cyrilzakka/clinical-trials huggingface dataset:
Vasodilation in Patients With Fabry's Disease

Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme alpha-galactosidase A. The disease is characterized by abnormal collections of glycolipids in cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia, decreased sweating, tingling sensations in the extremities, and cataracts. Patients with Fabry 's disease die from complications of the kidney, heart, or brain.

The objective of this study is to test the belief that patients with Fabry's disease have a problem with blood vessels becoming larger. The walls of blood vessels contain muscles that when they relax the vessel becomes larger. This process is referred to as vasodilation. It is controlled by a substance released by cells in blood vessels called EDRF (endothelium-derived relaxing factor).

Several drugs can affect vasodilation. Researchers believe some drugs may work by blocking the affect of EDRF. Researchers would like to test the effects of these drugs on the blood vessels of normal volunteers and patients with Fabry's disease.

Fabry disease is a systematic genetic disease in which patients have abnormal blood vessels, and leads to numerous complications including cerebrovascular strokes. The objective of this study is to test the hypothesis that patients with Fabry disease have abnormal endothelial-derived vasodilation. If found to be abnormal, endothelial-derived vasodilation will serve as a useful clinical outcome measure in the evaluation of the efficacy of specific treatment of Fabry disease, and possibly of other causes of cerebrovascular stroke. The endothelium modulates vascular tone by the release of contracting and relaxing substances that act on the underlying smooth muscle. It has been previously demonstrated that patients with essential hypertension have a blunted vascular response to acetylcholine (an endothelium-dependent vasodilator). In the present study, we shall analyze the regional vascular responses to acetylcholine and sodium nitroprusside alone, and in the presence of L-NMMA (an inhibitor of the synthesis of EDRF by endothelial cells) in 12 patients with Fabry disease and 12 normal age matched control subjects. We will infuse drugs into the brachial artery and will measure the responses of the forearm vasculature by means of strain gauge plethysmography. Forearm blood flow and vascular resistance at baseline and after infusion of vasoactive drugs, in Fabry patients, will be compared to the responses obtained in the healthy control population. This study will be performed with collaboration of Dr. Julio A. Panza, Senior Clinical Investigator from the Cardiology Branch, NHLBI.

Eligibility Criteria:
Male patients with the classic form of Fabry disease, aged 18-50.

Normal male volunteers of the same approximate age will be included as a control.

No patients or volunteers with hypertension, hypercholesterolemia, diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.

No volunteers who are taking any kind of medication.

Must be able to give informed consent.
Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have designed a comparative study between the conventional and the minimally invasive treatment. Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision with a Bascom out-midline closure (Control group).


Eligibility Criteria:
Inclusion Criteria:

* Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria:

* Absence of consent to the study
* Acute abscess
Eye Rubbing and Keratoconus in Montpellier CHU

Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits


Eligibility Criteria:
Inclusion criteria:

- Having a keratonus at least in one eyes

Exclusion criteria:

- Refus to participate
A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk

In patients with heart attacks, the treatment of choice is to restore blood flow with percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages). After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications block full function of the platelet cells, which are responsible for clotting. Despite their use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome the resistance, are now available; however, they come with an increase chance of severe bleeding and costs. An ideal solution would be to identify at-risk patients and selectively treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This type of strategy (personalized strategy) would decrease heart attacks and death (compared to clopidogrel), while also preventing bleeding complications (compared to treating all patients with the new drugs).

Of resistant patients, many carry genes (inherited units) that prevent proper absorption of clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies carriers of at-risk genes. However, this technique alone does not identify all at-risk patients. Consequently, we have now devised a novel tool, which combines genetics with patient characteristics to identify high-risk patients.

The present study combines this new tool into a strategy for personalized treatment. Patients with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor strategy (stronger approved drug). The function of the platelet cells will be measured at 1 month to determine potential benefits. Evaluation of this new personalized strategy is important for improving patient outcomes after PCI. The hypothesis is that patients receiving a personalized strategy will have decrease risk for future heart attacks and bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients: age \>18 yrs, \< 75yrs

  -\> 60 kg ( since March 2015 age \>75 and \< 60 kg eligible - but prasugrel reduced to 5mg daily if randomized to personalized therapy arm)
* NSTEMI undergoing PCI will be eligible

Exclusion Criteria:

- Patients will be excluded if they have: i) a contra-indication for clopidogrel or prasugrel or ticagrelor (as per monograph), ii) have an intolerance to aspirin, iii) have absolute requirement for ticagrelor or prasugrel (e.g. stent thrombosis, allergic reaction to clopidogrel), iv) requirement for anti-coagulation treatment, v) a history of stroke, TIA or intracranial hemorrhage , vi) a platelet count \< 100,000/μl, vii) a known bleeding diathesis, viii) hematocrit \<30% or \>52%, ix) severe liver dysfunction, x) renal insufficiency (creatinine clearance \< 30ml/min), xi) adjuvant therapy with a glycoprotein IIbIIIa inhibitor.
The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise

Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results.


Eligibility Criteria:
Inclusion Criteria:

* Injury-free, trained, male runners

Exclusion Criteria:

* Female, untrained, injured
Cryolipolysis on Localized Adiposity

The aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: Control Group or Intervention Group. The following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. The expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.

Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 to 45 or not being on menopause
* Sedentary according to International Physical Activity Questionnaire
* Body Mass Index lower than 27 Kg/m²
* Skinfold: more than 3 centimeters at the lower abdomen

Exclusion Criteria:

* Cryoglobulinemia
* Cold urticaria
* Paroxysmal cold hemoglobinuria
* Raynaud disease
* Pregnancy and Breastfeeding
* Cancer
* Vascular diseases
* Heart diseases
* Epidermal lesions at the site of application
* Autoimmune diseases
* Osteoporosis
* Metallic implants and pacemaker
* Alterations of sensibility
* Inflammatory process and active infection
* Abdominal hernia
* Abdominal muscle diastasis
* Diabetes
* Anemia
* Previous plastic surgery on the area
* Liver and kidney diseases
* Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form
Subclinical Hypothyroidism and Chronic Inflammation in PCOS

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. Concomitant endocrinopathies, i.e. obesity, dyslipidemia, insulin resistance, diabetes and thyroid diseases, may additionally influence the activity of chronic inflammation. There is no data indicating the relationship between chronic inflammation and PCOS phenotypes, the severity of metabolic disorders, ovarian reserve and the influence of thyroid function on its activity in PCOS.

The aim of the study is:

i) to assess and compare serum concentrations of selected inflammatory markers (leucocytosis, CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha) in women with different phenotypes PCOS and hypothalamic-pituitary-ovarian axis dysfunction (HPOD) (control), ii) to evaluate the impact of subclinical hypothyroidism (defined as TSH\>2.5 uIU/ml, fT3 3,1-6,80 pmol/l, fT4 12,0-22,0 pmol/l), with the presence and absence of circulating antithyroid antibodies (a-TPO and a-TG), on the balance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes, iii) to assess the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices, expressed as FSH and AMH concentrations.

The study population will be characterized in terms of demographic (age, BMI), gynecological (age of first and last menstrual period, cycle length, history of reproductive organ surgeries, ultrasound measurements of endometrial width, ovarian volume) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes) will be recognized by the Rotterdam criteria. HPOD will be diagnosed according to WHO criteria. During hospitalization, blood samples will be collected for scheduled analyzes (30 ml of blood in total).

Eligibility Criteria:
Inclusion Criteria:

* age 18-45 years,
* cycle length \<21 days or \> 35 days,
* unsuccessful attempts to conceive for at least 12 months of regular intercourse with sonographically confirmed anovulation with excluded male, tubal and uterine infertility factors.

Exclusion Criteria:

* absence of at least one ovary,
* previously diagnosed thyroid disease
Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency

The purpose of this research is providing valuable traditional chinese medicine theory and formula in treating Primary Ovarian insufficiency.

Primary ovarian insufficiency is a problem that is to be solved urgently in the field of reproductive endocrine. According to the basic theory of traditional Chinese Medicine and clinical experience, investigators developed a Chinese medicine formula(Hu yang yang kun,Hyyk). This research is designed according to the principle of randomized double blind control and evaluated the effectiveness and safety of Hyyk, hope to provide a kind of effective medicine in treating primary ovarian insufficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-40
2. Menstrual cycle change more than 7 days at least 2 times,amenorrhea less than 6 months.
3. Sex hormone:bFSH\>10u/L;or E2\>80pg/ml.
4. AMH\<1ng/ml.
5. Informed consent and truthfully answer the question.

Exclusion Criteria:

1. Dose not meet the inclusion criteria.
2. Genital tract malformation,congenital germinal aplasia, uterine amenorrhea and so on organic disease.
3. Endocrine diseases such Polycystic ovary syndrome、hyperprolactinemia 、dysfunctional uterine bleeding、low gonadotropin menstrual disorders and hyperthyreosis
4. Autoimmune disease patients:Hashimoto's thyroiditis,SLE,Primary chronic adrenal cortical insufficiency,Asthenic bulbar paralysis,Arthritis deformans,Idiopathic thrombocytopenic purpura, type I diabetes and so on.
5. Someone who have the following gynecological operation history: oophorocystectomy,ovarian drilling,wedgeshaped oophorectomy,adnexectomy,tubal resection,ligation of oviduct,pelvic abscess surgery,uterine arterial embolization.
6. Someone who have used reproductive toxicity drugs: tripterygium wilfordii,tripterygium hypoglaucum hutch,chemotherapeutics and so on.
7. A family history of ovarian failure.
8. Have receive hormone therapy in recent 3 months.
9. Pregnant or lactating women.
10. with serious heart,liver and kidney disease
11. With severe psychiatric disorders .
12. Have participated in other clinical trials in 3 months.
Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?

