cyrilzakka/clinical-trials huggingface dataset:
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults

The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.

Polyphenols may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. The aim of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults. Seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of four weeks. Participants will be asked to make two appointments to the university clinical lab. Anthropometric measurements (height, weight, waist circumference), blood and saliva samples will be taken during each of the 2 visits. Compliance will be tested by the measure of total polyphenols in a 24-hour urine sample in some random samples before and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary and a physical activity questionnaire will be collected before the start of the study and after four weeks. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor.

Eligibility Criteria:
Inclusion Criteria:

* Adults with no history of hypertension, diabetes and cardiovascular diseases
* BMI from 18-24.9 and BMI \>25
* Males and Females
* Age: 18-65 years

Exclusion Criteria:

* Participants with cardiovascular diseases, hypertension or diabetes
* Smokers and heavy alcohol drinkers
* Participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure
* Participants taking dietary supplements containing high doses of antioxidants
* Postmenopausal women taking HRT (Hormone Replacement Therapy)
* Participants who recently participated or are currently on a weight management program
* Participants with regular consumption of cocoa or DC (\> 1 serving/week)
Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.

Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.

First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.

Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.

Eligibility Criteria:
Inclusion Criteria:

* Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
* World Health Organization(WHO) risk score ≥7, and less than 13
* Age≤60 years; female, Chinese women
* Initial treatment is chemotherapy
* Performance status: Karnofsky score≥60
* Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(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,blood urea nitrogen, Cr≤ normal
* Provide written informed consent.

Exclusion Criteria:

* Patients with unconfirmed diagnosis of GTN
* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* WHO risk score less than 7
* With severe or uncontrolled internal disease, unable to receive chemotherapy
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents
* Unable or unwilling to abide by protocol
Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver

A 12-month prospective observational cohort study assessing eGDR's utility in diagnosing MAFLD (via FibroScan® CAP ≥248 dB/m) and correlating it with steatosis/fibrosis severity. Secondary aims compare eGDR to FLI/FIB-4 scores and identify optimal diagnostic cut-offs

Primary Aim

Determine eGDR's diagnostic accuracy for MAFLD using FibroScan® (CAP ≥248 dB/m) as the gold standard.

Secondary Aims

Correlate eGDR with MAFLD severity (steatosis via CAP, fibrosis via liver stiffness measurement \[LSM\]).

Compare eGDR's performance to Fatty Liver Index (FLI) and FIB-4 in detecting MAFLD and predicting fibrosis.

Identify optimal eGDR cut-offs for MAFLD detection (\<6 mg/kg/min) and advanced fibrosis staging (\<4 mg/kg/min).

Evaluate eGDR's reclassification improvement (net reclassification index \>10%) over existing scores.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Suspected/confirmed MS per IDF criteria:
* Central obesity (waist circumference ≥94 cm \[men\]/≥80 cm \[women\]) plus ≥2 of: Triglycerides ≥150 mg/dL.

HDL \<40 mg/dL (men)/\<50 mg/dL (women). Blood pressure ≥130/85 mmHg or antihypertensive treatment. Fasting glucose ≥100 mg/dL or diabetes diagnosis.

Exclusion Criteria:

* Other liver diseases (viral/autoimmune hepatitis).

Alcohol intake \>20 g/day (men) or \>10 g/day (women).

Pregnancy, malignancy, advanced cirrhosis.

Medications affecting metabolism (e.g., steroids)
Home Blood Pressure Monitoring in Kidney Transplant Recipients

Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.

Adult kidney transplant recipients (n=458) will be randomized 1:1 to standard-of-care (SOC) or home blood pressure measurement (HBPM). The SOC group will target office blood pressure \<130/80 mmHg. The HBPM group will measure BP at home, twice morning and evening for (3-)7 days before routine clinical visits (ideally 28 measurements); the mean value from day 2-7 is used; target home mean BP is \< 125/80 mmHg.

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant recipient
2. Male or female subject ≥ 18 years old
3. Any or more of the following at the baseline clinic

   * Conventional office BP ≥130 mmHg systolic and/or ≥ 80 mmHg diastolic
   * HBPM ≥125 mmHg systolic and/or ≥ 80 mmHg diastolic measured within the last 3 months (see appendix 1 for details on methodology)
   * Daytime ambulatory blood pressure monitoring (ABPM) ≥125 mmHg systolic and/or ≥ 80 mmHg diastolic measured within the last 3 months
4. Signed informed consent and expected cooperation of the patient for the treatment and follow up.
5. Have a national personal identification number and not be expected to emigrate during study
6. Enlisted in the Norwegian Renal Registry

Exclusion Criteria:

1. Standing systolic BP \< 110 mmHg (to avoid adverse events). Measured after one and three minutes of standing. Not applicable if unable to stand due to wheelchair use.
2. Diagnosed atrial fibrillation (automated monitors not validated)
3. Unwilling to self-monitor
4. Female participant who is pregnant, lactating or planning pregnancy during the trial (management of essential hypertension in pregnancy is different)
5. Arm circumference too large or small to allow accurate BP measurement with available device (22-42 cm).
6. Any reason likely limiting adherence to interventions, as judged by the investigator; examples include active alcohol or substance abuse within the last 12 months, significant poor compliance with medications or attendance at clinic visits, residence in a nursing home, dementia, other medical or psychiatric conditions that may interfere with study participation.
7. Graft- or life expectancy less than 2 years, as judged by the investigator.
8. Current use of ≥ 4 antihypertensive medications
9. More than half of regular appointments planned as remote (e.g. phone or video) consultations.
10. Severe white-coat hypertension, e.g. patients already treated solely based on home BP values.
11. Multi-organ transplants (e.g. heart, lung, liver), though pancreas or beta-cell islet transplant is allowed.
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer

This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).

This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.

The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
2. Feasibility to undergo all procedures listed in protocol
3. Ability to provide written informed consent

Exclusion Criteria:

1. Prior diagnosis of prostate cancer
2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
3. Contraindication to prostate biopsy
Prognostic and Predictive Factors for Small Breast Tumors

Because of mammography screening increasingly more women are diagnosed with centimeter or subcentimeter node-negative breast cancer (i.e., T1abN0); these tumors account for approximately 19% of all newly diagnosed breast cancers in Sweden. Although the long term relapse-free survival rates among patients with such tumors is as high as ≥90%, some reports suggest that certain patient subgroups may have rates \<75%. Firmly established prognostic and predictive factors for patients with T1abN0 tumors are, however, lacking. This is a nationwide, register-based cohort study investigating prognostic and predictive factors in women with centimeter or subcentimeter breast cancer. The study hypotheses are: 1) Established prognostic and/or predictive factors in overall breast cancer are prognostic and/or predictive factors also in centimeter or subcentimeter node-negative breast cancer; 2) The established relative reduction in risk of recurrence and death of adjuvant treatment for overall breast cancer are similar in centimeter or subcentimeter node-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Female.
2. Operated for centimeter or subcentimeter breast cancer.

Exclusion Criteria:

1. Previous breast cancer.
2. Metastatic breast cancer at diagnosis.
Study of DMXAA (Now Known as ASA404) in Solid Tumors

This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.

This is a dose escalation study conducted at a single center in New Zealand. Patients received dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once every three weeks, up to a maximum of 12 courses.

Cohorts of 3 patients received escalated doses of DMXAA until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity.

Patients had solid tumors for which there was no standard therapy or were refractory to conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy
2. Performance status WHO 0-2
3. Life expectancy greater than 3 months
4. Hemoglobin at least 90 g/L; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
5. Bilirubin within normal limits; ALT less than 2 times upper limit of normal (ULN); Alkaline phosphatase less than 2 times ULN
6. Creatinine less than 130 umol/L
7. INR and APTT within normal limits
8. Fertile patients must use effective contraception
9. At least 4 weeks since prior anticancer therapy and recovered from toxic effects

Exclusion Criteria:

1. Concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin
2. Other serious medical condition
3. Uncontrolled infection or serious infection within the past 28 days
4. Pregnant or lactating
5. Treatment with glucocorticosteroids within previous two weeks
2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste

The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study
* Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
* Children ages 10-14 years at baseline.
* Presence of second molars or evidence of erupting permanent molars.
* Subjects should be of good general health as evidenced by a review of the medical history.
* Presence of two or more active caries lesions (ICDAS scores of 2 or greater) and with a previous caries experience (DMFS ≥ 2). Exclusion Characteristics
* Subjects presenting with any of the criteria below will be excluded from the study:
* Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
* Use of medication that could increase the risk of developing dental caries, i.e. medication that reduces saliva flow.
* Long-term antibiotic therapy.
* Children with cognitive and/or motor impairment.
* Severe malocclusion.
* Presence of severe caries (ICDAS 5 or 6) on five or more teeth.
* Evidence of moderate to severe periodontal disease.
* Participation in any other clinical study within the 30 days preceding the clinical study.
* History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
* Pregnant or lactating.
Validation of the Wisconsin Stone-QOL

The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are:

1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?"
2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"

The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed specifically for patients with kidney stones. Its development has been published. Internal and other validity tests on the instrument have been conducted and reported. Further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones.

Upon enrollment at each site, patients will be asked to complete a medical history form and the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3 months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys will usually be mailed to patients to the addresses they provide. Alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. At each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of kidney stones, either in the past or currently
* 18 years of age or older

Exclusion Criteria:

* Under 18 years of age
* No previous or current diagnosis of kidney stones
Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application

This was a single center, comparison among treatments, 8-week study of the efficacy and safety of Jet Floss EX.

Totally 72 eligible subjects were recruited in this study and randomly divided into 2 groups. During wash out phase (7 days before the study), subjects used distributed manual toothbrush and toothpaste every morning and evening to replace their own products. After that, subjects screened by dentist to ensure met the inclusion criteria. During treatment phase, for group1 (treatment group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (Jet Floss EX) twice a day. For group2 (control group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used auxiliary product (interdental brush) twice a day. During the study, any other oral care products and non-emergency oral treatment were not allowed.

Test Objective:To evaluate the efficacy and safety of test product by means of intraoral exams of BOP, PD, MGI, RMNPI, hard and soft tissues exams and selfassessment.


Eligibility Criteria:
Inclusion Criteria:

* Chinese men or women aged 18-60 years old;
* In general good health at the time of the study;
* Possess a minimum of 20 scorable teeth;
* Each quadrant has ≥4 inter tooth gaps that can be inserted by interdental brush；
* RMNPI≥0.6;
* BOP≥50%;
* MGI≥1.75;
* PD≤5 mm;
* There were no diseases that will affect the test results;
* Willing and able to participate as evidenced by signing of informed consent;
* Willing to comply with all study protocol requirements.

Exclusion Criteria:

* Intending to get pregnant, pregnant, lactating or within 6 months of delivery;
* Those who have known allergies against oral care product or have severe oral disease;
* Simultaneous participating in another oral study;
* Have any fixed facial orthodontic appliances or removable partial dentures;
* Severe presence of tartar or stain which will affect the test;
* Others whose participation in the study is determined inappropriate by the dentist.
Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum

Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.

Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.

All of these procedures are part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Normotensive postpartum women
* Singleton pregnancy
* Cesarean delivery

Exclusion Criteria:

* Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)
* Current diagnosis of hypertensive disease
* Skin rash in location of cuff placement
* Tobacco user
* Chronic narcotic user
* Vaginal delivery
* cognitively impaired persons
The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.

After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with steroid. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-85 year-old.
* Diagnosis was confirmed using an electrophysiological study and ultrasonography

Exclusion Criteria:

Cancer

* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS