cyrilzakka/clinical-trials huggingface dataset:
Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

The present study examined the effect of Montmorency tart cherry juice on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants consumed Montmorency tart cherry juice or a placebo beverage continuously for 7 days in a randomised, crossover trial. Outcome variables were measured immediately prior to supplementation and post-supplementation. Furthermore, on the 7th day of supplementation outcome variables were measured pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice would improve cardio-metabolic markers, particularly fasting insulin and systolic blood pressure. Furthermore, the study aimed to identify the mechanism of action for any effects of Montmorency tart cherry juice on blood pressure.


Eligibility Criteria:
Inclusion Criteria:

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:

1. Waist Circumference: \>102cm (men), \>88cm (women)
2. Fasting Serum Triglycerides: ≥1.69 mmol.L-1
3. Fasting High Density Lipoprotein: \<1.03 mmol.L-1 (men), \<1.29 mmol.L-1 (women)
4. Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
5. Fasting Plasma Glucose: ≥6.1 mmol.L-1

Exclusion Criteria:

* Smokers
* Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease
* Currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg)
* Allergy to fructose, maltodextrin or specific fruit products
* Currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs)
* Currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (\>14 units per week).
Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period

The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.

This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.

For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.

All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.

In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.

So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.

A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from cystic fibrosis
* Height between 90 et 130cm
* No respiratory exacerbation since 4 weeks
* Benefit from an insurance disease regime

Exclusion Criteria:

* Law-protected patient
* Patient's parent don't understand french language
* Opposition to participation
A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with RA
* Physician has decided, with the subject's consent, to begin treatment with infliximab
* Written informed consent form signed by both the subject and the physician.

Exclusion Criteria:

* Subjects who have previously been exposed to infliximab
SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment.

PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.

OBJECTIVES:

* Determine if polymorphisms resulting in greater activation of cyclophosphamide (CYP2B6, CYP3A4, and CYP3A5) are associated with disease-free survival and treatment toxicities in women with breast cancer.
* Determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (NQO1, NQO2, NOS2, NOS3, CBR3) are associated with disease-free survival and treatment toxicities in these patients.

OUTLINE: This is a multicenter study.

Tissue samples archived on clinical trial SWOG-8897 are genotyped for polymorphisms in the CYP3A4, CYP3A5, CYP2B6, NQO1, NQO2, NOS2, NOS3, and CBR3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. Variant alleles are correlated with patient outcome.

PROJECTED ACCRUAL: A total of 1,577 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Node-negative breast cancer
* Enrolled on clinical trial SWOG-8897

  * Archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment
* Hormone receptor status known

PATIENT CHARACTERISTICS:

* Female
* Pre- or post-menopausal

PRIOR CONCURRENT THERAPY:

* Not specified
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.

The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
* Ability to provide written informed consent prior to study-specific screening procedures
* TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
* Age 18 years or older
* Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
* Performance status 0-1
* Required Initial Laboratory Data:
* Granulocytes \>=1,200/µl
* Platelet count \>=100,000/µl
* Calculated Creatinine Clearance \> 30 mL/min
* Total bilirubin \<= Upper Limit Normal
* Alkaline Phosphatase \<=Upper Limit Normal
* SGPT, SGOT \<=Upper Limit Normal
* Normal chest x-ray

Exclusion Criteria:

* HER2 positive breast cancer
* Pregnant or lactating woman
* Life expectancy \< 3 months
* Serious, uncontrolled, concurrent infection(s)
* Any prior fluoropyrimidine therapy or other chemotherapy
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
* Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
* Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
* Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
* Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
* Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
* Any of the following laboratory values:
* Abnormal hematologic values (neutrophils \< 1.0 x 109/L, platelet count \< 100 x 109/L)
* Impaired renal function (estimated creatinine clearance \<30ml/min as calculated with Cockcroft-Gault equation)
* Serum bilirubin \> upper normal limit.
* SGOT, SGPT \> upper normal limit
Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients

This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.

This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.

All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.

Eligibility Criteria:
Inclusion Criteria:

1) age ranged from 16\~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. -

Exclusion Criteria:

* 1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy

The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy. It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients. Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.

This study is designed as stratified cluster randomized, parallel-control research. The HR+HER2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pCR are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery. After enrollment, the patients were stratified according to multiple gene test based recurrence risk level (High risk or Low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (Capecitabine) group or negative control group. The primary endpoint is 2-year disease free survival. The second endpoint is 5-year disease free survival (DFS), 2-year overall survival (OS), 5-year OS, safety of additional chemotherapy. The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients.

Eligibility Criteria:
Inclusion Criteria:

1. Invasive breast cancer at the first diagnosed
2. Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles
3. Neoadjuvant chemotherapy regimen should include anthracyclines and taxane
4. Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy
5. Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor)

Exclusion Criteria:

1. Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy
2. Pregnant breast cancer
3. IHC or FISH test of primary tumor confirmed HER2 positive at anytime
4. Complete fewer than 6 cycles chemotherapy before surgery
5. Deficiency of surgery after neoadjuvant
6. Contraindication of chemotherapy or surgery
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the AQUABEAM for treatment of LUTS resulting from BPH.

PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Male
* BPH symptoms

Exclusion Criteria:

* Serious concurrent medical conditions
Application of the Web-based Acceptance and Commitment Therapy for Depression

PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY

Acceptance Commitment Therapy (ACT) is known to help people recover from depression by improving psychological flexibility through acceptance, defusion, self-as-context, present moment, committed action, and helping them live a values-based life. This study is a randomized controlled trial to determine if web-based ACT leads to changes in the psychological flexibility and cognitive fusion. Also, through the functional MRI study, possible treatment mechanisms by which the web-based ACT exerts will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed major depressive disorder

Exclusion Criteria:

* Patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease
* Women who were pregnant or nursing
* Patients at high risk for suicide
Hemodialysis Frequency and the Calcification Propensity of Serum

The aim of this clinical research project is to test the hypothesis that daily dialysis has favorable effects on the calcification propensity of human serum, when determined by the investigators' newly developed in vitro serum test. The investigators' hypothesis is that shorter interdialytic intervals will result in an improved calcification propensity of serum. The determination of serum calcification has the potential to become a novel measure of dialysis quality in the future.

Background

The serum calcification test has been established and validated by A. Pasch and coworkers, the expertise to perform the necessary statistical analyses is present in the investigator's department, all patient-related procedures necessary for this project are routinely performed in the investigator's department.

Objective

Does short daily hemodialysis strengthen the calcification-inhibitory forces inherent in hemodialysis patient sera, when compared to conventional three-times weekly hemodialysis?

Methods

Serum calcification test

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis \>3 months
* Anuria (\<100ml urine per day)
* Written informed consent

Exclusion Criteria

* Citrate dialysis
* Significant fistula recirculation (\>15%)
* Infection
Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

This study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain.

The most common primary cause of pain and stiffness from the SIJ is sacroiliac joint dysfunction. Currently, conservative treatments for SIJ dysfunction-related pain include oral anti-inflammatory pain medications, exercise therapy, physical therapy, and local injection therapies such as corticosteroids, dextrose, and platelet-rich plasma. Although there are multiple non-surgical options available for SIJ pain management, clear treatment guidelines have not yet been established. Among these options, intra-articular corticosteroid injections in the SIJ are frequently used by rehabilitation specialists in clinical practice, and their effectiveness in relieving pain from SIJ dysfunction has been demonstrated. However, the effects of corticosteroids in treating musculoskeletal-related diseases are typically short-term. Extracorporeal shock wave therapy (ESWT) has become increasingly common in the management of musculoskeletal conditions such as calcific tendinitis, tennis elbow, and plantar fasciitis, showing long-lasting benefits and inducing tissue repair responses that studies suggest may last up to two years. However, literature on ESWT for lower back pain is limited, and research on its use for SIJ pain is even rarer. Therefore, this study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain, aiming to achieve rapid, short-term pain relief through corticosteroid injections, followed by potential long-term effects through ESWT.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain lasting for 3 months or more
* Pain VAS score of 4 or higher
* Three or more positive results in sacroiliac joint provocation tests
* At least 50% pain relief following ultrasound-guided sacroiliac joint injection with local anesthetic

Exclusion Criteria:

* Currently undergoing extracorporeal shockwave therapy in other areas
* Suspected pain caused by other lumbar spine or hip joint conditions (e.g., lumbar spine or disc disorders, radicular pain, spondylolisthesis/disc degeneration, hip arthritis)
* Presence of complex comorbidities, including trauma, systemic infections (e.g., fever, chills, night sweats), local sacroiliac joint infections, autoimmune diseases, or immunosuppression
* Sacroiliac joint injection therapy received within the past 6 months
* Contraindications for extracorporeal shockwave therapy (e.g., cancer or current/prior infections at the treatment site, pacemakers, pregnancy, epilepsy, or coagulation disorders caused by disease or medication)
* Impaired renal function preventing the administration of contrast agents for sacroiliac joint bone scanning
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers

This is a quasi-experimental study that will examine whether mindfulness based stress reduction, adapted to an online learning management system, will reduce factors related to burnout in private practice licensed clinical social workers in New York State.

Mindfulness Based Stress Reduction (MBSR) is an evidenced based intervention utilized to reduce stress. In this study, MBSR is adapted as psychoeducational/instructional videos to be viewed on a learning management system by licensed clinical social workers in order to determine its efficacy in reducing symptoms related to burnout in licensed clinical social workers.

The videos are 30 minutes in length, and designed to be watched once a day, Monday-through-Friday, over an eight-week period. Additionally, a coaching video of three minutes in length will be available to participants on Mondays. Participants will watch the videos and engage with the content and activities as prompted by the videos. Activities include guided meditations, guided mindfulness activities, such as body scans where participants notice the sensations they feel in various parts of their body, and relaxation exercises. Participants will also be asked to complete light exercises to their comfort level, which involves getting comfortable, light self-guided stretching, and relaxation exercises that are no more physical exertion than they otherwise might experience while moving around completing their normal tasks/activities of daily living outside of this program.

Participants will complete a pre-test involving two validated measures, and several Likert scale, non-validated questions, and demographic questions, and a post-test, involving the same two validated measures in the pre-test (in order to determine if a statistically significant change in stress reduction has occurred) as well as completing several non-validated Likert scaling questions, and qualitative questions to determine participant's attitudes and beliefs as it relates to their participation in this research project, and their overall impression of the project elements.

Eligibility Criteria:
Inclusion Criteria:

* Licensed Clinical Social Workers in New York State
* Working in Private Practice in New York State

Exclusion Criteria:

* Anyone who does not hold a license to practice clinical social work in New York State
* Anyone who is not working in private practice as a licensed clinical social worker in New York State
Sugammadex ED90 Dose in the Obese Patients

The purpose of this study is to determine the minimum effective dose of sugammadex, an antagonist of neuromuscular blockade used during anesthesia practice, in obese patients, considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg but no studies were found with obese patients.

Prospective study with the sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).

The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8 mg.kg-1.

The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of sequential electric stimuli) "train-of-four" (TOF).

After induction of general anesthesia and the calibration of the peripheral nerve stimulator and accelerometer, rocuronium 0.6 mg.kg-1 was injected.

Continuous intravenous infusion of the anesthetics propofol and remifentanil, and intermittent bolus of rocuronium were offered throughout the procedure.

Eligibility Criteria:
Inclusion Criteria:

* a body mass index ≥ 40 kg/m2
* bariatric surgery
* informed consent signed

Exclusion Criteria:

* history of neuromuscular diseases,
* use of drugs that could interfere with neuromuscular transmission,
* allergy to neuromuscular agents of the aminosteroids class,
* anticipated difficulty in airway management,
* renal failure