bioihbjkbjnl/mcl2 huggingface dataset:
Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
Condition: Head Injury; Sport Injury
MeSH terms: Craniocerebral Trauma; Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested
      athletes on these teams will be invited to voluntarily participate in biomechanical data
      collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation
      with head impact sensors. In aim 3, two youth football teams at the middle school level will
      be recruited to pilot an intervention developed this study. The football coaches of each team
      will be prospectively recruited and enrolled. All interested athletes on these teams will be
      enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation
      with head impact sensors. Baseline and post-season neurocognitive data will be collected.
    

Detailed description: 
      This study hypothesizes that (a) determinants at the individual (athlete), interpersonal
      (team & coach), and community levels (built & social environment) of the social ecological
      model may be identified and targeted to reduce head impact exposure in youth football
      practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may
      be developed and pilot tested using a community-engaged approach.
    

Intervention name(s): On-field activity group - Aim 3
Intervention type(s): Behavioral
Intervention description(s): Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: All interested football players on the 2 teams will be enrolled; of those enrolled, 15-20 per team (n=30-40 total) will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure.
Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team (n=30-40 total) will be randomly selected for instrumentation with head impact sensors using a random numbers table.
Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sport Safety; Youth Football; Head Impact Exposure
Effect of Virtual Reality Glasses Use During Episiotomy Repair Related
Condition: Midwifery; Labor Delivery
Study type: Interventional

Summary: 
      H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level
      of pain.

      H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level
      of anxiety.

      H1-3: Watching video with virtual reality glasses during episiotomy repair increases the
      level of satisfaction.
    


Intervention name(s): virtual reality glasses
Intervention type(s): Other
Intervention description(s): OculusQuest 2 128GB brand virtual reality glasses will be used in our research. OculusQuest 2 128GB is the original all-in-one gaming system for virtual reality. It can only be used as desired with the VR headset and controllers. It adapts to its environment. In this way, it can be played standing and sitting in small and large areas. When glasses will be used on another pregnant women within the scope of COVID-19 measures, disinfection will be provided with 'DiverseyOxivir Plus (hydrogen peroxide)' surface disinfectant. Before the episiotomy repair, the video glasses will be opened, the video will be adjusted to suit the woman. In order for the repair method to be the same for all women, It will be planned to use absorbable, synthetic, braided, sterile surgical thread produced from 1-0 polyglactin.
Other intervention name(s): Video will be watched with virtual reality glasses during episiotomy repair
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sample size G-power 3.1.9.7. program (Faul et al 2007, Faul et al 2009). Shourab et al. anxiety score average in the study; It was found to be 24.9±1.9 in the intervention group and 21.2±1.1 in the control group. In the light of this study, 0.897 effect size, 0.95 power, 0.05 alpha level and bidirectional hypothesis options were selected in the program, and the number of participants for each group was 34 (Shourab et al 2016). The pregnant women who came to the hospital will evaluate in terms of sample criteria and randomized sampling will divide into two groups. In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups over the number determined on the site https://www.random.org/. Pregnant women will be assigned to groups according to the randomization scheme. Considering that there may be data loss, 20% more was determined and it was planned to study with 82 (41 intervention, 41 control) pregnant women.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: episiotomy; Virtual Reality; pain; satisfaction; anxiety
ACT for the Home Management in Malagasy Children
Condition: Fever; Suspected Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      The purpose of this study is to assess the feasibility, the acceptability and the
      effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home
      management of presumed malaria in Malagasy children by the community-based service providers.
    

Detailed description: 
      Primary objective

      To assess the feasibility, the acceptability and the effectiveness of the use of the
      Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria
      in Malagasy children by the community-based service providers

      Secondary objectives

      To assess the reliability of the use of the malaria rapid diagnostic tests (RDT) by the
      community-based service providers in the Malagasy home management strategy

      To assess the frequency of short-term and long-term side effects of the Artesunate +
      Amodiaquine Fixed Dose Combination used for the home management of presumed malaria in
      Malagasy children by the community-based service providers

      To assess the real burden of the malaria in children under the age of five years in 2
      different epidemiological strata of Madagascar (central highlands and equatorial strata)

      Type of study

      Follow-up of a cohort of 1200 children under the age of five years during 1 year

      Studied population

      All children under the age of five years (2 months to 5 years) having fever and consulting
      the community-based service provider, residing in the zone covered by the community-based
      service provider throughout the entire follow-up period Investigators Four community-based
      service providers, four field physicians and two supervisors number of district: 2 (Moramanga
      and Manakara)

      condition: fever intervention: artesunate + amodiaquine phase: phase IV
    

Intervention name(s): Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)
Intervention type(s): Drug
Intervention description(s): Tablet:
Children aged between 2 and 11 months: Artesunate 25 mg + Amodiaquine 67.5 mg et Children aged between 12 and 59 months: Artesunate 50 mg + Amodiaquine 135 mg Per os one intake per day/3 day
Intervention MeSH terms: Artesunate; Amodiaquine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Whole blood
    
Keywords: Protozoan Infections; Communicable Diseases; Malaria Infection; Malaria, falciparum; Malaria, vivax; Artesunate Amodiaquine
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Condition: Insomnia; Major Depressive Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once
      daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
    

Detailed description: 
      The drug being tested in this study is called ramelteon. Ramelteon is being tested to treat
      people who have insomnia with depression. This study will look at sleep activity of
      participants who take ramelteon.

      The study will enroll approximately 30 patients. Participants will be administered:

      • Ramelteon 8 mg

      Participants will be asked to take 1 tablet orally at bedtime. This multi-center study will
      be conducted in Japan. The overall period to participate in this study is 9 weeks (Run-in
      period for 1 week and treatment period for 8 weeks). Participants will make multiple visits
      to clinic including the final visit 8 weeks after the start of treatment.
    

Intervention name(s): Ramelteon
Intervention type(s): Drug
Intervention description(s): Ramelteon tablets
Other intervention name(s): Rozerem; TAK-375
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
SPECT Study With SB-773812 In Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted in 2 groups of schizophrenic patients: in group 1 the
      relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A
      receptor occupancy at stable plasma concentration (Cp) of SB-773812 will be investigated
      using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In
      group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at
      least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO,
      measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and
      PK at steady state after repeated doses, to efficacy readouts will be investigated. The
      SB-773812 dose administered will be selected as the highest dose proven to be safe and well
      tolerated from a previous study.
    


Intervention name(s): SB773812; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): SB-773812 tablets will be available with dose strength of 60 mg; Risperidone tablets will be available with dose strength of 3 and 6 mg
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: SB-773812; SPECT; D2 RO; pharmacokinetics; schizophrenic patients; 5HT2A RO
Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are recruiting for a chronic hives study. This research is being done to
      test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for
      treating people with Chronic Idiopathic Urticaria who continue to have symptoms despite
      taking antihistamines. The word "investigational" means that AZD1981 is not approved for
      marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of AZD1981
      in this study.

      People with chronic hives lasting for at least 6 months and without a known cause may join.
      The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take part
      in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be
      treated with the study medication and/or placebo for 8 weeks.

      The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who
      don't respond well to antihistamines by generating experience and data to support the design
      of a larger, multicenter trial investigating the efficacy of AZD1981 in treating
      antihistamine refractory CIU.
    

Detailed description: 
      The investigators propose to use AZD1981 in subjects with chronic idiopathic urticaria (CIU)
      who are otherwise uncontrolled on first-line, oral antihistamine therapy. The skin lesion
      pathology in CIU shows a perivascular infiltrate of lymphocytes (both Th2 and Th1),
      eosinophils, and basophils, and closely resembles an allergen-induced late-phase reaction.
      Further, murine studies show that the chemoattractant receptor-homologous molecule expressed
      on Th2 (CRTh2) pathway is important in leukocyte recruitment following allergen challenge of
      the skin. Our proposed hypothesis is that AZD1981 in CIU will reduce CRTh2-expressing,
      leukocyte recruitment to the skin and reduce leukocyte activation through CRTh2, thus
      reducing the signs and symptoms in CIU refractory to control with antihistamines.
    

Intervention name(s): AZD1981; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).; Sugar pill manufactured to mimic AZD1981 10 mg tablet
Other intervention name(s): Oral CRTh2 antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Idiopathic Urticaria
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
Condition: Sleep Apnea Syndromes; Overweight and Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Overweight; Syndrome
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of an endoluminal gastric plication using an
      endoluminal-suturing device to improve severe OSAS in patients with a BMI above or equal to
      28 kg/m² until 34.9kg/m².
    

Detailed description: 
      Obesity is one of the most critical public health burdens worldwide. Its prevalence is
      increasing, as well as its comorbidities. The main comorbidity of obesity on the respiratory
      system is the obstructive sleep apnea syndrome (OSAS). The prevalence of OSAS in the obese
      population is around 45%. OSAS increased cardiovascular risk and decreased quality of life.
      The most alterable risk factor of OSAS is obesity. Therefore, weight loss is the cornerstone
      of the treatment. There is some evidence of the efficacy of weight loss surgery (lap band,
      sleeve gastrectomy, biliary pancreatic deviation, duodenal switch, and Roux-and-Y-gastric
      bypass) to improve OSAS. Current recommendations suggest bariatric surgery management for
      patients with a BMI > 35kg/m2 and OSAS. However, most studies have limited scientific value
      (retrospective observational trials), and the follow-up of patients is limited, mainly due to
      patients' inadequate compliance. Moreover, until now, there is no reliable predictor for the
      percentage of reduction of AHI caused by weight loss. On the other hand, there is no approved
      treatment in patients presenting a BMI between 28 kg/m² to 34.9kg/m² and OSAS.

      Endoscopic endoluminal approaches to address obesity have become an important topic of
      interest over the past decade. Endomina® (Endo Tools Therapeutics, Gosselies, Belgium) is a
      novel restrictive endoluminal approach. This new procedure permitted a weight loss of 29 % on
      average sustained at one year. This technique was not yet evaluated in patients with 28 kg/m2
      ≤ BMI ≤ 34.9/m2 to improve OSAS.

      The current feasibility study aims to evaluate the efficacy of an endoluminal gastric
      plication using an endoluminal-suturing device to improve severe OSAS in patients with above
      or equal to 28 kg/m², BMI until 34.9kg/m².
    

Intervention name(s): Endomina- Endoscopic Sleeve Gastroplasty; Diet
Intervention type(s): Device; Behavioral
Intervention description(s): Endoscopic gastric reduction; Multidisciplinary follow up
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.
      This clinical study is designed to test the hypothesis that Lurasidone in combination with
      either Lithium or Divalproex is effective among patients with bipolar I depression.
    


Intervention name(s): Lurasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets 20-120 mg, PM dosing,daily for 6 weeks; Equivalent to Lurasidone dosing
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Depression; Lurasidone; Latuda
Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
Condition: Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the immunogenicity and safety of a booster dose of
      BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a
      second dose of PriorixTM, in healthy 3 and 4-year-old children.
    


Intervention name(s): Boostrix PolioTM; RepevaxTM; PriorixTM
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose, intramuscular administration.; Single dose, intramuscular administration.; Single dose, intramuscular or subcutaneous administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MMR; dTpa-IPV; Boostrix Polio; Repevax; Priorix
Allopurinol for Mania: A Randomized Trial Administering Allopurinol vs. Placebo as add-on to Mood Stabilizers and/or Antipsychotics in Patients in a Bipolar Manic Episode
Condition: Mania
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,
      as add-on to mood stabilizers and/or antipsychotic in the treatment of patients with bipolar
      disorder, in a manic episode.
    

Detailed description: 
      An emerging body of evidence supports a role for dysfunctional purinergic related
      neurotransmission in mood disorders [1, 2]. Adenosine agonists have been shown to have
      properties similar to those of dopamine antagonists and there is a well characterized
      antagonistic interaction between adenosine and dopamine receptors in the ventral striatum.
      Increased adenosynergic transmission has been demonstrated to reduce the affinity of dopamine
      agonists for dopamine receptors. It has been theorized that adenosine may exert some of its
      antipsychotic effects through modulation of glutamatergic transmission.

      Two double-blind, randomized, add-on, placebo-controlled trials comparing allopurinol and
      placebo in acute mania have showed statistically significant greater improvements in YMRS
      scores in the allopurinol vs. placebo groups. These empiric data, together with the
      theoretical and basic science background cited, provide the impetus for this proposed study.
    

Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Allopurinol 1 capsule 300 mg, BID; Placebo 1 capsule, 300 mg, BID
Other intervention name(s): Alloril, Zylol, Zyloric
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mania, allopurinol, add-on treatment
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      A 12-week Evaluation Period will be used to characterize potential cognitive and
      neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4
      - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive
      treatment with placebo.
    


Intervention name(s): Levetiracetam; Placebo (PB)
Intervention type(s): Drug; Other
Intervention description(s): Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.; Oral tablets and oral solution
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Partial onset seizures; epilepsy; levetiracetam; Keppra; cognition; behavior; pediatry