cyrilzakka/clinical-trials huggingface dataset:
Effects of the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults.

The blood, urine, and feces samples of the subjects need to be collected at 0,4 and 8 week and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. Randomized grouping was used to provide probiotic BL21 or placebo intervention. The total duration of the study is 8 weeks, including 8 weeks (1-8 weeks) of intervention expectations. The subjects were followed up at weeks 2 and 6, and sampled at weeks 0, 4, and 8. After the intervention during the follow-up period, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity;
2. Willing to take the test formulation daily during the study period;
3. Subjects who understand clinical research and commit to complying with research requirements and procedures.

Exclusion Criteria:

1. Patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications;
2. Patients with severe allergies and immune deficiencies;
3. Pregnant, breastfeeding, or expectant women during the study period
4. Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.);
5. Have a history of intervention with lipid-lowering drugs or health products within the past 2 months;
6. Individuals who have used antibiotics within the past two weeks;
7. Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy
8. Subjects deemed unsuitable by other researchers to participate.
Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin

This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)

Exclusion Criteria:

* (1) Patients with gastric or duodenal ulcer (in the active \[A1, A2\] or healing \[H1, H2\] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.

This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group.

Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice.

The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.

Eligibility Criteria:
Inclusion Criteria:

Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan

Exclusion Criteria:

* A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
* Bleeding tendency
* For scheduled endoscopic treatment
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy

The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.

A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy

Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)
* Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry

Exclusion Criteria:

* Non-response to antipsychotic treatments for manic symptoms in previous episodes
* A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1. Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) \>8.5%, 2. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
* An absolute neutrophil count (ANC) of 1.5 x 10\^9 per liter
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults

The purpose of this study is to describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults.

A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety, insulin and blood glucose were measured at baseline and selected intervals pre- and post-meal.

Eligibility Criteria:
Inclusion Criteria:

* normal body weight

Exclusion Criteria:

* breakfast skippers
* smokers
* dieters or individuals with diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases
Role of Genomic Imprinting in Cancer Diagnosis

The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
* Biopsy samples available.
* Male or female patients aged ≥ 18 years.
* Participants signed informed consent form.

Exclusion Criteria:

* Age under 18 years.
* Severe cardiovascular diseases.
* Central nervous system diseases.
* Mental disorder.
* Pregnant.
* Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.
Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis

It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.

Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.

Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.

Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.

The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
* Patients with low to moderate disease activity (DAS28 ≤5.1)
* No pharmacological treatment changes for RA in the last 3 months
* Have not had any surgery in the last 6 months
* Understand and cooperate with testing guidelines
* to be literate

Exclusion Criteria:

* Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
* Pregnancy
The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects

Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 and older
* Patients Fitzpatrick skin phototype IV-VI
* Patient able to understand requirements of the study and risks involved
* Patient able to sign a consent form

Exclusion Criteria:

* A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* A known history of photodermatoses
* A known history of melanoma or non-melanoma skin cancers
* Those planning on going to the tanning parlors
* Using any of the photosensitizing medication within the visible light range or additional medications at the discretion of the investigator (examples include (but not limited to) thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole)
* A woman who is lactating, pregnant, or planning to become pregnant
* Patient planning on exposing the irradiated or control areas to the sun
* known allergy to anesthetics (lidocaine or epinephrine)
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders

This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation biomarkers in HIV-infected immunological non-responders.

About 120 patients will be recruited from 4 HIV/AIDS clinical centers in China and randomized 1:1 into intervention group and placebo-controlled group. Triptolide wilfordii (20mg tid po) would be given to invention group for 24 weeks. T cell activation and inflammation biomarkers including CD8+HLA-DR+CD38+, IL-6, D-Dimer and high-sensitivity C-reactive protein (hsCRP), protein degradation-1 (PD-1), Ki67 ,soluble CD14 and CD163, PD-1, CCR5 and CD57 would be tested. Patients in placebo-controlled group will change to take Triptolide wilfordii (20mg tid po) for another 24 weeks. All patients will be followed up till 48 weeks. We hypothesis that Triptolide wilfordii might reduce immune activation and inflammation of HIV immunological non-responders and increase CD4 T cell count, which provides a new strategy for treatment of HIV-infected immunological non-responders.

Eligibility Criteria:
Inclusion Criteria:

* Continuous antiretroviral therapy \> 24 months ， and consistent HIV-RNA\< 40 copies/mL more than 12 months ;
* 18-65 years old;
* Male or female;
* Good adherence and promise to follow-up;
* Inform Consent signed;
* CD4 T cells less than 250/ul .

Exclusion Criteria:

* Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
* hemoglobin (HGB) \< 9 g/dl 、 white blood cell (WBC) \< 2000/ul 、 granulin (GRN) \< 1000 /ul 、 platelet (PLT) \< 75000 /ul 、 Cr \>1.5x ULN 、 ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN) 、 total bilirubin (TBIL) \>2x ULN 、 creatine kinase (CK) \> 2x ULN;
* Pregnant or breastfeeding woman or woman with pregnancy plan;
* Active drug-user;
* Severe neurological defects;
* Active alcohol abuse;
* Severe gastrointestinal ulcer .
* End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc
* Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

The purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.

Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in DNA repair pathways. Non-BRCA deficiencies in homologous recombination DNA repair genes could also enhance tumor cell sensitivity to PARP inhibitors. Therefore, PARP inhibitors are also selectively cytotoxic for cancer cells with deficiencies in DNA repair proteins other than BRCA1 and BRCA2.

In melanoma, genetic HR mutation/ alterations are rather common. Retrospective data showed that nearly18-40% of melanoma harbors a mutation in at least 1 of the HR genes in their tumor. The commonly altered genes were ARID1A, FANCA, ATM, BRCA1, ATRX and BRCA2, ATR, BRCA1 BRIP1 and SF3B1. These findings indicate that HR mutations / alterations are frequently observed in metastatic melanoma, and they suggest that PARP inhibitors could potentially be of a great clinical value in a substantial portion of the patients with advanced melanoma.

In this clinical study, clinical efficacy of fluzoparib in combination with camrelizumab and temozolomide will be evaluated by assessing an objective clinical response rate in patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma;
2. Must have genetic HR and/or SF3B1 mutation/ alteration;
3. Must have measurable disease based on RECIST 1.1;
4. Must have an ECOG performance status of 0 to 1;
5. Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline;
6. Anticipated overall survival more than 3 months;
7. Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

1. Previously treated with a PARP inhibitor;
2. Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
5. Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;
Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent

This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to provide inform consent
2. Patients must be ≥ 18 years of age at the time of consent
3. Estimated life expectancy ≥ 12 months.
4. Body mass index (BMI) \<35
5. Patients to whom the DUO Venous Stent can be implanted according to the IFU (this includes acute iliac deep vein thrombosis (DVT), post-thrombotic syndrome, non-thrombotic iliac vein compression (e.g. May-Thurner), non-thrombotic iliac vein compression (e.g. compression from ecstatic or tortuous iliac arteries))
6. As per IFU, clinically significant symptomatic venous outflow obstruction in the iliac venous segment, associated by at least one of the following:

   * CEAP score ≥3
   * VCSS pain score ≥2
7. Subject is willing and able to comply with physician's recommendation for compression therapy -

Exclusion Criteria:

1. Presence or history of clinically significant pulmonary emboli within 180 days prior to enrolment.
2. Uncontrolled or active coagulopathy or known, incorrectable bleeding diathesis
3. Prior surgical or endovascular procedure of the target vessel except for catheter-directed or mechanical thrombolysis for DVT within 90 days prior to the index procedure or prior venoplasty
4. Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
5. Previous stenting of the target vessel
6. Combination of stents from different manufacturers
7. Participation in another investigational study in which the subject has not completed all primary endpoints or which involves any investigational drug or device that may potentially confound the results of the study
8. Other comorbidities that, in the opinion of the investigator, would preclude the patient from receiving this treatment and/or participating in study-required follow-up assessments
9. Women who are pregnant or lactating
10. Suspected alcohol or drug abuse
11. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.

The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases.

Main Objective: to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of health professionals in primary care on the empowerment of patients with chronic diseases.

Methodology:

Design: cluster randomised controlled.

Scope: primary care centers (PCC) belonging to the Regions of Catalonia, Madrid and Canary Islands.

Population: primary care health professionals (family doctors and nurses).

Sample size: 270 healthcare professionals and 1382 patients.

Randomization: Randomization unit: PCC; unit of analysis: primary care health professionals. 9 pairs of PCC by region will be randomly selected and randomly assigned to the intervention or control group. Randomization will be performed after the selection of professionals and patients.

Intervention: the intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.

Measurements: the primary outcome will be measured by Patient-Provider Orientation Scale (PPOS) questionnaire at baseline and 12 months. Secondary outcomes: sociodemographic of professionals; sociodemographic and clinical characteristics of patients; Patient Activation Measure (PAM) questionnaire for patient activation; outcomes regarding use of the CdP.

Analysis: A linear mixed-effects regression to estimate the effect of participating in the CdP will be estimated. Additionally, an analysis of how the CdP is functioning through techniques of social network analysis and control charts will be performed.

Eligibility Criteria:
Inclusion Criteria:

Clusters:

* Primary Care Centres (PCC) with Electronic Record system with more than 1 year of implementation
* PCC belongs to the Automonous Comunities of Canary Island, Catalonia and Madrid

Healthcare professionals:

* Acceptance to participate
* stable contract with the Primary care centre
* Physician or Nurses

Exclusion Criteria:

Clusters:

- Primary Care Centres where its directors do not accept to participate in the trial

Healthcare professionals:

* Students
* Medical and Nursing residents