bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels
Condition: Multiple Sclerosis; Covid-19
MeSH terms: COVID-19; Multiple Sclerosis; Sclerosis; Fatigue
Study type: Observational

Summary: 
      Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after
      the first patients were identified in Wuhan, China. Just like other members of the community,
      MS patients are uncomfortable with the emotional distress and health anxiety caused by the
      COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies.
      Patients taking immunosuppressive agents are theoretically at increased risk of being
      affected by viral pandemics, and a higher health concern is expected in this group of
      patients. Moreover, MS patients lose social support. Patients with increased duration of stay
      can no longer access physical and cognitive rehabilitation therapies. We also know that
      increased anxiety and sleep disorders can cause MS patients to have an attack.

      When literature is examined, it is known that MS patients' physical activity levels decrease,
      fatigue, sleep quality and anxiety levels increase, so their quality of life and
      participation in daily life activities decrease. MS patients lose social support during the
      COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level,
      anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further
      affected for these reasons.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with Multiple Sclerosis
      
Keywords: Multiple Sclerosis; Covid-19 pandemic; Fatigue; Physical activity; Sleep quality; Anxiety
Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The goal of this proposal is to test the overall hypothesis that subjects with chronic or
      recurrent low back pain have an abnormal soft tissue response to acupuncture needling, and
      that this altered response is associated with abnormal perimuscular connective tissue
      structure and biomechanics. We will also test whether or not altered needling responses in
      low back pain are generalized, or localized to specific locations as predicted by traditional
      acupuncture theory. This proposal is part of a series of projects investigating the role of
      connective tissue in the mechanism of acupuncture and, in addition, constitutes a first step
      in examining the role of connective tissue in low back pain. Acupuncturists describe
      qualitatively different needling responses at locations believed to be "involved" in the
      patient's disease process. Although assessing abnormalities in the needling response is a
      fundamental aspect of acupuncture therapy, what constitutes a normal vs. abnormal needling
      response has never been studied quantitatively. Thus the nature of tissue changes underlying
      these phenomena remains unknown. We have recently developed a new in vivo technique based on
      ultrasound elastography that allows visualization and quantification of tissue displacement
      and strain patterns developed in tissues during needle manipulation in humans [1] (Appendix
      A). In this proposal, we will use ultrasound elastography, ultrasound image analysis and
      biomechanical modeling to perform 1) quantitative measurement of soft tissue behavior during
      needling and 2) detailed analysis of perimuscular connective tissue structure and
      biomechanics in human subjects with and without low back pain.
    

Detailed description: 
      See Brief Summary
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture of low back and legs.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acupuncture; Torque; Force Decay
Evaluation of Repeat Administration of Purified Poloxamer 188
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of repeat administration of MST-188
      during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate
      the development of acute chest syndrome during VOC and re-hospitalization for recurrence of
      VOC.
    


Intervention name(s): MST-188
Intervention type(s): Drug
Intervention description(s): Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Other intervention name(s): vepoloxamer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle cell; vaso-occlusive crisis
Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at the efficacy, durability, safety, and tolerability of multiple
      single doses of Ketamine vs. active placebo for treating patients with treatment resistant
      depression who are taking an antidepressant that is not working for them.
    

Detailed description: 
      The primary objective is to investigate whether all doses (0.1 mg/kg, 0.2 mg/kg, 0.5 mg/kg,
      and 1.0 mg/kg) of ketamine are superior to active placebo (midazolam 0.045 mg/kg) therapy in
      the acute treatment of patients with treatment resistant depression within 72 hours (Day 3),
      when added to ongoing and stable antidepressant therapy.
    

Intervention name(s): Ketamine; Ketamine; Ketamine; Ketamine; Placebo Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose of Ketamine will be 0.1 mg/kg - one single infusion; Dose of Ketamine will be 0.2 mg/kg - one single infusion; Dose of Ketamine will be 0.5 mg/kg - one single infusion; Dose of Ketamine will be 1.0 mg/kg - one single infusion; Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Treatment Resistant Depression; Ketamine; Antidepressant; MDD; Major Depression
GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
      tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more
      tumor cells by making them more sensitive to the drug.

      PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and
      prednisone works in treating patients with prostate cancer that has not responded to hormone
      therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of GTI-2040, docetaxel, and prednisone, in terms of
           prostate-specific antigen (PSA) response rate, in patients with hormone-refractory
           prostate cancer.

      Secondary

        -  Determine objective tumor response in patients treated with this regimen.

        -  Determine the median time to progression in patients treated with this regimen.

        -  Determine the safety and tolerability of this regimen in these patients.

        -  Determine the median duration of PSA response in patients treated with this regimen.

        -  Correlate baseline and post-treatment levels of ribonucleotide reductase activity in
           tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc,
           R2 subunit protein, and markers of cellular proliferation and apoptosis with clinical
           outcomes in patients treated with this regimen.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive GTI-2040 IV continuously on days 1-14, docetaxel IV on day 3 of course 1 and
      on day 1 of subsequent courses, and oral prednisone twice daily on days 1-21. Treatment
      repeats every 21 days for up to 10 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 3.6-9.5
      months.
    

Intervention name(s): GTI-2040; docetaxel; prednisone
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Prednisone; Docetaxel
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer
Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      This study evaluates the use of a health-related quality of life report based on the SPADE
      cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low
      energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain.
      Half of the participants will receive the report, while the other half will not.
    

Detailed description: 
      The health-related quality of life report provides participants with an overall score on the
      SPADE cluster and scores on each of its five component scales. The recently released Federal
      Pain Research Strategy states that pain cannot be measured in isolation, but rather should be
      assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of
      life. It recognizes that pain may be affected by, and affect, such patient attributes as
      sleep, mood, cognition, function, and quality of life. Further, the report states that
      improvement in pain without concomitant improvement in other domains may not constitute a
      clinically meaningful outcome. This study primarily aims to assess the utility of a
      health-related quality of life report in improving quality of life, back pain intensity, and
      back-related disability in participants with chronic low back pain. Another aspect of the
      study will be to determine how the health-related quality of life report may impact the
      physician-patient interaction. This will be assessed using validated measures of physician
      interpersonal manner, empathy, and communication style, as well as end-of-trial survey data
      acquired from participants assigned to the experimental group. The survey will include an
      overall assessment of the report, as well as specific actions attributed to the report.
    

Intervention name(s): Health-Related Quality of Life Report
Intervention type(s): Other
Intervention description(s): Two page report and interpretation guide based on SPADE cluster scores
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back Pain; Quality of Life; PROMIS-29; PRECISION Pain Research Registry
Contact Lens Optics and Visual Performance
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study will evaluate changes in visual performance at different pupil sizes between a
      single vision soft contact lens and multifocal soft contact lens, and compare refractive
      error measured between these two lenses with an autorefractor and an aberrometer
    


Intervention name(s): Single vision contact lens; Multifocal contact lens
Intervention type(s): Device; Device
Intervention description(s): Subjects will wear a single vision soft contact lens only during the study visit; Subjects will wear a multifocal soft contact lens only during the study visit
Other intervention name(s): comfilcon A; comfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
Condition: Major Depressive Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Depression; Depressive Disorder; Depressive Disorder, Major; Alcohol Drinking
Study type: Observational

Summary: 
      The purpose of this study is to determine if having an alcohol use disorder affects recovery
      from depression, and also whether recovery from depression in patients who have alcohol use
      disorders is also accompanied by improvement in the alcohol use disorder.
    

Detailed description: 
      This is an extension of the multi-site sub-study of the National Institute of Mental Health
      (NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), which
      utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects
      diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of
      treatment with the anti-depressant citalopram. The thrust of this study was to test treatment
      algorithms for those subjects who did not respond adequately to initial monotherapy treatment
      with citalopram or who were unable to tolerate it. The parent protocol also contained several
      ancillary studies, including a sub-study of subjects with co-morbid alcohol use disorders,
      which enrolled 130 subjects. Treatment response data was collected at multiple intervals
      during the 12 week treatment period on depressed subjects both with and without a co-morbid
      alcohol use disorder.

      Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder
      will be compared to treatment outcome measures of subjects diagnosed with Major Depressive
      Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment
      period. This comparison will show whether having a co-morbid alcohol use disorder affects
      recovery from depression. In addition, alcohol use data of depressed subjects who
      demonstrated a positive response to anti-depressant treatment will be compared with alcohol
      use data of depressed subjects who did not have positive treatment outcomes. This comparison
      will show whether recovery from depression is associated with improvement in the co-morbid
      alcohol use disorder.
    

Intervention name(s): citalopram
Intervention type(s): Drug
Intervention description(s): tablets, 60 mg maximum, daily, 12 weeks
Other intervention name(s): Celexa
Intervention MeSH terms: Citalopram
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the Sequenced Treatment Alternatives to Relieve Depression
      
Keywords: Depression; Alcohol Abuse; Alcohol Dependence
The Effects of Nutritional Supplementation and Drug Abuse on HIV
Condition: HIV Infections; Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether supplementation with multivitamins and
      selenium will delay disease progression in HIV infected individuals in Botswana. The study
      will also assess how drug abuse modifies the effect of nutritional supplementation on HIV
      disease progression.
    

Detailed description: 
      Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has
      become an emerging problem in Botswana. Past research suggests that multivitamin and selenium
      supplementation slows the progression of HIV disease. The purpose of this trial is to
      evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected
      individuals in Botswana.

      This trial will last 2 years. Participants will be randomly assigned to 4 groups: a
      combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.
    

Intervention name(s): Multivitamins; Selenium; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): dietary supplement of multivitamins; dietary supplement of selenium only; placebo pill
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment Naive; Multivitamins; Selenium; Supplementation; HIV Disease Progression
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine
      in India adult subjects.

      Primary Objectives:

        -  To describe the neutralizing antibody response to each dengue virus serotype before the
           first vaccination and after each vaccination with CYD dengue vaccine in all subjects.

        -  To describe the safety of the CYD dengue vaccine after each dose in all subjects.

      Secondary Objective:

        -  To detect symptomatic dengue cases occurring at any time in the trial.
    

Detailed description: 
      Participants will receive 3 doses of their randomized treatment (vaccine or placebo).
      Flavivirus status will be determined at baseline (before the first dose) and the vaccine
      immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will
      be collected in all subjects after each dose. Serious adverse events and adverse events of
      special interest will be collected throughout the study.
    

Intervention name(s): Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus; Placebo: NaCl 0.9% solution
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 ml, Subcutaneous
Other intervention name(s): CYD Dengue vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Dengue Virus; Flavivirus
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid
Condition: Human Immunodeficiency Virus Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two
      injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study
      volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6
      (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total
      of 18 months following the first injection with the exception of group G in which volunteers
      will be followed for 12 months after the first injection (6 months after the second
      injection). This study will explore whether boosting is possible, and compare a shorter and
      more practical six-month time interval with a twelve-month time interval.
    

Detailed description: 
      The study design will also assess the effect of the presence of anti-AAV2 capsid neutralizing
      antibodies at the time of vaccination on the safety and immunogenicity of tgAAC09. Since the
      prevalence of pre-existing neutralizing antibodies to AAV2 capsid is high (IAVI and Targeted
      Genetics, data on file), this protocol amendment adds Group G which is composed of volunteers
      who have documented pre-existing anti-AAV2 capsid neutralizing antibodies titers ≤ 1/8. This
      will assure that there are sufficient numbers of volunteers with and without antibodies for a
      useful comparison.
    

Intervention name(s): tgAAC09; tgAAC09; tgAAC09; Formulation buffer
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Sterile isotonic buffered salt solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; HIV seronegativity; preventative vaccine
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label two-arm study will assess the safety and efficacy of a combination of
      bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in
      childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma
      soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard
      chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of
      induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1
      of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy
      with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time
      on study treatment is 1-2 years.
    


Intervention name(s): Standard chemotherapy; bevacizumab [Avastin]
Intervention type(s): Drug; Drug
Intervention description(s): As prescribed; 7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment