bioihbjkbjnl/mcl2 huggingface dataset:
Changes of Optical Quality During the Peak of the Covid-19 Pandemic
Condition: Corneal Wavefront Aberration; SARS-CoV-2
MeSH terms: COVID-19; Corneal Wavefront Aberration
Study type: Observational

Summary: 
      To explore whether cornea structure, and optical quality are affected by the covid-19
      infection.
    

Detailed description: 
      Participants with healthy corneas admitted to Tianjin Eye Hospital from November 25 to
      January 20, 2022 were followed up . At the end of the follow-up, the investigators recorded
      in detail whether the patients had undergone real-time reverse transcriptase polymerase chain
      reaction (covid-19 RT-PCR tests) testing, testing time and results. The presence of
      PCR-positive during follow-up is considered to be covid-19 infection; PCR-Negative and no
      symptoms of infection during the follow-up period are considered not infected; participants
      with symptoms but no PCR test were excluded from the study.Participants were divided into
      three groups according to the RT-PCR results and the presence or absence of symptoms of
      infection during follow-up. pentacam (Pentacam HR, Oculus, Wetzlar, Germany) was performed
      during follow-up and the results were recorded,and the data was statistically managed and
      compared.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients admitted to refractive center of Tianjin Eye Hospital
      
Keywords: optical quality
Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm the combination rationale for the combination of ASA + paracetamol + caffeine
      compared with the combination of ASA + paracetamol and the individual substances ASA,
      paracetamol, caffeine, and placebo administered orally to headache patients for two headache
      episodes
    


Intervention name(s): Low dose ASA; High dose ASA; Low dose paracetamol; High dose paracetamol; Caffeine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fluoroquinolone Associated Disability
Condition: Bronchitis; Sinusitis; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Bronchitis; Sinusitis
Study type: Observational

Summary: 
      The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ),
      Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan
      Commercial Claims and Encounters database (CCAE) database, and specifically among individuals
      in the Health and Productivity Management (HPM) during the observation period; 2) describe
      the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs)
      and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of
      disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.
    


Intervention name(s): Fluoroquinolone (FQ); Azithromycin (AZ); Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants exposed to an oral FQ will be observed. The oral FQ included are Levofloxacin, Ciprofloxacin, Moxifloxacin, Ofloxacin, Gemifloxacin. Participants will not receive any intervention as a part of this study.; Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study.; Participants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study.
Intervention MeSH terms: Azithromycin; Fluoroquinolones; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population will include participants in the Truven Commercial Claims and
        Encounters (CCAE) database who were eligible for disability insurance and can be linked to
        the Truven HPM database. The study population will include individuals who had
        uncomplicated acute bacterial sinusitis, or bronchitis and were prescribed an oral
        fluoroquinolone (FQ) or oral azithromycin(AZ) and sulfamethoxazole/trimethoprim (ST) for
        urinary tract infection.
Individual and Family Therapy for Children With Anxiety Disorders
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare three treatments to determine which is most effective
      in reducing anxiety in children.
    

Detailed description: 
      Children and their parents will complete a comprehensive diagnostic assessment to determine
      eligibility. The assessment will include an individual diagnostic interview with the child,
      interviews with the parents, and written observations of the child from family members and
      teachers. Participants will then be randomly assigned to receive individual cognitive
      behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5
      months. Children in the ICBT group will meet individually with a therapist. In the FCBT and
      ESA treatment groups, children and their parents will meet weekly with a therapist.

      At the end of treatment and 1 year following treatment completion, families will complete
      another assessment to determine the effectiveness of each treatment at reducing short- and
      long-term anxiety symptoms in their children.
    

Intervention name(s): Individual Child CBT; Family CBT; Education/Support/Attention
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety of IV administration of rIX-FP.
      Safety will be evaluated by adverse events and laboratory changes over time. The secondary
      objective of the study is to evaluate the pharmacokinetics parameters, following a single
      intravenous dose of rIX-FP.
    

Detailed description: 
      This study is comprised of both a rIX-FP dose-escalation safety segment (25, 50 and 75 IU/kg
      of rIX-FP), and PK evaluation of rIX-FP after a single dose of 50 IU/kg, as well as PK
      evaluation after a single dose of 50 IU/kg of the previously given Factor IX (FIX) product
      (recombinant FIX [rFIX] or plasma derived FIX [pdFIX]) which is used as the reference
      product.
    

Intervention name(s): Recombinant Coagulation Factor IX Albumin Fusion Protein; Plasma derived FIX [pdFIX]
Intervention type(s): Biological; Biological
Intervention description(s): Single dose of 25, 50 or 75 IU/kg of rIX-FP, given as intravenous infusion; Single dose of 50 IU/kg of reference product, given as intravenous infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motivations to Transplant Registry Participation
Condition: Healthy
Study type: Interventional

Summary: 
      The current study seeks to understand factors that influence college students' likelihood of
      participating the National Marrow Donor Program (NMDP)/Be the Match for bone marrow and stem
      cell donations. The secondary aim is to compare emotional and rational approaches to
      encouraging participation in the registry and how these approaches may impact intentions to
      participate in the NMDP.
    

Detailed description: 
      This study is a randomized controlled trial that will randomize participants to receive
      either an emotional appeal about a child with cancer who needs a bone marrow transplant or a
      rational appeal using data on the racial/ethnic disparities within the transplant registry.

      Participants will be recruited through the Psychology Subject Pool, which will then link
      students to the study measures in an online survey. Participants will be asked their age to
      confirm eligibility to participate (students must be between 18-35), and eligible students
      will be presented with the consent form through the online survey system. Participants will
      then be asked to complete measures of demographic information, personality/psychological
      characteristics, and transplant-related knowledge, intentions, and attitudes. All
      participants will then be given background information on bone marrow transplants.

      Randomization: Students will be randomized by sex in the online survey system to the
      emotional presentation condition or the rational presentation condition. The emotional
      condition will tell the story of a fictional pediatric patient with cancer who needs a
      transplant. The rational condition will describe the facts about the need for diversity in
      the registry.

      After being presented with the rational or emotional appeal, participants will again be asked
      about their intentions to register, their motivations for registering, and their mood.
    

Intervention name(s): Emotional Appeal; Rational Appeal
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be presented with a short vignette about a child undergoing cancer treatment and needing a bone marrow transplant in order to survive cancer.; Participants will be presented with data regarding the importance of considering race/ethnicity when looking for a bone marrow transplant donor and the likelihood of finding a match based on the patient's racial/ethnic background.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: stem cell transplant; bone marrow donor; motivations; altruism
Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study examines the impact of certified diabetes education, and the role of different
      educational approaches to medical nutrition therapy. in addition the role of patient health
      literacy level is assessed
    

Detailed description: 
      150 patients with type 2 diabetes with most recent a1c>7% will be enrolled. patients are
      randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a
      modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an
      rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes
      education and health promotion. education sessions will be administered over a 4-6 week
      period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is
      a1c.
    

Intervention name(s): Active Control; int arm 1; int arm 3
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion; VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method; patients receive 3 individualized visits with an rd-cde for education focused on carb counting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; education; health literacy
Patient Specific Induced Pluripotency Stem Cells (PSiPS)
Condition: Hepatic Disorders; Eye Disorders
MeSH terms: Liver Diseases; Eye Diseases
Study type: Observational

Summary: 
      Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically
      reprogrammed to an embryonic stem cell-like state by being forced to express genes and
      factors important for maintaining the defining properties of embryonic stem cells. The
      reprogramming of adult cells into embryonic stem (ES) cells enables the generation of
      patient-specific stem cells and thus has enormous potential for the treatment and analysis of
      degenerative diseases. In this project the investigators are going to induce pluripotent stem
      cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for
      modeling diseases and drug discovery as well as basic research.
    

Detailed description: 
      iPS cells are typically derived by transfection of certain stem cell-associated genes into
      non-pluripotent cells, such as adult fibroblasts. Transfection is typically achieved through
      viral vectors, such as retroviruses. Transfected genes include the master transcriptional
      regulators Oct-3/4 (Pouf51) and Sox2, although to enhance the efficiency of induction some
      other genes e.g. Klf4, c-Myc. In this study after separation the fibroblasts from patient's
      skin biopsy, the cells are transfected with 4 Yamanaka factors (human Oct4, Sox2, Klf4,
      c-Myc) after 3-4 weeks, transfected cells are isolated through morphological selection.
    

Intervention name(s): Biopsy
Intervention type(s): Procedure
Intervention description(s): Skin biopsy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient who suffering from metabolic disorders
      
Keywords: Induced pluripotent stem cells; Hepatic disorders; Eye disorders; Blood groups
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
Condition: Healthy
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      It is well established that endothelial dysfunction is an early predictor of cardiovascular
      events in at-risk patients. Finding safe and effective product able to improve endothelial
      function is of public health interest.

      Many clinical studies have shown that monomer of flavanols from cocoa significantly improved
      endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD)
      after a single dose. Grape is also a main source of flavanol monomers, that's why many human
      studies have shown significant effects of grape-derived products on endothelial function
      within 2 hours following a single dose intake.

      The objective of this study is to assess the effect of 2 doses of a proprietary and
      standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in
      comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a
      grape extract and a blueberry extract. In order to provide supportive evidence on the
      mechanisms and biological plausibility to the clinical effects of the product, appropriate
      biological parameters and circulating metabolites will be assayed.
    


Intervention name(s): Memophenol 300 mg; Memophenol 600 mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.; 600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.; Colored maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: endothelial function; healthy adults; grape and blueberry extracts; flavanol monomers
Monitoring Subjects With Fluid-Management Issues In the Home Environment
Condition: Heart Failure; Hypertension
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This study is designed to validate ease-of-use for the CoVa Monitoring System, along with
      simple statistical parameters such as reproducibility and inter-subject agreement between
      test and reference devices.
    

Detailed description: 
      The study has the following objectives:

      Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if
      subjects could use the test device on a daily basis, and if the components of this system
      (Sensor, Gateway, Web-based System) were indeed operational

      Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in
      any skin irritation

      Objective 3: determine that the long-term reproducibility of measurements made by the test
      device is as good or better than the long-term reproducibility of the reference device
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or
        more diuretic medication(s) prescribed by a physician
      
Keywords: Heart Failure; Impedance; Fluids
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
Condition: Nasolabial Folds; Lipoatrophy; Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested
      the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4
      Gel administered once daily to 50 cm2 of skin for 14 days.
    


Intervention name(s): TAT4 Gel concentration A; TAT4 Gel concentration B; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is conducted in order to find out if repeated doses of the monoclonal (artificially
      manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently
      respond to a treatment with methotrexate (MTX).
    

Detailed description: 
      Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6
      months of treatment with methotrexate fulfilling all other inclusion criteria including
      written informed consent and none of the exclusion criteria (see below) have the opportunity
      to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a
      double-blind set-up.
    

Intervention name(s): BT061; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous administration of the monoclonal antibody BT061; subcutaneous injection of placebo
Other intervention name(s): immune-modulatory antibody BT061; end formulation buffer without active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis
Financial Incentives for Maintenance of Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of financial incentives in improving and
      maintaining weight loss.
    

Detailed description: 
      Study participants will be obese volunteers recruited from a major community-based weight
      loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to
      enrolling in the study. Among these participants, the following will be assessed: 1. The
      effectiveness of a daily lottery-based financial incentive, relative to the control group, on
      weight loss and weight maintenance; 2. The effectiveness of a direct payment incentive,
      relative to the control group, on maintenance of weight loss; 3. Assess the comparative
      effectiveness of lottery-based and direct payment financial incentives on weight loss and
      maintenance; 4. The degree to which weight loss is maintained in the intervention groups
      relative to usual care during the 6 months following cessation of the intervention will also
      be determined.

      During Phase I, incentives will be provided to some study participants (direct payment and
      lottery arm) for the first 6 months and subjects will be followed for 6 more months to
      examine effects following cessation of incentives.
    

Intervention name(s): Financial incentive
Intervention type(s): Behavioral
Intervention description(s): Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Mila Blooms Intervention Study
Condition: Childhood Cancer
Study type: Interventional

Summary: 
      This study is focused on the development and pilot/feasibility testing of a smartphone
      application to promote a healthy diet, increase physical activity, and prevent weight gain in
      adolescent survivors of childhood cancer.
    

Detailed description: 
      While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL)
      have resulted in a growing cohort of survivors, these survivors are at risk for a number of
      long-term health problems. This study proposes to develop and conduct feasibility testing for
      a smartphone application that would deliver a health behavior intervention to this
      population.

      A formative phase focused on intervention and software development will be followed by a
      pilot/feasibility test of the intervention. Participants in the intervention will receive a
      customized study-designed mobile phone app with a social networking component in which users
      will be able to support one another. They will also receive personal support from a health
      counselor to help set goals and discuss areas of concern.
    

Intervention name(s): Mila Blooms
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention will be administered to 30 adolescent childhood cancer survivors & their parents (3 blocks of 10 survivor-parent(s) groups) who serve as their own controls. The intervention phase begins at Week 9 (immediately following the 8-week control phase) and runs for 9 weeks (Weeks 9 - 17). Adolescents are assigned a smartphone installed with the Mila Blooms app to use for the first 8 weeks (Weeks 9 - 16) of the intervention. The app integrates (1) tools for tracking health behaviors (e.g., diet, physical activity, etc.); (2) an avatar system to provide virtual rewards, and (3) a social network of users for support. As part of the intervention, adolescents will also receive weekly coaching phone calls from study staff to discuss areas of concern and to encourage goal-setting & participation. During the 9th week (Week 17), participants complete one final survey & accelerometer wear.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy survivorship; Smartphones; Treatment