cyrilzakka/clinical-trials huggingface dataset:
Immunological Mechanisms of Rejection in Uterine Transplantation

The objective of this study is to understand the mechanisms of rejection in uterine transplantation and to search for non-invasive markers of rejection. The biological samples necessary for our research have been or will be collected during procedures (biopsies, smears, vaginal swab, blood tests) carried out as part of the scheduled follow-up of patients. These will be samples whose collection is minimally or not invasive

In the context of uterine transplantation, non-invasive rejection markers will be sought by different approaches, including transcriptomics on a prospective cohort of patients with different types of samples: blood, smear and biopsy. A microbiota study will also be carried out. 3 groups will be studied: 1 group of 10 patients benefiting or having benefited from a uterine transplant, 1 second group made up of their 10 donors, 1 group of 10 control women

Eligibility Criteria:
Inclusion Criteria:

* Patient going to or having received a uterine transplant OR Patient going to or having donated a uterus for a recipient included in the study OR Premenopausal woman to undergo gynecological surgery under general anesthesia: for 4 of them it was a hysterectomy and they must be under 45 years old, the other 6 must be under 38 years old.

Exclusion Criteria (For witness):

* Pregnancy in progress
* Current infection
* Cervical dysplasia
* History of transplant or transfusion
* Cancer or history of cancer
* Menopause
* Patient aged 38 or over for the 6 controls without hysterectomy, patient aged 45 or over for the 4 patients with hysterectomy.
* Endometriosis
Developing a Web-based Shared Decision-making Tool for Fertility Preservation

The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.

Background: The pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive- age patients with breast cancer have safe options when choosing the type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed.

Objective: The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.

Methods: We used the action research cycle of observing, reflecting, planning, and acting to develop a web-based SDM tool. The following four phrases were applied: (1) Observe and reflect: Collect and analyze the decision-making experiences of patients and health care providers; (2) Reflect and plan: Apply the initial results to create a paper design and modify the content; (3) Plan and act: Brainstorm about the web pages, and modify the content; (4) Act and observe: Evaluate the effectiveness, and refine the website SDM. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. The effectiveness was evaluated using the Preparation for Decision-Making (prepDM) scale.

Eligibility Criteria:
Inclusion Criteria:

* Health provider who ever cared the patients with breast cancer.
* Patients with breast cancer who are younger than 50 years old.

Exclusion Criteria:

* none
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
* Hoehn and Yahr Stage 1-3 in an "on" state;
* Require levodopa-containing medication regimen at least 3 times during the waking day;
* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
* Are on stable PD medication regimen;
* Total daily LD dose \<1600 mg/day;
* Able to perform a spirometry maneuver in the ON and OFF states;
* Normal cognition confirmed by MMSE score ≥25

Exclusion Criteria:

* Pregnant or lactating females;
* Previous surgery for PD or plan to have stereotactic surgery during the study period;
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Known contraindication to the use of levodopa;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
* Any contraindication to performing routine spirometry.
Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control

Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR, sitagliptin, or pioglitazone. The CGM measurements collected will help determine the characteristics of glucose control prior to treatment and during treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* type 2 diabetes
* A1c 7.1 - 11
* BMI 25 - 45
* stable weight for 3 months before screening
* fasting glucose \< 280 at screening
* stable dose of metformin for at least 2 months before screening
* not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight
* male or female, non-lactating, non-pregnant and willing to use birth control
* lab values that are not clinically significant at screening
* physical exam and ECG that are not clinically significant at screening
* able to read, understand, and sign consent form

Exclusion Criteria:

* liver disease
* renal disease
* cardiovascular disease
* gastroparesis
* cancer within 5 years of screening
* macular edema
* chronic infections
* drug or alcohol abuse
* fasting triglycerides \> or = 600 at screening
* previous exposure to exenatide LAR
* has donated blood within 60 days of screening or is planning to donate during the study
* has had a major surgery or blood transfusion within 2 months before screening
* is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin
* has received an investigational drug within 1 month before screening
* has allergies or hypersensitivity to any component of the study drug
* has previously had an adverse event related to TZD or Januvia
* is an immediate family member of the study sight or directly affiliated
* is employed by Amylin, Lilly or Alkermes
Evaluation of Rocker sOles in Diabetis

The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

Eligibility Criteria:
Inclusion Criteria:

* Patient with Type 2 Diabetes
* Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
* Can walk without technical assistance
* Age from 18 to 75
* Having made his non-opposition

Exclusion Criteria:

* Presence of ulceration of the foot (or a history of this type)
* History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.
PREVALENCE OF FEMALE GENITAL MUTILATION IN BENI-SUEF LOCALITIES

Female genital mutilation /cutting (FGMC) includes all procedures that involve partial or total removal of the external female genitalia, or another injury to the female genital organs for non-medical reasons". It constitutes an extreme form of discrimination against women due to the health consequences, pain, and risks involved. Regardless of its prevalence, the physical and psychological complications of FGM in Egypt were shown to be enormous. These complications are usually categorized into primary or acute complications and secondary or long-term complications. The primary complications include pain, bleeding, and psychiatric trauma while the secondary complications include several emotional, menstrual, and sexual disorders

Despite being internationally recognized as a human rights violation of girls and women, FGM has been performed on at least 200 million girls and women in 31 countries. According to the 2015 Egypt Health Issues Survey (EHIS), 87% of all women aged 15-49 years in Egypt had undergone FGM. Social norms, religion, ensuring premarital virginity and marital fidelity, increasing marriageability, and cultural ideals of femininity and modesty were among the most commonly cited reasons for performing FGM. A survey conducted among Egyptians aged 10-29 years in 2014 indicated that the reasons given for practicing FGM were customs and traditions (56.7%) and religion (35%).

FGM has many types ranging from excision of the prepuce with/out clitoris (Type I or Clitoridectomy) and excision of the clitoris and labia minora (Type II or Excision) to profound excision of the external genitalia with stitching and tightening the vaginal opening (Type III or Infibulation). Type IV describes pricking, piercing, scraping, and cauterization of the external genitalia without flesh removal. In societies with Muslim majorities, type I: is known as "Sunna Circumcision"; a religious term linking the practice to the commands of the Prophet of Islam or "Khifad" the Arabic synonym of "reduction"; a term claiming that the Prophet of Islam endorsed partial rather than complete excision of the external genitalia. In Egypt, types I and II are also called "Ta-hara"; the Arabic synonym of "purification" which points to the hygienic drive of the practice.

Eligibility Criteria:
Inclusion Criteria:

* Living in Beni Suef Governorate.

Exclusion Criteria:

* Women and men who complaining of any psychological problems
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis

The purpose of this pilot study is to test whether an 8-week course of glucocorticoids, combined with rituximab, is effective in treating ANCA-associated vasculitis.

The primary aim of this pilot study is to examine whether an 8 week course of glucocorticoids, in combination with rituximab, is effective in inducing and maintaining disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis (AAV) who have a more favorable prognosis.

This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure that any patients who require courses of glucocorticoids longer than two months will receive longer therapy, if appropriate for their well-being.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18-85 years old
* Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference
* New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's granulomatosis (BVAS/WG) of \> 3

Exclusion Criteria:

* Renal disease in patients with PR3-ANCA as defined by any of the following:
* Urinary red blood cell casts
* Biopsy-proven glomerulonephritis
* Increase in serum creatinine of \>30% over baseline
* Severe renal disease in patients with MPO-ANCA as defined by both of the following:
* Urinary red blood cell casts or biopsy-proven glomerulonephritis
* Estimated glomerular filtration rate \< 30 ml/min/1.73m2
* Diffuse alveolar hemorrhage requiring ventilatory support
* GC treatment for longer than 14 days prior to enrollment unless patient has been on a stable maintenance dose of prednisone at the time of the flare
* Daily oral cyclophosphamide within 1 month prior to enrollment
* Completed a remission induction course of cyclophosphamide or rituximab within 4 months of enrollment
* Hepatitis B infection
* HIV infection
* History of anti-GBM disease
* Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
* Pregnancy or breastfeeding
* History of severe allergic reactions to human or chimeric monoclonal antibodies
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media

The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy

The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 50 and 85 years of age
* Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)
* Patient informed consent

Exclusion Criteria:

* Previous penetrating keratoplasty
* Corneal neovascularisation
* Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
* Glaucoma
* Aphakia
* Infectious diseases of the cornea
* Neurodermitis
* Participation of the patient in another clinical trial within the last four weeks that precede the recruitment
* The patient is unlikely to comply with the requirements of the protocol
* Previous or current abuse of medications, narcotics or alcohol
* Pregnancy
High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are:

* High protein formula intake benefit in successful weaning from ventilator
* Core muscle rehabilitation benefit in successful weaning from ventilator
* neuromuscular electric stimulation benefit in successful weaning from ventilator

Participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES).

Researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.

The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator:

* High protein formula intake benefit in successful weaning from ventilator
* Core muscle rehabilitation benefit in successful weaning from ventilator
* neuromuscular electric stimulation benefit in successful weaning from ventilator

Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).

Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 20 year old
2. using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)
3. stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability)
4. maximal inspiratory pressure (MIP) \< 30mmHg
5. under enteral nutrition (EN) via NG tube.

Exclusion Criteria:

1. Acute infection and sepsis (fever up to 38.5 degree)
2. Severe neuromuscular disease, or uncontrolled epilepsy
3. Bony fracture or DVT history
4. Wound over the abdomen
5. Congestive heart failure with EF \< 40% or using pacemaker
6. BMI\>35 kg/M2, or severe edema
7. Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded.
8. Under parenteral nutrition (PN)
9. Use pacemaker
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the diagnosis of AD
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
* Caregiver will participate and be able to attend clinic visits with patient.

Exclusion Criteria:

* Significant neurological disease other than AD, or a major psychiatric disorder
* Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
* Woman of childbearing potential
The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke

This study is to investigate the immediate effects of intermittent theta burst stimulation (iTBS) on intracortical excitatory and inhibitory circuits, neural connectivity, and network properties in patients with chronic stroke, using transcranial magnetic stimulation and electroencephalogram (TMS-EEG) and TMS-electromyography (EMG) and approaches.

The neurophysiological effect of intermittent theta burst stimulation (iTBS) has been examined with TMS-electromyography (EMG)-based outcomes in healthy people; however, its effects in intracortical excitability and inhibition are largely unknown in patients with stroke. Concurrent transcranial magnetic stimulation and electroencephalogram (TMS-EEG) recording can be used to investigate both intracortical excitatory and inhibitory circuits of the primary motor cortex (M1) and the property of brain networks.

This study is to investigate the immediate effects of iTBS on intracortical excitatory and inhibitory circuits, neural connectivity, and network properties in patients with chronic stroke, using TMS-EEG and TMS-EMG approaches.

In this randomized, sham-controlled, crossover study, 21 patients with chronic stroke receive two separate stimulation conditions: a single-session iTBS or sham stimulation applied to the ipsilesional M1, in two separate visits, with a washout period of five to seven days between the two visits after crossover. A battery of TMS-EMG and TMS-EEG measurements are taken before and immediately after stimulation during the visit.

Eligibility Criteria:
Inclusion Criteria:

1. suffered from first-ever, ischemic or hemorrhagic, unilateral stroke, verified by neuroimaging examinations such as CT or MRI.
2. detectable motor evoked potentials from the affected first dorsal interosseous muscle;
3. provided written informed consent.

Exclusion Criteria:

1. had any contraindication to transcranial magnetic stimulation;
2. had a known neurological disease excluding stroke, or psychiatric disease;
3. were using a psychostimulant, sedative, antidepressant, or antiepileptic medication.
Oral Pyrophosphate Absorption in PXE Disease

Pyrophosphate is an endogenous, non-toxic metabolite inhibiting soft tissue calcification. The aim of our study is to find optimal dosing and safety of oral disodium-PPi (Na2H2PPi). Absorption curves (pharmacokinetics), AUC0-t, Cmax and Tmax for PPi and phosphate will be provided for healthy controls and PXE-patients both fasting and with standard meal intake.

Phase II oral capsulized disodium-PPi (Na2H2PPi) powder absorption study in subjects with PXE (n=8-12) will be done in the ward of Internal Medicine of Tampere University Hospital and University Medical Center Utrecht.

After a 10-hour fast at 8.00 a.m. 30 mg/kg (first day) and 50 mg/kg (second day) capsulized dose of PPi will be given with 2 dl water. At 12.00 a.m. another capsulized 30 mg/kg (first day) or 50 mg/kg (second day) single dose of PPi with a standard mixed meal (lunch) will be given with 2 dl water at the time when a subject starts eating.

Plasma and urine sampling include plasma and spot urine electrolytes, creatinine, and pyrophosphate. Plasma sampling will be done at 0, 15, 30, 60, 120 and 240 min after ingestion of PPi. Urine spot sample will be taken at 0 and 240 min after ingestion of PPi.

Physical activity is restricted. Side-effects will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 yrs)
* clinically and genetically proven PXE
* Body mass index (BMI) 18,5-34,9 kg/m2

Exclusion Criteria:

* Special groups according to researchers' decision.
* Pregnancy
* No effective contraception in females in child-bearing age.