bioihbjkbjnl/mcl2 huggingface dataset:
Effects of A-GPC on Reaction Time and Cognitive Function
Condition: Cognitive Change; Reaction Time
Study type: Interventional

Summary: 
      This is a randomized, double blind, crossover design study which measures the effect of
      alpha-glycerylphosphorylcholine (A-GPC) on reaction time and cognitive function in
      non-resistance trained males and females. Participants will complete baseline testing and
      then be randomized into one of two crossover treatments. Participants will report to the lab
      for five consecutive days whilst only getting a maximum of five hours of sleep per night from
      Monday through Thursday night. Once testing is complete on Friday, participants will receive
      a one week washout period then return to complete the opposite treatment.
    

Detailed description: 
      Subjects expressing interest in doing the study will be interviewed in the UMHB Human
      Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon
      qualification, participants will be scheduled a familiarization session in which participants
      will be taught how to use the Makoto Arena, a reaction time machine. Participants will then
      schedule their first testing session which will include: questionnaires, hemodynamic
      measures, reaction time testing, cognitive function testing via ImPACT, an acute exercise
      bout, reaction time testing, and cognitive function testing via ImPACT. Participants will
      then be randomized into one of two treatments.

      Supplementation protocol: Participants will be randomly assigned into one of two treatments
      and will be given 4oz of either a placebo or active treatment mixed in orange flavored
      Gatorade everyday for 5 days. On Monday, participants will consume the beverage after testing
      is complete. Tuesday through Friday the beverage will be consumed as the participants arrive
      in the HPL.

      On Mondays and Fridays, testing will be as follows: questionnaires, hemodynamic measures,
      reaction time testing, cognitive function testing via ImPACT, an acute exercise bout,
      reaction time testing, and cognitive function testing via ImPACT. On Tuesdays and Thursdays,
      participants will come check into the HPL for 30 minutes. On Wednesday, participants will
      come into the HPL to complete the acute exercise bout. To control their sleep to the best of
      our ability, participants are required to send emails every 30 minutes beginning at 10pm
      until their designated sleep time so the investigators know the participants are not asleep
      and gaining more than 5 hours of sleep.
    

Intervention name(s): A-GPC; Sugar
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Taken orally in liquid form; Taken orally in liquid form
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two groups: placebo and active
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: A-GPC; focus; non-resistance trained
Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the impact of the combination therapy of linagliptin
      and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and
      metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of
      with type 2 diabetes mellitus.
    


Intervention name(s): metformin placebo; linagliptin placebo; metformin; metformin; linagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): metformin placebo tablets 500mg; linagliptin placebo tablets 5mg; metformin tablets 500mg; metformin tablets 500 mg; linagliptin tablets 5mg
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Baby Care Training Given to Fathers After Birth
Condition: Mothers; Fathers
Study type: Interventional

Summary: 
      The aim of this study is to provide infant care training to fathers and to measure
      father-infant attachment and maternal postpartum depression and quality of life.
    

Detailed description: 
      Objective: The aim of this study is to provide infant care training to fathers and to measure
      father-infant attachment and maternal postpartum depression and quality of life.

      Design: The data for the study were collected using the introductory information form (IIF)
      and the father-infant attachment scale (FIAS) for fathers, Edinburgh Postpartum Depression
      Scale and Postpartum Quality of Life Scale for mothers.

      Participants and setting: A total of 64 fathers and 64 mothers, including 32 in the
      intervention group and 32in the control group who met the inclusion criteria of the study
      were included randomly.
    

Intervention name(s): Training group
Intervention type(s): Other
Intervention description(s): For the experimental group, "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers in the clinic after birth as a pre-test. In the clinic, baby care training was given to fathers practically in 30-35 minutes. After the applied training, the "Baby Care Training Program Content" prepared by the researchers was given to the fathers.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Tailored Drug Titration Using Artificial Intelligence
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP),
      a clinical decision support system for hypertension (HTN) treatment optimization to standard
      of care in patients with essential HTN.
    

Detailed description: 
      Nearly 34 million Americans have their blood pressure (BP) uncontrolled. Hypertension (HTN)
      claims 1000 deaths every day. Despite medication and life-style management, the cost of HTN
      associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital
      costs, with >135 million Emergency Department (ED) visits.

      Uncontrolled HTN for even a few weeks is associated with increased risk for acute
      cardiovascular (CVD) events [stroke, heart failure (HF), myocardial infarction (MI)] and
      death. Medication treatment optimization to BP goal reduces the incidence of stroke by
      35-40%, HF by up to 64%, and MI by 15-25%.

      optima-for-blood pressure [optima4BP] transforms the episodic and reactive nature of
      uncontrolled HTN pharmacological treatment management into a process that is continuous,
      proactive, and personalized. The innovation simulates the established clinical reasoning
      treatment decision process undertaken during a patient's visit.
    

Intervention name(s): optima4BP
Intervention type(s): Other
Intervention description(s): optima4BP establishes a "no gaps" computational framework in determining the most effective treatment change that can optimize a patient's HTN management towards BP Target. All possible drug combination options available through the 16 anti-HTN drug classes and subclasses are quantitatively evaluated in the context of 5 actions: add a drug, remove a drug, replace a drug, increase a drug dose, and decrease a drug dose. The pharmacological intervention efficacy ranking is computed and the highest ranked treatment recommendation is selected for consideration by the treating physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, intervention versus control.
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of
      subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a
      proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty
      treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were
      800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.

      This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the
      dose-response and concentration-response curves. The results from this study will be used to
      select doses for future clinical studies in HIV-1 infected subjects.
    


Intervention name(s): GSK2248761; Lopinavir/ritonavir; HAART; Placebo; GSK2248761
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK2248761 30 mg capsule once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class.; Lopinavir 400 mg and ritonovir 100 mg every 12 hours for 28 days. Lopinavir/ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class. Kaletra is a trademark of Abbott Laboratories.; Highly Active Antiretroviral therapy of the doctor's choice.; Placebo is a capsule with no drug in it.; GSK2248761 10 mg -20 mg or 40 mg - 90 mg once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class.
Other intervention name(s): Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IDX12899; adaptive; monotherapy; pharmacokinetics; Treatment-naive; HIV-1; GSK2248761; NNRTI; HIV Infections; treatment naive
The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Condition: Renal Dialysis; Exercise
Study type: Observational

Summary: 
      Hemodialysis (HD) is the most commonly used renal replacement therapy in patients with
      end-stage renal disease (ESRD). More than 553,000 ESRD patients in China are currently
      receiving HD, but the long-term survival rate is low and the mortality rate is as high as
      18%, which is significantly associated with low physical activity (PA). Low PA could decrease
      cardiopulmonary and muscle function, limit the ability to perform activities of daily living,
      and increase risk of death. The National Kidney Foundation Disease Outcomes Quality
      Initiative (K/DOQI) recommends PA as cornerstone of ESRD rehabilitation. However, HD patients
      still live with inactive lifestyle. The investigators' previous study have demonstrated that
      enhancing PA benefits physical function in HD patients. Therefore, this study intends to
      establish Physical ACtivity Enhancement Scheme (PACES), that is, to take PACES (measured by
      pedometers) as the investigation core and motivate patients to PACES.

      This study will consists of three distinct parts: 1, 2 and 3. In Part 1, the investigators
      will conduct research on the PA of HD patients through pedometer and questionnaire, and
      understand the participants' attitude to PA through a series of questionnaires. In Part 2,
      the investigators will conduct a semi-structured interview to understand HD patients'
      attitudes and habits towards PA, as well as recommendations for PACES. In Part 3, the
      investigators will take the results of Part 1 and 2 as the initial draft of PACES and modify
      the initial draft through the Delphi method to form the final PACES.

      The study aims to develop PACES from the perspective of patients to address the above
      cognitive factors, making it easier for HD patients to enhance PA.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This investigation intends to investigate the patients in hemodialysis centers of four
        hospitals in Xi 'an, and include all patients who meet the inclusion and exclusion
        criteria.
      
Keywords: hemodialysis; physical activity; barriers; benefits
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to examine the safety and tolerability of ZDV when given to
      premature infants born to HIV-positive women to prevent HIV infection.

      ZDV has been used successfully to prevent the transmission of HIV from mother to child during
      pregnancy and birth. However, ZDV has been given to very few premature babies, and the best
      dose to use has not yet been determined.
    

Detailed description: 
      In the preliminary group of premature infants, those receiving q 6h dosing had an average
      trough concentration of 7.3 uM (18%). However, the premature infants in the preliminary
      pharmacokinetic study did not have long term follow-up to assess toxicity. Due to the
      potential for altered ZDV pharmacokinetics and increased toxicity in this population, an
      evaluation of ZDV pharmacokinetics in premature infants is proposed.

      Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by
      their clinical caregivers will be entered into the protocol within the first 5 days of life.
      Upon entry, ZDV will be administered every 12 hours intravenously or orally. The study will
      require 9 serum samples for ZDV assay collected over 30 days, some additional clinical
      laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection
      of routine clinical data.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zidovudine; Anti-HIV Agents
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Condition: Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at
      the same speeds as non-amputees and this discrepancy is more apparent at faster walking
      speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking
      speed is likely influenced by elevated metabolic energy, but the underlying reason for slower
      preferred walking speeds is not fully understood. Unilateral amputees exhibit highly
      asymmetrical gait patterns that likely require more metabolic energy and impair functional
      mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back
      pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively
      effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to
      reduce metabolic energy would be especially useful for rehabilitation in older, ill
      individuals with reduced exercise capacities and could literally restore walking ability in
      people that are currently non-ambulatory.

      Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered
      Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed,
      and improved gait symmetry during walking than amputees wearing a conventional prosthesis and
      will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during
      walking as age, gender, height, and weight matched non-amputees.
    


Intervention name(s): Powered ankle-foot prosthesis; No device
Intervention type(s): Device; Other
Intervention description(s): The powered ankle-foot prosthesis is comprised of a series-elastic actuator (SEA) and an elastic leaf spring. This technology has been previously developed for robotic and human rehabilitation applications. The SEA allows for precise force control of the ankle joint, thus mimicking the spring-like behavior of the human ankle, as well as providing adequate energy for forward progression of the body. From the early stance period to the mid-stance period of walking, the SEA will be controlled so that the ankle joint behaves like a spring. During the late stance period, the SEA will be employed to power the forward movement of the body. The elastic leaf spring will provide shock absorption during foot strike, energy storage during early stance, and energy return during late stance.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Unilateral below the knee amputation
Effects of Complementary Therapies Delivered Via Mobile Technologies
Condition: Acute Pain; Anxiety; Self Efficacy
MeSH terms: Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of complementary therapies delivered
      via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and
      self-efficacy in healing reports before, following, and at 10-day follow-up.
    

Detailed description: 
      Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may
      result in increased perceptions of pain and lower self-efficacy in healing. Complementary
      therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have
      been shown to benefit patients undergoing surgery. The aim of this study was to examine the
      effects of audio relaxation technique (ART), music intervention (MI), nature video
      application with music (NVAM), and nature video application without music (NVA) delivered via
      mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy
      in healing.

      Methods A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to
      an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were
      assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain
      using the numeric rating scale (NRS), and self-efficacy with the general self-efficacy scale
      (GSE) four days prior to surgery, immediately prior and following the surgical intervention,
      and at day five post-operative.
    

Intervention name(s): Audio Relaxation Technique; Medical Music Intervention; Nature Therapy without Music; Nature Therapy with Music
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Audio relaxation technique created by an Icelandic Registered Nurse.; Audio recordings of non-lyrical relaxing music; Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients; Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
Other intervention name(s): Guided Imagery; Music Therapy; Ecotherapy; Ecotherapy with Music
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: complementary medicine; state anxiety; acute pain; self-efficacy; surgery; medical music intervention; nature therapy; relaxation technique
Buprenorphine Combination Tablet Feasibility - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine target dose range of buprenorphine/naloxone
      combination tablet that provides therapeutic response in opiate addicts with low to moderate
      dependence, and to identify appropriate initial induction dose in opiate addicts with low to
      moderate dependence."
    


Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Masking: Double
Primary purpose: Treatment
Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P
      Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and
      parent-mediated behavioral intervention (intervention condition) to improve home dental care,
      oral health outcomes, and dental office visit experiences.
    

Detailed description: 
      Participation in routine dental care is a significant challenge for children with autism
      spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD
      symptoms and associated anxiety and behavioral difficulties. Lack of routine, effective
      dental care has contributed to a substantial unmet healthcare need for children with ASD, who
      are at increased risk for excessive plaque, caries, and oral infections.

      The purpose of this study is to test a parent-training intervention designed to improve home
      dental hygiene, compliance with dental office visits, and oral health outcomes in children
      with autism spectrum disorder. Families of children with an existing diagnosis of ASD will be
      recruited for participation. All families will receive the Autism Intervention Research
      Network on Physical Health (AIR-P) Dental Toolkit, which is designed to provide parents with
      guidance and information about dental care and support strategies for children with ASD. Some
      families will also participate in a 10-week behavioral parent-training intervention focused
      on improving home dental care and dental office visit experiences.
    

Intervention name(s): AIR-P Dental Toolkit; Parent Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The AIR-P Dental Toolkit is designed to provide caregivers with guidance and information related to dental care and support strategies for children with autism spectrum disorder.; The parent-training intervention integrates strategies shown to be efficacious for: 1) improving adherence to dental care, 2) enhancing dental experiences for children with neurotypical development and high levels of dental fear, and 3) evidence-based behavioral techniques established for children with autism spectrum disorder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parent training; Dental care