cyrilzakka/clinical-trials huggingface dataset:
Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy after carpal tunnel syndrome (CTS). Although many conservative managements of UNE were found, their effectiveness were often unsatisfied without existed guideline. Recently, the perineural injection of 5% dextrose wate (D5W) is a novel management for CTS but its effect for UNE is not obviously as CTS. Hence, it is very important to find another novel injectate for UNE.

The platelet-rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Our previous research shown single injection with PRP was superior to D5W for CTS. However there is no study investigating the effect of PRP for UNE now. Hence, the purpose of this study was to assess the effect of perineural PRP injection for UNE.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-80 year-old.
2. Diagnosis as ulnar neuropathy at elbow at least one month

Exclusion Criteria:

1. Cancer
2. Coagulopathy
3. Pregnancy

3. Any active infection status 4. Polyneuropathy of upper extremity 5. Brachial plexopathy 6. Thrombocytopenia Previously undergone wrist surgery or steroid injection for ulnar neuropathy
Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.

This study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. The purpose of the PACTS Intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.

Eligibility Criteria:
Inclusion Criteria:

* Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units
* English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)
* Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.

Exclusion Criteria:

* Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population
Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes.

Patients who are not eligible for either cryocompression or cryotherapy are included in a control group.

The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.

In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period.

The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group.

Additionally every patient (excluding the control group) receives cryotherapy for the feet.

Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.

Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer or other gynecological tumors
* planned neoadjuvant, adjuvant or palliative chemotherapy
* \</= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
* at least three cycles of chemotherapy with taxanes
* written consent
* 18 years and older

Exclusion Criteria:

* PNP \>/= 2
* neuralgia
* metastases in bones, metastases in soft tissue (located in skin, hands or feet)
* Raynaud syndrome
* peripheral arterial ischemia
* hand-feet syndrome
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
* Outpatient status as enrollment

Exclusion Criteria:

* Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy

The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

This is a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel-group study in patients with essential hypertension who fail to respond adequately to telmisartan (Micardis) 40 mg monotherapy.

After a screening and a 2-week washout period (screening period), the patients will enter 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy to assess eligibility. The study will be terminated for those who have responded to telmisartan (Micardis) 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy (mean seated DBP \< 90 mmHg). About 200 patients not responding adequately to telmisartan (Micardis) 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan (Micardis) 40 mg or a fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg (double-blind treatment period).

Study Hypothesis:

The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis) 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Comparison(s):

For the primary comparison the change from baseline in mean stated trough DBP at the end of the 8-week double-blind treatment will be expressed.

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertensive patients who meet all the criteria as follows:

  * Mean seated DBP must be \>= 95 and \<= 114 mmHg at Visit 2
  * Mean seated SBP must be \>= 140 and \<= 200 mmHg at Visit 2
  * Mean seated DBP must be \>= 90 and \<= 114 mmHg at Visit 3
  * Mean seated SBP must be \<= 200 mmHg at Visit 3

Exclusion Criteria:

* Patients taking 4 or more anti-hypertensive medications at Visit 1
* Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis

This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA).

A total of 120 elderly individuals with Knee Osteoarthritis (KOA) will be recruited and randomly assigned into four groups using a digital randomization method: low-intensity group (n = 30), medium-intensity group (n = 30), high-intensity group (n = 30), and control group (n = 30). The elderly individuals in the low-, medium-, and high-intensity groups will receive five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps will perform an isometric contraction and relaxation for 1 second each. The low-, medium-, and high-intensity groups will perform 10, 20, and 30 repetitions per set, respectively, of Muscle Isometric Contraction (MIC) (guided by a rhythmic timer), completing a total of 10 sets with a 30-second rest between sets. The entire intervention will last for 16 weeks. Researchers will follow up with participants weekly to complete exercise record forms, ensuring that all subjects maintain their original lifestyle and dietary habits. The study aims to compare the effects of three different intensities of MIC on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with KOA.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 60 to 80 years;
* Based on the diagnostic criteria for knee osteoarthritis (KOA) established by the American College of Rheumatology in 2001, participants with KOA graded 1 to 3 were selected;
* Compliance with the Declaration of Helsinki and signing of the informed consent form.

Exclusion Criteria:

* Cardiovascular diseases;
* Need for surgery or pharmacological treatment in the near future;
* Neuromuscular diseases;
* Currently engaged in regular exercise.
Sono-ease Device for Internal Jaguar Vein Cannulation

A novel device attached to ultrasound probe designed to increase success rate and safety of internal jugular vein cannulation.


Eligibility Criteria:
Inclusion Criteria:

* all patients indicated for IJV catheterization

Exclusion Criteria:

* neck deformities-coagulopathy
Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods

In recent years, biologics (such as infliximab, adalimumab, vedolizumab, and ustekinumab) have shown great potential in the treatment of inflammatory bowel disease (IBD), transforming the traditional treatment model for IBD. Despite achieving good efficacy, some patients do not respond to biologics, which may be related to low drug concentrations in the blood. Guidelines recommend therapeutic drug monitoring (TDM) during the treatment of IBD. Currently, many commercial testing methods are available to detect the trough levels of biologics; however, data on the diagnostic accuracy and practicality of these methods remain limited. This study compares the detection of blood samples from IBD patients after administration using ELISA, PICA, and CLIA methods, aiming to provide more accurate guidance and evidence for TDM in Chinese IBD patients undergoing biologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) .

Exclusion Criteria:

* Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice

This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.


Eligibility Criteria:
Inclusion Criteria:

* Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening

Exclusion Criteria:

1. Unable to provide written informed consent
2. Any woman who is known being pregnant at screening
3. Subject who is participating or going to participate in another study which involves GARDASIL administration
Antibiotic Resistance in Global Pediatric Oncology Centers

Antibiotic resistance is one of the major health threats facing global as well as domestic populations, however it is not well characterized in pediatric patients. Pediatric patients receiving cancer-directed therapy have several risk factors implicated in development of antibiotic resistance including multiple courses of antibiotics, repeated exposures to the hospital environment, indwelling devices and chemotherapy-related damage to mucosal barriers. The investigators propose to capitalize upon the unique position of St. Jude Global within the global pediatric oncology community by using its regional alliance network to describe the molecular epidemiology of antibiotic resistance in Gram-negative bacteria in this population.

Primary Objectives

1. Describe the epidemiology and the phenotypic and previously determined molecular determinants of antimicrobial resistance in Gram-negative organisms isolated from pediatric diagnostic specimens in selected Central American and US sites with capacity to treat pediatric cancer
2. Utilize strain typing by whole genome sequencing to describe relatedness between organisms at participating sites

Participating clinical microbiology laboratories will flag any Gram-negative bacteria meeting inclusion criteria. Bacteria will be subcultured; one sample will be lysed and shipped to St. Jude; the remaining sample will be stored onsite for the duration of the study. Samples of bacteria from both oncology and non-oncology patients will be included. Whole genome sequencing will be performed on the bacterial samples at St. Jude and the genotypic and phenotypic antimicrobial resistance testing (AST) results compared. Genotypic results will additionally be used to describe phylogenetic relationships and potential transmission events both within and between sites.

Each participating location will collect limited clinical data corresponding to disease and treatment related factors on the affected patient. This will include sociodemographic variables, oncologic diagnosis, treatment phase, presence of a central venous catheter or other foreign body, antibiotic treatment within the past month, and previous history of colonization or infection by a resistant organism.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric (0-18 years of age) patients having a bacteria isolated from a sterile site (blood, cerebrospinal fluid, body fluid) or urine positive for a Gram-negative bacteria nonsusceptible to at least 1 of the following: third generation cephalosporin, fourth generation cephalosporin or carbapenem OR screening positive for carbapenemase or extended spectrum beta lactamase (ESBL) production.

Exclusion Criteria:

* Repeated isolation of the same organism from the same patient within the study period.
Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

This is a multi-center, expanded access protocol to provide access to the investigational product, abrocitinib, to adolescent and adult patients with moderate to severe atopic dermatitis who have inadequate treatment options with available and approved medicated topical and systemic therapies and who are otherwise ineligible for participation in clinical studies with abrocitinib.

This is a multi-center expanded access protocol (EAP) for the treatment of up to approximately 500 adult and adolescent (defined as age \< 18 years) patients with moderate to severe atopic dermatitis for whom standard, approved medicated topical and systemic treatment options are inadequate and who would be suitable candidates for a trial of abrocitinib for potential treatment of moderate to severe atopic dermatitis. The study will also collect safety and exploratory efficacy data. Participants who meet the inclusion criteria and none of the exclusion criteria may be enrolled into the EAP to receive open-label oral treatment with abrocitinib.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Clinical diagnosis of chronic atopic dermatitis for at least 6 months
* Inadequate treatment options with available, approved medicated topical and systemic therapies for moderate to severe atopic dermatitis
* Moderate to severe atopic dermatitis as indicated by at least one of the following: IGA ≥3; EASI ≥16
* Not eligible for participation in any ongoing clinical trial of abrocitinib, including lack of access due to geographical limitations

Exclusion Criteria:

* Medical, psychiatric, or laboratory abnormality that may increase the risk associated with study participation
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Require treatment with prohibited medications during the study
* Discontinued prior treatment with any systemic JAK inhibitor due to safety or tolerability issues
* 12 to \<18 years old without documented evidence of having received at least one dose of the varicella vaccine or without evidence of prior exposure to varicella zoster virus based on serological test
* Pregnant or breastfeeding women or women of childbearing potential who are sexually active and unwilling to use contraception
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for mitral valve repair.
* Patient able and willing to return to the implant center for follow-up visits.
* Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

* Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
* Evolving endocarditis or active endocarditis in the last 3 months.
* Heavily calcified annulus or leaflets.
* Congenital malformation with limited valvular tissue
* Patient requires mitral valve replacement.
* Previously implanted prosthetic mitral valve or annuloplasty ring/band.
* Patient requires aortic or pulmonic valve replacement or repair.
* Patient is pregnant (urine HCG test result positive) or lactating.
* Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
* Life expectancy of less than twelve months.
* Patient is participating in concomitant research studies of investigational products
The Effect of Exercise on Ovarian Reserve

The purpose of this study is to examine how different levels of physical activity impact the ovarian reserve during the pre-menopausal period

Two groups are included:

1. The study group: women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years
2. The control group: women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years

Women who meet the criteria for inclusion for will be recruited to the study after signing a consent form. Recruitment will be done through sport centers. The control group will include women being examined in gynecologic emergency department, after signing a consent form, if they meet the control group's inclusion criteria. These women will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information (see below). Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow.

Data collection:

1. Demographic information on age, weight, height, BMI, marital status
2. Medical information regarding chronic diseases and medications
3. Obstetrical history
4. Information regarding physical activities in the version of International Physical Activity Questionnaire .
5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5 pads).
6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone, Estradiol, Thyroid-stimulating hormone .
7. Antral Follicle Count, Anti-mullerian hormone
8. Leptin levels -reflecting metabolic changes.

Eligibility Criteria:
Inclusion Criteria:

Study group:

1. Women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
2. BMI 18-25
3. Regular menstruation

Control group:

1. Women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
2. BMI 18-25
3. Regular menstruation

Exclusion Criteria:

1. Polycystic ovary syndrome 2. Endometriosis 3. Diabetes 4. Hyper/hypothyroidism 5. BMI\>25, BMI\<18 6. Active or past eating disorder

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