cyrilzakka/clinical-trials huggingface dataset:
Optilene® Suture Material for Dermal Sutures

In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.

The study is designed as a prospective, unicentric and single-arm observational study to evaluate Optilene® suture material for skin closure.

The product under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). After operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing skin closure using Optilene® suture material.
* Small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk, neck or extremities (in the event that more than one incision is performed in the same patient, only one incision will be included).
* Written informed consent.

Exclusion Criteria:

* Emergency surgery.
* Transplant surgery.
* Pregnancy.
* Facial laceration or incision.
* Visible dirt in the wound.
* Non-linear shape.
* Patient with limb ischemia.
* Patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
* Patient with hypersensitivity or allergy to the suture material.
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children

The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.

1. Baseline analysis of a population-based, multicentre, prospective cohort study

1. A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).
2. Eligible participants were identifi ed by door-to-door survey with a household sampling design.
3. Participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (QuantiFERON \[QFT\]) to test for latent infection.

2. Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens

1. Individuals who had tuberculosis infection at baseline (QFT-positivity or TST tuberculin reaction size \[induration\] of ≥10 mm) were divided and treatment with different therapeutic schedule.
2. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB

Eligibility Criteria:
Inclusion Criteria:

* Children (0-18 years old).
* Children with QFT-positive or TST induration ≥10 mm).

Exclusion Criteria:

* Patients are allergic to anti-tuberculsis drugs.
* Parents and/or guardians do not agree to participate in this study.
* Participants with active tuberculosis.
PLADO for Conservative Management of CKD

The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet.

The main questions it aims to answer are:

* Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD?
* Is the PLADO diet safe, viable, and economically attractive adults with CKD?

Researchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis.

Participants will:

* Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months.
* Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and above, having controlled glycemic and blood pressure parameters on treatment, with an established diagnosis of stages 3-5 CKD and an estimated GFR ≤59 ml/min/1.73 m2 stable for at least three months, and with a normal nutritional status as defined by the GLIM criteria, attending the CKD outpatient clinics at LAUMC-RH, willing to undergo the baseline screening and attend the monthly face-to-face visits at the outpatient department at LAUMC-RH.

Exclusion Criteria:

* Patients with overt infection, persistent anorexia, vomiting, or diarrhea within the last month, presence of wasting diseases such as cancer, tuberculosis, liver failure, heart failure, and those with serum potassium \>5.5 mEq/L during the past 6 months.
Non-Helium Magnetoencephalography in Pediatric Brain Tumors

This observational study aims to evaluate the effectiveness of magnetoencephalography (MEG) in the preoperative assessment of pediatric brain tumors, particularly in determining the extent of resection, and compare it with computed tomography (CT) and magnetic resonance imaging (MRI).

The main questions this study aims to answer are:

What is the consistency between MEG and CT/MRI in localizing pediatric brain tumors? What is the clinical efficacy of MEG in determining the extent of resection of pediatric brain tumors preoperatively?

Participants will:

Undergo both MEG and CT/MRI examinations for preoperative assessment, and the extent of tumor resection will be determined by the comprehensive results of the above examinations.

Be followed up with MEG and CT/MRI at 1, 3, and 6 months after surgery, along with neurological and quality-of-life assessments.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 3-18 years old;
* Clinically diagnosed with brain tumor;
* Capable of cooperating with magnetoencephalography evaluation and recording.

Exclusion Criteria:

* Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination.
* Patients using drugs that affect central nervous system function;
* Patients who are not suitable for surgical procedures;
* Patients with progressive neurological disorders.
Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy

Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE alone.

Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-70
* Undergoing colonoscopy after standard bowel preparation

Exclusion Criteria:

* Known familial polyposis
* Small amount of feces or semi-solid stool in last rectal effluent
* Inflammatory Bowel Disease
* Lactated or pregnant women
* Unable to provide informed content
Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

The proposed study will test the feasibility and tolerability of transcranial direct current stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to 4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit) while they complete the cognitive training tasks.

Transcranial Direct Current Stimulation (tDCS) is a novel, safe, well-tolerated, and low-cost treatment approach that may enhance the benefits of cognitive remediation. The application of tDCS is a relatively recent therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. To meet this study's objectives, investigators will focus specifically on working memory (WM) in both training and outcome. Limiting training to WM exercises will provide the opportunity to test proof of concept for the combined therapies within this shorter two-week time frame, and maximize the synergistic effect by engaging the same regions as targeted by the tDCS.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Clinician Referral for cognitive remediation.
* Have undergone a neurological examination and neuropsychological examination as part of standard of care.
* Has access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable)
* Able to commit to the designated period of study training sessions with baseline and follow-up visits.
* Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating clinician or study staff
* Primary, uncontrolled psychiatric disorder that would influence ability to participate
* Poorly controlled epilepsy
* Medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
* Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
* Treatment for a communicable skin disorder currently or over the past 12 months
* Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
* Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score \<85\*
* Symbol Digit Modalities Test (SDMT) ≥3.0 SD below published norms\*
* Learned English language after 12 years of age
* Pregnant or breastfeeding

  * In the case of the potential participant having either speech, motor or vision impairment secondary to their condition that will limit the completion of the SDMT and WRAT-4 screening measures the substitutions as mentioned above will be used.
Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn

The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

The potential of acellular dermal matrix (ADM) had been proved to improve cosmetic and functional outcomes, nevertheless, there had been few reports about the long term results of the morphological, histological and functional changes after placement. The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Eligibility Criteria:
Inclusion Criteria:

* the patient's skin with ADM implant

Exclusion Criteria:
Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt

DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. The investigators have determined the HLA-A\*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the prevention of the recurrence of the bladder cancer after surgery using these peptides.

Eligibility Criteria:
Inclusion Criteria DISEASE CHARACTERISTICS

1. Bladder cancer without solitary and low grade tumor
2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

1. Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.
2. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.
3. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy
4. ECOG performance status of 0 to 1
5. Age ≥ 20 years, ≤80 years
6. WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl
7. Samples of bladder cancer must express MPHOSPH1 or DEPDC1
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge
Cassava Intervention Project

Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.

The proposed project seeks methods to prevent and elucidate biomarkers of neurocognition and motor deficits associated with chronic dietary reliance on cyanogenic cassava, a staple food crop for more than 600 millions of people living in the tropics. Aim 1 will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists (2 intervention training arms). Aim 2 will determine whether post-intervention reductions in cassava cyanogenic content and child U-SCN are associated with changes in biomarkers of cassava neurotoxicity particularly 8,12-iso-iPF2α-VI isoprostane (oxidant marker), carbamoylated albumin fragments KVPQVSTPTLVEVSR (residues 438-452) and LDELRDEGKASSAK (residues 206-219), or homocitrulline (carbamoylating markers), and scores at the KABC-II cognition and BOT-2 motor testing.

Eligibility Criteria:
Inclusion Criteria:

* Households with a konzo child and non-konzo sibling between 5 and 12 years
* Presence of a biological mother primarily responsible for the household food preparation and caring for the children
* Mother consenting to participate in this study

Exclusion Criteria:

* History of seizures
* History of cerebral malaria
* History of retroviral (HIV-HTLV) infections
Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure

Green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure.

Green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure. We would like to investigate the long-term effects of green tea on gut flora, fat absorption, resting energy expenditure and body composition.

The study will be conducted in a randomized, placebo-controlled, double-blind parallel design with four groups consisting of control groups and green tea groups with normal weight subjects and obese subjects. At three time points (baseline, 6 weeks and 12 weeks) faeces are collected for analyzing the gut flora composition and fat content. Furthermore, measurements of resting energy expenditure and body composition will be conducted. Activity will be measured during three weeks (baseline, week 6 and week 12).

a hundred healthy subjects (50 males and 50 females) with a BMI between 18.5-25 kg/m2 and ≥30 kg/m2 and aged between 18-50 years will be included in the study. All subjects will be non-smoking, non tea-drinkers, weight stable, dietary unrestraint, and at most moderate alcohol and caffeine consumers. Subjects will be free of medication except for oral contraceptives use in women.

Intervention (if applicable):

Subjects will receive either green tea or placebo in capsule form after their baseline measurement, which they have to consume three times daily for a period of twelve weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5-25 kg/m2 and ≥30 kg/m2
* Age between 18-50 years
* Healthy
* Weight stable
* Dietary unrestraint
* Not using a more than moderate amount of alcohol (\>10 consumptions/wk)
* Not using more than 100 mg caffeine per day
* Not drinking tea
* Not using probiotics
* Being weight stable (weight change \< 3kg during the last 6 months)
* Dietary unrestraint
* Not using antibiotics during the last 6 months.
* Free of medication except for oral contraceptives use in women.

Exclusion Criteria:

* Not healthy
* Smoking
* Using a more than moderate amount of alcohol
* Using more than 100 mg caffeine per day
* Drinking tea
* Using probiotics
* Not being weight stable
* Dietary restraint
* Using medication or supplements except for oral contraceptives in women
* Using antibiotics
* Not meeting the criteria for BMI and age.
* Pregnant or lactating women
* Having allergies for the used food items will also be excluded from participation.
Efficacy of Changing to TRAVATAN® From Prior Therapy

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
* Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
* Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
* IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
* Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
* Any clinically significant, serious, or severe medical condition.
* Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Women who are pregnant, lactating.
* Women not using reliable means of birth control.
* Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
* Any clinically significant, serious, or severe medical condition.
* Participation in any other investigational study within 30 days of Screening Visit.
* Other protocol-defined exclusion criteria may apply.
Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B. Patients with chronic hepatitis B who met eligibility criteria were randomly assigned (1:1) to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24 weeks in addition to their ongoing entecavir therapy. Patients and investigators were both blinded to group allocation. The primary outcome, serum HBsAg level (log IU/mL) at weeks 24 and 36, was analysed using a linear mixed-effect model. The intention-to-treat populations were included in primary and safety analyses.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg-negative chronic hepatitis B
* Ongoing treatment with Entecavir for more than 12 months
* HBV DNA \< 500 IU/mL
* Quantitative HBsAg \< 3 log IU/mL
* ALT and AST \< 2 × upper limit of normal (ULN)
* Agree to take contraceptive measures during participation for women of a fertile age
* Agree not to engage in other clinical trials during participation
* Understand and sign the informed consent form before taking any steps related to this study

Exclusion Criteria:

* Diabetes mellitus
* Alcoholic liver disease
* Drug-induced liver damage
* Autoimmune liver disease
* Decompensated cirrhosis
* Liver cancer
* Liver transplantation
* Pregnant or lactating women
* Other conditions unsuitable for participation