradiction |
5,158 | 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, ages 45-65 years and post menopausal, as defined by a history of amenorrhea
for a minimum of 24 months and a serum FSH (follicle-stimulating hormone)
concentration of 25 mIU/mL (milli-International unit per milliliter) and negative
pregnancy test.
Exclusion Criteria:
- Current or prior use of medications known to affect bone (e.g. bisphosphonates,
calcitonin, selective estrogen receptor modulators, denosumab, diphenylhydantoin,
recent systemic glucocorticoid use), bone mineral density T score of less than -2.5
and greater than +2, Vitamin D level less then 12 ng/ml, BMI (body mass index) of
greater than 32, current alcohol or drug abuse: more than 3 alcoholic beverages per
day or current abuse of illicit drugs or prescription medication, uncontrolled or
untreated cardiac or pulmonary disease liver disease: history of hepatitis or ALT
(alanine aminotransferase) or AST (aspartate aminotransferase) greater than 2x ULN
(upper limit of normal), renal disease: history of renal disease or serum creatinine
greater than 2x ULN diabetes, pacemaker or metallic implants considered a
contraindication to MR scanning.
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 65 Years | Micromechanical Modeling Using Low Magnitude Mechanical Stimulation | NCT01921517 | Contradiction |
2,939 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as
defined by revised El Escorial criteria.
2. ALSFRS-R Aggregate score of 37 or greater
3. No more than 24 months from diagnosis.
4. Able and willing to give informed consent, follow trial procedures, and make multiple
clinical site visits.
Exclusion Criteria:
1. Any other central or peripheral nervous system disease that may interfere with the
evaluation of ALS or its progression.
2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory
support for 23 hours per day or more).
3. History of malignancy within the previous 5 years, except for localized non-melanoma
skin cancers.
4. Abnormal function of the immune system resulting from:
- Clinical conditions affecting the immune system (e.g. HIV infection,
agammaglobulinemia),
- Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20
mg/day of prednisone for more than 14 consecutive days within 90 days prior to
screening,
- Administration of anti-neoplastic and/or immunomodulating agents (e.g. TNF α
antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to
screening.
5. Recipient of Stem Cell or Gene Therapy.
6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
7. History of deep venous thrombosis or pulmonary embolism.
8. History of active substance abuse within the past 2 years;
9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes.
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.
| Multiple Doses of AT-1501-A201 in Adults With ALS | NCT04322149 | Entailment |
4,753 | 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:
- Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are
included into this study.
Exclusion Criteria:
- Patients refused our prepared four kinds of treatments are excluded from this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Stress Management Therapy for Meniere's Disease | NCT01099046 | Entailment |
6,496 | 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:
- Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least
moderate erythema with telangiectasia and a minimum of two inflammatory lesions
Exclusion Criteria:
- Individuals with active symptoms of allergy (mild active seasonal allergies are
acceptable) or atopic dermatitis
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 | Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application | NCT00436527 | Entailment |
3,774 | 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. Subject has granted written informed consent.
2. Subject is at least 18 years of age.
3. Subject has knee pain with radiographic evidence of osteoarthritis in at least one
knee (including an x-ray within the previous 2 years).
4. Subject's osteoarthritis knee pain has been present for ≥ 6 months.
5. Subject has osteoarthritis knee pain of ≥ 50 mm in one knee based on the visual analog
scale at screening.
6. Subject has regularly used topical over-the-counter pain relief products or
over-the-counter oral medication (acetaminophen or ibuprofen) to treat/manage pain
from osteoarthritis in the previous 3 months.
7. Subject is in good general health and free of any disease state or physical condition
which, in the investigator's opinion, exposes the subject to an unacceptable risk by
study participation.
8. Subject is capable of understanding and complying with all instructions and study
procedures, including the ability to accurately evaluate their symptoms.
9. Subject must be a male or non-pregnant female. If female, subject must be past
childbearing age or otherwise must test negative for pregnancy. Males and females must
agree to use effective birth control during the study or for at least 30 days after
last dose of study investigational product, if unable to complete the study.
Exclusion Criteria:
1. Subject has spontaneously improving or rapidly deteriorating osteoarthritis or knee
pain.
2. Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent
with a diagnosis of osteoarthritis.
3. Subject has used any topical steroids on or in the vicinity of the knees within 1 week
prior to Screening, or has had a knee injection within 1 month prior to Screening.
4. Subject is currently taking prescription pain medication.
5. Subject has shaved their knees within 2 days of first day of treatment (Day 1).
6. Subject has used any capsaicin containing product on or in the vicinity of the knees
within 2 weeks prior to first day of treatment (Day 1).
7. Subject has used any topically applied products (including emollient/moisturizer) on
or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day
1).
8. Subject has used topical therapy on the knees that, in the investigator's opinion,
might affect the study evaluations of signs and/or symptoms.
9. Subject has broken or damaged skin on their knees, or an open wound near the knees.
10. Subject has a history of allergy/sensitivity to topical substances.
11. Subject is not able to understand the nature, importance, or consequences of the
study.
12. Subject has a psychiatric disorder or has significant anxiety or depression that, in
the investigator's opinion, could interfere with the subject's ability to accurately
assess their pain, adhere to study instructions, or complete the study.
13. Subject has hypertension that is not adequately controlled (medication to treat
hypertension is allowed), vascular disease, psychological disorder, or other condition
that, in the investigator's opinion, contraindicate the use of medication.
14. Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.
15. Subject requires a surgical procedure in the immediate future.
16. Subject is pregnant or nursing.
17. Subject has been treated with an investigational drug, device, or therapy within 30
days prior to first day of treatment (Day 1).
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.
| Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 | NCT03124407 | Entailment |
3,521 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Female patients with chronic primary adrenal insufficiency due to autoimmune
adrenalitis or bilateral adrenalectomy (disease duration at least 6 months)
- Age ≥ 18 years
- Patient´s written informed consent
- Ability to comply with the protocol procedures
- Established stable replacement therapy, no anticipated change in medication
- Negative pregnancy test and contraception (besides oral contraceptive pill) in
pre-menopausal females
Exclusion Criteria:
- Diabetes mellitus
- Infectious disease with fever at time of investigation
- Known intolerance to the study drug or constituents
- Oral contraception
- Pregnancy or breast feeding
- Renal failure (creatinine >2.5 ULN)
- Disposition to vaginal mycosis (requiring treatment in the last 6 months or of
necessity >2 antimycotic therapies/year)
- Recurrent urinary tract infections (of necessity >2 antibiosis therapies/year)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Vaginal Prednisone Administration for Prevention of Adrenal Crisis | NCT02689960 | Contradiction |
6,838 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by a
physician (such as a rheumatologist, neurologist, or dermatologist) experienced in
treatment of PM/DM at least 6 weeks prior to first dose of the study drug
- Has PM or DM which is considered active despite receiving at least 1 standard-of-care
treatment by the investigator
- Must be receiving 1 or more of the following protocol-permitted, systemic
standard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the following
immunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oral
tacrolimus, or oral cyclosporine A
- Regular or as needed treatment with topical use of glucocorticoids are permitted to
treat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks prior to
first dose of the study drug
- Contraceptive (birth control) use by men or women should be consistent with local
regulations regarding the acceptable methods of contraception for those participating
in clinical studies
- Must be medically stable on the basis of clinical laboratory tests performed at
screening. If the results of the clinical laboratory tests are outside the normal
reference ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant
- Demonstrable muscle weakness at screening and Week 0 measured by the Manual Muscle
Testing (MMT)-8 less than or equal to (<=)135 units
- Demonstrable muscle weakness at screening measured by any 2 or more of the followings:
(i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 or more muscle
enzymes (Creatine kinase [CK], and aldolase) >=1.4*upper limit of normal (ULN), (iii)
Myositis disease activity assessment tool (MDAAT)-Extramuscular Global Assessment
>=1.5 cm
Exclusion Criteria:
- Has myositis other than PM/DM, including but not limited to amyopathic dermatomyositis
(ADM), clinically amyopathic DM, juvenile DM, inclusion body myositis (IBM)
immune-mediated necrotizing myopathy diagnosed based on muscle biopsy findings and
positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PM associated with
human immunodeficiency virus (HIV), and muscular dystrophy, congenital myopathy,
metabolic myopathy, and mitochondrial myopathy
- Has other inflammatory diseases that might confound the evaluations of efficacy,
including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
systemic lupus erythematosus (SLE), psoriasis, or Crohn's disease
- Has severe respiratory muscle weakness confirmed by the investigator based on the
consultation with a pulmonologist and the measures of respiratory muscle strength such
as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and/or
maximal voluntary ventilation (MVV) measurements and lung capacity such as forced
vital capacity (FVC). The results need to be within population appropriate normal
limits
- Has severe muscle damage (Myositis Damage Index-VAS [Muscle Damage] greater than (>) 7
centimeter [cm]), permanent weakness due to a non-IIM cause, or myositis with cardiac
dysfunction
- Has glucocorticoid-induced myopathy which the investigator considers the primary cause
of muscle weakness
- Has positive test result of anti-melanoma differentiation-associated protein 5 (MDA5)
antibody (anti clinically amyopathic dermatomyositis (C-ADM)-140 antibody).
- Has had a nontuberculous mycobacterial infection or opportunistic infection
- Has a history of, or ongoing, chronic or recurrent infectious disease
- Has past history of severe Interstitial lung disease (ILD) flare, severe
non-infectious lung inflammation which required active intervention, or multiple
relapses of these conditions
- Presence or history of malignancy within 5 years 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 18 Years old.
Subject must be at most 75 Years | A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments | NCT03981744 | Contradiction |
800 | 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. | Key Inclusion criteria:
• Osteoarthritis of the hand
Key Exclusion Criteria:
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
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.
| Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis | NCT00171652 | Entailment |
6,142 | 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:
- Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years
- Diagnosis of a proven or probable SARS-CoV-2 infection according to the following
criteria:
1. Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the
radio-clinical picture (other tests made available later and having good
diagnostic performance will be accepted)
2. Probable infection: negative PCR but association of
1. Evocative clinical signs, of recent installation: fever, respiratory signs
(cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache,
diarrhea / abdominal pain, frank asthenia, loss of taste / smell,
conjunctivitis, type of frostbite AND
2. evocative radiological signs, on CT: diffuse or diffuse aspect of frosted
glass, condensations including pseudo-nodular condensations, association of
frosted glass and condensation within the same lesion, nodules and
micronodules, thickening of the interlobular septa) or on chest radiography:
interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral
AND
3. absence of differential diagnosis
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19 | NCT04452604 | Contradiction |
3,699 | 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:
- All patients that are sent for knee MRI
- Patients over the age of 50 years old
- All patients will sign an informed consent for the study prior to the PET MRI
- Unilateral or Bilateral knee pain
- All patients were ambulatory pre-operatively, using no more then a single cane
- All patients had prior Weight Bearing AP x-rays and Lateral Radiogrphs
Exclusion Criteria:
1. Non ambulatory patients
2. History of knee arthroscopy or other surgery 1 year before the MRI
3. Bone scan performed in the past 3 months prior to the PET MRI
4. Clastrophobia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | PET MRI for Evaluation of Knee Osteoarthritis in Patients With Bilateral Knee OA | NCT03174080 | Contradiction |
3,149 | 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:
1. All recruited patients should be diagnosed with Sjogren's syndrome alone or in
association with other autoimmune conditions (rheumatic or not) based on their
rheumatologist opinion or have clinical and serological/imaging features which in the
opinion of their clinician raise the suspicion of Sjogren's syndrome.
2. Patients with symptoms onset /imaging, serological and glandular biopsy abnormalities
suggestive of SS (suspected SS) or SS diagnosis made by expert clinicians prior to age
18
3. Patients/ Carers who can provide informed consent and agree to provide access to the
results of their routine care investigations for research purposes irrespective of
being able provide blood or saliva samples.
4. Patients of 6 years or age or above
Exclusion Criteria:
1. Inability to provide informed consent or have informed consent provided on their behalf.
No condition on gender to be admitted to the trial.
Subject must be at least 6 Years old.
| Paediatric Sjögren Syndrome Cohort Study and Repository (PaedSSCoRe) | NCT04762108 | Contradiction |
1,896 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients age older than 18 years (including 18 years old);
- The primary lesion is located in the upper or middle third of the stomach, including
Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
- Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy
(including papillary, tubular, mucinous, signet ring cell and poorly differentiated
adenocarcinoma);
- Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
- The Eastern Cooperative Oncology Group performance status of 0 or 1;
- The American Society of Anesthesiology classes of I, II or III;
- Signed Informed consent.
Exclusion Criteria:
- Pregnant or lactating women;
- Suffering from severe mental disorder;
- Previous gastrectomy, including endoscopic submucosal dissection and endoscopic
mucosal resection;
- Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to
preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
- Siewert I type adenocarcinoma of the esophagogastric junction;
- Other malignant diseases (within 5 years);
- Other illnesses needed operation concurrently;
- Complications (bleeding, perforation or obstruction) required emergency surgery due to
primary gastric malignancy;
- Pulmonary function tests FEV1 less than 50% of predicted value;
- Patient suffered from bleeding tendency disease such as hemophilia or took
anti-coagulant medication due to deep vein thrombosis.
- Patients with obvious tumor infiltration in the spleen and splenic vessels which
require splenectomy.
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.
| Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC | NCT03708783 | Entailment |
119 | 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 60-80 years old
- Serum-testosterone levels <11.0 nmol/l
- Signed informed consent.
Exclusion Criteria:
- Prostate cancer
- Breast cancer
- Liver tumor/cancer
- Unstable angina
- Untreated congestive heart disease
- Epilepsy
- Migraine
- Hematocrit >50%
- PSA >4.0 ug/l
- Serum creatinine >130 umol/l
- ALAT >100 U/l
- Known intolerance to testosterone undecanoate
- Participation in another research trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Older Men and Testosterone | NCT00119483 | Contradiction |
5,470 | 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:
- Male and female of any age, including infants, children, adolescent and adults
- Informed Consent obtained (parents should sign for patients < 18 y.o.)
- Previous Diagnosis of VWD3 (VWF Antigen: undetectable or <5 U/dL)
- Detailed information on inherited pattern, history of bleeding, previous exposure to
blood products
- Availability of plasma and DNA samples
Exclusion Criteria:
• VWD3 patients who may not be available for follow-up
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Type 3 Von Willebrand International Registries Inhibitor Prospective Study | NCT02460458 | Entailment |
5,365 | 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:
- Male and female subjects between 0 and <12 years of age
- Diagnosed with VWD Type 1, 2A, or 3
- Desmopressin acetate (DDAVP) treatment is ineffective, contraindicated, or not
available for subject
- von Willebrand factor: ristocetin cofactor (VWF:RCo) is <20% at screening or the
subject has a history of VWF:RCo <10%
- Evidence of vaccination against hepatitis A and B or presence of antibodies against
hepatitis A and B due to either a previous infection or prior immunization
- Written informed consent given
Exclusion Criteria:
- Active bleeding immediately prior to initial PK period
- Received treatment with DDAVP or a VWF concentrate product for their VWD in the 5 days
prior to their first study treatment
- Have received aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) within 7
days of commencing the PK period.
- Known history or suspicion of having VWF or FVIII inhibitors
- Acute or chronic medical condition, other than VWD, which may affect the conduct of
the study
- Known or suspected hypersensitivity or previous evidence of severe side effects to
other FVIII/VWF concentrates
- Participation in a clinical study or use of an investigational compound in another
study in the 3 months preceding study start
- Unwillingness and/or inability to comply with the study requirements
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 12 Years | Study of Biostate® in Children With Von Willebrand Disease | NCT01213446 | Contradiction |
3,505 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- patients with Addison's disease
Exclusion Criteria:
- Type 1 diabetes
- malignant disease
- pregnant women
- cardiac disease
- lung disease
- neuromuscular diseases
- pharmacological treatment with glucocorticoids or drugs that interfere with cortisol
metabolism (anti-epileptics, rifampicin, St Johns wart, oral estrogens,
antidepressives).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure | NCT01847690 | Contradiction |
3,507 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Volunteers will be in self-proclaimed good health
- Volunteers will be free of illness on the day of testing
- Volunteers will not be taking drug therapy.
- Patients will be free of intercurrent illness on the day of testing
- Patients will have a confirmed diagnosis of hypoadrenalism or hypopituitarism
Exclusion Criteria:
- Is pregnant or lactating. Females of childbearing potential must have a negative
pregnancy test before enrollment onto the study. Non-child bearing potential is
defined as post-menopausal for at least 1 year, surgical sterilisation or hysterectomy
at least three months before the start of the study,
- Is using corticosteroids,
- has any significant intercurrent disease,
- has a history of thyroid or other autoimmune disease,
- has a previous history of hypersensitivity to Synacthen®,
- has a previous history of asthma
- has a history of allergic disorder
- has any mental condition rendering the patient unable to understand the nature or
possible consequences of the study, and/or evidence of an uncooperative attitude.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test | NCT00851942 | Contradiction |
4,703 | 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:
- dysmenorrhea
- dyspareunia
- non cyclic lower abdominal pain
- hypermenorrhea
- menometrorrhaghia
- pain while compressing the Uterus during gyn exam
- Patient wants to participate
- Patient will receive hysterectomy
Exclusion Criteria:
- Patient declines to participate
- contraindications against MRI
- contraindications against ultrasound
- minor
- cannot give informed consent
- no hysterectomy planned
Female
No healthy subjects accepted to join the trial.
| Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI | NCT04665414 | Entailment |
3,639 | 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:
- Patient with bleeding history sent to the Hemophilia Treatment Center in Dijon or
Nantes University Hospital with abnormal bleeding score (>3 in men and >5 in women
- Patient who has provided a signed consent to participate at this study and for blood
sampling
- Affiliation with French social security system
Non-Inclusion Criteria:
- Minors will not be included in the study.
- On-going pregnancy and postpartum period (3 months after delivery)
- Substitutive treatment with coagulation factor concentrates or desmopressin
administration within 10 days before sampling.
- Ongoing infectious or inflammatory disease that can modify VWF levels.
- Diagnosis of obvious hemostasis 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.
| Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding | NCT02792205 | Entailment |
3,588 | 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:
- Women with menorrhagia
- 18-49 years of age
- Regularly occurring menstrual periods
Exclusion Criteria:
- History or presence of clinically significant disease or abnormalities that may
confound the study
- History of bilateral oophorectomy or hysterectomy
- Hormone therapy for birth control
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Efficacy and Safety of XP12B in Women With Menorrhagia | NCT00401193 | Contradiction |
6,267 | 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. | Subject Inclusion Criteria:
An individual must meet the criteria below to be eligible.
- Individual is Illumina US personnel (eg, employee, contractor, consultant) and was
invited to participate in the study.
- Individual is 18 years or older at the time of consent.
- Individual is feeling well and, at the time of consent or specimen collection, does
not have any of the following symptoms of COVID-19: cough, shortness of breath or
difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore
throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or
diarrhea. [1]
- Individual is willing to participate in study procedures and able to provide written
informed consent in the English language.
Subject Exclusion Criteria:
An individual cannot meet the below criteria.
- Individual is confirmed to have COVID-19 and continues to require home isolation in
accordance with current CDC guidelines at the time of consent or specimen collection.
- Individual is asymptomatic but suspected to have COVID-19 due to recent close contact
(as currently defined by the CDC) with a person with COVID-19 and continues to require
quarantine in accordance with current CDC guidelines at the time of consent or
specimen collection. [4]
- Individual had symptoms of COVID-19 less than 10 days before time of consent or less
than 10 days before time of any subsequent specimen collection visit."
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel | NCT04561089 | Contradiction |
5,775 | 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:
- Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in
combination with clinical appearance will be used for diagnosis
- Patients who had symptoms such as burning sensation, pain
- Patients not on any immunosuppressive or immunomodulatory treatment. In case they
were,then such treatment should be stopped and a washout period of 1 month was given.
- Patients of both sexes between 30 to 70 year's old
- Patients who gave written informed consent
- Patients who were willing for evaluation in second week after therapy and every 1
month up to 6 months
Exclusion Criteria:
- The presence of histological signs of dysplasia
- Patients suffering from any localized or systemic disease
- Renal disease patients
- Pregnant patients
- Patients who can not continue the study for private or social reasons
- Patients who used lichenoid reaction including drugs
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 70 Years | Efficacy of Purslane in Treatment of Oral Lichen Planus | NCT00746772 | Contradiction |
5,917 | 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:
1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥
3 months
2. Hill's grade II and III of the gastroesophageal junction
3. One of the following abnormalities in the objective assessment 3.1. Excessive acid
exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH <
4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D
esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or
total length of less than 4cm or abdominal length of less than 2cm
Exclusion Criteria:
1. Age > 70 yrs of < 18 yrs
2. Pregnancy
3. Any type of Hiatus hernia
4. Patients with underlying malignancy
5. ASA above grade III
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 | Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux | NCT04194723 | Contradiction |
2,834 | 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 patients according to Airlie House criteria
- treated with riluzole
- respiratory quotient (RQ) of patients in indirect calorimetry (IC) should be in
between 0.7 and 0.87
Exclusion Criteria:
-
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.
| Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation | NCT03378375 | Entailment |
Subsets and Splits