bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacological Approach to Improve the Outcome of Social Cognition Training
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate whether oxytocin will facilitate the learning of social cognitive
      skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training
      (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin
      will demonstrate greater improvements in a summary measure of social cognition than subjects
      treated with placebo over the course of SCST.
    

Detailed description: 
      Individuals with schizophrenia often have serious deficits in their abilities to perceive and
      interpret socially relevant information. These deficits in social cognition can lead to
      misunderstanding the intentions of others and failing to interpret social signals that are
      important for successful social interactions. The relationship between social cognition and
      functioning has led our group to develop a research agenda that includes understanding the
      neural underpinnings of social cognitive deficits, measuring these impairments using
      brain-based biomarkers and clinical assessments, and enhancing our Social Cognitive Skills
      Training program to improve social cognition and promote recovery.

      Oxytocin, which is a hormone and neurotransmitter, is believed to impact social cognition
      through increased orienting toward and attending to socially salient visual features. There
      is also evidence that oxytocinergic signaling is impaired in schizophrenia. With this
      research, we hope to learn whether administration of oxytocin will improve different aspects
      of social cognition by examining the effects of oxytocin versus placebo administered
      intranasally before each of 12 sessions of a social cognitive skills training program on
      measures of independent living, work and social functioning.
    

Intervention name(s): Oxytocin; Placebo; Social Cognitive Skills Training
Intervention type(s): Drug; Other; Behavioral
Intervention description(s): Oxytocin 40 IU, intranasal inhalation; Placebo, matched to Oxytocin, intranasal inhalation; The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Social Cognition; Oxytocin
Online PHN CBT for PPD
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression
Study type: Interventional

Summary: 
      The primary objective of this study is to determine if online group CBT for PPD delivered by
      public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b)
      reducing relapse and recurrence, c) improving common comorbidities and complications of PPD
      including anxiety and the mother-infant relationship, and d) to determine if this treatment
      is cost-effective.
    

Detailed description: 
      A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data
      analysts will be blinded to maternal treatment will be used to compare online PHN-delivered
      group CBT for PPD to postnatal care as usual.

      The primary objective of this study is to determine if online group CBT for PPD delivered by
      public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b)
      reducing relapse and recurrence, c) improving common comorbidities and complications of PPD
      including anxiety and the mother-infant relationship, and d) to determine if this treatment
      is cost-effective.

      Women in the treatment group will participate in a 9-week group CBT intervention for PPD
      delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where
      core CBT skills are learned and practiced, and a new psychoeducational topic is introduced
      and discussed by women each week.
    

Intervention name(s): Group Cognitive Behavioural Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned in a 1:1 ratio to the treatment group (online PHN-delivered group CBT) or the control group (treatment as usual).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Parent-Based Treatment for Pediatric Overweight
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a parent/guardian intervention for
      adolescent overweight/obesity more effective than a nutritional counseling education
      curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.
    

Detailed description: 
      Rates of pediatric overweight (PO) among Americans are increasing and associated with
      significant psychological, social, quality of life, and health related outcomes. Because of
      the broad mental and physical health implications of PO and the difficulty in sustaining
      weight loss as an adult, it is of interest to find successful methods of weight loss and/or
      prevention of weight gain for obese children and adolescents. The family unit is a logical
      and empirically supported point of intervention for PO. Interventions on this level have
      shown good long term efficacy in young children, but there is very little research on
      adolescent family intervention. Within the eating disorder literature, there is growing
      support for the efficacy of family-based interventions (FBI) for adolescents. Given its
      trans-developmental applicability, focus on family as the unit of intervention, and utility
      in creating a healthy eating environment, FBI is a logical candidate for adaptation to
      intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of
      the current project is to test the feasibility and efficacy of an adapted FBI manual for
      adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders
      clinic and compare this modality to a minimal nutritional educational control (NEC)
      condition.
    

Intervention name(s): FBT-PO; NEC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.; Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
Other intervention name(s): Family Based Therapy for Pediatric Overweight; Nutritional Educational Control Condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Adolescents; Family Therapy
Influence of Physical Exercise on Endothelial Function in Pregnant Women
Condition: Pregnancy; Preeclampsia; Exercise
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effect of regular aerobic exercise on
      endothelial function in pregnancy.
    

Detailed description: 
      Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and
      remains as the major cause of maternal and neonatal mortality, especially in developing
      countries. Cost-effective interventions aimed to prevent the development of preeclampsia are
      urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative
      stress, endothelial dysfunction, infections, maternal constitutional factors, and others.
      Regular aerobic exercise recovers endothelial function, decreases oxidative stress and
      improves maternal constitutional factors.

      The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic
      exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the
      effect of exercise on biomarkers on vascular function and perinatal outcomes will be
      evaluated.
    

Intervention name(s): Regular aerobic physical exercise; Activities of daily living
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises.; Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: pregnancy; preeclampsia; exercise
Reliability, Validity, and Cross-cultural Adaptation of the Turkish Version of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) Questionnaire
Condition: Greater Trochanteric Pain Syndrome of Both Lower Limbs; Gluteal Tendinitis
MeSH terms: Tendinopathy; Bursitis
Study type: Observational

Summary: 
      The purpose of this study was to investigate adaptation, validity, and reliability of the
      Turkish version of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy
      (VISA-G) Questionnaire.
    

Detailed description: 
      Gluteal tendinopathy, also known as greater trochanteric pain syndrome, interferes with
      physical function and sleep, and is characterized by pain and tenderness over the greater
      trochanter.Clinical risk factors for the development of this condition include advanced age,
      female gender, back pain, overweight / obesity, poor abductor hip function, altered gait
      parameters, and psychological distress. The Victorian Institute of Sports Assessment for
      Gluteal tendinopathy (VISA-G) Questionnaire has recently designed as a patient-reported
      condition-specific outcome measurement tool to assess disability due to tendinopathy. VISA-G
      is scored between 0 and 100 (a higher score is expected) and consists of eight items covering
      three main areas (pain, function, and current activity level). Visual analog score for pain
      (0-10), the effect of pain on weight-bearing activities (0-30), and difficulty and / or
      function-related stairs use, including lying on the symptomatic side (0-10), climbing ramps
      (0-10), standing up without sitting (0-10), home or garden work (0-10) and regular exercise
      (0-10), physical activity and sports participation (0-10) are evaluated. The study is planned
      with 40 individuals with gluteal tendinopathy. After questioning the sociodemographic
      characteristics of the individuals, the patients will be asked to fill in VISA-G, Short
      Form-36, International Physical Activity Questionnaire, Numeric Rating Scale, Oswestry
      Disability Index, Oxford Hip Score and modified Harris Hip Score.Test-retest will be
      re-applied to those of the same individuals who can be reached after 1 week. The results will
      be analyzed using the SPSS version 22.0 computer package program.
    

Intervention name(s): Survey study
Intervention type(s): Other
Intervention description(s): Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) Questionnaire will be applied.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of individuals with diagnosis of greater trochanteric
        pain syndrome and gluteal tendinopathy.
      
Keywords: Validity; Reliability; Greater Trochanteric Pain Syndrome; Gluteal tendinopathy
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be
      assessed using carotid ultrasound
    


Intervention name(s): Pactimibe
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Randomized Clinical Trial on Transanal Irrigation
Condition: Low Anterior Resection Syndrome
MeSH terms: Low Anterior Resection Syndrome; Syndrome
Study type: Interventional

Summary: 
      Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter
      compared to standard of care.

      The secondary objective is to investigate quality of life and different benefits and aspects
      of treatment and satisfaction with the Peristeen cone catheter.

      Design of the investigation This is a randomised, open-label, parallel investigation
      comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS
      score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be
      randomized to the treatments stratified by neo-adjuvant radiotherapy.

      The comparator in this study will be current standard of care for patients with LARS which is
      conservative bowel management. This is defined as: Supportive therapy according to the
      individual treatment protocols available at each participating site.

      Primary endpoint and secondary endpoints

      Primary endpoint:

      • LARS score, obtained from the LARS score questionnaire*

      Secondary endpoints:

        -  Number of subjects with Major LARS*

        -  FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire*

        -  FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire*

        -  FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire*

        -  FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire*

        -  EQ-5D-5L - utility score*

        -  EQ-5D-5L - VAS score (scale 0-10 cm)*

        -  Satisfaction with treatment (scale 0-10 cm)*

        -  Number of adverse events* *All endpoints are measured per subject at study termination
    


Intervention name(s): Peristeen cone catheter
Intervention type(s): Device
Intervention description(s): The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses
      (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive
      dyskinesia in subjects with schizophrenia or schizoaffective disorder.
    


Intervention name(s): NBI-98854; NBI-98854; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12.5 mg powder in bottle once daily for 14 days; 50 mg powder in bottle once daily for 14 days; Solution containing no active substance
Intervention MeSH terms: Tetrabenazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antiviral effect, as measured by viral titer in
      nasal secretions in adults with acute uncomplicated seasonal influenza A following
      administration of VX-787.
    


Intervention name(s): VX-787 300 mg; VX-787 600 mg; Oseltamivir 75 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.; A oral dose of VX-787 600 mg (formulated as 2*300 mg tablets) will be administered over 5-6 days.; A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.; Subjects will receive matching placebo of Oseltamivir
Other intervention name(s): JNJ-63623872; JNJ-63623872
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza A
Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients
Condition: Intraoperative Hemodynamics; Liposuction
Study type: Interventional
Phase: Phase 3

Summary: 
      Liposuction is a procedure that has emerged over the last 30 years as a method to remove
      subcutaneous fat for cosmetic purposes. Numerous liposuction techniques have been developed
      .Tumescent liposuction involves using large volumes of dilute local anesthetic and
      epinephrine to facilitate anesthesia and decrease blood loss. Questions remain about the
      appropriate dose of local anesthetic, the use of general anesthesia in liposuction, and the
      setting in which the chosen liposuction method is used. Adrenaline is the most commonly used
      vasoconstrictor, the recommended concentration in the tumescent solution is 0.25-1 mg/L
      depending on the tissue vascularity. In the more vascular tissues, the concentration is 1
      mg/L and is decreased to 0.5 mg/L in the less vascular areas of the body. The dose should not
      exceed 50μg/kg. If the maximum dose is anticipated to exceed, the procedure should be done in
      several stages.
    


Intervention name(s): Epinephrine concentration of 1:1000000; Epinephrine concentration of 1:500000
Intervention type(s): Drug; Drug
Intervention description(s): Tumescence fluid contained Epinephrine concentration of 1:1000000 (one ampoule 1 mg per liter) lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter; Tumescence fluid contained Epinephrine concentration of 1:500000 two ampoule 2 mg/liter with same lidocaine and bicarbonate dose. lidocaine 500 mg and sodium bicarbonate 8.4% 10 ml per liter
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adrenaline; Tumescence Solution
Effects of TA-65, a Telomerase Activator on Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the efficacy of TA-65, a purified extract of
      Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals
      classified with metabolic syndrome.
    

Detailed description: 
      Short telomeres are strongly linked to increased risk of cardiovascular disease and diabetes,
      indications where tissue aging and senescence play significant roles. Shorter leukocyte
      telomere length has been linked to impaired glucose tolerance, Type 2 Diabetes, and coronary
      heart disease. Telomere length and telomerase activity have been shown to be significantly
      lower in CAD patients. Telomere length may play an important role in predicting
      cardiovascular disease and diabetes. TA-65 may not only ameliorate the symptoms associated
      with these disease states, but be a preventive measure as well.

      In this study, the researchers will investigate whether telomerase activator (TA)-65 can also
      improve the metabolic dysregulations associated with metabolic syndrome including oxidative
      stress, inflammation, high blood pressure and dyslipidemias.
    

Intervention name(s): TA-65
Intervention type(s): Dietary Supplement
Intervention description(s): 2 pills of TA-65 or placebo daily for 12 weeks. Subjects will be monitored weekly for side effects and every 4 weeks for compliance and safety monitoring. The whole intervention is a randomized double blind study for a duration of 27 weeks; 12 weeks for TA-65 or placebo allocated randomly and after a 3 week washout period, allocation to the alternate supplement TA-65 or placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects
Condition: Healthy Subjects; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate pharmacokinetics, in particular the routes of
      excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled
      ASP015K.
    

Detailed description: 
      Eligible subjects will be admitted to the clinical research unit and confined for a minimum
      of 8 days.
    

Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Peficitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ASP015K; Healthy volunteers
BI 44370 TA in Acute Migraine Attack
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to assess the safety, tolerability, and efficacy of three
      doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache
      pain of moderate or severe intensity, compared to placebo and an active comparator.
    


Intervention name(s): BI 44370 TA Low Dose; Eletriptan; Placebo; BI 44370 TA Medium Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment