bioihbjkbjnl/mcl2 huggingface dataset:
mHealth Intervention to Promote Cancer Survivors' Physical Activity
Condition: Physical Activity; Quality of Life
Study type: Interventional

Summary: 
      The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit
      Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit
      mHealth app. The target population will be childhood cancer survivors 14-18 years old
      recruited from Seattle Children's Hospital. For the intervention group, peer influences will
      be engaged via a private, social network (e.g. a Facebook group) customized for survivors.
      Measurements will be completed (1) at baseline, prior to randomization, and (2) during the
      final week of the intervention period (follow-up measure). This study will provide initial
      proof of concept and allow for further customization of the intervention for childhood cancer
      survivors in anticipation of a future, larger proposal to study physical activity and related
      outcomes over a multi-year period.
    


Intervention name(s): Fitbit; Facebook group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will use the FitBit device to track their physical activity; Participants will receive and post messages and receive badges on the Facebook group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Yoga in Treating Sleep Disturbance in Cancer Survivors
Condition: Fatigue; Cancer; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

      PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in
      cancer survivors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors
           experiencing persistent sleep disturbance.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender
      and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs >
      5). Patients are randomized to 1 of 2 arms.

        -  Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga
           intervention immediately after study completion.

        -  Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of
           Hatha yoga per week for 4 weeks.

      PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
    

Intervention name(s): Standard Care Control Condition; Yoga Intervention (YOCAS)
Intervention type(s): Procedure; Procedure
Intervention description(s): Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.; The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cancer-related sleep disturbance; fatigue; sleep disorders
A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,
      placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of
      ketamine sublingual wafer in adult subjects who experience post operative pain after
      undergoing third molar extraction.
    


Intervention name(s): Placebo; ketamine 25 mg; ketamine 35 mg; ketamine 50 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): placebo; ketamine; ketamine; ketamine
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the immunogenicity and safety of one or two doses
      of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two
      different processes, in adults aged 18 to 60 years.
    


Intervention name(s): GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One intramuscular injection of initial process-manufactured GSK2340272A vaccine; Two intramuscular injections of initial process-manufactured GSK2340272A vaccine; One intramuscular injection of new process-manufactured GSK2340272A vaccine; Two intramuscular injections of new process-manufactured GSK2340272A vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A
Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
Condition: Primary Osteoarthritis of Hip Nos; Secondary Osteoarthritis of Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis
      were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden.
      The patients were randomized to either CFP or Corail stem, both groups received Delta cup
      from Lima. Randomisation was done using envelopes. Patients could only participate with one
      hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.
    

Detailed description: 
      The concept of femoral neck preserving hip replacement is intended for the young and active
      patients. By preserving proximal bone load, the transmission to the proximal femur is
      supposed to improve and future revision surgery would be facilitated. The hypothesis is that
      a more conservative resection of the femoral neck could lead to better clinical outcomes
      compared to a conventional stem. The clinical outcomes and the fixation of a short femoral
      stem were therefore compared with a stem of standard length. 83 patients were included in our
      randomized controlled trial where patients either received a Collum Femoris Preserving (CFP)
      stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are
      studied and the early migration is being measured using radiostereometric analysis. All of
      the patients have gone through 1 year follow-up. The 2 years results will be available at the
      end of 2017.
    

Intervention name(s): Total hip replacement (2 different designs)
Intervention type(s): Device
Intervention description(s): Patients will randomly receive either CFP or Corail stem
Other intervention name(s): CFP stem or Corail stem
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: short stem
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Condition: Autoimmune Disorder; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Primary Sjögren's Syndrome
MeSH terms: Arthritis; Arthritis, Rheumatoid; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Autoimmune Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of treatment with
      branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or
      Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept
      treatment in study participants with active Rheumatoid Arthritis (RA).
    


Intervention name(s): branebrutinib; abatacept; branebrutinib placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Abatacept; Branebrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
iCBT for Adolescents With Co-morbid Insomnia
Condition: Dyssomnias
MeSH terms: Dyssomnias
Study type: Interventional

Summary: 
      Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It
      is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment
      of insomnia has been extensively examined in adults, but studies with adolescents are sparse.
      The purpose of this pilot study is to assess the feasibility and efficacy of internet-based
      cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth
      Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome
      will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly
      assessments will also be made during treatment on primary outcome and a presumed process
      variable constructed for the purpose of this trial.
    


Intervention name(s): Internet-based Cognitive Behaviour Therapy (iCBT)
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; Internet based
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising
      intervention methods to improve motor function in individuals with severe spinal cord injury.
      In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve
      spasticity and residual motor control in the same subject population. The present study
      explores whether single sessions of noninvasive SCS would improve walking performance and
      ameliorate spasticity in individuals with multiple sclerosis.
    


Intervention name(s): transcutaneous spinal cord stimulation
Intervention type(s): Device
Intervention description(s): electrical stimulation of the lumbosacral spinal cord through surface electrodes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromodulation; spinal cord stimulation; walking function; spasticity
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety and tolerability of EA1080
      following single and multiple ascending oral doses in healthy Caucasian and Japanese male
      participants.
    

Detailed description: 
      The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe
      and well-tolerated dose in healthy Caucasian and Japanese male participants. The study
      consists of 2 parts as mentioned below:

      Part A: This part of the study is fully adaptive and will be performed in three sub-parts as
      follows:

        -  Single ascending dose (SAD)

        -  Food Effect (FE) and optional bioavailability

        -  Multiple ascending dose (MAD)

      Part B: This part of study is comprised of four sub-parts to assess Formulation E and
      Formulation F as follows:

        -  SAD

        -  An additional FE period in SAD cohorts (SAD-FE)

        -  Food Effect and bioavailability (FE/BA)

        -  MAD
    

Intervention name(s): EA1080; EA1080; EA1080; EA1080; EA1080-matching placebo; EA1080; EA1080
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): EA1080 Formulation A.; EA1080 Formulation B.; EA1080 Formulation C.; EA1080 Formulation D.; EA1080-matching placebo.; EA1080 Formulation E.; EA1080 Formulation F.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: EA1080; Pharmacokinetics; Food effect study; Pharmacodynamics
Chinese Medicine Therapy on Menopausal Symptoms
Condition: Menopause
Study type: Interventional

Summary: 
      The objective of this study is to evaluate whether a Chinese medicine formula (Erxian
      Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile
      and bone turn-over.
    

Detailed description: 
      This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a
      Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms.
      This study will be conducted in Queen Mary Hospital and Chinese Medicine Clinic cum Training
      and Research Centers of the University of Hong Kong (Sassoon Road and Central). Women will be
      recruited from the general population by advertisements and promotion through media
      coverage.108 Chinese women with menopausal symptoms will be recruited and randomized into two
      groups.One is treatment group with 12 weeks of Erxian Decoction (well-controlled granules),
      the other is controlled group with 12 weeks of placebo. The treatment outcome measures
      include: 1) the severity of menopausal symptoms: self-recording of daily frequency of
      vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life
      (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). 2)biochemical indices:serum
      follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol, progesterone levels.
      3)safety indices: blood count,liver and renal function tests. All measures are conducted at
      baseline and endpoint except the self-recoding of vasomotor symptoms and MENQOL
      Questionnaire, MRS. We expect this research will provide an effective and low-cost therapy
      for menopausal symptoms.
    

Intervention name(s): EXD
Intervention type(s): Drug
Intervention description(s): Interventions: Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day and placebo therapy of 15g granules with similar colour and taste.
Other intervention name(s): Er-xian Decoction (Prod. Code:3PP3082-3083)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hot flushes; night sweats; menopausal symptoms; osteoporosis; complementary and alternative medicine
Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans
Condition: Hunger
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to observe whether different doses of pancreatic polypeptide infusions
      influence gastric accommodation (measured as intragastric pressure changes during a liquid
      meal infusion), gastric emptying and food intake.
    

Detailed description: 
      As pancreatic polypeptide (PP) influences food behavior in humans, our research group
      suggests a role via the the gastric accommodation or gastric emptying. Twelve healthy
      volunteers participated in this single blind, placebo-controlled, crossover trial. An
      infusion catheter and a manometry probe were positioned in the stomach. After a 15 min
      stabilization period, saline (placebo), PP 3 pmol/kg*min or PP 10 pmol/kg*min were
      intravenously infused. Thirty min after the condition, an intragastric nutrient drink (ND)
      infusion (60 ml/min) started until the volunteer felt maximal satiated. GE was evaluated
      using the 13C breath test during the 6 hours following the ND infusion. Satiation and hunger
      were scored on a visual analog scale every 5 minutes.
    

Intervention name(s): 3 pmol/kg*min pancreatic polypeptide; 10 pmol/kg*min pancreatic polypeptide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PP 3 pmol/kg*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.; PP 10 pmol/kg*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.; Placebo (saline solution) was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. The placebo consists of a 0.9 % saline solution containing 5 % albumin.
Other intervention name(s): Pancreatic polypeptide; Pancreatic polypeptide
Intervention MeSH terms: Pancreatic Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: gastric accommodation; gastric emptying; hunger; satiety; nutrient tolerance
Improving the Nutrition Status of Infants in South-Western Uganda
Condition: Infant Malnutrition; Nutrition Knowledge; Growth; Cognitive Development
MeSH terms: Malnutrition; Infant Nutrition Disorders
Study type: Interventional

Summary: 
      Undernutrition and growth restriction due to poor diet and inadequate nutrient intake
      continues to be a global challenge, particularly in the developing countries including
      Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources
      or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect
      brain and cognitive development.

      This study aims to evaluate nutrient intake, growth and cognitive function among children
      between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western
      Uganda. The investigators hypothesize that nutrition education to mothers can bring about
      improved dietary intake and nutritional status among children aged 6-36 months.

      A follow-up study is planned for the period January 2019 - December 2022.
    


Intervention name(s): Improving nutrition knowledge among mothers
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Child Nutrition Sciences; Growth and Development; Developing Countries
the Correlation Between Non-invasive Indicators in Patients With Biliary Atresia
Condition: to Find Out Non-invasive Indices to Predict the Status of Hepatic Fibrosis in BA Patients.
MeSH terms: Biliary Atresia
Study type: Observational

Summary: 
      we propose this study and try to find out possible clinical applicable non-invasive imaging
      indices or its combination with the laboratory indices to predict the status of hepatic
      fibrosis in BA patients.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        biliary atresia
Comparison of Left and Right Transradial Approach for CAG and PCI
Condition: Coronary Artery Disease; Stable Angina; Unstable Angina; Non-ST Elevation Myocardial Infarction; ST-segment Elevation Myocardial Infarction; Ischemic Heart Disease Without Angina
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Angina Pectoris; Angina, Stable; ST Elevation Myocardial Infarction; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This trial will compare the procedural success rate between right and left radial approach in
      patients undergoing coronary angiography and coronary intervention.
    

Detailed description: 
      The three operators who are proficient in the left radial approach for coronary angiography
      and coronary intervention will be assigned to the right radial approach for 3 months (phase
      1). After then, these three operators will switch approach site to the left radial for
      another 3 months (phase 2).

      Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will
      be compared between right radial approach (phase 1) group and left radial approach (phase 2).
    

Intervention name(s): Radial approach
Intervention type(s): Procedure
Intervention description(s): Approach site for coronary angiography and coronary intervention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 1~3 months: Right radial approach 4~6 months: Left radial approach
Masking: None (Open Label)
Primary purpose: Other
Keywords: Access site; Transradial access; Coronary artery disease; Learning curve