cyrilzakka/clinical-trials huggingface dataset:
The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER

Following a brain injury (BI) in addition to all other systems, there can be a failure in the control of the autonomic system activity. Heart rate (HR) has its own normal variability. Heart rate is controlled by the Sympathetic and Parasympathetic systems. Therefore, monitoring HR variability (HRV) can help us evaluate the balance of the two systems and their efficiency.Decrease in HRV was found to be in correlation with death among patients in the acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity and ventricular fibrillation.This disturbance can have a great impact on the patients health condition. In addition there was found an inverse correlation between this situation and the rehabilitation outcomes. Based on this data there is a great importance in monitoring HRV during rehabilitation among patients following BI while the patients are required to perform physical activity.The aim of this work is to check whether we can replace the traditional way of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the POLAR watch.

The aim of this work is to check if the data collected from a POLAR watch is reliable compared to the data collected from an EKG holter.


Eligibility Criteria:
Inclusion Criteria:

* Brain Injury

Exclusion Criteria:

* a medical condition which doesn't allow the patient to participate physical activity.
* patients that can not be there own legal guardian.
* uncontrolled psychomotoric restlessness.
Patterns of Injury and Mortality in Free-fall Trauma Patients

In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Falls from height is the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. Most victims presented to emergency department with major trauma, so initial evaluation and timely management are crucial for the survival. The knowledge of unique pattern of injuries helps clinicians to facilitate the diagnosis. In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with free-fall trauma

Exclusion Criteria:

* adult patients with free-fall trauma, not relating with traffic accidents
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program

The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement


Eligibility Criteria:
Inclusion Criteria:

* current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement
* two positive shoulder impingement tests
* pain reproduction during two of three additional categories of clinical tests
* the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg

Exclusion Criteria:

* cervical and periscapular pain
* positive labral injury tests
* history of shoulder surgery
Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia

The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.

Primary cervical dystonia (CD) affects about 20-40/100.000 population. The disease is chronic and life-long. The therapy of choice are local intramuscular Botulinum Toxin injections given every three months. Oral medication such as anticholinergics or dopamine depleting drugs are usually of limited efficacy or their use is limited by intolerable side-effects. About 5-10% of CD patients develop neutralizing antibodies against Botulinum Toxin. Two previous controlled multicenter trials have shown the efficacy and safety of bilateral pallidal stimulation in patients with primary segmental and generalized dystonia (one study was performed by our group).

Following surgery, patients will be randomized 1:1 to verum or placebo stimulation for a period of three months. Primary outcome measure is the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) - a validated and widely accepted physician-based outcome measure for cervical dystonia. The independent TWSTRS raters are movement disorders specialists unaware of the stimulation status (verum/placebo) and they compare the TWSTRS-score at baseline and 3-months follow-up. Our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation (placebo group).

After the 3-months period, all patients are unblinded and receive continuous effective stimulation by the implanted system. Regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation. Side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Primary cervical dystonia
* Disease duration 3 years or longer
* Adult patient (18 years or older)
* TWSTRS severity score 15 or more
* Non-response to Botulinum Toxin
* Non-response to oral antidystonic medication
* Informed consent

Exclusion Criteria:

* Dementia (Mattis Dementia Rating Scale below 120)
* Severe depression (Beck Depression Inventory \>25)
* Previous functional stereotactic surgery
* Hemidystonia or generalized dystonia
* Severe brain atrophy
* Contraindication against surgery
Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 3 months
* HbA1c between 7.5-11.0% on monotherapy or
* HbA1c between 7.0-10.0% on dual therapy
* BMI maximum 45 kg/m2

Exclusion Criteria:

* Any clinically significant disease history in the opinion of the investigator
* Severe heart disease
* Pregnancy
Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis

Intraarticular injection (IAI) of Platelet rich plasma (PRP) with Hyaluronic acid (HA) Versus Radiofrequency (RF) of genicular nerve for pain reduction of of knee osteoarthritis , Improving daily activity and reduction analgesia requirements

In this study the investigators to comparing between the effect of Intra articular injection of hyaluronic acid (HA) with platelet rich plasma (PRP) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis.

Knee assessment and pain score recorded according to Visual Analogue Scale (VAS) after one week, one month, three months, six months following intraarticular injection and radiation.

All analgesics stopped and only (Arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also.

Improvement of daily activities and clinical examination for the studied knees is observed.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Knee osteoarthritis.
* Body mass index: 24 - 42 kg/m2

Exclusion Criteria:

* Coagulopathy.
* Acute local or systemic infections with knee effusion Previous knee surgery (relative Contraindication).
Stereotactic MRI-Guided Radiation for Localized Prostate Cancer

This single arm, prospective study will determine the prostate-specific quality of life (QOL) of patients undergoing undergoing a 2 fraction MRI-guided stereotactic ablative body radiation (SABR) protocol. We propose prescribing a prostate dose of 26 Gy in 2 fractions and a dose of up to 32 Gy to the dominant intraprostatic lesion (DIL) in 2 fractions over one week.

Stereotactic Ablative Body Radiation Two weekly fractions of:

13 Gy to whole prostate +/- seminal vesicles AND Up to 16 Gy simultaneous boost to dominant MRI nodule

Treatment Delivery and Quality Assurance Treatment will be delivered on treatment units equipped with with volumetric arc therapy and hexapod couches. Only photons with megavoltage energies of 6 MV will be used. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. Imaging after each fraction of radiation will be performed and the shifts in prostate positioning (as measured by displacement of gold seed fiducials) will be measured and recorded. Also, the total treatment time for each fraction of radiotherapy will be recorded.

Patient Assessments / Follow-up Time zero will be the start of radiotherapy. Baseline and follow-up parameters are as listed in Appendix A. Baseline rectal and urinary function will be recorded. Acute toxicities will be assessed at weeks 1, 4, and 13 and late toxicities will be assessed at month 6 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, version 4.0. Bloodwork (PSA and testosterone), will be performed at months 3, 6 and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 13, month 6 and every 6 months until year 5.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained
2. Men \>18 years
3. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
4. Favorable risk prostate cancer, defined as clinical stage T1-2c, Gleason Sum less than or equal to 7, and PSA less than or equal to 20 ng/mL (patients can have only one of T2c, Gleason Sum 7 and PSA 10-20 ng/ml)

Exclusion Criteria:

1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) \> 6 mo
2. Prior pelvic radiotherapy
3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
4. Diagnosis of bleeding diathesis
5. Large prostate (\>90cm3) on imaging
6. Immunosuppressive medications
7. Inflammatory bowel disease
8. Presence of a hip prosthesis
9. Contraindications to having MRI
Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)

The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases. Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and currently three alternatives are on the market. Clinical results of these devices are promising but loss of patency is not uncommon. The major difference between the two devices is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. Intermittent hinchpoints could also have an effect on stent integrity and stenosis. By evaluating endograft movement during the cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the endograft. This might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability.

The choice for device is not part of this study.

Objectives:To compare the mobility of the hypogastic artery during the cardiac cycle before and six weeks after implantation of the Gore IBE device in conjunction with its dedicated self expandable Internal Iliac component (Sub-study A);and to quantitatively characterize the displacement of stents with regard to the main body and native IIA during the cardiac cycle on an implanted iliac branched endograft in conjunction with a non-dedicated IIA component (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self expandable Internal Iliac component (Gore IBE device). (Sub-study B) Study design: Sub-study A \& B: Multicenter observational case studies Study population: Sub-study A: 15 prospectively included patients and sub-study B: 15 patients in each group that have been treated in the period October 2006 - July 2016.

Eligibility Criteria:
Inclusion Criteria:

* Sub-study A. scheduled endovascular aneurysm repair using the Gore IBE device.
* Sub-study B. Patients that have been treated with an iliac branched device in the past in conjunction with either a dedicated IIA component (Gore IBE device) or non-dedicated IIA component (Cook IBD) and who are scheduled for follow-up imaging within the period July 2016-January 2017.

Exclusion Criteria:

* No specific exclusion criteria. Patients will be treated according to the hospital's standard practice.
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Compatibility

The purpose of this study is to demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Sweet Flower.


Eligibility Criteria:
Inclusion criteria:

Phototype Skin I,II, III e IV

* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients

The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
* Invasive mechanical ventilation
* Age between 1 mo and 21 yrs

Exclusion Criteria:

* Type I diabetes mellitus
* Have an illness that requires insulin daily
* Recipients of solid organ transplants
* Participation in an experimental trial that might affect outcome
* Post-operative patients with planned extubation upon recovery
* Patients on a dopamine infusion of less than 3 mcg/kg/minute
Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)

Background of the study: CRPS type-1 is a pain syndrome that usually develops after an initiating noxious event (e.g. fracture) in an extremity. Although treatment options life dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical therapy exist, the treatment effect is often unsatisfactory, even leading to amputation of the extremity. Surgical treatment of chronic pain disorders by dividing the sympathetic chain is an established treatment. Its more invasive nature has prevented widespread application. After introduction of minimal invasive techniques in recent years, the UMCG has now devised a truly minimal invasive, yet safe and effective thoracoscopic technique, that requires only a single 1 cm long incision in the anterior axillary line. This technique is developed as treatment for primary focal axillary and palmar hyperhidrosis, and is performed in over 50 patients producing very satisfying results. This fact has led to the hypothesis that this same surgical technique can offer this group of chronic pain patients a safe, effective treatment modality.

Objective of the study: The effect of the intervention on pain an regain of function in de affected extremity. This will be quantified in multiple questionnaires at baseline and three follow-up points, and by clinical evaluation of the hand function at baseline and two follow-up points.

Study design: Single center prospective feasibility study


Eligibility Criteria:
Inclusion Criteria:

Age 18 - 65 years.

* ASA 1 en 2.
* CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.

  1. Continuing pain which is disproportionate to any inciting event
  2. Must report at least one symptom in each of the four following categories

     * Sensory: reports of hyperesthesia
     * Vasomotor: reports of temperature asymmetry, skin color change or asymmetry.
     * Sudomotor/edema: reports of edema, sweating changes, sweating asymmetry
     * Motor/trophic: reports of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
  3. Must display at least one sign in two or more of the following categories:

     * Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
     * Vasomotor: evidence of temperature asymmetry, color changes, asymmetry
     * Sudomotor/edema: evidence of edema, sweating changes, sweating asymmetry
     * Motor/trophic: evidence of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)

Exclusion Criteria:

Known COPD \> Gold class 1.

* History of smoking \> 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
* Documented substance addiction.
* Previous intra-thoracic pleural drainage on affected side.
* Previous thoracic surgery on affected side (including sternotomy). - Gross pulmonary or pleural abnormalities on chest X-ray.
* Pregnancy, determined by preoperative pregnancy test.
* Unsuitable anatomy (e.g. due to severe physical malformations).
BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in treating patients who have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

OBJECTIVES:

I. Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase I) II. Determine the toxic effects of this regimen in these patients. III. Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II) IV. Determine the pharmacokinetics of this regimen in these patients. V. Correlate selected markers from peripheral blood mononuclear cells and tumor samples with toxicity and response in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation study of BMS-247550.

Phase I: Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional patients receive treatment as above at the recommended phase II dose of BMS-247550.

Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of BMS-247550.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy

  * No nasopharyngeal disease as primary site
* Extensive, local-regional or distant metastatic disease

  * Newly diagnosed OR
  * Recurrent disease after initial treatment with surgery or radiotherapy (including neoadjuvant chemotherapy or concurrent chemoradiotherapy)
* Measurable disease

  * If only site of measurable disease is in a previously irradiated area, disease progression after radiotherapy must be documented

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Hematopoietic

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2.0 mg/dL
* Transaminases no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver involvement)

Renal

* Creatinine no greater than 1.5 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No evidence of active infection
* No other malignancy within the past 2 years except curatively treated stage 0 or I cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy for recurrent disease

Radiotherapy

* At least 6 months since prior radiotherapy and recovered

Surgery

* Recovered from prior surgery
Comparison of Efficacy of Ivabradine Versus Metoprolol

Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.


Eligibility Criteria:
Inclusion Criteria:

* elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
* Resting heart rate \> 70 BPM
* age \> 18 years and informed consent

Exclusion Criteria:

* Heart rate \> 100 BPM
* BP \<100/60 mmHg
* recent congestive heart failure in 1 mo.
* SA node, AV node disease and AF
* on permanent pacemaker
* CrCL \< 15ml/min. , AST or ALT \> 3x UNL
* on HR reducing drug such as diltiazem, verapamil, digitalis
* contraindication for ivabradine or metoprolol