cyrilzakka/clinical-trials huggingface dataset:
Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Patients with type 1 or 2 Diabetes mellitus will be recruited according to eligibility criteria. Bone marrow mononuclear cells (BMMCs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. All patients will be explained in details about the procedures involved in BMMC transplantation and sign the informed consent for the study; The Ethics Committee of Qilu hospital, ShanDong university approved the treatment protocol. All patients undergo scheduled follow-up evaluations for 5 years after transplantation. Clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular OHA and/or insulin therapy .They are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* Between 16 to 65 years of age
* Requiring daily exogenous insulin injection for the glycaemic control
* With poor β-cell function
* Body mass index (BMI) \< 28

Exclusion Criteria:

* Acute or chronic infections
* Chronic uncompensated organic insufficiency including heart, liver, renal and lung
* Any malignancies, congenital or acquired immunodeficiency
* Hematological diseases or coagulopathy
* Acute or chronic pancreatitis
* History of thoracic or abdominal aorta diseases
* Allergy to iodine
* Pregnancy
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
* Willing to discontinue chronic treatment with antihistamines during the study

Exclusion Criteria:

* Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria
* Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
* Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)
S-Shearwave Elastography for Assessment of Hepatic Fibrosis

The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
* Signed informed consent

Exclusion Criteria:

* Acute hepatitis or bile duct obstruction
* Serum ALT\> 5 times the upper limit of normal within 3 months
* s/p Rt. hemihepatectomy
* s/p liver transplantation
* Large mass or infiltrative lesion in the right lobe of the liver
A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.


Eligibility Criteria:
Inclusion Criteria

1. Non-smoking, age greater than or equal to (\>=) 20 years and less than or equal to (\<=) 55 years old adult male at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
2. Body mass index (BMI) \>=18.5 and less than (\<) 25.0 kilogram per square meter (kg/m˄2) at Screening

Exclusion Criteria:

1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation
2. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
3. History of meningococcal infection or pneumococcal infection
4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example- psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening
6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline
7. History of prolonged QT/QTc interval
8. History of left bundle branch block (LBBB)
9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)
10. History of clinically significant arrhythmia or uncontrolled arrhythmia
11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology at Screening
12. History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
13. Liver function test with following values at Screening or Baseline:

    1. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (\>) upper limit of normal (ULN)
    2. direct bilirubin or total bilirubin: \>1.5\*ULN
ICD Shock Detection by a Wearable

Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD

Non-invasive, pain-free clinical evaluation of a wearable/proximity sensor designed to detect a high voltage therapeutic shock received by a patient from their Implantable Cardioverter Defibrillator (ICD) during defibrillation threshold testing (DFT), which is a routine part of the clinical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding procedure and making informed consent
* Listed for elective ICD Implant
* Having routine DFT as part of elective ICD implantation

Exclusion Criteria:

* Not indicated for ICD implant
* Incapable of making informed consent
* Pregnant
* Not on stabilised anti-coagulation
Study of Drug Therapy for Pediatric Heart Failure

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients.

The main questions it aims to answer are:

* Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?
* Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.


Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 14 years of age
* heart failure after congenital heart surgery
* Ross \> 2 or NYHA \> 2
* LVEF\<55%, or LVFS\<25%

Exclusion Criteria:

* single ventricle
* congenital heart disease without anatomical correction
* Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
* Patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 Wood·U)
* Patients with severe liver and kidney failure
* Patients who are allergic to related medications
* Patients with symptomatic hypotension who cannot tolerate related drugs
* Refuse to sign the informed consent or refuse to participate in this experiment
Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus

The purpose of the study is to analyze the effects of the consumption of yogurt with concentrated and lyophilized probiotic cultures on the parameters associated with glucose homeostasis, inflammation and oxidative stress in patients with Type 2 Diabetes Mellitus (T2DM).

After being informed about the study and the potential risks, all patients who gave their written informed consent underwent a screening period of 1 week to determine their eligibility to participate in the study. At week 0, patients who met the eligibility requirements were randomized in a double-blind manner (participant and investigator) to the American Diabetes Association (ADA) diet + yogurt with premium probiotics (300 g/d) or ADA diet + conventional yogurt (300 g/d) or ADA diet without fermented dairy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM diagnosed at least one year ago.
* That they are outpatients.
* Between 25 and 65 years old.

Exclusion Criteria:

* Smoking patients.
* Lactose intolerance.
* Pregnancy or breastfeeding.
* Presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder.
* Use of insulin, estrogen, progesterone or diuretic injections.
* Consumption of probiotic supplements two months before the start of the study
Branch Vein Occlusion Study

To determine whether scatter argon laser photocoagulation can prevent the development of neovascularization.

To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous hemorrhage.

To determine whether macular argon laser photocoagulation can improve visual acuity in eyes with macular edema reducing vision to 20/40 or worse.

Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none were proven to be effective. The only treatment that seemed at all promising in preventing visual loss from BVO was laser photocoagulation.

Approximately 500 patients were enrolled in the study. One-half were randomly assigned to treatment with argon laser photocoagulation; the other one-half remained untreated as controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser burns was applied in the drainage area of the occluded vein site, avoiding the fovea and optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old had to have been available for each patient. Treatment was performed under topical anesthesia using the argon laser to achieve a grid pattern over the area of capillary leakage identified by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea than the edge of the foveal avascular zone and did not extend peripherally beyond the major vascular arcade. The efficacy of treatment was judged on the basis of visual acuity measurements as well as assessment of the subsequent development of neovascularization and/or vitreous hemorrhage. Patients were followed for at least 3 years.

Eligibility Criteria:
Patients with three types of diagnoses were accepted:

1. major BVO without neovascularization;
2. major BVO with neovascularization;
3. BVO with macular edema and reduced vision. All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.

This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.

When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?

Eligibility Criteria:
Inclusion Criteria:

children with cerebral palsy -

Exclusion Criteria:

absent thermal sensation -
Validation of iPelvis App for Female Pelvic Floor Dysfunction

The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.

Urinary dysfunctions are widely discussed because they cause problems in social, emotional, sexual life and the quality of life of incontinent women. The overall objective of this research is to evaluate the use of the Application. Ipelvis in women with urinary incontinence. This is a longitudinal study of the type randomized controlled trial. Women with urinary incontinence of urgency, effort and effort will be evaluated and treated. Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic floor musculature function. As volunteers are drawn in four groups (Group I: Household Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Women with urinary incontinence by urodynamics, stress and mixed urinary incontinence, aged between 18 and 59 years, who have cognitive ability, have a compatible cell to install the Ipelvis application and who sign the Informed Consent Form.

Exclusion Criteria:

* Pregnant women, women up to six months postpartum, women with prolapse greater than stage III by Pelvic Organ Prolapse - Quantification (POP-Q), women with urinary tract infection, women with pelvic pain Performing therapies offered or having undergone pelvic surgery within a period of less than six months; With a pacemaker or contraceptive device (IUD); Women with intrapelvic tumor.
Data Collection Study From Donors and Recipients to Optimize Donor-recipient Matching in Liver Transplantation

A major limitation of liver transplantation is organ shortage. To avoid exposing patients to death on the waiting list, organs are used that would have been discarded few years ago. Graft allocation is regulated by the "agence de biomedecine" which establishes a national score. Each liver graft is proposed to the patient presenting the higher score. Acceptance or rejection of the graft only depends on the decision of each centre. We propose to submit a more efficient allocation model (enabling each proposed liver graft to be transplanted in the candidate whose transplantation will afford the greatest survival benefit after registration), by collecting and analysing variables from donors and candidates/recipients.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplant candidates : All adult LT candidates listed on the French wait list between 2009 and 2014 and followed prospectively by the mean yearly follow-up under the control of ABM.
* Donors : all adults donors registered over the same 2009-2014 period, including donors whose livers were procured and transplanted, whose liver were procured and discarded, and donors in whom liver was not harvested.

Exclusion Criteria:

* Pediatric recipients
* Pediatric donors
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection

This randomized controlled trial evaluates the efficacy of couples HIV testing and counseling retesting. Eligible couples previously enrolled in NCT05000866 are invited to participate. Those who do are randomized to either couples HIV testing and counseling (CHTC) retesting or an individual HIV testing control. Follow-ups occur 3 and 6 months post intervention.

The purpose of this study is to evaluate the benefits associated with couples HIV testing and counseling (CHTC) resting. After their 12-month follow-up, those participants who remain in the same relationship they were in at the time of their baseline will be offered the opportunity to continue in the components proposed in this revision. Those who consent will be randomized to either complete a second session of CHTC or to a comparison condition in which both partners receive a routine individual HIV test. HIV positive partners in serodiscordant couples randomized to the control condition will receive information about anti-retroviral treatment adherence and U=U (undetectable = untransmissible). Given potential attrition and rates of relationship dissolution, we anticipate randomizing 200 couples (80% of the original sample). Follow-up assessments will be conducted 3 and 6 months after retesting (15 and 18 months after the participants' original baseline appointment).

Eligibility Criteria:
Inclusion:

1. enrolled previously in the parent study DA050508 (NCT05000866).
2. in a relationship with the same main partner with whom they completed the baseline intervention session.
3. both partners in the couple must consent to continue with activities specified in this revision.
4. completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.

Exclusion: any of the following at the 12-month follow-up:

1. serious psychiatric symptoms;
2. current suicidal/homicidal ideation;
3. gross cognitive impairment
4. a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.
Vitamin and Asthma Study

The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma (under control)otherwise in good general health

Exclusion Criteria:

* Poorly controlled asthma
* Taking daily multivitamin or vitamin D supplementation
* Taking oral steroid medication
* History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders
Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of dry eye defined by protocol
* 18 years or older, and sign written informed consent
* negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion Criteria:

* use of any topical ocular medications
* any ocular surgery within 90 days of study
* laser refractive surgery within one year of study
* ocular, lid disease/abnormalities that may interfere with the study
* corneal transplants
* uncontrolled systemic conditions
* females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* participated in another drug trial within 30 days prior to study
Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma

comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma

Evaluation of the safety of MP-TSCPC , CW-TSCPC and endoscopic cyclophotocoagulation when combined with phacoemulsification in cases with CACG Comparing the efficacy of the combined procedures in control of the IOP and the success rate versus lens extraction combined with synechiolysis

Eligibility Criteria:
Inclusion Criteria:

* Patients between 20 to 70 years

chronic angle closure glaucoma

Exclusion Criteria:

* Patients in acute attack of angle closure.
* Patients with previous filtering surgery or cycloablative procedure
Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19

Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.

Achieved serum samples of the different testing groups are retrieved and tested with the immunoassays according to manufacturer's instruction.

The test results are then compared and analyzed with statistical tests to assess the immunoassays'performance

Eligibility Criteria:
Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19 infection

Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2 PCR

Exclusion Criteria:

-