bioihbjkbjnl/mcl2 huggingface dataset:
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
Condition: Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional

Summary: 
      The aim of study is to evaluate the prevalence of latent TB in second generation immigrants
      from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the
      control native Israelis without a family member who was born in a country with high incidence
      of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators
      expect that the second generation immigrants group will have more positive IGRA test than the
      control native group.
    


Intervention name(s): Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
Intervention type(s): Procedure
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: latent tuberculosis; tuberculin skin test; Interferon gamma release assay; immigration
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Condition: Interdental Papillary Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety profile and the treatment effect of
      Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study
      (IT-G-002, no NCT identification number)
    


Intervention name(s): Autologous Human Fibroblasts (azficel-T)
Intervention type(s): Biological
Intervention description(s): Collection of biopsy from palate
Papillary priming procedure
Seven injection treatments to target sites
Performance of study assessments (investigator and subject)
Other intervention name(s): LAVIV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      The main risk factors for failure after single-incision slings are reduced urethral mobility
      and stress urinary incontinence severity in long-term follow-up.
    

Detailed description: 
      The medical records of the 132 patients were retrospectively analyzed. Preoperative
      assessment included medical history and urogynecological examination. Patients were asked to
      answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence
      Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of
      demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative
      response to UDI-6, question 3. Patients were divided according to objective cure rate into
      two groups: cured (Group A) and failed patients (Group B).
    

Intervention name(s): Single-Incision Sling
Intervention type(s): Procedure
Intervention description(s): The women with stress urinary incontinence underwent single-incision sling procedure.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From September 2009 to September 2017, the medical records of the patients who
        underwentsingle-incision sling procedure for stress urinary incontinence without
        concomitant pelvic prolapse surgery were analyzed.
      
Keywords: Single-Incision Sling; Stress Urinary Incontinence; Failure
The Effect of a Weight Management Program During Treatment With Olanzapine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The study is a prospective, randomized, open-label study.
    

Detailed description: 
      The principal objective of this trial is to investigate the effect of a comprehensive
      behavioural treatment program on weight gain in schizophrenic patients under olanzapine
      treatment, and on subjective well-being.
    

Intervention name(s): weight management program; weight management program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 sessions, psychoeducation; 2 weekly, 12 sessions, psychoeducational weight management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schizophrenia, weight management programme
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections; Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization
      rates and to begin to address the utilization of outpatient resources for RSV
      medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age
      (GA) premature infants who are less than 6 months of age and do not receive treatment.
    

Detailed description: 
      The goals of this study are:

        -  To estimate the incidence of hospitalization attributable to RSV within 150 days from
           enrollment in premature infants who are:

             -  32-35 weeks GA

             -  less than 6 months of age at the start of the RSV season

             -  not receiving palivizumab prophylaxis and not recommended to receive palivizumab
                according to the AAP guidelines

        -  To estimate the incidence rate of hospitalization attributable to RSV in the other
           relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined,
           and subgroups based on chronological age at the start of the RSV season, GA, etc. within
           150 days from enrollment and other time periods based on RSV activity, etc.)

        -  To estimate the incidence of RSV-associated MALRI in the study populations

        -  To characterize the incidence and type of clinical interventions for MALRI in the study
           populations
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        2 cohorts of premature infants and premature newborns 32-35 weeks
      
Keywords: Premature infants (32-35 weeks GA) <6 months of age at the start of the RSV season who are not receiving palivizumab and do not have CLD of prematurity; Respiratory Syncytial Viruses
Physical Activity, Cognition, Motor Skills, and Well-beings
Condition: Motor Activity
Study type: Interventional

Summary: 
      The objective of this quasi-experimental study design was to examine effects of the
      coordinated-bilateral ball skills (CBBS) intervention on cognitive functions and aerobic
      fitness in elementary school students. The hypotheses of the study were: students in the
      intervention group will show a significant higher level of cognitive functions and aerobic
      fitness compared to the control students.
    

Detailed description: 
      Fourth-grade students at 5 elementary schools were recruited to participate. At each
      participating school, two fourth-grade classes were assigned to the CBBS intervention group
      and other two fourth-grade classes were assigned to the control group. The students in the
      intervention group received two, 30-min CBBS physical education (PE) lessons taught by the
      physical education teacher who were trained in implementation of the two CBBS lessons per
      week for 16 weeks. In contrast, the students in the control group received regular two PE
      lessons per week for 16 weeks taught by the other physical education teacher who were not be
      involved in the CBBS intervention training. All participating students who returned their
      parent/guardian' signed consent form were pre-tested and post-tested (immediately after the
      16-week intervention) in cognitive functions and aerobic fitness. Descriptive statistics and
      linear mixed models were performed to analyze the data. All data analysis were conducted in
      Physical Activity and Health Lab of the School of Kinesiology at University of Michigan
    

Intervention name(s): CBBS intervention
Intervention type(s): Behavioral
Intervention description(s): The CBBS intervention group received the 16-week intervention, including 16 CBBS lessons in basketball unit (two 40-minute lessons/week, 8 weeks) and 16 CBBS lessons in soccer unit (two 40-minute lessons/week, 8 weeks) during the 2018-2019 school year.
Intervention model: Single Group Assignment
Intervention model description: This study used 2 arms, quasi experimental study design with one intervention group and one control group. The intervention group included fourth-grade students of two fourth-grade classes taught by the physical education teacher who received the coordinated-bilateral ball skills (CBBS) intervention training at each of the five elementary schools. The control group included fourth-grade students of other two fourth-grade classes taught by the physical education teacher who did not receive the CBBS intervention training at each of the five elementary schools.
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB
      reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a
      food effect for the 10 mg tablet dose group
    


Intervention name(s): BI 1356 BS PIB - low dose; BI 1356 BS tablet - low dose; BI 1356 BS PIB - high dose; BI 1356 BS tablet - high dose; BI 1356 BS tablet - high dose with food
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite recent advances in the understanding and treatment of schizophrenia, this devastating
      disease still affects one percent of world's population. Existing antipsychotics reduce
      psychotic symptoms but are generally not very effective in treating so called negative
      symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the
      disease. Furthermore, a significant portion of patients is refractory to all current
      treatments. Therefore new treatment strategies are needed.

      Several studies suggest a strong association between schizophrenia and the endocannabinoid
      system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of
      the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is
      known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient -
      cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one
      of the most effective modern antipsychotics, amisulpride, but it induced significantly less
      side effects.

      In this phase I safety study, the investigators will evaluate the pharmacokinetics,
      pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new
      tablet pharmaceutical preparation of cannabidiol in healthy volunteers.
    


Intervention name(s): Cannabidiol CR; Cannabidiol; Amisulpride; Olanzapine; Quetiapine; Risperidone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Arvisol
Intervention MeSH terms: Cannabidiol; Olanzapine; Risperidone; Quetiapine Fumarate; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL
Condition: Genital Infection Viral; HUMAN PAPILLOMA VIRUS
MeSH terms: Infections; Virus Diseases; Papilloma
Study type: Interventional
Phase: Phase 2

Summary: 
      Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix
      vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell
      carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination
      with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The
      therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine
      targets these HPV infected women with normal or mild cervical cellular dyskaryosis as
      detectable infections with oncogenic potential.

      This will be a double-blind, randomised, placebo-controlled, parallel group study assessing
      the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).

      ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites
      as a vaccine adjuvant.

      The population proposed for this study represents an otherwise healthy female population who
      are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic
      vaccine has been shown in the ongoing Phase I study, and the proposed population may in
      theory derive benefit from this vaccine.
    


Intervention name(s): ProCervix; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod; Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Motivating Value of Vegetables Study
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to see if perceived barriers to vegetable consumption can be
      overcome by making it easier for people eat more vegetables and to see if the effects last
      over time.
    

