bioihbjkbjnl/mcl2 huggingface dataset:
Mild Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is
      based on symptoms, clinical findings and electrophysiological examination. Several
      conservative and surgical treatment options have been described.

      Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not
      been done and it is still unclear whether or not surgical treatment is better than
      conservative treatment.

      The aim of this study is to research has surgery better outcome in mild CTS than conservative
      treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and
      indirect costs will be evaluated.
    


Intervention name(s): open carpal tunnel release; Night-cast
Intervention type(s): Procedure; Other
Intervention description(s): surgery to release the carpal tunnel; individual night time splinting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carpal tunnel syndrome; CTS; medianus impingement
Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional

Summary: 
      This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.
    

Detailed description: 
      From 2 hospitals of Korean medicine, we will enrol 82 chronic TMD patients in Axis 1, Group Ⅰ
      according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP
      group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after
      which there will be 4 follow-up visits (6, 9, 13, and 25 weeks from baseline). The primary
      end point is 6 weeks after baseline, and the primary outcome is the difference in Visual
      analogue scale (VAS) score for temporomandibular pain between baseline and Week 6. Secondary
      outcomes will be Numeric rating scale (NRS) scores for temporomandibular pain and discomfort,
      temporomandibular joint range of motion, Korean version of Beck's Depression
      Index-Ⅱ(K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patien Global Impression of
      Change(PGIC), and quality of life. Using data on adverse events and cost-effectiveness in the
      two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic
      assessment).
    

Intervention name(s): hominis placental pharmacopuncture
Intervention type(s): Other
Intervention description(s): Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Genetic Variations in the Response to Brazil Nut Supplementation
Condition: Dietary Supplements
Study type: Interventional

Summary: 
      This study investigates the effect of genetic variations after supplementation with Brazil
      nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2
      months and will stop the intake for more 2 months. Five blood sampling collection will be
      performed in one month interval, starting at baseline and ending at 2 months without
      intervention.
    

Detailed description: 
      Brazil nuts are the richest source of selenium in nature, a micronutrient that has essential
      functions in human physiology.

      Selenium status can be measured by the quantification of biomarkers in the blood. Previous
      studies have shown that genetic polymorphisms can affect Se status and modulate risk for
      chronic diseases. In this study, five biomarkers will be quantified in the blood, before and
      after supplementation with Brazil nuts. The genetic variants will be used to stratify the
      biomarkers and multivariate linear regressions will be used to explore the influence of the
      polymorphisms on concentrations of the biomarkers .
    

Intervention name(s): Brazil nut
Intervention type(s): Dietary Supplement
Intervention description(s): one nut a day for 2 months, no intervention for 2 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nuts; micronutrients; nutrigenomics; nutrigenetics
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
Condition: Transfusional Iron Overload; Transfusional Hemosiderosis
MeSH terms: Hemochromatosis; Iron Overload; Hemosiderosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical research study in patients who have iron overload in the heart due to
      chronic blood transfusions.

      The study will have 2 treatment groups and will compare the safety and efficacy of chelation
      therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine
      (DFO). The study is aimed at finding out which of the two medicines is the best for treating
      iron overload in the heart.

      Patients will be treated for 12 months (core study phase). Patients who complete the core
      study phase will be offered to continue their study treatment in a 12 months extension phase.
      During the core and extension, the effects of treatment on iron overload in the heart and the
      liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.
    


Intervention name(s): Core Study: Deferasirox; Core Study: Deferoxamine; Extension: deferoxamine to deferasirox; Extension: deferasirox to deferoxamine; Deferasirox; Deferoxamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day; 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week; 40 mg/kg deferasirox once daily administered 30 minutes before taking food.; DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
Other intervention name(s): "ICL to ICL"; "DFO to DFO"; "DFO to ICL"; "ICL to DFO"
Intervention MeSH terms: Deferasirox; Deferoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron overload; cardiac iron; haemosiderosis; myocardial T2*; left ventricular ejection fraction; LVEF; cardiac dysfunction; thalassaemia; Diamond Blackfan anemia; DBA; sideroblastic anemia; myelodysplastic syndromes; MDS (low and INT-1 risk as per the IPSS for MDS); liver MRI; deferasirox; deferoxamine; ICL670; DFO; cardiovascular magnetic resonance imaging
Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of
      doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in
      treatment-naive subjects with type 2 diabetes mellitus
    


Intervention name(s): GSK189075; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet; Available as Placebo matching tablet to GSK189075
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes mellitus HbA1c
Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia
Condition: Malaria,Falciparum; Malaria; Antimalarials
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine
      in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in
      Colombia. The benefit will be assessed in terms of:

        -  Efficacy

        -  Tolerability

        -  Time of fever clearance

        -  Time of parasite clearance

        -  Proportion of gametocyte carriers
    


Intervention name(s): Artesunate
Intervention type(s): Drug
Intervention MeSH terms: Artesunate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
Condition: Impulsive Aggression Comorbid With ADHD
MeSH terms: Aggression; Impulsive Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and
      Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers
    


Intervention name(s): SPN-810M
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impulsive Aggression; ADHD
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether local infiltration analgesia (LIA) with
      Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major
      spine surgery.
    


Intervention name(s): Ropivacaine 0.5 %; Isotonic NaCl
Intervention type(s): Drug; Drug
Intervention description(s): Local infiltration analgesia; Local infiltration analgesia
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Local infiltration analgesia; postoperative pain; ropivacaine
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      The goal of this community trial is to provide HIV education based on the newly developed HIV
      education kit (PREM-Kit) and evaluate the knowledge, attitude and practices related to HIV
      prevention among the late adolescents (aged 18 to 19 years old) in Malaysia. The main
      question it aims to answer is does the PREM-Kit improve the knowledge, attitude and practices
      related to HIV prevention among the adolescent?

      Participants will be asked to:

        -  answer a questionnaire as a baseline screening to determine their knowledge, attitude
           and practices related to HIV prevention.

        -  Using PREM-Kit, they will participate in a series of health education sessions. There
           will be three sessions in total which will be delivered two weekly apart. Each of the
           sessions will take approximately 20 minutes duration.

        -  Following the last session (third session), participants will have to answer the same
           questionnaire ; once immediately after the last session, once at 3-months
           post-intervention, and lastly, at 4-months post-intervention.

      Researchers will compare participants who received the existing Basic Science and Biology
      module to see if there is any improvement in the knowledge, attitude and practices related to
      HIV prevention.
    


Intervention name(s): PREM-Kit
Intervention type(s): Other
Intervention description(s): The PREM-Kit, which was created based on the Information-Motivation-Behavioral Skills model, is used in a series of HIV education sessions as part of the intervention. Over the course of three sessions, there will be a total of six weeks (one session for every two weeks). Three sub-modules, namely HIV facts and information, motivation for HIV preventive behavior, and behavioral skills for HIV prevention, will be emphasized in each session to the participants via flip chart and health educational videos. Additionally, participants will receive a QR code that gives them access to the PREM-Kit's e-flip chart, which they can see at a later time.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Human Immunodeficiency Virus; Adolescents; Information-Motivation-Behavioral Skills Model
A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of itraconazole at steady-state on a
      single-dose pharmacokinetic (PK) of JNJ-56136379 in healthy adult participants.
    


Intervention name(s): JNJ-56136379; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-56136379 orally on Day 1 in Treatment Period 1 and on Day 38 in Treatment Period 2.; Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34.
Intervention MeSH terms: Itraconazole; JNJ-56136379
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sour Taste Intensity Matching With Fatty Acids Taste
Condition: Fat Taste
Study type: Interventional

Summary: 
      Investigators are trying to find the concentrations of fatty acids ( a part of the fat and
      flavor typically found in normal foods) that have a taste intensity similar to that to the
      sourness of vinegar solutions.
    

Detailed description: 
      Participants will first taste 5 sour solution containing acetic acid for sour compounds,
      sucrose esters, and xanthan gum to help them stay dissolved). Then rate them for their taste
      intensities. Next, participants will taste 5 butyric acid solutions, 5 hexenoic acid
      solutions, 5 caprylic acid solutions, 5 lauric acid solutions, 5 palmitic acid solutions, 5
      oleic acid solutions, and 5 linoleic acid solutions (all will also contain the sucrose esters
      and xanthan gums.) and rate them for their taste intensities. This should take no longer than
      1 hour. Participants will spit all samples into a cup after tasting them. They will not
      swallow any samples.
    

Intervention name(s): taste test
Intervention type(s): Other
Intervention description(s): rate intensity of sour solutions and fatty acid solutions
Intervention model: Single Group Assignment
Intervention model description: sensory
Masking: None (Open Label)
Primary purpose: Basic Science
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Insulin Resistance; Endocrine System Diseases; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to further characterize the treatment related changes in insulin
      sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with
      growth hormone deficiency (GHD).
    


Intervention name(s): growth hormone (genotropin)
Intervention type(s): Drug
Intervention description(s): Dosage regulation will follow the local recommendations of GHD treatment
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin sensitivity; substrate metabolism; fatty liver; intramyocellular lipids; growth hormone deficiency; Growth hormone deficiency (Adult)
Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Untreated, one third of patients undergoing general anesthesia will have postoperative
      nausea, vomiting, or both.

      Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative
      pain. PONV increases the risk of aspiration and has been associated with suture dehiscence,
      esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently
      delays discharge, and is the leading cause of unexpected hospital admission after planned
      ambulatory surgery.

      Nabilone (Cesamet®) is a synthetic cannabinoid developed in the 1970s which is a potent CB1
      agonist. The use of nabilone in preventing nausea and vomiting in patients receiving
      chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated the
      efficacy, safety, and tolerability of Cesamet in this population. There has been success in
      the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT
      receptor agonists including Ondansetron and Granisetron) to use in the perioperative
      environment.

      Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995,
      this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given
      90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women.
      This study failed to show any significant difference between groups. There are several
      limitations to this study including a poorly optimized dosing regimen, a small sample size,
      and a comparison group lacking clinical generalizability.

      This study will investigate the use Cesamet vs Placebo, in addition to the regular antiemetic
      treatment which patients receive at the discretion of the managing anesthesiologist, for the
      prevention of PONV. The study group will include patients undergoing general anesthesia for
      elective ambulatory surgery with at least 3 risk factors (>60% risk) for the development of
      PONV.
    

Detailed description: 
      See above
    

Intervention name(s): Nabilone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nabilone (0.5 mg) or placebo given preoperatively; Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively
Other intervention name(s): Cesamet
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hepatitis B Virus Prevalence and Risk Factors in Belgium
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B
      virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium.
      Additionally, the investigators will determine linkage of care in hepatitis B surface antigen
      (HBsAg) positive subjects.
    

Detailed description: 
      Although the HBV prevalence is generally low in Western countries, such as Belgium, pockets
      of higher HBV prevalence exist in areas with large immigrant populations. Therefore national
      prevalence figures can underestimate the burden of HBV infection. The prevalence of chronic
      HBV in the population-based study in 2003 is believed to be an underestimate due to
      under-representation of the non-Belgian population. Moreover, by this time there are no data
      regarding the risk factors for HBV infection in the general population of Belgium.

      Even in low-prevalence areas such as Belgium, HBV prevention and control is a public health
      priority, particularly since safe and effective vaccines are available. The aim of this study
      was to evaluate the current prevalence and risk factors of HBV infection in a multi-ethnic
      neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will
      determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.
    

Intervention name(s): Hepatitis B serology; Questionnaire
Intervention type(s): Diagnostic Test; Other
Intervention description(s): A serum specimen will be taken and assessed for hepatitis B serology (HBsAg and anti-HBc antibodies).; Participants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients between the age of 18 and 70 who presented at the emergency department of
        Ziekenhuis Oost-Limburg, a large hospital in Genk, situated in Middle Limburg.
      
Keywords: Belgium; Prevalence; Risk factor; Ethnicity; Linkage of care
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a prospective, randomized (open label), multi-center and post-market study. The study
      is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily
      injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in
      China
    

Detailed description: 
      Primary objective:

      To compare the length of time to achieve target glucose range using Self-Monitoring Blood
      Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI

      Secondary Objectives:

      To compare glycemic variability (using CGM as reference method) with the 722 Paradigm
      Real-Time insulin pump versus MDI

      This is a prospective, randomized (open label), multi-center study. The clinical study staff
      will conduct screening tests according to inclusion/exclusion criteria in order to verify the
      subject's eligibility for the study.

      Inpatient Period A patient is admitted into hospital for treatment of diabetes

      Randomization

      Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80
      subjects will be randomized into 2 study groups:

        -  Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin
           infusion)

        -  Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).

      It is anticipated that the total duration for the study will be within one year from site
      initiation to finalization of all data entry and monitoring.

      Each subject will participate in the study approximately 2 weeks.
    

Intervention name(s): Pump; CGMS Gold
Intervention type(s): Device; Other
Intervention description(s): 722 Paradigm Real-Time System; Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.
Masking: None (Open Label)
Primary purpose: Treatment