bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe
      and possibly effective in the treatment of acute myocardial infarction (heart attack).
    

Detailed description: 
      Cardiovascular disease is the single largest killer of males and females in the United States
      with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will
      suffer an acute myocardial infarction. The standard of care treatment for acute myocardial
      infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or
      other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk
      factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and
      exercise all work to reduce further atherosclerotic events. Yet, many patients go on to
      develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and
      slow the progression to failure but does not restore a functioning myocardium. A therapy that
      could improve the myocardial remodeling process and reduce the incidence or severity of CHF
      following acute MI would provide a significant benefit in an area of unmet medical need.

      Patients will receive standard of care in addition to stem cells or placebo.
    

Intervention name(s): Provacel; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ex vivo cultured adult mesenchymal stem cells; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Myocardial Infarction; Heart Attack; Cardiovascular Disease; Stem cells; Congestive Heart Failure; Heart Attack Repair
This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1323495 in healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
      proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the
      assessment of the PK/PD relationship.
    


Intervention name(s): BI 1323495; BI 1323495; BI 1323495; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low strength tablet; Middle strength tablet; High strength tablet; Placebo to low strength tablet; Placebo to middle strength tablet; Placebo to high strength tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
Condition: Oral Ulcer; Orthodontic Appliances, Fixed
MeSH terms: Oral Ulcer; Ulcer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study is a randomized controlled trial. The participants will be equally allocated into 2
      groups to compare clinical effectiveness of curcumin mouthwash in fixed orthodontic patients
      during the first month of treatment.
    

Detailed description: 
      Patients who require fixed orthodontic appliances as part of their orthodontic treatment at
      the Faculty of Dentistry, Chulalongkorn University will be asked if they will volunteer for
      this clinical research. Participants will be informed about the objectives of the study,
      study process, advantages, disadvantages before making a decision to participate in this
      study. The consent form will be signed prior to participating in the study. A week before
      bracket cementation visit, a participant will attend his/her appointment for a full clinical
      history taking and oral screening exam by one examiner. Each participant will be allocated by
      a trial number and receive 3 bottles of either placebo or curcumin mouthwash accordingly. A
      tube of sodium lauryl sulfate (SLS)-free, non-herbal toothpaste and 1 toothbrush will be
      provided to each participant. Moreover, the instruction VDO will be given to participants to
      "Rinse with 10 ml for 1 minute, twice a day for 28 days after brushing in the morning and at
      night, following proper oral hygiene and avoid taking any liquid or food for 30 minutes after
      rinsing" in the first 28 days after bracket cementation. Then, participants will be provided
      with a daily record form on Google Form and requested to record every day during the trial.
    

Intervention name(s): Curcumin mouthwash; Placebo mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): Rinse with 10 ml for 1 minute, twice a day for 28 days after brushing in the morning and at night, following proper oral hygiene and avoid taking any liquid or food for 30 minutes after rinsing.; Rinse with 10 ml for 1 minute, twice a day for 28 days after brushing in the morning and at night, following proper oral hygiene and avoid taking any liquid or food for 30 minutes after rinsing.
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Curcumin; Curcumin mouthwash; Traumatic ulcers; Fixed orthodontic appliances
Brain Training to Enhance Frontal Lobe Reasoning
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to improve the ability to diagnose and to achieve higher-levels of
      functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain
      Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12
      months).
    

Detailed description: 
      link to clinical trials methods paper

      http://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-14-29?site=trialsjournal.b
      iomedcentral.com
    

Intervention name(s): Brain Training Program 1; Brain Training Program 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.; The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TBI; Traumatic Brain Injury; combat related injury; blast injury; concussion; sleep problems; attention problems; memory problems; headaches; dizziness; OEF; OIF; Veterans; Civilian
A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
Condition: Healthy
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A single center, randomized, double blinded phase I/IIa exploratory study to evaluate
      reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in
      human adult
    

Detailed description: 
      -  Objectives: To explore the most effective dose of the third generation Hepatitis B
           vaccine through the evaluation of reactogenicity, safety, and immunogenicity.

        -  Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous
           injections of the conventional Hepatitis B vaccine.

        -  Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in
           addition to S antigen, has an ability to elicit faster protection and higher antibody
           titers than the second generation Hepatitis B vaccine in the subjects.
    