Detailed description: 
      High vegetable consumption is associated with maintenance of a healthy body weight. Americans
      do not eat vegetables in the amounts recommended by the dietary guidelines and interventions
      to increase intake have had limited results. Reported barriers to consumption include not
      knowing how to prepare them and being unused to eating them.To get people to eat vegetables,
      they have to be motivated to do so. Repeated consumption of snack foods increases overweight
      and obese individuals' motivation to eat snack foods. The investigators hypothesize that by
      increasing people's consumption of vegetables by making them easy to eat will increase the
      motivation value of vegetables. For this study the investigators propose to provide
      minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. The
      motivating value of vegetables will be measured using a computer task where people play a
      game to earn points towards portions of a vegetable or a neutral food (crackers). The
      investigators will determine potential moderators of the increase in the motivating value of
      vegetables such as genetics (single nucleotide polymorphisms) that are associated with the
      motivating value of food and whether people substitute eating vegetables for other foods. The
      investigators will also determine changes in adiposity as a result of vegetable consumption.
      Lastly, the investigators will determine if repeated consumption increases psychosocial
      predictors of vegetable intake, such as self-efficacy of eating vegetables.
    

Intervention name(s): Recommended Vegetable Intake; Usual Vegetable Intake
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans; Subjects will consume vegetables in their usual amount
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vegetables
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
Condition: Renal Insufficiency; Hemodialysis
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes
      medication
    


Intervention name(s): MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days
Intervention type(s): Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild, moderate, severe renal insufficiency; End stage renal disease
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 4 of 7)
Condition: Exposure to Man-made Visible Light
Study type: Interventional

Summary: 
      NOTE: This is the fourth of in total 7 sub-studies related to the Ethics Committee of the
      Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8
      arms, in total 350 participants will be assessed in all 7 sub-studies.

      General study information: This is a randomized, cross-over, quantitative study, which
      investigates physiological variables, mood, and affect of healthy participants in response to
      colored light exposure. The Participants take part in 5-8 arms and are exposed to colored
      light only, or are additionally asked to solve cognitive tasks during the colored light
      exposure. Primary aim is to measure the change in several physiological variables, mood, and
      affect during colored light exposure of 15 or 45 minutes. The risk for the participants is
      negligible and comparable to the risk during daily life.
    


Intervention name(s): Visible light exposure
Intervention type(s): Other
Intervention description(s): Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebral oxygen metabolism; functional near-infrared spectroscopy; partial pressure of carbon dioxide; heart rate variability; blood pressure; affect; mood; respiration; systematic randomized cross-over study; systemic physiology; electro-dermal activity; pulse-respiratory quotient
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety
      and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the
      treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell
      lymphoma.
    


Intervention name(s): Chidamide, Rituximab, Gemcitabine,Oxaliplatin
Intervention type(s): Drug
Intervention description(s): All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.
Patients with CR or PR will receive chidamide maintenance therapy.
Intervention MeSH terms: Rituximab; Gemcitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore whether LY2127399 is effective in relieving signs and
      symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or
      intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of
      these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept),
      Remicade® (infliximab), and Humira® (adalimumab).
    


Intervention name(s): LY2127399; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): LY2127399 will be administered as a single IV infusion over 30 minutes.; Placebo will be administered as a single IV infusion over 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients
Condition: Cornea; Anesthesia; Reaction
Study type: Interventional

Summary: 
      To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated
      under N2O + sevoflurane and O2 + sevoflurane general anesthesia.
    

Detailed description: 
      40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included
      in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry
      specular microscopy results at before surgery and 1 week and 1 month after surgery will be
      analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each
      group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.
    

Intervention name(s): Nitrogen protoxide; Oxygen
Intervention type(s): Other; Other
Intervention MeSH terms: Nitric Oxide; Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: nitrogen protoxide; oxygen; corneal endothelial; pediatric