bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms
      associated with schizophrenia in patients who are having an acute worsening of their
      psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007,
      placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on
      psychosis. The safety of ITI-007 will also be assessed.
    

Detailed description: 
      The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center
      study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The
      efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be
      evaluated as compared to placebo; risperidone has been included as a positive control.

      Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on
      standard antipsychotic medication and will be stabilized over a 5-day period before discharge
      from the study clinic. Patients will be seen for a final outpatient safety evaluation at the
      End-of-Study visit approximately 2 weeks after discharge.
    

Intervention name(s): ITI-007; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules containing ITI-007 for 28 days; Capsules containing inactive placebo for 28 days; Capsules containing risperidone for 28 days
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to determine the long-term safety of etanercept in
      adults with AS who had completed study 0881A3-311-EU.
    

Detailed description: 
      This was an open-label, multicenter extension study that was conducted to evaluate the safety
      and efficacy of etanercept in the treatment of adult subjects with AS who had completed study
      0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately
      96 weeks.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Patient Receptiveness to Using Virtual Reality
Condition: Pain; Anxiety
Study type: Observational

Summary: 
      This study will evaluate the acceptability, use, and general effect that exposure to virtual
      reality has on hospitalized patients reporting at least one discomfort including recent or
      current moderate-severe pain.
    

Detailed description: 
      Patients with moderate-severe pain will be approached with approval of nursing staff and
      front line nurse manager who determine their appropriateness for a trial of virtual reality
      (VR) exposure for up to 30 minutes. The trial and use of VR will be explained after meeting
      the inclusion criteria and they will be asked about their level of interest in trying the VR
      headset. If interested, the subject will indicate their verbal consent to proceed with the VR
      trial. They will be asked about any baseline discomforts of pain, anxiety/stress or other
      discomfort; which will be rated on a 0-10 numeric (visual analog) scale. A baseline heart
      rate will be recorded in beats per minute. The headset will be applied and adjusted for
      comfort, then the app will be started along with a timer to track the duration of their use
      up to a maximum of 30 minutes. When the Headset is removed, the duration of use will be
      noted. The change in post-exposure heart rate (in beats per minute) and discomforts of pain,
      anxiety/stress or other discomforts (subtracting baseline from 5 minute post-exposure data)
      will be recorded. Subjects will be asked about the ease of use, whether or not they would use
      VR again, and for any other comments they would like to express. The headset will be
      disinfected between patient use.
    

Intervention name(s): Virtual Reality Exposure
Intervention type(s): Device
Intervention description(s): Exposure to Virtual Reality program for up to 30 minutes
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients on adult general care medical/surgical units, regardless of genders will be
        identified via an existing pain assessment dashboard that allows the investigator to
        identify patients with 3 or episodes of moderate-severe pain in the prior 24-hour period.
        The investigator will scan the report for potential subjects in accordance with
        participating units, inclusion and exclusion criteria. The front-line nurse manager and
        registered Nurse caring for to patient will be contacted for appropriateness to consider
        including and the timing when the patient can be approached without interrupting planned
        tests, treatments or workflow.
A Brief Intervention
Condition: Dating Violence; Dating Abuse
Study type: Interventional

Summary: 
      This randomized controlled trial (RCT) study is a small scale test of the feasibility and
      preliminary efficacy of a brief motivational interview-style intervention. The intervention
      took place in the pediatric emergency departments by a trained interventionist and will
      followed an intervention algorithm developed by a team of dating abuse and brief intervention
      experts. The research design is as follows: the investigators will randomize youth ages 12-19
      years old to one of two groups: one group who receives the intervention (N=~18), and the
      other which does not (N=~18). The investigators compared changes in outcomes from baseline to
      1-month follow-up for those in both groups. The investigators looked at outcomes including
      dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and
      dating abuse behavior (perpetration and/or victimization).

      Statement of study hypothesis: Youth who receive the intervention will show improvements in
      dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while
      those in the comparison group will show no similar change.
    


Intervention name(s): Brief, motivational interview and one booster session
Intervention type(s): Behavioral
Intervention description(s): This is a one session brief motivational interview-style intervention that follows a 9-step intervention algorithm. The intervention is delivered by a trained motivational interview interventionist. There is one booster call 10 days after the intervention/
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: dating abuse; dating violence; domestic violence; sexual violence; sexual assault; youth violence; underage alcohol use; alcohol use
Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Different strategies of tourniquet application during elective primary total knee
      arthroplasty are thought to be associated with different outcomes. In that context, the study
      investigates different tactics in the search of optimal application of the tourniquet and the
      related fluid management during 24 perioperative hours.
    

Detailed description: 
      The optimal application of tourniquet should reduce perioperative blood loss, create
      bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile,
      inadequate application may increase the risk of deep vein thrombosis and pulmonary
      thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the
      perioperative blood loss did not show significant difference. The investigators use the
      volume loading test aiming to optimize the fluid status and obtain the hemoglobin
      concentration in the conditions of standardized plasma dilution. The test is deployed just
      before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible
      length of hospital stay is also evaluated.
    

Intervention name(s): Total knee arthroplasty performed under tourniquet
Intervention type(s): Procedure
Intervention description(s): Comparison of the different tourniquet tactics.
Other intervention name(s): Volume loading test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Tourniquet; Blood loss; Volume loading test
Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Structural brain alterations in pain-related areas have been demonstrated in patients with
      nonspecific neck pain. While manual therapy combined with therapeutic exercise is an
      effective management for neck pain, its underlying mechanisms are poorly understood. The
      primary objective of this trial is to investigate the effects of manual therapy combined with
      therapeutic exercise on brain imaging biomarkers in patients with chronic nonspecific neck
      pain. The secondary objectives are to assess neurochemical biomarkers, clinical features of
      neck pain, cervical range of motion and cervical muscle strength.
    

Detailed description: 
      This study is a single-blinded, randomized controlled trial. Forty-eight participants with
      chronic nonspecific neck pain will be recruited into the study. Participants will be randomly
      allocated to either an intervention or control group (1:1 ratio). Participants in the
      intervention group will receive manual therapy combined with therapeutic exercise for 10
      weeks (2 visits per week). The control group will receive routine physical therapy. Primary
      outcomes are brain imaging biomarkers (cortical gray matter: volume, thickness and area, and
      white matter: fractional anisotropy and mean diffusivity) in pain-related areas. Secondary
      outcomes are neurochemical biomarkers (N-acetylaspartate, NAA; creatine, Cr; glutamic
      acid/glutamine, Glu/Gln; myoinositol, mI; and choline, cho), clinical features (neck pain
      intensity, duration, neck disability and psychological symptoms), cervical range of motion
      and cervical muscle strength.
    

Intervention name(s): Manual therapy combinded with therapeutic exercise; Routine physical therapy
Intervention type(s): Other; Other
Intervention description(s): The treatment includes cervical mobilization and specific therapeutic exercises: craniocervical and cervical flexors and extensors, axioscapular muscles, and postural correction (30-40 minutes).
The participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).; The treatment includes routine physical therapy (e.g., modalities, range of motion and/or gentle stretching exercise) (30-40 minutes).
The participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blinded design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck pain; Manual therapy; Exercise; Magnetic resonance imaging; Magnetic resonance spectroscopy
Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)
Condition: No Condition
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the performance of the ZENEO needle free device in
      subcutaneous functioning limits (low performance limit and high performance limit) and for
      intramuscular injections.
    


Intervention name(s): Intramuscular ZENEO® injection; Subcutaneous high ZENEO® injection; Subcutaneous low ZENEO® injection
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Sodium Chloride (0.9 %); Sodium Chloride (0.9 %); Sodium Chloride (0.9 %)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Maternal Vitamin D for Infant Growth (MDIG) Trial
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3
      supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or
      decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum
      vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1
      year of age among infants born to women who received vitamin D 28,000 U/week during
      pregnancy. Infants enrolled in the study will be followed for 2 years to document the
      persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300
      pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be
      randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000
      IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be
      additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months
      postpartum. In addition to linear length, the trial will include analyses of inflammatory and
      hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D
      metabolism, and diarrheal and respiratory morbidity in the infants.
    


