cyrilzakka/clinical-trials huggingface dataset:
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy

Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.

Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.

Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.

Clinical results will be analyzed after completion of 12 months of followup.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 y
* No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
* Maximal tolerable angina and heart failure medication
* NYHA functional classification (I-III)
* Signed informed consent

Exclusion Criteria:

* Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
* Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
* History with malignant disease within 5 y of inclusion or suspected malignity
* Severe heart failure (NYHA functional classification IV)
* Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
* Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
* Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
* Patients with reduced immune response or treated with immunosuppressive medication
* Combined with severe infectious diseases
* Pregnant or fertile women
* Socially and mentally disabilities
Selenium Supplementation of Patients With Cirrhosis

This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.

Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet.

We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.

Eligibility Criteria:
Inclusion Criteria:

* adults with cirrhosis

Exclusion Criteria:

* Pregnancy or planning a pregnancy
* Selenium supplements of 25 µg or more within the past year
Efficacy of Multi-disciplinary Integrated Post-acute Care in Patients Admission for Heart Failure

Background: Clinical heart failure patients always suffering from (1) worsen symptoms such as decreased activity tolerance, end-to-end breathing and excessive body fluid volume; (2) high medical expenses results from hospitalization; (3) reduced quality of life . In 2018, following instruction from National Health Insurance Administration (NHIA), the National Taiwan University Hospital (NTUH) undertook National Health Insurance post-acute care program, PAC in charge of heart failure patients by multi-disciplinary integrated to reduce acute exacerbations(AE), control symptoms, improve quality of life and increase survival rate.

Objective: To evaluate the outcome of patients with heart failure who been taken are of multi-disciplinary integrated instructed by National Health Insurance Administration (NHIA)

Methods: Use retrospective case contrl study. Adopted the hospitalized patients diagnosed with heart failure in the NTUH as the research sample, and collected the retrospective data for analysis in a two-group study design. (1) The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge. (2)The control group received traditional health education in general care and routine health care.

Time of review: From February 2, 2018, the implementation of the National Health Insurance Agency's acute post-care plan day to December 31, 2019, and continuous tracking of effectiveness for one year.

Exclusion conditions: (1) Age over20 years, (2) long-term dialysis, (3) unconsciousness, (4) complete bed rest without self-care ability, (5) those with ventilator dependence, (6) ventricular assist device (VAD) has been implanted, (7) heart transplants , (8) refused to join the research.

The monitoring indicators: Hospitalization rate within 180 days, mortality rate within one year , functional recovery, left ventricle ejection fraction (LVEF), NT-pro BNP, etc.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Heart Failure

* The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge.
Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy.

This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* full term (≥37 weeks) gestations determined by routine obstetrical guidelines
* singleton gestation in cephalic presentation
* Both nulliparous and multiparous women
* Intact membranes
* Bishop score of ≤6 and cervical dilation ≤2cm

Exclusion Criteria:

* Any contraindication to a vaginal delivery or to misoprostol
* fetal demise
* Multifetal gestation
* major fetal anomaly
* prior uterine surgery, previous cesarean section
* women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage
* Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction \<10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction \<5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient

This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients


Eligibility Criteria:
Inclusion Criteria:

* Adult emmetropic patient
* Without complete posterior vitreus detachment in both eyes before having surgery.

Exclusion Criteria:

* Diabetic retinopathy
* Ophthalmological treatment in progress
* History of ophthalmological surgery
Late LTP-like Plasticity Effects of tDCS in Chronic Stroke Patients

Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols- in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. However, it is unknown how the motor cortex excitability changes that follow tDCS relate to the increase in motor learning and recovery potential. The currently upheld hypothesis is that motor learning needs to be synchronized in time with electrical stimulation (paired stimulation), but recent results from our lab suggest that tDCS also increases skill learning after stimulation has ended (unpaired stimulation). If this is true, tDCS has a much larger therapeutic window and is a more valuable clinical tool than currently believed. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects the increase in skill learning normally seen with tDCS when applied 24 hours before training. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.

Objective: Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients on skill learning 24 hours later.

Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic stroke patients. Main study parameters/endpoints: The main objective of the study is to determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a motor learning paradigm, the investigators will use a circuit tracking task which chronic stroke patients perform better if tDCS is applied concurrently. During this task, patients have to trace a cursor over a circuit as fast and accurately as possible by moving a computer mouse. Skill will be quantified by calculating a combined speed/ accuracy score and skill improvement compared to baseline (LI; the learning index) will be compared between the sham, conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like plasticity tDCS groups.


Eligibility Criteria:
Inclusion Criteria:

* Chronic (\> 6 months) stroke patient
* Aged 18-79 years
* Motor deficit in the upper limb due to the stroke

Exclusion Criteria:

* Absence of recordable MEPs from the ADM after TMS
* Absence of voluntary movement (Fugl-Meyer \< III)
* Head injury or the presence of intracranial metal or intracranial lesions
* History of cranial irradiation
* History of epilepsy
* Presence of a pacemaker
* Taking anticonvulsant or neuroleptic medication
* Substance abuse
* Inability to understand instructions
* History of psychiatric disorders
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (non-hysterectomized or hysterectomized)
* Women between 40 and 75 years of age
* Willing to participate in the study and sign an informed consent
* Women who have self-identified symptom(s) of vaginal atrophy
* For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Hypertension equal to or above 140/90 mm Hg
* The administration of any investigational drug within 30 days of screening visit
* Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening
Pulsed Dye Laser Treatment of Recent Surgical Scars

Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.

Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
* Age at least 18 years old.
* Patient able and willing to give written informed consent

Exclusion Criteria:

* Patients with planned surgical intervention on hands, feet and genital area
* Patients with a history of photodermatoses
* Patients with a history of keloids
* Patients with a history of adverse outcomes related to PDL
Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.

A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to provide written acknowledgement of giving informed consent
* Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
* Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2

Exclusion Criteria:

* IOP \>34 mmHg
* Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
* Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
* Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
* Use of other ophthalmic concomitant medications during the study
* Uncontrolled hypertension or hypotension
* Significant systemic or psychiatric disease
* Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
* Pregnant or lactating
Impact in Older Adults of Reducing Anticholinergic and Sedative Rx Burden on Physical Function Measured by Wearables

Medications with sedative or anticholinergic effects such as antidepressants, benzodiazepines, or opioids have been associated with impaired cognitive and physical function. They are referred to as potentially inappropriate medications or medications that are best avoided by older adults. The accumulated evidence has now shifted the clinical and research focus to evaluating the who, what, and how of the best way to deprescribe (i.e., dose reduction or cessation of these medications). The Drug Burden Index (DBI) allows researchers and clinicians to quantify the cumulative burden of anticholinergic and sedative medications in each patient. Deprescribing these medications is a complex health intervention based on trade-offs between their clinical benefits (e.g., symptom management and prevention of diseases) and their adverse drug events to improve physical and cognitive function. Existing physical function performance metrics, such as gait speed captured in the clinic, are often non-specific and do not reflect real-life performance. Innovative mobility metrics are required to better understand specific deficits with age and disease and the effects of medications on these deficits.

The goal of this project is to better characterize the impact of reducing the anticholinergic and sedative medication burden on physical function in older adults by novel mobility metrics in lab and real-life environments.

A prospective, longitudinal cohort of 182 community-dwelling older adults (≥ 65 years) with a DBI of ≥ 1 will be completed. Using a quasi-experimental design, recruited patients will undergo a medication deprescribing plan, as part of usual clinical care, that includes three gradual changes to their medication regimen resulting in three DBI levels. At each DBI level, physical function mobility including dual-task tests) will be assessed in the lab with wearable sensors during validated clinical tests such as the Short Physical Performance Battery. Objective balance and mobility metrics (e.g., sway area and frequency, stride length) will be extracted. Physical function will also be assessed continuously in the patient's real-life environment from recruitment to the last lab visit, using wearable (Apple Watch® with ankle inertial measurement unit) and environmental sensors. Cognition will be measured using the Montreal Cognitive Assessment, Trail Making Test Part A \& B, and Digit Symbol Substitution Test.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* community-dwelling
* Drug Burden Index score of ≥ 1
* Agree with a deprescribing plan targeting a reduction in Drug Burden Index score of ≥ 0.5.

Exclusion Criteria:

* Dementia
* Need of a walker as a mobility assistive device
* Unstable medical condition (≥ 1 unplanned hospitalization or ≥ 2 emergency department visits in the past month).
Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years

The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

Sporting activity has proven health benefits, particularly for older adults, whose balance and neuromuscular functions decline with age.

On the other hand, physical activity in the elderly population may be hampered by inadequate physical condition, muscle or proprioceptive deficits, or fear of falling or injuring. A proprioceptive knee brace could therefore make physical activity safer and thus improve performance, balance, and ultimately the quality of life of the participants.

The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

Eligibility Criteria:
Inclusion Criteria:

* Subject practicing recreational soccer
* Subject included in the LIBM (inter-university laboratory of motor biology) study: "Effect of recreational soccer practice in persons aged 60 to 80 years"
* Patient whose knee measurements are compatible with the knee brace sizes
* Patient who has signed a free and informed consent form
* Patient affiliated or entitled to a social security plan

Exclusion Criteria:

* Patients with any of the contraindications to the use of the knee brace, as indicated in the instructions for use
* Patient with a major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the conformity of a device impacting the judgment criteria
* Vulnerable patient according to article L1121-6 of the public health code, person subject to a legal protection measure or unable to consent freely
FAPI in Rectal Cancer TNT

The goal of the trial is to observe the changes of 68Ga FAPI signal before and after total neoadjuvant therapy for rectal cancers, and the correlation between the image parameters, immune checkpoints expression as well as the patient outcome. The trial will recruit patients with biopsy-confirmed rectal cancer aged 18 years old or older, with WHO/ECOG Performance Status 0-1, and eligible for total neoadjuvant therapy at the clinicians' discretion. After signing the informed consent, the participants will undergo a standard staging work-up if not already done, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. Kidney function (by serum creatinine) and liver function (by serum alanine aminotransferase) will also be assessed. Only patients with stage II-III rectal cancer will be recruited.

If patients meet the inclusion and exclusion criteria, they will undergo the first 68Ga-FAPI PET within 30 days before the beginning of total neoadjuvant therapy. At 22-24 weeks into the TNT, follow-ups for response evaluation will be conducted, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. The second 68Ga-FAPI PET will be performed within one month of these exams. Afterward, participants will either undergo surgery or have image follow-ups every 3 months. The participants will be followed up for up to 2 years after the second 68Ga-FAPI PET, and immunochemical staining with CD47, CD73, PD-L1, and FAP on the biopsy or surgical specimens will be performed in one batch to avoid batch-to-batch variation.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven newly detected adenocarcinoma of the rectum
2. Clinical stage II-III rectal cancer
3. Aged at least 18 years. No upper age limit.
4. WHO/ECOG Performance Status 0-1
5. Eligible for total neoadjuvant therapy

Exclusion Criteria:

1. Distant metastases found on either CT, MR or FDG-PET
2. Prior anticancer therapy for colorectal cancer
3. Prior radiotherapy of the pelvic region
4. Other concurrent antineoplastic therapy
5. Major surgery within the last 4 weeks prior to inclusion
6. Subjects pregnant or breast feeding
7. Serious concurrent diseases not compatible with study entry, including active, uncontrolled infections, active, disseminated coagulation disorder, clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia within 6 months before enrolment)
8. Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression
9. Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1)
10. Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline
11. Those deemed unsuitable for participation in the trial by the investigators.