bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Effects of Interactive Video Games in the Elderly
Condition: Virtual Rehabilitation
Study type: Interventional

Summary: 
      The aim of this study is to assess the effectiveness of interactive video-games on mobility
      and wellbeing and to compare them with activity-based approaches in geriatric population.

      100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the
      criteria will be included in the study. Persons will be placed in the study groups in
      consideration of their interests. One group will be included in Nintendo Wii program with
      balance board, which is the most frequently preferred game consoles in rehabilitation, and
      video-games will run for 30 minutes two days a week for 8 weeks. The other group will
      participate a program consisting of various physical activities for the same duration; The
      results of both groups will be compared with a control group.
    

Detailed description: 
      100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the
      criteria will be included in the study. Persons will be placed in the study groups in
      consideration of their interests. One group will be included in Nintendo Wii program with
      balance board, which is the most frequently preferred game consoles in rehabilitation, and
      video-games will run for 30 minutes two days a week for 8 weeks. The other group will
      participate a program consisting of various physical activities for the same duration; The
      results of both groups will be compared with a control group.
    

Intervention name(s): Virtual Rehabilitation
Intervention type(s): Other
Intervention description(s): Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation will be used
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be three groups in this study. Two intervention and one control gruop to be compared after the intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain
      plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)

      Main Secondary objectives:

      Comparison of the two arms for genotypic resistance profile in case of virological failure

      CD4 changes from baseline

      Evolution of the lipid profile and morphological changes in fat distribution, and safety

      Efficacy and genotypic profile data, results of lipid markers, morphological changes and main
      biological parameters
    


Intervention name(s): EFV+TDF; EFV+3TC+TDF
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HIV virological control; Lipid profile and morphological fat distribution; Treatment Experienced
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
Condition: Antifungal Drug Adverse Reaction
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of
      a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository
      or cream).
    


Intervention name(s): NES/EE CVR
Intervention type(s): Drug
Intervention description(s): Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)
Other intervention name(s): Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)
Intervention MeSH terms: Ethinyl Estradiol; Contraceptive Agents; Estradiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nestorone; miconazole nitrate
Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures
Condition: Non Displaced Atypical Femoral Fractures
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often
      occur without warning, are highly debilitating, and are slow to heal. As physicians learn
      more about them, AFFs are increasingly being identified prior to a total break. However,
      there's no evidence on the best way to treat these non-displaced AFFs. One option is
      teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct
      a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF
      patients with an incomplete break will help accelerate fracture healing and prevent surgical
      intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months
      and number of participants requiring surgical intervention at 12 months. Investigators will
      recruit 60 women and men over the age of 30 who have experienced an incomplete AFF.
      Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using
      an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial
      examining the use of Teriparatide in this population is urgently needed.
    


Intervention name(s): Teriparatide 20 mcg; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Teriparatide 20 mcg injection pen; Placebo 20 mcg injection pen
Other intervention name(s): Brand name Forteo
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults (COVID-19)
Condition: COVID-19 (Healthy Volunteers)
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2
      recombinant protein subunit vaccine (NBP2001) in healthy adults.
    

Detailed description: 
      This is a first-in-human, Phase I, randomized, placebo-controlled, observer-blinded study to
      assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein
      subunit vaccine (NBP2001) in healthy adults.

      A total of 50 healthy adults between 19 and 55 years of age will be enrolled and
      block-randomized in a 4:1 ratio to receive 2 doses of either one NBP2001 formulation (Test
      group 1 or 2) or placebo saline (Placebo group).

      Over the study period, participants will commonly attend 10 planned visits. Telephone calls
      will be made 7 days after each vaccination (Day 7+3 after Visit 2 and Visit 4). However,
      sentinel participants will be required to return at Day 7(+ 3 days) after 1st vaccination for
      rigorous safety assessment.

      Study vaccination will comprise 2 intramuscular injections of saline placebo, or a 30 or 50μg
      dose of NBP2001 in an injection volume of approximately 0.5mL. The study vaccines will be
      injected preferably into the deltoid muscle of the upper arm at a 28-day interval.

      Halting rules based on reactogenicity and safety outcomes are defined, and enrollment and
      study vaccination may be paused during the study if any halting rules are met.
    

Intervention name(s): NBP2001 adjuvanted with alum (RBD 30μg/dose); NBP2001 adjuvanted with alum (RBD 50μg/dose); Normal Saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): Participants will receive intramuscular (IM) injections of NBP2001(RBD 30μg/dose) on Days 0 and 28.; Participants will receive intramuscular (IM) injections of NBP2001(RBD 50μg/dose) on Days 0 and 28.; Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Intervention MeSH terms: Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat
      mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and
      video diaries.
    


Intervention name(s): Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Intervention type(s): Drug
Intervention description(s): Apply adapalene BPO gel once daily in the evening for 12 weeks
Other intervention name(s): Epiduo® Gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
Condition: Bronchiolitis, Viral
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether a single intramuscular injection of
      dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.
    

Detailed description: 
      Acute bronchiolitis is an infection of the lower respiratory tract causing inflammation of
      the small airways, leading to bronchiolar obstruction. Corticosteroids are frequently
      prescribed as anti-inflammatory drugs. The usefulness of corticosteroids for this disease
      remains controversial, despite many randomized controlled trials (RCTs). Recently, a
      meta-analysis and systemic review showed significant improvement in clinical symptoms, length
      of hospital stay and duration of symptoms in children with this disease after treatment with
      various regimens of systemic corticosteroids.

      Dexamethasone is a long acting corticosteroid with biologic half-life ranging from 36-72
      hours. A single dose of dexamethasone has been the standard recommendation for the treatment
      of croup which has a similar pathophysiology without evidence of adverse effects.
      Furthermore, there is no previous report of this single dosage form of dexamethasone for the
      treatment of acute bronchiolitis in young children.
    

Intervention name(s): dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bronchiolitis; wheezing; dexamethasone; young children
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032
      combination therapy in Japanese subject.

      The purpose of this study is to compare the anti-viral activity of the co-administration of
      Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese
      Hepatitis C virus (HCV) subjects
    

Detailed description: 
      Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
    

Intervention name(s): Daclatasvir; Asunaprevir; Ribavirin; pegIFNα-2b; Telaprevir
Intervention type(s): Drug; Drug; Drug; Biological; Drug
Intervention MeSH terms: Ribavirin; Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modafinil Treatment for Cocaine-Dependent Individuals
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite years of active research, there are still no approved medications for the treatment
      of cocaine dependence. The purpose of this study is to determine the effectiveness of
      modafinil in treating cocaine-dependent individuals.
    

Detailed description: 
      Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled
      conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe
      cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose
      of this study is to determine whether modafinil improves abstinence during early recovery
      from cocaine dependence.

      This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with
      current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks.
      Participants will be randomly assigned to receive a single morning dose of low-dose modafinil
      (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition,
      each week participants will receive manual-guided cognitive behavioral therapy at the
      Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo
      will be abruptly discontinued. One week following, an end of medication evaluation will
      occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after
      initial randomization. Efforts will be made to continue evaluation of subjects who decide to
      discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure
      cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be
      evaluated.
    

Intervention name(s): Low Dose Modafinil; High Dose Modafinil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): modafinil 200 mg/day; modafinil 400 mg/day; placebo 400 mg/day
Other intervention name(s): Provigil; Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with endometriosis-associated pain have conservative surgery performed to remove all
      visible lesions. Then, patients are randomized into two groups. In the first group patients
      have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In
      the second group patients have oral contraceptive combined pills everyday for 6 months.
      Patients are followed up on recurrence of pain for 1 year after medication.
    


Intervention name(s): intramuscular depot medroxyprogesterone acetate; ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg, Intramuscular, every 3 months; one tablet orally, everyday
Other intervention name(s): Depo Provera; Gynera
Intervention MeSH terms: Medroxyprogesterone Acetate; Ethinyl Estradiol; Medroxyprogesterone; Gestodene; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pelvic pain; postoperative; medical therapy
PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption
      by Extending the Absorption Site.

      To overcome the shortcomings of the currently existing sustained release drug delivery
      technologies the investigators have recently developed a novel drug delivery system to enable
      a drug to be dissolved irrespective of the surrounding environment and further absorbed up to
      colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
    

Detailed description: 
      Basically, this system is a triple-layered tablet, comprised of upper and lower layers that
      swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that
      rapidly draw water into the tablet core simultaneously.

      The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself)
      functions as an additional media which enables additional and later drug release out of the
      dosage form. This serves to overcome the shortage of surrounding media that has been reported
      to be one of the key reasons for mal-absorption of a drug in colon.

      As the middle layer induces a rapid water draw into the tablet core, the penetrated water
      also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and
      controls drug release.

      At virtually the same time, the swollen upper and lower layers form to surround a lateral
      side of the middle layer, which can, in turn, further control drug release.

      This relatively rigid swollen matrix structure makes drug release not affected by surrounding
      mechanical flux, which can provide relatively consistent in vivo drug release irrespective of
      degree of gastrointestinal motility.
    

Intervention name(s): Pregabalin 150mg; Pregabalin 75mg
Intervention type(s): Drug; Drug
Intervention description(s): GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days; Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Other intervention name(s): GLA5PR GLARS tablet 150mg; Lyrica Capsule 75mg
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pregabalin, GLARS
Lifetime Impact of Achondroplasia Study in Europe-LIAISE
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Observational

Summary: 
      Observational study looking at the burden of illness in achondroplasia subjects aged 5-70.
      The study will include a 5 year review of historical clinical data as well as a single point
      collection of questionnaire data to look at the impact on the following in individuals with
      achondroplasia versus a normative population:

        -  Quality of life

        -  Clinical burden

        -  Healthcare resource use

        -  Socio-economic burden

        -  Psychosocial burden

      Up to 300 subjects will be included in sites in Germany, Spain, Italy, Sweden, Austria and
      Denmark
    

Detailed description: 
      This is a multinational, epidemiological, observational, retrospective, cross-sectional study
      of individuals with achondroplasia (subjects). This study will be conducted at up to
      approximately 20 sites in European countries.

      Subjects will be invited to enroll via 3 routes:

        1. During routine hospital visits

        2. From subject lists of those previously treated but no longer followed at the study site.

        3. Through collaboration of the Investigator with achondroplasia patient organizations,
           other achondroplasia-related organizations, other healthcare professionals in their
           country and achondroplasia-related social media sites. A recruitment flyer will be
           provided to these organizations, healthcare professionals and social media sites and
           will to be distributed to potential subjects.

      Data will be collected over a minimum of the five years prior to the date of enrolment.
      Clinical and healthcare resource use data will be collected from medical records. For each
      subject enrolled, data from medical records will be collected and entered onto an electronic
      case report form (eCRF) at each site. Data collection from medical records will be
      supplemented by records provided by the subject and, if necessary, confirmed by the family
      doctor.

      Data about QoL, psychosocial burden, socioeconomic burden and healthcare resource use will be
      collected via a booklet of validated and structured questionnaires.

      Characteristics of subjects with achondroplasia (QoL scores, healthcare resource use,
      educational level, family status, employment status) will be compared with those of the
      general population, where available.

      As this is an observational study, participation will not affect the subject/Investigator
      relationship, nor influence Investigator's treatment, therapeutic or other management of the
      subject.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with a diagnosis of Achondroplasia aged 5 years or older in Sweden, Germany,
        Spain, Italy, Austria and Denmark.