bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Condition: Epileptic Encephalopathy; Continuous Spike and Wave During Sleep
MeSH terms: Brain Diseases; Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and
      pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric
      subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).
    


Intervention name(s): NBI-827104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Triple T-type calcium channel blocker.; Non-active dosage form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of
      single rising doses.
    


Intervention name(s): BI 1358894; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety for Frequent Use Conditions of Hair Removal Device
Condition: Hair Removal
Study type: Interventional

Summary: 
      To measure the safety of hair removal device when used frequently.
    

Detailed description: 
      The primary endpoint of this study is to measure the safety of the Hair2Go device when used
      frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks
      after the last treatment, and gathering information about the pain associated with the
      procedure
    

Intervention name(s): Hair2Go (Mē)
Intervention type(s): Device
Intervention description(s): Treatment with Hair2Go (Mē) three times every 2-4 days
Other intervention name(s): Mē my elōs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hair removal; Hair Clearance; Epilation
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will provide the Senegal Ministry of Health with data on the clinical efficacy of
      the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy
      considerations for influenza vaccine.
    

Detailed description: 
      This study is a double-blind, individual-randomized, placebo-controlled, clinical efficacy
      trial among healthy children aged 24 through 71 months in the Niakhar area of Senegal. A
      total of 1,761 healthy children will be randomized in a 2:1 ratio of LAIV to placebo.

      For evaluation of efficacy, passive and active surveillance will be conducted weekly
      throughout the study to identify outcomes among vaccinated subjects. Children meeting the
      protocol-defined clinical case definition will have a nasal swab and throat swab specimen
      collected for testing by rRT-PCR for evidence of influenza virus infection.

      100 of the 1,761 participants were also included in a substudy designed to evaluate virologic
      evidence of LAIV replication. As such, nasal and throat swab specimens were collected on day
      0 (prior to vaccination), as well as on post-vaccination days 2, and 4 from all subjects
      included in the substudy. These specimens will be tested for presence of wild-type and
      vaccine virus. Additionally, a more detailed assessment of vaccine reactogenicity will be
      made among these children by actively collecting solicited and unsolicited reactions at each
      study visit for the week post vaccination (days 2 and 4).
    

Intervention name(s): SIIL Live Attenuated Influenza Vaccine; Matched placebo
Intervention type(s): Biological; Biological
Intervention description(s): Trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010; Matched placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza vaccine; trivalent live-attenuated influenza vaccine; efficacy; Africa; Senegal
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
Condition: Asherman Syndrome
MeSH terms: Gynatresia; Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mindfulness based stress reduction are
      effective on improve anxiety, depression and quality of life in women with intrauterine
      adhesion
    

Detailed description: 
      This is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned
      intrauterine adhesions patients to mindfulness based stress reduction group and wait-list
      control group.The study compared anxiety and depression levels and quality of life in
      patients with intrauterine adhesions before and after the completion of mindfulness based
      stress reduction program.Anxiety, depression and quality of life level measured by the Zung
      self-rating anxiety scale, Zung Self-Rating Depression Scale and The 36-item Short-Form
      Health Survey.
    

Intervention name(s): Mindfulness Based Stress Reduction
Intervention type(s): Other
Intervention description(s): Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this study was to examine whether MBSR is effective, and has potential as an intervention to decrease depression, anxiety ,and to improve quality of life of intrauterine adhesion patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Asherman syndrome; Mindfulness; Anxiety; Depression; Quality of Life
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody
      directed against FVIII, versus placebo in healthy male volunteers.
    


Intervention name(s): TB-402; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety and tolerability
RehabTouch Home Therapy for Stroke Patients
Condition: Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people
      in the subacute stage after a stroke compared to a traditional tabletop exercise program.
      RehabTouch uses embedded sensors that can track and record the patient's direction and degree
      of movement as they perform exercises described on a computer.
    


Intervention name(s): RehabTouch; Conventional tabletop exercise program
Intervention type(s): Device; Other
Intervention description(s): Exercise using the motion sensing devices and a computer; Exercise following printed sheets of exercises
Other intervention name(s): FitMi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Depression Treatment and Risk for Cardiovascular Disease
Condition: Depression
MeSH terms: Cardiovascular Diseases; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT)
      that involved treating depression among participants with an elevated risk for cardiovascular
      disease. It is expected that treating depression through non-pharmacological means will
      impact heart rate variability, a proximal measure of CVD risk.
    


Intervention name(s): Behavioral Activation (BA)
Intervention type(s): Behavioral
Intervention description(s): Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects
Condition: Type 2 Diabetes; Impaired Glucose Tolerance; Healthy
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism
      parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic,
      impaired and normal fasting glucose subjects.

      This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design.
      Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or
      normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.
    


Intervention name(s): Pinitol
Intervention type(s): Dietary Supplement
Intervention description(s): Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Other intervention name(s): 3-O-methyl-D-chiro-inositol
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Influenza Challenge Study in Healthy Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99)
      virus for use in other Influenza challenge studies for the development of Influenza vaccines,
      antiviral agents and to better understand the host response to Influenza infection.
    

Detailed description: 
      The primary aim was to determine the infectious titre of an Influenza A (H1N1) (A/New
      Caledonia/20/99) virus for use in other Influenza challenge studies for the development of
      Influenza vaccines, antiviral agents and to better understand the host response to Influenza
      infection.

      In addition, the safety of the inoculum, the virus shedding from the nasal mucosa following
      challenge with Influenza., changes in mRNA and protein expression from blood and nasal brush
      samples. were assessed Self reported symptoms following challenge were recorded. Samples were
      taken to facilitate validation of CMI and other immunologically relevant assays in
      development

      Overall Trial Design:

      For each group of subjects, quarantine, challenge phase, release from quarantine and
      decontamination occured concurrently at the designated study site throughout the challenge
      phase of the study.

      The volunteers were be stratified into four groups depending on their intended challenge
      titre of virus:

      High titre Medium-high titre Medium-low titre Low titre Influenza inoculation (nasal drops)
    

Intervention name(s): High Titre Influenza virus; Medium - High Influenza virus; Medium Low Titre Influenza virus; Low titre
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): High Titre Influenza virus; Medium - High Influenza virus; Medium Low Titre Influenza virus; Low titre
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: immunology; pathogenicity
Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well
      tolerated in obese female subjects. The study will also provide information on how much
      ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other
      biological markers.
    

Detailed description: 
      This protocol is designed to test the safety and preliminary efficacy of a drug called
      ZGN-433. It is to be tested for its ability to reduce weight in severely obese female
      subjects who are post menopausal or infertile.
    

Intervention name(s): ZGN-433
Intervention type(s): Drug
Intervention description(s): Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.
Other intervention name(s): Beloranib hemioxalate
Intervention MeSH terms: CKD732
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obese; Obesity; Overweight
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to
      Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and
      the process of rehabilitation.
    

Detailed description: 
      The method of immediate adjustment of a temporary Prosthesis has been developed in the past,
      aiming to reduce the healing time of the stump and the process of rehabilitation. According
      to this method, a temporary Prosthesis is being adjusted immediately after amputation, or
      during the first week after it. Rehabilitation starts with the patient's standing while
      partial weight bearing on the Prosthesis.

      In spite of many experiments and trials to adopt this process of rehabilitation, it is not
      universally adopted, because of the bad adjustment and damages to the stump caused by the
      Plaster of Paris. At present, with the improvement of materials and research experiments are
      being renewed, to check the efficiency of the process, using the Air- Limb a temporary
      Prosthesis.
    

Intervention name(s): Air- Limb
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Transtibial amputees due to vascular diseases.
A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in
      healthy Japanese and Caucasian participants. The study will also investigate how much
      lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan
      when given to Japanese and Caucasians. The study will last up to 47 days for each
      participant.
    


Intervention name(s): Lasmiditan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Complications in Lower Body Lifts
Condition: Surplus Skin After Massive Weight Loss
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      A prospective study on 50 consecutive patients who are going to have a lower body lift
      procedure is performed. Measures include comorbidities and complications. Risk factors
      assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max),
      current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.
    


Intervention name(s): body contouring surgery of back, abdomen and thighs
Intervention type(s): Procedure
Intervention description(s): simultaneous body contouring surgery of back, abdomen and thighs
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients which are referred to Department of Plastic Surgery for body contouring surgery
      
Keywords: lower body lift; body contouring surgery; massive weight loss
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome
Condition: Sleep Apnea Syndrome
MeSH terms: Acromegaly; Apnea; Sleep Apnea Syndromes; Syndrome
Study type: Interventional

Summary: 
      Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that
      comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with
      acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly
      gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the
      association are based on maxillofacial modifications linked to acromegaly, a thickening of
      soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated
      obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative
      muscles of the pharynx.

      At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation
      for sleep apnea syndrome.
    

Detailed description: 
      60 investigators will participate to this study. They will be chosen among those
      participating to the sleep observatory of the federation of pneumology (www.osfp.fr).

      All participating pneumologists would have to fill in the questionnaire (co-morbidities,
      concomitant treatments, biological analysis) directly online and also clinical signs and
      symptoms of acromegaly. A blood test for the insulin-like growth factor (IGF-1) dosage will
      be systematically prescribed to the patient. Pneumologists will have to include all
      consecutive patients presenting with sleep apnea syndrome suspicion.

      According to first IGF-1 results, patients may have to do a second blood test in a referenced
      laboratory to confirm the dosage.
    

Intervention name(s): Diagnosis of acromegaly
Intervention type(s): Other
Intervention description(s): Biological analysis of IGF-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effectiveness of a Brief Motivational Nursing Intervention
Condition: Behavior, Addictive
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      This was a two-staged study undertaken in entertainment-sector workers in Spain: the first
      part was transversal and observational, and the second was semi-experimental. A short
      group-based motivational intervention session was implemented by nursing staff, and a before
      and after evaluation was completed. By reducing the patients' perception of their quality of
      life, this brief nursing intervention facilitated a favourable increase in the motivation for
      change among these workers and was effective in 12% of cases.
    

Detailed description: 
      Checking whether changes in the perception of the quality of life related to health, after
      the nursing intervention, influence these patients' motivation to change. This was a
      two-staged study undertaken in entertainment-sector workers in Spain: the first part was
      transversal and observational, and the second was semi-experimental. First part undertook in
      284 entertainmentsector workers, selected by non-probabilistic sampling, while second part
      undertook in 50 entertainment-business workers, selected by consecutive sampling from those
      who consumed substances. A short group-based motivational intervention session was
      implemented by nursing staff, and a before and after evaluation was completed. The EuroQol-5D
      and Test for the Evaluation of the Quality of Life in Addicts to Psychoactive Substances
      (TECVASP) were used. The patients' motivation to change was evaluated through the Stages of
      Change Readiness and Treatment Eagerness Scale.
    

Intervention name(s): brief motivational psychoeducational therapy
Intervention type(s): Behavioral
Intervention description(s): The brief motivational psychoeducational therapy (BMPT) it lasted an average of 90 min and followed the following structure: (i) brainstorming the concepts of health, lifestyle, and substance-use prevention; (ii) analysis of a work accident at an international rock group concert, which was used to generate (iii), a debate on consumer habits (30 min); (iv) discussion of the substance types and classifications known by the participants; (v) Prochaska and DiClemente's stages of change and (vi), the consequences of drug use (50 min); and finally, (vii) a true/false quiz used to discuss myths and beliefs about drugs (10 min).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cannabis; cocaine; alcohol; entertainment workers; nursing interventions
A Phase I Study of Quadrivalent HPV Recombinant Vaccine
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus
      (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects
      aged 9-45 years.
    


Intervention name(s): HPV vaccine; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention