cyrilzakka/clinical-trials huggingface dataset:
The Use Of AMH for the Discrimination of Polycystic and Multicystic Ovaries in Nonhyperandrogenic Patients

AMH is a member of the transforming growth factor family. It is produced by the granulosa cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown. There are data showing elevated serum AMH level is due to the increase in the number of follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian is defined by the presence of more than six follicles 4-9 mm in diameter and mixed morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of the increase in stroma / volume.The aim of this study is to investigate whether there is a difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary goal is to investigate the usability of AMH as a marker besides ultrasound for discrimination of nonhyperandrogenic patients with PCO or multicystic ovaries.

It is planned to compare the values of FSH/LH, AMH, and 75 gr OGTT between 20 patients diagnosed as PCOS according to the AES-Rotterdam criteria and 20 patients with multicystic ovarian structure but do not provide the PCOS-D3 criteria. The second purpose of this study is to investigate the mechanism that leads to the elevation of AMH in patients with PCOS, and to reveal the effects of intraovarian paracrine factors,insulin resistance and FSH /LH.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 15-43
* \>6 4-9 mm follicles in bilateral ovaries at ultrasonographic examination
* Increased ovarian volume (\>10 ml )

Exclusion Criteria:

* Hormonal drug users
* Late onset congenital adrenal hyperplasia,androgen secreted ovarian or adrenal tumors
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.

The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.


Eligibility Criteria:
Inclusion Criteria:

* Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty
* Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use
* Patient aged between 40 and 75 years old

Exclusion Criteria:

* Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle
* Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint)
* Patient with ankle deformity \> 20° (weight bearing X-rays)
* Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture)
* Patient with neuropathy or with a history of diabetes mellitus for more than 15 years
* Patient with avascular necrosis of the talus \>25%
* Patient already included in the study for the other ankle
The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.

Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c \> 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication

Exclusion Criteria:

* Inability to consent to the study
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.

PRIMARY OBJECTIVES:

I. To determine the feasibility and efficacy of 2 different Body Warming to Alter (Thermo) Regulation and the Microenvironment (B-WARM) regimens on altering tumor blood flow in patients with a variety of malignancies.

SECONDARY OBJECTIVES:

I. To determine if duration and thermal dose of B-WARM changes duration and extent of tumor blood flow changes in patients with a variety of malignancies.

OUTLINE: Patients are randomized to 1of 2 arms.

ARM I: Patients undergo B-WARM at 39 degrees Celsius (C) for 30 minutes.

ARM II: Patients undergo B-WARM at 39 degrees C for 2 hours.

After completion of study, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck, renal, breast, lung, ovary, liver)
* Patients must have measurable disease (1.0 cm or greater) by computed tomography (CT) scan
* Have an estimated glomerular filtration rate (eGFR) (using the Cockcroft-Gault equation) of more than 60 mL/min
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* History of prior myocardial infarction or arrhythmia
* History of any condition deemed by the principal investigator to be a contraindication to B-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc)
* All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive B-WARM
* Received an investigational agent within 30 days prior to enrollment
* Received any systemic therapy within 21 days prior to planned B-WARM therapy

  * Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
* Patients should not have either CT scanning or B-WARM if they have a fever at the time

  * Fever should be worked up and treated as appropriate
  * Patients should be afebrile for 24 hours prior to scanning or B-WARM therapy
A Study Comparing the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Combination With Two Different Heparin Regimens in Patients Undergoing Percutaneous Coronary Intervention.

The purpose of this study is to compare the safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered in combination with two different heparin regimens. Please see attached results.

This is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: abciximab/low-dose weight-adjusted heparin, abciximab/standard-dose weight-adjusted heparin, or placebo/standard-dose weight-adjusted heparin. The primary outcomes of the study include the number of deaths, myocardial infarctions, or repeat revascularizations within 6 months, and the number of deaths, myocardial infarctions, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days. Please see attached results.

Abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; Abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; Placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for elective or urgent percutaneous coronary intervention with an FDA-approved device
* Having a target artery (native or graft) stenosis of 60% by visual estimation

Exclusion Criteria:

* Patients with unstable angina/non-Q-wave myocardial infarction meeting EPIC criteria within the previous 24 hours, or with acute Q-wave myocardial infarction meeting EPIC criteria with onset of chest pain within previous 24 hours
* With active internal bleeding, having a condition that may increase the risk of bleeding, or currently receiving administration of oral anticoagulants at the time of study entry
* With confirmed hypertension with systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg
* Having had a percutaneous coronary intervention within the previous 3 months
* Having an unprotected left main coronary artery stenosis \> 50%
Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors

The study is an RCT study, comparing the proactive and reactive balance training among stroke survivors, the participants will be chronic stroke patients aged between 50- 75 years old, and the participants will receive a balance training program for 8 weeks 3 sessions in the week, the participants will randomly be allocated in two groups proactive group and the reactive group, at the end of the study will compare the different effects between proactive and reactive balance training

The objectives of the study are: (1) To investigate the effect of reactive balance training on balance and functional performance, (2) To investigate the effect of proactive balance training on functional activity and balance stroke survivors, and (3) To study the reactive balance training versus the proactive balance on balance and functional performance among stroke survivors.

The study will be a single-blinded RCT study will consist of 40 chronic stroke patients and will allocate randomly into 2 groups, the first intervention group n=20 will have proactive-balance training, and the second group n= 20 will have reactive balance training, the two groups will be blinded.

The study population will be chronic stroke patients discharged from Bethlehem Arab Society for Rehabilitation (BASR), Alahli Hospital, Al Mezan Hospital, and Alehsan Society for Rehabilitation, and lives in Hebron City and their villages.

The program will consist of 24 sessions in 8 weeks, through 3 sessions weekly. The sessions will be 45 minutes, starting with a 10 Min warm-up exercise and then the balance training and the sessions will end with 5 Min cool-down exercise.

The session will be individualized, the program has sequences depending on the patient's ability.

The program consists of:

1. Sitting training
2. Standing training
3. Walking training The sequences of the training will be based on a balance training protocol.

Eligibility Criteria:
Inclusion Criteria:

1. chronic stroke patients
2. Males and females
3. Age from 50-75 years old
4. Able to follow up on instructions
5. Able to walk at least 10 meters continuously
6. Able to perform sub-maximal physical activity
7. stable health condition

Exclusion Criteria:

1. Acute stage or Subacute stage (less than 3 months)
2. stroke patients with other severe diseases
3. Head injuries
4. patients with mental problems
5. patients with vestibular problems
6. Patients refuse to sign the consent form
Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study

This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.


Eligibility Criteria:
Inclusion Criteria:

* Subject participation in the TASMA study
* Ability and willingness to provide informed consent.
* Ability to comply with the study protocol

Exclusion Criteria:

* Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.
Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial

The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years;
* Recently diagnosed Type 2 Diabetes (\<= 10 years):
* HbA1c \< 9%:
* Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
* Anti-diabetic therapy stable during the last 3 months before inclusion
* BMI between 30-34.9 kg/m² with adaptation for Asian population 27.5-32.5kg/m²
* Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific procedures);
* Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria:

* Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
* Type I diabetes characterized by C peptide \<0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
* Unstable diabetic retinopathy
* Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
* Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (\<5 years)
* Contra-indication to endoscopic gastroplasty (...)
* Impending gastric surgery 60 days post intervention;
* Participant involved in another interventional clinical study
* Patients having alcoholic or drug addiction;
* Patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder;
* Person deprived of liberty by judicial order
* Person under guardianship or curatorship
Mindfulness Training in the Medical Health Care System

The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are between 18 and 80 years of age
2. Individuals who are fluent English speakers
3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
4. Individuals who are willing and able to consent to participate in the study

Exclusion Criteria:

1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients

The purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient with COVID 19 or outpatient under investigation for or diagnosed with COVID 19
* Clinically stable (on 4L O2 or less, non ICU)
* Demonstrates ability to be trained in use of digital stethoscope technology

Exclusion Criteria:

* Pregnancy
* Delirium
Counteracting Age-related Loss of Skeletal Muscle Mass

Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.

Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (\<16 OR ≥16). The five groups are: Heavy Resistance Training (N=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content.

Assessments will be performed at Baseline (before intervention start), and after 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).

The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.

The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, independently living
* Age at least 65 years

Exclusion Criteria:

* Subjects dependent on help/nursing etc.
* Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
* Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
* Implanted magnetic devices incompatible with MRi-scanning.
* Weekly alcohol consumption \> 21 units (1 unit equals 4g of ethanol) for men and \> 14 for women.
* Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
* \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation

This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation (iCOS).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 20 to 35 years (including both)
* Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG)
* Subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care

Exclusion Criteria:

* Subjects undergoing ART treatment with mild stimulation protocol
* Concomitant use of Gonal-f® with clomiphene citrate
* With an In vitro fertilisation (IVF)/ Intracytoplasmic sperm injection (ICSI) history of greater than or equal to (\>=) 3 times
* Known history of poor ovarian response in a previous COS cycle for IVF/ICSI, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as Antral follicle count (AFC) less than (\<) 5 to 7
* Presence of confirmed or suspected endometriosis Grade III - IV
* Presence of unilateral or bilateral hydrosalpinx
* Using other Gn during stimulation period (such as urinary FSH/human menopausal Gn, except for recombinant luteinizing hormone (r-LH))
* Known history of recurrent miscarriage
* Any contradiction to Gn/GnRH analogues
* Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
* According to the judgment of the Investigator, any medical condition or any concomitant
* surgery/ medications that would interfere with evaluation of study medications
* Simultaneous participation in another clinical study
Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia

CALIF study is a monocentric observational study which aim is to analyse the value of adding procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the management of chemo-induced febrile neutropenia occurring in patient with solid tumour. Febrile neutropenia will be managed according to international guidelines. PCT will be dosed at initial presentation. Primary objective is to determine the optimal value of PCT for the detection of septicaemia in low risk (according to MASCC score). The investigators plan also to compare two risk stratification scores: the validated MASCC score and a recently developed score which includes PCT and other more objective items.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* Patients with solid malignant tumor treated by chemotherapy (neoadjuvant, concomittant, adjuvant or metastatic)
* Febrile neutropenia chemo-induced (fever \> 38°C, neutrophils \< 500 /microliter or nadir \< 500 /microliter)
* Patients non hospitalized at the event (when he presented febrile neutropenia)
* Informed consent signed

Exclusion Criteria:

* Thyroid medullar carcinoma
* Patient not able to understand protocol (mental retardation, psychiatric disorders, .... )