bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of AGS-004 as an Immunotherapeutic in Antiretroviral Therapy (ART)-Treated Subjects Infected With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication
      and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated,
      to determine if immunotherapy increases the body's immune response to HIV-1; and, to
      determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.
    

Detailed description: 
      Although chronic ART raises cluster of differentiation CD 4+ T cell counts and improves
      immune function, the immune systems' ability to control HIV-1 replication is not improved.
      AGS-004 is an immunotherapeutic agent made from autologous DCs co electroporated with
      amplified in vitro transcribed (IVT) ribonucleic acid (RNA) encoding CD40L and with IVT RNA
      encoding three or four autologous HIV-1 antigens. The HIV-1 RNA is derived from the plasma
      sample taken immediately prior to the initiation of ART.
    

Intervention name(s): AGS-004
Intervention type(s): Biological
Intervention description(s): HIV-1 Immune Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Human immunodeficiency virus; Immunodeficiency Virus, Human; HIV-1; ART; antiretroviral therapy; HAART; highly active retroviral therapy; cluster of differentiation CD 4+ T cell counts; HIV-1 Subjects successfully ART treated; Treatment Experienced
A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise
      and decrease systemic blood pressure in multiple populations, including COPD. The chronic
      effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.
    

Detailed description: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise
      and decrease systemic blood pressure in multiple populations, including COPD. The chronic
      effect of dietary nitrate in OSAS has not been reported.

      The investigators hypothesize that chronic nitrate consumption might increase exercise
      tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of
      life and pulmonary function.

      This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline,
      mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory
      blood pressure will be assessed in conjunction with demographics and blood draw. After
      baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for
      14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and
      endpoint assessments or the converse.
    

Intervention name(s): Dietary nitrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.; 140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Other intervention name(s): Beetroot juice; Nitrate depleted beetroot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered
      with metformin in subjects with type 2 diabetes mellitus.
    

Detailed description: 
      Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus
      therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi
      USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and
      safety profile of S-707106 in preparation for full clinical development as a novel treatment
      for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and
      patients with a new therapeutic option to treat type 2 diabetes mellitus with potential
      advantages over existing therapy.
    

Intervention name(s): S-707106 Dose A; S-707106 Dose B; S-707106 Dose C; Placebo A tablet; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One S-707106 A tablet; One S-707106 B tablet; Four S-707106 4 X B tablets; Up to 4 Placebo A tablets; The standard of care dose of metformin for each patient
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Metformin
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to understand the effectiveness of valproate (a common
      mood stabilizer) to further reduce alcohol misuse when given in addition to attending an
      alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main
      goal of this project is to understand if people receiving valproate will have a better
      recovery than people receiving the standard treatment for alcohol dependence: naltrexone.
    

Detailed description: 
      Veterans are vulnerable to develop complex forms of addictive disorders characterized by the
      presence of traumatic brain injury and psychiatric conditions such as post-traumatic stress
      disorder and mood disturbances. Alcohol use disorders are frequently observed among veterans
      and exert a detrimental effect on community reintegration after deployment. Attending to this
      veteran health problem, the VA is devoting extraordinary efforts to develop adequate
      treatment strategies. In this study we will evaluate treatment outcomes and identify specific
      factors that influence alcohol use disorders treatment response in a VA Intensive Outpatient
      Program offering rehabilitation treatment to the growing number of veterans with alcohol use
      disorders. Cooperation between researchers and clinical staff will allow optimizing treatment
      strategies that enhance the recovery of veterans with alcohol use disorders.
    

Intervention name(s): Valproate; Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day; 25mg per day, taken by mouth for 7 days, then 50mg per day
Other intervention name(s): Depakote ER; Revia
Intervention MeSH terms: Naltrexone; Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Use Disorders; Traumatic Brain Injury; Mood and Anxiety Disorders
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV
Condition: Kwashiorkor; Marasmus; Severe Acute Malnutrition; HIV
MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Observational

Summary: 
      It is unclear whether children with HIV and severe acute malnutrition can be started on
      highly active antiretroviral therapy (HAART) safely while they are still malnourished and the
      manner in which this therapy should start. This study will examine the safety, efficacy, and
      metabolism of children started on HAART while still severely malnourished.
    


Intervention name(s): zidovudine, lamivudine, nevirapine
Intervention type(s): Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Nevirapine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6-59 months with HIV and kwashiorkor and marasmus who are not currently on
        HAART will be recruited from the Nutritional Rehabilitation Unit at Queen Elizabeth Central
        Hospital in Blantyre, Malawi. Controls will be recruited from the outpatient cotrimoxazole
        clinic who are about to start on HAART for a non-nutritional reason.
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Condition: Hematologic Diseases; Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms; Hematologic Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the maximum tolerated dose and evaluate the safety
      of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem
      cell transplant from a related, haploidentical donor, in patients with severe hematologic
      malignancies.
    

Detailed description: 
      Allogeneic stem cell transplantation is the treatment of choice for many patients with
      leukemia and other hematologic malignancies. However, a major limitation of this therapy is
      that for a significant number of patients no fully HLA-matched donor can be found. The
      application of partially HLA-matched (haploidentical) family donors, who are virtually always
      available, has some complications. If there is no T-cell add-back it increases the risk for
      life-threatening infections and disease relapse, while in case of T-cell add-back the risk of
      graft-versus-host disease is raised.

      Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through
      photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of
      functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the
      stem cell transplant. This method enables early immune reconstitution while preventing
      graft-versus-host disease.
    

Intervention name(s): Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
Intervention type(s): Biological
Intervention description(s): Single intravenous infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haploidentical stem cell transplantation; Graft-versus-host disease; Immune reconstitution; Alloreactive T-cells; Photodepletion; TH9402; Transplant related mortality; Hematologic malignancy
Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects
Condition: Neuropsychiatric Disorders
Study type: Interventional

Summary: 
      Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced
      by a language task were significantly lower in a semantic region of the left hemisphere
      (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri
      medium and angular) in schizophrenic patients compared with controls matched for age, sex,
      level of education and handedness.

      Investigators wish to test the hypothesis that functional modification of the hemispherical
      specialization is specific language and also specific for schizophrenia.
    


Intervention name(s): IMRf; language task and a reference task (rest and Tamil)
Intervention type(s): Device; Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether treating sleep difficulties in patients
      with bipolar disorder also improves their mood stability.
    

Detailed description: 
      Patients with euthymic bipolar disorder, although free of significant mood symptoms, often
      have continued sleep disturbances. Improving patients' sleep by also normalizing the
      circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more
      pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon
      for bipolar patients will improve sleep and will cause fewer mood exacerbations.

      Patients with bipolar disorder often experience frequent mood alterations that are attempted
      to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of
      medications have numerous significant side effects. Establishing that ramelteon is helpful in
      the sleep of patients with bipolar disorder and helpful in mood stability will increase the
      number of treatment options for bipolar patients.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one 8 mg tablet at bedtime for up to 6 months; one tablet at bedtime for up to 6 months
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dexmedetomidine vs Fentanyl for BMT
Condition: Otitis
MeSH terms: Otitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an
      α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
    


Intervention name(s): Saline; Fentanyl; Dexmedetomidine; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Normal saline, given intranasally; Fentanyl, nasal transmucosal, 2 micrograms/kilogram; Dexmedetomidine, transmucosal, 1 microgram/kilogram; Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Other intervention name(s): Normal Saline; Actiq, Fentora; Precedex; Precedex
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine, transmucosal, myringotomy,
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to evaluate an investigational auto-injector system for
      delivering sumatriptan under the skin for a single migraine attack.

      The study could take approximately 5 weeks and will include about 3 office visits to the
      study doctor, the patient will be contacted every 2 weeks until the patient experiences a
      migraine and uses the auto-injector. The last visit will be done by a telephone follow-up
      call.
    

Detailed description: 
      Investigational Plan:

        1. Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]

        2. Baseline Visit [Visit 1 / Provision of study drug and subject training]

        3. Treatment Visit [Visit 2 / within 72 hours after study drug administration]

        4. Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug
           administration]
    

Intervention name(s): "Investigational"Auto-injector (sumatriptan succinate)
Intervention type(s): Drug
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine
Safety and Immunogenicity of MVA85A, in Healthy Volunteers in Cape Town
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town.
      We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population
      in the UK and in a more mycobacterially exposed population in The Gambia. The studies
      described here will be to assess the safety of MVA85A in 2 groups of adults, those with and
      without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will
      assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.
    

Detailed description: 
      This is an open label Phase I safety study of a single intradermal injection of 5 x 107pfu
      MVA85A, when administered to healthy subjects with no evidence of infection with M.tb

      Sample size:

      This is an observational and descriptive safety study, 12 subjects with evidence of prior BCG
      vaccination and 12 adults with no evidence of prior BCG vaccination will be recruited and
      vaccinated with MVA85A. This sample size should allow determination of the magnitude of the
      outcome measures, especially of serious and severe adverse events rather than aiming to
      obtain statistical significance. Once three month follow-up of these two arms of the study is
      complete, we will recruit 12 adolescent school children (aged 12-14) and assess the safety
      and immunogenicity of a single immunisation with MVA85A in this group.

      Rules for progression from adult studies to adolescents:

        1. No increased incidence in local and systemic side-effects compared with trials with
           MVA85A in Oxford and The Gambia.

           In the trials in the UK and The Gambia, all volunteers experience some mild local
           side-effects for 1-4 days after vaccination.

           Approximately two- thirds of volunteers experience some mild systemic side-effects in
           the first 24 hours after vaccination. These are self-limiting and all spontaneously
           resolve.

           These side-effects are consistent with data from use with other recombinant MVAs
           expressing other antigens (Moorthy VS et al, 2003).

        2. Immune responses measured 1 week after vaccination. We see strong immune responses 1
           week after vaccination in the Oxford and Gambian volunteers (McShane et al, 2004). We do
           not know how long the responses in the South African volunteers will last for, but we
           would expect to see the induction of significant (compared with baseline) immune
           responses as measured by the ex-vivo Elispot assay, 1 week after vaccination
    

Intervention name(s): MVA 85A
Intervention type(s): Biological
Intervention description(s): ID vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; TB; MVA 85A
Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal
      weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.
    

Detailed description: 
      Twenty normal weight adolescents between ages 12-18 that are age and gender would receive
      vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be
      measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other
      demographic variables will be assessed.The primary endpoint in this study is the 25 OH
      Vitamin D level at 12 weeks.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): 2000 IU orally once daily for 12 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D; Supplementation; Adolescence
The Greek Version of Modified Baecke Questionnaire
Condition: Physical Activity
Study type: Observational

Summary: 
      The purpose of this study was to translate and investigate the validity and reliability of
      the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population.
    

Detailed description: 
      The purpose of this study was to translate and investigate the validity and reliability of
      the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population. The
      cross-cultural adaptation of the mBQ was performed according to official guidelines.The
      reliability was determined by filling out the mBQ, two times, one week apart. For validation,
      the scores between the mBQ and the IPAQ were compared and the correlation between mBQ and
      VO2max and between mBQ and interview (METS) were assessed.
    

Intervention name(s): observational
Intervention type(s): Other
Intervention description(s): The reliability was determined (n=100) by filling out the mBQ, two times, one week apart (test-retest).
For validation (n=45), the scores between the modified Baecke Questionnaire and the International Physical Activity Questionnaire were compared and the correlation between the modified Baecke Questionnaire and VO2max(via Astrand-Rhyming Cycle Ergometer Test) and between mBQ and interview (via METS) were assessed.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy
      
Keywords: validation; reliability; adaptation; questionnaire; Greek version; Baecke
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Condition: Iron Deficiency Anemia Treatment
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the
      transferrin family which was discovered 70 years ago, and isolated simultaneously from human
      and bovine milks in 1960. It is widely distributed in all biological fluids and is also
      expressed by immune cells, which release it under stimulation by pathogens
    


Intervention name(s): Lactoferrin Bovine; Ferrous Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): treatment for 30 days; treatment for 30 days
Other intervention name(s): Pravotin sachet; ferrovit syrup
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Iron deficiency anemia; Lactoferrin; Ferrous sulfate