cyrilzakka/clinical-trials huggingface dataset:
DBRCT on the Effect of Grip Strength in Brachial Plexus vs Distal Forearm Nerve Blocks

This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.


Eligibility Criteria:
Inclusion criteria:

1. American Society of Anesthesiologists physical status I to III
2. Aged 18 and above
3. Able to provide own consent
4. Elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia

Exclusion criteria:

1) Surgery outside the median and ulnar nerve distribution in the hand 2) Bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) Diabetes with peripheral neuropathy or end organ damage 9) allergy to LA agents 10) coagulopathy 11) Past surgery on the same upper limb 12) Any other contraindication to supraclavicular block or forearm blocks 13) Contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia.

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A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA

The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation.

1. Unknown adverse reactions, especially serious adverse reactions
2. Incidences of adverse reactions under routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the efficacy of the drug

This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.


Eligibility Criteria:
Inclusion Criteria

Rheumatoid Arthritis

* Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
* Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX

Psoriatic Arthritis

- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs

Exclusion Criteria

* Patients to whom Enbrel is contraindicated as per the local labeling
* Patients with known hypersensitivity to Enbrel or any component of the product
* Patients with sepsis or risk of sepsis
* Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)
TreAtments and outComes in paTients With prImary CutAneous Lymphoma

In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.

Primary cutaneous lymphomas (PCLs) are defined as non-Hodgkin lymphomas presenting in the skin with no evidence of extracutaneous disease at the time of diagnosis. Primary cutaneous lymphomas include a heterogeneous group of cutaneous T-cell lymphomas (CTCLs) and cutaneous B-cell lymphomas (CBCLs). The different types of PCLs have highly characteristic clinical and histologic features, often a completely different clinical behavior and prognosis, and require a different type of treatment. Various studied in terms of the treatment and outcome of patients with different types of PCLs has been conducted in recent years. While the data of Chinese patients with PCLs are limited. Considering the different proportion of PCLs and limited treatment modalities in China, a nationwide multi-center prospective study is designed to summarize the current treatment status and outcome of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
* Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.

Exclusion Criteria:

* Patients who fail to provide informed consent form.
* Patients who cannot complete the questionnaire independently or under the guidance of investigators.
Validation of a Diagnostic Algorithm of Giant Cell Arteritis

Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years
* C reactive protein (CRP) above normal
* Suspected of GCA according to clinician expertise and / or aortitis arteritis or of one or more arteries from the aorta imaging (CT angiography, magnetic resonance angiography or positron emission tomography TDM18FDG)
* Benefiting from Social Security or receiving it via a third party
* have given their participation agreement by understanding and accepting the constraints of the study

Exclusion Criteria:

* Received corticosteroid dose ≥ 20 mg of prednisone equivalent for more than 7 days in the month before inclusion
* Underwent temporal artery biopsy before color Doppler ultrasound
* History of GCA
* Terminal palliative phase or suffering from a disease or comorbidities such as life is involved in less than a year
* Patient with severe cognitive impairment
* Patient that can not be followed by the investigator for the duration of the study
* Refusal to participate in the study
* With enhanced protection (namely those deprived of liberty by a court or administrative order, patient staying in a health or social institution, under legal protection, and patients in emergencies)
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
* Participating in another clinical trial.
A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions

Liver cancer is often diagnosed too late for effective treatment. The VOCAL2 study is developing a simple, non-invasive breath test to help detect liver cancer earlier and monitor liver conditions like cirrhosis. The test analyzes tiny chemicals in exhaled breath called volatile organic compounds (VOCs) to identify signs of liver disease.

Who can take part?

Adults aged 18 or older who:

Have liver cancer (hepatocellular carcinoma or cholangiocarcinoma), or Have liver cirrhosis or primary sclerosing cholangitis, or Have tummy symptoms but a normal liver scan. What's involved?

Participants will:

Give a breath sample after fasting for 6 hours. Answer a few health questions. Allow access to relevant medical records. The appointment lasts about 1 hour at an NHS hospital. Benefits \& Risks

This research could lead to an earlier, easier way to detect liver cancer, but there's no direct health benefit for participants.

There are no risks, as breath sampling is completely non-invasive and safe. Where is the study happening? Led by Imperial College London, running in NHS hospitals across the UK.

Who is funding the study? The study is funded by Rosetrees and Stoneygate Trust.

Contact Information Email: vocal-study@imperial.ac.uk Phone: +44 (0)20 7594 3396


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Adult participants ≥ 18 years old
* Participants with either:

  1. Histologically or radiologically-confirmed\* hepatocellular carcinoma or cholangiocarcinoma (participants with liver cancer)
  2. Liver cirrhosis, confirmed on imaging or histology from biopsy (participants with benign liver disorders)
  3. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy (participants with benign liver disorders)
  4. Non-specific gastrointestinal symptoms, but a radiologically-normal liver (healthy controls)

Exclusion Criteria:

* Active infection, or receiving immunosuppressive medications, within the preceding eight weeks
* History of another cancer within the previous five years
* Previous liver resection
* Already received chemotherapy, radiotherapy or surgery for their liver cancer
* Comorbidities preventing breath collection
* Pregnant women (checked verbally with participant).
* Unable to provide informed written consent
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"

Eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study.

the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Chronic tympanic membrane perforation (\>6 months).
* Central tympanic membrane perforation.
* Air bone gar of 35 dB or lower at the operated ear.
* No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
* No evidence of a retraction pocket and no suspicion for a cholesteatoma.

Exclusion Criteria:

* Known ossicular chain dysfunction
* The tympanic membrane perforation edges are not accessible/visualized transcanal
* Pregnancy
* Allergy to lidocaine
the Effect of Gut Microbiota on the Prognosis of Sepsis

Sepsis is a life-threatening condition that arises when the body's response to infection injures its own tissues and organs. Common signs and symptoms include fever, increased heart rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea often result in a bad prognosis. Gut microbiota consists of a complex community of microorganisms that live in the digestive tracts of animals. The gut microbiota comprises the largest and most diverse reservoir of mutualistic microorganisms associated with animals. The aims of this study is to determin the effect of gut microbiota on the prognosis of Sepsis, by using 16s pyrosequencing, comparing the blood culture result.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with sepsis
* 18 years to 65 years of age

Exclusion Criteria:

* patients had complications such as acute cerebral infarction or acute myocardial infarction
* The use of antibiotics, pro-prebiotics within 3 months
* \<18 years or \>65 years
* History of intestinal surgery
* patients withdraw from this study
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.


Eligibility Criteria:
Main Inclusion Criteria:

* Postmenopausal women (hysterectomized or non-hysterectomized)
* Women between 40 and 75 years of age.
* Willing to participate in the study and sign an informed consent.
* Women who have self-identified symptom(s)of vaginal atrophy.
* For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study.

Main Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* Hypertension equal to or above 140/90 mm Hg.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patient, aged from 18 to 65 years
* Patient presenting a primary fibromyalgia answering the criteria of the ACR
* At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
* Patient presenting a stable treatment since at least 1 less

Exclusion Criteria:

* Patient minor
* pregnant woman
* women in age to procreate without contraception
* patient deprived of freedom further to a court or administrative order
* patient presenting a secondary fibromyalgia
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Collected data include procedural parameters relevant to pulmonary vein isolation as outlined in the protocol section, DE identified patient demographics, follow up information including rhythm status, antiarrhythmic medication usage, and symptoms or signs to suggest procedural complications relevant to the pulmonary vein isolation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Exclusion Criteria:

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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.

After the patients are admitted to our hospital we randomise them to either std. fluid therapy (NaCl/RA) or HyperHAES. After PCI we state the rate of cerebral edema by carrying out a cerebral MRI before the cooling starts. We treat the patients with the different fluids for 24 hours. We then evaluate the edema after 24 and 72 hours by the same method. In addition we state the rate of peripheral capillary leak by Wick'S method. The capillary leak is calculated every 8.th hour for the 1. day the patients are treated in our ICU. AFter 1 year, those who survive are invited to a follow-up where we test the patient using Mini MEntal Status, SF-36, in addition to neurophysiological tests as EEG and the P300-test. We then relate the results to the fluid given initially after the cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Witnessed cardiac arrest,
* ALS started within 15 min.
* ROSC within 60 min.
* Still unconscious,
* Age 18-80

Exclusion Criteria:

* Other malignancies,
* Persons who wake up,
* Pregnancy
Duchenne Muscular Dystrophy Clinical Trial

The primary objective of this investigation is to assess the effectiveness of transcutaneous electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne Muscular Dystrophy and reduce the impact of DMD upon the participants' quality of life.

The primary outcome measures will include:

1. increased muscle strength,
2. increased range of joint motions and
3. improved sleep parameters of ASI, N3 and REM.

Muscle Strength and Joint Range of Motion Testing - All muscle and joint testing was performed at the MedCenter Therapy clinic in Houston, Texas. JTech computerized testing system was utilized including Goniometry, Grip testing, Inclinometry, Muscle Testing and Joint Range of Motion testing occurred on Day 0, 30, 60, 90, 180, and repeated at 12 months to determine muscular strength and joint Range of Motion. JTech computerized testing system was chosen on the basis of reliability and accuracy. At each of the testing intervals, the testing was administered by the same technician with the same equipment to all of the participants. Inter-and intra-tester reliability of the JTech computerized testing system has been the subject of multiple studies. Each of which found high ICCs (\>0.93) for both inter- and intra-tester reliability.

All sleep studies were performed at Sleep Diagnostics of Texas in The Woodlands, Texas. Prior to the clinical trial, all of the participants spent two nights in the sleep unit and their sleep study examinations were performed. The second night was used as the Day 0 data. Sleep, breathing, arousals and limb movements were scored manually according to guidelines set forth by the American Academy of Sleep Medicine. The sleep studies were repeated at 6 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have Duchenne Muscular Dystrophy diagnosis as confirmed by licensed physician, wheelchair bound, \& age 8 - 20 years old.

Exclusion Criteria:

* Active cancer in the area of application of the treatment, infection, skin infection, pregnancy, thrombophlebitis, pacemaker, amputation of any part of feet or hands, taking steroids. In addition, the participant may not be in any other clinical trial during the time they are in this study.
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.

Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion.

Clinically useful pretreatment bladder function required.

No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying.

No active urinary tract infection.

PRIOR/CONCURRENT THERAPY:

At least 1 course of prior standard intravesical therapy required.

At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0 or 1.

Hematopoietic:

WBC at least 3,300;

Hemoglobin at least 10 g/dL.

Hepatic:

Bilirubin no greater than 1.5 mg/dL;

AST and ALT no greater than 2 times normal.

Renal: Creatinine no greater than 1.5 mg/dL.

OTHER:

Medically able to undergo cystoscopy.

No pregnant women.
Evaluation of Synchrony in the Post-operative Patient

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.


Eligibility Criteria:
Inclusion Criteria:

* adult \> 18 yr-old
* abdominal post-operative patient
* able to trigger the ventilator

Exclusion Criteria:

* infant
* pregnancy
* esophageal surgery
* recent esophageal variceal bleeding
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease

This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.

This study is a three-arm randomized controlled trial. Participants will be randomly allocated to the once-a-week exercise group, thrice-a-week exercise group, or usual care control group. The exercise intervention groups will receive once-a-week or thrice-a-week exercise (with matched weekly exercise volumes). The usual care control group will receive general health education. All interventions will last for 4 months. Outcome measures will be examined at baseline, 4 months (post-intervention), and 10 months (6-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Cantonese, Mandarin, or English speaking Chinese;
2. Aged 18-69;
3. Male or female;
4. Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
5. With NAFLD (defined as \>5% intrahepatic triglycerides assessed by 1H-MRS);
6. Willing to participate in exercise training to improve NAFLD.

Exclusion Criteria:

1. Regular exercise training (\>3 sessions of \>60 min of moderate-intensity exercise training weekly) in the past 6 months;
2. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD;
3. Somatic conditions that limit exercise participation (e.g., limb loss);
4. Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases);
5. Daily smoking habit;
6. Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year;
7. Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis;
8. Surgery, therapy, or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program);
9. Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.