cyrilzakka/clinical-trials huggingface dataset:
Neural Mechanisms of the Contextual Interference Effect: A fNIRs and EEG Study

The overall goal of this study is to gain insight into the neural mechanisms of learning multiple tasks. By examination of cognitive and behavioral output during the performance and learning of several computer maze tasks, and through a detailed examination of the neural activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it may be possible to gain insight into the impact of the amount of practice and the organization of practice has on learning fine motor skills. This insight may provide direction as to how to better develop instructional and rehabilitation protocols in addition to clinical interventions to facilitate recovery of function, relearning and transfer of cognitive and fine motor skills based upon neural responses to physical practice.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years of age
* vision correctable to 20/20
* right-handed
* English is first language or learned English before age of 5 years

Exclusion Criteria:

* 17 years or younger and 56 years or older
* pregnant
* have latex or tape adhesives allergies
* self-exclude if:
* had a history of seizures, head injury or neurological dysfunction
* history or diagnosis of depression, schizophrenia or social phobia
* previous admission to alcohol/drug treatment program or diagnosis of alcohol/drug abuse
* take medications know to affect neurological function.
Caffeine & Bodybuilding Dehydration Ability

15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight.

The purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. Methods: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. Record time from exercise to completion of dehydration, heart rate, HRV, energy expenditure, fat oxidation rate and carbohydrate oxidation rate.

Eligibility Criteria:
Inclusion Criteria:

* having won the top 8 places in a national competition,
* having no cardiovascular or joint diseases
* being an adult male

Exclusion Criteria:

* no top 8 finishes at national level
* cardiovascular or joint disease, or any other condition that could be impaired by exercise
* female and underage participants
* previous caffeine allergy
Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.

To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-70 intracerebral hemorrhage patient
* With stroke history of more than 3 months, less than 60 months
* National Institutes of Health stroke scale(NIHSS) score of 7 or more points
* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

* History of neurological disease, head injury or psychiatric disorder;
* Pregnant women;
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
* Progressive apoplexy;
* With malignant tumors.
MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology

* Prospective Atrial Flutter Ablation Registry investigating IntellaTip Mifi XP 8 mm technology and MVG isthmus ablation approach
* Design: National, multi-centre, prospective observational registry documenting right atrial isthmus ablation
* Observational treatment: Combination of MVG ablation strategy and the IntellaTip Mifi XP 8 mm sensor technology
* Duration: Patients will be followed for 6 months post-ablation

The MIFI Flutter Registry is a non-interventional, multi-centre, prospective registry in consecutive patients with atrial flutter and indication for right atrial isthmus ablation. The registry is an observational study and patient's participation in this study has no impact on his/her indication for treatment, diagnostics or therapy. Patients are supposed to be treated according to current guidelines and the site's internal directives.

Treatment pattern and treatment initiation, continuation or changes are solely at the discre-tion of the physician and the patient. There will be no attempt to influence the treatment patterns of any individual treating physician. All drug prescriptions will be in the usual standard of care. Participation in the registry will in no way influence payment or reimbursement for any treatment received by subjects during the study.

A minimum of 10 hospitals in Germany treating atrial flutter and using the Maximum voltage-guided (MVG) ablation technique are eligible for participation. The enrolment period is estimated to be 6 months.

Eligible are all patients with atrial flutter, who will visit consecutively a participating site of the MIFI Flutter Registry. It is planned to enrol approximately 120 patients in total.

The follow-ups of patients will be performed using a standardized patient interview (telephone call) at 6 months by Institut für Herzinfarktforschung (IHF). In case of relevant complications, the treating physician is asked to provide medical records for verification. If the patient is not accessible by phone, local registration offices will be contacted for further information.

Eligibility Criteria:
Inclusion Criteria:

* Atrial flutter and clinical indication for atrial flutter (AFL) ablation
* 18+ years
* Written informed consent for participation in observational study (incl. telephone follow-ups)
* Not simultaneously participating in any randomized trial
* At least one ECG-documented, symptomatic, typical atrial flut-ter episode \>30sec.
* Isthmus ablation conducted in association with other ablation procedures (e.g. for atrial fibrillation) is permitted

Exclusion Criteria:

* Any prior AFL ablation
* Acute reversible causes for atrial flutter (e.g. acute myocarditis)
* Tricuspid valve replacement
* Right atrial thrombus
* Present pregnancy or breastfeeding woman
* Drug or alcohol abuse
oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.

The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).

The main questions it aims to answer are:

length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.

