bioihbjkbjnl/mcl2 huggingface dataset:
Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the
      pancreas. The investigators have discovered the specific autoimmune cells responsible for
      destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means
      of destroying those cells.
    

Detailed description: 
      The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine
      used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the
      abnormal immune cells can be depleted. This is the first step in trying to cure established
      type 1 diabetes.
    

Intervention name(s): BCG; Saline
Intervention type(s): Biological; Biological
Intervention description(s): BCG vaccination at 0 and 4 weeks; Saline vaccination at 0 and 4 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 1 diabetes mellitus; immune modulation; cure; autoimmunity
Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born
      children, characterized by the development of retinal neovascularisation, macular dragging
      and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially
      in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in
      the development of the disease. Recently, the BEAT ROP study tested the efficacy of
      intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized,
      stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit
      for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths
      after treatment. The authors also concluded that safety could not be assessed due to the
      small sample size. Other authors raised concerns regarding the results of the BEAT ROP study
      and the safety of bevacizumab.

      The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus
      ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single
      injection of ranibizumab.
    

Detailed description: 
      The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection
      of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6
      months.
    

Intervention name(s): intravitreal injection of 0.03ml ranibizumab
Intervention type(s): Drug
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ranibizumab; intravitreal therapy; ROP; Plus disease; stage 3 plus
Mapping COVID-19 Spread in a Tertiary Hospital
Condition: Covid19; Spatial Visualization; Neural Network; Respiratory Disease; Pandemic; Disease Spread
MeSH terms: COVID-19; Respiratory Tract Diseases; Respiration Disorders
Study type: Observational [Patient Registry]

Summary: 
      One of the major problems in suppressing the spreading of an epidemic resides in
      understanding and monitoring its propagation patterns, and in evaluating how these are
      modified by enforced policies. The standard solution requires detailed information at the
      microscopic scales, e.g. how infected people have moved and whom they came in contact with,
      which is hardly ever available. The researchers propose a novel approach to the study of the
      propagation of COVID-19, in which a proxy of this information is derived at macroscopic
      scales. This will be based on two ingredients: the spatiotemporal study in shiny with
      mathematical models with aggregated or non aggregated data and the reconstruction of
      functional networks of spreading patterns, and the development of a supporting software.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): just descriptive analysis of clinical data
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a positive test (PCR or serology) for SARS-CoV-2 in an outpatient regime
        system
Resilience Models in Adolescence and Youth With Cancer in Taiwan
Condition: Childhood Cancer; Coping Behavior; Hope; Resilience
Study type: Observational [Patient Registry]

Summary: 
      Validation of Resilience Models about Cancer in Adolescence and Youth in Taiwan
    

Detailed description: 
      This study uses the disease resilience model as a framework to explore the relationship
      between physical, mental, spiritual, and social aspects of resilience in adolescents with
      cancer and to verify the resilience model. It is expected that the research results will
      serve as a reference for designing nursing interventions in the future and develop local
      Resilience model to improve quality of care.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        childhood cancer at age between 10 and 24
      
Keywords: Resilience; Hope; social support; Coping; adolescent and young adult; uncertainty
Calcium-protein Co-ingestion and Gut Hormones
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2
      diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein
      ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims
      to assess whether the addition of calcium to protein ingestion augments postprandial gut
      hormone availability in humans.
    


Intervention name(s): Milk Mineral Supplement; Whey Protein Hydrolysate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Milk Minerals containing 1000 mg calcium; 50 g whey protein hydrolysate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, double-blind crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and
      safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of
      3 days for the treatment of occasional or recurrent episodes of self-reported gastric or
      intestinal spasm-like pain or discomfort
    


Intervention name(s): Hyoscine Butylbromide - Tablet; Hyoscine Butylbromide - Capsule; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Context and Objectives: Erectile dysfunction severely compromises not only sexual
      satisfaction, which is well known to be closely linked to overall life satisfaction but is
      also associated with a lower quality of life, lower self-esteem, depression, anxiety and
      adverse effects on interpersonal relationships. The objective was to assess the efficacy of
      psychotherapy and/or sildenafil for psychogenic erectile dysfunction.

      Design and Settings: randomized controlled single-blind trial performed at Institute of
      Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil Methods:
      Thirty patients with mild and moderate psychogenic erectile dysfunction (ED) were randomized
      to receive for six months: group psychotherapy (GP) plus 50mg sildenafil on demand, or 50mg
      sildenafil exclusively, on demand, or GP exclusively. Changes in score from baseline for
      three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were
      evaluated at end-point and after 3-months follow-up.

      Results: satisfaction with the treatment, confidence and naturalness increased in GP plus
      sildenafil and GP exclusively groups (p=0.001) from baseline to endpoint. The
      treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in
      the three groups. No difference was observed in the sildenafil group in the three study
      periods (P >0.05) Conclusions: Patients with mild and moderate psychogenic ED had higher
      treatment satisfaction, confidence and naturalness in engaging in sexual activity when
      receiving GP plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as
      assessed by these three EDITS questions after 6-months treatment
    


Intervention name(s): Group Psychotherapy; Group Psychotherapy plus Sildenafil citrate; Sildenafil citrate
Intervention type(s): Behavioral; Other; Drug
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Group Psychotherapy; Sildenafil [Substance Name]; Patient Satisfaction; Efficacy; Randomized Controlled Trial [Publication Type]
Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)
Condition: Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU)
      health care providers face, this study will evaluate burnout rates in intensive care unit
      (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a
      bereavement card on these burnout rates
    

Detailed description: 
      This study will evaluate:

        1. Burnout rates among nurses and ancillary staff with the Abbreviated Maslach burnout
           inventory. This is a well validated tool that is used to evaluate symptoms of burnout
           such as denationalization, emotional exhaustion and lack of personal accomplishment.

        2. Burnout rates at the beginning of and at the end of the house staff's ICU rotation to
           gauge the effect of an ICU rotation on burnout rates amon medical trainees.

        3. Determine whether the introduction of a bereavement card will improve symptoms of
           burnout as gauged by the abbreviated maslach burnout inventory

        4. Staff perceptions and response to the introduction of a bereavement
    

Intervention name(s): Survey
Intervention type(s): Diagnostic Test
Intervention description(s): Burnout rates before and after the introduction of a bereavement card Burnout rates before and after an ICU rotation for physicians
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
Condition: Liver Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Hepatitis; Virus Diseases; Digestive System Diseases; Hepatitis B, Chronic; Hepatitis B; DNA Virus Infections
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Viral, Human; DNA Virus Infections; Hepatitis; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases
Study type: Observational

Summary: 
      The purpose of this study is to collect epidemiological data in children and adolescents with
      chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with
      associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric
      population. Family history and history of HBV transmission is essential to assess the course
      of the disease and can be used to determine the best mode of treatment This information will
      be used to assist with the feasibility and design of studies for the Novartis clinical
      pediatric development program, as the current epidemiology of ediatric CHB is not accurately
      known in Western countries or the rest of the world making pediatric studies difficult to
      plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a
      post marketing approval commitment to the EMEA Pediatric Committee.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eligible patients will be identified in the treatment centers by the investigators. These
        patients can include those patients being referred to the practice or patients currently
        being seen by the investigator who are male or female, children or adolescents with chronic
        hepatitis B, aged 2 to < 18 years . Patients visiting the center during the 2 year
        enrolment period may be eligible for the study. This visit will constitute the data
        captured for the "current disease state" in the questionnaire. Patients will be recruited
        from Asian and Western countries.
      
Keywords: hepatitis B; HBV; chronic hepatitis B; pediatric
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study involves people who have schizophrenia or schizoaffective disorder who are
      currently taking antipsychotic medications. Some antipsychotic medications may cause weight
      gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this
      study is to find out what happens if another medication (ramelteon) is used along with your
      antipsychotic medication. We want to find out whether doing this will:

        -  Change the way your body breaks down fat and sugar.

        -  Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).

        -  Improve how your body responds to insulin.

        -  Affect your quality of sleep.

        -  Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug
           Administration (FDA) to treat people that have difficulty falling asleep. It is not
           approved for such things as affecting waist size or improving how the body breaks down
           fat and sugar. Its use in this study is investigational.
    

Detailed description: 
      This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week
      follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks
      as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon
      effects on body composition, glucose and lipid metabolism, sleep quality and symptoms of
      tardive dyskinesia using the Massachusetts General Hospital General Clinical Research Center.
      As far as we know, no previous study has been done to explore the potential role of ramelteon
      in improving metabolic, sleep, and movement disturbances in schizophrenia subjects. The novel
      approach of adjunctive ramelteon treatment in the schizophrenia population is promising.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.; Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; metabolism; antipsychotics; diabetes; rozerem
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement
Condition: Atrial Fibrillation; Cryoablation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective trial investigating the effectiveness of a modified MRI preparatory
      pulse sequence to improve pulmonary vein isolation visualization.
    


Intervention name(s): Pulse Sequence; CMRI
Intervention type(s): Procedure; Procedure
Intervention description(s): Cylindrical Navigator Preparatory Pulse Sequence; Cardiac Magnetic Resonance Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Impact of Spectacles on Compliance to Mask-wearing Directives
Condition: Covid19
Study type: Observational

Summary: 
      Primary objective of this study is to identify the compliance of Greek people in mask-wearing
      directive and explore potential associations with refractive errors, spectacles and contact
      lenses use.
    

Detailed description: 
      Present study aims to identify whether Greek people have complied with mask-wearing directive
      and to investigate the correlation of outcomes with visual acuity - refractive errors,
      spectacles and contact lenses use. For the purposes of this research, a questionnaire of 20
      items including the following sub scales have been developed: a) near vision, b) distance
      vision, c) ocular discomfort, d) driving, e) limitations, need for help, work collaboration,
      and emotional impact
    

Intervention name(s): Questionnaire completion
Intervention type(s): Behavioral
Intervention description(s): Participants are contacted through social networks (Facebook) which provide a link to website that contains the questionnaire. Then, they complete the questionnaire which consists of the following 2 parts:
participant's demographic characteristics with questions regarding age, visual acuity - refractive error, spectacles and contact lenses use, and compliance to mask-wearing directives.
20 items that construct 5 subscales: a) near vision (5 items), b) distance vision (3 items), c) ocular discomfort (3 items), d) driving (2 items), e) limitations (3 items), need for help (2 items), work collaboration (1 item), and emotional impact (1 item).
The impact of spectacles on the compliance of Greek people to mask-wearing directives will be assessed via this questionnaire.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People who use social networks, with permanent residence in Greece, aged above 18 years old
        and adequate literacy of Greek language
      
Keywords: face masks; spectacles; contact lenses; compliance in mask-wearing directive
Escitalopram Treatment of Night Eating Syndrome
Condition: Night Eating Syndrome
MeSH terms: Syndrome; Night Eating Syndrome
Study type: Interventional

Summary: 
      Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night,
      sleep disturbance and morning anorexia. This 12-week study examines the effect of
      escitalopram on symptoms of NES.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10-20 mg; Placebo
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eating disorder
Voxelotor CYP and Transporter Cocktail Interaction Study
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is examining multiple doses of voxelotor (a study drug intended for
      treatment of sickle cell disease) and how it interacts with additional substrates (substrates
      are drugs or other substances that are metabolized by cytochrome enzymes. The substrates used
      in this study are FDA approved medications). The study will help to determine the safety and
      tolerability of the study drugs taken together, as well as the pharmacokinetics (PK) on how
      your body processes and responds to the combination of the study drug and substrates.
      Although these drugs are FDA approved, their use in this study is experimental.
    

Detailed description: 
      This is an open-label, fixed-sequence, 2-period evaluation study. This means the study doctor
      and participants in the study will know what study drugs they are taking. There will be
      approximately 46 healthy male and female participants between the ages of 18 - 55. There will
      be two parts of the study: parts A and B.

      Part A will consist of 26 healthy male and female participants (at least 20% African
      American). For Part A, participant involvement is expected to last approximately 81 days,
      including a 33-day screening period and a 48-day on study period (consisting of 2 study
      treatment periods, a washout period lasting 7 to 14 days, and the Follow-up visit).

      Part B will consist of 20 healthy male and female participants (at least 20% African
      American). For Part B, participant involvement is expected to last approximately 68 days,
      including a 33-day screening period and a 35-day on study period (consisting of 2 study
      treatment periods, a washout period lasting 7 to 14 days, and the Follow-up visit).

      You will only be allowed to be in one part of the study.
    

Intervention name(s): Voxelotor; Bupropion; Repaglinide; Flurbiprofen; Omeprazole; Midazolam; Metformin; Furosemide; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction; Drug drug interaction
Other intervention name(s): Oxbryta; Wellbutrin; Prandin; Ansaid; Prilosec; Dormicum; Glucophage; Lasix; Crestor
Intervention MeSH terms: Metformin; Repaglinide; Flurbiprofen; Furosemide; Midazolam; Bupropion; Omeprazole; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug drug interaction