cyrilzakka/clinical-trials huggingface dataset:
Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).

This study is for patients who will be having a blood/marrow transplant (BMT) to treat leukemia, lymphoma or other cancer of the blood. The blood or marrow cells will come from another person (donor)-allogeneic BMT. Bacterial infections and acute graft versus host disease (AGVHD) are frequent complications of allogeneic BMT. Bacterial infections sometimes happen because injury to the gut during transplant allows gut bacteria to cross the injured gut barrier and get to the blood. AGVHD happens when certain white blood cells, called T-cells, in the donor cells (the graft) attack the patient's body.

Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).

Eligibility Criteria:
Inclusion Criteria:

1. Allogeneic HSCT recipients between the ages of 2 and 21 years.
2. Underlying hematologic malignancy, regardless of donor type or graft source.
3. Myeloablative conditioning regimen.

Exclusion Criteria:

1. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
2. Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens induce minimal myelosuppression and gut injury, patients receiving them probably stand little to gain from antibiotic prophylaxis.
3. Patients with ongoing bacterial, viral or fungal active infections are not eligible for this study. Patients who remain on broad spectrum antibiotics for the treatment of a previous infection are not eligible.
4. The use of prophylactic antibiotics is not permitted.
5. Following the standard practice in blood and marrow transplantation, pregnant or breast feeding patients will be excluded
Valvular Heart Disease Registry

Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.


Eligibility Criteria:
Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent
Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms

(b) The investigators propose to conduct a four-week randomized controlled crossover trial on healthy adults with occasional sleeplessness to examine the efficacy of Wholetones music on their health-related quality of life, sleep quality and quantity, anxiety/stress levels, mood, and EMFIT sleep tracker data. Baseline sleep data will be obtained for the first week of the study. Using a crossover design, each participant will then be randomized for 10 days to each of the following two conditions: (1) Wholetones music and (2) classical music. The participants will be instructed to listed to the music for 30 minutes prior to sleep each night. The self-report assessments will be taken at Day 0 (baseline), Day 7, Day 17, Day 21, and Day 31. The participants will also complete a sleep daily survey and use the EMFIT tracker nightly. It is hypothesized that the music conditions will result in improved sleep behaviors and self-report health outcomes compared to the classical music condition. It is also hypothesized that a dose-response will be evidenced with stronger effects found for Wholetones music compared to the classical music.

To determine if the Wholetones® or classical music was successful at alleviating symptoms of insomnia or sleeplessness when compared to not listening to any music, self-report data from large surveys was collected both at baseline, and during the interventions at day 17 (after the first music condition), and at day 31 (after the second music condition. Participants also completed daily diaries which was comprised of 6 questions that assessed their music adherence, sleep quality, and music likeability. These were completed daily from baseline through to the end of the study.

Objective data was also collected during baseline period of 1-week, throughout both of the interventions (10 nights each for a total of 20 nights) and the washout period (4 nights) using the EMFIT tracker. This device relies on ballistocardiography, was used to objectively assess nighttime sleep in the natural environment. This sleep tracker is automatic, autonomous, and is installed under the mattress.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia Index score indicating occasional sleeplessness

Exclusion Criteria:

* BMI over 34
* smokers
* heart conditions
* sleep apnea
A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes

This study is to evaluate the efficacy of a postbiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics postbiotic) and placebo.

The SlimBiotics postbiotic formula is the first plant-based postbiotic targeting weight management and metabolic health. Other competing postbiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal)

This product contains L. fermentum K8 Postbiotic.


Eligibility Criteria:
Inclusion Criteria:

* Women \& Men
* 18+
* BMI between 25-32 (average BMI of subjects shall not exceed 30)
* Generally healthy - don't live with any uncontrolled chronic disease
* Own a sleep-tracking device (smart watch etc.)

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Subjects currently enrolled in another clinical study
* Subjects having finished another clinical study within the last 4 weeks before inclusion
* Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
* Condition after implantation of a cardiac pacemaker or other active implants
* Sulfonylurea treatment
* Any disease or condition which might significantly compromise the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
* History of or present liver deficiency as defined by Quick \< 70%
* Regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.)
* History of hepatitis B, C, HIV
* Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which - may cause protocol deviations
* Simultaneous study participation by members of the same household
* Pregnancy and lactation
* Ascites as assessed by sonography
* Any diet to lose body weight
* Eating disorders or vegan diet
* Anorexia drugs Present drug abuse or alcoholism
Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

This retrospective cohort study was intended to analyze the incidence and risk factors of perioperative severe cardiovascular events in patients with diastolic dysfunction.

The investigators retrospected patients underwent noncardiac surgery with pre-operative echocardiography and was diagnosed with diastolic dysfunction in 2015 in Peking University First Hospital. Patients' perioperative data were collected. Major adverse cardiovascular events(MACE), other complication incidence, and post-operative hospital stay were reviewed. propotional harzad ratio cox survival model was established. Risk and protective factors relative to MACE were analysed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older, with echocardiographic diagnosis of left ventricular diastolic dysfunction (while ejection fraction was \> = 50%) conducted by cardiologist within 90 days before surgery.

Exclusion Criteria:

* congenital heart disease, moderate to severe valvular disease (stenosis or insufficiency), atrial fibrillation / atrial flutter, pericarditis, unsatisfied cardiac ultrasound image, ejection fraction \< 50%, ASA greater than 4, or Echocardiography is missing or incomplete.
My Diabetes, My Community

Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.

To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) \<7.5%, \<8.0%, or \<8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources.

Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.

Eligibility Criteria:
Inclusion Criteria:

1. History of type 2 diabetes
2. Seen in clinic within past year
3. A1C\>7.5%
4. Community dwelling
5. Access to personal email address OR internet access
6. Speaks and reads English
7. Resides in the target geographic region (zip codes)

Exclusion Criteria:

1. Unable to consent to study for themselves
2. Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
PediLoc® Blade Plate in Distal Femoral Osteotomies

Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. This study describes the surgical technique and retrospectively analyses consolidation rates of distal femoral osteotomies using this system, comparing them to distal femoral osteotomies using the DePuy Synthes® 90°LCP Pediatric Condylar Plate.

Materials and methods: A retrospective review was conducted for patients who underwent distal femoral osteotomy with the PediLoc® Blade Plate (Blade Plate) and the DePuy Synthes® 90°LCP Pediatric Condylar Plate (90°LCP-PCP) at the University Children's Hospital Zurich (2020-2024). Consolidation rates were assessed using Reborn-, Rust-, and modified Rust-scores at 6 weeks, 3 months, and 6 months postoperatively and compared using an unpaired t-test. Geometric planes of osteotomy were analysed, and a stepwise correction technique was described.


Eligibility Criteria:
Inclusion Criteria:

* All Patients that underwent distal femoral osteotomies
* informed consent

Exclusion Criteria:

* intraoperative technical error
* missing data
* missing IC
Excimer Laser, Serum Markers & Psoriasis

The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.

The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.

Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Male or female with diagnosis of psoriasis
* Psoriasis involvement of 5-15% BSA
* Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
* Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
* Fitzpatrick Skin Types I-VI

Exclusion Criteria:

* Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
* Any suspicion that the psoriasis is of the photosensitive variant.
* Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
Assessment of the Potential for Pressure Ulcer Formation

Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill patients. Pressure ulcers result in significant pain, changing quality of life, and often leading to significant morbidity and prolonged hospital stays, and ultimately increased the healthcare cost.

According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This survey also indicated that the highest rate of pressure ulcers is in the long term acute care population (22%).

Researchers developed a non-contact optical imaging technology call Spatial Frequency Domain Imaging which can identify the tissue regions that are at risk of developing pressure ulcers prior to development of irreversible tissue damage. The Spatial Frequency Domain Imaging can identify metabolic and biochemical differences in the tissues near bony prominences which are at risk for developing pressure ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older
* Diagnose with potential of pressure ulcers

Exclusion Criteria:

* No potential of pressure ulcers
* Has history of vascular disease in both lower extremities
TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.

PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed malignant ovarian germ cell tumors.

SECONDARY OBJECTIVES:

1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Age≤65 years; female, Chinese women;
* Histologically confirmed ovarian stromal tumor, including the following cell types:

  * Granulosa cell tumor
  * Granulosa cell-theca cell tumor
  * Sertoli-Leydig cell tumor (androblastoma)
  * Steroid (lipid) cell tumor
  * Gynandroblastoma
  * Unclassified sex cord-stromal tumor
  * Sex cord tumor with annular tubules
* Newly diagnosed, stage IIA-IVB disease;

  * Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.
  * May or may not have measurable residual disease.
* Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
* Performance status: Karnofsky score≥60;
* Provide written informed consent.

Exclusion Criteria:

* With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
* History of organ transplantation, immune diseases;
* History of serious mental illness, a history of brain dysfunction;
* Drug abuse or a history of drug abuse;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS

The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.

The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years old
* Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .

Exclusion Criteria:

* All other diseases with ovulation disorders or hyperandrogenism
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group

Eligibility Criteria:
Inclusion Criteria:

* new diagnosis of ALL
* TBIL≤34umol/L，Cr≤120umol/L，a normal EF
* age \<18 years

Exclusion Criteria:

* patients with uncontrolled infection
* patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis

The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis.

Hypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. However, there is a lack of studies that determine its effectiveness and clinical utility.

The aim of the study will be to analyze the effects of Hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature.

A case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* primiparous or multiparous
* abdominal diastasis previously diagnosed
* commitment to perform, at least, 80% of the exercises
* signed informed consent

Exclusion Criteria:

* BMI \> 40 Kg/m2
* pelvic floor disorders before childbirth
* drugs with effects on continence or functional properties of the pelvic floor muscles
* treatment for abdominal diastasis in the last 6 months
* systemic disease that impairs pelvic floor physiology and urination
* menopause
* contraindications to the practice of physical exercise and physical therapy
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.


Eligibility Criteria:
Inclusion Criteria:

* Participants of ASA class 1 to 2.
* Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Exclusion Criteria:

* Participants in whom a difficult intubation because of anatomical malformations is expected.
* Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
* Participants known or suspected to have a (family) history of malignant hyperthermia.
* Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
* Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg\^2+.
* Participants who have already participated in this trial.
* Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.