bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine
      compression after vaginal delivery with respect to blood loss and maternal pain. It is a
      randomized controlled trial that will be conducted at the American University of Beirut
      Medical Center - Delivery Suite.
    

Detailed description: 
      Women allocated to either the massage or compression group will be given 10 units of oxytocin
      intramuscularly immediately after delivery of the shoulder and controlled cord traction will
      be performed to assist placental delivery. The umbilical cord will be clamped and cut
      approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and
      blood clots expelled as quickly as possible after delivery of the placenta.
    

Intervention name(s): Uterine Massage; Uterine Compression
Intervention type(s): Procedure; Procedure
Intervention description(s): The massage will be performed as follows: palpating the uterine fundus, manually stimulating the fundus and the whole body of the uterus using fingers and palms steadily and repetitively.; The sustained uterine compression will be performed as follows: placing one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Uterine; Massage; Compression
The Therapeutic Efficacy of Neurofeedback in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The investigators examined the therapeutic efficacy of neurofeedback in depression subjects.
      The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate
      depressive symptoms.
    

Detailed description: 
      Subject

        -  Fulfilled DSM-IV criteria for depressive disorders.

        -  Persons who had organic disorders were excluded.

        -  Who had been treated by psychoactive drugs for at least 2 months prior to the study were
           excluded.

      Design

        -  Subjects were randomly assigned to two groups (EEG biofeedback /psychotherapy placebo)
           by block randomization.

        -  EEG biofeedback training was provided for 5 weeks(10 sessions, twice per week). Each
           training session was composed of 6 four minute trials followed by 5 thirty second rest
           periods

        -  Psychotherapy placebo session was provided for 5 weeks. These sessions consisted of
           additional assessment, interpretation of the test results and providing information on
           course and treatment of mood disorder.

        -  After subjects completed the training, they participated in a month-long (twice per
           week) self-training session to maintain a similar mental state during neurofeedback
           training sessions without feedback system's assistance.

        -  Subjects who had finished the psychotherapy placebo were referred to other therapists as
           necessary.
    

Intervention name(s): Neurofeedback; Psychotherapy placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): enhance relative activity level of left frontal activity; These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
Other intervention name(s): Asymmetry training
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Biofeedback; Psychophysiology
Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Condition: CBT Decoupling; CBT Anxiety Reduction; CBT Combined
Study type: Interventional

Summary: 
      The purpose of this study is to establish a brief CBT intervention that can largely, if not
      fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol
      use disorder treatment outcomes.
    


Intervention name(s): De-coupling; Anxiety Reduction; Combined
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Six sessions of CBT for anxiety-alcohol de-coupling; Six sessions of CBT for anxiety reduction.; Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: alcohol; anxiety
Response of Psychiatric Outpatients to the Great East Japan Earthquake
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Observational

Summary: 
      Objective: Reports have described how hospitalized psychiatric patients respond to disasters;
      however, few reports have described the response to disaster among psychiatric outpatients,
      who have relatively mild disease in comparison with hospitalized, severely ill psychiatric
      patients. Here the investigators have analyzed the response to disaster among this
      under-studied population.

      Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The
      investigators studied psychiatric change among a population of psychiatric outpatients in
      Tochigi prefecture, located ~160 km (~100 miles) southeast of the Fukushima nuclear power
      plant, in an area that suffered moderate damage from the earthquake. A total of 328
      psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2
      (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4
      (neurotic, stress-related, and somatoform disorders). All diagnoses were made using
      International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were measured
      as a change in psychotropic medication after the disaster.
    

Detailed description: 
      Patient progress was determined by whether a change in medication was needed. We focused on
      psychotropic drug use, including the use of neuroleptics, antidepressants, and
      benzodiazepines, directly after the disaster on March 11, 2011. Changes in other psychotropic
      drugs that are prescribed less frequently, such as lithium or anticonvulsants, were not
      considered in this study. Changes in symptoms that did not require a need to change
      psychotropic medications were not considered as part of a patient's progress. Physicians
      rated the relationship between each change in psychotropic drug and the disaster as direct,
      indirect, or not relevant. Only when three physicians rated the relationship as direct did we
      consider the change in a patient's progress to be due to the earthquake. Worsening or
      improvement of symptoms was defined as a change in psychotropic medications as a result of
      the deterioration or improvement, respectively, of symptoms. The data were stratified by
      disease category and sex and analyzed using chi-square tests.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        a total of 328 psychiatric outpatients of Ashikaga Red Cross Hospital
Topiramate and Cerebrovascular Response in Migraineurs
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of topiramate on cerebrovascular
      reactivity and mean flow velocity to photic stimulation in migraineurs.
    


Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of
      simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227),
      when these drugs are co-administered in healthy Japanese participants.
    


Intervention name(s): AL-335; Odalasvir (ODV); Simeprevir (SMV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36.; ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36.; Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36.
Intervention MeSH terms: Simeprevir; Odalasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aerobic Exercise Training in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      Decreased exercise capacity, peripheral muscle strength and quality of life and increased
      dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension.
      It was demonstrated exercise training has beneficial effects in patients with pulmonary
      arterial hypertension. However, no study investigated the effects of upper extremity aerobic
      exercise training, therefore effects of upper extremity aerobic exercise training on outcomes
      in patients with pulmonary arterial hypertension.
    

Detailed description: 
      Patients were diagnosed with pulmonary arterial hypertension according to the Task Force for
      the Diagnosis and Treatment of Pulmonary Hypertension of f the European Society of Cardiology
      (ESC) and European Respiratory Society (ERS). Primary outcome measurement was exercise
      capacity, secondary outcomes were respiratory and peripheral muscle strength, physical
      activity, quality of life, fatigue, dyspnea and depression.
    

Intervention name(s): Upper extremity aerobic exercise training; Alternative upper extremity exercises
Intervention type(s): Other; Other
Intervention description(s): Training group will receive upper extremity aerobic exercise training using arm ergometer at 50-80% of maximal heart rate and breathing exercises.
Training will exercise with arm ergometer 3days/week, for 6 weeks with the assistance of a physiotherapist. Training workload will be undercontrol both using target heart rate and Modified Borg dyspnea scale. Training group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.; Control group will receive alternative upper extremity exercises and breathing exercises. Control group will perform alternative upper extremity exercises 3days/week, for 6 weeks and also breathing exercises 120 times/day, 7 days/week, for 6 weeks.
Control group will be followed-up by telephone once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pulmonary arterial hypertension; aerobic exercise training; upper extremity; exercise capacity
Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy
Condition: Laparoscopic Hysterectomy for Benign Conditions
Study type: Interventional

Summary: 
      We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy
      reduces operative time (from skin incision to detachment of the uterus) and lateral termal
      damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine
      manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all
      aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,
      thereby hastening electrosurgical transection, reducing activation time and reduce lateral
      thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,
      due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which
      also affects speed of transection, electrosurgical device activation time and lateral thermal
      damage.
    


Intervention name(s): Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy
Ezopiclone Improves the Quality of Overnight Polysomnography
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients often have difficulty sleeping during overnight sleep testing in a lab environment.
      The purpose of this study is to determine if taking a sleep aid will improve sleep and
      therefore the quality of the sleep study.
    

Detailed description: 
      The increasing awareness of sleep-disordered breathing (i.e obstructive sleep apnea) has
      created a growing demand for polysomnography (sleep study), resulting in excessive waiting
      times in many laboratories. Sleep centers have therefore needed to develop methods to improve
      their efficiency. Unfortunately many patients find it difficult to fall asleep in the
      unfamiliar environment of a laboratory setting (the "first-night effect"), circumstances that
      may prolong falling alseep and staying sleep. Likewise, intolerance of continuous positive
      airway pressure (CPAP) may also reduce the quality of the sleep study. Poor quality studies
      may lead to an inability to make a diagnosis or adequately titrate CPAP therapy.
      Unsatisfactory studies may need to be repeated.

      Sleep aids (hypnotics) are commonly used to treat both acute and chronic insomnia. These
      agents have minimal side-effects and do not disrupt normal sleep architecture or alter
      respiratory events. These attributes make such agents ideal for use to improve the quality of
      sleep studies and enhance the efficiency of sleep centers.

      In a recent retrospective review, we found that the use of a hypnotic prior to the sleep
      study resulted improved patient satisfaction and improved quality of the sleep study with
      significantly less studies needing to be repeated. Although promising, these results must be
      validated with a prospective, randomized, placebo-controlled trial.

      Eszopiclone (Lunesta) is a new non-narcotic, non-benzodiazepine hypnotic agent which received
      FDA approval on December 15, 2004 for the treatment of acute and chronic insomnia. Multiple
      clinical trials have found that eszopiclone decreases sleep latency, improves sleep
      efficiency/maintenance and reduces wake time after sleep onset (WASO). Given its efficacy in
      promoting sleep onset and sleep maintenance and its excellent safety profile, this agent
      should be ideal as a pre-study sedative. The purpose of this study is to validate the use of
      Lunesta in improving the quality of overnight sleep studies.
    

Intervention name(s): Lunesta; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): Lunesta 3mg prior to PSG; matching placebo
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Obstructive Sleep Apnea; Polysomnography; Non-benzodiazepine hypnotics
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
Condition: Healthy
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of REGN14284 in
      healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and
      treatment-emergent serious adverse events (SAEs).

      The secondary objectives of the study are:

        -  To assess the concentration-time profile of REGN14284 in serum

        -  To assess the immunogenicity of REGN14284
    


Intervention name(s): REGN14284; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol; Single ascending IV or SC administration per the protocol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronavirus disease 2019 (COVID-19) vaccinated; Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization
A Progressive Resistance Training Program in Patients With Haemophilia
Condition: Haemophilia
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      This study evaluates the clinical impact of a progressive resistance training program in
      adults patients with haemophilia
    

Detailed description: 
      The training program aims improving muscular strength and endurance in the relevant muscles
      and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in
      the patients.
    

Intervention name(s): Progressive resistance training; Normal daily activities
Intervention type(s): Other; Other
Intervention description(s): Progressive resistance training program; Usual daily activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Thai Massage on EMG
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of Thai massage on electromyogram in
      patients with chronic upper back pain associated with myofascial trigger points.
    


Intervention name(s): Thai massage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Condition: Contraception; Breastfeeding; Postpartum Contraception
Study type: Interventional

Summary: 
      The investigators goal is to measure the impact of timing of postpartum contraceptive implant
      insertion on breastfeeding success and duration and to explore women's experiences with and
      attitudes towards contraceptive and breastfeeding counseling in the peripartum time period
    

Detailed description: 
      Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to
      decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with
      term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to
      have any adverse effects on lactogenesis or breastfeeding continuation. However, no high
      quality study to date has examined the effects of progestin-only contraception in women known
      to be at risk for low milk supply, including women with a premature delivery, obesity,
      polycystic ovarian syndrome, diabetes, or a prior history of low milk supply.

      The investigators goal is to measure the impact of timing of postpartum contraceptive implant
      insertion on breastfeeding success and duration. This will be a three-armed randomized
      non-inferiority study of women who plan to breastfeed, have known risk factors for low milk
      supply, and who intend to use the contraceptive implant postpartum. Women will be randomized
      to one of three groups for the timing of contraceptive implant placement: within 30 minutes
      of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be
      assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to
      Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and
      satisfaction with the contraceptive implant, and side effects, including bleeding patterns,
      associated with the implant.

      Findings from this trial will be used by clinicians, hospital systems, and policy makers
      working to expand access to immediate postpartum implants while supporting women in meeting
      their breastfeeding goals.
    

Intervention name(s): Etonogestrel Contraceptive Implant
Intervention type(s): Device
Intervention description(s): Women will be randomized to the TIMING of implant placement
Other intervention name(s): Nexplanon
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Oxytocin and the Processing of Social Stress-Associated Chemosignals
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether oxytocin modulates the processing of
      stress-associated chemosignals and which substrates are involved.
    

Detailed description: 
      Social transmission of stress and fear is not restricted to visual or auditory cues, but
      extends to the olfactory domain, a phylogenetically more ancient sense. Exposure to axillary
      sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious
      stress response on the behavioral and neural level.Particularly, anxious individuals have
      been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary
      sweat). The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual
      and auditory modalities, however, it still elusive whether OXT also modulates the processing
      of stress-associated chemosignals. Axillary sweat were obtained from an unrelated sample of
      30 healthy men undergoing the Trier Social Stress Test and ergometer training as
      control.Subsequently, subjects completed a forced-choice emotional face recognition task
      composed of stimuli with varying intensities (neutral to fearful), while they were exposed to
      both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo
      administration, respectively. The investigators expect that OXT selectively diminishes
      chemosensory-induced behavioral biases and neural responses to stress-related odors.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds; Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
Other intervention name(s): Syntocinon-Spray, Novartis; Placebo-Spray, Novartis
Intervention MeSH terms: Lactitol; Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science