cyrilzakka/clinical-trials huggingface dataset:
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 70 years of age, inclusive
* Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing method
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Participant has not consumed tobacco or nicotine-containing products for 42 days prior to first dose of study drug, and must agree to refrain from such products while on study
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
* History of or current clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/= 2 hypertension or unstable angina
* Current dyspnea at rest due to complications of advanced malignancy or any requirement for supplemental oxygen
* Active central nervous system lesions (participants with radiographically unstable, symptomatic lesions)
* Participants with CYP1A2 gene mutation (-3113G-\>A), either in one or two alleles
* Allergy or hypersensitivity to vemurafenib or tizanidine formulations
* Current severe uncontrolled systemic disease
* Inability or unwillingness to swallow pills
* History of malabsorption or other condition that would interfere with enteral absorption of study treatment
* History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or human immunodeficiency (HIV) infection requiring antiretroviral treatment, acquired immune deficiency syndrome (AIDS)-related illness, or active hepatitis B or C
* Pregnant or breastfeeding women
Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children

The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.

The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes.

The current Swiss administration schedule of giving MMR at 9 and 12 months of age ("current schedule") will be compared with a "modified schedule". This is expected to maximise the beneficial non-specific effects of MMR by giving it at 6 and 13 months of age, separately from other vaccines ("modified schedule"). Factorial analysis will enable assessment of the benefit of the intervention on each of the two doses of MMR separately or in combination.

The clinical aims are to determine whether a modified schedule of MMR administration reduces both the risk and severity of: (i) infections with unrelated pathogens and (ii) atopic and allergic diseases.

The laboratory aims are to: (i) quantify and characterise the immunological non-specific effects of MMR, and (ii) identify the biological pathways and molecular mechanisms that are altered by MMR vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by signature
2. 6-month-old children
3. In overall good health, without any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) and no clinically significant abnormal finding on history and/or physical examination
4. Fully immunised for age according to the Swiss vaccination schedule

   1. with at least 2 doses of DTP-containing vaccine
   2. the last dose of vaccine received at least 2 weeks prior to enrolment

Exclusion Criteria:

1. Contra-indications to MMR, including

   1. immunosuppression (i.e. proven, suspected, or planned)
   2. allergy to a component of the vaccine
   3. receipt of a live-attenuated vaccine in the four weeks prior to inclusion
2. Vaccine refusal
3. Indication for an early MMR vaccination, including

   1. Measles outbreak
   2. Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment)
   3. Travel to a region with a high risk of measles outbreak
4. Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including

   1. severe eczema
   2. parental will
5. Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
6. Plan to move out of the country or have prolong absence during the trial
7. Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised)
8. Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)
Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries.

Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

Exclusion Criteria:

* Patient refusal to be included
* Presence of language barrier that prohibits proper communication with patient
* Under age of 18,
* Pregnancy
* History of allergy to local anesthetics or opioids
* Presence of a progressive neurological deficit
* Chronic opioid or drug abuse
* Diabetes
* Active infection in leg
* Unstable cardiovascular, renal or hepatic disease,
* Unwillingness to comply with follow up.
Studies of Avian Influenza Transmission to Humans in Egypt

The main focus of the study is:

* To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations.
* To estimate the incidence of AI in poultry-exposed and non-exposed human populations.
* To investigate risk factors associated with AI infections in occupationally-exposed poultry workers.

The secondary objectives of the study:

* To investigate patterns in transmission of AI to household contacts of AI clinical cases
* To isolate AI viruses from acute cases
* To monitor the pathogenicity and disease severity of AI viruses causing human infections

This 4-year prospective cohort study to compare individuals with occupational exposure to poultry with non-poultry exposed adult controls for evidence of incident and previous infections with AI viruses. At the start of this study, study staff will obtain informed consent, and a blood sample will be obtained from study volunteers to establish baseline levels of antibodies against avian influenza types H4-H12. Subjects will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. After one year, study subjects will be interviewed again to note any changes in exposure variables. At this time, another blood sample will be obtained and tested for any changes in antibodies' levels. The same procedures will be repeated at the final visit after another year. Exposed individuals will be selected from rural areas where poultry is commonly raised. Non-exposed controls will be selected from urban neighborhoods in Cairo.

Eligibility Criteria:
Inclusion Criteria:

* Be willing to participate by signing a consent/assent form, completing the study questionnaire, and permitting the withdrawal of blood.
* Does not buy poultry from live bird markets (for controls only).

Exclusion Criteria:

* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy.
* Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.
* Children who are less than 2 years old when baseline enrollment is performed.
GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region

Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.

Multicentre, descriptive study conducted in a declarative manner and supplemented by direct observation by an investigator.

Main objectives:

* Assess existing practices of the various actors involved in flu and pertussis vaccination of pregnant or postpartum women medically followed in maternity wards.
* Assess acceptability of pertussis and flu vaccination during pregnancy by women medically followed in maternity wards, and by health professionals of theses facilities.

Secondary objectives:

* Assess flu and pertussis immunization coverage of pregnant and postpartum women and of health professionals working in maternity wards.
* Assess the links between immunization coverage of health professionals and their current practices in promoting flu and pertussis vaccination of women in maternity wards.

Main outcome measures:

* Identify in each maternity hospital facilitators of flu and pertussis vaccination.
* Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.
* Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.

Secondary endpoints:

* Flu and pertussis immunization coverage of pregnant and postpartum women.
* Flu and pertussis immunization coverage of health professionals.
* Proportion of patient records with vaccination trace.
* Link between understanding of vaccines and vaccine-preventable diseases, and immunization coverage of health professionals.
* Link between attitudes and practices of health professionals, and immunization coverage of patients.
* Link between immunization coverage of patients and health professionals.

Eligibility Criteria:
Inclusion Criteria:

Pregnant and postpartum women over 18 medically followed in maternity wards included. Femmes enceintes ou en post-partum :

Health professionals over 18 working in maternity wards included.

Exclusion Criteria:

Women under the protection of a conservator Temporary Health staff
Non-invasive Assessment of Arterial Blood Pressure and Functional Hemodynamic Parameters

Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). To evaluate this new device the investigators compared esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 80 years old
* Written informed consent obtained

Exclusion Criteria:

* Renal failure
* Heart failure (EF \< 25%)
* Peripheral artery occlusion disease
* M. Raynaud
* Rhythms other than sinus
Non Invasive Cancer Test (NICT): a Proof of Principle Study.

The investigators aim to collect tumor DNA out of blood of cancer patients. If this is successful this could lead to the development of a cancer test in blood in the future, which is less invasive than current diagnostic methods.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy.
2. Patients age \> 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent

Exclusion Criteria:

1. Patients with a history of malignant disease other than the disease under study, with an exception for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma of the skin and in situ cervix carcinoma.
2. Pregnancy
Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder

The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).

OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-65 ,
* Having diagnosed with OAB,
* Being a volunteer

Exclusion Criteria:

* Being pregnant,
* presence of severe pelvic organ prolapse,
* malignant disease,
* urinary infection,
* neurological disease,
* have electronic and metal implant,
* loss of sensation,
* lumbosacral peripheral nerve lesion
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction

The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.

Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.

Eligibility Criteria:
Inclusion Criteria:

1. All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.
2. Baseline free testosterone levels less than age-specific normal values.
3. Males 18 years and older

Exclusion Criteria:

1. Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.
2. Current use of testosterone, clomiphene or over the counter testosterone boosters
3. Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
4. Congestive heart failure, New York Heart Association class IV
5. Life expectancy less than 1 year,
6. Baseline hematocrit of \>50%
7. Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)
8. Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)
9. Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study
10. Patients formerly diagnosed with obstructive sleep apnea.
11. Patients using opiate analgesics
12. Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal
13. History of Deep venous thrombosis
Retinal Blood Flow and Microthrombi in Type 1 Diabetes

The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic patients often precedes any evidence of clinical retinopathy and may contribute to the development of retinopathy.

Specifically, the projects tests the hypothesis that reduced retinal blood flow found in young patients with type 1 diabetes reflects increased resistance in the small vessels of the retina caused by the formation of small blood clots, called microthrombi; and that antiplatelet agents normalize the reduced retinal blood flow.

The ultimate goal of this research is to contribute to the development of strategies to prevent diabetic retinopathy. This project will test the hypothesis that antiplatelet agents normalize the reduced blood flow observed early in the course of type 1 diabetes. If the hypothesis is proven correct, the results will indicate that the formation of small blood clots (microthrombi) occurs early in diabetic retinal vessels. In turn, because microthrombosis could readily account for the occlusive microangiopathy that causes the sight-threatening stages of diabetic retinopathy, the results will propose the desirability of antiplatelet therapy for the prevention of diabetic retinopathy.

We have three specific aims:

1. To confirm that, under basal conditions, retinal blood flow measured with the laser Doppler method in a group of type 1 diabetic patients with no or minimal retinopathy differs from the flow measured in age- and sex-matched nondiabetic control subjects;
2. To determine whether the response of retinal blood flow to low-dose aspirin (81 mg/day) administered for 2 months versus placebo, differs between type 1 diabetic patients with no or minimal retinopathy and age- and sex-matched nondiabetic control subjects;
3. To determine whether in type 1 diabetic patients with no or minimal retinopathy the response of retinal blood flow to low-dose aspirin differs from the response to clopidogrel, a drug that interferes with platelet function downstream of the site of aspirin action.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years,
* type 1 diabetes duration 1-15 years,
* absent or minimal retinopathy (EDTRS 20).
* Age- and gender-matched healthy controls

Exclusion Criteria:

* smoking,
* systemic diseases other than diabetes,
* retinal diseases other than diabetic retinopathy,
* pregnancy,
* bleeding disorders,
* aspirin allergy,
* use of anti-platelet agents,
* non-steroidal anti-inflammatory agents,
* angiotensin converting enzyme inhibitors,
* angiotensin receptor antagonists,
* Vitamin E in large doses.
Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention group, patients are going to inject an enoxaparin (40 mg) daily concurrent by chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to control group (only chemo-radiotherapy) and intervention group (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological findings (after esophagectomy) are considered as clinical and pathological response, respectively.

This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]) with or without enoxaparin (40 mg daily). During radiotherapy and before each course of chemotherapy, all patients are going to visit by physician and complete blood count will be checked. All patients are going to undergo gastrointestinal endoscopy and then esophagectomy, 4-6 months after completion of chemo-radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation
* Non-metastatic esophageal cancer
* Patient who are candidate for chemo-radiation treatment
* Normal complete blood count
* Normal kidney function test
* Normal liver function test
* Normal fasting blood sugar

Exclusion Criteria:

* Previous history of chest wall radiotherapy
* Previous history of chemotherapy
* Past medical history of Hypertension, diabetes mellitus, renal failure and liver failure
* Pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other organs
* Discontent for the study
* Inability to do daily radiotherapy
* Unwillingness to esophagectomy
Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis

Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year by year, which has become an important public health problem in China. As NAFLD can progress to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification and quantitative evaluation of liver steatosis and its dynamic changes are crucial. While liver biopsy is still the gold standard in the diagnosis of NAFLD, its application is limited because of the invasive procedure.The Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) is a new non-invasive diagnostic method for fatty liver and liver fibrosis.

In order to evaluate the diagnostic value of non-invasive assessment for the degree of liver steatosis and staging liver fibrosis, this non-invasive method will be assessed by the golden standard of liver biopsy among 400 NAFLD patients.The treatment protocols will be decided by doctor and patient both (treatment protocols and medicine are not required). Blood routine, blood biochemistry, abdominal ultrasound and Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) are detected during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age:18≤,≥65
* Gender:male or female
* NAFLD patient,agree with the paracentesis of liver tissue
* Regular follow-up
* Signing the Informed Consent Form

Exclusion Criteria:

* Hepatic decompensation：Including cirrhotic complications,such as ascites,hepatic encephalopathy,digestive tract bleeding,hepatorenal syndrome,spontaneous bacterial peritonitis,and HCC.
* Complications of HBV,HCV,HIV.Complications of alcoholic liver disease,autoimmune liver disease,hereditary metabolic liver disease, drug-induced liver disease and other chronic liver disease.
* AFP\>100ng/ml and imaging indicates malignant occupying.Or AFP still\>100ng/ml within 3 months.
* Creatinine was 1.5 times higher than the upper limit of the normal value.
* Combined with other malignant tumors(except those cured).
* Serious diseases of heart, lung, kidney, brain, blood and other important organs with dysfunction.
* severe neurological and psychiatric diseases (such as epilepsy, depression, mania, schizophrenia, etc.)
* Pregnant women and breast-feeding women.
* The researchers consider that it is not suitable for the patients to participate in this study.