cyrilzakka/clinical-trials huggingface dataset:
Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for opiate-dependent individuals in Malaysia.

Heroin and injection drug use (IDU) are highly prevalent and driving the HIV epidemic in Malaysia and other countries in the region. In our original RCT, buprenorphine was superior to naltrexone and placebo in treatment retention, weeks of consecutive abstinence and time to heroin use. However, there is room for improvement, since only 50% of subjects assigned to buprenorphine and counseling remained in treatment for 6 months; only 28% avoided relapse to heroin; and treatment reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S. buprenorphine treatment effectiveness may be even less, because buprenorphine is provided with relatively minimal psychosocial services (often brief physician management (PM) alone, without additional counseling), and without additional behavioral interventions or contingency management. Hence, we propose a follow up study to evaluate whether standard buprenorphine treatment (consisting of buprenorphine provision, PM, and non-contingent provision of take-home doses of buprenorphine, NCB) is sufficient or whether one or a combination of two behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve its efficacy. BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia. ACB, a low cost and feasible alternative to non-contingent take-home buprenorphine (NCB), retains many of its advantages--abstinent patients manage their medication supplies outside of the clinic--but ACB also provides positive incentives for abstinence and directly observed buprenorphine for those with continuing heroin use. In the proposed 2X2 study, heroin dependent patients (N=240) will be inducted onto buprenorphine (weeks 1-2) and then randomized to PM with NCB, PM with ACB, PM with BDRC and NCB, or PM with BDRC and ACB (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests) and reductions in drug- and sex-related HIV risk behaviors. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

Eligibility Criteria:
Inclusion Criteria:

* opioid dependence

Exclusion Criteria:

* current dependence on alcohol, benzodiazepines or sedatives current suicide or homicide risk current psychotic disorder or major depression inability to understand protocol or assessment questions life threatening or unstable medical problems more than 3x normal liver enzymes
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.


Eligibility Criteria:
Inclusion Criteria:

* History of Type 2 diabetes and currently being treated with high dose metformin
* BMI between 22.0 and 40.0 kg/m2
* HbA1c between 7.0-10.0%
* Fasting C-peptide \>1.21 ng/mL

Exclusion Criteria:

* History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
* Treatment with anti-diabetic therapies other than metformin
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
* Males or women of childbearing potential
Comprehensive Prognostic Model: The Study Introduces a Novel Prognostic Model That Incorporates a Wide Range of Clinical and Laboratory Variables, Providing a More Holistic Approach to Predicting Overall Survival in HCC Patients

Background: Hepatocellular carcinoma (HCC) is a significant health problem in China, with high incidence and mortality rates. This study aimed to identify the prognostic factors of elderly HCC patients in southwest China and construct a new prognostic model for predicting overall survival (OS).

Methods: This retrospective cohort study collected clinical data from 958 patients with liver cancer on January 1, 2019, and December 12, 2020. The Cox regression model was used to test the significance of all available variables as prognostic factors of OS. Independent prognostic factors were identified based on multivariable analysis to model nomograms. The concordance index (C-index), the area under the receiver operating characteristic (AUC), the Time-dependent C-index, the Time-dependent AUC, the calibration curve, and decision curve analysis (DCA) were measured to assess the model performance of the nomogram.

Conclusions: The comprehensive risk prediction model for OS in HCC patients developed through this retrospective cohort study offers a promising avenue for improving clinical outcomes and patient care.


Eligibility Criteria:
Inclusion Criteria:

* (1) age ≥ 18 years; (2) had pathologically confirmed primary liver cancer; (3) received the main treatment in our hospital; (4) provided baseline clinical information and follow-up information; (5) completed the entire course of radiotherapy, chemotherapy and targeted therapy.

Exclusion Criteria:

* no follow-up records and a history of cancer treatments.
Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

The goal of this randomized controlled trial is to determine whether the digital health app Five Lives MED can improve cognitive function in people with mild cognitive impairment (MCI). The main question it aims to answer is:

Can 12 weeks of using Five Lives MED improve global cognitive function in people diagnosed with MCI?

Researchers will compare with a control group who receives a leaflet with standard health information.

Participants in the intervention group will be asked to use the Five Lives MED app 3 times per week at home for 12 weeks.

All participants, in both groups, will undergo cognitive testing and will complete questionnaires at baseline and exit.

Mild cognitive impairment is a significant public health concern. Non-pharmacological interventions, specifically multi-domain lifestyle and computerised cognitive training interventions, offer an accessible, scalable, engaging and potentially effective solution to improve cognitive function.

Five Lives MED is an interventional digital health app consisting of a physical activity habit forming coaching programme and cognitive training exercises.

The purpose of this study is to evaluate the efficacy of the Five Lives MED device; the primary hypothesis is that there is a significant difference in MoCA scores between the intervention group and the control group after the 12-week Five Lives MED intervention, with an effect size of d = 0.50 or greater favouring the intervention group.

This is a multi-centre, randomised, single-blind, controlled study in participants aged ≥ 50 years with mild cognitive impairment. Participants will be randomly assigned to the intervention (Five Lives MED) or control group for a 12-week period on a 1:1 allocation ratio.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (also known as mild cognitive disorder \[ICD-10-CM; G31.84\] or mild neurocognitive disorder (DSM-5)
* Age ≥ 50
* Participant or informant is willing and able to give informed consent for participation in the study
* Ability to read and understand English (UK) or French (France)
* Access to a mobile phone (Apple iOS 12.4 or above or Android 6.0 (Marshmallow) or above) or iPad (Apple iOS 12.4 or above only) with internet connection (mobile or WiFi).

Exclusion Criteria:

* Diagnosis of dementia or evidence of functional impairment inconsistent with MCI
* Severe visual impairment
* Currently undergoing any other cognitive remediation programme
* Currently taking part in any other investigational study that in the opinion of the investigator may impact the data integrity of the current study
* Physical impairment that makes using a mobile device impossible
* Lack of access to an informant
* Participant under guardianship
* Unwilling or unable to tolerate or engage with study procedures
* Physical impairment that makes standing/walking unassisted impossible.
Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.


Eligibility Criteria:
Inclusion Criteria:

* Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

Exclusion Criteria:

* Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.
Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease

The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Deterioration of Crohn's disease
* CDAI\>150
* Treated with systemic steroids or TNF alfa inhibitors
* Lesion found on ultrasound

Exclusion Criteria:

* Disease location not reachable with ileocolonoscopy
* Pregnancy
* Acute coronary disease
* Unstable coronary disease
* Previous allergic reaction to SonoVue or its components
Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

This will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. The program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin A1c, and body composition before and after starting the program. The price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥18 years of age

Exclusion Criteria:

* Use of recreational drugs in the past 6 months
* Pregnancy or intention to become pregnant during the study period, as verified by self-report
* Unstable medical or psychiatric illness
* Lack of English fluency
* Inability to maintain current medication regimen
* Inability or unwillingness to participate in all components of the study
Ocular Penetration of Topical Tacrolimus Eye Drops

Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.

Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.


Eligibility Criteria:
Inclusion Criteria:

* Any age or gender
* Patients scheduled for routine cataract surgery
* Clear healthy cornea

Exclusion Criteria:

* Corneal pathology
* Ocular surface disease
* Intraocular inflammation
Head Position for Endotracheal Intubation

The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.

The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* Elective operation time ≤2hrs
* American Society of Anesthesiologist, Physical Status 1 or 2
* age ; 18 - 90 years

Exclusion Criteria:

* patient has upper respiratory infection symptoms
* limited mouth opening
* teeth problems
* expecting difficult airway
* congenital heart disease
* patient has a possibility of aspiration pneumonia
Wound Complications in Head and Neck Surgery

This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim of this study is to identify risk factors for poor wound healing as well as biologic markers associated with wound related complications in head and neck surgery. Most specifically, this study evaluates the effects of thyroid hormone on wound healing. This study will also evaluate pre-operative labs and comorbidities as well as reconstructive factors, post-operative labs, and other variables associated with wound healing. All interventions regarding wound healing fall under current standards of care and standard practice. Data regarding post-operative wound complications will be collected in a prospective fashion on the variables under study using study-specific datasheets. Data sheet will be entered into a secure database for analysis.


Eligibility Criteria:
Inclusion Criteria:

* In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the head and neck.

Exclusion Criteria:

* Children and vulnerable populations are not eligible for participation. Patients undergoing functional (non cancer related) surgery, patients who have undergone more than 1 course of radiation to the head and neck, patients with a history of thyroid cancer, patients presenting initially with a malignant fistula, patients with previous intolerance or allergy to levothyroxine, and patients without a cancer diagnosis are not eligible. Patients may enroll if they are currently hypothyroid, but will be excluded from the study if thyroid function is not normalized by the time of surgery.
Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent

Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent

A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016.

The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.

Eligibility Criteria:
Inclusion Criteria:

1. 19 years old or older
2. Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction).
3. Vessel diameter 2.25 \~ 3.5mm, stenosis more than 50% (However, the number of blood vessels, the number of lesions, and the lesion length are not limited)
4. Voluntary written consent to participate in the trial

Exclusion Criteria:

1. Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
2. Life expectancy within 2 years
European Registry on STEMI Patients Transferred for PCI With Upstream Use of Abciximab - EuroTransfer Registry

EUROTRANSFER Registry is a prospective, international, web-based European Registry on Patients with ST-Elevation MI Transferred for Mechanical Reperfusion (PCI) with a Special Focus on Upstream Use of Abciximab.

This registry is designed to collect data on approximately 1800 patients during a 12 month enrollment period in up to 20 interventional cardiology centres with hospital transfer networks from all over Europe.

Analysis of this registry should allow to monitor transfer timelines of patients arriving to the cath-lab from the regional hospital with or without upstream start of abciximab and scheduled for mechanical reperfusion (PCI) as well as to monitor regional differences across Europe in regard to the impact that time of various stages of the treatment chain may have on clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

PATIENTS:

* All consecutive STEMI patients \>=18years arriving to the Cath Lab hospital (invasive facility center) from transfer.

  * Transfer with respect to this registry is defined as patients that reach the Cath Lab hospital:

    1. transferred from a surrounding regional community hospitals that the Cath Lab hospital has an established referral pattern with or
    2. after being picked-up by an ambulance which is equipped/staffed to provide specific medical therapy (like prehospital thrombolysis or upstream abciximab). Usually these have a physician or specifically trained nurse on board.

       CENTRES:
  * Provide 24 hour/7 days on duty PCI service.
  * Has an established regional hospital referral network with \>=8 patients/month arriving from transfer (as defined above).
  * A rate of \>=10% of these transfer patients who receive upstream abciximab before or during transfer to the Cath Lab hospital. Start of abciximab in the ER or CCU of the Cath Lab hospital will not be considered as upstream start of abciximab.

Exclusion Criteria:

* Patients who arrive to the Cath Lab from other pathways than those specified above (a. and b.), e.g. those who come by ambulances that do not provide specific medical therapy or arrive directly to the ER of the Cath Lab hospital by own feet/car will not be included in this registry.
* Patients from controlled clinical trials shall be included as long as their actual treatment is fully known. Thus, participants from randomized trials with blinded treatment cannot be included in this registry.
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients

The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.

PHAGOBURN is a Phase I/II clinical trial randomized, multicentric, open label, standard of care (Silver Sulfadiazine) controlled aiming at assessing tolerance and efficacy of local bacteriophage treatment of wound infections due to E. coli or P. aeruginosa in burned patients using Pherecydes Pharma anti-Escherichia coli and anti-Pseudomonas aeruginosa bacteriophage cocktails GMP produced. This project is a European Research \& Development (R\&D) project funded by the European Commission under the 7th Framework Programme for Research and Development. This project is involving 7 clinical sites in EU.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Adult Informed consent obtained from patient or next of kin
* In-hospital patient treated for burn wounds in a burn unit
* Burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by SFETB criteria:

  * A local or loco-regional inflammatory reaction;
  * And/or an adverse and unexpected local evolution;
  * And/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or haemorrhage), unexplained conversion from a superficial lesion to a deep one (\> 48th hour);
  * And/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bedsore;
  * And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
* Burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to Escherichia coli or Pseudomonas aeruginosa whatever their resistance profile
* Treated by povidone-iodine

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Intercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy
* Patient included in an interventional research protocol with therapeutic intervention still ongoing upon inclusion time or having participated into anti-infective drug trials during the previous month.
* Patient considered as part of a vulnerable population
* Patient for whom treatment limitation or withdrawal during study period is considered
* Allergy to Silver Sulfadiazine
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.

The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.

Eligibility Criteria:
Inclusion Criteria:

i. ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye.

Exclusion Criteria:

i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.