bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Genetics in Infantile Spasms
Condition: Infantile Spasms; West Syndrome
MeSH terms: Muscle Cramp; Spasm; Spasms, Infantile; Syndrome
Study type: Observational

Summary: 
      Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters
      with an onset in the first year of life. West syndrome represents a subset of ISs that
      associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or
      regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many
      patients, however, remain without etiological diagnosis, which is critical for prognostic
      purpose and genetic counselling. In the present study, the investigators performed genetic
      screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5
      genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic
      encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a
      subset of ISs.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infantile spams or West syndrome
      
Keywords: Infantile spasms; West syndrome; variant; mutation; CNV; sequencing
The Minnesota Manual Dexterity Test As A Measure Of Hand Function in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The aim of the study is to report the results of manual dexterity using the Minnesota Manual
      Dexterity Test in people with Multiple Sclerosis.
    

Detailed description: 
      Upper limb can be affected even in early stage in people with Multiple Sclerosis (pwMS).
      Manual dexterity is important to maintain upper limb function and 9-Hole Peg Test (9HPT) is
      used as gold standard to assess dexterity in pwMS. There are no studies evaluating manual
      dexterity with the Minnesota Manual Dexterity Test (MMDT) in pwMS. This study aims to:

        1. reporting the results of manual dexterity using the Minnesota Manual Dexterity Test and
           comparing the test results with healthy volunteers,

        2. examining the relationship between MMDT and 9HPT, ABILHAND, grip strength, pinch
           strength, fatigue.
    

Intervention name(s): Test Group; Control Grup
Intervention type(s): Other; Other
Intervention description(s): Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.; Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Test group: 80 people with multiple sclerosis will be evaluated. Inclusion and exlusion
        criteria listed above. Control group: 40 healthy volunteers with demographic
        characteristics similar to people with multiple sclerosis will be evaluated to compare
        people with multiple sclerosis.
      
Keywords: multiple sclerosis; upper limb; manual dexterity; assessment; minnesota manual dexterity test
Cannabinoids and Cerebellar-Motor Functioning
Condition: Cannabis; Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the dose-related effects of
      delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor
      functions.
    

Detailed description: 
      The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC
      administration mediates cerebellar versus forebrain-dependent associative learning in humans
      as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests
      will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task,
      paced finger tapping).
    

Intervention name(s): THC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.; Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cannabinoids; Eyeblink Conditioning; EBC
A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
Condition: Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of
      oral capecitabine in combination with intravenous (IV) cisplatin in participants with
      metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine
      treatment, and cisplatin will be administered on the first day of each cycle. The anticipated
      time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.
    


Intervention name(s): Capecitabine; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).; Participants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Efficacy of Sodium Oxybate in the Long-term Maintenance of Abstinence in Alcoholic Patients
Condition: Alcohol Use Disorder (AUD); Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      Additional pharmacotherapies in the treatment of alcohol dependence are needed. Sodium
      oxybate showed efficacy in the maintenance of abstinence in alcohol-dependent patients in
      several small randomized trials of short duration. The aim of the present phase III/IV study
      is to confirm in a randomized-controlled study the efficacy and safety of oral sodium oxybate
      in the maintenance of abstinence.
    

Detailed description: 
      Alcohol dependence (AD) is the most severe form of alcohol use disorder. It occurs in 2.6% of
      people aged 15+ years worldwide and can result in a reduction of life-expectancy by several
      years as compared with the general population.

      Currently, disulfiram, acamprosate and naltrexone are the main medicinal products registered
      for the maintenance of abstinence in AD patients. Although effective on the group level,
      effects sizes are limited, and many AD patients fail to respond to these medications.
      Therefore, additional pharmacological treatments are needed.

      Sodium oxybate 50mg/kg/day showed evidence of efficacy compared to placebo and naltrexone in
      the maintenance of abstinence in AD patients in a series of open label and blinded randomized
      controlled trials (RCTs). However, studies were generally small and did not investigate the
      sustainability of the Sodium oxybate effect post-treatment.

      The present phase III/IV RCT (GATE 2) aimed to confirm the efficacy and safety of oral Sodium
      oxybate in the maintenance of abstinence. Secondary aims included the assessment of sustained
      SMO effects during the 6-month medication free period immediately following the 6-month
      treatment period and monitoring the risk of Sodium oxybate dependence.
    

Intervention name(s): Sodium Oxybate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution for oral administration; solution for oral administration
Other intervention name(s): gamma-hydroxy butyrate (GHB)
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo-controlled study with parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism; alcohol; alcohol dependence; relapse prevention
Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both
      alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All
      subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will
      be completed at 1, 3, 6, and 9 months after treatment.
    


Intervention name(s): ondansetron (Zofran); naltrexone (ReVia); Cognitive Behavioral Therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Naltrexone; Ondansetron
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple
      ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional
      part to investigate whether CORT113176 ameliorates the effects of prednisone on various
      pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially
      provided that this is justified by pharmacokinetic (PK) and safety data obtained from
      completed cohorts. The first MAD cohort will not start until data are available from at least
      2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect
      cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The
      expected exposure for the daily MAD level at steady state (taking into consideration
      potential accumulation on repeat dosing) must not exceed the highest exposure considered to
      be safe and well tolerated during preceding SAD cohorts.
    


Intervention name(s): CORT113176 Lipid Capsule Formulation; Placebo matching CORT113176 Lipid Capsule Formulation; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration; Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration; Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration
Intervention MeSH terms: Prednisone; Cortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Chinese University of Hong Kong Early Arthritis Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      The purpose of this study is:

        1. To ascertain whether the quantitative assessment of enhancing synovial volume and
           perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful
           indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using
           biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.

        2. To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with
           Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).
    

Detailed description: 
      This was a 24-week open-label randomized study. Forty patients are randomly assigned to
      receive either combination infliximab plus Methotrexate(MTX) (n=20) or Methotrexate(MTX)
      alone (n=20)

      All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with
      persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5
      mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 Patients in
      combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.
      Comprehensive assessment will be made on week 0, 12, 24.
    

Intervention name(s): Methotrexate; Infliximab
Intervention type(s): Drug; Drug
Intervention description(s): All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5 mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8; Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.
Other intervention name(s): MTX; Remicade
Intervention MeSH terms: Infliximab; Methotrexate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MTX; anti-TNF; Early RA
Dairy Products and Metabolic Effects (Norwegian Part)
Condition: Metabolic Syndrome X; Heart Disease
MeSH terms: Heart Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty
      acids and possibly some other nutrients or micronutrients with effect on energy intake,
      satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone
      to develop abdominal adiposity and metabolic syndrome.

      The aim of the study is to test the hypothesis that intake of dairy products has a favorable
      effect on markers of the metabolic syndrome.

      To explore such a hypothesis the participants have to be in a free living situation during an
      extended study period.
    


Intervention name(s): Increased intake of dairy products
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen
Condition: Solar Elastosis
Study type: Interventional

Summary: 
      Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen.
      However, there is no histologic study about the effects of anti-inflammatory and
      anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
    

Detailed description: 
      Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and
      anti-oxidant agents have become the important ingredients in sunscreen. However, there is no
      histologic study about the effects of anti-inflammatory and anti-oxidative properties of
      sunscreen to prevent premature aging from UVA and UVB.
    

Intervention name(s): Sunscreen
Intervention type(s): Other
Intervention description(s): Apply sunscreen before and after UVA and UVB irradiation
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the
      efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with
      HBeAg negative chronic hepatitis B
    


Intervention name(s): adefovir dipivoxil tablets
Intervention type(s): Drug
Intervention description(s): adefovir dipivoxil once daily 10 mg orally
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adefovir dipivoxil; e Antigen negative; chronic hepatitis B; Chinese
Single Versus Multiple Visits Endodontic Treatment
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Healing rate after single visit or multiple visit endodontic treatment using triple paste
      intracanal medicament will be assessed both clinically and radio-graphically for follow-up
      period up to one year
    

Detailed description: 
      Patients with necrotic teeth with apical periodontitis will be selected according to the
      eligibility criteria and patients are then randomized to either single visit or multiple
      visit using triple paste intracanal medicament. Postoperative pain will then assessed using
      numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing
      will be assessed every 3 months up to one year.
    

Intervention name(s): mixture of metronidazole, ciprofloxacin, and minocycline
Intervention type(s): Drug
Intervention description(s): placement of intracanal medication
Other intervention name(s): no other names
Intervention MeSH terms: Metronidazole; Ciprofloxacin; Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Smart Autonomous Neuro-Rehabilitation System
Condition: Cognition Disorders; Cognitive Deficits
MeSH terms: Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Cognitive rehabilitation is defined as a systematic functionally oriented intervention of
      therapeutic cognitive activities based on the assessment and understanding of patient's brain
      behavior deficits. This project focuses on restoring cognitive functions in order to
      understand the underlying deficits in the patient's brain by developing integrated cognitive
      rehabilitation scenarios in virtual reality that combine memory, attention and problem
      solving training with context specific motor movements.
    


Intervention name(s): Cognitive rehabilitation training with RGS in the clinic; Passive/conventional cognitive training at home.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).; Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive rehabilitation; memory; attention; spatial neglect; executive dysfunctioning
Using Neuroscience to Optimize Digital Health Interventions Across Adulthood
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this study is to investigate the extent to which brain imaging data predict
      health behavior change, compared to participant self-reports.
    


Intervention name(s): Motivational Messages
Intervention type(s): Other
Intervention description(s): Messages regarding physical activity will be texted to participants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Bioavailability of Vitamin D2 in Yeast and Bread
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to test the bioavailability of vitamin D in bread.
    

Detailed description: 
      Vitamin D helps in reducing the risk for the development of many chronic diseases. Humans get
      vitamin D mainly from direct exposure to sunlight, from diet, or from dietary supplements.
      The bioavailability of vitamin D from dietary supplements has been tested. In one study,
      subjects had initial vitamin D level of less than 10ng/ml, and it rose to 60ng/ml 24 hours
      after taking a vitamin D supplement capsule that contained 50,000 IU of vitamin D2. Food
      contains vitamin D2 or vitamin D3 either naturally or after being fortified. Fortification of
      dietary products date back to the first half of the 20th century when Steenbock discovered
      that irradiation of food helped in promoting the healing of rickets in vitamin D deficient
      rachitic rats. Since that time, companies started to fortify their products to enhance their
      vitamin D content. In the 1930s Bond Bread fortified its bread with vitamin D2. Recently the
      FDA approved yeast vitamin D2 which is a yeast that was exposed to ultraviolet radiation.
      This yeast is active and when used to raise bread the bread contains vitamin D2. The baking
      process does not affect the vitamin D content. What is unknown is whether the vitamin D2 that
      is produced in the bread is bioavailable. The purpose of this study is to determine the
      bioavailability of vitamin D2 that is present in yeast, in bread that was raised with vitamin
      D2 yeast and vitamin D2 in the cell walls of yeast compared to a vitamin D2 supplement and a
      vitamin D3 supplement.
    

Intervention name(s): Consumption of capsule/bread with vitamin D
Intervention type(s): Other
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: Vitamin D; Bioavailability; Fortified Bread