bioihbjkbjnl/mcl2 huggingface dataset:
Exercise as a Treatment for Substance Use Disorders Protocol
Condition: Stimulant Abuse and Dependence
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if health interventions (intensive exercise or
      health education) can be used to help improve substance abuse treatment. The primary
      objective of this protocol is to compare percent days of abstinence between Vigorous
      Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on
      stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding
      caffeine and nicotine) use during a 12-week acute phase.
    

Detailed description: 
      This study is designed as a two-group, randomized controlled trial to test the effectiveness
      of the addition of exercise and health education to treatment as usual in improving drug
      treatment outcomes in 330 eligible and interested participants who provide informed consent
      at 8-10 sites across the nation. These participants will be randomized to one of two
      treatment arms: (1) Vigorous Intensity High Dose Exercise Augmentation (VIHD): Usual Care
      Augmented with Vigorous Intensity High Dose Exercise or (2) Health Education Intervention
      Augmentation (HEI): Usual Care Augmented with Health Education. This study will include
      individuals diagnosed with stimulant abuse or dependence (cocaine, methamphetamine,
      amphetamine or other stimulant, except caffeine or nicotine) who begin treatment while in a
      residential setting.
    

Intervention name(s): Vigorous Intensity High Dose Exercise; Health Education Intervention
Intervention type(s): Other; Other
Intervention description(s): Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.; Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
Other intervention name(s): Exercise; Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic
      (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the
      investigated drug on the body) properties of faster-acting insulin aspart in subjects with
      Type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin); Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine
Condition: Migraine; Common Migraine; Classic Migraine; Headache
MeSH terms: Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate
      (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The
      study will also assess dose response relationship of topiramate, estimate the relative
      efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect
      of migraine prevention with topiramate versus placebo on Health Related Quality of Life.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
      evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in
      the prevention of migraine headaches. The study consists of 4 phases: Baseline Phase
      (evaluation of eligibility criteria and tapering of any migraine prophylaxis medications
      patients are taking), Core Double-Blind Phase (patients are randomized to receive either 100
      milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day propranolol or placebo for a
      total of 26 weeks), Blinded Extension Phase (patients continue the same dose of medication
      until the sponsor terminates the study or a patient withdraws from the study), and Taper/Exit
      Phase (medication of patients exiting from the study is tapered over 7 weeks). The primary
      hypothesis is that one or two topiramate doses (100, 200 mg/day) will be superior to placebo
      in the prophylaxis of migraine based on the change in the monthly (28 days) migraine period
      rate from the prospective Baseline Phase to the Core Double-Blind Phase. Oral medication (100
      milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day propranolol, or placebo)
      during the 26-weeks Core Double-Blind Phase. Doses may be continued until the termination of
      the study or withdrawal by the patients during the Blinded Extension Phase.
    

Intervention name(s): topiramate, propranolol
Intervention type(s): Drug
Intervention MeSH terms: Topiramate; Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Common Migraine; Classic Migraine; Headache; Topiramate; Propranolol; Prophylaxis; Prevention
Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of
      higher than standard doses rifampicin will be studied during the intensive phase of
      tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB
      regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid,
      ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin
      plus the other drugs in standard dosages (third study arm). All patients will get the
      standard TB regimen during the continuation phase of treatment.
    


Intervention name(s): Rifampicin in higher doses
Intervention type(s): Drug
Intervention description(s): Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tuberculosis; rifampicin; pharmacokinetics; pharmacodynamics
Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
Condition: Fatigue Syndrome, Chronic; Chronic Pain; Anxiety Disorders; Depressive Disorder; Sleep Disorders
MeSH terms: Fatigue Syndrome, Chronic; Sleep Wake Disorders; Chronic Pain; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to examine if repetitive computerized cognitive training improves
      working memory in patients who are on sick leave due to complex symptom disorders (chronic
      pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of
      cognitive control training transfer to other tasks.
    


Intervention name(s): Cogmed working memory training; Control group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive therapy
Base Positioning Wheelchair Hemiplegic
Condition: Wheelchair
Study type: Observational

Summary: 
      The investigators looked at the population of hemiplegic stroke participants hospitalized
      with GHIV : the investigators assessed the postural control of the participants of the chair
      using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The
      investigators then had to the participants try positioning equipment and then prescribed it
      once the choice was made. The investigators then reassessed postural control and wheelchair
      pain with this positioning equipment.
    

Detailed description: 
      For each hemiplegic participants with wheelchair user stroke, the investigators collect :
      date of birth, date of stroke, side of hemiplegia. The wheelchair propulsion mode, the degree
      of autonomy (FAC and Enjalber scales), the way bed - wheelchair transfers are made.
      Assessment of wheelchair pain in the spine and Ischia with EVA. Time to travel 10 meters in a
      wheelchair. Postural control of the wheelchair is evaluated by the MCPAA. The investigators
      then carry out tests of positioning equipment : backrest, cushion, form elements and belt.
      This material is tried for several days. If it is appropriate (improvement on the postural
      control and on the pains), otherwise another material is tried.

      When the choice is made, the material is prescribed. The participant is seen again 3 months
      after the delivery of his personal material, and the same evaluation is redone.
    

Intervention name(s): Measurement of sitting postural control of the adult (MCPAA)
Intervention type(s): Other
Intervention description(s): The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture.
It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture.
Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA).
the speed of propulsion by a wheelchair.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Positioning of all hemiplegics by stroke requiring a wheelchair even punctual at the exit
        of the SSR compared to patients with hemiplegic sequelae.
      
Keywords: Wheelchair; Hemiplegia; Stroke; Postural control; Pain
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
Condition: FGFR Inhibition, Pharmacokinetics, Biomarkers; ER+ Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination
      with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy
      (FISH4/5) or gene amplification (FISH 6)
    


Intervention name(s): AZD4547; Exemestane; Placebo; Fulvestrant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet oral twice daily; Tablet oral once daily; Tablet oral twice daily; A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Intervention MeSH terms: Fulvestrant; Exemestane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Cancer; ER+; FGFR1; Exemestane; AZD4547; Fulvestrant
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Condition: Thromboembolism; Postpartum DVT; Thrombosis
MeSH terms: Thrombosis; Thromboembolism
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular
      weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery
      women. Half of participants will receive a fixed dose of LMWH, while the other half will
      receive a weight-based dose. The hypothesis is that the use of a weight-based dose will
      result in more women reaching prophylactic levels.
    

Detailed description: 
      Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The
      immediate postpartum period is a high risk time for VTE, and cesarean delivery is an
      additional risk factor. In the United States, use of postpartum VTE prophylaxis with
      low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose
      across all hospitals. A fixed-dose of LMWH is frequently used based on data from
      non-obstetric studies. However, there are concerns that in the postpartum population this
      fixed dose may not be adequate for prophylaxis.

      This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach
      prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized
      controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of
      participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a
      weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic
      anti-Xa levels.
    

Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention description(s): Low molecular weight heparin
Other intervention name(s): Lovenox
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Factor Xa; Biomarkers; Enoxaparin
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The main objective is to compare the physiological reactivity (heart and respiratory rates,
      galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion
      between depressive subjects, subjects remitted from depression and control subjects.
    


Intervention name(s): psychometric tests; MRI; transcranial doppler and TPI; explicitative interview
Intervention type(s): Behavioral; Device; Device; Behavioral
Intervention description(s): NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia; ASL, rest f-MRI, FLAIR, white matter hyper intensities load; transcranial doppler TPI
Other intervention name(s): Tissue Pulsatility Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: major depressive disorder; cerebrovascular reactivity; emotional reactivity
Effects of Maternal Folate and Folic Acid Supplementation on DNA Methylation in the Newborn Infant
Condition: Pregnancy; Maternal Nutrition; Fetal Health; Epigenetics; Maternal B Vitamins
Study type: Observational

Summary: 
      An overwhelming body of evidence of the protective effect of folic acid supplementation on
      neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada
      in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in
      DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated
      in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming
      occurs in utero and has the potential to be modulated by the methyl donor supply of which
      folate is a contributor. Animal studies have shown maternal folate exposure can modulate
      epigenetic changes in the offspring, however, there is limited evidence of this relationship
      in humans. The aim of this research is to determine the effects of maternal dietary folate
      and supplemental folic acid intake during the periconceptional and in utero periods on global
      and gene-specific DNA methylation in human infants. This is a prospective observational study
      involving 368 Canadian mother-child pairs recruited from St. Michael's Hospital in Toronto,
      Ontario. Dietary and demographical information was collected from consenting pregnant women
      at study baseline (12-16 weeks gestation) and in the third trimester (34-37 weeks gestation).
      Maternal blood samples were obtained at baseline and prior to delivery and a sample of
      umbilical cord blood was collected at parturition to measure levels of folate status. Global
      and gene-specific DNA methylation in umbilical cord blood will be correlated with cord and
      maternal folate status. The data will be analyzed using separate ordinary least squares (OLS)
      regressions. Results from this study will contribute to a better understanding of how
      maternal folate and folic acid intake can modulate epigenetic modifications in the offspring
      and potentially have an effect on disease susceptibility later in life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women were recruited from obstetrics clinics at St Michael's Hospital, a tertiary
        teaching hospital affiliated with the University of Toronto.
      
Keywords: Folate; Folic Acid; One-Carbon Nutrients; Epigenetics; Pregnancy; Fetal Health
Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study is investigating whether combining noninvasive brain stimulation with behavior
      therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and
      response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment
      for OCD. This study will test whether a form of noninvasive brain stimulation called
      transcranial direct current stimulation (tDCS), can help ERP work better.
    


Intervention name(s): ERP plus tDCS; ERP plus sham tDCS
Intervention type(s): Other; Other
Intervention description(s): Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.; Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy
Condition: Regional Anesthesia Morbidity
Study type: Interventional

Summary: 
      Current healthcare delivery models emphasize enhanced postoperative recovery (ERAS) with
      minimal morbidity and shorter hospital stays. Most tracheostomy cases are tumour patients.
      The more the patients have difficulty in breathing, the more difficult it is to anaesthetize
      them. Adequate intraoperative anaesthesia and postoperative analgesia with minimal sedation
      play an essential role in this patient model. In tracheostomy patients, moving away from the
      general anaesthesia option increases airway safety, and avoiding the local anaesthesia option
      in the incision area increases patient comfort. The purpose of this study is to assess the
      safety and efficacy of regional anaesthesia in tracheostomy patients.
    

Detailed description: 
      after being informed and about the study and potential risks, all patients giving written
      informed consent will undergo 24 hours screening period to determine the eligilibity for
      study entry. After a computer-generated randomization list with a 1:1 intergroup ratio,
      ensuring equal distribution in the two groups, 30 opaque sealed envelopes numbered 1-30 were
      prepared. The patients were randomly divided into the Group with bilateral CPB with 15 ml
      0.5% bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition
      to bilateral CPB.

      CPB: cervical plexus block.
    

Intervention name(s): ST
Intervention type(s): Procedure
Intervention description(s): After a computer-generated randomization list with a 1:1 intergroup ratio, ensuring equal distribution in the two groups, 30 opaque sealed envelopes numbered 1-30 were prepared. The patients were randomly divided into the Group with bilateral CPB with 15 ml 0.5% bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition to bilateral CPB.
Following inclusion, two research assistants, with no further involvement in the study, prepared 15mL syringes and 5 ml syringes according to the envelope's specifications. The syringes were marked with the patient's randomization number. All other investigators, staff, and patients were blinded to group allocations. Before surgery, the patients were transferred to the specified block room area monitored with 3-lead electrocardiography, pulse oximetry, and non-invasive blood pressure. All patients had two intravenous cannula lines, and then bilateral CPB block procedures were performed in awake non-sedated patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the new indication for cervical plexus block.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Regional Anesthesia; Tracheostomy; Ultrasound