bioihbjkbjnl/mcl2 huggingface dataset:
Shoulder Injury Prevention Program in Swimmers
Condition: Shoulder Injury
MeSH terms: Shoulder Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder
      movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial
      width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder
      strengthening and stretching program in division I collegiate swimmers. The result of this
      study may demonstrate the effectiveness of a strengthening and stretching program to
      positively influence factors that have been associated with pain and injury in division I
      collegiate swimmers and indicate the need to implement this program for the entire team.
      Following a 6-week strengthening and stretching program, it is believed that scapular
      kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be
      improved compared to control subjects.
    


Intervention name(s): Shoulder Strengthening
Intervention type(s): Procedure
Intervention description(s): The intervention program is a 6 week shoulder and scapular stabilizer strengthening program that is performed 3 times per week. The program includes 10 exercises that are performed with Theraband rubber tubing and 2 stretches. The exercises are: shoulder flexion, Ys, Ts, Ws, IR @ 90, ER @ 90, Throwing acceleration, Throwing deceleration, dynamic hug, and low rows. The stretches include the sleeper stretch and the corner stretch.
Other intervention name(s): Shoulder injury prevention, tubing program for athletes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: tubing program; shoulder strengthening; injury prevention
Sildenafil Citrate and Recurrent Abortion
Condition: Recurrent Abortion
MeSH terms: Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      Two groups of unexplained recurrent spontaneous abortion, each included 65 participants.
      scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The
      intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and
      continued till the 12th-week of gestation.

      The primary outcome measure was the difference in the live birth between both groups.
      Secondary outcome measures were the differences between both groups regard pulsatility index
      (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of
      treatment and the pregnancy-related complications.
    

Detailed description: 
      Two groups of unexplained recurrent spontaneous abortion, each included 65 participants.
      scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The
      intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and
      continued till the 12th-week of gestation.

      The primary outcome measure was the difference in the live birth between both groups.
      Secondary outcome measures were the differences between both groups regard PI and RI, a
      number of take-home babies, the reported side-effects of treatment and the pregnancy-related
      complications, e.g., preeclampsia and intrauterine growth restriction (|IUGR).
    

Intervention name(s): Sildenafil Citrate vaginal suppositories; Placebo vaginal suppositories; Uterine artery Doppler before treatment; Uterine artery Doppler after treatment
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.; Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.; Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy; Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Other intervention name(s): Sildenafil Citrate; Placebo
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
a Bike Application to Support Cardiac Patient
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The pilot study will investigate the usability of a mobile cycling application in a cardiac
      patient population during a one month study period.

      The application's effectiveness regarding ability to reduce fear and increase motivation to
      exercise will be assessed.
    

Detailed description: 
      This pilot study investigates the use of a mobile cycling application for patients with a
      cardiac disease that was developed by the Expertise Centre for Digital Media of Hasselt
      University in collaboration with the Faculty of Medicine & Life Sciences of Hasselt
      University. During the pilot study, the use of the cycling application and its impact on fear
      and motivation of patients with a cardiac disease during the rehabilitation is studied. The
      cycling application will be used on a smartphone, in combination with a wrist-worn heart rate
      monitor.

      During the study, the patients will use the cycling application for one month, in which they
      can make use of the cycling application each time they are cycling outdoor in their home
      environment. Through questionnaires and interviews, the patients' experiences with respect to
      fear and motivation will be collected. Furthermore, the usability of the cycling application
      is evaluated through these questionnaires and interviews.
    

Intervention name(s): Bike application arm
Intervention type(s): Behavioral
Intervention description(s): The intervention patients will use the cycling application on a smartphone, in combination with a wrist-worn heart rate monitor. During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Low risk coronary artery disease patients that completed phase II of cardiac
        rehabilitation.
      
Keywords: Human-computer interaction; Fear; Motivation; Usability
Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the benefits of a painless lancing device among
      diabetes subjects in improving self-monitoring frequency and HbA1c compared to the
      conventional lancing device.
    

Detailed description: 
      Self-monitoring of glucose forms the cornerstone of diabetes management. There are multiple
      limiting factors towards efficient self- monitoring of blood glucose, including cost
      barriers, inconvenience, investment of time, pain associated with pricking etc. Pain has
      perceived as a major impediment to the self-monitoring of blood glucose.

      Genteel lancing device offers a painless pricking experience and hence helps to report blood
      sugar values at least 4 times a day. The perceived pain sensitivity of the study subjects
      would be assessed using the 4- point pain screening questionnaire during the course of the
      study.

      The aim of this study is to gather information on the percentage reduction in HbA1c values in
      diabetes patients as compared to the baseline values after three months and six months
      respectively brought about by percentage SMBG adherence, defined as the percentage of total
      recorded SMBG values as compared to the ideal number of readings over the 24-week period.
      SMBG adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice
      weekly in type 2 subjects).

      SMBG adherence can be provisionally attained by multiple pricking using painless Genteel
      lancing device compared to the conventional lancing device. Additionally, the subject is
      asked about the likelihood they would use the device if available for routine SMBG practice
      in the future.
    

Intervention name(s): Genteel lancing device; Conventional lancing device
Intervention type(s): Device; Device
Intervention description(s): Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively; Conventional lancing device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lancing device; HbA1c; painless lancing; SMBG adherence
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will include the patients who are Japanese children with bronchial asthma aged 5
      years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at
      about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of
      100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study
      D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with
      bronchial asthma in need of inhaled glucocorticosteroid treatment.
    


Intervention name(s): Budesonide; Conventional Asthma Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily; According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
Other intervention name(s): Pulmicort® Turbuhaler®
Intervention MeSH terms: Budesonide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Bronchial
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the efficacy and safety of cluster immunotherapy
      with highly polymerized allergen extracts.
    


Intervention name(s): Subcutaneous injections with highly polymerized allergen extract; Subcutaneous injection with placebo
Intervention type(s): Biological; Biological
Intervention description(s): cluster schedule; cluster schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections
Condition: Acute Uncomplicated Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy and safety of Broncho-munal®, capsules, 7 mg (Sandoz dd,
      Slovenia) versus Placebo in the treatment of patients with acute uncomplicated respiratory
      tract infections.
    

Detailed description: 
      Patients who meet the inclusion criteria and do not meet the exclusion criteria will be
      randomized into 2 groups in a 1: 1 ratio.

      Group 1 (n = 278) will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd,
      Slovenia),

      Group 2 (n = 278) will receive a placebo
    

Intervention name(s): Broncho-munal®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days; 1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Condition: Sleep
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen
      sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and
      an ibuprofen and diphenhydramine combination
    


Intervention name(s): Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg; Naproxen Sodium 440 mg (BAYH6689); Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg; Naproxen Sodium 220 mg (BAYH6689); DPH 50mg; Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.; Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.; One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg; Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.; Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.; Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Intervention MeSH terms: Diphenhydramine; Promethazine; Ibuprofen; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Naproxen sodium; Diphenhydramine; Drugs, Investigational
Acupuncture for Pain Control After Elective Caesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study entitled "Acupuncture vs. placebo acupuncture and vs. standard therapy for pain
      control after elective caesarian section - a randomized controlled trial" aims to investigate
      whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as
      compared to placebo and standard therapy in patients after after elective caesarian section
      (CS) in the period from January 2015 to May 2016.

      For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia
      will be recruited according to eligibility criteria. 120 patients will be randomized either
      to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard
      therapy" arm. The outcome measures are: postoperative analgesic requirement, pain intensity,
      incidence of side effects and physiological parameters.
    


Intervention name(s): Standard therapy; Verum acupuncture; Placebo acupuncture
Intervention type(s): Drug; Device; Other
Intervention description(s): Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital; Verum acupuncture will be performed using indwelling permanent acupuncture needles "New Pyonex" with 1,5 mm length, manufactured by Seirin Corp. Japan; Placebo acupuncture will be performed using the placebo "New Pyonex" adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan
Other intervention name(s): Pharmacologic therapy of postoperative pain; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Condition: Opiate Dependence
MeSH terms: Recurrence; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as
      self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release
      from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
    

Detailed description: 
      This protocol randomizes persons soon-to-be-released from a large urban jail to treatment
      with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the
      activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit
      heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid
      agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to
      relapse and risk accidental overdose at release. All N=40 participants receive a two-session,
      individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be
      randomized to pre-release treatment with XR-NTX. Immediately and one month following release,
      participants will be offered continued psychosocial and medication-assisted treatment
      (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX
      dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use
      during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly
      lower rates of sustained opioid relapse following release.
    

Intervention name(s): Extended-Release Naltrexone; Motivational Enhancement Counseling
Intervention type(s): Drug; Behavioral
Intervention description(s): 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).; The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extended-release naltrexone; Prisoners; Opioid addiction prevention; Medication Treatment Alternatives; Prevention of Relapse to Opioid Addiction
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Condition: Insomnia; Spinal Cord Injury; Tetraplegia; Sleep Disorders
MeSH terms: Spinal Cord Injuries; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Quadriplegia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if replacing melatonin function with a melatonin
      agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia)
      helps to alleviate self-reported sleep disruption.
    


Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg nightly; Nightly 8mg of placebo (same appearance as ramelteon)
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; melatonin; spinal cord injury; insomnia; tetraplegia
Gray Matters Alzheimer's Disease Prevention Intervention
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This is a randomized controlled trial to develop and test the efficacy of a multi-domain
      lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to
      lower Alzheimer's disease risk among persons aged 40 to 64 years.
    

Detailed description: 
      This is a randomized controlled trial to develop and test the efficacy of a multi-domain
      lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to
      lower Alzheimer's disease risk among persons aged 40 to 64 years. Participants are randomized
      to treatment or control condition. The intervention, spanning a six month period, is an
      evidence-based health education program.
    

Intervention name(s): Health education program
Intervention type(s): Behavioral
Intervention description(s): The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals. Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes "cafeteria style" (i.e. based on their individual preferences).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Alzheimer's disease prevention lifestyle intervention
Validating Interventions for Diverse Adolescents
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare a culturally adapted and a non-culturally adapted
      group-based substance abuse treatment with Latino adolescents.
    


Intervention name(s): Standard Cognitive Behavioral Treatment; Culturally Adapted Cognitive-Behavioral Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard CBT for Substance Abuse; Culturally Adapted CBT for Substance Abuse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Abuse; Substance Addiction
Grazax Asthma Prevention
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with
      grass pollen allergy
    

Detailed description: 
      Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in
      children with grass pollen allergy.

      Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment.
      Grazax has been approved for treatment of grass pollen allergy in adults and children,
      diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass
      pollen and with clinically relevant symptoms. This study will explore prevention of asthma in
      children with grass pollen induced allergy.
    

Intervention name(s): Grazax; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with 75.000 SQ-T once daily; Tablet with no active grass component.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rhinitis; allergic; Seasonal; grass; Asthma
Antistax® in Patients With Chronic Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine the efficacy and tolerability of two dose levels of Antistax relative to
      placebo in patients suffering from CVI grade I or incipient grade II
    


Intervention name(s): Antistax®, low dose; Antistax®, high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment