cyrilzakka/clinical-trials huggingface dataset:
Functional MRI (fMRI) in CGRP Induced Migraine

In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata.

Then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail.

This study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.


Eligibility Criteria:
Inclusion Criteria:

* Patients know with migraine without aura.
* No less then 1 migraine attach pr month and no more then 6 attaches per month.
* Weight 50-100 kg.
* Women must be using secure birthcontrol.

Exclusion Criteria:

* Tension type headache more then 1 day/month.
* All other prim. og sec. headache types then migraine without aura.
* Daily use of medication other then birthcontrol pills.
* Pregnant and lactation women.
* Headache on the trail day or 5 days previous to the trail day.
* Contraindications to MRI-scans.
* Hypertension or hypotension.
* Known heart or lung condition.
* Mental illness or substance abuse.
* Other considerable conditions judged by the including doctor.
Acupuncture for Post-stroke Shoulder-hand Syndrome

Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.


Eligibility Criteria:
Inclusion Criteria:

- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period.

Exclusion Criteria:

- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers

The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males subjects, 20-40 years inclusive
* weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive
* Written informed consent given
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Hypersensitivity to drugs(aspirin, antibiotics and so on)
* History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology
* Have a history of drug abuse, or show positive for drug abuse at urine screening
* Have participated in another clinical study within 2 months prior to entering inth the study
* Have been persistently drinking alcohol or can not stop drinking alcohol during the study
* Smokers whose average smoke for last 3 months is more than 10 cigarettes/day
* Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
Stimulation for Colonic Motility

The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
* Neurologically stable
* Skeletally mature
* Suprasacral spinal cord injury, stroke, or multiple sclerosis
* At least 6 months post neurological injury or disease diagnosis

Exclusion Criteria:

* Active sepsis
* Open pressure sores on or around pelvis
* Significant colon trauma or colostomy
* History of autonomic dysreflexia
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

1. Subjects who used any of the following systemic treatments during the washout periods given below:

   1. Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
   2. Treatment with more than 1 NSAID within 14 days at baseline.
   3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
   4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
   5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Sleep Disturbances in Dermatology Patients

This study is to investigate sleep disorders in patients with dermatologic diseases by taking into consideration dermatologic (itch, pain) and non- dermatologic (medication, depression) factors.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients of the dermatologic university clinic

Exclusion Criteria:

* Insufficient knowledge of German language
* Illiteracy
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment.

PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or cervical cancer or high grade soft tissue sarcoma.

OBJECTIVES: I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast, head and neck, prostate, or cervical carcinoma or high grade soft tissue sarcomas. II. Define the toxic effects of EF5 in this patient population.

OUTLINE: This is a dose-escalation study. Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 24-48 hours after EF5 treatment, patients undergo surgical resection or biopsy of tumor. Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding. Patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven breast, head and neck, prostate, or cervical carcinoma or high grade (defined as grades 2 or 3) soft tissue sarcoma Sarcoma tumors must be confined to truncal or extremity locations Must have a clinical condition and physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection Tumors no greater than 15 cm in any diameter Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No significant cardiac disease that would preclude the safe use of general anesthesia Pulmonary: No significant pulmonary disease that would preclude the safe use of general anesthesia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study No grade 3 or 4 peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Effectiveness of Different Interventions for Implementing Surviving Sepsis Campaign (SSC) Guidelines on Compliance and Mortality: Systematic Review and Meta-analysis

This is a systematic review and Meta-Analysis of interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction

The implementation of the sepsis resuscitation bundle recommended by the SSC guidelines has been shown to increase compliance and reduce mortality in several settings. Different implementation strategies have been utilized, including education, posters, reminders, audit and feedback, paper-based and electronic sepsis screening tools, clinical pathway and sepsis response teams. Different studies showed a considerable variation effect on compliance and mortality.It has been suggested that implantation strategies vary in there effect from low impact for human-based interventions such as education and training, rules and policies, reminders, checklists and double checks, however, reaching high effect for system based interventions like automation and computerization and forcing function. However, this has not been studied in relation to the implementation of SSC bundle. As such, many projects continue to invest on low-impact interventions with modest change in compliance and mortality. Multiple interventions were adopted by different centers worldwide to implement SSC guidelines. These interventions vary on their level of compliance and outcomes. The effectiveness of intervention if system oriented is more effective than human oriented. The hierarchy of effectiveness assigning forcing function intervention on the top of the pyramid and the training and education on the bottom.

The investigators hypothesize that interventions system based interventions are more likely to be more effective in improving the compliance with sepsis resuscitation bundle and in improving mortality.

The aim of this study is to assess the effectiveness of different interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction.

Eligibility Criteria:
Inclusion Criteria:

Any study or data

1. assessing any intervention method for implementing SSC guidelines in regards to compliance and mortality,
2. has a comparison group,
3. reported data on sepsis resuscitation bundle compliance and mortality

Exclusion Criteria:

Any study used other than SSC guidelines in sepsis management will be excluded.
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients (eGFR \< 60 mL/min/1.73 m2)
* Serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention within 6 months
Enhanced Biofeedback for Musculoskeletal Pain

The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help individuals regulate their chronic musculoskeletal pain more effectively.

Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback treatment to try and enhance the capacity of relaxation to engage pain inhibitory circuits. Specifically, a biofeedback system (Biofeedback Training for Conditioned Pain Regulation, BT-CPR) will be used to monitor the participant's level of sympathetic arousal and will use this to control the intensity of painful stimulations delivered to the participant during biofeedback training. Thus, when the participant successfully relaxes (and reduces their arousal), the intensity is lowered and produces pain relief. Efficacy of the treatment will be tested in a small, randomized controlled trial in which individuals with a verified diagnosis of chronic musculoskeletal pain will receive 10 treatment sessions, or 10 sessions of a control condition (traditional biofeedback, to control for the effects of relaxation on pain). The aim will be to assess whether the treatment results in improvements in clinical pain outcomes (e.g., pain intensity, quality of life, pain interference) and psychosocial variables (e.g., coping, self-efficacy, mood).

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older) with a verified diagnosis of chronic musculoskeletal pain and currently experiencing pain

Exclusion Criteria:

* under 18 years of age (given the nature of the treatment study)
* if female, currently pregnant
* persistent feelings of numbness in hands and feet
* difficulty being able to feel or sense things
* lack of access to a computer or smartphone (to complete electronic pain diaries)
* injuries that prevent sensor application
* use of narcotic pain medications with 48 hours of treatment sessions
Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center

Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for development of chronic pain are investigated. Questionnaire survey.


Eligibility Criteria:
Inclusion Criteria:

* thoracotomized patients

Exclusion Criteria:

* mental incapacity,
* poor understanding of French,
* pre-existing chronic pain before surgery,
* redo-surgery
Battery-preserving Stimulation Patterns for Deep Brain Stimulation

The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.

Deep brain stimulation (DBS) is an effective surgical therapy for medication-refractory symptoms of Parkinson's disease, tremor, and dystonia. Patients implanted with DBS experience a significant improvement of their symptoms with relatively low risk of intolerable side effects. Implanted patients must undergo repeat surgeries to replace the Implantable Pulse Generators/batteries (IPG) approximately every 2 to 5 years. The DBS program (at the University of Florida) has studied battery consumption and has been interested in potential strategies to extend the life of the IPG to reduce the need for frequent battery replacement surgeries, while improving symptom-relief, patient satisfaction, and the potential associated financial burdens.

The research study will evaluate the effects of novel stimulation patterns on tremor, bradykinesia, rigidity and gait in Parkinson's disease and essential tremor patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease or Essential Tremor by strict criteria
* Deep brain stimulation (DBS) already implanted
* Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)

Exclusion Criteria:

* Other neurological diagnoses (co-existent Alzheimer's or ALS)
* No Deep brain stimulation (DBS)
* less than 4 Deep brain stimulation (DBS) programming
Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)

The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements.

Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,

Objective: To compare the effectiveness of a home-based treatment program involving Kinesio taping (KT) or transcutaneous electrical nerve stimulation (TENS) among carpal tunnel syndrome (CTS) patients.

Methods:

30 participants with CTS were enrolled, age range, 30 to 60 years. The participants who met the inclusion criteria were randomized into one of two treatment groups: KT group and TENS group. Participants were blinded to the treatments used in the other group.

Patients with CTS received aforementioned treatments compared with reliable qualitative and quantitative evaluation tools before and after 4-week treatment, as well as at a additional 4-week follow-up. The main parameters include the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), hand grip and key pinch strengths, two-point discrimination (2PD), Modified Moberg pick-up test (MMPUT), and Pain assessment (visual analog scale, VAS).

Eligibility Criteria:
Inclusion Criteria:

* numbness and tingling in the median nerve territory of the hand.
* nocturnal paresthesia.
* induction test (Tinel's sign and Phalen's test) showing a positive finding.,
* is defined as mild and moderate CTS according to nerve conduction studies (NCSs).

Exclusion Criteria:

* is defined severe CTS symptoms.
* are currently pregnant or have any secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism, previous wrist trauma).
* cervical radiculopathy or polyneuropathy.
* previous history of carpal tunnel decompression surgery.
* corticosteroid injection into the carpal tunnel.
Training Induced Muscle Exosome Release

The primary objective of this study is to quantify miR-1 release from muscle in extra-cellular vesicles following an acute resistance exercise bout and potential delivery to subcutaneous adipose tissue in young healthy and obese adults.

Numerous studies in humans and animals have shown that aerobic exercise is beneficial to adipose tissue function and whole-body metabolism. Both acute and chronic aerobic exercise enhance adipocyte catecholamine sensitivity in humans and animals. Although relatively few studies have investigated whether adipose adrenergic signaling is affected by resistance exercise (RE), it is known that a single bout of RE can increase circulating NEFA and resting energy expenditure and decrease respiratory quotient for up to 24 hours, indicative of increased adipocyte lipolysis and muscle fatty acid oxidation. Furthermore, the lipolytic response to RE is impaired in obese men. Using synergist ablation, a model of RE in mice, the investigators show that adipose transcriptional responses are exosome-dependent, and that serum exosomes enhance adipocyte catecholamine sensitivity and lipolysis for at least 24 hours. To the investigator's knowledge, this is the first demonstration of a potential mechanism whereby RE imparts metabolic adaptations in adipose. Since adipose metabolic function is crucial for determining whole-body metabolic outcomes, the ability of RE-induced exosomes to improve adipose metabolism has significant clinical implications.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age.
* Either BMI \<25 or \>30.
* Relatively sedentary, reporting no participation in regular (\>1 day per week) exercise for at least the past 3 months.
* Non-smoker.

Exclusion Criteria:

* BMI between 25 and 30.
* Evidence or signs and symptoms for cardiovascular disease (previous heart attack, arrhythmias, angina, shortness of breath, extreme fatigue, unusual pain in neck, jaw, throat, upper abdomen, or back, swelling in feet, legs, or ankles).
* Evidence or signs and symptoms of metabolic syndrome or disorder (diagnosis of diabetes or insulin resistance, elevated BP, high fasting blood sugar, abnormal cholesterol or triglyceride levels).
* Chronic aspirin or NSAID use (unless it can be safely stopped prior to the biopsies), and any other use of an anticoagulant (e.g., Coumadin) or history of bleeding including history of hypo- or hyper-coagulation disorders.
* Neurological, musculoskeletal, or other disorder that would preclude safe participation in the weight lifting tasks and all performance tests.
* Any other medical condition that would interfere with testing or increase one's risk of complications during exercise, as judged by the study physician.
* Any other condition or events considered exclusionary by the PI and/or physician, such as non-compliance.
* Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
* Pregnancy.