Participants will:

Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years
* Informed consent obtained
* Transverse diameter of ventral hernia \>4cm - 15cm
* Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment

Exclusion Criteria:

* precedent hernia treatment with mesh placement in the retromuscular space
* precedent anterior or posterior component separation or transversus abdominis release (TAR)
* active wound infection
* current cancer diagnosis
* presence of ileostomy, colostomy or ileal conduit
* liver disease defined by the presence of ascites
* end-stage renal disease requiring dialysis
* need of an emergency surgery
* pregnancy

Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.
Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa

Food insecurity can contribute to poor adherence to both tuberculosis treatment and antiretroviral therapy (ART). Interventions that target food insecurity have the potential to improve treatment adherence and decrease mortality. The goals of this study were to determine the cost, feasibility, acceptability, and potential impact of implementing nutritional support to improve adherence and treatment completion among HIV-TB co-infected adults in the Casamance region of Senegal, West Africa.


Eligibility Criteria:
Inclusion Criteria:

* HIV-Tuberculosis co-infection
* Age ≥18 years
* Initiating treatment for tuberculosis
* Provide written informed consent

Exclusion Criteria:

• Unwilling or unable to provide written informed consent
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.


Eligibility Criteria:
Inclusion Criteria:

* Previously or currently prescribed antihypertensive therapy
* Average office BP ≥ 140/90 mmHg \<180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
* Documented daytime ABP ≥ 135/85 mmHg and \< 170/105 mmHg after 4-week washout/run-in period

Exclusion Criteria:

* Lacks appropriate renal artery anatomy for treatment
* Known, uncorrected causes of secondary hypertension other than sleep apnea
* Type I diabetes mellitus or uncontrolled Type II diabetes
* eGFR of \<40
* Brachial circumference ≥ 42 cm
* Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
* Repeat (\>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
* Primary pulmonary hypertension
* Night shift workers
* Pregnant, nursing or planning to become pregnant
Risk of Uncomplicated Peptic Ulcer in the General Population

The analyses are conducted in a previous population-based cohort study using The Health Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses are:

To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the general population To estimate the dose-response and duration-response associated with use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the general population To investigate the management of low dose ASA/oral antiplatelets after UPU

Risk of uncomplicated peptic ulcer in the general population

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 40-84 years in 1997-2005 ( see study population description)

Exclusion Criteria:

- Patients aged below age 40 and 85 years and above ( see study population description)
Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

hyperthyroidism


Eligibility Criteria:
Inclusion Criteria:

* Patients in outpatient department.
* Patients recieved at least 1 ECG examination.
* Patients without TSH test before ECG examination or patients with subclinical hyperthyroidism without anti-thyroid drug usage.

Exclusion Criteria:

* The patients recieved ECG at the period of inactive AI-ECG system.
Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

* Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers

This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.


Eligibility Criteria:
Part A/B/C Inclusion Criteria:

1. Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose \< 100 mg/dL and HbA1c \< 5.7%.
2. Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

Part A/B/C Exclusion Criteria:

1. Pregnant, lactating or intending to become pregnant during the study.
2. Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
3. Presence of clinically significant ECG findings
4. Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
5. Abnormal laboratory results at Screening.
6. History of renal disease or abnormal kidney function tests at Screening
7. Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Type 1 or 2 diabetes mellitus
* Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
* BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
* HbA1c of ≤12%.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Presence of center-involved DME in the Study Eye
* Prior PRP in the Study Eye.
* Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
* Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
* Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
* Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study
* Active or suspected ocular or periocular infection or inflammation.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
* Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
* Other protocol-specified exclusion criteria may apply.
Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics

Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta). Recent animal studies have shown that extended wakefulness is associated with increased production of these Abeta proteins and that sleep leads to a marked fall in their production.

Aim: The investigators aim to distinguish a similar effect of sleep disturbance on cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an important factor in AD development.

Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep deprivation night and before and after a control night with unrestricted sleep.

Expected results: The investigators expect sleep deprivation to lead to an increase in CSF Abeta levels, as compared to the levels in the control night.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 40-60 years
* Male
* Subject is in good health as established by medical history, physical examination, ECG and laboratory examination
* Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator
* Normal sleep behaviour, Pittsburg Sleep Quality index score ≤5
* MMSE 28 or higher
* Medication free

Exclusion Criteria:

* Presence of blood coagulopathy, established by medical history
* Allergy to local anesthetic agents
* Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
* Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history
* Subjects with a history of drug or alcohol abuse
* Subjects who are part of the study staff personnel or family members of the study staff personnel
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.

The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed for more than 3 months
* HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
* Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)

Exclusion Criteria：

* History or family history of drug allergy
* Subjects treated with any other anti-diabetes drug within 8 weeks before screening
* Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
* Smoker or alcohol abuse
* Currently use or plan to use systemic corticosteroid
* History of recurrent severe hypoglycemia
* Type 1 diabetes or secondary diabetes mellitus
* Uncontrolled active or untreated hypertension
* History of pancreatitis (acute or chronic)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Serious unconscious hypoglycemia history
* Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control
* Subject was not used for the study as determined by the Investigator