bioihbjkbjnl/mcl2 huggingface dataset:
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral
      training or relaxation training) vs. a time-matched 5-wk health education condition on
      psychosocial adaptation and physiological adaptation in women being treated for breast
      cancer. Participants assigned to either of the stress management conditions will show
      improved psychosocial adaptation and physiological adaptation compared to those assigned to
      the health education condition.
    

Detailed description: 
      This is a randomized controlled trial comparing the effects of 5-wk group-based stress
      management interventions (cognitive behavioral therapy [CBT] or relaxation training [RT]) vs
      a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation
      (negative and positive mood, social disruption) and physiological adaptation (cortisol and
      immune function) in women with non-metastatic breast cancer who are undergoing primary
      treatment. Participants are recruited in the weeks after surgery and before the start of
      adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological
      adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are
      re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up.
      Primary hypothesis is that women assigned to CBT or RT will show greater reductions in
      negative affect and social disruption, and greater increases in positive affect over time
      compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT
      will show greater decreases in cortisol and greater increases in immune functioning over time
      compared to those assigned to HE.
    

Intervention name(s): Cognitive Behavioral Training; Relaxation Training; Health Education Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training); Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation); Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis
Condition: Pulmonary Hypertension; Pulmonary Fibrosis; Sarcoidosis, Pulmonary
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Sarcoidosis, Pulmonary; Hypertension; Sarcoidosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2b, open label study to assess the safety and efficacy of increasing doses of pulsed,
      inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis and sarcoidosis on long term
      oxygen therapy followed by a long term extension study
    

Detailed description: 
      A phase 2b, open label study to assess the hemodynamic effects of increasing doses of pulsed,
      inhaled nitric oxide (iNO) in subjects with pulmonary hypertension associated with pulmonary
      fibrosis or sarcoidosis on long term oxygen therapy followed by an open label extension study
    

Intervention name(s): iNO
Intervention type(s): Combination Product
Intervention description(s): inhaled nitric oxide
Other intervention name(s): iNOPulse
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; Pulmonary Fibrosis; Sarcoidosis
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Condition: Excessive Daytime Sleepiness; Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a
      histaminergic agent which therefore may improve alertness and awakeness in patients with
      excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS
      when treated with this compound compared to placebo in patients with narcolepsy is
      hypothesized.
    


Intervention name(s): Placebo; PF-03654746
Intervention type(s): Drug; Drug
Intervention description(s): Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at 1.0 mg; decrease to 0.5 mg or increase to 2.0 mg based upon the clinicians judgment regarding efficacy and side effects at the 1.0 dose level. The patient will then remain at the determined dose for a 3 week stable dosing period, with a 7 (-2/+ 9) day wash out and then crossover to repeat the same sequence for the second arm of the study.; Each patient will receive PF-03654746 tablets in a fixed dose titration schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at the 1.0 mg dose; decrease to 0.50 mg or increase to 2.0 mg based upon the clinician's judgement regarding efficacy and side effects at the 1.0 mg dose. The patient will remain at the determined dose for a 3 week stable dosing period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; double-blind; placebo-controlled; crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy
Effects of Neuromobilization on Median Nerve Elasticity
Condition: Median Nerve Disease
MeSH terms: Nervous System Diseases; Median Neuropathy
Study type: Interventional

Summary: 
      Purpose: The aim of this study was to investigate the effect of median nerve
      neuromobilization on median nerve elasticity using shear wave elastography.

      Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years.
      Inclusion criteria; no known systemic neuromuscular and metabolic diseases, no nerve
      impingement syndrome, and no upper extremity bone-tendon-muscle surgery in the last six
      months. Sociodemographic data of the participants were recorded. Wrist flexion and extension
      bilaterally with universal goniometer and finger grip strength bilaterally were measured with
      pinchmeter. Median Nerve Stress Test was performed. Median nerve elasticity was measured by
      Shear Wave Ultrasound Elastography. The extremity of the dominant side as a study group and
      the non-dominant side as a control group were measured bilaterally. Median nerve
      neuromobilization (stretching (n = 18) and shifting (n = 18)) was applied to the upper
      extremities of the dominant side. The application was carried out as 3 sets in one session.
      Evaluations were repeated after application.
    


Intervention name(s): neuromobilization exercises
Intervention type(s): Other
Intervention description(s): Median nerve neuromobilization (stretching and shifting) was performed. For median nerve stretching; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. For median nerve shift; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The researcher who performed shear wave elastography did not know which group the case was evaluated during the measurement.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuromobilization; elasticity; shear wave elastography
Effect of Abrupt Plavix® Discontinuation on Platelet Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The well established importance of regular administration of antiplatelet drugs stands on
      firm grounds, as large meta-analyses have shown these therapies to significantly reduce the
      risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce
      the risk of periprocedural thrombotic complications, for up to one year. As the current
      recommendations suggest clopidogrel use for no longer than one year, the drug is normally
      discontinued within that period. In the limited state of knowledge on antiplatelet drug
      withdrawal, an early sound of alarm has risen from early thromboembolic complications
      reported after the interruption of antiplatelet treatment used in prevention of ischemic
      vascular disease. Although little information is available, discontinuation of
      thienopyridines has been associated with increased thromboembolic complications, mainly acute
      stent thrombosis. These complications may signal a platelet sensitization effect to
      aggregating stimuli by antiplatelet drugs taken chronically.

      The current study aims to evaluate the impact of clopidogrel discontinuation on platelet
      function, in order to shed light on underlying mechanisms leading to increased risk of acute
      thrombo-occlusive events.
    


Intervention name(s): Platelet function testing
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with stable coronary artery disease
      
Keywords: Clopidogrel discontinuation; Platelet aggregation
Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation
Condition: Tracheal Intubation Morbidity; Pain
Study type: Interventional

Summary: 
      The objective : to investigate a correlation between ANI following a standardized nociceptive
      stimulus and hemodynamic or somatic reactions during orotracheal intubation.

      Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus
      stimulation followed by orotracheal intubation were collected.
    

Detailed description: 
      Background: The Analgesia Nociception Index reflects the balance between analgesia and
      nociception and allows early detection of a defect in analgesia. Orotracheal intubation is
      responsible for a sometimes deleterious hemodynamic reaction. The Analgesia Nociception Index
      could allow an individual adjustment of the investigator's anesthetic inductions during this
      period.

      Objective: The objective of this study is to investigate if there is a correlation between
      variations in the ANI following a standardized nociceptive stimulus and the occurrence of
      hemodynamic or somatic reactions during orotracheal intubation without muscle relaxation.

      Materials and Methods: Prospective, interventional, analytical, monocentric, piloted study
      carried out in the operating theatre after obtaining patient's informed consent between
      January 2014 and November 2014. Under steady state total intravenous anaesthesia with
      propofol and remifentanil at constant dosage (entropy between 40 and 60) tetanus stimulation
      of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and
      hemodynamic parameters as well as the somatic response associated with both maneuvers were
      collected.
    

Intervention name(s): ANI
Intervention type(s): Device
Intervention description(s): Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage, tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.
Intervention model: Single Group Assignment
Intervention model description: Prospective, interventional, analytical, monocentric, piloted study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ANI; hemodynamic responses; tracheal intubation
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Condition: Juvenile Idiopahtic Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3
      subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis
      related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96
      weeks of participation in study 0881A1-3338 (B1801014). The study contains an active
      treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
    


Intervention name(s): etanercept
Intervention type(s): Drug
Intervention description(s): Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).
Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.
Intervention MeSH terms: Etanercept
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Use of etanercept to treat pediatric subjects with extended oligoarticular JIA; enthestitis related arthritis (ERA); or psoriatic arthritis (PsA).
Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA,
      might be useful in combination with diabetes medication. Some studies show that CLA can
      modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce
      body weight and body fat without interfering with the diabetes medications' effects on blood
      sugar.
    

Detailed description: 
      The long term goal of this research is to develop effective complementary strategies to aid
      in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body
      weight and body fat mass when administered concomitantly with oral diabetes medication, The
      rationale of this study is that using CLA to reduce body weight and body fat in people with
      T2DM may improve efficacy and longevity of the oral diabetes medications in the management of
      T2DM. We plan to test our central hypothesis and accomplish the overall objective of this
      research by pursuing the following three specific aims.

      Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in
      people using oral diabetes medication for management of T2DM.

      Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined
      with oral diabetes medication.

      Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral
      diabetes medication.
    

Intervention name(s): Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant; conjugated linoleic acid (CLA); conjugated linoleic acid (CLA)
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32; 3.2 g/day, capsule, week 0 to week 32; 6.4 g/day, capsule, week 0 to week 32
Other intervention name(s): Avandia; Tonalin, Clarinol; Tonalin, Clarinol
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; conjugated linoleic acid; weight loss; rosiglitazone; glucose control; insulin sensitivity
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      To examine the effects of calligraphy activity on symptoms, attention, emotion, and quality
      of life in people with schizophrenia. We hypothesized that through a six-month intervention
      using calligraphy activity, people with schizophrenia will have their symptoms decreased,
      attention improved, emotion enhanced, and quality of life increased. This study will adopt
      single-blind, randomized controlled trial, and 160 people with schizophrenia will be
      recruited in this study. They will be randomly assigned to either a calligraphy activity
      group (treatment group; n=80) or an occupational activity group (control group; n=80).
      Participants will complete assessments at pretest, posttest, and 3-month follow-up using the
      following instruments: Positive and Negative Syndrome Scale (PANSS), Chu's Attention Test,
      The Taiwanese version of Montreal Cognitive Assessment (MoCA-T), WHO questionnaire on the
      Quality of Life, Brief Form (WHOQOL-BREF), and Chinese Depression Anxiety Stress
      Scales(DASS21).
    


Intervention name(s): Calligraphy
Intervention type(s): Behavioral
Intervention description(s): Participants will (1) detect the emotion him or herself; (2) do the calligraphy activity by writing positive terms (e.g., peace, life); (3) detect emotion again; (4) share the experience with group members.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Registry of Preterm Newborns With Severe Pulmonary Hypertension
Condition: Pulmonary Hypertension; Preterm Infant
MeSH terms: Hypertension, Pulmonary; Premature Birth; Hypertension
Study type: Observational

Summary: 
      The purpose of this prospective research registry is to collect data on treatment strategies
      and outcomes for premature newborns with severe pulmonary hypertension (PH).
    

Detailed description: 
      There is a lack of consensus on the role of inhaled nitric oxide (iNO) therapy and other
      pulmonary vasodilators for the treatment of severe pulmonary hypertension (PH) in premature
      newborns (<34 weeks gestation). However, a proper randomized, controlled trial of iNO in
      premature newborns with severe PH has not been completed. Some practices embrace the American
      Academy of Pediatrics (AAP) statement that there is no condition for which iNO should be used
      in the premature newborn, and others selectively treat premature infants with inhaled nitric
      oxide (iNO) who suffer life threatening hypoxemia due to suprasystemic PH and right-to-left
      veno-arterial admixture across the arterial duct and/or oval foramen. The number of neonatal
      intensive care units (NICUs) adopting each of these approaches is currently unknown, but it
      is possible that the former group is increasing due to administrative pressure to reduce
      uncompensated off-label iNO use. A prospective registry collection of treatment strategies
      and outcomes for this subset of premature newborns will help define current treatment
      strategies and yield important information about safety and efficacy of the different
      approaches to management, and would inform the debate more effectively than a series of iNO
      treated infants alone. Data collected includes maternal age, race/ethnicity, pregnancy and
      delivery complications, prenatal medications, infant characteristics such as Apgar scores,
      birthweight, congenital anomalies, respiratory status, pharmacologic therapy used for PH and
      its side effects, and blood gas data. Up to 100 sites in North America will be invited to
      monitor for appropriate cases.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment
      of acute ankle sprain.
    


Intervention name(s): Diclofenac diethylamine 2.32% gel; Placebo; Diclofenac diethylamine 2.32% gel / Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Diclofenac diethylamine 2.32% gel twice daily; Vehicle 2 times daily; Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ankle, sprain, diclofenac diethylamine