cyrilzakka/clinical-trials huggingface dataset:
Microcirculatory Effects of Methylene Blue

International guidelines recommend Methylene Blue (MB) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (VS) after Cardiopulmonary Bypass CPB. Macrocirculatory effects of MB in this setting are now well established but microcirculatory effects of MB remain unknown.

The purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory VS post CPB.

Microcirculatory effect will be monitored before and one hour after MB infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (VOT).


Eligibility Criteria:
Inclusion Criteria:

* patients receiving methylene blue prescribed by the clinician in charge of the patient
* patient receiving a dose of norepinephrine \> 0.5µg/kg/min
* normal or increase cardiac (\> 2 L.min-1.m-2) at the time of inclusion
* vasoplegic syndrome post cardiopulmonary bypass for cardiac surgery

Exclusion Criteria:

* the need for hemodynamic intervention during the time of study (fluid resuscitation, introduction of inotropic or vasopressor support, change in inotropic support dose)
* age under 18 years
Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia (currently unmedicated)
* Subjects at risk for the development of schizophrenia (prodromal symptoms)
* Healthy subjects
* Written informed consent

Exclusion Criteria:

* Neurological or severe somatic disorders
* Women during pregnancy or lactation
* Occupational exposition to radiation \> 15mSv
* Medication known to interfere with IBZM
* Contraindications for the use of amphetamine challenge
Paula Method of Exercises in Patients With LARS Syndrome

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection
* Able to read, understand and communicate in Hebrew

Exclusion Criteria:

* Pregnancy
* Actively undergoing Chemotherapy or Radiation
* Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome)
* Concurrent performance of other exercise methods
* Unable or unwilling to perform the Paula exercises
Muscle Mass and Function in Chinese Adults

To describe the normal range of muscle mass and function in Chinese adults.

The study objective is to setup a normal range of muscle mass and function in Chinese adults.

Eligibility Criteria:
Inclusion Criteria:

1. Young adult ages between 25 and 34 years, inclusively.
2. Adult is judged to be in good health as determined from his/her medical history as his/her self-report to the enrolling center personnel and as confirmed through a clinical examination by a physician.
3. Adult with BMI between 18.5 to 26.9.
4. Male or non-pregnant non-lactating female. Non-pregnant should be confirmed by urine pregnant test. And non-lactating is defined as postpartum more than 18 months.
5. Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

1. Subject who is heavy manual labor.
2. Subject who is professional or semi-professional athlete or game player.
3. Subject who is physical disabilities, such as loss of hand or foot or limbs or any physical disability which may affect the physical activities and affect the distribution of muscle mass by the opinion of the study physician.
4. Subject has known chronic diseases such as endocrine system diseases (including type 1 or type 2 diabetes mellitus, or hyperthyroidism or hypothyroidism), cardiovascular diseases, liver diseases, and renal diseases as self-report.
5. Subject who has active infection of TB, HIV and hepatitis as self-report.
6. Subject who currently experiencing diarrhea or anorexia within 7days prior to the enrollment.
7. Subject who has or plans for intensive physical activities 3 days prior to the scheduled BIA measurement.
8. Subject who is thyroid malfunction (as serum fT4 level and/or serum TSH level out of the reference range of the lab)
9. Subject has implanted electronic device, orthopedic metal implantations, such as pacemaker, cardiac defibrillator, or metal hip, metal knee joint, metal fracture internal fixation, etc.
10. Subject is drug addiction or alcohol addiction.
11. Subject is anemia (as blood hemoglobin level less than 120 g/L in males and 110 g/L in females).
12. Subject is malnourished by study physician's opinion
13. Subject has active cancers as self-report
14. Subject has lost or gained more than 5% of body weight in the past 3 months
15. Subject attends other clinical trials and is not approved by AN
Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery

The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

Most open spine surgery exacts a high degree of postsurgical pain due to the incision and muscle dissection of the vertebra. The postoperative pain control and early mobilization improve the quality of the surgical care. Inadequate pain relief might result in perioperative morbidity, resulting in prolonged hospital stays.

Erector spinae plane block (ESPB) is an interfascial plane block where local anaesthetic is injected in a plane preferably below the erector spinae muscle. It can provide thoracic, abdominal, and even some lower extremity analgesia. It was also theorised that erector spinae plane block can reduce opioid use and provide analgesia for lumbar surgery. The financial cost that is saved by reducing the length of hospital stay, perioperative morbidity will warrant the use of erector spinae plane block in patients undergoing lumbar spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Patients with Glasgow Coma Scale of 15.
* American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients
* Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.

Exclusion Criteria:

* Cognitive impairment
* Patient refusal
* Weight\<50kg, \>120kg
* Allergy to local anesthesia
* Alcohol/ drug abuse
* Renal failure or liver failure
* Coagulopathy/thrombocytopenia
* Chronic pain with chronic opioid usage
* Ischemic heart disease
The Function of PET Molecular Imaging Targeting Fibroblast Activation Protein in the Hepatobiliary Malignancies

Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies

Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate and sign a written informed consent;
2. 18-80 years old (inclusive) male or female;
3. Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
4. Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
5. Have willingness and ability to participate in all research procedures.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding;
2. Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
3. Those who have a history of other malignant tumors in the past;
4. Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
5. Patients with claustrophobia;
6. Those who cannot tolerate lying down for 15-30 minutes;
7. The researchers believe that it is not suitable to participate in this clinical trial;
8. Those who have participated in clinical trials or are participating in other clinical trials within the past month
Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 12-18 months of age at the time of booster vaccination.
* Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
* Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
* Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
* Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
* Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
* Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Tympanic or axillary/ oral temperature \>= 37.5°C or rectal temperature \>= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
* Acute disease at the time of enrolment.
Effectiveness of Exercise Given With Ergonomics Training in Tea Workers

The aim of our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers.

Individuals who volunteer to participate in the study will be evaluated considering the inclusion and exclusion criteria, and participants will participate in the study after reading and signing the Informed Consent Form. Tea workers who collect tea will be divided into 2 groups. .Demographic Information Form, Visual Analogue Scale (VAS), Upper Extremity Discomfort Analysis, Rapid Upper Extremity Assessment (RULA), Sleep Quality, Scandinavian Musculoskeletal System Questionnaire will be given to the participants of both groups. The surveys will be carried out face to face. After the application of the surveys, statistical data will be obtained. analyzes will be made. One group will be given exercise, the other group will not be given exercise. Post-exercise surveys will be conducted again to check the effectiveness of the exercise.

Eligibility Criteria:
INCLUSION CRITERIA

* Being between the ages of 25-45.
* Having been a tea craftsman for at least 10 years.
* Having the ability to read and write Turkish.
* Agreeing to participate in the study voluntarily.

EXCLUSION CRITERIA

* Being diagnosed with a serious psychological illness.
* Malignancy
* Advanced osteoporosis
* Being under 25 years of age.
Dedicated Sheath Feasibility Study

Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).

This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.

During the study, the patient will undergo the following tests:

* Physical examination (includes blood pressure, age, height, weight).
* Echo assessments prior to procedure.
* Hemodynamic study prior and post BAV.
* Full blood count
* Angiography

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patient understands the implications of participating in the study and provides written informed consent.
* The patient has an indication for balloon aortic valvuloplasty (BAV).

Exclusion Criteria:

* Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
* Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

This is an open label, single-arm study designed to evaluate the safety and PK of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male or female subjects of any race, 12 to 16 years of age (inclusive).
* Verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian.
* Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.
* Target great toenail for all subjects, and both great toenails for subjects in the PK subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed.
* Subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation).

Key Exclusion Criteria:

* Females who are pregnant, nursing an infant, or planning a pregnancy during the study period.
* History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection.
* History of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject).
* Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).
Nitrofurantoin and Urinary Tract Infections (UTIs)

Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects.

This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.

Abstract:

Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo.

Study Design: Randomized double-blind placebo-controlled trial.

Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC.

Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test.

Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.

Eligibility Criteria:
Inclusion Criteria:

* Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital

Exclusion Criteria:

* Known drug allergy to nitrofurantoin
* A history of renal insufficiency
* Renal transplant
* Renal nephropathy
* A recent history of more than 3 Urinary Tract Infections (UTIs) per year
* Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).
Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy

Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).

The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.

Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.

Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.

It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone \< 1.7) for at least 6 months at the time of inclusion

Exclusion Criteria:

* WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Eligibility Criteria:
Inclusion Criteria:

* Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
* Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) \> 10 ppm at screening
* Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
* On stable antidepressant treatment for MDD (stable dose for at least 2 months)
* Major depressive episode, using DSM IV TR, in the past 2 years successfully treated

Exclusion Criteria:

* Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
* Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
* Current use of either bupropion or nortryptiline.