bioihbjkbjnl/mcl2 huggingface dataset:
Artemisinin Resistance in Bangladesh
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate
      monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
    

Detailed description: 
      A total number of 100 volunteers with acute uncomplicated falciparum malaria will be randomly
      assigned one of 3 arms to be treated with artesunate monotherapy or quinine/doxycycline for 7
      days at a ratio of 2:2:1. The study design will be based on the WHO recommendations for the
      'Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated
      Falciparum Malaria' (WHO, 2003). Study participants will be otherwise healthy malaria
      patients aged 8 to 65 years with uncomplicated falciparum malaria recruited at the Bandarban
      Sadar Hospital, Bangladesh.

      The artesunate will be administered orally (a single dose of 2 or 4 mg/kg/day) over a total
      duration of 7 days by directly observed therapy.

      Patients will be admitted to the hospital for the duration of study drug administration or
      until all signs and symptoms of malaria have disappeared, whichever comes later. Thereafter
      they will be followed as outpatients until Day 42 with scheduled follow-up visits on Day 14,
      28, 35, and 42.

      In vitro drug sensitivity assays will be performed from samples on inclusion and in case of
      recrudescence. Drug levels will be measured on the first and last day of therapy.

      Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR) on
      Day 28 and 42. Secondary outcome measures are time until parasite, fever, and gametocyte
      clearance (PCT, FCT, and GCT). Parasite genotyping will be used to distinguish recrudescences
      from reinfections by PCR for patients in whom recrudescences cannot be fully excluded.
      Subjects will be monitored for clinical adverse events throughout the study duration.

      Blood will be drawn on the day of admission (before initiating therapy) for in vitro drug
      sensitivity testing and for PCR (markers of drug resistance and to distinguish recrudescence
      from reinfection by genotyping). Malaria smears will be prepared twice daily until parasite
      clearance and on Days 7, 14, 21, 28, 35, and 42 or whenever symptoms consistent with malaria
      appear. Plasma samples for determining drug levels will be obtained on the first and last day
      of therapy. Study participation for each individual will be 42 days.
    

Intervention name(s): Artesunate; quinine-doxycycline
Intervention type(s): Drug; Drug
Intervention description(s): 2 or 4 mg/kg/day for 7 days; quinine-doxycycline for 7 days
Intervention MeSH terms: Doxycycline; Artesunate; Quinine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncomplicated P. falciparum malaria
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      To identify the following items through the post marketing surveillance under routine
      clinical practice after marketing authorization of Brilinta Tablet: the occurrence of
      unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events
      (AEs), the factors that may influence safety and efficacy of the drug.
    

Detailed description: 
      A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who take Brilinta according to the local approval condition
      
Keywords: Unstable angina
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Condition: Hypercholesterolaemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
      after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants
      aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per
      litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying
      therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at
      least 4 weeks prior to the screening period.

      Secondary Objective:

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the pharmacokinetics profile of alirocumab.

        -  To evaluate the effects of alirocumab on other lipid parameters.
    

Detailed description: 
      For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6
      (+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).

      For Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 [+1]
      weeks, open-label dose finding treatment period: 12 weeks).

      Optional extension period: up to a maximum of 2 years for the first participants enrolled in
      Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled
      in Cohort 4.

      For all participants who declined participation in the phase 3 study, their last alirocumab
      injection was on December 2018.
    

Intervention name(s): alirocumab SAR236553 (REGN727); statins; ezetimibe; cholestyramine; fenofibrate; omega-3 fatty acids; nicotinic acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution Route of administration: subcutaneous injection; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral
Other intervention name(s): Praluent
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide; Ezetimibe; Alirocumab; Cholestyramine Resin; Fenofibrate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Surgical and Economical Parameters of Total Knee Replacement.
Condition: Osteo Arthritis Knee; Total Knee Arthroplasty
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty
      performed using two different specific surgical techniques.
    

Detailed description: 
      Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single
      use instruments versus Stryker Navigation surgical techniques performed with conventional
      instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee
      which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational
      surgical technique patients will not require a CT scan. Both groups of patients will undergo
      total knee arthroplasty.
    

Intervention name(s): MyKnee with single use Efficiency Instrument; Stryker Navigational with conventional metal instruments
Intervention type(s): Device; Device
Intervention description(s): Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation; Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility of Using a Structured Daily Diary
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This protocol explores the feasibility and acceptability of using two daily diary methods to
      analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency
      Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the
      potential of diaries for use in feedback-based interventions.
    


Intervention name(s): Structured daily diary
Intervention type(s): Behavioral
Intervention description(s): The intervention is a structured daily diary to describe fluctuations in key psychological and behavioral variables impacting daily risk behavior among HIV-positive young men who have sex with men (YMSM), aged 16 to 24 years old who engage in substance use and sexual risk behaviors.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Drug-drug Interaction Study of FYU-981 and Oxaprozin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-period add-on study to assess the drug-drug interaction between
      FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of
      each period in a single administration of FYU-981 and concomitant administration of FYU-981
      with oxaprozin at steady -state in healthy volunteers.
    


Intervention name(s): FYU-981; Oxaprozin
Intervention type(s): Drug; Drug
Intervention description(s): Single administration; Repeated administration
Intervention MeSH terms: Oxaprozin; Dotinurad
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes
Condition: Vision Correction
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to compare the overall lens fit acceptance of two
      different soft contact lenses in an Asian population.
    


Intervention name(s): etafilcon A
Intervention type(s): Device
Intervention description(s): Each study subject will be exposed to both test lenses following a washout period of five minutes between test periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"A Study to Assess Knowledge and Opinion Regarding Adoption Among Adults Residing in Rural and Urban Area"
Condition: Knowledge
Study type: Observational

Summary: 
      A cross - sectional comparative study to assess knowledge and opinion regarding adoption
      among adults residing in rural and urban area of Ambala, Haryana.
    

Detailed description: 
      ABSTRACT INTRODUCTION: Children are regarded as the precious gift in world. It is estimated
      that between 8% and 12% of couples worldwide suffer from infertility with rate of 10% in
      India and about 20 million children are orphan even then adoption rates are falling in India.

      OBJECTIVES: To assess and compare the knowledge score and opinion score regarding adoption
      among adults of different age groups.To determine relationship between knowledge and opinion
      regarding adoption among adults.To seek association of knowledge score and opinion score
      regarding adoption with selected variables.

      METHODOLOGY: A descriptive cross sectional survey design was used. 400 adults of rural (200)
      and urban (200) area were selected by using quota sampling technique. The data was collected
      by structured knowledge questionnaire and structured likert scale.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population of the present study was Adults residing in rural and urban area of Haryana.

        Target population:- Adults residing in rural areas and urban areas of Ambala District
        Haryana.

        Accessible population:- Adults residing in rural area (Mullana) and urban area (muncipal
        corporator ward number 14 and ward number 15 of Mahesh Nagar) of Ambala District Haryana
        and available during data collection.
      
Keywords: Knowledge; Opinion; Adoption; Adults; Cross-Sectional
Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a
      potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized,
      double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the
      clinical activity and safety of danirixin compared with placebo in participants with COPD.
      Following baseline assessments collected over a 7 day period participants will be randomized
      (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25
      mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for
      24 weeks. Participants will continue with their standard of care inhaled medications (i.e.
      long acting bronchodilators with or without inhaled corticosteroids) while receiving study
      treatment. Follow up will continue up to 28 days post last dose. Approximately 700
      participants will be screened with a target of 540 participants completing 24 weeks of
      treatment and key study assessments.
    


Intervention name(s): Danirixin; Danirixin matching placebo; Standard of care; Rescue medication
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Danirixin is available as 5, 10, 25, 35 and 50 mg white, film-coated, oval or round shaped tablets for oral administration.; Danirixin matching placebo will be available as white, film-coated, oval or round shaped tablets for oral administration.; Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) during the study treatment.; Participants will continue to use rescue medication(s). The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCRU exacerbations; SGRQ; CXCR2 antagonist; GSK1325756; Danirixin; COPD
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      This study was planned to determine the effects of upper extremity functional capacity,
      physical activity level and physical functions of patients receiving hemodialysis treatment.
    

Detailed description: 
      Upper extremity functional capacity, physical activity level and physical functions were
      evaluated in healthy subjects and hemodialysis patients.
    

Intervention name(s): Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
Intervention type(s): Diagnostic Test
Intervention description(s): Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Hemodialysis; chronic renal failure; upper extremity; physical activity; physical function
Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients receiving haplo-SCT are at high-risk of relapse. Vγ9Vδ2 T cells exhibit is a
      well-known population able to exert cytotoxicity toward a large range of tumor in vitro or in
      vivo. Activating and expanding Vγ9Vδ2 T cells early after haplo-SCT by using a combination of
      Zoledronic acid and low-dose interleukine (IL) -2 may be of benefit for patients by reducing
      incidence of relapse. The optimal dose of IL-2 to use remains to be determined.

