bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is
      a condition that causes breathing to repeatedly stop and start during sleep due to blocked
      upper airways.

      This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves
      into, through and out of the body in healthy Japanese male participants.

      The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or
      to receive a placebo. A placebo looks like a treatment but does not have any medicine in it.
      The participants will receive their study treatment either 1 single time or once a day for 5
      days through a nasal spray.

      The participants will be in the study for a total of about 12 weeks. They will stay at their
      study site for either 5 or 9 days, depending on which study treatment they receive. During
      this time, the doctors will take blood and urine samples and check the participants' health.
      About 6 to 8 days after the participants receive their last treatment, the researchers will
      check the participants' health again.

      The main aim of this study is to learn more about how safe BAY2586116 is compared to the
      placebo. To answer this question, the researchers will count the number of participants who
      have medical problems that may or may not be related to the study treatment. These medical
      problems are also known as "adverse events" while they are in the study.
    


Intervention name(s): BAY2586116; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nasal administration; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obstructive sleep apnea; Phase I study; Japanese healthy volunteer study
A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There
      have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week
      106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In
      participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of
      treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering
      hemoglobin A1C (HbA1c).
    


Intervention name(s): Sitagliptin; Placebo to sitagliptin; Metformin; Rescue
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients whose FPG >240 mg/dL from Week 16 or HbA1C >8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently >240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C >8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C >7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dietary Intervention With Brain-friendly Diet
Condition: Physiological Stress; Cognitive Performance; LDL Cholesterol
Study type: Interventional

Summary: 
      To evaluate the effect of dietary intervention on metabolic risk profile, and on potential
      simultaneous changes in physiological and cognitive functions and to collect a unique
      database using state-of-the-art technologies on variables related to the above mentioned
      areas.
    

Detailed description: 
      The study is compiled from 4 phases: 1) a pilot study to evaluate performance and feasibility
      of the measurements and logistics for the BRAVE intervention study (N=10), 2) a pre-screening
      phase to select volunteers for the intervention study based on metabolite analyses (N=600),
      3) the BRAVE intervention study as a controlled non-randomized open-label fixed sequence diet
      switch trial (N=88)and 4) a non-interventional reference group to estimate the learning
      effect due to repeated cognitive testing (N=30).

      The Brainfood dietary regime is planned optimal for metabolism and cognitive function; having
      focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced
      light lunch at work -according to the so-called plate model and optimized recipes- will be
      provided.
    

Intervention name(s): Control diet; Intervention diet
Intervention type(s): Other; Other
Intervention description(s): Regular diet; Brainfood dietary regime planned to be optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work according to the so-called plate model and optimized recipes- will be provided.
Other intervention name(s): Brainfood diet
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Open, fixed sequence diet-switch 4-week intervention
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diet; Metabolites; Cognitive function; Physiology; LDL; Diet Habit; Diet Modification
Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
Condition: Brachial Plexus Block
Study type: Interventional

Summary: 
      In this study investigators will compare two different approaches of brachial plexus block
      ;supraclavicular approach and retroclavicular approach regarding success rate, duration of
      block, complications
    


Intervention name(s): supraclavicular brachial plexus block; Retroclavicular brachial plexus block
Intervention type(s): Procedure; Procedure
Intervention description(s): group will receive brachial plexus block above clavicle,Injection of anaesthetic will be done in brachial plexus around subclavian artery; group will receive brachial plexus block inferior to the clavicle,injection of anaesthetic will be done around axillary artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in
      habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.
    

Detailed description: 
      This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over,
      daily-wear design involving two different FRP lens types. Each lens type will be worn for
      approximately one month.
    

Intervention name(s): Lens A (comfilcon A lens); Lens B (lehfilcon A lens)
Intervention type(s): Device; Device
Intervention description(s): 1 month; 1 month
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Health is Power: An Ecological Theory-based Health Intervention for Women of Color
Condition: Physical Activity
Study type: Interventional

Summary: 
      Health Is Power (HIP) was a community based health intervention designed to increase physical
      activity among women of color. It was funded by a grant from the National Cancer Institute of
      the National Institutes of Health. The purposes of the study were (1) to determine whether a
      6 month, group cohesion intervention is more effective for increasing physical activity
      compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to
      determine whether residence in a neighborhood supportive for physical activity helped women
      maintain their physical activity from 6 to , and (3) to determine whether this effect was
      transculturally replicable.
    

Detailed description: 
      Objective Physical inactivity and poor dietary habits plague Americans as health challenges,
      with women of color most vulnerable to their detrimental effects. Individually focused
      interventions have not demonstrated lasting success, possibly due to the lack of focus on
      sustainable social and physical environment factors. Health Is Power (HIP) was a
      transcultural, community based, randomized controlled trial that investigated the
      effectiveness of a group cohesion intervention to increase physical activity in African
      American and Hispanic or Latina women in Houston and Austin, Texas and then tested whether
      women living in more supportive areas maintained their physical activity over time.
      Intervention development was guided by group dynamics principles anchored within an ecologic
      model. Women participated in three health assessments and a six month face to face
      intervention that included evidence-based behavioral methods - integrated into strategies to
      promote group cohesion - framed to account for environmental factors contributing to health
      disparities. Women participated in team building activities, environmental mapping exercises,
      and supervised walks or taste tests. Neighborhood contextual and environmental measures were
      measured to test ecologic factors that may contribute to behavioral maintenance.
    

Intervention name(s): Group Cohesion
Intervention type(s): Behavioral
Intervention description(s): See description in arm/group above
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; Social Cohesion; Intervention Development; Ethnic Minorities; Nutrition
Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early,
      chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not
      been investigated within a controlled setting with patients with PTSD following early,
      chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the
      efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can
      be improved by adding a stabilization phase (Skills training in affective and interpersonal
      regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions
      will be compared:

        1. Imagery Rescripting

        2. STAIR + Imagery Rescripting

        3. Wait-list control
    


Intervention name(s): Imagery Rescripting and Reprocessing Therapy; STAIR + Imagery Rescripting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting; A two-phased treatment. Phase 1 is comprised of 8 (weekly) sessions of Skills Training in Affective and Interpersonal Skills (STAIR). Phase 2 consists of 16 sessions (twice weekly) of trauma-focused imagery rescripting.
Other intervention name(s): IRRT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Imagery rescripting; Imagery rescripting and reprocessing therapy; Skills Training in affective and interpersonal regulation; Post-traumatic Stress Disorder; Childhood abuse; Childhood sexual abuse
Epi-On Corneal Crosslinking for Keratoconus
Condition: Keratoconus; Keratoconus, Unstable
MeSH terms: Keratoconus
Study type: Interventional
Phase: Phase 4

Summary: 
      Epithelium-On Corneal Crosslinking for Keratoconus.
    

Detailed description: 
      Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a
      candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked
      to participate in this study and will undergo the required screening procedures to determine
      study eligibility. Informed consent will be obtained from each subject before performance of
      any required any required study procedures that are not part of the investigator's routine
      examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day),
      then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and
      measurements of best spectacle-corrected visual acuity will be obtained and baseline and at
      appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the
      study will include observations at appropriate times for adverse events, clinically
      significant findings on ophthalmic examination, and slit-lamp examination.

      The primary efficacy parameter is the change from baseline over time in maximum keratometry
      (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and
      best corrected visual acuity (BCVA).
    

Intervention name(s): Riboflavin 5'-Phosphate
Intervention type(s): Drug
Intervention description(s): Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.
Other intervention name(s): Photrexa
Intervention MeSH terms: Riboflavin; Flavin Mononucleotide
Intervention model: Single Group Assignment
Intervention model description: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keratoconus; Corneal Crosslinking; CXL
A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter
      dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical
      formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16
      weeks in healthy male subjects with androgenetic alopecia.
    

Detailed description: 
      This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter
      dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical
      formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16
      weeks in healthy male subjects with androgenetic alopecia.

      The trial will be performed at three centers in Germany. The aim of the trial is to determine
      the most efficacious dose of FOL-005 topical formulation based on efficacy dose trends. It is
      planned to randomize 220 subjects (with a ratio 1:1:1:1 FOL-005 0.1%; FOL-005 0.5%; FOL-005
      1.5%; vehicle).

      The trial consists of a screening period of up to three weeks and a treatment period of 16
      weeks.

      Eligible subjects will be randomized at Baseline (Day 1) and will apply the investigational
      products themselves at home once daily for 16 weeks. Subjects will return to the sites bi-
      weekly for check of compliance and assessment of local tolerability. At Day1, Day 84 and Day
      112 subjects will be evaluated for hair growth parameters by TrichoLAB imaging. The end of
      the clinical trial for each individual subject is defined as the Final Visit at Day 112. In
      case of premature termination of a randomized subject an Early Termination (ET) visit should
      be performed.
    

Intervention name(s): Topical formulation
Intervention type(s): Drug
Intervention description(s): Topical administration on the scalp once daily for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Three New Strategies to Fight Obesity in Families
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Context: Endeavours to reduce overweight by calorie-restriction diets are often neither
      sufficient nor sustained. The growing obesity epidemic demands additional measures to enhance
      and sustain weight loss.

      Objective: To evaluate three alternative weight-loss measures on top of a calorie-restriction
      diet.

      Design, Setting, and Participants: Six-month randomized and controlled trial using a
      three-factorial design. The participants were 110 families with 142 obese parents and their
      119 obese children.
    

Detailed description: 
      Intervention: All families kept to a calorie-restriction diet and were assigned at random to
      one or more of three additional weight-loss strategies: (1) a diet on top of
      calorie-restriction with preference for carbohydrates having a low glycemic index (dual
      diet), (2) financial incentive, and (3) continuous telemetric control of weight and physical
      activity (telemonitoring). The design made it possible to determine the effect of each single
      measure: financial incentive vs. no financial incentive (54 vs.56 families),
      calorie-restriction vs. dual diet (53 vs. 57 fami-lies) and telemonitoring vs. no
      telemonitoring (19 vs. 91 families). The design also allowed an assessment of the effects of
      combinations of the additional measures, each adapted for possible effects of the other
      factors.

      Main Outcome In the parents the outcome variable at 6 months was the relative weight loss. In
      children, be-cause of their body growth, the outcome variable was the age-adjusted BMI
      standard deviation score (BMI-SDS). Analysis was done by three-factorial ANOVA and by a
      one-factorial ANOVA with the included Dunnett test as a post-hoc comparison, to distinguish
      between the effects of the different combinations of the additional strategies.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participating families were recruited by means of newspaper advertisements in the area
        around the German city of Magdeburg. The children had to be older than 7 years to ensure
        that they were able to read, and younger than 13 to minimize interferences due to puberty.
        177 families responded by telephone and received a letter de-scribing the aim and character
        of the study. 110 families then decided to participate and were invited to the first of
        four meetings with intervals of one week between successive meetings.
      
Biospecimen description: 
      blood samples
    
Keywords: Different Strategies to Fight Obesity in Families
Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome
Condition: Lymphoblastic Leukemia, Acute, Childhood
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two cohort, open-label, pilot study to describe the efficacy of administration
      timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events
      in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic
      leukemia with high versus low pre-infusion tumor burden following redirected autologous T
      cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).
    

Detailed description: 
      The duration of active protocol intervention is approximately 12-15 months from the screening
      visit. The protocol will require approximately 12-18 months to complete
      enrollment.Approximately 39 enrolled patients to reach at least 35 infused patients, with the
      ultimate goal of 15 patients in the high tumor burden cohort (Cohort A). Inclusion criteria
      are designed to include pediatric patients aged 1-24 years with CD19 expressing
      relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).Tocilizumab will be given once
      to high disease burden patients, and then the patients will be managed for CRS as per the
      standard algorithm (including subsequent tocilizumab, if needed).

      Two cohorts are defined based upon pre-infusion high versus low tumor burden; with the high
      tumor burden cohort (high risk of severe CRS) to receive earlier administration of
      tocilizumab for CRS management and the low tumor burden cohort (low risk of severe CRS) to
      receive standard timing of tocilizumab for CRS
    

Intervention name(s): Tocilizumab; Tocilizumab; CART 19
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Patients with ≥ 40% blasts in the bone marrow at pre-infusion will be enrolled in the early tocilizumab cohort and will follow early CRS treatment algorithm.; Patients with ˂ 40% blasts in the bone marrow at pre-infusion (~ Day -5 to -1) will follow the standard CRS Rx algorithm; CART-19 cells transduced with a lentiviral vector to express either anti-CD19ζ scFv TCRζ:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of ~1.5 x107 - 5 x109 (~3x105 - 1x108/kg) T cells.
Other intervention name(s): high tumor burden; low tumor burden
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment