cyrilzakka/clinical-trials huggingface dataset:
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?

Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. LE is mostly the result of the overuse and repetitive movements of wrists and hands because of occupational or recreational activities. Diagnosis depends on clinical symptoms, history and physical examination including manual provocation tests. Magnetic resonance imaging, ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not response to conservative treatments. It is known that the radial nerve cross sectional-areas (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal. There is insufficient evidence to prove the superiority of any of conservative treatments to the others in patients with LE. The literature indicates that Kinesio taping decreases pain intensity, recovers grip strength, and improves functional status in patients with LE. The investigators design a randomized, single-blind, controlled trail to evaluate the effects of Kinesio taping both clinical and using ultrasonography.

After obtaining written informed consent, patients of clinically diagnosed with LE are randomized into intervention and control group. To all patients, activity modification is suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6 sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs. The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* the presence of pain in the lateral elbow region at least for three months
* tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors.

Exclusion Criteria:

* bilateral LE
* presence of trigger point in the extensor muscles of the forearm
* history of proximal upper extremity or neck symptoms
* cervical pathology
* central or peripheral neurologic disease
* nerve entrapment syndromes
* surgical treatments for LE
* presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal disorders, using anticoagulant)
* trauma history of upper extremity
* previous steroid injection around the lateral epicondyle
* physical therapy targeted for LE in the past 6 months
* presence of structures like fibrous bands, arc or recurrent radial artery around the radial nerve that may cause the entrapment of nerve
* pregnancy and having any systemic disease that may cause swelling at nerves such as diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball

Very little is known about the potential for preventing the prevalence of shoulder complaints in handball players, particularly younger players. The aim of this study is to evaluate the effect of a shoulder training program on shoulder pain during a season of team handball.

Six teams, consisting of 13 to 25 players each, were randomized into two groups throughout their competition seasons. Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training. Effects of this strength--training program were evaluated by comparing pre-- and post--training data from a survey on shoulder complaints based on a self--report questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS on pain once a month. In addition to that the players were tested in a maximum push up test, dynamometer test for internal and external rotation strength in the shoulder and throwing distance in the pre- and posttest.

Eligibility Criteria:
Inclusion Criteria:

- team handball players in the top division in the J16 class in the Trøndelag region in Norway

Exclusion Criteria:

- previous shoulder operations og fractures in the shoulder region
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1GrnVsPCockqqdfxC9LWd6ndbzS2wpJVvTbCOAhn4DLM/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1I8FVmpPzC5wQN9DFIv1Rbwh1N0SLEv0B?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability)

Inclusion Criteria:

* 1. Aged \>/= 65 years on the index date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3. At least two claims with breast cancer diagnosis measured 365 days prior to drug initiation

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior history of nursing home admission anytime prior to cohort entry date
* 3. Prior history of Anastrozole or Exemestane/Letrozole use anytime prior to cohort entry date
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.

Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons: 1. AGO provides a unique pharmacological profile by combining antidepressive potency, sleep regulation and enhancement of frontocortical dopaminergic activity by 5-HT-2C-blockade. 2. AGO might exert favourable effects on cognition. 3. While pharmacokinetic interactions are generally possible, major influences on antipsychotic substances are unlikely due to metabolism by cytochrome isoenzymes CYP1A2 and CYP2C9/19. 4. AGO is characterized by a favourable range of adverse events (AE) which do not overlap with typical antipsychotic AEs such as weight gain and sexual dysfunction. Thus, the risk of additive effects seems to be small. The investigators plan to enroll 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine. As predefined primary and secondary endpoints, we are going to investigate whether AGO is able to improve MDE severity, sleep quality, general and psychosocial functioning as well as cognitive function in schizophrenia without detrimental effects on the psychotic syndrome. Moreover, we intend to monitor for pharmacokinetic interactions. The results obtained will allow designing future randomized and controlled clinical trials in order to improve the range of therapeutic options for affective and cognitive deficits in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years.
2. Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
3. Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
4. Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
5. Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
6. The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient's participation.

Exclusion Criteria:

1. Contraindications against AGO treatment
2. Insufficient contraception in women of childbearing potential when sexually active.
3. Gravidity or breastfeeding.
4. Addiction to alcohol
5. Current abuse of THC and other illegal substances according to ICD-10
6. Dementia
Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor

Parkinson´s disease (PD) diagnosis is based upon clinical examination. Although imaging has helped doctors to identify many diseases, it still does not add too much information for the diagnosis of Parkinson´s disease. The investigators are going to perform a large sample study including PD patients, essential tremor and healthy volunteers in order to evaluate if MRI can help in the diagnosis. Our hypothesis is that fractional anisotropy (FA) in the caudal portion of substantia nigra is decreased in PD patients.

The diagnosis of Parkinson's disease (PD) is based on a set of clinical assessments that do not provide great accuracy. Although magnetic resonance imaging (MRI) and transcranial sonography (TCS) have provided important advances in the diagnosis of a number of neurological diseases, few biomarkers of PD have been described in order to support its clinical diagnosis.

Recently, one single study showed that high field MRI using diffusion tensor imaging (DTI) was able discriminate PD from healthy volunteers. This study had a small sample size (14 patients and 14 controls) and did not include the main differential diagnosis of PD.

The main objective of this study is to confirm previous findings, with a larger sample size, describe possible changes of DTI parameters in patients with essential tremor (one of the main differential diagnosis of PD), and compare DTI MRI with TCS. Our primary outcome will be the fractional anisotropy (FA) in the caudal portion of substantia nigra. As a consequence, new algorithm to discriminate PD, essential tremor and healthy volunteers will be proposed. This has a pivotal importance in order to provide support to clinical diagnosis of PD and increase its accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson´s disease patients according to UK Parkinson´s Disease Brain Bank Criteria
* Essential Tremor Patients according to Movement Disorder´s diagnosis consensus criteria.
* Healthy Volunteers: paired with PD patients by age and gender.

Exclusion Criteria:

* Contraindication to MRI
* Claustrophobia.
* Serious structural brain anomalies.
* Condition or situation in which, in the opinion of the investigator put the patient at significant risk, which can confound the results, or substantially interfere with the individual's participation in the study.
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial

Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.


Eligibility Criteria:
Inclusion Criteria:

* BCLC C stage with unresectable diseasehigh-recurrence risk factor;
* Child-Pugh A or B (7 score) liver function;
* Anticipated survival more than 3 moths

Exclusion Criteria:

* Pregnant woman or sucking period;
* With other malignant cancer;
* Received anti-HCC therapy before this study
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed esophageal squamous carcinoma
* 18≤age≤75
* ECOG PS is 0-1
* TanyN+M0 or T3-4NanyM0 tumors
* Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
* No prior chemotherapy,radiotherapy and immunotherapy
* Disease must be clinically limited to the esophagus
* No esophageal perforation and no active esophageal bleeding
* No interstitial pneumonia or history of interstitial pneumonia
* FEV1\>1.2L
* Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance \>40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) \<470 ms calculated from 3 ECGs using Frediricia's Correction
* Able to provide written informed consent
* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion Criteria:

* Previous treatment with chemotherapy, radiotherapy or immunotherapy
* Cervical esophageal cancer
* Esophageal perforation or active esophageal bleeding
* Interstitial pneumonia or history of interstitial pneumonia
* Patients with evidence of metastatic disease
* Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
* Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
* 14 days before the first dose, the patient had an active infection that required systemic treatment
* Inability to understand or may not comply with test requirements
Study of Methylnaltrexone in Opioid-Induced Constipation Patients

This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.

Methylnaltrexone is a quaternary derivative of the pure opioid antagonists naltrexone. It is fairly lipid soluble and readily cross the blood-brain barrier. This property provides methylnaltrexone with the potential to block the undesired side-effects of opioid pain medications predominantly mediated by receptors located peripherally while sparing opioid effects mediated at receptors in the central nervous system, most importantly analgesia.

This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness. The randomization schedule was used to assign patients in a 2:1 ratio to multicenter or an equal volume of placebo administered subcutaneously on alternate days for 2 weeks. The clinical trail was estimated to enroll 180 patients totally.

Eligibility Criteria:
Inclusion Criteria:

* A life expectancy of 3 month or more
* Qualifying patients received opioids for analgesia for 1 week or more and a stable regimen of opioids and laxatives for 3 or more days before study entry
* Patients had opioid-induced constipation with either fewer than three laxation during the preceding week and no clinically meaningful laxation (as determined by the in investigator ) within 24h before the first study dose or no clinically meaningful laxation within 48h before the first study dose
* During the two-week trail , patients would keep their life habits (dietary fiber , fluid intake and physical activity)
* Patients volunteered for the trail
* Women of childbearing potential had negative pregnancy tests. Both male and female patients need to take effective contraceptives to avoid pregnancy.

Exclusion Criteria:

* Constipation that was not primarily caused by opioids ( as determined by the investigator)
* Mechanical gastrointestinal obstruction, an indwelling peritoneal catheter, clinically active diverticular disease , fecal impaction , acute surgical abdomen , and fecal ostomy
* Patients had the surgery plan which would effect the results of pain assessment
* Patients had hypersensitivity to methylnaltrexone , naltrexone or naloxone or if any investigational drug or experimental product
NIRS and DO2i Correlation

This study evaluates the association between near infrared spectroscopy (NIRS) and indexed oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.

Literature evidences show that levels of DO2i under 262-272 mL/min/m2 during cardiopulmonary by-pass (CPB) are associated with an increased incidence of acute kidney injury (AKI).

Furthermore, it has been demonstrated that keeping a NIRS of 75-80% compared to the basal value reduces the risk of perioperative morbidity. On the other hand, a NIRS \< 50% of basal value seems to be predictive of an increase in morbidity.

All of those studies had been performed during CPB and knowledge lacks in management of DO2i and NIRS before and after CPB.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been signed the consent informed

Exclusion Criteria:

* Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
2. Left ventricular outflow tract gradient \<30 mmHg at rest and with provocation.
3. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
4. Access to exercise equipment at home or at a fitness center.
5. Ability to complete study related testing including online surveys and smart phone use
6. Ability to perform 24 weeks of exercise training

Exclusion Criteria:

1. History of exercise-induced syncope or ventricular arrhythmias
2. LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
3. History of septal reduction therapy - surgery or ablation
4. History of ICD placement in the previous 3 months
5. History of hypotensive response with exercise testing (\>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure \>20 mm Hg)
6. Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
7. Left ventricular ejection fraction less than 50% by echocardiography
8. Life expectancy less than 12 months
9. Pregnant or planned pregnancy
10. Inability to exercise owing to any medical or other limitations
11. Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.

Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the ameliorating atherosclerosis effects in many reports.There maybe some correlations between retinoic acid and PON1 activity and the study aim to prove it.

Eligibility Criteria:
Inclusion Criteria:

* subject has a fasting total cholesterol concentration between 200 and 310mg/dl.
* subject is between 25 and 65 years of age, inclusive.
* subjects' BMI is between 18.5 kg/m2 and 35 kg/m2.

Exclusion Criteria:

* subject that is pregnant.
* subject that has coronafy artery desease, diabetes mellitus, thyroid disorders, mental disorder, cancer, cirrhosis, renal disease and hepatic desease.
* subject that has had operation less than six months prior to screening visit.
* subject that is smoking.
* subject uses any drugs that could influence the measurement of lipid paramerters or inflammatiory makers.