The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.


Eligibility Criteria:
Inclusion Criteria:

-All male patients (\>18 years of age) undergoing shoulder arthroscopy

Exclusion Criteria:

* Female patients
* patients with active acne
* patients who have taken antibiotics in the past month
* doxycycline allergy
* benzoyl peroxide allergy
* clindamycin allergy
* patients with psoriatic/eczematous or other lesions on the shoulder girdle.
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:

1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)?
2. What is the rate of Event-free survival at first month and 2-3 months after intervention?
3. What is the rate of Overall survival at first month and at 3 months after the intervention?

B-cell acute lymphoblastic leukemia (B-ALL), as the most common type of pediatric tumor, is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood. Also, relapse and refractory B-ALL (R/R B-ALL) is the main reason of global mortality due to the constraints of combination chemotherapy.

Over the past few years, substantial advancements have been made in treatment of ALL, specifically in the R/R context. Chimeric antigen receptor T (CAR-T) cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface. CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of r/r B-ALL. In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with R/R B-ALL.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
* Presence of disease in the bone marrow
* Able to tolerate the apheresis process
* Life expectancy \&gt; 12 weeks
* Lansky or Karnofsky score \&gt; 50%
* At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
* Informed consent
* Having potential donor for stem cell transplantation

Exclusion Criteria:

* Presence of active malignancy other than the disease under study
* Chloroma and leukemic infiltration on MRI or significant neurological symptoms
* Any CNS disorder
* Presence of active GVHD
* Radiation therapy within last 14 days
* History of Anti-CD19 or Anti-CD20 therapy
* Donor lymphocyte injection or other cell therapy methods within the last 30 days
* Presence of severe active infection
* Organ dysfunction
Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke

In order to discover dysphagia scales, which shows meaningful predictability of aspiration and functional health status in patients with acute stroke, authors plan to find out more predictable indicators than existing penetration-aspiration scale (PAS) to validate their predictions and their internal and external validity over 6 months following stroke .

To determine the dysphagia scale with significant predictions of aspiration and functional health status in patients with acute stroke, video-fluoroscopic swallowing study (VFSS) will be performed to the patients who will be referred for VFSS among stroke patients who would be diagnosed by Brain MRI / CT. When any type of dysphagia is found, participant will be assigned to the test group (DYS), and when no dysphagia is found, they will be assigned to the control group (NOD).

Numerous kinds of assessment will be conducted before and after VFSS, before discharge, and 3, 6, and 9 months after the stroke onset.

Eligibility Criteria:
Inclusion Criteria:

* brain MRI / CT-based stroke patients who were referred for VFSS

Exclusion Criteria:

* In case of a history of dysphagia
* Unstable patient in neurology
* 2 or higher of NIHSS 1a (level of consciousness)
* Patients with other neurological diseases
* Patients with decompression skull resection
* Refusal of participation
The Effect of Cardiac Educational Program on Level of Knowledge and Satisfaction Among Coronary Artery Disease Patients in North of Jordan

Background: Although patients' education programs improve health-related knowledge that promote individual capacity to understand basic health information, there is a scarcity in the studies that address cardiac educational programs for patients with coronary artery diseases in Jordan and their impact on patients' health outcomes.

Aim: the aims of this study are to assess the level of knowledge and satisfaction of patients with coronary artery disease and to evaluate the effect of implementing a cardiac educational program on patient's level of knowledge and satisfaction.

Methods: This study will be carried out using a true experimental two groups pre and post- test. The necessary information will be collected from 138 patients with CAD in the north of Jordan using the Coronary Artery Disease Education Questionnaire (CADE-Q) and the Patient Satisfaction Scale (PSS).

The expected outcomes include establishing foundational knowledge about the effectiveness of cardiac educational program on patient health related out comes. Evidence on the effect of cardiac educational program will help patients to recover from a heart attacks, prevent future heart problems, hospital stays and death related to heart problems as well as making a necessary life style changes.

Keywords: coronary artery disease, educational program, patient satisfaction, patient knowledge.


Eligibility Criteria:
Inclusion Criteria:

1. mentally competent since cognitive impairment negatively affects the comprehension of the cardiac educational program content
2. able to communicate verbally
3. able to read and write Arabic language
4. more than 18 years
5. stable and the previous attack not less than 24 hours

Exclusion Criteria:

* Exclusion criterion included patients with life- threatening comorbidities like (heart failure (HF), Valve Diseases, Chronic Obstructive Pulmonary Disease (COPD), patients with Pacemaker or Implanted Cardioverter Defibrillator (ICD), and any type of chronic cardiac arrythmias.