bioihbjkbjnl/mcl2 huggingface dataset:
Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
Condition: Healthy Volunteers; Narcolepsy Type 1
MeSH terms: Narcolepsy
Study type: Observational

Summary: 
      The purpose of this study is to determine whether portable devices can provide measurements
      at home similar to those taken in the clinic, in particular in participant with NT1, and to
      investigate night-to-night changes in sleep patterns using these devices at home. This study
      may enable future at-home studies and ultimately lead to a decreased burden on the people who
      need these measurements.
    

Detailed description: 
      This is a non-drug study including participants with NT1 and healthy participants using
      devices designed for at-home assessments. The study will assess whether a portable EEG device
      provides an EEG signal comparable to inpatient nPSG. The frequency and characteristics of
      wake and sleep patterns and transitions over multiple nights will also be characterized.
      Participants with NT1 who will complete the study TAK-994-1501 (NCT04096560) will be eligible
      to enter the current study following the appropriate washout period (60 days).

      The study will enroll approximately 32 participants (16 participants with NT1 and 16 healthy
      participants). Participants will be enrolled in the 2 groups:

        -  NT1 Participants

        -  Healthy Participants

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 8 days. The follow-up visit will occur on Day 10
      and during this debrief, participants will answer a questionnaire on user experience (device
      comfort) for the wearable devices.
    

Intervention name(s): Portable EEG Device; Portable ECG Device; Accelerometry
Intervention type(s): Device; Device; Device
Intervention description(s): Portable EEG device is lightweight and designed for nighttime wear.; Portable ECG device is waterproof and will be adhered to the chest of the participant.; Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.
Basic Auditory Processing and Auditory Hallucinations
Condition: Schizophrenia
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the
      population worldwide. Although pathophysiology of this disease remains unclear, a growing
      interest is emerging for low-level sensory function, acknowledging that deficits in early
      stages of sensory processing are related to higher-order cognitive disturbances in
      schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were
      found correlated with disabilities to discriminate psychoacoustic parameters of sounds.
    

Detailed description: 
      Outcomes: Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are
      correlated with the percentage of wrong answers in a Tone-Matching Task test. The main
      objective is to assess this correlation. Our other objectives are to assess correlation
      between AHRS as well as other symptoms scales and psychoacoustic tests assessing intensity,
      length discrimination of non-verbal tones and self-monitoring abilities. Impact of
      therapeutic procedures (neuromodulation, psychotherapy) conducted independently of our study
      on these psychoacoustic tests will also be assessed.

      Methods: 30 subjects with schizophrenia will be included. Clinical and psychoacoustic
      measures will be carried out at J-0. In the case of patients receiving therapeutic procedures
      independently of our study, new clinical and psychoacoustic measures will be carried out at
      J+7 and J+30.
    

Intervention name(s): Clinical and psychoacoustic measures
Intervention type(s): Other
Intervention description(s): Our study focuses on psychoacoustic tests, specialist care protocols (psychotherapy, neuromodulation ...) being made independently of our study, as part of medical activity of Cerletti care unit or differentiated protocols. Thus, our study shows no individual benefit for the patient. However, a better understanding of the neurophysiological mechanisms underlying auditory hallucinatory phenomenon could allow a better management of these patients in the near future
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pitch discrimination; auditory processing disorders; auditory perception; auditory-verbal hallucinations; theory of mind
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Condition: Critically Ill; Respiratory Failure
MeSH terms: Respiratory Insufficiency; Respiratory Aspiration; Critical Illness
Study type: Interventional

Summary: 
      Inspiratory muscle training (IMT) is an intervention used with success in the outpatient
      setting within the COPD population. Use of IMT is also theoretically possible during
      mechanical ventilation. This study will will assess the feasibility and safety of the study
      of IMT in the patient population.
    


Intervention name(s): Inspiratory Muscle Trainer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Critically ill; intubated; safety; feasibility; inspiratory muscle training
Economic Evaluation of the MEWE Intervention
Condition: Depression; Mental Health Issue; Intimate Partner Violence; Domestic Violence; Gender-based Violence; Rape Sexual Assault; Battered Women
MeSH terms: Depression
Study type: Interventional

Summary: 
      Cash transfers have shown promise in preventing intimate partner violence, and in reducing
      recipients' stress levels. Cash transfers with behavioral or psychological interventions have
      shown limited effectiveness at reducing stress in some African countries. Little is known of
      the cost-effectiveness of interventions delivered alongside cash transfer programs. The MEWE
      economic evaluation sub-study (MEWE-EE) runs alongside MEWE, a three-arm cluster-randomized
      controlled trial in Sindh, Pakistan. MEWE-EE will assess the costs and cost-effectiveness of
      delivering a cash-transfer program (BISP-CT) combined with a life-skills building curriculum
      (LSB curriculum), compared to the BISP-CT alone. The LSB curriculum is offered to either
      women who receive BISP-CT, or to women who receive BISP-CT and their husbands.
    


Intervention name(s): Life Skills Building (LSB) curriculum for males; Life Skills Building (LSB) curriculum for females; Cash transfer to adult females
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions.
All male study participants attending LSB curriculum classes are married to BISP-CT clients.
For men, the MEWE intervention provides access to the LSB curriculum only.; The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions.
All female study participants attending LSB curriculum classes are BISP-CT clients.
For females, the MEWE intervention comprises access to LSB curriculum + BISP CTs.; The BISP intervention offers access to quarterly unconditional cash transfers to adult females.
Other intervention name(s): MEWE males; MEWE females; BISP-CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: violence; abuse; coercion; assault; aggression; gender; women; girl; wife; partner; spouse; sexual; physical; psychological; economic
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and
      Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
    


Intervention name(s): 5 mg Serlopitant Tablets; Matching Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Serlopitant Tablets; Placebo Tablets
Other intervention name(s): VPD-737
Intervention MeSH terms: Serlopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pruritus
Health Assessment Study (0954-946)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will look at the effects of losartan or atenolol on frequency of sexual intercourse
      in subjects with newly diagnosed mild to moderate hypertension.
    


Intervention name(s): MK0954, /Duration of Treatment : 16 Weeks; Comparator : atenolol /Duration of Treatment : 16 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride
      Tablets in Healthy Adult Volunteers
    


Intervention name(s): Jaktinib Hydrochloride Tablets
Intervention type(s): Drug
Intervention description(s): Orally, one tablet at a time
Other intervention name(s): Jaktinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain
      perception was altered in Parkinson's disease patients and could be related to nociceptive
      cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an
      electrophysiological tool which can modify cortical excitability. Its efficacy was
      demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In
      this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be
      evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain
      free Parkinson's disease patients. Each group will receive a high frequency Repetitive
      Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of
      one week.

      The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session
      with an infraliminary intensity on the primary cortical motor, modulating nociceptive
      cortical areas activity, could modify the nociceptive threshold perception in Parkinson's
      patients.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
Other intervention name(s): non applicable
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Repetitive Transcranial Magnetic Stimulation; pain threshold; Parkinson's disease; Pain threshold in Parkinson's disease
Increasing Vitamin Intake and Physical Activity
Condition: Heart Diseases; Diabetes Mellitus, Type 2; Behavior; Motivation
MeSH terms: Heart Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To help employees to adopt and maintain a healthy lifestyle, it is imperative to increase
      their self-management competencies. Aim of this research project is to evaluate an evidence-
      and theory-based computerized expert system in comparison to waiting control group. Employees
      will be treated psychologically and followed up over 18 months. The computerized expert
      system is expected to help employees significantly changing their lifestyle. The intervention
      is hypothesized to improve self-management competencies over and above the regular check-up
      at their medical appointment (i.e., waiting control group).
    

Detailed description: 
      In a change setting (employees having a regular medical appointment), two interventions (one
      for nutrition change and one for activity change) will follow and assessments over a time
      period of 12 to 20 weeks will be conducted afterwards. Study participants in the intervention
      groups receive an interactive, computerized expert system (Intervention Group, IG).
      Individuals in the waiting control group (WCG) get nothing. Employees (N = 1000) will be
      recruited at their regular medical appointment. Study participants will be followed up over
      three measurement points: One to nine weeks after T1, T2 will take place. Five to 13 weeks
      after T1 the T3 measurement will be conducted.

      The hypotheses are: In comparison to the WCG the employees in the IG are expected to have a
      higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be
      less likely to relapse into previous unhealthy routines. Also, IG employees will be healthier
      as well as they will report more quality of life, more work satisfaction and more
      occupational efficiency . In comparison to WCG, the IG is also hypothesized to be more
      effective than the WCG regarding social-cognitive predictors of behavior.

      Moreover, the interventions are supposed to be more effective for individuals with more risk
      factors (obese ect.). After successful evaluation and some adoptions the intervention will be
      implemented as a self-help program in all eligible employees in the Intranet.
    

Intervention name(s): Intervention Group (IG)
Intervention type(s): Behavioral
Intervention description(s): Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Other intervention name(s): HAPA-based stage-matched intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Randomized Controlled Trial; evidence- and theory-based behavioral intervention; expert system; stages of change; motivational interviewing; tailoring; Self Care; Expert Systems
Effect of Self Management Program on Clinical Status of COPD Patients
Condition: COPD
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of self management programs based on 5A model on the
      lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary Disease
      patients. Participants were randomly assigned to an intervention group or a control group.
      The control group were receiving standard practice care and the intervention group were
      receiving intervention in addition to standard practice care. The intervention content
      include implementation of a self management plan based on 5A model.
    

Detailed description: 
      5 A model implemented during a period of 12 weeks including 5 stags: assessment of behavior,
      beliefs and motivation of the patient (Assess); provide information about personal health
      risks and benefits of change (Advise); mutual contribution of patients and health care
      provider on setting realistic goals based on the patient's interest and confidence in their
      ability to change the behavior (Agree); help anticipate barriers and develop practical
      applications based on the identified patient's strategies, problem-solving techniques and
      social/environmental support (Assist) and specify plan for follow-up (Visits, Phone calls)
      and providing support in the course of follow up (Arrange).
    

Intervention name(s): 5 A model
Intervention type(s): Behavioral
Intervention description(s): self management program based on 5A model
Other intervention name(s): self managment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chronic lung disease
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
Condition: Management of Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of hydromorphone
      hydrochloride by intrathecal administration using a programmable implantable pump.
    

Detailed description: 
      A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and
      Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a
      Programmable Implantable Pump
    

Intervention name(s): Hydromorphone Hydrochloride; Programmable Implantable pump
Intervention type(s): Drug; Device
Intervention description(s): Opioid for chronic pain; Programmable Implantable pump delivering intrathecal hydromorphone
Other intervention name(s): Hydromorphone; Opioid
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Hydromorphone; Hydromorphone Hydrochloride; Pain Management; Non-narcotic analgesics
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass
Condition: Coronary Bypass Graft Stenosis of Autologous Vein
MeSH terms: Seroma
Study type: Interventional

Summary: 
      The great saphenous vein is the most commonly used material in coronary vascular bridging
      operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the
      incision open groin to ankle. This operation may damage the lymphatic, cause lymph
      circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around
      hematoma and other a series of symptoms.Based on some studies and our experience that vacuum
      assisted closure （VAC）is effective in complex wound failures following Stripping saphenous
      vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary
      bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC
      application on postoperative complications and wound healing after Stripping saphenous vein
      in Coronary bypass in comparison to conventional suction drain.
    


Intervention name(s): vacuum assisted closure; Axillary dissection
Intervention type(s): Procedure; Procedure
Intervention description(s): Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.; Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Treatment of Unilateral Posterior Cross Bite in Children
Condition: Malocclusion; Maxillary Expansion; Pain Children
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Rapid maxillary expansion and quad-helix are two well established appliances in dentistry
      used for posterior cross bite treatment. This study aims to compare this two different
      appliances in patients in their early mixed dentition, regarding treatment effects of the
      extra oral soft tissue but also dental and skeletal effects, if the children experience any
      pain and discomfort during treatment and the study also aims to make a cost minimization
      analysis. Comparison of these different treatments are barely made and no randomized
      controlled trial is yet published. No study has evaluated the difference of subjective
      experience during these two treatments. After this study we will know which one of these two
      appliances are the most effective, regarding cost minimization and treatment result but we
      are also able to put it in relation to the patients subjective experience
    


Intervention name(s): Maxillary expansion
Intervention type(s): Procedure
Intervention description(s): Correction of the unilateral posterior cross bite in children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment