bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Epidemiology--Development of Cardiovascular Risk
Condition: Cardiovascular Diseases; Hypertension; Obesity; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To determine how genetic and environmental factors influence the co-occurrence of obesity and
      hypertension during development and to identify cardiovascular risk factors in adolescence
      that will predict cardiovascular disease in adults.
    

Detailed description: 
      BACKGROUND:

      Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD)
      and those with obesity have a greater risk of hypertension. In children and adolescents, high
      body mass index correlates with elevated blood pressure. Genetic factors make a significant
      contribution to the variation of obesity and hypertension.

      DESIGN NARRATIVE:

      Anthropometric, cardiovascular, physiologic and physical fitness data were used to
      investigate a series of critical issues about the etiology, heterogeneity, comorbidity and
      developmental trajectories of CVD risk factors, including obesity, hypertension and
      cardiovascular health. Using the two datasets, the main questions of the study were
      addressed. How do genes and environment act and interact to create covariation between
      obesity and hypertension, and were the genetic and environmental factors the same at all ages
      (from childhood to late adolescence and adulthood) in both sexes? Areas of research included
      the following: causes of individual differences in anthropometric and cardiovascular
      characteristics, their covariation and developmental change or continuity in adolescence,
      parent-offspring transmission, prediction of cardiovascular risk, and sex, race and
      population differences in genetic and environmental contributions on cardiovascular risk
      factors.
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin
      inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in
      mechanically ventilated patients receiving IV antibiotics.
    

Detailed description: 
      The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin
      fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin
      solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System
      (eFlow Inline System). All patients will receive a standardized course of intravenous (IV)
      antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of
      treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy
      endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score
      (CPIS) during the randomized course of study drug. The study was designed to enroll up to 150
      patients with the desire to enroll at least 140 patients with gram negative pneumonia. The
      study was terminated at 143 when that goal was achieved
    

Intervention name(s): Amikacin fosfomycin inhalation solution; Aerosolized placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System; Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
Other intervention name(s): Amikacin fosfomycin inhalation system (AFIS); eFlow Inline System; eFlow Inline System
Intervention MeSH terms: Amikacin; Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gram-negative pneumonia; Aerosol antibiotics; Mechanical ventilation; Amikacin; Fosfomycin; Pneumonia, Bacterial; Pneumonia; Bacterial Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions
Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention
Condition: Emergency Patient Transported by Ambulance
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      This study aims to verify the effectiveness of the connected network for EMS comprehensive
      technical-support using artificial intelligence (CONNECT-AI) system through demonstration in
      the local community. The study was designed as a prospective non-random cross-intervention
      study design in two preselected communities. The subjects of the study are patients
      transferred to the local emergency department(ED) through an ambulance of a fire department
      in the selected community. If the storage and transmission of information collected by an
      ambulance fails or the information of the transferred patient cannot be verified in the
      transferred ED, it is excluded from the study. In this study, the developed CONNECT-AI system
      was installed in all emergency vehicles and EDs in two regional cohorts, and the
      effectiveness was measured by operating an intersection for the same period. The primary
      outcome is the transfer time spent in the pre-hospital stage, and the secondary outcome is
      whether the optimal transfer hospital is selected.
    


Intervention name(s): CONNECT AI system group
Intervention type(s): Other
Intervention description(s): A. During the Intervention period, paramedics wear equipment for multi-faceted data acquisition and press the start button of the system.
B. During the Intervention period, inside the ambulance, a application that implements a function that automatically evaluates the patient's severity, displays a list of optimal transfer hospitals based on this, and shares real-time information of the hospitals, is installed so that paramedics can refer to the work.
C. ED's medical staff will receive through ER-kiosk pre-hospital patient information collected and analyzed through the CONNECT AI system before arrival.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity
Condition: Upper Limb Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle
      overactivity in the upper limb following stroke or brain traums. This is a critical step in
      the development of local intramuscular treatment for patients with muscle overactivity
      following an acute brain lesions, as opposed to the more classic oral treatments.

      This study will be a multicenter, randomized, prospective, parallel, double blind study that
      enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and
      Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared
      to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as
      evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will be
      an 18 week study. Subjects are eligible if they have been medically stable with upper limb
      spasticity 6 months after their first stroke. Subjects will be randomized to one of three
      treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo, Treatment Group
      II - intramuscular placebo plus oral Zanaflex®, Treatment Group III - intramuscular placebo
      plus oral placebo. The dose of BOTOX® will be at the discretion of the investigator with a
      maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day to a maximum of
      36mg/day. The study anticipates that 150 subjects will be enrolled to provide sufficient
      information to answer the primary objective of safety and efficacy of the study.
    


Intervention name(s): BOTOX®; Zanaflex®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tizanidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Condition: Blepharospasm
MeSH terms: Blepharospasm
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline.
      Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to
      five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
    


Intervention name(s): incobotulinumtoxinA (Xeomin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection; Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TD-9855 Mass Balance Study
Condition: ADHD; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the absorption, distribution, metabolism, and
      excretion (ADME) of a single oral dose of [14C]TD-9855
    


Intervention name(s): TD-9855
Intervention type(s): Drug
Intervention description(s): radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Fibromyalgia
Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      It is important to confirm health benefits experienced by breast cancer survivors after
      participation in a physical activity behavior change intervention. One such potential benefit
      is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk.
      Because little is known about how physical activity behavior change interventions influence
      inflammation in breast cancer survivors, the investigators study will measure inflammation
      with blood markers known as cytokines among breast cancer survivors before and after a
      physical activity intervention. Such information has the potential to lead to improved
      physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer
      risk in breast cancer survivors.
    


Intervention name(s): Exercise Behavior Change
Intervention type(s): Behavioral
Intervention description(s): Multidisciplinary
Other intervention name(s): physical activity; exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast cancer; Exercise; Biomarkers
Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study aims to develop Turkish version of the Diabetes Quality of Life Brief Clinical
      Inventory (DQL-BCI) and to perform validity and reliability evaluations.
    

Detailed description: 
      The study will be carried out in two phases: DQL-BCI will be translated into Turkish and
      adapted to the cultural context, and the reliability and validity of the Turkish version of
      DQL-BCI will be investigated. The translation process will be performed in accordance with
      generally accepted international principles of translation and cultural adaptation of
      measurement tools. At least 150 subjects with type 2 diabetes will complete the Turkish
      version of DQL-BCI, the EQ-5D-3L questionnaire and the SF-12 quality of life questionnaire.
      The examination will provide information about the reliability and the construct validity of
      the studied tool.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): The original form of the Diabetes Quality of Life-Brief Clinical Inventory was first developed in 1999 to establish a valid and reliable form of diabetes-specific quality of life. Inventory items were developed to address the issues that have the greatest impact on assessing patient self-care behaviors and satisfaction with diabetes care. Items are ranked on a 5-point Likert scale and are in two general formats. One format includes satisfaction with treatment and quality of life and is scored from 1 (very satisfied) to 5 (not very satisfied). The second format includes the frequency of adverse effects of diabetes itself or diabetes treatment and offers response options from 1 (never) to 5 (always). Therefore, higher scores on the DQL-BCI items and subscales include negative values indicating problem frequency or dissatisfaction. In order to use the DQL scale more efficiently in clinics, Burroughs et al. organized the 15-item DQL-BCI in 2004.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Aged between 18-65 years old with diabetes
      
Keywords: Diabetes; Quality of Life
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
Condition: Chronic Lower Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment
      withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced
      subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid
      treatment ≥ 40 mg morphine equivalent dose (MED). The study includes 5 phases: A Screening
      Phase (up to 2 weeks), a Transition Phase (up to 2 weeks), an Open-Label Titration Phase (up
      to 10 weeks), a Double-Blind Treatment Phase including a Final Study Visit (12 weeks), and a
      Follow-up Phase (4 weeks). The overall duration of participation in the core phase of the
      study (randomized Double-Blind Phase) is up to 30 weeks, from the Screening Phase through the
      Follow-up Phase. Subjects who complete the Double-Blind Treatment Study Phase will be offered
      an opportunity to continue treatment in an open label safety extension for up to 60 weeks.
      Additional subjects may be recruited to open label safety extension to meet the goal of 100
      subjects with 60 weeks of treatment.
    


Intervention name(s): buprenorphine; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): CAM2038
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
      cancer cells from growing.

      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating
      patients who have metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+
           antigen-specific T-cell clones in patients with metastatic melanoma.

        -  Estimate the duration of in vivo persistence of adoptively transferred CD8+
           antigen-specific cytotoxic T-cell clones in these patients.

        -  Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.

      OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic
      T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients
      receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes
      on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of
      courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed for approximately 1 year after the last infusion.

      PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
    

Intervention name(s): aldesleukin; therapeutic tumor infiltrating lymphocytes
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aldesleukin
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
HAIC Plus Lenvatinib and Toripalimab for Advanced HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion
      chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in
      patients with advanced hepatocellular carcinoma (HCC)
    

Detailed description: 
      Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin
      was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib
      in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death
      protein-1 (PD-1) antibody was effective and tolerable in patients with advanced
      hepatocellular carcinoma. No study has evaluated HAIC plus lenvatinib and toripalimab. Thus,
      the investigators carried out this prospective, single-arm study to find out it.
    

Intervention name(s): Hepatic arterial infusion chemotherapy; Lenvatinib; Toripalimab
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks; 12 mg (or 8 mg) once daily (QD) oral dosing.; 240mg intravenously every 3 weeks
Intervention MeSH terms: Lenvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Hepatic artery infusion chemotherapy; Oxaliplatin, 5-Fluorouracil and Leucovorin; Lenvatinib; Toripalimab
Two Preventive Measures on Caries Progression in Mixed Dentition Patients.
Condition: Dentist's Role
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      Assessing the clinical effect of SDF and Laser on the prevention of initial caries
      progression with and without pits and fissure sealants in both permanent and primary molars.

      Secondary Objective:

      Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
    

Detailed description: 
      Primary Objective:

      Assessing the clinical effect of SDF and Laser on the prevention of initial caries
      progression with and without pits and fissure sealants in both permanent and primary molars.

      Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period

      Secondary Objective:

      Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

      Measured by Simonson's criteria over 1 year follow up period.
    

Intervention name(s): SDF1; Diode Laser; Pit Fissure Sealant
Intervention type(s): Drug; Device; Drug
Intervention description(s): Topical SDF application; Irradiating Enamel by Diode laser; Sealing occlusal pits and fissures
Other intervention name(s): silver diamine fluoride; Class 4 dental laser; PFS
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SDF; Diode Laser; Pits and fissure sealants; primary molars; permanent molars
Raltegravir and Ezetimibe PK Study
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when
      co-administered to male and female healthy volunteers.
    


Intervention name(s): Raltegravir and ezetimibe; Ezetimibe and raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): Group 1: raltegravir 400 mg orally twice daily for 10 days followed by 10 days of raltegravir 400 mg twice daily and ezetimibe 10 mg orally once daily for 10 days followed by a 10 days wash out period and ezetimibe 10 mg once daily for 10 days; Group2: ezetimibe 10 mg orally once daily for 10 days followed by ezetimibe 10 mg and raltegravir 400 mg orally twice daily for 10 days followed by a 10 days wash out period and raltegravir 400 mg twice daily for 10 days
Intervention MeSH terms: Raltegravir Potassium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment