cyrilzakka/clinical-trials huggingface dataset:
Effects of Limb Ischemic Postconditioning in Young sICAS

The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians.

Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.

Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 45 Years old;
2. Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery;
3. National Institutes of Health Stroke Scale(NIHSS) score 0-15
4. Written informed consent was signed.

Exclusion Criteria:

1. Cerebral hemorrhage and other parts of the active bleeding disease;
2. Severe aphasia, unable to express himself;
3. A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
5. Blood Pressure\< 90 mmHg/60 mmHg or \>200 mmHg/110 mmHg after treatment;
6. Dementia and mental illness;
7. Using angiotensin-converting enzyme inhibitors;
8. A history of major surgery or trauma 4 weeks prior to admission;
9. Without informed consent.

Elimination Criteria：

1. Patients with poor compliance，refuse to take regular treatment and examination;
2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.
Robotic Pedaling Therapy for Targeted Neural Plasticity

The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling therapy can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients, half will be randomly assigned to the robotically-targeted training ("robotic") group and will receive training on the targeted training task. The other half of the patients will perform a duration-matched aerobic pedaling exercise ("control" group). All stroke patients will be scanned before and after their training program while performing or imagining simple motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to 5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate motor learning and brain activity in a novel motor control task. Additional healthy pilot subjects (up to 60) will test training protocols and assessments during preparatory design phases of the project.


Eligibility Criteria:
Patients:

Inclusion criteria:

* Subjects will be stroke patients with persistent moderate unilateral lower extremity deficits, age 50-85 years at time of enrollment.
* Time since stroke will be greater than 6 months ("chronic" stroke survivors).
* Persistent moderate unilateral lower-limb impairment (defined as NIH Stroke Scale - Motor Leg section score of 1-2, to be discussed with the patient verbally during phone screening and assessed by the investigator during the initial enrollment visit).
* Fluent in spoken and written English

Exclusion criteria:

* Allergy to electrode gel, surgical tape and metals.
* Subjects under treatment for infectious diseases will be excluded from the study.
* Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
* Contraindications for MRI
* Age over 85 years at time of enrollment.

Healthy Controls:

Inclusion criteria:

* Ages 18-85 years
* Non-Stroke Group 1 ("Matched Controls"): 50-85 years old at time of enrollment, to match the population of stroke patients to be studied
* Non-Stroke Group 2 ("Pilot Controls"): 18-50 years old at time of enrollment (Pilot subjects to be initially enrolled early in the design phase of the study, and with enrollment ongoing throughout the study to continue development.)
* No known neurologic, psychiatric or developmental disability.
* Fluent in spoken and written English

Exclusion criteria:

* Allergy to electrode gel, surgical tape, and metals.
* Subjects under treatment for infectious diseases will be excluded from the study.
* Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
* Contraindications for MRI
* Age over 85 years at time of enrollment.
Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination

A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.

Eligibility Criteria:
Inclusion Criteria:

* LDL-cholesterolemia between 130 and 190 mg/dL

Exclusion Criteria:

* Type 2 diabetes
* Previous cardiovascular disease
* Assumption of lipid-lowering drugs or dietary supplements
* Previous intolerance to red yeast rice
"Patient Reported Outcome After Dislocation of a Primary THA"

The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation.

Knowledge about the patient's own perception of both general health and more hip-related issues after experiencing a hip dislocation is lacking (19). Hip surgeons need this information in order to incorporate it with other objective aspects, when advising patients with their first hip dislocation. Due to the large study population, this study will provide solid information of what to expect after a hip dislocation and be the largest study ever conducted within this topic. Depending on the results, this study may change the path we choose to advise for our patients after single or recurrent dislocations.

A matched case-control study involving the share of THA patients with at least 1 episode of hip dislocation.

The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Given a 3-5% approximated incidence of dislocation, 1100-1800 cases will have been identified.

Patients are subdivided in groups depending on the number of dislocations and one group containing THA revisions. In order to be included, a time frame of at least 0,5 year since the last episode of dislocation or surgery must have passed.

A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to:

1. Age (+/- 5 years)
2. Gender
3. Date of surgery and hospital

The study will be conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

After 01.01.2019, all patients included will be receiving 3 questionnaires (a generic - EQ-5D, a hip-specific - HOOS, and an activity scale - UCLA) by e-boks (a mandatory secure email system couplet to the patient's CPR number). Some elderly are exempt and will instead receive the questionnaires by regular mail and a pre-labeled return envelope is attached. Reminders are sent after 2 months.

Eligibility Criteria:
Inclusion Criteria:

* patients with one or more events of hip dislocation after a primary THA
* controls with a primary THA without events of hip dislocation

Exclusion Criteria:

-
Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes

The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes.

Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes.

Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study.

Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet.

The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.


Eligibility Criteria:
Inclusion Criteria:

* To have had type 1 diabetes for at least 1 year
* Age \>=20 years old

Exclusion Criteria:

* Cardiovascular disease NYHA class IIIB or more
* Kidney disease \> stadium 3
* Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
* BMI \< 18.5 kg/m\^2
* c-peptide ≥ 0.3 nmol/l
* Pregnant/breastfeeding women, women that plan to get pregnant during study period
* Other circumstances, which, according to the examiner, make it difficult for an individual to participate.
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.

Eligibility Criteria:
Inclusion Criteria (Screening):

* Male and female participants 18 to 55 years of age, inclusive, at the time of informed consent.
* Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) v 1.2.
* Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and up to the 30 (+ 2)-day follow-up period.

Exclusion Criteria:

* Participants with a history of inadequate response or suboptimal tolerability to atomoxetine.
* Participants who report allergies (lifetime treatment history) to stimulant or nonstimulant ADHD medications.
* Participants with other DSM-5 disorders including psychosis (current or lifetime), bipolar disorder (current or lifetime), current major depressive disorder, or current panic disorder; or another psychiatric diagnosis that the investigator believes is primary or that will confound efficacy or safety assessments of the trail or interfere with participation in the trial otherwise.
* Participants with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, obsessive compulsive, or dependent personality disorders.
* Participants who currently have clinically significant dermatological, neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV (human immunodeficiency virus) seropositive status/acquired immunodeficiency syndrome, or active or chronic hepatitis B or C.
* Participants with a history of obstructive sleep apnea.
Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Patients With Chronic Stroke

The purpose of this study was to investigate the effects of gait training with the new wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung Electronics Co, Ltd, Korea) in patients with chronic stroke.

Seven chronic stroke patients will participate in this study. All subjects will receive training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min (including rest period of 10 min). Brain activity and gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.

Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and cortical activation measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany).

Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Dynamic Gait Index (DGI), Timed Up and Go (TUG) test, Push and Release (P\&R) test, Functional Reach Test (FRT), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

Eligibility Criteria:
Inclusion Criteria:

1. Age: between 20 and 84 years
2. ≥ 3 months post stroke
3. Ability to walk at least 10m regardless of assist devices
4. Adequate gait function (FAC \> 3)
5. Physician approval for patient participation

Exclusion Criteria:

1. Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
2. Advanced liver, kidney, cardiac, or pulmonary disease
3. History of concussion in last 6 months
4. History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
5. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.

Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.

Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.

Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.

To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.

This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.

Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.

Eligibility Criteria:
Inclusion Criteria:

* Is able to give informed consent
* Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer
* Is clinically stable to tolerate the surgical procedure
* Age 18 years or greater
* Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit

Exclusion Criteria:

* Inability or unwillingness to give informed consent
* Current system infection requiring generator explantation or lead extraction
* Generator replacement requiring planned lead extraction
* Participating in another cardiovascular investigational drug or device registry
* A life expectancy of less than six months
* Expected to receive a heart transplant within 6 months
* All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or other sign of Acute Uncomplicated Malaria and, with Microscopic confirmation using Giemsa-stained thick film, and a Parasitemia of \>= 40 to \<= 10,000 Asexual Parasites/Microliter (μL) of Blood.
* Axillary Temperature \< 37.0 degree Celcius (ºC) or oral/Tympanic/rectal Temperature\< 37.5ºC; without history of fever during the previous 48 hours.
* Have a body weight \>= 45 kilogram (kg)
* Participants capable of giving Signed Informed consent which includes Compliance with the requirements and restriction listed in the Informed consent form
* Other Protocol defined Inclusion Criteria could apply

Exclusion Criteria:

* Participants with any disease requiring Chronic Treatment
* Participants with any Preplanned surgery during the study
* Participants with any previous Treatment with pyronaridine as part of a combination therapy during the last 3 months
* Participants with any adequate Hematological, Hepatic, and renal function as defined in the Protocol
* Other protocol defined Exclusion Criteria could apply
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial

The purpose of this study is:

1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.
2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.
3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age between 35-65 years old, male or female;
* Grade 1 essential hypertension;
* Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
* Sign the informed consent;

Exclusion Criteria:

* Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR\<60ml/(min·1. 73m2);
* Gastrointestinal diseases, which may affect drug absorption;
* Be allergic to the clinical trial medicine;
* Pregnant or breastfeeding women, men who plan to give birth within half a year;
* Combined with other serious primary diseases or malignant tumors;
* Hyperlipidemia with or without taking lipid-lowering drugs;
* Combined with left ventricular hypertrophy, ABI \< 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;
* Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes);
* Other serious conditions in which is not fit for the study.