cyrilzakka/clinical-trials huggingface dataset:
Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers

This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.

Participants will go through an initial washout maintaining a low-fiber diet for 14 days. After washout, participants will be instructed to consume 100 grams of durian pulp every day following their breakfast or dinner for 1 week. Participants will then continue to consume 200 grams of durian pulp every day during the 2nd week of intervention and then will go through another washout for 2 weeks. During the intervention period, participants will be informed to maintain low-fiber diet. All participants will be required to note down their stool consistency and stool frequency and 3-days dietary records. Stool and blood samples will be collected at 4 time points during the study period (baseline, 1-week of intervention, 2-weeks of intervention and 2-weeks washout) and will be stored at -80 °C until analysis.

The first outcomes of this study will provide insights into the interplay between durian consumption, gut microbiome, and host metabolome, as well as whether durian consumption can improve the clinical parameters (plasma glucose levels, lipid profiles and HbA1c levels) of healthy subjects. The interplay between diets, gut microbiome, host metabolome and genetic polymorphism data in healthy population will lay the groundwork to develop the precision nutrition strategy based on our regional food. These findings have potential to improve the health and well-being of the communities in our region.

Eligibility Criteria:
Inclusion Criteria:

1. Male and/or female subjects between the ages of 21 and 60 years, inclusive
2. Willing and able to provide written informed consent
3. Must be in generally good health with clinically insignificant screening results (Fasting plasma glucose level \& Lipid profile), as determined by the Investigator
4. Agrees to consume durian for 2 weeks
5. Agrees to maintain a low-fiber diet during the intervention
6. Have not received any antibiotics therapy, consumed prebiotics, probiotics, symbiotic /vitamin supplement, and/or TCM for at least 1 month before the start of the study
7. Have not received any medical treatment that would impact on intestinal microbiota at least 6 months before the start of the study or during the study
8. Recent COVID-19 vaccination received or infection with COVID-19 at least 2 months ago

Exclusion Criteria:

1. Known or suspected sensitivity/allergy to durian
2. Multiple food/drug allergies
3. Smoker
4. History or presence of current metabolic conditions and gastrointestinal diseases
5. Diagnosed with Inflammatory Bowel Disease (IBD) or significant liver enzyme abnormality
6. Presence of current haemorrhoids or piles causing rectal bleeding when passing stool
7. Pregnant, breastfeeding or intending to conceive during study period
Effect of Incentive Spirometer and Pursed Lip Breathing After Whipple Procedure.

Whipple procedure is one of the most complex surgeries among hepatobiliary surgeries. It has named as Pancreaticoduodenectomy. It can cause many PPCs. Lung volumes are reduced due to atelectasis and pneumonia. Incentive spirometer (IS) is used to prevent PPCs. Due to general anesthesia, atelectasis is among most frequent PPCs. Pursed Lip Breathing (PLB) supports the patient to control the breath. The shriveling lips provide resistance to the air flowing out of the lungs. Airway collapse can be prevented by prolonged exhalation. Dyspnea occurs during 6MWT when patient performs walk in corridor. The aim of this study is to check the effect of Incentive Spirometer and Pursed Lip Breathing to improve dyspnea, oxygen saturation and hospital stay after Whipple procedure. This research of RCT will check the effect of IS and PLB by taking sample size of 60 post-operative patients through convenient sampling technique by allocating them randomly in group A and group B. Group A will receive PLB and group B will receive IS with baseline treatment chest percussions up to the duration of every day till discharge (reading will be collected on every 4rth day), dyspnea will be assessed through 6MWT and measured by Modified MRC dyspnea scale. The data will be analyzed through SPSS 26.


Eligibility Criteria:
Inclusion Criteria:

* Age (45 to 70)
* Type of Abdominal Surgery (Whipple Procedure) (11)
* Gender (Male and Female)
* Patients who has no history of pulmonary disease
* Smokers and nonsmokers

Exclusion Criteria:

* COPD (COPD patient with postoperative whipple procedure)
* Heart patient (patients who had history of heart disease along with whipple procedure)
* Uncontrolled Hypertension (patients who has have history of uncontrolled hypertension in postoperative whipple procedure)
X-3 Polyethylene Survival Outcomes Study

The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected.

It is hypothesized that X3 would perform equally well to N2Vac at 10 years.

This is a prospective, randomized and blinded clinical trial. Participants will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3, both FDA approved via 510k clearance) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. Specifically, the primary endpoint will be the revision rate at ten years. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled patient.

Eligibility Criteria:
INCLUSION CRITERIA:

1. Subjects willing to sign the informed consent.
2. Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
3. Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
4. Subjects requiring a primary total knee replacement.
5. Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
6. Subjects with intact collateral ligaments as determined by the surgeon investigator.

EXCLUSION CRITERIA:

1. Subjects with inflammatory arthritis.
2. Subjects with a history of total or unicompartmental reconstruction of the affected joint.
3. Subjects that have had a high tibial osteotomy or femoral osteotomy.
4. Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
5. Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
6. Subjects that are immunologically compromised, or receiving chronic steroids (\>30 days).
7. Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis.
8. Subjects with knee fusion to the affected joint.
9. Subjects with an active or suspected latent infection in or about the knee joint.
10. Subjects that are prisoners.
Febrile Whole Blood Specimen Collection and Testing

Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. Study site will test whole blood samples received from collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data generated will demonstrate product specificity when testing febrile whole blood samples.

Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will be advised of collection requirements specific to patient population with the goal of collecting samples form patient between the ages of 2-89 years of age. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor. Samples must be shipped to MRIGlobal or designated study site on the day of collection.

Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients (anticoagulant: K2EDTA or defined alternative) from each patient enrolled into the study. Patients may not be enrolled in the study more than once. Patients considered for enrollment will be logged on an enrollment log. Log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor.

Study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. Sample testing must be performed in accordance with the Applied Biosystems™ Bacillus anthracis Detection Kit instructions for use.

At study start, study site will test whole blood samples received from collection sites daily (e.g. Tuesday, Wednesday, Thursday, and Friday) using the Applied Biosystems™ Bacillus anthracis Detection Kit. No reference testing will be required since the study is designed only to demonstrate product specificity. Samples are assumed to be negative for Bacillus anthracis. A minimum of 50, but likely 100 febrile whole blood samples will be tested at MRIGlobal.

Data generated will demonstrate product specificity when testing febrile whole blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Fever

Exclusion Criteria:

* None
Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy

Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.

Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
* Patients at or over 17 years

Exclusion Criteria:

* Previous thyroid surgery
* Patients below 17 years
A PK and Salvage Study for Children With HIV-infection

To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai children.

The PK and 24 week data has been published in Pediatric Infectious Diseases Journal. It showed that plasma drug concentrations of saquinavir, lopinavir and ritonavir were at the higher limits of expected ranges for adult treatment at approved dosages (1000/100 mg BID for saquinavir, 400/100 mg BID for lopinavir/r). The regimen was well tolerated and showed significant CD4 rise and VL decline at 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV-1 infection by HIV-DNA PCR if \< 18 months old or by HIV ELISA if greater than or equal to 18 months old
2. Subject is less than or equal to 16 years of age at the day of the first dosing.
3. Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.
4. Results of biochemistry and haematology testing should be within pre-specified ranges.
5. Subject is able to swallow capsules
6. Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

1. History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.
2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
3. Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.
4. Use of any of concomitant medication, including the drug listed below, that may interfere with the pharmacokinetics of LPV/r or SQV.

   * NNRTIs
   * Rifampicin
   * Rifabutin
   * Phenobarbital
   * Phenytoine
   * Carbamazepine
   * Dexamethasone
   * Ketoconazole
   * Clarithromycin
5. Pregnancy
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

The basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo.

The exercise task is intended to be fatiguing and demanding but is not expected to create failure.

The supplement makes claims related to boosting exercise performance and reducing fatigue.

The study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults.

The primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* physically active
* non-smoker

Exclusion Criteria:

* known cardiovascular, pulmonary, or metabolic disease
* body mass index greater than 35
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing total shoulder arthroplasty (not a reverse)
* Age ≥ 18 years
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
* ASA patient status I-III patients
* Weight Greater than or equal to 50 kg

Exclusion Criteria:

* Contraindications to an interscalene block or phrenic blockade
* Infection at injection site
* Pre-existing neurological dysfunction affecting the operative extremity
* Chronic pain diagnosis or opioid use \>40mg oxycodone daily equivalents or use of long-acting opioids
* BMI \>40
* Uncontrolled diabetes (A1c \>8.0)
* Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery
* Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)
* Patients who are wards of the state
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
* Patients with moderate-severe hepatic or renal impairment
Golidocitinib Plus CHOP in Newly Diagnosed PTCL

This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years;
* Histopathologically confirmed diagnosis of PTCL of one of the following subtypes: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) Anaplastic large cell lymphoma (ALCL); or (4) other PTCL subtypes considered eligible by the investigator;
* Patients must have at least one measurable lesion according to the Lugano 2014 criteria: For lymph node lesions, the measurable lymph node must have a long diameter \>1.5 cm; for non-lymph node lesions, the measurable extranodal lesion must have a long diameter \>1.0 cm;
* ECOG performance status score of 0-3;
* Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, and hemoglobin (HGB) ≥90 g/L (for patients with bone marrow involvement, ANC can be relaxed to ≥1.0×10\^9/L, PLT to ≥50×10\^9/L, and HGB to ≥75 g/L);
* Adequate organ function: alanine aminotransferase (ALT) \<3 times the upper limit of normal (ULN), total serum bilirubin (TBIL) ≤1.5 times ULN, creatinine clearance ≥50 mL/min, and left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography.

Exclusion Criteria:

* Extranodal NK/T-cell lymphoma;
* History of acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmias, or significant QT interval prolongation (men \>450 ms, women \>470 ms) within the past 6 months;
* Uncontrolled active infection;
* ANC ≤0.5×10\^9/L, lymphocyte count ≤0.4×10\^9/L, PLT ≤75×10\^9/L, ALT ≥3 times the ULN, or creatinine clearance ≤50 mL/min;
* Presence of primary or secondary central nervous system (CNS) lymphoma at the time of enrollment;
* Pregnant or breastfeeding women;
* Patients who have received any investigational drug or radiotherapy within the past 4 weeks;
* Individuals deemed unsuitable for participation by the investigator;
The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Caucasian male
* Body mass index between 19 and 27 kg/m2
* Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (\< 42 mmol/mol)
* Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)

Exclusion Criteria:

* Liver diseases evaluated by plasma alanine aminotransferase (ALAT) \> 3 × normal level or an International Normalized Ratio (INR) below normal values
* Diabetes mellitus
* Nephropathy
* First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder
* Other diseases the investigator finds disruptive for participation in the study
Engaging Clinical Champions to Improve HPV Vaccination

This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert. Other clinics will receive the same training from a vaccine champion from their healthcare system.

The researchers will conduct a cluster randomized non-inferiority trial. The trial will compare two ways of delivering a communication workshop called Announcement Approach Training (AAT). AAT is designed to improve communication about HPV vaccination in primary care. The researchers will randomize clinics within participating healthcare systems. Some clinics will receive the training from an outside expert. Other clinics will receive the same training from a vaccine champion from their own system. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 12 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.

Eligibility Criteria:
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.

Inclusion Criteria

Clinics are eligible if they:

* provide primary care to children ages 9-12
* specialize in pediatrics or family medicine

Children's medical records will be eligible to be included in the dataset if children:

* are between the ages of 9-12 years at baseline
* are attributed to a participating clinic at 12-month follow-up

Exclusion criteria

Clinics are excluded if they:

* do not provide primary care to children ages 9-12
* have a specialty other than pediatrics or family medicine

Children's medical records will be excluded if children:

* are not between the ages of 9-12 years at baseline
* are not attributed to a participating clinic at 12-month follow-up
* are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications