bioihbjkbjnl/mcl2 huggingface dataset:
Improving Quality of Life in Men and Women With Overweight or Obesity
Condition: Obesity; Overweight and Obesity; Quality of Life; Health Behavior
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of the Noom Healthy Weight Program, a
      digital behavior change weight loss intervention, on quality of life as measured both by
      self-report and objective measures, compared to a waitlist control condition.
    


Intervention name(s): Noom Healthy Weight
Intervention type(s): Behavioral
Intervention description(s): Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach. Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study will be to evaluate the effect of FES on stimulation of the anterior
      tibial group by using the WalkAide foot drop stimulator on improving walking and balance
      abilities in children with hemiplegic CP.
    

Detailed description: 
      The aim of this study will be to evaluate the effect of FES on improving walking and balance
      abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned
      randomly into two groups (A & B). Control group (A) will receive conventional rehabilitation
      program for lower limb, balance and gait training. Study group (B) will receive conventional
      rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop
      stimulator. Patients' evaluation will be carried out before and after training to assess
      walking ability and balance performance.
    

Intervention name(s): Traditional Treatment
Intervention type(s): Other
Intervention description(s): conventional rehabilitation program for lower limb, balance and gait training
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton
Condition: Obesity, Morbid; Gastric Bypass
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Obesity is a chronic illness of staggering proportions. Because weight loss through diet and
      exercise is difficult to attain and maintain, there has been escalating interest in bariatric
      surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term
      weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality.
      Emerging evidence suggests, however, that gastric bypass may have negative effects on bone
      health. Because of the serious consequences of osteoporosis and fracture, this is of great
      concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton
      may positively impact the clinical care of gastric bypass patients by their surgeons, primary
      care providers, and endocrinologists. Further, the knowledge gained may inform future
      investigation into the relationships between obesity, weight loss, and bone biology.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women 25 to 70 years old scheduled to undergo gastric bypass surgery
      
Biospecimen description: 
      serum, urine
    
Keywords: Obesity, Morbid; Bariatric Surgery; Gastric Bypass; Calcium Metabolism Disorders; Vitamin D; Bone Density; Body Composition; Weight Loss
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients
Condition: Epidural/Anesthesia
Study type: Interventional

Summary: 
      Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural
      analgesia/anesthesia for childbirth will have epidural catheter placement per our standard
      procedure, which includes using the gravity flow technique to confirm that the tip (aperture)
      of the epidural needle is indeed located within the epidural space. The study procedure will
      be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the
      lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia
      to cold will be taken a sign of successful lumbar epidural block.
    

Detailed description: 
      The purpose of this study is to quantify the reliability of the gravity flow technique to
      accurately validate the position of the epidural needle tip when performing lumbar epidural
      analgesia/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI
      greater than 30 kg/m2.
    

Intervention name(s): Cold Stimulus (Ice)
Intervention type(s): Other
Intervention description(s): The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: epidural
Study of GSK3511294 in Healthy Chinese Participants
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability
      and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese
      healthy participants
    


Intervention name(s): GSK3511294
Intervention type(s): Biological
Intervention description(s): GSK3511294 will be administered.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single dose study; Immunogenicity; GSK3511294; Chinese healthy participants
Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations
      (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF
      IIb
    


Intervention name(s): BI 1356 - Tablet TFII; BI 1356 - Tablet iFF; BI 1356 - Tablet TFIIb
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia
      who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test.
      This study has 3 phases. The first phase is the vaccination phase, where patients are
      vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second
      phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12
      week period approximately 8 weeks following the last vaccination. The third phase occurs
      after the 12 week treatment interruption phase and is called the treatment reinstitution
      phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The
      primary objective is to evaluate the safety of the vaccines during the three phases of the
      study. A secondary objective is to evaluate the immunogenicity of the vaccines during the
      vaccination phase of the study.
    

Detailed description: 
      GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia
      who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test.
      This study has 3 phases. The first phase is the vaccination phase, where patients are
      vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen at weeks 1 and
      9 (JS7 DNA vaccine) and weeks 17 and 25 (MVA62B). Both vaccines express Gag, Pol, and Env.
      The second phase of the study is a treatment interruption phase, whereby ART is interrupted
      for a 12 week period approximately 8 weeks following the last vaccination. The third phase
      occurs after the 12 week treatment interruption phase and is called the treatment
      reinstitution phase, because subjects reinstitute ART and are followed for an additional 24
      weeks. The primary objective is to evaluate the safety of the vaccines during the three
      phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines
      during the vaccination phase of the study.
    

Intervention name(s): JS7 plasmid DNA and MVA62B vaccine
Intervention type(s): Biological
Intervention description(s): JS7 plasmid DNA (3 mg at weeks 1 and 9) and MVA62B vaccine (10(8) TCID(50) at weeks 17 and 25)
Other intervention name(s): pGA2/JS7 and MVA/HIV62B vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapy for HIV Infection; Suppressive ART with no failures; Treatment interruption
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect
Condition: Purpura, Thrombocytopaenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, five-period, balanced crossover study conducted in
      approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects
      receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted,
      PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours
      after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day
      washout between periods, and between the last dose of study drug and the follow-up visit.
      During each treatment period, subjects undergo serial PK sampling over 72 hours for
      measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical
      safety laboratory assessments, and adverse events reporting.
    

Detailed description: 
      This is a randomized, open-label, five-period, balanced crossover study conducted in
      approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects
      receive five eltrombopag treatments: tablet fasted, PfOS fasted, PfOS with a high calcium
      meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal,
      and each treatment is a single 25 mg dose. There is a 10 to 14 day washout between periods,
      and between the last dose of study drug and the follow-up visit. During each treatment
      period, subjects undergo serial PK sampling over 72 hours for measurement of plasma
      eltrombopag concentrations. Safety is assessed by vital signs, clinical safety laboratory
      assessments, and adverse events reporting.
    

Intervention name(s): Eltrombopag; Eltrombopag
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet; 25 mg powder for oral suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy; powder for suspension; tablets; bioavailibility; eltrombopag
Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
Condition: Elasticity Imaging Techniques; Tendinopathy; Rotator Cuff Tendinitis; Musculoskeletal Disease
MeSH terms: Tendinopathy; Musculoskeletal Diseases; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This study aims at testing the discriminative validity of strain elastography in the normal
      and abnormal/pathological Supraspinatus tendon due to tendinopathy
    

Detailed description: 
      The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus
      tendinopathy by MRI and 48 healthy subjects.

      In this study the investigators will compare the outcome of tissue elasticity measured by
      sonoelastography, with MRI and conventional ultrasound.

      Patients will be recruited through different radiology department and healthy volunteers will
      be recruited primarily through advertising in local newspapers and social media.
    

Intervention name(s): Diagnostic
Intervention type(s): Diagnostic Test
Intervention description(s): No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
Intervention model: Single Group Assignment
Intervention model description: A case-control study without intervention
Masking: None (Open Label)
Primary purpose: Diagnostic
The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Although the patients with schizophrenia can be treated with new generation of antipsychotics
      medication, additional approaches are necessary to improve schizophrenics' cognitive
      functions, interpersonal relationships as well as social adjustment. When some of patients
      return to community, they expose to practical pressure that contribute to worsen and relapse
      of disease. That further damages patient's cognitive functions. Integrated Psychological
      Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has
      formed structured treatment gradually on relieving illusion, hallucination as well as
      negative symptoms. This study aims at conducting 12-week structured IPT group therapy. The
      intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community,
      outpatient and inpatient service. The overall treatments are designed to provide 1-2 hours
      weekly group therapy which focuses on relieving illusions, hallucination, and negative
      symptoms. Patients' cognitive functions, ability of emotional adjustment and interpersonal
      relationship would be evaluated in pre-test and post-test to indicate whether the significant
      difference exists. There is a controlled group, in which patients who still receive treatment
      as usual (TAU). The study also compares the evaluation results between IPT group and TAU
      group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.
    


Intervention name(s): Group Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): integrated group psychotherapy, including the interpersonal and cognitive group therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Observational

Summary: 
      The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and
      safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total
      10,000 healthy infants volunteers aged from 6 to 35months old.
    

Detailed description: 
      The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed
      on March 2013 in China. The data from the phase III study suggested that the inactivated EV71
      vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth
      disease caused by EV71 within one-year surveillance period, and had clinically acceptable
      safety and good one-year immune persistence.

      This study is the phase III, open-labelled, follow-up research, in order to evaluate the
      two-year efficacy, safety and immune persistence.
    

Intervention name(s): EV71 vaccine
Intervention type(s): Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Chinese infants aged 6 to 35 months old
      
Biospecimen description: 
      Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after
      the first vaccination.

      Throat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease
      for the detection of PCR assays and the isolation of EV71.
    
Keywords: EV71 vaccine; EV71-associated HFMD; efficacy; safety; immune persistence
Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could
      offer potential advantages over fixed level pressure support, in particular, in patients with
      obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an
      innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency
      while delivering the correct level of ventilation each user requires, whatever their body
      position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the
      initial titration of therapy, while providing long term comfort and assuring therapy
      compliance. However, studies on the physiologic and clinical effects have not yet been
      performed. The aim of our singled-blind randomised multicentre controlled trial is to
      prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the
      AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange,
      symptoms, body composition, level of physical activity and health-related quality of life in
      OHS patients.
    

Detailed description: 
      Efficacy on sleep quality, symptoms, physical activity and quality of life
    

Intervention name(s): BiPAP - A40; BiPAP - ST
Intervention type(s): Device; Device
Intervention description(s): Patients receiving BiPAP AVAPS - AE ventilatory mode at home; Patients receiving BiPAP- ST mode at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
Condition: Nulliparous Women With Prolonged Latent Phase
Study type: Interventional

Summary: 
      The purpose of the study was to compare early induction versus expectant management regarding
      outcome and experience of delivery in nulliparous women with a prolonged latent phase.
    


Intervention name(s): Early induction; Expectant mamagement
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest
      that placing HCG into the uterus prior to embryo transfer can enhance implantation.
    

Detailed description: 
      The study is in pilot phase, uncontrolled. The risks appear to be minimal and there are
      conflicting new reports being announced.

      A small amount of fluid with HCG is injected into the uterus. HCG is a potent signal to the
      uterus for preparation for implantation.

      This is not a funded study. Three published studies suggest the approach is valid; one
      refutes the concept.
    

Intervention name(s): HCG is introduced
Intervention type(s): Drug
Intervention description(s): must have good blastocysts
Other intervention name(s): Improve results of IVF and embryo transfer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF , embryo implantation, HCG
A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
Condition: Total Knee Arthroplasty; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to test for significant differences in functional outcomes
      obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is
      predicted that an increase in postoperative range of motion will be experienced by patients
      treated with the NexGen LPS-Flex knee implant.
    

Detailed description: 
      This study will compare the clinical results of the NexGen LPS femoral component with the
      higher flexion potential of the NexGen LPS-Flex femoral component in all patients with
      degenerative joint disease that require total knee arthroplasty. The primary variable of
      interest is postoperative range of motion achieved with the two devices, which are implanted
      with slightly different surgical techniques in patients who may also be subjected to
      different rehabilitation programs depending on the device they are assigned.
    

Intervention name(s): NexGen LPS-Flex Fixed Bearing Knee; NexGen Legacy Posterior Stabilized Knee
Intervention type(s): Device; Device
Intervention description(s): NexGen LPS-Flex Fixed Bearing femoral component; NexGen Legacy Posterior Stabilized femoral component
Other intervention name(s): LPS-Flex Knee; LPS Knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Osteoarthritis; Knee
Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A controlled, double blinded study to determine the safety and reactogenicity in healthy
      adults of a single dose of a trivalent cell-derived influenza vaccine administered by
      intramuscular injection.
    


Intervention name(s): Seasonal cell-derived influenza vaccine; Placebo Comparator
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL im, single dose; 0.5 mL im, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cell-derived subunit influenza vaccine; Safety; Reactogenicity