bioihbjkbjnl/mcl2 huggingface dataset:
Early In-bed Cycling in Critically Ill Children
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the
      efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual
      care physiotherapy, on functional recovery in critically ill children.
    

Detailed description: 
      This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual
      care physiotherapy, compared to usual care physiotherapy, on functional recovery in
      critically ill children. We will conduct a qualitative substudy to evaluate caregiver
      impressions of the intervention, and to understand barriers and facilitators to implementing
      early mobilization in critically ill children.
    

Intervention name(s): In-bed cycling; Usual Care
Intervention type(s): Device; Other
Intervention description(s): In-bed cycling will be applied using a cycle ergometer (RT300 Supine Cycle Ergometer) for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first). This cycle ergometer is specifically designed for pediatric use, and can be applied to facilitate lower or upper limb cycling. The intervention will be applied by a trained physiotherapist and/or clinician. Pre-defined Safety Criteria for interrupting or aborting the intervention will be observed. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.; Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.
Other intervention name(s): Cycle ergometry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
Condition: Healthy Diet; Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The overall objective of this study is to explore the glycemic index and glycemic load
      induced by an alcohol-free beer with modified composition (including almost full fermentation
      of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as
      its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free
      beer with a usual composition; b) an alcohol-free beer with modified composition (including
      almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This
      study includes two cross-over sub-studies recruiting healthy participants. In the first one,
      10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer
      (RB), alcohol-free beer with almost completely eliminated maltose and enriched with
      isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free
      beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB)
      and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of
      carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates
      coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h,
      every 15 min, after ingestion.
    


Intervention name(s): Sub-study 1; Sub-study 2
Intervention type(s): Other; Other
Intervention description(s): Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).; Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Carbohydrates; Alcohol-free beer; Maltodextrin; Isomaltulose
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared
      with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic
      alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5%
      solution which will be provided open-label.
    


Intervention name(s): bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C; bimatoprost vehicle solution; minoxidil 5% solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Other intervention name(s): Rogaine®; Regaine®
Intervention MeSH terms: Bimatoprost; Minoxidil; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy
Condition: Intracranial Pressure Increase; Pneumoperitoneum
MeSH terms: Pneumoperitoneum; Intracranial Hypertension
Study type: Interventional

Summary: 
      Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure
      associated with pneumoperitoneum. However, there are no studies on the effect of the timing
      of reverse Trendelenburg position on intracranial pressure. This study will monitor the
      effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial
      pressure and regional cerebral oxygen saturation.
    

Detailed description: 
      The literature includes studies that investigate the relationship of pneumoperitoneum and
      different positions with intracranial pressure during laparoscopy. Reverse Trendelenburg
      position has been shown to slightly reduce the intracranial pressure associated with
      pneumoperitoneum. However, there are no studies on the effect of the timing of reverse
      Trendelenburg position on intracranial pressure. This study will monitor the effect of
      reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and
      regional cerebral oxygen saturation. Ultrasound guided measurement of the optic nerve sheath
      diameter as a non-invasive method will be used for measurement. The investigators believe
      reverse Trendelenburg position before pneumoperitoneum may prevent undesired sudden increases
      in intracranial pressure.
    

Intervention name(s): Pneumoperitoneum Timing (Before Positioning); Pneumoperitoneum Timing (After Positioning)
Intervention type(s): Procedure; Procedure
Intervention description(s): Before Reverse Trendelenburg Position; After Reverse Trendelenburg Position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: optic nerve sheath diameter; intracranial pressure; laparoscopic cholecystectomy; pneumoperitoneum
Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops
Condition: Visual Acuity
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a single-visit, multi-site, randomized, single-masked, bilateral,
      active-controlled, non-dispensing, 2X2 crossover study.
    


Intervention name(s): Blink® Tears eye drops in a multidose bottle; Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
Intervention type(s): Drug; Drug
Intervention description(s): Control; Test
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer
      patients. Despite this, there has been virtually no research evaluating treatment for
      cancer-related fatigue in this young patient group. The investigators are undertaking a small
      qualitative study to co-design a fatigue intervention, that will then be evaluated in future
      research to assess its effectiveness.
    

Detailed description: 
      This small qualitative study will involve 7-10 patients who are within one year of completing
      cancer treatment, as well as some parents. Participants will be recruited from one centre,
      the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases
      will involve a) participants being interviewed individually and attending a focus group, b)
      patients receiving the prototype co-designed intervention, and c) participants being
      interviewed after the intervention to provide feedback to allow further refinement of the
      intervention. The intervention will be delivered by an Allied Health Professional in the
      setting that participants have chosen. It is likely to involve, at a minimum, education about
      fatigue and support with increasing activity. It will not include administration of any
      medication.
    

Intervention name(s): Fatigue Intervention
Intervention type(s): Behavioral
Intervention description(s): The Fatigue Intervention will include education, energy conservation and activity promotion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phenotypic and Genotypic Markers of Performance Vulnerability to Sleep Loss
Condition: Sleep Restriction Then Total Sleep Deprivation; Total Sleep Deprivation Then Sleep Restriction
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Insufficient sleep is common, affecting 20-40% of adults, and resulting from sleep disorders,
      medical conditions, work demands, stress/emotional distress, and social/domestic
      responsibilities. It produces significant social, financial and health-related costs, and it
      has increasingly become a major public health concern as population studies worldwide have
      found that reduced sleep duration is associated with increased risks of obesity, morbidity,
      and mortality. It is well established that sleep loss causes fatigue and sleepiness, as well
      as errors and accidents that are due to its adverse neurobehavioral effects on alertness,
      mood, and cognitive functions. However, there are substantial, trait-like differences among
      people in the extent to which they experience such neurobehavioral deficits when sleep
      deprived. Common genetic variations involved in sleep-wake, circadian, and cognitive
      regulation may underlie these large inter-individual differences in neurobehavioral
      vulnerability to sleep deprivation, though it remains unclear whether different types of
      sleep deprivation involve the same phenotypic responses and same genotypic contributors. This
      project will be the first large-scale investigation of markers of differential cognitive
      vulnerability to both acute total sleep loss and chronic partial sleep loss. It will identify
      individuals who are at significant risk for fatigue and severe impairments from sleep loss. A
      total of 110 healthy adults will undergo a 13-day laboratory protocol to thoroughly
      characterize their cognitive, psychological and physiological responses to two of the most
      common forms of sleep loss--acute total sleep deprivation (1 night of sleep loss) and chronic
      partial sleep deprivation (5 nights of sleep limited to 4 hr). The findings from this study
      will represent a critical first step toward tailoring appropriate follow-up interventions for
      sleep loss and its symptomatic relief by finding predictors of at-risk individuals who should
      avoid sleep loss whenever possible, and/or seek effective countermeasures. Whether or not
      markers of neurobehavioral vulnerability to sleep loss are identified, the results of the
      project will help inform public policies pertaining to the need for adequate sleep and for
      countermeasures for sleep loss, and also will further our understanding and management of
      vulnerability to excessive sleepiness due to common sleep and medical disorders.
    


Intervention name(s): Sleep
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exercise and Life Modification for Text-Neck
Condition: Pain; Exercise; Posture
Study type: Interventional

Summary: 
      Objectives: The purpose of the study was to investigate the effects of exercise and life
      modification on pain and disability in "text neck".

      Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29),
      Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest,
      activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional
      assessment was done by using Neck Disability Index at the beginning and at the end of 4
      weeks.
    

Detailed description: 
      Objectives: Smartphones or tablets have made an important place in our lives. However
      long-term use of technological tools causes postural disorders and neck pain called "text
      neck". The purpose of the study was to investigate the effects of exercise and life
      modification on pain and disability in "text neck".

      Methods: Eighty-five participants with "text-neck" were randomly divided into three groups:
      Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). First group
      received a home exercise program treatment for 4 weeks. Second group received life
      modification suggestions additional to home exercise treatment program. Control group did not
      receive any treatments. Pain intensity during rest, activity, and at night was evaluated with
      Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index
      at the beginning and at the end of 4 weeks.
    

Intervention name(s): Exercise program; Life modification
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of
      evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).

      The primary objective for Part B of the study is to demonstrate a reduction of low-density
      lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients
      with HoFH.

      The secondary objective for Part A of the study is to evaluate the safety and tolerability of
      evinacumab administered intravenous (IV) in pediatric patients with HoFH.

      The secondary objectives for Part B of the study are:

        -  To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B
           (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),
           lipoprotein a [Lp(a)]) in pediatric patients with HoFH

        -  To evaluate the safety and tolerability of evinacumab administered IV in pediatric
           patients with HoFH

        -  To assess the PK of evinacumab in pediatric patients with HoFH

        -  To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time

        -  To evaluate patient efficacy by mutation status
    

Detailed description: 
      Part A is Phase 1b Part B is Phase 3
    

Intervention name(s): Evinacumab
Intervention type(s): Drug
Intervention description(s): Part A: Single IV dose Part B & C: IV dose Q4W
Other intervention name(s): REGN1500; Evkeeza™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HoFH
Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Primary Objective: Part A

        -  To quantify deficits in cognitive functioning in adolescents with moderate-to-severe AD,
           using the Conners' Continuous Performance Test 3rd Edition (CPT-3) d' T-score

        -  To determine the entry criterion (CPT-3 d' score) for Part B

      Primary Objective: Part B

        -  To measure changes in cognitive functioning in adolescents with moderate-to-severe AD
           treated with dupilumab

      Secondary Objectives

        -  To evaluate the relationship of cognitive and sensory functioning with severity of AD in
           adolescent AD patients

        -  To evaluate the relationship between changes in AD severity and changes in cognitive and
           sensory functioning scores following treatment with dupilumab (Part B only).
    

Detailed description: 
      Per protocol Study Stop Criteria, study has concluded with Part A. Part B was not initiated
      and no data were collected.
    

Intervention name(s): dupilumab
Intervention type(s): Drug
Intervention description(s): Weight based dosing for 16 weeks in accordance of United States prescribing information (USPI)
Other intervention name(s): DUPIXENT®
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with moderate-to-severe atopic dermatitis (AD) will be assessed for quantifying
        deficits in cognitive functioning at a single visit only and no study-related treatment
        will be offered.
Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series
Condition: Bulimia Nervosa; Anorexia Nervosa
MeSH terms: Anorexia; Bulimia; Anorexia Nervosa; Bulimia Nervosa
Study type: Interventional
Phase: Phase 1

Summary: 
      This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex
      repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with
      Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is
      heavily implicated in the regulation of mood and affect, and has been suggested to be
      involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might
      lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by
      improved regulation of mood and affect. Improvements in important areas of comorbidity might
      allow for better response to intensive treatment for AN and BN, and reduce relapse rates
      after such treatment. The DMPFC may be a more appropriate target for compared to the
      Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in
      the past. Our initial preliminary pilot work has noted unexpected and significant
      improvements in some core ED symptoms (bingeing and purging) and in important areas of
      comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have
      allowed some treatment resistant patients to either complete intensive treatment or be
      successful in maintaining their progress post intensive treatment. Subjects will receive up
      to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via
      psychometric measures, and pre and post fMRI.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.
Other intervention name(s): High-frequency rTMS; Magventure DB80 Coil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorders; rTMS; Anorexia; Bulimia
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the efficacy and safety of linzagolix
      administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in
      combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg /
      norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe
      endometriosis-associated pain (EAP).
    

Detailed description: 
      This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the
      efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and
      200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the
      management of moderate to severe EAP in 450 women.

      Eligible subjects who have completed the 6-month treatment period may enter a separate
      extension study for 6 additional months of active treatment (no placebo control). Subjects
      who do not continue in the extension study will enter a 6 month treatment-free follow-up
      phase.
    

Intervention name(s): 75 mg linzagolix tablet; 200 mg linzagolix tablet; Add-back capsule (E2 1 mg / NETA 0.5 mg); Placebo tablet to match 75 mg linzagolix tablet; Placebo tablet to match 200 mg linzagolix tablet; Placebo capsule to match Add-back capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): For oral administration once daily; For oral administration once daily; For oral administration once daily; For oral administration once daily; For oral administration once daily; For oral administration once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Dyspareunia; Dyschezia; Non-menstrual pelvic pain