Intervention name(s): CVI-HBV-001; Conventional Hepatitis B vaccine (20 μg)
Intervention type(s): Biological; Biological
Intervention description(s): Investigational Product; Investigational Product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers
Condition: Ulcers, Leg
MeSH terms: Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous
      or mixed leg ulcers.
    

Detailed description: 
      Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the
      treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.
    

Intervention name(s): Urgo 310 3166 dressing
Intervention type(s): Device
Intervention description(s): Experimental: Urgo 310 3166 dressing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single-center, randomized, double-blind, placebo-controlled,
      single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and
      pharmacokinetics of FBL-MTX in healthy male and female subjects.
    

Detailed description: 
      The product FBL-MTX consists of Methotrexate (MTX) encapsulating liposomes functionalized
      with a folate peptide (SP-DS3), which targets activated macrophages of rheumatoid arthritis
      (RA).

      This is a prospective, single-center, randomized, double-blind, placebo-controlled,
      single-ascending dose (SAD) phase 1 study in healthy subjects.

      This study is planned to investigate up to 4 dose levels of FBL-MTX. Each dose level will
      consist of 8 healthy male and female subjects (ratio 1:1, male:female) to have 6 subjects
      being administered FBL-MTX and 2 subjects being administered placebo (ratio 3:1,
      active:placebo).

      The study is designed to meet the following objectives:

        -  Primary: To evaluate the safety and tolerability of FBL-MTX following single-ascending
           intravenous doses to healthy male and female subjects.

        -  Secondary: To investigate the PK of FBL-MTX following single-ascending intravenous doses
           to healthy male and female subjects.
    

Intervention name(s): FBL-MTX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FBL-MTX is available as sterile liposomal dispersion for injection at nominal dose strength of 1 mg/mL of methotrexate free base. The dose of 0.1 mg was selected as starting dose in the present study. Three subsequent FBL-MTX dose levels are pre-planned: 0.33 mg, 1 mg and 2.5 mg.; Placebo will consist of sterile saline 0.9% NaCl solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A maximum of 4 dose levels (0.1 mg, 0.33 mg, 1 mg and 2.5 mg) is preplanned to be investigated in separate sequential cohorts. Each cohort will consist of 8 healthy male and female subjects (3 subjects of either sex on FBL-MTX, 1 of either sex on placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: rheumatoid arthritis; healthy
Orientation for Hearing Aid Users: Information Retention
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are
      retained by new hearing aid users and analyze whether age, degree of hearing loss, academic
      and socio-economics status have an influence on this
    

Detailed description: 
      Introduction: The understanding and retention of orientations provided by the health
      professional increases patient's satisfaction and compliance to treatment and reduces
      treatment duration and costs. Aim: To verify how much of the orientation provided at
      diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether
      age, degree of hearing loss, academic and socio-economics status have an influence on this.
      Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from
      18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types.
      Orientations were offered at the time of diagnosis and hearing aid fitting. At the first
      follow up visit patients were interviewed regarding their hearing loss' characteristics as
      well as hearing aid care and use (probed recall task). It was also evaluated how participants
      manipulated their devices. A protocol was used to score participant's responses. Results: on
      average participants could retain 31,6% and 83,6% of the orientation provided regarding their
      hearing loss and hearing aid care and use. There was a negative correlation between age and
      amount of information retained. There was no influence of degree of hearing loss, academic
      and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to
      recall orientation provided therefore the use of facilitation strategies to information
      retained is necessary.
    

Intervention name(s): Counseling
Intervention type(s): Behavioral
Intervention description(s): Informational Counseling provided after hearing aid fitting
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual
        uni or bilateral hearing loss of various degrees and types.
      
Keywords: hearing aids; counseling
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      Purpose:

      To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with
      neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial
      growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers
      potentially influencing prognosis.

      Methods:

      18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the
      Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean
      period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal
      anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated
      as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using
      spectral domain optical coherence tomography (SD-OCT).
    


Intervention name(s): OCT
Intervention type(s): Device
Intervention description(s): Patients were recruited, visual acuity and optical coherence tomography Pictures were taken
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related
        Macular Degeneration (MANTA) trial [16]. These patients received a loading dose of 3
        intravitreal injections of anti-VEGF and were subsequently treated as-needed [pro re nata
        (PRN)] [16]. From that study population we recruited for another long term follow up visit.
        Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%)
        died before the last study visit and 14 former participants (25%) did not approve further
        study participation.
A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)
Condition: HIV Infections
MeSH terms: AIDS-Related Complex
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS
      related complex. Also to determine the effect of various doses of AS-101 on immune functions
      and the occurrence of infections in these patients. AIDS is a viral disease that is
      characterized by a loss of some immune function and the development of frequent, eventually
      fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients
      with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs.
      AS-101 is a synthetic organic compound containing the metal tellurium that is being tested
      because in laboratory studies it improved immune functions.
    

Detailed description: 
      AIDS is a viral disease that is characterized by a loss of some immune function and the
      development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has
      prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for
      more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the
      metal tellurium that is being tested because in laboratory studies it improved immune
      functions.

      Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks. The first
      group of 6 patients receives a dose that did not cause toxic effects in a preliminary study.
      If no adverse effects occur, the next 6 patients receive a higher dose level and so on, until
      an optimum dose has been reached. The investigators will determine the optimum dose based on
      the type and severity of adverse effects experienced by the patients on the study and by the
      effect of the drug on the immune function of the patient and its effect on the HIV infection.
      Samples of blood and urine are taken periodically during the study and skin tests are
      performed 3 times to aid in the evaluation of AS-101. Patients receive standard treatment for
      any infections that develop during the study.
    

Intervention name(s): AS-101
Intervention type(s): Drug
Intervention MeSH terms: Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infusions, Intravenous; Immunologic Surveillance; Drug Evaluation; Adjuvants, Immunologic; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute
The Effects of Weighted Waist-Hooping
Condition: Healthy
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Purposes: 1) To determine the effects of weighted waist-hooping on balance in healthy
      individuals and 2) to observe whether these effects are attributed to neuromuscular
      conditioning or core strength gains.

      Methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the
      control. The intervention consisted of six weeks of weighted waist-hooping four times a week
      for 10 minutes each session. Balance was assessed pre and post intervention using the BESS,
      SEBT, and Neurocom SOT. Core strength was assessed using hold duration of a bilateral and
      unilateral plank.
    


Intervention name(s): weighted waist-hooping
Intervention type(s): Device
Intervention description(s): weighted waist-hooping
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Weighted waist-hooping; Balance; Proprioception; Neurocom
Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)
Condition: Individuals at Risk of Developing Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      In this randomized controlled trial, the investigators will compare the long term
      effectiveness of intermittent fasting (IF) versus an energy matched moderate calorie
      restriction (CR) over 18 months, and relative to a non-active intervention standard control
      (SC) in individuals who are at increased risk of developing type 2 diabetes. All participants
      will be required to attend the blood tests following a 12-hour overnight fast for the "A"
      visit at Month 0, 2, 6 (active) and 18 (follow up).

      Fast424hGlucose: A subset of 100 participants enrolled in either IF or CR group in the parent
      study will be fitted with a continuous glucose monitor (CGM) to measure 24-hour glycaemic
      profile at month 0 and month 6.

      Fast4Switch: Additional bloods will be collected after a "B" visit at month 6 to compare the
      fed to fasted switch. The B samples will be collected after a 12-hour overnight fast (CR, SC)
      or 20-hour fast (IF) to assess the metabolic switch to fasting in metabolites and hormones.

      Fast4Stress: Additional subcutaneous adipose tissue, urine and saliva samples will be
      collected in ~32 men in IF and CR groups at month 0 and 6 at A and B visits to examine
      changes in stress response and resistance markers.

      Experience2Fast: In-depth, semi-structured interviews will be carried out at month-8
      follow-up visit in a subset of completers from IF or CR groups to explore the experience of
      intervention diets and understand contributing factors towards change and maintenance of
      dietary behaviours.

      Fast4Flux: Additional blood samples will be collected in ~100 individuals in SC, IF and CR
      groups at month 0, month 2 and month 6 at A visit to measure autophagic flux in peripheral
      blood mononuclear cells following treatment of whole blood.
    


Intervention name(s): Intermittent Fasting (IF); Daily Restriction (DR); standard care (SC)
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.; Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.; Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intermittent fasting; calorie restriction; overweight and obesity