cyrilzakka/clinical-trials huggingface dataset:
Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.

This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

Eligibility Criteria:
Inclusion Criteria:

* unilateral lower extremity paresis
* haemorrhagic or ischemic stroke
* a minimum of six months after the acute infarction/onset of the disease
* full passive range of motion in lower extremity or at least at neutral position
* be able to stand freely
* be able to walk with or without aid for at least 20 meters in less than 2 minutes

Exclusion Criteria:

* peripheral nervous system pathology
* epilepsy
* weight over 100 kg
* no cognitive ability to follow the study instructions
* pregnancy
* use of implanted devices
* instable lower extremity joints or fixed contracture
A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome

This study is to test the feasibility and tolerability of the metoprolol optimal dosing pathway by observing the percentage of patients achieving target dose followed the pathway on ACS patients during hospitalization.

Acute coronary syndrome(ACS) is one of the main manifestations of cardiovascular disease and one of the main causes for hospitalization in adults.

Previous studies showed that β-receptor blockers can reduce ACS patients' cardiovascular risk in both acute phase and secondary prevention. We summarized the metoprolol optimal dosing pathway based on Chinese and foreign guidelines as well as Chinese clinical practice.

Primary endpoint is the percentage of patients achieving target dose at time of discharge.

Secondary endpoints are the mean HR \& BP at discharge and during the follow up period of the Patients who have achieved target dose at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above;
* Hospitalized due to acute coronary syndrome;
* Able and willing to provide written informed consent and to comply with the study.

Exclusion Criteria:

* Cardiac shock;
* Unstable heart failure;
* Beta-agonist therapy on a continuous or intermittent basis;
* Hypotension (BP\<90/60 mmHg) or bradycardia (HR\<50 bpm) with symptoms;
* Sick sinus syndrome;
* Ⅱ\~Ⅲ atrioventricular block;
* Killip \>Ⅱ;
* Suspected acute myocardial infarction with heart rate\<45 beats/min, P- R interval\>0.24 sec or systolic blood pressure \<100 mmHg;
* Existing contraindication for metoprolol or allergic to metoprolol or any excipients;
* Participation in another clinical study with an investigational product during the last 3 months;
* Previous enrolment in the present study;
* Subjects the investigator thinks not suitable for this study. E.g. cancer etc.;
* Inability to sign the informed consent form;
* Pregnancy or lactation.
Treatment of RP and LCA by Primary RPE Transplantation

Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of RP or LCA;
2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
3. Patient understand and sign the consent form.

Exclusion Criteria:

1. Blood routine examination is abnormal (hemoglobin\<10gm/dL; blood platelet count\<100k/mm³; neutrophil count\<1000/mm³)
2. Blood biochemistry is abnormal (ALT／AST\>1.5; creatinine\>1.3mg/dL)
3. Experimental eye has optic nerve atrophy caused by glaucoma
4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
5. Patients with uveitis and other endophthalmitis
6. Patients with other ocular disease affecting vision.
7. Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
8. Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
9. Patients with medical history of myocardial infarction
10. Patient with diabetes
11. Patient with Parkinson disease or Alzheimer's disease
12. Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
13. Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* males, 18 or older
* proven advanced prostate cancer
* documented metastatic disease
* rising PSA levels
* castrate levels of testosterone

Exclusion Criteria:

* symptomatic CNS (brain or spinal cord) metastasis
* medical condition which may increase the risk of toxicity
* any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents
* unable to take oral medication
Alcohol: Thiamine and or Magnesium 1

Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE).

Intravenous (IV) thiamine replacement is standard practice in the treatment of alcoholic patients presenting to the Accident \& Emergency (A\&E) department, however routine co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme transketolase in red blood cells, is not routine practice in the treatment of these patients. Without correction of concomitant magnesium deficiency there may be impaired utilisation of thiamine resulting in a failure to treat WE.

This study is designed to determine if administration of magnesium to AUD patients affects red cell transketolasae and serum lactate concentrations by itself, or only acts to increase the effect of thiamine on the activity of this enzyme.

This is a 3- arm randomised, open label, controlled study in a cohort of alcoholic patients admitted through A\&E. Patients will be randomised to concurrent infusion of one of the following:

* Arm 1: IV thiamine
* Arm 2: IV magnesium sulphate followed by delayed IV thiamine
* Arm 3: IV thiamine and IV magnesium sulphate Thiamine will be administered as IV Pabrinex, a compound preparation which also contains B vitamins and vitamin C. Administration of IV Pabrinex is standard care in this patient group and magnesium sulphate is routinely co-administered at Glasgow Royal Infirmary.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or non-pregnant or breastfeeding females ≥18 years of age For women of child-bearing potential a negative pregnancy test will be required prior to treatment.

(Women of non-childbearing potential are defined as those defined as women who are post-menopausal or permanently sterilised (e.g. hysterectomy, tubal occlusion, bilateral salpingectomy).

• Chronic alcohol dependence as confirmed by

* FAST questionnaire
* GMAWS scale

Exclusion Criteria:

* Unable to give consent
* Less than 18 years of age
* Chronic renal or hepatic failure/hepatic encephalopathy (investigator assessment as documented in past medical history i.e. Clinical Portal.)
* Known hypersensitivity or previous allergy to any of the active substances in either trial medication, or to excipients
* Severe concurrent medical condition that would prevent participation in study procedures (e.g. myasthenia gravis, clinically significant cardiac disease, or cardiac failure with severe pulmonary oedema)
Multimodal Monitoring Study in Neuro Critical Care

During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders.

Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS).

Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.


Eligibility Criteria:
Inclusion Criteria:

* - Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
* Monitored with the CNS MOBERG® monitoring system

Exclusion Criteria:

* - Refusal to participate
* Patients under legal protection
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

1. OBJECTIVES

   Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months

   Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months
2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea


Eligibility Criteria:
Inclusion Criteria:

* Stable angina patient with angiographically confirmed significant residual stenosis
* Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery

Exclusion Criteria:

* No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET
* Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)
Cognitive Determinants of Psychoeducation and Information in Psychoses

The aim of the study is to examine whether the efficacy of psychoeducation in patients with schizophrenia or schizoaffective disorders is dependent on their cognitive performance level and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation

Schizophrenic inpatients are examined shortly after admission with a broad battery of clinical and neurological rating scales and neuropsychological tests. They are then randomized to either standard treatment (including antipsychotic medications, art and occupational therapy, psychotherapy) or to standard treatment plus daily computerbased cognitive training (COGPACK; ten 1-hour sessions over two weeks). After repetition of the broad assessment battery all patients (and some of their family members) take part in a bifocal psychoeducation group program (eight 1-hour sessions over four weeks). Specific pre-post measures are illness knowledge, self and expert ratings of adherence to treatment, insight to the illness, treatment satisfaction. The study also includes a 9-month follow-up, with number of rehospitalizations, days in hospital and psychopathology as the primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* Informed consent
* German as first language or very good knowledge of German

Exclusion Criteria:

* Mental retardation
* Any serious somatic illness
Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women

The goal of this observational case-control study is to find out the impact of PCOS as a risk factor for the presence of urinary tract stones taking into account the BMI of women aged 18-40 years consulting the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital.

The study aims to collect information from approximately 200 women with polycystic ovary syndrome and 200 volunteers who do not have PCOS.

A written consent was obtained from all the participants. The information collected included age, weight, and height. In addition, focused history and clinical examination were conducted for all patients, and for some patients, one or more additional blood tests were obtained. The additional tests included but not limited to serum levels of testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin. Moreover, ultrasonography of the abdomen and pelvis was obtained for all patients as part of the diagnosis of PCOS and as screening for urinary tract stones. Also, transvaginal ultrasonography was obtained for some patients according to the individual condition as requested by the treating gynecologist. The diagnosis ofc PCOS was based on the Rotterdam criteria. (1)

The main questions the study aims to answer are:

* Is PCOS a risk factor for urinary tract stones when taking BMI into account?
* Is PCOS a risk for urinary tract stones at all?
* Is there an association between PCOS and BMI?
* Does BMI affect the presence of urinary tract stones at all and the presence of urinary tract stones when taking PCOS into account?


Eligibility Criteria:
Inclusion Criteria:

* female
* age 18-40 years

Exclusion Criteria:

* A medical or surgical condition that affects urinary tract stone formation.
* A medical or surgical condition that affects body weight or height.
* A medical or surgical condition that affects hormonal balance.
Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

This observational study is a large-scale, prospective, and multi-institutional observational study.

Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).

The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 19 years to 75 years (on registration date)
2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
3. Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

   * Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
   * Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
   * Pregnant and lactating women
   * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
2. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.

Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects (male and female) must be between 18-60 years of age
* Subjects must have Chronic Hepatitis C
* Subjects must be treatment naive
* Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

* Evidence of cirrhosis
* Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
* any other cause of significant liver disease in addition to hepatitis C
* Diagnosis of or suspected hepatocellular carcinoma
Online Cognitive Behavioral Therapy for Bulimia Nervosa

Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment and the gold-standard for treating bulimia nervosa. The current study aims to compare two forms of CBT: face-to-face group therapy and online group therapy via cbt4bn.org.

All treatment is conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or Western Psychiatric Institute (in Pittsburgh) who are experienced in the treatment of eating disorders.

Participants will participate in 16 1.5 hour long group sessions of group CBT over 20 weeks. Groups will include 5-8 participants, one or two co-therapists, and two sessions by a registered dietitian. Participants will be expected to complete self-monitoring forms which assess their mood and behavior. Groups will either take place face-to-face or online in a therapist-moderated chat group.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for BN
* Internet access at home
* Either off psychotropic medication for at least one month or on a stable dose of psychotropic medication

Exclusion Criteria:

* Any major medical condition that would interfere with treatment or require alternative treatment
* Alcohol or drug dependence in the last three months
* Current significant suicidal ideation
* Developmental disability that would impair the ability to use the internet program effectively
* Psychosis, including schizophrenia, or bipolar I disorder
Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

This study is being done to see if the Nova Creatinine Meter can give a correct measure of creatinine (a blood test used to measure kidney function) when the blood is taken from a capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory creatinine testing can take up to an hour. Since chemotherapy patients need to have their creatinine measured prior to treatment, this meter could make testing easier and faster.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Must have a creatinine \> or = to than 3.5 mg/dl

Exclusion Criteria:

* Patients who are less than 18 years of age
Growth Hormone and Heart Failure

Heart failure induces modification in several neurohormonal systems. The aim of this study is to determine if the growth hormone/IGF1 axis is modified in heart failure patients compared to healthy volunteers.

One hundred and sixty three heart failure patients were evaluated by clinical examination, echocardiography, exercise test and measurement of blood BNP. Growth hormone and IGF-1 plasma levels were determined in each patient. The same biological measurements were performed in a group of 148 healthy controls. Comparisons were performed between groups for Growth hormone plasma level, IGF-1 plasma level and Growth hormone/IGF-1 index. A correlation between the severity of heart failure and the different biological parameters was searched.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients in stable condition

Exclusion Criteria:

* cancer
* pituitary disease
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients

The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)


Eligibility Criteria:
History of congestive heart failure