cyrilzakka/clinical-trials huggingface dataset:
A Cross-sectional Study on IBS Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions

The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes.

It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes. The primary outcome will be the distribution of IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship between CM pattern and their microbiota and metabolic profiling. The relationship between IBS subtype distribution and other predetermined factors will be assessed, including gender, age, weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview for DSM-5 Disorders-(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed. After the collection of serum, urine and stool samples, bacterial total DNA will be extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA and BA profiles in serum and feces will be tested as well.

Eligibility Criteria:
Inclusion Criteria:

* 1) meet of diagnosis of IBS(ROME 4); 2) age of 18 to 65 years (inclusive); 3) IBS Symptom Severity Scale \[17\] (IBS-SSS) \> 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period; 4) Normal colonic evaluation (colonoscopy or barium enema) within 5 years; 5) Written informed consent.

Exclusion Criteria:

* 1) pregnancy or breast-feeding; 2) medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases; 3) Having suicidal ideas or attempts or aggressive behavior; 4) Use of medications known to influence gastrointestinal transit.
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102

The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.

The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
* Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria:

* Subjects who suffer from, or show signs of eczema or other skin lesions.
* Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
* Subjects with a significant history of drug allergy as determined by the Investigator.
* Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
A Microneurography (MNG) Study of VX-150 in Healthy Participants

The purpose of this study is to determine if C fiber conduction is impacted by NAV1.8 modulation.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2)
* A total body weight \>50 kg

Key Exclusion Criteria:

* Participants who have any 1 of the following criteria in the foot/ankle in which MNG will be performed:

  * Injection of local anesthetics or steroids within 35 days prior to randomization
  * Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot/ankle)
  * Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments
* History of febrile illness within 14 days before study drug dosing
* Any condition possibly affecting drug absorption
* Participants with Type 1 or Type 2 diabetes mellitus
* Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability

Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.


Eligibility Criteria:
Inclusion Criteria:

* Body weight of \>= 39 kg at screening.
* Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer \>= 64 at 4 degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (\<=) 1+, and f) No overt malignant disease.
* History of at least one documented blood transfusion within 6 months of enrollment.
* Hemoglobin level \<= 10.0 g/dL.
* Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.

Exclusion Criteria:

* Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy.
* Clinically relevant infection of any kind within the month preceding enrollment (e.g., active hepatitis C, pneumonia).
* Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms adjudicated on a case-by-case basis during the Confirmatory Review of Patient Eligibility.
* Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening.
* Positive human immunodeficiency virus (HIV) antibody at screening.
* Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.
Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC

Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,...), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.

1. Qualification of Xpert® Testing:

   Three 50 mL fresh urine samples will be collected in sterile containers according to Cepheid instructions of use:
   * the "baseline sample" before the first BCG instillation,
   * the "study sample" taken during the initiation course of treatment instillations, preferably at the 4th or 5th instillation of BCG therapy,
   * the "follow-up sample" at the time of the first follow-up cystoscopy, approximately 3 months after the last BCG instillation of the initiation course.

   Xpert® test results will be qualified as positive or negative, according to Cepheid instructions for use.

   Samples tested positive at baseline will not be included in the analysis and the patient's participation in the study will be discontinued.

   Samples obtained in patients with no recurrence at follow-up cystoscopy after the initiation course will be considered for analysis.
2. Threshold of detection of theXpert® Bladder test:

   * One urine sample of a patient tumor free (negative Xpert test) under BCG treatment will be spiked into 3 log dilutions of the 2 distinct tumor cell lines SW780 and BE(2)-C (100, 1000, and 10000 cells per ml).
   * A mix of fresh and frozen cells from en bloc harvested tumors from distinct donors will be tested at the set concentration in BCG urines from distinct patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with high-risk transitional cell carcinoma of the bladder, according to the EAU guidelines/EORTC risk stratification, who are offered adjuvant BCG instillations.

Exclusion Criteria:

-
The Effect of Intensive Multifactorial Therapy on Endothelial Function in Newly Diagnosed Type 2 Diabetes

The endothelial dysfunction is the early event in atherosclerosis. The investigator previous study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The investigators hypothesize that intensive multifactorial therapy including intensive blood control and intensive hypertension control as well as intensive blood lipids control of 1 year can improve vascular endothelial function. Moreover, the improvement of endothelial function maintains after 5 years or 10 years of intensive multifactorial therapy, called "Metabolic Memorial Effect of improvement of endothelial function".

* We select 1000 patients with newly diagnosed type 2 diabetes. They are divided into two groups, respectively (Intensive multifactorial therapy and conventional multifactorial therapy groups). After those therapy for one year, a 10 years of follow up study will be performed. During this period, we take them together intensive education, and take conventional multifactorial therapy for both of two groups.
* At the beginning (0 year),the end of intensive multifactorial therapy (1 year), 5 years and 10 years, we will measure the endothelium-dependent arterial dilation, endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c for all of individuals.
* We will compare the endothelial function,endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c between intensive therapy group and conventional therapy group at different time points.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes,
* Age: 40 \>= age \<=70 year old,

Exclusion Criteria:

* Type 1 diabetes,
* Mitochondrial diabetes
* Patients with clinical detectable angiopathy,
* Body Mass Index (BMI) \> 30 Kg/m2,
* Age \< 40, or \> 70 years old,
* Malignant neoplasms, renal or liver diseases,
* Smokers
* Known diabetes
Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

The purpose of this study is to improve the platelet level of PTR patients; Prevent and improve bleeding; Help patients to successfully through the bone marrow suppression period after chemotherapy; Reduce the overall rate of PTR and allo-immunity; Saving platelet resources and reducing blood burden.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ALL，AML，MDS, CML,CLL that suffered from PTR before, with or without HLA antibodies
* The platelet level \>150\*10E9/L when considering autologous PLT collection
* Age less than 70 years
* The expected life more than 3 months
* Agree to receive autologous platelet cryopreservation and infusion treatment, and sign the informed consent form

Exclusion Criteria:

* Blast cells are found in peripheral blood or bone marrow
* Patients with bacteremia or sepsis
* Coagulation function abnormality
* Patients who have a history of thrombosis and are receiving anticoagulant treatment
* Severe bleeding within 2 weeks
* Participate in another clinical study within 1 month, and have treatment with potential impact on platelets
* Patients with mental disease
Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)

Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.

The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.

In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.

The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).

Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy
* Listing for Liver transplantation for HCC fulfilling or not Milan criteria
* No extra-hepatic spread
* No vascular involvement

Exclusion Criteria:

* Salvage transplantation
* Transplantation contra-indication
* Evaluation for Liver transplantation older than 1 month
* Incidental HCC
Effects of Lutein on Visual Function

Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.

The participants will be given a brief explanation of the study and asked to sign an informed consent form. During the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate.

These include:

1. Medical History
2. Vital signs, Height and weight and BMI calculation
3. Visual Parameters
4. Blood draw for clinical chemistry and hematological safety

Intervention Period:

At baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. A final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers.

Compliance check:

The number of tablets dispensed at baseline and returned, as well as all intake information from a subject diary. Per protocol population is defined apriori as \>80%.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 40-60 years
* Corrected Visual Acuity of 20/20 to 20/25
* MPOD 0.05- 0.30 OD units
* Must be able to give written informed consent in English
* BMI \< or = 30 kg/m2
* Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period

Exclusion Criteria:

* Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
* Ocular pathologies
* History of active small bowel disease or resection
* Uncontrolled hypertension
* Diabetes mellitus
* Pancreatic disease
* Pregnancy (or planning to become pregnant) or lactation
* Diseases that interfere with fat absorption
* Medication or supplements that contain a significant level of carotenoids
* Medications that interfere with fat absorption
* Use of drugs suspected of interfering with metabolism of blood clotting
* Chronic alcohol intake
* Stroke, head injury with loss of consciousness or seizures
* Severe Amblyopia resulting in visual acuity worse than 0.4 MAR
* Subject is a heavy smoker (\> 1 pack/day)
* A regular consumer of lutein rich foods or lutein supplements
* A regular consumer of foods high in DHA intake or DHA supplements
* Subject has donated more than 300 mL of blood during the last three months prior to screening
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Type I, II, or III skin as assessed by the Fitzpatrick Scale.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
* Acceptable state of health and nutrition, in the opinion of the Investigator.

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
* Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
* Subjects with platelet or coagulation disorders.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* Current systemic therapy with cytotoxic drugs.
* Current therapy with chronic (\> 10 days) oral corticosteroids.
* In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.
Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.


Eligibility Criteria:
Inclusion Criteria:

* Age≥40
* Received EGD;
* Subjects must have given written informed consent, and the subjects compliance are good.

Exclusion Criteria:

* Subjects who could not accept EGD;
* Subjects who had previously undergone total or partial gastrectomy;
* There are other serious acute or chronic medical or mental diseases or laboratory abnormalities that may interfere with the interpretation of the research results and make the subjects unsuitable for the study in the judgment of the researchers;
* Subjects with a history of malignant tumor or two or more malignant tumors at the same time;
* Pregnant subjects;
* Subjects who had a history of bone marrow or organ transplantation, or had a history of blood transfusion one month before enrollment.
* The subjects with incomplete clinical data collection or other reasons judged by the researchers are not suitable for this study.
Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients

Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
* Patients diagnosed according to ACR classification criteria.

Exclusion Criteria:

* Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
* Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
* Pregnant and breast feeding females.
* Patients have hemoglobin values \<10 g/dl or platelet values\<150,000/ml.
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


Eligibility Criteria:
Inclusion criteria:

* 12 months minimum delay with bariatric surgery
* female, BMI\<30kg/m2
* Age greater than or equal to 18 years
* Stable weight for more than 6 months
* lack of volume in gluetal region
* agree with clinical trial

Exclusion criteria:

* Patient under tutorship or curatorship
* Pregnancy or breastfeeding
* hemoglobinemia\< 12g/dL
* Albuminemia\<3,5g/dL
* active smoking more than 1 month before surgery