cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Elasticity of the Mitral Valve

There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

The prospective study will be conducted on 20 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

The harvested tissue will not be frozen and will kept in natural conditions as close as possible.

Eligibility Criteria:
Inclusion Criteria:

All patients programmed for mitral valve replacement who have more than 45 years old

Exclusion Criteria:

* Patients with mitral calcification
* Mitral valve rheumatic disease
* Mitral valve infections
* Redo surgery on the mitral valve
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.

MBCR is a step wise standardized behavioral intervention of MBSR. The program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. During class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. In addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. A full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer, gynecologic cancer or colorectal cancer
* Cancer survivor at least 18 years of age at the time of study enrollment
* Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed)

Exclusion Criteria:

* Psychologic disease in which informed consent cannot be obtained from the subject
* Need for ongoing chemotherapy and/or radiation therapy
Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients

this study will be carried to investigate the effect of cryolipolysis and high intensity interval training on insulin resistance and body composition in pco women

This study will be carried out on ninety females with polycystic ovarian syndrome (PCOS)l. Their age ranges from 17-28 years, body mass index 25-30 Kg/m2. They experience hyperandrogenism and hyperinsulinemia.

PCOS females will be randomly assigned into three equal groups: group (A) consists of 30 women who receive cryolipolysis and group (B) consists of 30 women who receive high intensity interval training and group (C) receive both

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with polycystic ovarian syndrome
* age ranges from 17-28 years
* body mass index ranges 25-30 Kg/m2

Exclusion Criteria:

* Diabetic patients.
* Women with BMI\>30
* Women having circulatory dysfunction.
* Women with respiratory or cardiac disease
* liver disease.
* Skin disease .
* Previous abdominal or uterine surgery
* any medications affecting hormones
* any physical impairments
* Physical impairment
Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain

This study was planned to investigate the relationship between pain perceptions and pain beliefs of individuals in different age groups with chronic low back pain and symptom severity.

The study will be conducted as an observational descriptive and cross-sectional research. Participants will be recruited after the purpose and content of the research are explained by the researchers, their written consent is read, and the volunteers who agree to be included in the study are given their written consent. The data collection process was carried out face-to-face and via a Google Forms survey over the internet, and will be conducted with the participants face-to-face and online. In the study; The pain beliefs questionnaire (PBQ), the centrality of pain scale (COPS) and the numerical rating scale (NRS-11) will be used.

Eligibility Criteria:
Inclusion Criteria:

* having low back pain for at least the past three months
* be between the ages of 18-79.

Exclusion Criteria:

* Those outside the age limit of 18-79 and illiteracy.
Influenza Vaccination in Patients Living With HIV in the Northern Region

Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza is a viral infection that has a significant impact on the health care system. However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country. Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.

Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for a scheduled consultation as part of their HIV follow-up in the spring of 2020. Non-opposition letter given to the patient. Collection of data a posteriori from the medical file recorded in the eNadis patient file.

Eligibility Criteria:
Inclusion Criteria:

* Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020
* People who do not read French may participate if they wish with the help of a medical or paramedical staff member.
* Patient did not object

Exclusion Criteria:

* Minor patients
* Major under guardianship, curatorship, protected person
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers

Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 20 and \<= 35 years
* Weight: BMI \>= 18.5 and \< 25 (Weight (kg) / Height (m²)
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* History of alcohol or drug abuse
* Participation to another trial with an investigational drug within 4 months prior to the administration
* Whole blood donation more than 400 ml within 3 months prior to the administration
* Whole blood donation more than 100 ml within 1 month prior to the administration
* Donation of constituent of blood of more than 400 ml within 1 month prior to the administration
* Any medication within 10 days prior to the administration
* Excessive physical activities within 7 days prior to the administration
* Alcohol drinking within 3 days prior to the administration
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.

The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
* Currently tolerating the treatment regimen in the parent protocol
* Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest

Exclusion Criteria:

* Known or suspected presence of other cancer
* Other life- threatening illness or organ system dysfunction compromising safety evaluation
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer

Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Eligibility Criteria:
Inclusion Criteria:

* stage I or II breast cancer; woman; 50-65 years old; post-menopausal

Exclusion Criteria:

* history of previous cancer or chemotherapy; significant neurological or psychiatric history
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
3. MAS score of 2 or greater in the gastrocnemius of the treated limb.
4. Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164
5. No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
6. Participant is able and willing to comply with the protocol.

