bioihbjkbjnl/mcl2 huggingface dataset:
Expect Respect Middle School Randomized Trial
Condition: Adolescent Behavior; Violence in Adolescence; Group, Peer; Violence, Non-accidental; Violence, Sexual; Violence, Physical; Violence, Domestic; Emotional Abuse; Coping Skills; Communication, Personal
Study type: Interventional

Summary: 
      This cluster-randomized school-based study will examine the effectiveness of a teen dating
      violence (TDV) and sexual violence (SV) prevention program called Expect Respect for
      preventing serious violence perpetration among middle school students.
    

Detailed description: 
      This cluster-randomized controlled school-based study will examine the effectiveness of a
      support group-based teen dating violence (TDV) and sexual violence (SV) prevention program on
      the primary prevention of serious (and potentially lethal) violence perpetration among middle
      school students (both male and female-identified) who have prior exposure to trauma and
      violence. Expect Respect gender-specific support groups are for youth with prior history of
      exposure to violence including witnessing domestic violence, loss of loved one to homicide,
      TDV, and SV.

      Expect Respect is a theory and research-informed program intended to alter norms condoning
      violence and rigid gender expectations that foster violence perpetration, promote bystander
      intervention, and reduce TDV/SV perpetration. Implemented by trained facilitators, the
      24-session curriculum focuses on gender equity and respect, recognizing abuse and impact on
      self and others, regulating emotions, skills for healthy relationships, and becoming active
      proponents of safe and healthy relationships.
    

Intervention name(s): Expect Respect; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Expect Respect is a 24 session curriculum designed to support middle school students to increase skills in emotion regulation, relationship skills, communication, and positive bystander intervention behaviors.; Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This cluster-randomized school-based study will examine the effectiveness of a support group-based teen dating violence (TDV) and sexual violence (SV) prevention program on the primary prevention of serious (and potentially lethal) violence perpetration among middle school students (both male and female-identified) already exposed to violence. The study will be located in western Pennsylvania across 36 middle schools (anticipated number of 'clusters'), randomized either to receive the "Expect Respect" program (i.e., intervention schools, n=18) or to an enhanced usual care condition (n=18 schools).
Masking: None (Open Label)
Primary purpose: Prevention
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl
      following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and
      severe hepatic impairment, as compared to healthy volunteers.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Bardoxolone Methyl
Intervention type(s): Drug
Intervention description(s): Oral, Single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of
      conjugate pneumococcal vaccine in adult sepsis survivors.
    

Detailed description: 
      The aim of VACIRiSS trial is to evaluate the immunogenicity and heterologous effects of
      single dose 13-valent conjugate pneumococcal vaccine (PCV-13) in preventing infection related
      rehospitalisation in sepsis survivors and to collect outcome event data with necessary
      precision to inform future definitive trial design.
    

Intervention name(s): Prevenar 13; Sodium Chloride 0.9%
Intervention type(s): Biological; Other
Intervention description(s): Pneumococcal polysaccharide conjugate vaccine; Placebo
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after
      administration of 50 mg of BIBR 1048 bid over three days each administered as two
      experimental formulations relative to drinking solution with and without coadministration of
      40 mg Pantoprazole.
    


Intervention name(s): BIBR 1048 MS Capsule I; BIBR 1048 MS Capsule K; Pantoprazole; BIBR 1048 MS drinking solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg BIBR 1048 MS; 50 mg BIBR 1048 MS; 40 mg pantoprazole; 50 mg BIBR 1048 MS powder plus solution
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine
      attacks and duration of relief provided. This study will also provide additional efficacy
      data on rizatriptan 5 mg and 10 mg for the treatment of migraine.
    


Intervention name(s): rizatriptan benzoate; rizatriptan benzoate; Comparator: sumatriptan; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose administration of 5mg rizatriptan (by Mouth) p.o.; single dose administration of 10 mg rizatriptan p.o.; single dose administration of sumatriptan 100 p.o.; placebo to rizatriptan
Other intervention name(s): rizatriptan; MK0462; rizatriptan; MK0462; sumatriptan
Intervention MeSH terms: Sumatriptan; Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.
    


Intervention name(s): ACT-1004-1239; Placebo; ACT-1004-1239 (Food-effect subpart); Placebo (Food-effect subpart)
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.; Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.; ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.; Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, double-blind, randomized, placebo-controlled, single-ascending dose, Phase 1 study. The food effect will be assessed using a two-period, fixed-sequence design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Condition: Neuromyelitis Optica (NMO); NMO Spectrum Disorder (NMOSD)
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic,
      pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
    


Intervention name(s): Satralizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).; Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Other intervention name(s): SA237; RG6168
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Whey Protein in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objectives of this study are to examine the effects of chronic, (12 weeks) administration
      of Whey protein on HbA1c, and postprandial glucose (PPG).
    

Detailed description: 
      Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic
      /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its
      gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as
      endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity,
      which might be an additional mechanism accounting for the glucose lowering effects of Whey.

      In the investigators previous study, the acute administration with Whey protein resulted in
      postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This
      was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1,
      suggesting that the peptides generated from Whey protein may have dual beneficial effects
      (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia
      regulation in subjects with type 2 diabetes.

      Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2
      diabetic subjects and there are also clinical evidence in non-diabetics individuals, that
      acute and chronic administration of Whey protein has antihypertensive activity.

      The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined
      previously in type 2 diabetics.
    

Intervention name(s): Whey Protein (WPC) at breakfast; Other Protein Sources at breakfast; Low Protein at breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The type 2 diabetic subjects in Whey Protein (WPC) group will consume at breakfast WPC (35 g) in 250ml of milk, Total 42 g protein breakfast for 12 weeks.; The type 2 diabetic subjects in PBdiet will consume also 42 g of protein but from different sources : i.e soy,tuna, eggs, at breakfast in bottle mixed with 250 ml water twice a day (30 min before breakfast and before dinner) for 12 weeks.; The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.
Other intervention name(s): WBdiet; PBdiet; CBdiet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes (T2D); Whey Protein Concentrate (WPC)
Bone Metastasis on the Survival of Gefitinib Effective Patients
Condition: Overal Survival, Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine
      kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has
      been confirmed by a number of prospective clinical trials. The researches aim to analysis
      whether bone metastasis could affect the survival of NSCLC patients who were effective in
      Gefitinib treatment over 6 months.
    

Detailed description: 
      The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell
      growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly
      improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment.
      Compelling study also demonstrate Gefitinib may be effective in the treatment of bone
      metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone
      metastasis would shorten the survival time of the patients or reduce the quality of life of
      patients is worth studying. The researches aim to analysis whether bone metastasis could
      affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6
      months.
    

Intervention name(s): Gefitinib
Intervention type(s): Drug
Intervention description(s): Daily oral administration of 250 mg Gefitinib
Other intervention name(s): Iressa
Intervention MeSH terms: Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to test the feasibility of a large-scale clinical
      trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy
      outcomes so that we can better plan a large-scale study; we will estimate the effect size and
      variability of effect and resource utilization of once-daily prophylaxis to allow us to set a
      sample size for a definitive trial.
    

Detailed description: 
      Hemophilia is an important and costly disorder; if left untreated, it may have serious
      consequences. The greatest impact of hemophilia occurs from recurrent bleeding into joints.
      The consequences of joint bleeding include pain associated with acute bleeding and later
      chronic arthropathy. Half of affected children with severe hemophilia have joint damage;
      joint damage is more frequent with increased bleeding. The prevention and treatment of
      bleeding is very expensive and therefore finding a cost-effective treatment is of high
      priority.

      Worldwide, two major treatment strategies have been used to prevent arthropathy - on demand
      therapy and factor prophylaxis. The goal of prophylaxis is to convert the severe to the
      moderate phenotype by providing circulating factor activity of greater than 1%. Patients with
      greater than 1% circulating factor VIII activity rarely have spontaneous hemarthroses.
      Therefore, the goal of providing circulating factor at this level is to eliminate spontaneous
      hemarthroses. The term primary prophylaxis suggests using preventative factor VIII
      replacement from a very early age. The term secondary prophylaxis is used to describe the
      application of prophylaxis at a later disease stage. In this study, secondary prophylaxis
      will be used.

      Once-daily prophylaxis is a novel application of hemophilia factor prophylaxis for youth and
      young adults. Before embarking on a costly definitive trial we feel that it is necessary to
      demonstrate that subjects will be willing to enroll and will be compliant with the therapy.
      Moreover, we need to establish an estimate of the effect of once-daily prophylaxis on
      bleeding rates, quality of life, and joint damage progression in order to design a definitive
      trial.
    

Intervention name(s): Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS
Intervention type(s): Drug
Intervention description(s): Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia; Prophylaxis; Youth; Young Adults; Feasibility
Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls
Condition: Ghrelin
Study type: Interventional

Summary: 
      This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl
      transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.
    

Detailed description: 
      Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and
      desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our
      previous study showed that combined exercise program in overweight children increases DAG
      with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on
      GOAT, AG, and DAG in obese girls.
    

Intervention name(s): Combined exercise program; Control
Intervention type(s): Other; Other
Intervention description(s): Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet; 300 kcal deficit diet only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if a medication called Curosurf can reduce the length of
      time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,
      stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a
      medication that is already used in other countries around the world but not yet in Canada.

      Babies born under 32 weeks of gestation frequently need respiratory support after birth,
      including being placed on a breathing machine or respirator. The most common reason is
      Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a
      soapy like substance that helps the air sacs open and close. Our current standard treatment
      is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore
      the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be
      able to be removed from the ventilator sooner.

      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the
      investigators will monitor their progress during their Neonatal Intensive Care Unit
      admission.

      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra
      tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this
      study.
    


Intervention name(s): Curosurf-Group1; BLES-group 2
Intervention type(s): Drug; Drug
Intervention description(s): Maximum of 3 doses are administered to infants diagnosed with RDS.; Maximum of 3 doses are administered to infants with RDS
Intervention MeSH terms: Poractant alfa
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prematurity
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single- and
      multiple-ascending oral dose study conducted in three parts.
    


Intervention name(s): DNL201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose(s); Oral dose(s)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of treatment with XP19986
      Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal
      cord injury
    

Detailed description: 
      This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and
      safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of
      subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30
      mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment
      segment. Each subject serves as their own control in this cross-over study.
    

Intervention name(s): XP19986 SR1, 10 mg BID; XP19986 SR1, 20 mg BID; XP19986 SR1, 30 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods; XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods; XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods; Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
Other intervention name(s): Sustained release Polyox WSR N750, 10 mg; Sustained release Polyox WSR N750, 20 mg; Sustained release Polyox WSR N750, 30 mg; sugar pill
Intervention MeSH terms: Arbaclofen placarbil; Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment