cyrilzakka/clinical-trials huggingface dataset:
Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.

Women with a BMI\>30 and women with a BMI\<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:

1. Dinoprostone in women with a BMI\>30.
2. Dinoprostone in women with a BMI\<30.
3. Cervical ripening balloon in women with a BMI\>30.
4. Cervical ripening balloon in women with a BMI\<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

The study is a randomized controlled test in which women with a BMI\>30 and women with a BMI\<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:

1. Dinoprostone in women with a BMI\>30.
2. Dinoprostone in women with a BMI\<30.
3. Cervical ripening balloon in women with a BMI\>30.
4. Cervical ripening balloon in women with a BMI\<30. All subjects participating in the study will be induced for obstetrical indications alone.

The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

The participants will finish participation in the study after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman at term with an obstetric indication for labor induction.

Exclusion Criteria:

* Previous cesarean section.
* Positive Oxytocin challenge test.
* Positive contraction stress test.
Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy

Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma


Eligibility Criteria:
Inclusion Criteria:

* Progressive Primary Open Angle Glaucoma

Exclusion Criteria:

* Age under 18yrs
* Myopia or Hyperopia higher than -6D or +6D
* Secondary glaucoma
* Ocular surgery other than cataract
* Other ocular pathology
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of \>24kg/m2
* Fasting serum glucose \<126 mg/dL

Exclusion Criteria:

* BMI\</=24 kg/m2
* Fasting serum glucose \>/=126 mg/dL
* Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
* Serum Calcium \>10.2 mg/dL
* Serum inorganic phosphorous \>4.5mg/dL
* Pregnancy or breastfeeding
* Diagnosis of Diabetes Mellitus
* Diagnosis of Rheumatoid Arthritis
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Renal in sufficiency/failure ( serum creatinine \>1.5 mg/dL men, \> 1.3 mg/dL women)
* Chronic active liver disease (bilirubin \>1.2 mg/dL, AST\>144IU/L, or ALT \>165 IU/L)
* History of chronic hepatitis
* Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months)
* Oral warfarin group medications or history of blood clotting disorders
* Platelet count \<100,000 per uL within the last 7 days
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)
* Debilitating chronic disease (at the discretion of the investigators)
* The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis)
* Any malignancy
Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.

The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3

Exclusion Criteria:

* Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year
Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

This study will evaluate the effectiveness of a novel cardiovascular disease prevention program designed for delivery through existing primary health care services in rural villages in Andhra Pradesh.

The primary aim is to increase the number of high-risk individuals in the population that are appropriately managed with proven, low-cost preventive interventions. The corresponding null hypothesis is therefore that the prevention program will result in no change in the proportion of high-risk individuals identified and treated in villages assigned to intervention compared with those villages assigned to control.

STUDY TYPE This project is a community intervention study that will use a large-scale, cluster-randomised design to compare the management of individuals at high cardiovascular risk in villages assigned to receive the cardiovascular prevention program (intervention) and villages assigned to continue usual practices (control). The definition of high-risk for treatment is based on an established history of previous vascular disease -heart attack or stroke- known hypertension or systolic blood pressure \> 160mmHg, or the presence of other risk factors such as smoking, high blood pressure, obesity, older age and family history which combined would result in a very high level of risk.

INTERVENTION PROGRAM TO BE EVALUATED The program to be evaluated comprises: (1) simple strategies designed to facilitate the opportunistic identification of high-risk individuals, (2) clinical algorithms for the implementation of proven preventive interventions based on World Health Organisation recommendations (3) a health promotion campaign designed to aid self-identification and self-referral of high-risk people and (4) simple, structured education programs to assist patients to comply with their treatment.

DATA COLLECTION Data to be collected will comprise an interviewer administered questionnaire with demographic details, basic medical history, cardiovascular risk factors, previous cardiovascular disease and any current treatments. This will be followed by a brief physical examination including measurement of blood pressure, heart rate, weight, height, waist and hip circumferences. Urine will be tested using a dipstick in all and all will have a fasting blood glucose assay. Fasting venous blood samples will be collected for assay of cholesterol, glucose and creatinine from a sample of 1,000.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 years and above
* Personal history of heart attack or stroke
* Presence of other cardiovascular risk factors such as smoking, overweight, diabetes

Exclusion Criteria:

* Mental disability
* Not living in the Study area
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 4 through 55 years
* Clinical history of allergy to peanuts or peanut-containing foods
* Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™\* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
* Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL\*\* guidelines
* Not be residing at the same address as another subject in this or any peanut OIT study

UniCAP™\*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies

PRACTALL\*\*: PRACTical issues in ALLergology Joint United States/European Union Initiative

Key Exclusion Criteria:

* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
* History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
* History of steroid medication use
* History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
* Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
* Having the same place of residence as another subject in the study
Influenza Immunization of Children in India

Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.

Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely contributed to by the lack of information from India about disease burden due to influenza and because influenza vaccines have not been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home. The study described here is an extension of an earlier study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza in the fall. The current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of India. Reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.

Eligibility Criteria:
Inclusion Criteria:

Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age.

All individuals in enrolled households will be eligible for enrollment into surveillance arm.

Exclusion Criteria:

Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of the vaccines.
Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome

Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.

No more details

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
* All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium \<5 mm at the time of hCG administration

Exclusion Criteria:

* patients with hyperprolactinaemia,
* hypercorticism and
* thyroid dysfunction.
* patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants
Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

Primary:

1. To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
2. To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks, oxidative stress and circulating adhesion molecule including thiobarbiturate acid reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and vascular cell adhesion molecule 1 (VCAM-1).

Secondary:

1. To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP\<140 mmHg and /or DBP\<90 mmHg)
3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including A1166C gene with about 4% of the minor allele frequency in Chinese population and other single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is related to reduction of BP


Eligibility Criteria:
Inclusion Criteria:

Patients with mild to moderate hypertension with office diastolic BP (DBP) 90-109 mmHg and/or systolic BP (SBP) 140-179 mmHg before entering each treatment

Exclusion Criteria:

* females: who are pregnant or breast feeding
* office DBP ≧ 110 mmHg or office SBP ≧ 180 mmHg
* history of significant cardiovascular diseases which include: acute myocardial infarction within six months or any ischemic heart disease requiring medication, or cerebrovascular disease
* history of significant renal diseases including: serum creatinine \> 3.0 mg/dl, or creatinine clearance \< 30 ml/min.
* severe biliary cirrhosis and cholestasis
* refractory hypokalemia, hypercalcemia
* history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
* hepatic disease as indicated by any of the following : Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvate Transaminase (SGPT) \>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma

This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists

Exclusion Criteria:

* Prior use of any monoclonal antibody before study treatment
* Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment
* Completion of autologous stem cell transplant within 6 months prior to study treatment
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with IV antibiotics or hospitalization prior to study treatment
* Recent major surgery (prior to study treatment), other than for diagnosis
* Presence of positive test results for Hepatitis B or Hepatitis C
* Known history of HIV seropositive status
* Women who are pregnant or lactating
* Childbearing potential without agreement to use effective form of contraception for the duration of the study
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary infertility.
* Normal Hysterosalpingo-graphy
* Normal Semen analysis of the husband.

Exclusion Criteria:

* Patient's refusal.
* Male factors of infertility and/or abnormal Hysterosalpingo-graphy
* Hyperprolactinemia (prolactin ≥ 22 ng/dl).
* FSH on day 3 \> 15 mIU/mL.
* Gross ovarian pathology diagnosed by ultrasound.
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.


Eligibility Criteria:
Inclusion Criteria:

* Be a healthy ambulatory postmenopausal woman from 50 to 85 years of age (inclusive) with osteoporosis.
* Be postmenopausal for at least 5 years. Postmenopausal status was established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of ≥30 IU/L.
* Be to have a bone mineral density (BMD) T score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low-trauma femoral, radius, humerus, sacral, pelvic, or ankle fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \> -5.0

Exclusion Criteria:

* History of more than 4 spine fractures, mild or moderate, or any severe fractures.
* Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
* Unevaluable hip Bone mineral density (BMD) or patients who had undergone bilateral hip replacement (unilateral hip replacement was acceptable).
Smartphone-App Based Prediction of Large Vessel Occlusion

The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).

The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.

Eligibility Criteria:
All patients above the age of 18 with suspected acute stroke transferred to the university hospital Essen.

Inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted FAST-ED by EMS prior to admission.

Exclusion criteria: Known symptom onset beyond 24 Hours.
Lactoferrin Treatment in HIV Patients

Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-positive participants receiving Antiretroviral Therapy (ART) for \>1 year
2. HIV RNA level \<200 copies/mL for at least 6 months (≥2 separate values)
3. Age \>40 years

Exclusion Criteria:

1. Prior cardiovascular disease or stroke
2. Diabetes
3. Rheumatologic Diseases
4. Pregnancy
5. Chronic kidney disease, stage IV or V (creatinine clearance \<30 mL/min/1.73m2)
6. Cirrhosis or end-stage liver disease
Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

Transradial approach has been preferred for coronary angiography (CAG) and percutaneous coronary intervention (PCI) due to several advantages, including decreased associated vascular complication, patients' convenience, and early ambulation compared with transfemoral approach. With these advantages, current guidelines support that radial access is recommended for CAG and PCI in acute myocardial infarction (AMI) patients with and without ST-elevation if performed by an experienced radial operator. Recently, Kiemeneij introduced a distal radial artery approach, called the snuffbox approach, and several studies have been published. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Moreover, optimal hemostasis duration for PCI via snuffbox approach has not been investigated, even though shorter hemostasis duration would be expected compared with the conventional radial approach as diameter of snuffbox radial artery was significantly smaller than conventional radial artery. In addition, there are few data regarding the feasibility of PCI via snuffbox approach. Therefore, the aim of the study is to evaluate the optimal hemostasis duration for PCI via snuffbox approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old requiring PCI
* Patients who are palpable distal radial arter
* The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria:

* Patients who are not palpable distal radial artery
* Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study.
* Patients who are not appropriate for this study