bioihbjkbjnl/mcl2 huggingface dataset:
Homecoming Line: Telephone Support for Veterans
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will determine whether telephone support improves clinical outcomes of veterans
      who begin outpatient treatment for posttraumatic stress disorder. Participants will be
      randomly assigned to receive either usual care or usual care supplemented by biweekly
      monitoring and support by telephone during the first 3 months of treatment. Patients in both
      conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking
      at 4 months and 12 months after entering treatment.
    

Detailed description: 
      This multisite randomized controlled trial will test whether a 3-month period of providing
      telephone monitoring to PTSD patients as a supplement to usual specialty mental health care
      improves 12-month clinical outcomes (a reduction in PTSD symptoms, violence, and substance
      use). Secondarily, this study will determine whether telephone monitoring promotes better
      engagement in outpatient treatment (Number of mental health and psychotherapy visits during
      the 3-month intervention period).

      Demand for VA PTSD treatment is increasing as troops return from combat deployments in
      Afghanistan and Iraq. Telemedicine is likely to be an important component in developing more
      effective and efficient models of PTSD care that improves patient functioning and treatment
      utilization. It is hoped that using telephone case monitoring as an inexpensive adjunct to
      standard care may improve clinical outcomes and reduce hospitalization among veterans with
      PTSD.
    

Intervention name(s): Telephone Case Monitoring; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.; Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Stress Disorders, Post-Traumatic; Ambulatory Care; Telemedicine; Remote Consultation; Health Services Accessibility
Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
Condition: Moderate to Severe Allergic Asthma
MeSH terms: Asthma; Disease Progression
Study type: Observational

Summary: 
      The study was designed to collect data about inadequately controlled moderate to severe
      allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at
        least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining
        symptomatic
      
Biospecimen description: 
      A venous blood sample was collected at either screening (Visit 1) or enrollment (Visit 2).
      These samples were collected for DNA extraction. The extracted DNA is stored at Novartis
      Pharmaceuticals Corporation for pharmacogenetic analysis and storage.
    
Keywords: Allergic asthma; Pediatrics; Exacerbations; Perennial aeroallergens; Inhaled corticosteroids
Dry Needling and Pain Education in the Treatment of Chronic Neck Pain
Condition: Pain, Neck
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      to compare the effects on pain, disability and psychological factors of the combination of
      MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control
      electrotherapy usual care in patients with chronic neck pain.
    


Intervention name(s): Dry needling; Pain neuroscience education; Conventional treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Insertion of solid filament needles in the muscle; Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain; Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux
Condition: Inadvertent Perioperative Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      Nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. Over
      30% of the patients undergoing a caesarean section experience a fall of the body core
      temperature under 36°C during the procedure. Following a retrospective cohort design, this
      study aims to examine the magnitude of hypothermia in the parturient and newborn population
      as well as the impact and efficiency of forced-air warming on preventing it. The researchers
      plan to conduct a retrospective analysis of the caesarean section treatment protocol at our
      institution over a period of 5 months including approximately 300 patients who underwent both
      elective and emergency caesarean sections.
    

Detailed description: 
      This research seeks to address the necessity of standardizing the use of forced-air warming
      and monitoring the maternal temperature during caesarean sections. We will also examine the
      impact of the maternal hypothermia on the newborn temperatures at the time of partus and also
      2 hours after birth. The key research question of this study is whether the use of forced-air
      warming will significantly lower the hypothermia rates and account for a faster temperature
      recovery in our parturient patients.

      A major contribution of our research is that it provides modern high-resolution, continuous
      and user-error free thermometry. This is achieved through zero-heat-flux technology and
      automatically recorded by data-loggers. Also, the heterogeneity of our study population,
      which has not been attended in previous studies, corresponds to the clinical reality of the
      most obstetric clinics.

      This research could provide new information about the necessity of standardizing the use of
      forced-air warming and monitoring the maternal temperature during caesarean sections, in the
      concept of bonding the babies to the mother's chest immediately after birth, and derive
      practical implications on the efficiency of intraoperative warming for the standard clinical
      routine of the majority of the obstetric clinics.
    

Intervention name(s): Convective Forced-Air Active Warming
Intervention type(s): Procedure
Intervention description(s): Underbody Blanket Model 585 of the 3M BairHugger Series
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Included will be patients undergoing spinal anaesthesia for elective and emergency
        caesarean delivery in accordance with our clinical day-to-day operative protocol.
      
Keywords: cesarean section; C-Section; Hypothermia; Spinal Anesthesia; caesarean section; zero heat flux technology; active warming
Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the impact of a synbiotic containing
      fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit
      in middle-aged subjects characterized by a low number of defecations per week.
    

Detailed description: 
      Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets
      of either synbiotic or for 5 days, then they received daily 1 sachet for the next 25 days.

      The primary endpoint of this trial is to evaluate the effect of supplementation in synbiotic
      containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on
      intestinal transit in middle-aged subjects characterized by a few bowel movements per week.
      The secondary endpoints are to evaluate both clinical criteria such as changes in stool
      appearance, quality of life and mood, relief and satisfaction of participants; and biological
      criteria such as changes in markers of gut function, low-grade chronic inflammation markers
      and gut microbiota composition. The safety of product use and compliance are also evaluated

      Synbiotic group. The dietary supplement under study was composed of fructo-oligosaccharides -
      FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion /
      sachet. Sachets of powder were diluted in a in 200 ml of water at room temperature to be
      taken before breakfast. Doses were 2 sachets per day for the first 5 days and then 1 sachet
      per day for the next 25 days.

      Placebo group. The placebo looked strictly identical to the synbiotic and contained only
      excipients (60% maltodextrin / 40% sucrose). Sachets of powder were diluted in a in 200 ml of
      water at room temperature to be taken before breakfast. Doses were 2 sachets per day for the
      first 5 days and then 1 sachet per day for the next 25 days.
    

Intervention name(s): Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of synbiotic (Bifidobaterium animalis lactis Vesalius 002 and Fructo-Oligosaccharrides) for 5 days, then they received daily 1 sachet for the next 25 days; Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of placebo (maltodextrin and sucrose) for 5 days, then they received daily 1 sachet for the next 25 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotics; constipation; FOS
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to
      compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese
      drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different
      groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or
      Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
    


Intervention name(s): Nateglinide; Acarbose
Intervention type(s): Drug; Drug
Intervention description(s): Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.; Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Intervention MeSH terms: Acarbose; Nateglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Nateglinide; Acarbose; glucose fluctuation
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease
Condition: Transcranial Magnetic Stimulation; Functional Magnetic Resonance Imaging; Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To investigate the treatment effect of continuous transcranial magnetic stimulation on
      patients with Parkinson disease, and the underlying neural mechanism by functional MRI
    

Detailed description: 
      All patients underwent a medical evaluation that included physical examination and routine
      laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS)
      treatment. Patients were randomly allocated to rTMS group and the sham group by coin toss.
      There are at least 20 patients in each group. The decision to enroll a patient was always
      made prior to randomization. Patients were studied using a double-blind design. Study
      participants, clinical raters, and all personnel responsible for the clinical care of the
      patient remained masked to allocated condition and allocation parameters. Only rTMS
      administrators had access to the randomization list; they had minimal contact with the
      patients, and no role in assessing clinical symptoms. Each patient would be treated for
      continuous 14 days by rTMS.

      Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor
      Symptom Scale were obtained by a trained investigator to assess baseline severity. The
      patients had receiving a battery measure of neuropsychological tests(mini-mental state
      examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton
      depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal
      test, and delay discount), magnetic resonance imaging scan in multimodalities, and
      electroencephalography (EEG) record.

      In the second day after the last treatment, all the tests were reassessed. Patients were
      instructed to focus their answers on the past 14 days. The patients had also receiving a
      battery measure of neuropsychological tests, magnetic resonance imaging scan in
      multimodalities, and EEG record.

      The clinical symptom and cognition of participants were followed in two month after the last
      treatment. They were instructed to focus their answers on the past week. Additionally, they
      were also asked to assess the battery of neuropsychological tests, and have magnetic
      resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by
      the study coordinator.
    

Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Other
Intervention description(s): The stimulations were performed by MagStim Rapid2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; Functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation
Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine
Condition: Healthy
Study type: Interventional

Summary: 
      Evaluation of the CapScan intestinal collection device in characterizing the metabolism of
      sulfasalazine in the digestive tracts of healthy volunteers.
    

Detailed description: 
      The objective is to evaluate the effectiveness of the CapScan intestinal collection device in
      characterizing the regional distribution of sulfasalazine, the metabolic breakdown products
      of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.
    

Intervention name(s): CapScan intestinal sampling device
Intervention type(s): Device
Intervention description(s): CapScan is an intestinal collection device used to characterize the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the effect of Mulligan's mobilization with movement in osteoarthritis of the
      knee.
    

Detailed description: 
      Patients with knee OA diagnosed at the orthopaedic clinic of Tumair general hospital and
      referred to the physiotherapy department who attended the rehabilitation centre of Majmaah
      university will be recruited.

      Patients will be excluded if they had knee or hip injury, sensory deficits in the lower
      extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring
      muscle injury, had low back-related leg pain, or had any contraindication to manual therapy.

      The protocol was submitted to and approved by the Majmaah University Research Ethics
      committee (MUREC Dec.2/ COM-2021/19-3)

      Participants will be requested to sign a written informed consent form approved by the
      institutional ethics committee. A total of 60 participants were randomly assigned to group A
      (experimental group): Mulligan's mobilization with movement MWM added isometric strength
      training, and group B (control group): Sham MWM added isometric strength training. Pre and
      post-test readings were taken at baseline, week 2, and week 4, respectively. The outcome
      measures for this study will be maximal voluntary isometric contraction of quadriceps
      strength (measured by ISOMOVE dynamometer), ROM, and Western Ontario and McMaster
      universities osteoarthritis (WOMAC) index.
    

Intervention name(s): Mulligan's mobilization with movement MWM added isometric strength training
Intervention type(s): Behavioral
Intervention description(s): Mulligan's mobilization with movement added isometric exercise:
the participants in the experimental group will receive a Mulligan's mobilization with movement added isometric exercise.
Treatment will be given for the period of three weeks, for five days a week in both groups.
Data will be collected before intervention and after 2nd & 4th week of intervention.
Other intervention name(s): Sham MWM added isometric strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Isometric exercise; Osteoarthritis; Rehabilitation
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2 part, single-dose and crossover study conducted to assess the
      relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the
      effect of food on the GSK3640254 tablet in healthy participants. This study will also
      evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the
      pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will
      be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment
      periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences
      (CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to
      receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions
      and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each
      treatment period. Approximately 30 participants will be enrolled.
    


Intervention name(s): GSK3640254 Tablet; GSK3640254 Capsule
Intervention type(s): Drug; Drug
Intervention description(s): GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.; GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Eligible participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in Part 1 and 1 of 3 treatment sequences (CDE, DEC, or ECD) in Part 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; GSK3640254; Human immunodeficiency virus; Relative Bioavailability
Gastric Emptying During the Labour
Condition: Pregnancy; Healthy Volunteers; Parturition
Study type: Interventional

Summary: 
      Current recommendations permit the ingestion of all clear fluids (water, apple juice, black
      coffee..) during labour. However, regarding food during labour, the recommendations vary.
      British and European guidelines permit the ingestion of low-residue food during labour whilst
      guidelines from the United States prohibit having any solid food during labour. The reason
      for this variation in recommendations is the lack of data on gastric emptying during labour
      with a conservative approach adopted due to the fear of delayed gastric emptying increasing
      the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This
      study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down
      during labour, using a validated, non-invasive ultrasound method, in four groups of women :
      Women in labour with epidural analgesia (Analgesia group), women in labor without any
      epidural analgesia (Parturient group), women in the third trimester of pregnancy (Pregnant
      group) and women who are not currently pregnant (Non-pregnant control group). The
      investigator propose the hypothesis that the gastric emptying of a light, solid meal is
      slowed by 30% during labour under epidural analgesia.
    


Intervention name(s): Ultrasound assessment of gastric emptying of a flavoured yoghourt.
Intervention type(s): Other
Intervention description(s): Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = π x D1 x D2 / 4.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science