bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and preliminary immune response to recombinant adenoviral
      serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
    

Detailed description: 
      One of the more promising approaches in the development of a preventive HIV vaccine uses a
      DNA plasmid to prime the immune response to an adenoviral vector boost. This primary purpose
      of this study is to evaluate the safety, tolerability, and immune response to recombinant
      adenoviral serotype 35 (rAd35) and serotype 5 (rAD5) HIV-1 vaccines in Ad-5 naive and Ad-5
      exposed HIV-uninfected adults.

      This study will last approximately 12 months. Participants will include those who are both
      rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will
      consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3
      will be rAD5-naive. Participants in Group 4 will be rAD5-exposed.

      Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry
      and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through
      Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo
      at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or
      placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire,
      and counseling will occur at all visits. Blood and urine collection will occur at most
      visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur
      at all visits.

      Participants will be contacted for safety follow-ups after the injection every year for 5
      years. Health and adverse events will be recorded. Participants will not need to return to
      the study clinic unless HIV confirmatory testing is needed.
    

Intervention name(s): DNA Vaccine; DNA Vaccine placebo; rAd35; rAd35 placebo; rAd5; rAd5 placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4 mg VRC-HIVDNA044-00-VP administered as 1 mL; 1 mL VRC-PBSPLA043-00-VP; VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL; 1 mL VRC-PBSPLA043-00-0VP; 4 mg VRC-HIVADV038-00-VP administered as 1 mL; 1 mL VRC-DILUENT013-DIL-VP
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; Adenovirus
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
Condition: HIV Infection; Infection, Human Immunodeficiency Virus
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a two-part study. Part one is designed to see how different formulations of
      GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in
      the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in
      the body.
    


Intervention name(s): GSK364735 oral solution and oral tablets
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; repeat dose; pharmacokinetics; bioavailability; single-dose; food effect
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
Condition: Female Sexual Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on
      acute sexual arousal and sexual interest in post menopausal females, as well as examining the
      safety and toleration of the drug.
    


Intervention name(s): PF-00446687; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single 200mg dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cold Stress Stimulate the Browing of Subcutaneous White Adipose in Healthy Adults
Condition: Obesity; Type 2 Diabetes
Study type: Interventional

Summary: 
      Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),
      play an essential role in regulating whole-body energy homeostasis. Recent studies also
      reveal the presence of a subset of cells in WAT that could be induced by environmental or
      hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been
      suggested to have strong antiobesity and antidiabetic benefits. More recently, same studies
      showed that cold stress stimulate the browning of subcutaneous white adipose. However, to the
      investigators knowledge, there are no direct data that clearly show that cold stress can
      promote the browning of subcutaneous white adipose.
    

Detailed description: 
      Individuals have cold exposure at 15C for 2 hr everyday for one week.Biopsy for subcutaneous
      white adipose was performed before and after one week cold exposure programme under local
      anesthesia. Measure the brown fat characteristics of biopsy samples. The expression levels of
      uncoupling protein-1 (UCP-1), peroxisome proliferator-activated receptor (PPAR)-r, peroxisome
      proliferator-activated receptor r coactivator 1 a (PGC1a) , growth factor receptor binding
      protein-10 (Grb10), PR domain containing 16 (PRDM16) will be determined before and after cold
      stress programme from the biopsy samples. In addition, a combination of PET and computed
      tomography (CT) - with the glucose analogue 18F-fluorodeoxyglucose (18F-FDG) as a tracer will
      be performed for brown adipose tissue before and after cold stress programme.
    

Intervention name(s): cold stress
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Brown adipose tissue; Subcutaneous white adipose tissue; White adipose tissue
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
Condition: Coronary Disease Undergoing CABG
MeSH terms: Coronary Disease; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Opioids provide greater patient comfort during intubation, but are not able to abolish
      completely the release adrenergic hormones during the laryngoscopy, which may cause
      undesirable hemodynamic changes.

      In this study the investigators selected two techniques commonly used for intubation,
      laryngoscopy and track light, so the investigators can verify which intubation techniques
      provides less hemodynamic changes in coronary patients under standard anesthesia induction.
    


Intervention name(s): laryngoscopy; track light
Intervention type(s): Procedure; Procedure
Intervention description(s): tracheal intubation with two different techniques, track light and laryngoscopy.
Other intervention name(s): rigidy laryngoscopy,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intubation; coronary disease; hemodynamic response; anesthesia with tracheal intubation; assessment of hemodynamic response
Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
Condition: TBI (Traumatic Brain Injury)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a pilot trial investigating cognitive training in
      older Veterans with a history of traumatic brain injury (TBI) to assess training effects,
      acceptability of training to participants, and to explore whether other factors influence
      training effects.
    

Detailed description: 
      A study of older Veterans (60-85 years old) who have 1) a history of repetitive mild TBI or
      at least one moderate TBI and 2) subjective cognitive complaints. Participants will be
      randomized to one of three conditions for 4 weeks: Project:Evolution (EVO) multitask video
      game, EVO words video game, or an assessment only control condition. Participants will
      complete assessment visits at baseline, post-intervention (1 month after baseline), and 3
      months post-intervention (4 months after baseline).
    

Intervention name(s): EVO multitask video game; EVO words video game
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will play a multitasking game for 4 weeks; Participants will play a word puzzle game for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: traumatic brain injury (TBI); aging; cognitive training; Cognitive Aging
Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of
      adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese
      subjects with Crohn's disease.
    


Intervention name(s): Adalimumab; Placebo for adalimumab
Intervention type(s): Biological; Biological
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection.; Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease; Pharmacokinetics
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using
      as the primary endpoint the change in body weight following 5-day intravenous administration
      of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF
      patients with volume overload despite having received diuretics other than vasopressin
      antagonists
    


Intervention name(s): OPC-61815; Tolvaptan Tab 15 MG
Intervention type(s): Drug; Drug
Intervention description(s): Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg; Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
Condition: Protective Lung Ventilation Using:; Low Tidal Volume (6-8 mL/kg Predicted Body Weight); PEEP of 6-8 cmH2O; Intraoperative RMs
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the influence of a lung protective ventilation with
      conventional ventilation on postoperative complications following major abdominal surgery.
    

Detailed description: 
      Postoperative complications are associated with a significant and quantifiable rate of both
      morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal
      surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary
      and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative
      respiratory failure which may require respiratory support.

      Recent data from both experimental and clinical studies suggested that, compared with
      conventional ventilation using high tidal volume (TV) without positive end-expiratory
      pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and
      recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation
      promotes sustained cytokine production and could therefore contribute to development of lung
      injury with in patients with normal lungs. Conversely, lung protective ventilation was found
      to reduce pulmonary and systemic inflammation.

      The primary objective is to compare a lung protective ventilation with conventional
      ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional
      ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective
      lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.

      Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and
      extra-pulmonary complications compared with conventional ventilation.
    

Intervention name(s): Abdominal surgery
Intervention type(s): Other
Intervention description(s): to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mechanical ventilation; Postoperative pulmonary complications; Positive end-expiratory pressure; Protective lung ventilation; Alveolar recruitment maneuver; General anesthesia; Abdominal surgery
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and
      pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion
      in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2
      subjects will receive VNRX-5133 for 7 days.
    


Intervention name(s): VNRX-5133; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Pharmacokinetics
Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)
Condition: NHL; DLBCL; Non-hodgkin's Lymphoma; Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 platform protocol designed to evaluate various targeted agents for the
      treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).
    

Detailed description: 
      This is a Phase 1 platform protocol designed to evaluate various targeted agents for the
      treatment of relapsed/refractory aggressive Non-Hodgkin's lymphoma (NHL). Each study arm will
      be conducted in a predefined disease subset. All study arms are open label and allocation to
      each study arm will not be randomized.

      As this master platform protocol has multiple study arms, subjects can be screened for
      several study arms at once. Likewise, a subject who ends participation in one study arm may
      be rescreened for participation in another (separate) study arm.

      The primary objective of the study is to evaluate the safety of targeted agents for the
      treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL). This protocol has a
      modular design, with the potential for future treatment arms to be added via protocol
      amendment.
    

Intervention name(s): AZD9150; Acalabrutinib; AZD6738; Hu5F9-G4; Rituximab; AZD5153
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): AZD9150 will be administered as a 1-hour intravenous (IV) infusion on Days 1, 3, 5 of Cycle 1, followed by weekly infusions (starting Day 8 of Cycle 1 and beyond).; Acalabrutinib will be administered orally twice daily (bid).; AZD6738 will be administered orally twice daily (bid).; HU5F9-G4 infusions will be given on Weekly (Day 1, 8, 15, and 22) during the first two 28-day cycles, then will be given every two weeks (Day 1 and Day 15) in Cycle 3 and beyond.; Rituximab infusions will be given Weekly starting on Day 8 (Day 8, 15, and 22) during the first 28-day cycle (4 weeks), then Day 1 of each 4 week cycle for Cycles 2-6. Starting with Cycle 8, Rituximab will be infused on Day 1 of every other cycle (every 8 weeks).; AZD5153 will be administered orally once per day (qd).
Other intervention name(s): STAT3 inhibitor; CALQUENCE®; ACP-196; ATR inhibitor; anti-CD47 antibody; RITUXAN®; BRD4 inhibitor
Intervention MeSH terms: Rituximab; Magrolimab; Acalabrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acalabrutinib; CALQUENCE®; ACP-196; Platform study; Master protocol; PRISM; Hu-5F9; Rituximab; ATR; STAT3; Anti-CD47; BRD4
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate quality of life in patients after 10 days pause of thyroid medication
      (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine
      uptake and treatment in a double-blinded, randomised cross-over design.
    

Detailed description: 
      Patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in
      oncological department . The patients after thyroidectomy will be treated with Liothyronine
      and this treatment will be paused 10 days before radioiodine. As a routine these patients
      will be re-evaluated with iodine uptake 4 months later.

      The patients will be randomised to either T3 pause related to the first radioiodine treatment
      and Thyrogen injection (recombinant TSH) related to the second treatment/uptake - or Thyrogen
      related to the first treatment and T3 pause related to the second treatment /uptake.

      All medication given in the 10 days period right before radioiodine treatment/uptake will be
      delivered to the patients and marked with a protocol number. In the period with T3 pause the
      patients will be given placebo tablets and an injection of saline (instead of Thyrogen)
      before treatment/uptake at the similar time as given the Thyrogen injection. A nurse
      otherwise not involved in the study will give the injection.

      Patients will be evaluated by VAS, SF-36, and Eortc QLC30 (version 2.0) before radioiodine
      treatment and 3 weeks after treatment.
    

Intervention name(s): rhTSH
Intervention type(s): Drug
Intervention description(s): The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
Other intervention name(s): Thyrogen - GEnzyme
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: quality of life
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD
      in postmenopausal Asian women.
    


Intervention name(s): lasofoxifene; Placebo; Lasofoxifene; Lasofoxifene
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.05 mg tablets; 0 mg; 0.25 mg tablets; 0.5 mg tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This single centre, open-label, non-randomised, single period, single-dose study in healthy
      male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite
      profile and metabolite identification of SJP-0008.
    


Intervention name(s): [14C]SJP-0008
Intervention type(s): Drug
Intervention description(s): Single oral dose of [14C]SJP-0008
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass Balance Recovery; Metabolite Profile; Metabolite Identification
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Condition: Autism; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system)
      for the treatment of attention and behavioral symptoms in children with Autism Spectrum
      Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total
      of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism
      spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal
      route of administration in this population will also be assessed.

      The researchers hypothesize that Daytrana is a safe and effective medication for children
      with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and
      impulsivity.
    

Detailed description: 
      The design will be an open-label trial of eight weeks duration with 20 children with Autism
      co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will
      be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is
      complete. After each week of treatment, response will be reassessed and the dose will be
      increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which
      case, the dose will be reduced to the previous dose or the patch wear time may be revised.
    

Intervention name(s): Methylphenidate Transdermal System
Intervention type(s): Drug
Intervention description(s): 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
Other intervention name(s): Daytrana, MethylPatch, MTS
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; ADHD