Intervention name(s): Vitamin D3 (cholecalciferol); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention is an oral tablet containing vitamin D3 (cholecalciferol). This vitamin D supplement will be provided in the form of small tablets (approximately 10 mm diameter) and will be custom- manufactured by Toronto Institute for Pharmaceutical Technology (TIPT) in Toronto, Ontario, Canada. Each weekly dose will consist of a single tablet. Across trial groups, the tablets will only vary with respect to the vitamin D3 dose, as described above.; This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy; Infant Growth; Vitamin D; Bangladesh
RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D)
      therapy using a retrospective approach and patients with slow or fast diabetes progression.
    

Detailed description: 
      PILOT Phase (March 2013 - Dec 2014) Patients will be recruited initially from 2 centres, plus
      Exeter as a pre-PILOT centre. Patients with particularly good or poor response to second- and
      third-line Type 2 diabetes treatments and patients progressing to insulin either particularly
      quickly or particularly slowly will be recruited from primary, secondary, or community
      settings. Fasting blood and urine samples will be collected, along with standard biomeasures
      and information will be collected about medical history and prescribing history.

      All study documentation and sample materials will be sent out to sites from the coordinating
      centre. Sites will be expected to process and freeze samples and send them to the Central
      Laboratory managed by the Chief Inspector's site where they will be analysed for genetic
      factors, glycaemic markers and other markers related to drug response.

      POST-PILOT Phase (Jan 2015- Oct 2017): Subject to feasibility, interim analysis and
      continuation of funding from Medical Research Council (MRC), this project will continue for
      another three years.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be identified in primary care and secondary care. The method for patient
        identification may differ between sites and could involve:

        GP Searches; Secondary Care Clinician Referral; Research Database Searches.
      
Biospecimen description: 
      At Visit 1 a fasting blood sample (approximately 35 mls) will be taken for DNA extraction,
      and to measure for markers of the progression of diabetes or response to diabetes medication
      and for secondary markers that may predict response. A urine sample is also collected to
      measure for biomarkers.
    
Keywords: Diabetes; Type 2 diabetes; Diabetes therapy response; Diabetes progression
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Condition: Patients With Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment
      compared with pharmacologic treatment in patients with chronic migraines.Besides, the
      investigators tested whether the clinical effects of acupuncture in chronic migraine
      prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).
    

Detailed description: 
      Subjects who completed the prospective baseline periods and meet met the prespecified entry
      criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment
      group.

      Subjects will be allowed to continue taking acute migraine medications for the treatment of
      breakthrough attacks during the trial, but any migraine preventive medications will be
      prohibited.

      Written informed consent was obtained from all participants before entering the study.
    

Intervention name(s): acupuncture; topiramate
Intervention type(s): Procedure; Drug
Intervention description(s): Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.
Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).
Sterile disposable and steel needle (3210) were used .
The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.; The patients were submitted to the topiramate treatment also for 12 consecutive weeks.
The study phase consists of a 4-week titration and a 8-week maintenance period.
All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).
Study drug was administered daily in equally divided twice daily doses.
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic migraine; acupuncture; Topiramate; Randomized trial
Effects and Safety of Menthol on Blood Pressure and Metabolic Parameters in Prehypertensive and Mild Hypertensive Patients
Condition: Hypertension; Prehypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Prehypertension and mild hypertension are associated with an increased risk of
      atherosclerosis and coronary artery disease, and often complicated with the metabolic
      disorder of glucose and lipid. The comprehensive prevention of hypertension is still an
      important and complex clinical issue. Peppermint is a popular flavoring agent, and peppermint
      tea help relax tension and could lower blood pressure. The effect of oral peppermint on blood
      pressure is not consistent, however, our previous animal study has shown that oral
      administration of menthol, the main component of peppermint, could reduce 24-hour mean
      arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore,
      menthol increases uncoupling protein(UCP)1 dependent thermogenesis and energy expenditure
      through transient receptor potential melastatin(TRPM)8 activation, and helps prevent obesity
      and metabolic disorders. In a prospective, double-blind, randomized, and parallel-group
      study, we will evaluate the effects of DANSHU capsule(menthol) on blood pressure and
      metabolic parameters in prehypertensive and mild hypertensive patients. This study will help
      develop future comprehensive prevention and treatment strategies for hypertension.
    


Intervention name(s): Menthol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule 48mg three times a day after meals 8 weeks; Capsule 48mg three times a day after meals 8 weeks
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hypertension; Menthol; Metabolism