bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
Condition: Pemphigus
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Determine the response rate and 1-year event-free survival of patients with refractory
      pemphigus treated with high-dose cyclophosphamide.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF)
      beginning on day 10 and continuing until blood counts recover.

      Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a
      year, and then annually thereafter.
    

Intervention name(s): cyclophosphamide; filgrastim
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide
Primary purpose: Treatment
Keywords: immunologic disorders and infectious disorders; pemphigus; rare disease
Quantification of Immune Cells in Women Using Contraception (CHIC II)
Condition: HIV; Immune Cells (Mucosal and Systemic); Contraception
Study type: Observational

Summary: 
      This study is being done to understand if using birth control causes changes in the immune
      cells within the reproductive tract (including the cervix and the lining of the uterus) of
      healthy women. Immune cells are important because they help prevent infections from starting
      and help fight infections that have started. Immune cells are also the type of cells that HIV
      (human immunodeficiency virus) infects so understanding more about them will help to better
      understand how to prevent the spread of HIV.

      Immune cells will be studied from the reproductive tract of women who want to start using one
      of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the
      levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal
      implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women
      who are not using birth control and who are not at risk of pregnancy for comparison.
    


Intervention name(s): levonorgestrel exposure; DMPA exposure; etonogestrel exposure; IUD insertion; subdermal contraceptive implant insertion
Intervention type(s): Drug; Drug; Drug; Device; Device
Other intervention name(s): LNG-IUD (Mirena); LNG/EE oral contraceptive pills (Levora); DMPA (Depo-Provera 150mg IM); ENG-implant (Nexplanon or Implanon); LNG-IUD (Mirena); Copper T-380A IUD (ParaGard); ENG-implant (Nexplanon or Implanon)
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Levonorgestrel; Etonogestrel; Desogestrel; Contraceptives, Oral; Contraceptives, Oral, Combined
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
      
Biospecimen description: 
      whole blood, plasma archive, vaginal swabs, serum
    
Keywords: immune cells; contraception; intrauterine device; IUD; copper; microflora; DMPA; etonogestrel; subdermal implant
Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
Condition: Smokers
Study type: Interventional

Summary: 
      Little is known about the support needed to improve compliance with Chantix for smoking
      cessation. This is a two arm pilot study of African American smokers to provide varying
      levels of side effect management and compliance support during a 12 week treatment period.
      The primary aim of the study is to estimate the effect of induction support compared to
      standard care in increasing compliance with Chantix at month 3
    


Intervention name(s): Chantix; Adherence Counseling; Standard Counseling
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3; Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change.; Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
Other intervention name(s): varenicline
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: African american; smokers; smoking cessation; African American smokers
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
Condition: Healthy
Study type: Interventional

Summary: 
      This study is being done to measure the amount of skin shrinkage caused by a non-invasive
      skin tightening device.
    


Intervention name(s): Radiofrequency device
Intervention type(s): Device
Intervention description(s): One treatment pass on one arm. 2-5 treatment passes on the other
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: None- Normal healthy upper arm skin will be used.
Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Gait Disorders in Children; Gait Disorders, Neurologic
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The aim of this study was to develop a gait assessment instrument for Duchenne Muscular
      Dystrophy patients (DMD-GAS), and investigate its validity and reliability.The scale was
      developed considering the expert opinions which included 10 physiotherapists who had
      experience in the management of patients with DMD over the 2-round Delphi method, and the
      Content Validity Index (CVI) was calculated. The final version of the DMD-GAS that was agreed
      upon the experts consisted of 10 items, and each item scored between 0 and 2. The intra-rater
      reliability was established by the video analysis of children with a 1-month interval and
      inter-rater reliability was determined by the scores of 3 physiotherapists. The criterion
      validity was determined by investigating the relationship between the total score of the
      DMD-GAS and Motor Function Measure (MFM), 6 Minute Walk Test (6MWT), and the data obtained
      from GAITRite system.
    


Intervention name(s): Duchenne Muscular Dystrophy Gait Assessment Scale
Intervention type(s): Other
Intervention description(s): a special gait assessment scale for Duchenne Muscular Dystrophy patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Duchenne Muscular Dystrophy; gait pattern; scale development; reliability and validity; gait analysis
Assessment of Nutritional Status After Gastric Bypass Surgery
Condition: Obesity; Nutritional Deficiencies
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and
      nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try
      quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake
      of various common dietary protein sources 16 female patients with BMI > 40 kg/m2 and on a
      waiting list for bariatric surgery will be included. The following measurements will be
      performed before, and 1, 3, 6, 12, and 36 months after RYGP

        -  body weight

        -  body composition (bio impedancemetry)

        -  basal metabolic rate (open circuit indirect calorimetry)

        -  24-hour urinary urea excretion

        -  fasting blood chemistry

        -  energy and macronutrient's intake (3-day dietary recall)
    


Intervention name(s): Roux-en-Y gastric bypass (RYGP)
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        16 female obese subjects on a waiting list for gastric bypass bariatric surgery
      
Keywords: Obesity; Gastric bypass; Energy balance; Nutritional status; Protein balance
The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the
      hypothalamus - is a key mediator of complex social and affective behaviors, including
      emotional empathy. Recently, several theoretical studies suggested that PTSD patients have
      abnormal functioning of the OT system. According to these theories, dysfunction in the
      oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and
      therefore intranasal OT may potentially relieve these symptoms. The main goal of this study
      is to examine the effects of administration of nasal OT on empathic abilities among PTSD
      patients. Another goal of this study is to examine the relationship between empathic
      abilities and the ability to retrieve autobiographical memories among PTSD patients.
    


Intervention name(s): syntocinon nasal spray; placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations); nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Other intervention name(s): nasal oxytocin - 24 IU,; nasal placebo - 24 IU,
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD; empathy; oxytocin
Supporting Patient Decisions About UE Surgery in Cervical SCI
Condition: Cervical Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The goal of this study is to collect and describe patient and caregiver reported outcomes
      regarding surgical and non-surgical treatment for improving hand and arm function in the
      setting of cervical spinal cord injury. Eligible study participants will be recruited across
      the 4 sites and the investigators plan to recruit the following groups and numbers of
      participants:

        1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or
           tendon (N=10) transfer surgery to restore some hand and arm function as part of their
           standard clinical care and their caregiver (N=20)

        2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)
    

Detailed description: 
      At present, there is limited information that provides the exact time course and probability
      of gain in specific function (such as hand function) that might help patients and clinicians
      make decisions regarding novel and time-sensitive surgical treatment options.

      Understanding the pros and cons of any surgical intervention, especially in the setting of
      complex and often incomplete information, is challenging. Ultimately, this project will
      create a decision support intervention (DSI) that can be used to help clinicians and people
      living with cervical level SCI and their caregivers. It will be most useful to those with
      acute or sub-acute injury (< 1year after SCI) for both military personnel and the general
      public. Clinicians and patients will have evidence to help them make decisions about
      treatments to improve upper extremity function.

      In such a manner, patients can make more well-informed choices that are consistent with their
      values, needs and goals.
    

Intervention name(s): Semi-structured interview; Spinal Cord Independence Measure (SCIM-SR); SF-36
Intervention type(s): Other; Other; Other
Intervention description(s): Semi-structured interviews to be conducted by a study team member.; The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.; A health-related quality of life (QoL) self-reported survey.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve Transfer Surgery; Tendon Transfer Surgery; Decision Support Intervention
Effects of Brain Stimulation During Daytime Nap on Memory Consolidation in Younger, Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The beneficial effect of daytime sleep on memory consolidation has been shown in young,
      healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory
      enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity
      typically occuring during SWS has been implicated in the consolidation effect. In this study
      we investigate if the consolidation effect can be amplified by the application of a weak
      transcranial oscillatory electric current within the frequency range of SWS in humans
      (0,7-0,8 Hz) during daytime SWS.
    


Intervention name(s): brain stimulation; no stimulation
Intervention type(s): Device; Device
Intervention description(s): oscillating direct current brain stimulation; sham Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: young healthy subjects; brain stimulation; tSOS; tDCS; sleep; daytime sleep; nap; memory; memory consolidation
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison
      to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent
      flares of acute gouty arthritis.
    


Intervention name(s): Canakinumab pre-filled syringe; Canakinumab lyophilized powder; Triamcinolone Acetonide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Canakinumab pre-filled syringe; Canakinumab lyophilized powder; Triamcinolone Acetonide; Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid
Single Dose Pharmacokinetics of Egalet® Hydrocodone
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®
      hydrocodone formulations and compare to a marketed hydrocodone drug.
    

Detailed description: 
      Outcomes:

      Pharmacokinetic parameters and bioequivalence testing.
    

Intervention name(s): hydrocodone; hydrocodone & acetaminophen combination
Intervention type(s): Drug; Drug
Intervention description(s): Extended Release tablet; Immediate Release tablet, hydrocodone and acetaminophen combination product
Intervention MeSH terms: Acetaminophen; Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Hydrocodone; Pharmacokinetics; Safety & Tolerability
Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Condition: Birth-weight
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Birth Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to test whether four lifestyle intervention programs (diet alone;
      diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise),
      delivered to women with GDM during 24-26 weeks of gestational age will help women to improve
      their metabolic pattern, and decrease the incidence of adverse maternal and neonatal
      outcomes.
    

Detailed description: 
      Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal
      outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic
      goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose
      and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise
      on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral
      treatment in women with GDM is available.

      The purpose of the study is to test whether four lifestyle intervention programs (diet alone;
      diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise),
      delivered to women with GDM during 24-26 weeks of gestational age will help women to improve
      their metabolic pattern, and decrease the incidence of adverse maternal and neonatal
      outcomes.
    

Intervention name(s): Behavioral therapy; Exercise; Behavioral therapy and exercise
Intervention type(s): Behavioral; Other; Other
Intervention description(s): General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.; The exercise groups will be advised to walk at least 20-minute a day.; General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
Written recommendations for physical activity A brief written guide on behavior change
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gestational diabetes mellitus; fasting glucose; insulin resistance; birth-weight; Glucose values; Insulin concentrations; Cesarean sections
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Condition: Nail Diseases; Nail Abnormality
MeSH terms: Nail Diseases; Nails, Malformed
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone
      for nail-procedure associated pain management. The investigators hypothesize that ropivacaine
      with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for
      managing pain.
    


Intervention name(s): Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Acetaminophen 1000mg; Ibuprofen 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg/325 mg tablet; 1000 mg tablet; 400 mg tablet
Other intervention name(s): Vicodin; Norco; Lortab; Tylenol; Advil; Motrin
Intervention MeSH terms: Acetaminophen; Ibuprofen; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nail diseases; nail biopsy; nail procedure; pain management
Change Your Life With Seven Sheets of Paper
Condition: Postnatal Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to deliver CBT based intervention called "Change your life with 7
      Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained
      traditional birth attendants (TBAs). Participants will be recruited from low income area in
      Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers
      having children between birth till 12 months. Group intervention will be delivered through
      trained TBAs.
    

Detailed description: 
      The prevalence rate of PND in Pakistani women and its effect on the growth and development of
      young children and child mortality is very high. Despite availability of interventions to
      improve maternal health, the major issue in implementation of those interventions is because
      of limited availability of trained health professionals . Therefore the aim of this study is
      to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called
      "Changing your life with seven sheets of paper". Participants will be recruited from low
      income area in Karachi. Total 36 participants will be recruited and randomized into 2 groups;
      intervention and Treatment As Usual (TAU) group. Total 8 sessions will be delivered by
      trained TBAs over the period of 3 months.
    

Intervention name(s): CBT
Intervention type(s): Other
Intervention description(s): 8 sessions of CBT based intervention called "change your life with seven sheets of paper by Prof. Chris Williams. These sheets cover key skills of CBT that are;
Five Areas vicious circle
Bad thought spotter
Amazing Bad thought Busting Programme (ABTPB)
Easy 4 Step plan
Things you do that mess you up/Confidence sheet
Happy List/ Things you do that boost how you feel sheet
Planner and Review sheets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: postnatal depression; Cognitive behaviour Therapy; Traditional Birth Attendants; low income country