      This will be a Phase 1 3+3 escalation study. Three to 15 patients are planned. It will be
      proposed to Patients who refuse to participate to have samples collected until day +70 to
      study immune and gamma/delta T cells reconstitutions after haplo-transplant.
    

Detailed description: 
      Zoledronic acid will be administered as a single dose according to marketing and regulatory
      authorization at the dose of 4 mg over 15 min intravenously at day+15 post-transplant.
      Zoledronic acid infusion must be stopped in case of grade 3/4 adverse events during infusion.

      IL-2 will be administered at a unique low-dose level 5 days per week for 4 consecutive weeks
      from Monday to Friday subcutaneously . IL-2 has already marketing authorization for various
      indications.

      Three IL2 levels will be tested:

      Level 1: 2 millions UI/Infusion Level 2: 4 millions UI/Infusion Level 3: 6 millions
      UI/Infusion Zoledronic acid and IL2 have to start at day+15 if it is a Monday or the first
      Monday following day+15 in order to avoid administration on week-end.
    

Intervention name(s): IL2; Zoledronic Acid
Intervention type(s): Drug; Drug
Intervention description(s): Three IL2 levels will be tested:
Level 1: 2 millions UI/Infusion Level 2: 4 millions UI/Infusion Level 3: 6 millions UI/Infusion 4 weeks, 5 days per week from day + 15 post graft to day + 40; 4 mg at day +15 post graft
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: a group of patient will received IL2+ zoledronic acid a group of patient will not received IL2+ zoledronic acid
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haplo-SCT; Phase 1; Zoledronic acid; IL-2; g/d T cells
A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety
Condition: Diabetes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, open, parallel group, active-controlled study. The study
      period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24
      weeks.
    

Detailed description: 
      After the screening visit, all patients who met all inclusion criteria and do not meet any of
      the exclusion criteria were randomized into the experimental group or the controlled group.
      The subjects in the experimental arm will receive insulin aspart injection combined with
      basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ®
      (active control) combined with basal insulin (Lantus ®). The experimental drug or the
      controlled drug will be administered subcutaneously prior to three meals (or can be
      administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be
      administered at bedtime. The treatment period is 24 weeks, during which the subjects will be
      followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of
      24-week treatment, if the adverse events continue, the subjects will be followed until
      recovery or stabilization of the AEs.
    

Intervention name(s): insulin Aspart injection; insulin Aspart injection (NovoRapid)
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.; Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ulcerative Colitis Relapse Prevention Trial, Hypnosis
Condition: Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Study type: Interventional

Summary: 
      The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will
      maintain remission in patients affected by Ulcerative Colitis.
    

Detailed description: 
      The purpose of the study is to determine whether hypnotherapy can serve as an effective
      therapy for patients with Ulcerative Colitis (UC), a chronic, relapsing and remitting
      inflammatory bowel disease (IBD).

      The goal of this study is to determine if mind-body therapy is an effective complementary
      therapy for IBD, meaning a therapy to be used in conjunction with your standard treatment
      provided by your gastroenterologist. Standard treatment for UC often includes a combination
      approach and may include medications such as mesalamine, corticosteroids or immunomodulators.
      Mind-body therapy or hypnosis has been used to reduce stress and subsequent disease activity
      in patients with gastrointestinal diseases including IBD and Irritable Bowel Syndrome. It has
      also been shown to improve immune function and reduce inflammation in other health conditions
      such as cancer and arthritis.

      In this study, patients with inactive UC will be randomized to one of three groups. Two
      groups will undergo one of two mind-body therapies, which may include relaxation techniques
      or other techniques aimed at identifying the impact of UC on your psyche along with standard
      care for their UC. The other group will undergo 8 weeks of standard care without mind-body
      therapy. Clinical assessment measures will be repeated at 8 weeks, 12 weeks, 24 weeks and 52
      weeks.
    

Intervention name(s): Hypnotherapy; Standard care; Mind Body Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 8 weeks of gut-directed hypnotherapy; 8 weeks of standard of care; 8 weeks of mind-body therapy
Other intervention name(s): HYP; SC; MB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypnotherapy; Ulcerative Colitis; Inflammatory Bowel Disease; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases