bioihbjkbjnl/mcl2 huggingface dataset:
Therapy to Elevate CD4 Counts in HIV-1 Disease
Condition: HIV Disease
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment
      for patients who have inherited alpha-1-proteinase inhibitor deficiency. Adult patients with
      this condition eventually develop emphysema. Most HIV-1 patients who have low viral load also
      have alpha-1-proteinase inhibitor deficiency. The number of CD4 cells in blood increases when
      alpha-1-proteinase inhibitor increases. Patients will be asked to participate in a pilot
      study to see whether the use of Zemaira® (alpha-1-proteinase inhibitor) can increase blood
      levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.
    

Detailed description: 
      HIV-1 patients will be asked to participate in a pilot study to see whether the use of
      Zemaira increases blood levels of alpha-1-proteinase inhibitor and consequently increase CD4
      counts.

      HIV-1 patients will receive weekly treatment with Zemaira for 8 weeks by intravenous
      infusion. Blood will be collected immediately prior to each infusion. Blood will be collected
      at each visit. Exploratory assessments and not pre-specified outcome measurements will
      include complete blood count, lymphocyte phenotype, HIV-1 viral load, lipid levels, blood
      chemistry, and markers of inflammation from patient medical records. Exploratory and not
      pre-specified outcome measures will include extended lymphocyte phenotype and lymphocyte
      function using residual blood collected.
    

Intervention name(s): alpha-1-Proteinase Inhibitor
Intervention type(s): Biological
Intervention description(s): Alpha-1-Proteinase Inhibitor was delivered I.V. A patient weighing 150 pounds was infused with approximately ½ cup containing 8.4 grams of alpha-1-Proteinase Inhibitor. Patients were admitted to hospital for infusion. The I.V. infusion was approximately 1 teaspoon/minute. Patients received weekly infusions of alpha-1-Proteinase Inhibitor for 8-12 weeks. At the time of infusion, 40ml (3 Tablespoons) of blood was collected (IRB approval #R04-003). The blood sample was used to monitor viral load, CD4 cell numbers, and alpha-1-Proteinase Inhibitor.
Other intervention name(s): Zemaira; Prolastin
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD4 counts; cholesterol
A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN
      (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1
      month to 18 years of age.

      The initiation of this immunotherapy trial will provide multiple benefits by assessing in
      asymptomatic HIV-infected children a therapy currently being tested in their adult
      counterparts, in the hope of forestalling the progression of HIV immunosuppression and
      clinical disease.
    

Detailed description: 
      The initiation of this immunotherapy trial will provide multiple benefits by assessing in
      asymptomatic HIV-infected children a therapy currently being tested in their adult
      counterparts, in the hope of forestalling the progression of HIV immunosuppression and
      clinical disease.

      Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant
      placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When
      three of four patients at the low dose of a vaccine have received two immunizations without
      evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is
      initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of
      six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24
      weeks after the last immunization.
    

Intervention name(s): rgp120/HIV-1MN; rgp120/HIV-1 SF-2; gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological; Biological
Masking: Double
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Therapeutic Vaccine
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for
      the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions
      (IDD) and to obtain preliminary efficacy information.
    

Detailed description: 
      The Biostat Disc Augmentation System is a combination product combining a resorbable biologic
      product with a delivery device system used to prepare and insert the biologic material into a
      lumbar intervertebral disc.

      Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar
      intervertebral disc, which appears as fissures, cracks or tears within the internal
      structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain
      located in the low back (axial pain), but also as somatic referred pain involving the
      posterior hips, buttock, lateral hips, groin, or posterior thighs.

      The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies,
      physical examination, or symptoms alone, and must be established with meticulously conducted
      disc provocation studies (provocation discography) that include pressure manometry, and
      identification of an adjacent normal disc.

      This treatment and study are not designed for patients exhibiting other potential sources of
      chronic low back pain such as more advanced degenerative disc disease with significant loss
      of disc height (> 33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).
    

