cyrilzakka/clinical-trials huggingface dataset:
Effect of Cervical Traction on Balance in Cervical Radiculopathy

A randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy.

Authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. Three different loads of traction are compared Main outcome measures are balance parameters (clinical and stabilometric). Patients are followed for during six months.

A randomized clinical trial was designed to assess the effect of cervical intermittent traction on balance parameters among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of three groups (A, B and C). Patients are treated with 2 Kg load intermittent cervical traction (A), 8 kg (B) and 12 kg (C). Patients in the three groups are treated additionnally with 12 rehabilitation sessions. Patients are assessed at baseline, at the end of the treatment (1 month), and at 3 and 6 months. Outcomes are mainly clinical balance assessment and stabilometry, and secondary, epidemiological parameters, pain intensity (VAS), cervical spine ROM and proprioception, grip strength, cervical spinal muscle strength, functional status (NDI), the psychological distress (HAD), and Quality of life All parameters are assessed at the Three follow-up points.

Eligibility Criteria:
Inclusion Criteria:

* CR evolving for at least 3 months Well tolerated manual cervical traction test.

Exclusion Criteria:

* Rehabilitation or chiropractic treatment for head or neck pain within the previous 3 months.
* neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance.
* Surgery or traumatic damage to the cervical spine.
* Ear, Nose and Throat pathology and ophthalmological disorders causing a balance disorder.
* Diabetes at the stage of neurovegetative complications
* Cardiac arrhythmia
* Neurological impairments (balance disorders, motor and/or sensory deficits).
* Severe osteoporosis or long-term treatment with corticosteroids .
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice

This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

The purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery devices for severe, symptomatic calcific aortic stenosis. In addition, the information collected will serve post market safety and surveillance regulatory obligations.

Consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from severe, symptomatic, calcific aortic stenosis
* STS Score ≥ 8
* Logistic EuroSCORE ≥15

Exclusion Criteria:

* Congenital unicuspid or congenital bicuspid aortic valve
* Evidence of intracardiac mass, thrombus or vegetation
* Active infection or endocarditis
Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Chronic coronary artery disease
* NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
* Ejection fraction between 35% and 55%.
* Stable medical therapy for at least one month
* Patients clinically treated with coronary angioplasty with or without intraluminal stent.
* Patients with surgical revascularization and without the possibility of new invasive intervention.

Exclusion Criteria:

* Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
* An active uncontrolled infection.
* Pregnancy.
* Mental disability.
* Terminal illnesses.
* Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
* Life perspective by other diseases under 1 year.
* History of severe arrhythmias
* Renal dysfunction or against medication
* Inability to perform cardiac catheterization.
The Efficacy Comparing Daily and After-each-case Room Disinfection.

The aim of our study was to evaluate the difference of effectiveness between daily and after-each-case room disinfection in the endoscopy unit during the COVID-19 pandemic.

This study divided into 2 groups: daily room disinfection and after-each-case room disinfection. Each group was also subdivided into general anesthesia or non-general anesthesia gastroscopy, and with or without ventilation consultation room.

Samples collection include: operation unit air (six-stage sieve percussion air sampler for sampling, airflow rate 28.3L/min, sampling time 4 min); workstation's mouse (wiping sterile cotton for sampling); endoscopist's gown, control panel buttons, and patient's bed headboard (contact plate for sampling).

Eligibility Criteria:
Inclusion Criteria:

* All the cases received gastroscopy.

Exclusion Criteria:

* High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.
BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas

In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .


Eligibility Criteria:
Inclusion Criteria:

* Subject who will have thyroid surgery

Exclusion Criteria:

* Subject who underwent thyroid surgery
* Subject who underwent any radiotherapy on neck
* Subject who need to neck dissection
* Subject under 18 years or over 70 years
* Bad general condition
* High American Society of Anesthesiologists(ASA) score (over 3)
* Breast feeder or pregnancy
* Subject who disagree to do this trial
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease

In this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.

Patients with chronic kidney disease (CKD) are exquisitely salt-sensitive. Salt-sensitivity in CKD is linked to hypertension and cardiovascular outcomes. Dietary salt restriction is an accepted intervention for salt-sensitivity in CKD. Another strategy, however, could be to block sodium uptake by the kidney pharmacologically by diuretics. Especially diuretics acting on the distal tubule may be effective, because this appears to be the site of increased sodium reabsorption in CKD. It is currently unknown how these two strategies, diet or diuretics, relate. The investigators hypothesize that diuretics are non-inferior to diet.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* CKD stage 3 or 4 (MDRD-GFR 15-60 ml/min)
* Use of any anti-hypertensive drugs
* No anti-hypertensive drugs but an average office systolic blood pressure \> 140 mmHg (as measured by datascope)

Exclusion Criteria:

* Salt-wasting CKD
* Nephrotic syndrome
* Pregnant or breastfeeding women
* Life expectancy \< 6 months
* Severe heart failure (NYHA III or IV) or liver cirrhosis with ascites and the inability to withdraw diuretics
* Rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months
* Kidney transplant recipients
* Use of immunosuppressive drugs
* Use of non-steroidal anti-inflammatory drugs
* Previous intolerance or allergy to hydrochlorothiazide or amiloride
* Serum sodium \< 135 mmol/l
* Serum potassium \< 3.5 mmol/l or \> 5.0 mmol/l
* Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).

IPX056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old.
* Agrees to use a medically acceptable method of contraception throughout the study
* Diagnosed with MS as defined by Poser or McDonald Criteria.
* Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit that has resulted in improved spasticity.
* Willing to wash out and remain off other antispasticity medications during the study.

Exclusion Criteria:

* If female, the subject is pregnant, planning to become pregnant, or breastfeeding.
* History of allergy or severe intolerance to baclofen.
* Did not respond to previous baclofen treatment in any formulation.
* Has experienced an exacerbation of MS within 1 month.
* Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months prior to the study.
* Subjects with clinically significant impairment of renal function
* History of active seizure disorder or epilepsy, or currently taking an anticonvulsant for treatment or control of seizure.
* Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's Disease).
* Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol or therapeutic alcohol nerve block within 12 months or planned use of these drugs during this study.
* Has clinically significant limitation of passive range of motion of lower extremities.
* Has had major surgery within 6 months prior to Screening Visit that may affect spasticity assessments such as abdominal surgery, back surgery, lower leg and knee surgeries.
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release

The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60 years
* Scheduled to undergo open carpal tunnel release (OCTR) by a study group member
* Gives informed consent
* diagnosis of chronic carpal tunnel syndrome

Exclusion Criteria:

* -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease)
* History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease)
* Chronic skin condition in the affected upper limb (e.g. psoriasis)
* Pregnancy
* Inability to comprehend the consent form (in Finnish) or inability to give consent
* Previous surgery or scar in the palmar aspect of the affected wrist
* Recurrent carpal tunnel syndrome
* Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome
Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test.

An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals.

Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria:

* any other subject
* pregnant women
* protected adult
Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders

Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Therefore, there is need for combined treatment (integrated therapy) of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until today, there are no systematic outpatient treatment offers for this special group of patients in Germany. In this study we want to investigate if integrated outpatient cognitive behavioral therapy can prevent and decrease alcohol relapse within the first three months after detoxification. Therefore we hypothesize that immediate start of integrated outpatient psychotherapy will reduce relapse variables compared to treatment as usual which is characterized by non-immediate start of therapy due to the required application for insurance coverage.


Eligibility Criteria:
Inclusion Criteria:

* alcohol dependence
* comorbid anxiety or mood disorder

Exclusion Criteria:

* severe mental illness: psychosis, mania, personality disorders
* current suicidality
* non-compliance with appointments during first 5 sessions
The PEACE (Posthumous Evaluation of Advanced Cancer Environment) Study

Historically, cancer research has been limited by sample acquisition in late stage disease, often restricted to single sites of disease with limited parallel clinical data collection in terms of prior therapy exposure. The PEACE study is intended to facilitate tissue donation from multiple tumour sites in the post-mortem setting and enable future research using samples collected at post-mortem within different disciplines related to cancer research.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Confirmed diagnosis of any form of solid malignancy with metastatic disease (where the site of origin is known or unknown), with the exception of primary brain tumour in which there may not be evidence of metastatic disease
* Oral and written informed consent from patient to enter the study and to undergo tumour harvesting after death or informed consent from a person in a qualifying relationship after the patient has died.

Exclusion Criteria:

* Medical or psychiatric condition that would preclude informed consent
* History of intravenous drug abuse within the last 5 years
* History of known high-risk infections (e.g. HIV/AIDS-positive, hepatitis B/C, tuberculosis and Creutzfeldt-Jacob disease).
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk

The purpose of this research study is to determine whether a positive psychology intervention paired with a health behavior intervention is successful in decreasing perceived stress and increasing positive affect in residents of Vance and Granville County. Participants will attend 4 classes that occur once a week. The first class will focus on nutrition, the second class will focus on exercise, the 3rd class will focus on tobacco use, and the 4th class that will review the previous 3 classes and help participants incorporate the strategies taught in the Destress for Health Program into their everyday lives. The duration of each class is 1 hour and the classes will be held once a week for a total of 4 weeks. Participants in this research study will be asked to complete 2 surveys. The first survey will occur during class 1, and will ask participants about their demographic information, health behaviors, stress levels, emotions, and behaviors. The second survey will be conducted over the phone and will occur 30-days after the final class and will ask participants about their health behaviors, stress levels, emotions, behaviors and also about whether or not they felt the classes they attended were useful to them. Total study duration is about 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Live in Granville or Vance Counties;
* \>18 years old;
* Interested in participating a stress reduction study
* Speak English

Exclusion Criteria:

* Does Not Live in Granville or Vance Counties
* Under 18 years of age
* Not interested in participating in a stress reduction study
* Does not speak English
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
* Satisfy office msSBP ≥140 mmHg and \<180 mmHg at baseline.

Exclusion Criteria:

* Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
* History of angioedema, drug-related or otherwise, as reported by the patient.
* Any other following renal disorder:
* Patients show eGFR \< 15mL/min/1.73m\^2
* Patients on dialysis
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol-defined inclusion/exclusion criteria may apply.
Exercise Testing in Peripheral Artery Disease Patients

The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

This is a non interventional prospective cross sectional, monocentric study. All patients addressed in our vascular unit for exercise testing were included. All patients' data performed in clinical routine can be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* All patients addressed in our vascular unit for exercise limitation

Exclusion Criteria:

* Incapacity to walk on the treadmill.
* A severe cardiopathy contraindicating a stress test
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

* Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
* Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parameters. Concentrations below the lower limit of quantification, samplings which are not applicable, or missing data will be substituted by "\<LLOQ", "NA", or "MD" respectively. Pharmacokinetic analyses will be performed on CG100649 only.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
2. No significant chronic/congenital disease
3. Normal results for lab test
4. Ability of informed consent

Exclusion Criteria:

1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
3. History of known hypersensitivity to drugs including CG100649.
4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.

Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions. While these disorders are rare, they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies. Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. Newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population.

This study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. Two additional visits with blood sampling will occur. The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between ages of 5 and less than 17 years.
* Patients meeting DSM-IV criteria for PDD-NOS about to initiate clinical treatment or currently clinically treated with risperidone.
* Patients with autistic disorder or PDD-NOS currently on risperidone as a participant in one of the multi-site RUPP protocols.

Exclusion Criteria:

* Children taking psychotropic or other medication that will interact with target CYP 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. CYP2D6 or CYP3A4; to be decided by the PI)
* Patients with known renal or hepatic dysfunction (e.g. serum creatinine \> 1.5 normal upper limit, transaminases or bilirubin \> 2 times normal upper limit)
* Failure of the parent/legal guardian to give informed consent.