bioihbjkbjnl/mcl2 huggingface dataset:
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
Condition: Nerve Injury; Digital Pulp Defect
Study type: Interventional

Summary: 
      The aim of the current report is to investigate the feasibility of transferring the free
      dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to
      reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed
      digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of
      the donor middle and ring fingers was measured.
    

Detailed description: 
      Sensory restoration of the reconstructed digit was evaluated via static two-point
      discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was
      measured. The data were compared with those of the contralateral, uninjured hand.
    

Intervention name(s): Free dorsal digital flap
Intervention type(s): Procedure
Intervention description(s): The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dorsal digital free flap; dorsal branch of proper digital nerve; dorsal branch of proper digital artery; proper digital artery
Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in
      participants with normal renal function and moderate to severe renal impairment.
    


Intervention name(s): BMS-986177
Intervention type(s): Drug
Intervention description(s): Oral Suspension
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Desensitization Protocol for Deceased Donor List
Condition: Transplant; Failure, Kidney
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      Purpose of the study:

      The specific aims of this study are to evaluate overall efficacy and safety of the
      pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors
      affecting treatment outcomes in order to improve patient selection and treatment protocols
      for future patients.
    

Detailed description: 
      Background:

      Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease
      antibody levels for highly sensitized kidney transplant candidates [1, 2]. This approach can
      potentially give a chance of kidney transplantation to end-stage renal failure patients who
      could never receive transplantation because of high levels of antibodies and persistent
      positive crossmatches to all potential kidney donors. Many transplant centers have used this
      strategy in order to increase transplant rates of highly sensitized patients with various
      levels of anti-HLA antibodies. However, the responses to the treatment seem to be different
      in each patient and factors affecting treatment outcome have yet to be determined.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Approximately 100 subjects are expected to participate from 2007 to current, and another
        100 subjects are expected to participate during the next 12-month period.
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to investigate the safety and tolerability of AZD2423 single
      doses in healthy volunteers.
    


Intervention name(s): AZD2423; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, single administration; oral administration and single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; pharmacokinetics
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and
      computer-assisted counseling may help people stop smoking.

      PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling
      helps African American smokers stop smoking.
    

Detailed description: 
      OBJECTIVES:

        -  Develop and evaluate the efficacy of an interactive, culturally sensitive,
           individualized, palmtop computer-delivered smoking cessation intervention for African
           American smokers.

        -  Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered
           treatment on abstinence.

      OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for
      pilot testing. All other participants are randomized to 1 of 2 intervention arms.

        -  Arm I (standard care [SC]): Participants receive nicotine patch therapy on days -5 to
           31. Participants also receive a Pathways to Freedom self-help guide and undergo 5
           in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical
           Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit
           smoking date and at 3, 10, and 31 days after the quit smoking date.

        -  Arm II (computer-delivered treatment [CDT]): Participants receive the same intervention
           as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting
           strategies; motivation and support; general smoking information; calendars and fun
           stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing
           for 31 days after the quit smoking date.

      All participants complete questionnaires at baseline, during the counseling sessions, and
      then at approximately 6 months after the quit smoking date.

      After completion of study intervention, participants are followed at approximately 6 months.

      PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
    

Intervention name(s): Smoking cessation intervention; Counseling intervention; Nicotine patch
Intervention type(s): Behavioral; Other; Drug
Intervention description(s): 6 weeks of computer delivered treatment for quitting smoking; In-person counseling (5 sessions); 6-week supply of the nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic
      response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in
      pre-dialysis participants with anemia with repeat dosing for 42 days.
    


Intervention name(s): AKB-6548; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral dose administered once daily for 42 days; oral Placebo administered once daily for 42 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics
Nudging, Healthy Diet and Physical Activity
Condition: Obesity
Study type: Interventional

Summary: 
      The present study is a randomized school-based trial of a sample of 5th and 6th grade
      students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of
      Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the
      intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables
      and water consumption and daily energy expenditure, in a factorial design.
    


Intervention name(s): educational activities; nudging; nudging + educational activities
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Group 2 will receive classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans; In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices; Group 4 will receive both interventions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
Condition: Ventricular Tachycardia; Coronary Artery Disease; Left Ventricular Dysfunction
MeSH terms: Coronary Artery Disease; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Interventional

Summary: 
      The main objective of this study is to compare the time from randomization to the first
      recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable
      VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and
      patients not undergoing ablation, with both groups under the protection of an ICD.
    

Detailed description: 
      The main objective of this study is to compare the time from randomization to the first
      recurrence of any VT in patients undergoing VT ablation (for stable VTs) and substrate
      ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing
      ablation, with both groups under the protection of an ICD.

      Prior to the ablation, the patients will undergo electrophysiologic study (EPS) with
      programmed ventricular stimulation, with the aim to reproduce the clinical VT. Most patients
      with coronary artery disease, systolic LV dysfunction, and one episode of clinical sustained
      VT have more than one inducible VT at electrophysiologic study. Since any inducible VT can
      become a potential clinical VT (24), an attempt will be made to ablate the clinical stable
      VT, as well as all inducible morphologies, stable or unstable.

      One of the following 2 ablation strategies will be possible for each VT:

        -  Substrate modification in sinus rhythm in case of unstable induced monomorphic VT which
           does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.

        -  VT ablation in tachycardia in case of stable VT

      For each procedure the number of tachycardias , the type of each tachycardia (inducible or
      noninducible, stable or unstable), the ablation strategy for each tachycardia (it is possible
      that lesions deployed for one tachycardia will render another tachycardia noninducible as
      well) and the procedural outcome for each tachycardia will be documented.
    

Intervention name(s): Substrate modification; VT ablation; ICD Implantation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Catheter Ablation procedure - Substrate modification in sinus rhythm in case of unstable induced monomorphic Ventricular Tachycardia (VT) which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.; Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT; Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Catheter Ablation; Defibrillators, Implantable
A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This single arm study will assess the efficacy and safety of rituximab in combination with
      fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line
      treatment of participants with CLL.
    


Intervention name(s): Cyclophosphamide; Fludarabine; Rituximab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cyclophosphamide 250 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.; Fludarabine 25 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.; Rituximab 375 mg/m^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Other intervention name(s): MabThera, Rituxan
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      Pneumonia is a leading cause of morbidity and mortality in children in developing countries.
      Zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.At
      least two randomised controlled trials have shown that zinc supplementation improves the
      outcome of severe pneumonia in children (reducing duration of hospital stay and complications
      related to pneumonia).

      However, there are conflicting results from other randomised controlled trials about its
      efficacy in children with pneumonia.The purpose of the current study is to determine the
      efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. We
      hypothesize that the proportion of children who recover from severe pneumonia following zinc
      adjunct therapy [(10 mg once daily for seven days) for children aged <12 months and 20 mg
      daily for children aged ≥12 months]will be higher than the proportion of children who recover
      from placebo therapy.
    

Detailed description: 
      Zinc deficiency is a global nutritional problem affecting people with a low socioeconomic
      status in developing and developed countries. There is a high prevalence of zinc deficiency
      in Uganda as documented by Bitarakwate et al.Two clinical studies have shown that zinc
      supplementation improves the outcome of severe pneumonia in children by reducing duration of
      hospital stay and complications related to pneumonia. However, there are conflicting results
      from some previous studies about its usefulness in patients with pneumonia.

      The objective of this study is to determine the effect of zinc supplement as adjunct therapy
      in the treatment of severe pneumonia in children less than five years admitted to Mulago
      hospital, Kampala, Uganda.

      This will be a randomized, double-blinded, placebo-controlled trial of zinc adjucnt therapy.
      Three hundred and twenty eight children with severe pneumonia will be randomised to receive
      either zinc (a daily dose of 20 mg for children more than one of age and 10mg for those less
      than one year or placebo once daily for seven days.

      The primary outcome will be Time taken to :normalisation of respiratory rate, temperature and
      oxygen saturation.

      Secondary outcome:Proportion of study children who will die during the follow up
      period,Proportion of children who develop drug adverse effects data will be analysed using
      Kaplan Meir survival curves.
    

Intervention name(s): Zinc acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Zinc; placebo; severe pneumonia; children
Safety Surveillance of MenACWY-CRM Vaccine in Children
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      The purpose of this study is to summarize the occurrence of incident serious medically
      attended events and events of interest up to 1 year following MenACWY-CRM vaccination
      administered as part of routine clinical care. This US FDA post-marketing commitment study is
      an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine
      in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The
      26 events of interest are events commonly evaluated in vaccine safety studies and include
      certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All
      events are collected retrospectively.
    

Detailed description: 
      This is an observational study, vaccines administration and data that is collected is only as
      part of routine clinical care. Vaccinated subjects are not actively recruited.

      Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic
      Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease,
      Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria,
      Anaphylaxis, Meningococcal Disease, Intentional Injury
    

Intervention name(s): MenACWY-CRM
Intervention type(s): Biological
Intervention description(s): MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is selected from the Health Maintenance Organization population of the
        Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.
      
Keywords: observational; serogroup A, B, Y, W; meningococcal meningitis; meningococcal vaccines; safety; MenACYW-CRM; post-marketing; children
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Condition: Prostatic Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Prostatic Intraepithelial Neoplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether dietary lycopene supplementation lowers
      serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia
      (HGPIN).
    

Detailed description: 
      Observational studies suggest higher lycopene intake or higher lycopene blood levels are
      associated with a lower risk for prostate cancer. Two recent trials of lycopene
      supplementation conducted in men with prostate cancer, during the three weeks prior to
      radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate
      cancer.

      High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men
      with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The
      objective of this study is to determine whether dietary lycopene supplementation lowers serum
      prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in
      men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard
      multivitamin alone.
    

Intervention name(s): - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day); - Certagen (multivitamins with minerals)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prostatic Intraepithelial Neoplasia; Prostate-Specific Antigen; lycopene
Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.
Condition: Resilience, Psychological; Loneliness; Youth; Surveys and Questionnaires
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all
      European countries.

      This online survey assesses these measures implications on Mental Health in emerging adults.

      The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental
      Health status (mental health professional help-seeking, use of psychotropic drugs, or
      possible diagnosis) before and during Lock-down Measures.

      At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the
      survey during the SARS-CoV2 Pandemic Lock-down Measures.
    


Intervention name(s): Survey and Questionnaire
Intervention type(s): Other
Intervention description(s): Resilience and Loneliness questionnaires
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy youth living in a European Country where SARS-CoV2 Pandemic Lock-down Measures are
        underway.
      
Keywords: Mental Health; Emerging Adulthood