Exclusion Criteria:

1. History of surgical procedures of the lower extremity.
2. Ankle contracture.
3. Sever, inflammatory arthritic diseases.
4. Thrombosis.
5. Anticoagulant medications.
6. Pregnancy.
7. Cancer.
8. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
Study on the Efficacy and Safety of Gelaspan

It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.


Eligibility Criteria:
Inclusion:

* Male or female patients ≥ 18 years of age and ≤ 80 years of age.
* Patients scheduled to undergo open elective abdominal or pelvic surgery.
* Anticipated intraoperative volume requirement for gelatine solution is at least 15 mL/kg body weight
* Negative pregnancy test (urine dipsticks) in women of child bearing potential.
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the regulatory authorities of the Russian Federation and Local Ethics Committee (LEC) prior to all evaluations.

Exclusion:

* Patients of ASA-class \> III.
* Known hypersensitivity to gelatine or to any of the constituents of the solution.
* Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery.
* Patients on hemodialysis.
* Patients suffering from:

  * Decompensated renal function (i.e. serum creatinine \> 3.0 mg/dL)
  * Hypervolemia;
  * Severe heart failure;
  * Moderate lung edema;
  * Hyperhydration;
  * Severe blood coagulation disorders (aPTT \>2.5 x ULN or fibrinogen \< 0.5 x LLN or INR \>2.5 x ULN);
  * Hypernatremia (serum Na+ \> 150 mmol/L);
  * Hyperchloremia (serum Cl- \> 110 mmol/L);
  * Hypercalcemia (serum ionized Ca++ \> 1.5 mmol/L);
  * Metabolic alkalosis;
  * Severe generalized edema;
  * Intracranial haemorrhage;
  * Hyperkalemia (serum K+ \> 5.5 mmol/L).
* Pregnancy and/or nursing.
* Hypertension with the Systolic Blood Pressure \> 180 mm Hg and Diastolic Blood Pressure \> 110 mm Hg identified at screening.
* Patients who in the investigator's opinion couldn't take part in the study.
* Simultaneous participation in another clinical trial.
* Emergencies.
The Optimal Timing for Cerclage Removal

Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery

The optimal timing of cervical cerclage removal is yet unclear.

In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/

Primary outcome:

Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).

Secondary outcomes:

Time interval between cerclage removal and gestational age of delivery.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Elective or emergent cerclage in the current pregnancy
* Cerclage that was removed after 36 weeks of pregnancy

Exclusion Criteria:

* Multiple pregnancies
* Major congenital anomalies
* Cerclage removal before 36weeks of pregnancy
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.


Eligibility Criteria:
Main Inclusion Criteria:

* Advanced stage hepatocellular carcinoma
* Patients exhibiting progressive disease under Sorafenib treatment
* Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included
* ECOG performance status 0, 1 or 2
* Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks

Main Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated \> 3 years prior to entry is permitted
* Renal failure requiring hemo- or peritoneal dialysis
* Known central nervous system (CNS) tumors including symptomatic brain metastasis
* Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy \> Grade I
* Pregnant or breastfeeding women
* Sorafenib intolerance
* Major surgery within the last 4 weeks
The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation.

Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This recommendation emphasizes on the timing and frequency of ventilation during CPR. However, poor clinical evidence had been established concerning adequate volume, airway flow and pressure in each cycle.

There are increasing evidence that hyperventilation during resuscitation reduces pulmonary venous return and, therefore, compromises cardiac output and circulation. Another research reported that using high flow oxygen mask alone during basic life support (BLS) results in better survival rate and overall outcome compared with conventional positive pressure ventilation.

Our study applies flowmeter to measure ventilation parameters as frequency, duration, exhaled volume and airway pressure on intubated patients who received artificial ventilation during CPR. The parameters will correlate with information from accelerometry and capnometry simultaneously during resuscitation. . Investigators also focus on the influence of chest compression, which increases intra-thoracic pressure considerably. This effect may act against positive pressure ventilation and probably minimize the efficiency in each ventilation or circulation..

Details about how to ventilate one patient during CPR include right timing, duration, adequate volume and coordination are in debate. Unfortunately, current practice based on clinical guidelines emphasizes little on this issue. Investigators are committed to refine contemporary practices and hopefully improve qualities of resuscitation.

Investigators proposed the hypothesis that coordinate chest compression and ventilation may minimize the increasement of airway pressure and improve the effect of circulation


Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years old, \< 100 years old

Exclusion Criteria:

* Trauma related out of hospital cardiac arrest