bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Condition: Persistent Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      The investigators aimed to assess the ability of a modified version of Behavioral Activation
      for occupational and social improvement to produce change in: 1. social adjustment, 2. work
      functioning, 3. avoidance behavior and 4. behavioral activation.
    

Detailed description: 
      Psychosocial functioning was assessed before and after BA treatment in medication responsive
      depressed individuals who continued to have impaired social functioning. The primary goal was
      to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to
      whether there are benefits from this brief psychotherapy approach in this population. The
      investigators also planned to refine measures and estimate the effect size of any treatment
      response to estimate power and sample size with the goal of completing a future controlled
      study.
    

Intervention name(s): Behavioral Activation for return to work
Intervention type(s): Behavioral
Intervention description(s): See Arm Description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic depression; Dysthymic disorder; Double Depression; Behavioral Activation therapy; Work impairment; Unemployment
Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to establish the methodology of bronchial provocation tests with
      house dust mites in China, and to evaluate its safety and effects on upper and lower airways
      inflammation.
    

Detailed description: 
      After screening,each participant undergo baseline lung function test,airway inflammation
      evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway
      responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

      On the second day,the participant undergo bronchial house dust mites challenge tests.

      On the third day,the participant undergo the lung function test,airway inflammation
      evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness
      tests(methacholine bronchial provocation,nasal histamine provocation).
    

Intervention name(s): house dust mites
Intervention type(s): Other
Intervention description(s): house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: asthma; allergy; bronchial hyperresponsiveness; provocation
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e.,
      infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring
      who has a compatible blood type). To measure the distribution and survival of allogeneic
      lymphocytes in the circulation of HIV-infected patients, and to determine whether their
      infusion results in enhanced immunity. To determine whether enhanced immunity is passively
      transferred or actively induced.

      There is evidence that periodic infusion of allogeneic lymphocytes obtained from the
      peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in
      some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled
      studies are needed to better quantitate the immunologic reconstitution seen with this type of
      therapy.
    

Detailed description: 
      There is evidence that periodic infusion of allogeneic lymphocytes obtained from the
      peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in
      some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled
      studies are needed to better quantitate the immunologic reconstitution seen with this type of
      therapy.

      Lymphocytes obtained by leukapheresis from a healthy, HIV-negative parent, sibling, or adult
      offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8. A small
      portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion, and two
      total body scans will be performed. Patients also undergo two tonsillar biopsies. Patients
      are followed weekly for 16 weeks, then by telephone periodically for 3 years (at 1 year, 2
      years, 2.5 years, and 3 years).
    

Intervention name(s): Allogeneic lymphocyte transfer
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: T-Lymphocytes; Acquired Immunodeficiency Syndrome; Transplantation, Homologous; Immunotherapy, Adoptive
Postural Control in Breast Hypertrophy
Condition: Hypertrophy; Sensation Disorders
MeSH terms: Sensation Disorders; Hypertrophy
Study type: Observational

Summary: 
      Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor
      alterations and impairment in body balance due to postural misalignment. The investigators
      conducted this study to evaluate the postural control with different sensorial information
      condition in women with breast hypertrophy.
    

Detailed description: 
      Up to the moment, changes caused by breast hypertrophy are described based on the alteration
      of body mass distribution leading to an impact of psychological and physical aspects.
      However, the investigators hypothesize that due to alterations in postural alignment,
      sensoriomotor inputs are also impaired and postural or motor control are ultimately
      compromised.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The fourteen women for breast hypertropy group were recruited from the Department of
        Plastic Surgery and Department of Gynecology of Clinical Hospital, Faculty of Medicine,
        University of São Paulo, and the fourteen women of control group (without breast
        hypertrophy)was compound by women dwelling community.
      
Keywords: hypertrophy; breast; postural balance
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled,
      single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody
      Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific
      to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of
      GSK2831781 in humans and will evaluate in two parts the safety, tolerability,
      pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of
      GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette
      Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with plaque
      psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in
      biopsies and clinical response endpoints in these populations, as well as investigate
      systemic biomarkers will provide useful information prior to conducting studies in other
      immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the
      pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from
      Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from
      patients with psoriasis, will be helpful in understanding of the dose response relationship,
      which will be important for designing future studies in immuno-inflammatory diseases,
      including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and
      critical assessments. The subject numbers will be split to approximately 40 healthy subjects
      (Part A) and 27 patients with psoriasis (Part B).
    


Intervention name(s): GSK2831781; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.; Commercial saline solution administered by IV over approximately 2 hours
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tuberculin Purified Protein Derivative; Delayed Type Hypersensitivity; Biopsy; Induration; First time in human; T-cells; LAG-3; safety; GSK2831781; psoriasis
Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether taking the medication memantine reduces
      impairment of memory and attention associated with electroconvulsive therapy.
    

Detailed description: 
      The primary objective of this study is to determine whether the novel NMDA antagonist
      memantine, FDA approved for use in moderate to severe alzheimers dementia, may reduce the
      neurocognitive deficits associated with right unilateral ECT treatments in patients receiving
      ECT for a severe and relatively refractory Major Depressive episode.

      Our hypothesis is that the use of an NMDA antagonist would reduce intracellular calcium
      levels, and glutamatergic stimulation during ECT. This reduction in excitatory stimulation
      during ECT would reduce hippocampal and prefrontal neuronal endangerment and dysfunction,
      thereby reducing cognitive impairment associated with right unilateral ECT treatments. We
      also hypothesize that ACTH and cortisol levels will correlate with neurocognitive impairment
      in placebo treated subjects, but not in the memantine treated individuals.
    

Intervention name(s): memantine; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT; Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
Other intervention name(s): Nameda; Sugar Pill
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
LBH Phase II in Small Cell Lung Cancer (SCLC)
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to
      cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour
      relapse and a very poor life expectancy. Combination chemotherapy based on cisplatin or
      carboplatin and etoposide represents the most widely used regimen. Despite of the high
      response rate, approximately 80% of patients with limited disease and nearly all patients
      with extended disease develop disease relapse or progression. Topotecan is, at present, the
      only approved second line treatment in Europe.

      The search of a new therapeutic agent that could alter the natural history of SCLC would be
      an important goal to be reached. LBH589 (Panobinostat) is a histone deacetylase (HDAC)
      inhibitor available for intravenous and oral administration. LBH589 could be classified as
      PAN-DAC inhibitor targeting both histone and non histone proteins and as such it could be
      suitable for combination with cytotoxics. Three phase I dose escalation studies with both the
      intravenous and the oral formulation of LBH589, examining various dose schedules of
      administration have been conducted in advanced solid tumours and haematological malignancies.

      Single agent activity was observed in phase I in patients with haematological cancer. In
      solid tumours one response (Hormone-refractory Prostatic Cancer) and some prolonged
      stabilizations have been observed with intravenous formulation. Phase II studies are now in
      progress.
    


Intervention name(s): LBH581
Intervention type(s): Drug
Intervention description(s): 25 mg/5 ml solution packaged in 6 ml type I glass vials and given as a 30 minutes infusion at the dose of 20 mg/m2 i.v., on day 1 and 8, every 21 days.
Other intervention name(s): Panobinostat
Intervention MeSH terms: Panobinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LBH581; Panobinostat; Small Cell Lung Carcinoma
Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients
Condition: Gynecological Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and
      vomiting (PONV). However, precise dose-response studies have not been completed, especially
      in patients at high risk for PONV who require combination therapy. This study sought to
      identify the optimal dose of haloperidol that could be combined with dexamethasone without
      adverse effects in high-risk PONV patients receiving intravenous patient-controlled
      anesthesia (IV PCA) after gynecological laparoscopic surgery.
    

Detailed description: 
      Female adults with three established PONV risk factors based on Apfel's score were randomised
      into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given
      intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients
      were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and
      late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and
      adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed
      postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).
    

Intervention name(s): Dexamethasone iv injection; Dexamethasone, haloperidol; Dexamethasone, haloperidol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexamethasone 5mg iv during anesthesia induction; dexamethasone + haloperidol 1mg; Active Comparator: dexamethasone + haloperidol 2mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Haloperidol; Haloperidol decanoate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: non-smoker; female; IV PCA; patient-controlled analgesia
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the safety and efficacy of an increased frequency of octreotide acetate
      injections or an increase in dose in partially responsive acromegalic patients with
      persistently uncontrolled disease.
    


Intervention name(s): Octreotide acetate 30 mg suspension
Intervention type(s): Drug
Intervention description(s): Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.
Other intervention name(s): Sandostatin LAR
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acromegaly; octreotide acetate; partial responder patients
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical study is to determine the appropriate doses of entecavir to use
      in children and adolescents. Safety, tolerability and efficacy will also be studied
    


Intervention name(s): Entecavir
Intervention type(s): Drug
Intervention description(s): Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
Other intervention name(s): Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This is a non-interventional study in children and adolescents (ages 6-17 years) with
      attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in
      glutamatergic signaling and neuronal connectivity. The screening in this study will be
      conducted through a combination of online and site performed activities.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects between the ages of 6 and 17 years, who have been told that they have ADHD, will
        be eligible for screening.
      
Biospecimen description: 
      Saliva
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and
      course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of
      the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with
      wholebody MRI etc.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): sc. inj. Humira 40 mg every other week from week 0 to 52
Intervention MeSH terms: Adalimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease
        activity starting TNF-alpha inhibitor
Safety and Efficacy Study
Condition: Infant Term Birth
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the experimental formula
      supplemented with a prebiotic vs the control formula.
    

Detailed description: 
      Randomized, double-blind, controlled interventional clinical trial design. The purpose of
      this study is to evaluate the safety and efficacy of a new term infant formula supplemented
      with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.
    

Intervention name(s): Experimental Infant Formula; Standard Infant Formula
Intervention type(s): Other; Other
Intervention description(s): Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum; Standard bovine milk-based term infant formula, fed ad libitum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of LY2801653 in Healthy Participants Who Are Not Able to Have Children
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how much of the LY2801653 drug is available in the
      body when given in 2 different formulations with and without a meal to healthy participants
      who are not able to have children. In addition, this study will measure how much of the drug
      gets into the blood stream and how long it takes the body to get rid of it. Information about
      any side effects that may occur will also be collected. The study will last about 27 days.
      Screening is required within 28 days prior to the start of the study.
    


Intervention name(s): LY2801653
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Microdialysis and Pharmacokinetic Study of TR-701
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose
      tissue and skeletal muscle after a single oral dose of 600 mg TR-701
    

Detailed description: 
      This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study
      will be conducted to assess recovery of exogenously administered TR-700 (microbiologically
      active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be
      determined in both soft tissues (via microdialysis) and plasma after a single oral dose of
      600 mg TR-701 (prodrug).
    

Intervention name(s): TR-700 (active moiety); TR-701 (pro-drug)
Intervention type(s): Drug; Drug
Intervention description(s): A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of approximately 2 µg/mL at a flow rate of 1.5 µL/min for 60 minutes for a total maximum dose of 0.36 µg (0.18 µg per probe).; Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701
Intervention MeSH terms: Tedizolid phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Microdialysis; Antibiotic; Healthy subjects