bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.
Condition: Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Personality Disorder
MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Personality Disorders; Anorexia Nervosa; Bulimia Nervosa
Study type: Interventional

Summary: 
      The aim of this study is to determine whether in-patient treatment is better then intensive
      out-patient group treatment for patients with concurrent eating disorder and personality
      disorder.
    

Detailed description: 
      The main aim of the study is to compare the effects of in-patient treatment with a group
      based intensive out-patient treatment. It is a randomized controlled comparison study
      including patients with concurrent eating disorder and personality disorder. 18 patients will
      receive an in-patient treatment lasting one year. 18 patients will receive intensive
      out-patient treatment consisting of two-weekly group sessions, lasting one year. Personality
      disorder, eating behavior, symptoms, and function will be followed for two years.
    

Intervention name(s): inpatient treatment; outpatient treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): inpatient treatment during 1 year; intensive outpatient treatment consisting of two-weekly group sessions during 1 year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Eating disorders; Anorexia nervosa; Bulimia nervosa; Personality disorders; In-patient treatment; out-patient treatment; group therapy
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
Condition: Essential Blepharospasm
MeSH terms: Blepharospasm
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against
      Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
    


Intervention name(s): Hugeltox; Botulinum Toxin Type A(Botox®)
Intervention type(s): Drug; Drug
Intervention description(s): 1.25U~2.5U/site, Maximum dosage 12.5U~60U/person; 1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Diagnosis and Mechanism of Pleural Effusion
Condition: Pleural Diseases
MeSH terms: Pleural Effusion; Pleural Diseases
Study type: Observational

Summary: 
      The diagnosis, treatment and mechanism of pleural diseases
    

Detailed description: 
      The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of
      pleural diseases
    

Intervention name(s): Collection of pleural effusion
Intervention type(s): Other
Intervention description(s): Detection of pleural effusion
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with pleural effusion
      
Biospecimen description: 
      The blood and pleural effusions if there is any, will be collected and detected
Dexpramipexole SAD/MAD Study
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single
      doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID
      dexpramipexole in healthy volunteers.
    

Detailed description: 
      Preclinical and clinical data to date support the exploration of doses of dexpramipexole
      higher than 150 mg twice daily for their effectiveness in slowing the progression of ALS.
      Exploration of doses of dexpramipexole higher than 150 mg twice daily is justified by
      preclinical and clinical data that suggest that higher doses could potentially be more
      effective in slowing the progression of ALS than the dose of dexpramipexole currently being
      explored in Phase 3 studies (150 mg twice daily).

      This is a Phase 1, single-center, blinded, randomized, placebo controlled, ascending-dose
      study consisting of 2 parts; Part A (single-ascending dose [SAD]) and Part B (multiple
      ascending dose [MAD]). The study will explore safety, tolerability, and pharmacokinetics of
      single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300
      mg BID dexpramipexole in healthy volunteers.
    

Intervention name(s): Dexpramipexole; Dexpramipexole Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet at varying doses; Oral tablet at varying doses
Other intervention name(s): BIIB050
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.
    

Detailed description: 
      This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF. A
      total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and
      provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg
      CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every
      4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).
    

Intervention name(s): CTX-4430; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970
Condition: Healthy; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in
      healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo
      (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD),
      compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the
      pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution
      versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to
      evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe
      psoriasis when administered daily for 6 weeks.
    


Intervention name(s): GLPG3970 oral solution; Placebo oral solution; GLPG3970 capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLPG3970 for oral administration; Placebo for oral administration; GLPG3970 for oral administration
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Condition: Spinal Cord Injury; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of penile vibratory stimulation on the
      muscle spasticity of men with chronic spinal cord injury.
    

Detailed description: 
      Spinal cord injury can result in mild to severe muscle spasms that can both inhibit
      functional capability and increase the likelihood of injury due to fall. Anecdotal reports
      and a recent study suggest that triggering the ejaculatory reflex in men with vibratory
      stimulation can result in a significant decrease in spasm activity over a period of 2 to 42
      hours. This study examines the effects of penile vibratory stimulation on spasticity when
      conducted daily in the home setting.
    

Intervention name(s): Penile Vibratory Stimulation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Penile Vibratory Stimulation; Muscles Spasticity; Spasms; Ferti Care Vibrator; Antispasmotic treatment
Hypnotic Intake and Motor and Cognitive Performances at High Altitude
Condition: Physiology
Study type: Interventional

Summary: 
      This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep,
      cognitive and motor performances and on acute mountain sickness symptoms at high altitude.
      Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high
      altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms,
      cognitive and motor performances will be assessed to determine potential residual effects of
      Zolpidem within such conditions.
    


Intervention name(s): Zolpidem; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The hypnotic will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.; The placebo will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)
Condition: Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection.
      Successive participants will be enrolled as dose levels are evaluated to find the maximum
      safe and well tolerated dose of Ruzasvir. Part I will be for participants with hepatitis C
      virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV
      genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts
      II and III may run concurrently. The primary study hypothesis is that a safe and tolerable
      dose of Ruzasvir that reduces viral load will be found to support further clinical
      investigation.
    


Intervention name(s): Ruzasvir
Intervention type(s): Drug
Intervention description(s): Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.
Other intervention name(s): MK-8408
Intervention MeSH terms: Ruzasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Neoplasms; Neoplasm Recurrence, Local; Neoplasm Metastasis
MeSH terms: Neoplasms; Carcinoma, Squamous Cell; Neoplasm Metastasis; Head and Neck Neoplasms; Neoplasm Recurrence, Local; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to compare time to progression and overall survival after
      treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the
      first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of
      the head and neck.
    


Intervention name(s): docetaxel (XRP6976); cisplatin; 5-fluorouracil (5-FU)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Taxotere
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tocilizumab Effect iN pOlymyalgia Rheumatica
Condition: Polymyalgia Rheumatica
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 1:

      Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is
      performed using PMR-AS.

      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting
      purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale
      (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)
      [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

      At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

      Phase 2:

      All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3
      months. Two arms are possible according to the PMR-AS. Either the classical GC treatment
      (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .
    


Intervention name(s): TCZ
Intervention type(s): Drug
Intervention description(s): Tocilizumab at week 0, 4 and 8.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tocilizumab; Polymyalgia Rheumatica; Glucocorticotherapy; PMR-AS
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
Condition: Suicide, Attempted; Suicide, Ideation; Depression
MeSH terms: Suicide; Suicide, Attempted
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A non invasive treatment study including participants at risk for suicide attempts and
      undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real
      time inside the scanner.
    


Intervention name(s): neurofeedback training involving dACC; neurofeedback training involving amygdala
Intervention type(s): Other; Other
Intervention description(s): Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four ~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity > baseline and red = Activity < baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.; Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four ~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity > baseline and red = Activity < baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
Intervention model: Parallel Assignment
Intervention model description: Comparing two different targets of treatment: either amygdala or dorsal anterior cingulate cortex neurofeedback
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to evaluate the safety and tolerability of lucerastat, and
      to determine its pharmacokinetic profile as single oral doses at different strengths.
    

Detailed description: 
      The subjects were enrolled sequentially to five dose groups, starting with the lowest dose
      level. Subjects could participate in only one Group.
    

Intervention name(s): Lucerastat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsule for oral administration containing lucerastat; Matching placebo capsules
Other intervention name(s): OGT-923; ACT-434964
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: safety; pharmacokinetics
Aldosterone and Glucose Homeostasis
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Determine the effect of aldosterone on how the body handles glucose (sugar).
    

Detailed description: 
      Determine the effect of aldosterone on glucose metabolism in humans.
    

Intervention name(s): Aldosterone infusion (A); Vehicle Infusion (V); High Sodium Diet (HS); Low Sodium Diet (LS)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs); Vehicle infusion for 12.5 hours; 160 mmol/d sodium diet for 7 days; 20 mmol/d sodium diet for 9 days
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glucose; Insulin
Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder; Sleep
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study involves research to test how Vyvanse (study drug) affects sleep in 24 children
      aged 6 to 12 years who have ADHD. Vyvanse is approved by the FDA for the treatment ADHD of in
      children aged 6 to 12 years. The experimental part of this study is to determine how Vyvanse
      affects sleep.
    

Detailed description: 
      Treatment with psychostimulants has been associated with sleep disturbances, including both
      sleep onset and maintenance problems, in children with ADHD. This analysis evaluated the
      effect of lisdexamfetamine dimesylate (LDX) on sleep in children with ADHD.

      This single center, double-blind, placebo-controlled, parallel-group trial enrolled children
      aged 6-12 years with a DSM-IV-TR diagnosis of ADHD. The study included a screening period,
      1-week washout, 3-week open-label LDX dose optimization phase, and a 4-week double-blind
      treatment phase in which subjects were randomized to placebo or active LDX treatment at 30,
      50, or 70 mg/d. Polysomnograph and actigraph measures as well as assessments of subjective
      sleep parameters were performed in all subjects prior to treatment and reassessed after
      treatment with either LDX or placebo.
    

Intervention name(s): lisdexamfetamine dimesylate
Intervention type(s): Drug
Intervention description(s): Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Vyvanse; lisdexamfetamine dimesylate; LDX; sleep
The Effect of Exercise and/or Diet on Health Related Parameters
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The study evaluates the effect of exercise and/or diet during on body weight, body
      composition and health related blood parameters. Participants are overweight sedentary
      females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet
      + exercise, Low-carb-high-fat diet + exercise.
    

Detailed description: 
      Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body
      composition and improve many different health related blood parameters such as cholesterol
      and glucose tolerance.

      Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but
      adherence to exercise program can be a huge challenge for overweight individuals. While
      exercise has profound effect on metabolic health, diet has been superior when it comes to
      weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose
      tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.

      We wish to see if the combination exercise and diet is superior to diet only when it comes to
      over all health.
    

Intervention name(s): Exercise; Normal Diet; LCHF Diet
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise program - indoor bicycle interval exercise, duration 60 min 3x week; Normal diet recommended by the health authorities; LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Diet and exercise, or diet only
Masking: None (Open Label)
Primary purpose: Other
Keywords: Low-carbohydrate-high-fat diet (LCHF); Low-density-lipoprotein (LDL); High-density-lipoprotein (HDL); Triglycerides (TG); Lipids; Glucose tolerance (GT); Insulin resistance (IR); Body composition; Weight