Intervention name(s): Biostat® Disc Augmentation System
Intervention type(s): Biological
Intervention description(s): Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intervertebral Disk; chronic low back pain; internal disc disruption; degenerative disc disease
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this pilot study is to examine the effects of combined pharmacotherapy
      (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy
      patients.
    

Detailed description: 
      This is a one-arm, open label pilot study of MMT patients to determine whether bupropion,
      nicotine replacement therapy, and behavioral counseling is a feasible and potentially
      effective intervention for smoking cessation. The smoking behaviors of participants will be
      be followed for 6 months post quit-date to determine effect-size estimates for a future,
      large scale trial.
    

Intervention name(s): Combined intervention
Intervention type(s): Other
Intervention description(s): 300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Challenge Study to Assess the Safety, Immunogenicity and Efficacy of a Malaria Vaccine Candidate
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI
      trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine
      RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18
      and 45 years.

      Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR
      CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and at the
      CCVTM, Oxford and Guys and St Thomas' NIHR CRF, London for the Phase IIa stage.
    

Detailed description: 
      This is a descriptive phase I trial to assess the safety and immunogenicity of the RH5.1/AS01
      vaccine in healthy volunteers at different doses, and to establish whether the RH5.1/AS01
      vaccine can demonstrate a reduced parasite multiplication rate in vaccinated subjects
      compared to infectivity controls in a blood-stage controlled human malaria infection model.

      There will be 6 study groups across two phases of the trial, with a total of 66 - 78
      volunteers.

      Vaccination of groups will be sequential from Group 1 to Group 3. Group 3 and 4 can be
      recruited simultaneously. Volunteers will be able to choose which group they are allocated
      to.

      The vaccination dose for Group 5 has been decided following the analysis of safety and
      exploratory immunology assays from Groups 1, 2 and 4. They will undergo blood-stage CHMI 2
      weeks after the final vaccination and will be followed up until approximately 6 months after
      the final vaccination.

      Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.

      Volunteers will be recruited and undergo screening visits, vaccination and clinic visits
      post-vaccination at their local trial site. Procedures will be performed on the visit time
      points indicated in the schedule of attendances.. Additional procedures or laboratory tests
      may be performed, at the discretion of the Investigators.
    

Intervention name(s): RH5.1/ ASO1
Intervention type(s): Biological
Intervention description(s): The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.
The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
Condition: Low Back Pain; Lumbar Disc Disease; Lumbar Disc Herniation; Lumbar Radiculopathy; Physical Therapy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Motorized traction and non-surgical spinal decompression treatments are relatively new
      treatments for which there is insufficient evidence in the literature. In this study
      investigators aimed to retrospectively compare the effectiveness of these treatments, which
      are in the field of their routine practice in their clinic.
    

Detailed description: 
      Low back pain is one of the leading causes of disability worldwide. People with physically
      demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at
      greater risk for low back pain. Anatomical structures that potentially nociceptive
      contributors to low back pain are intervertebral discs, facet joints, and vertebral end
      plates. It has been determined that nonsurgical treatments are clinically effective in
      reducing pain and functional improvement in patients with lumbar disc herniation. However,
      the level of evidence has generally not been highly evaluated, which can be attributed to the
      paucity of well designed randomized controlled trials. Despite moderate evidence, exercise
      and traction are recommended. In this study investigators aimed to retrospectively compare
      the effectiveness of these treatments, which are in the field of their routine practice in
      their clinic.

      01.01.2019-10.11.2022. Investigators planned to examine the records of patients aged 20-75
      years who underwent physical therapy with the diagnosis of lumbar discopathy in AFSU FTR
      Department Physical Therapy Unit. Investigators planned to examine the routine anamnesis
      examination, treatment card and control evaluation records of the patients made in the FTR
      outpatient clinic from the automation system of their hospital.
    

Intervention name(s): Physical Therapy
Intervention type(s): Procedure
Intervention description(s): Therapy methods using physical agents in treatment
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients aged 20-75 who underwent physical therapy with the diagnosis of Lumbar discopathy
        in Afyonkarahisar Health Sciences University, Department of Physical Medicine and
        Rehabilitation Physical Therapy Unit between 01.01.2019-10.11.2022.
Combination Treatment for Augmenting Language in Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will consist of two main elements: the enrollment of 72 children aged 6-11 years
      with ASD and low language competency to receive a thrice-weekly one hour language
      intervention for 12 weeks; and, beginning at the same time, subjects will be equally
      randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or
      placebo for 12 weeks.
    

Detailed description: 
      Following screening for eligibility and baseline, study visits will be scheduled three times
      per week, with 2 sessions on-site at UCLA and one at home for parent training (allowing
      flexibility, as needed); study physician visits will occur once weekly for 6 weeks, then
      biweekly. Screening procedures may be completed in one or two visits, and measures obtained
      in other UCLA clinical or research setting may be used if assessments were done within one
      month of screening. Major outcome assessments will occur at baseline (Week 0), mid-point
      (Week 6), and final week (Week 12) by study personnel blind to visit number and drug group
      assignment; minor assessments will occur weekly along with study physician assessments
      occurring weekly for side effect and compliance checks. EEG will occur at or prior to
      baseline and at Visit 36 (Wk12). Arrangements will be made to transfer participants to
      standard clinical care following visit 36. Six months after visit 36, families will be seen
      for final follow-up assessments of language usage, social communication, overall functioning,
      health and ongoing treatment.
    

Intervention name(s): Behavioral Therapy; Aripiprazole; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.; 50% of the subjects will be randomized to aripiprazole (active study medication); 50% of the subjects will be randomized to placebo (inactive study medication).
Other intervention name(s): language intervention; abilify; inactive study medication
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SER100 in Isolated Systolic Hypertension
Condition: Isolated Systolic Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Study type: Interventional
Phase: Phase 2

Summary: 
      Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people.
      Much attention has recently been drawn to the strong relationship between the systolic blood
      pressure and cardiovascular morbidity.

      In previous clinical studies carried out in individuals with normal blood pressure at
      baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the
      effect on systolic blood pressure in hypertensive patients will be larger or equal to the
      fall seen in normotensive patients.
    


Intervention name(s): SER100; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
Condition: Mild Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway
      pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study
      is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness,
      cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic
      cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea
      -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body
      mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must
      have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three
      groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline
      evaluation, six months, one year and three years, all subjects will be submitted to sleep
      questionnaires, physical examination, ear-nose and throat evaluation, baseline
      polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness
      Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale,
      Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of
      Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality
      of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory,
      metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood
      pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three
      groups. Analysis mean and standard deviation will be used for descriptive statistical and a
      general linear model will be applied for analysis within groups on different time.
    


Intervention name(s): Continuous Positive Airway Pressure (CPAP); Oral Appliance (BRD)
Intervention type(s): Device; Device
Intervention description(s): The device is a flow generator used to open the airway during sleep.; The device increases the volume of the airway by mandibular traction.
Other intervention name(s): Resmed (trademark). Autoset Vantage - fixed pressure.; Brazilian Dental Appliance (BRD).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Continuous positive airway pressure; Oral appliance; mild Obstructive Sleep Apnea Syndrome
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily
           with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or
           without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet
           (RCD) compared with placebo in medically stable and otherwise healthy obese male and
           female subjects

        2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once
           daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54
           weeks on a RCD compared with placebo in medically stable and otherwise healthy obese
           male and female subjects

        3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered
           orally once daily with the morning meal after a 6-week LCD with or without S-2367
           followed by 54 weeks on a RCD in obese male and female subjects

        4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily
           with the morning meal during an initial 6-week LCD compared with placebo in medically
           stable and otherwise healthy obese male and female subjects
    


Intervention name(s): S-2367 Placebo; S-2367 1600 mg q.d. 54 Weeks; S-2367 1600 mg q.d. 60 weeks; LCD (low calorie diet); RCD (reduced calorie diet)
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks; Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks; Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks; A low calorie diet was utilized during the first 6 weeks of the study; A reduced calorie diet was used during the last 54 weeks for the study
Other intervention name(s): Velneperit; Velneperit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity