bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Epidemiology of Change in CVD Risk Factors
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To extend knowledge of the genetic factors affecting the course of cardiovascular disease
      risk factor development over a substantial portion of an individual's lifetime.
    

Detailed description: 
      BACKGROUND:

      While the onset of symptomatic cardiovascular disease (CVD) typically occurs in middle age or
      later, the development of the underlying pathology is clearly a long-term process, and
      early-state lesions having been identified at autopsy even in children. Understanding the
      course of CVD risk development from childhood into middle age will clearly be valuable both
      in understanding the pathology of CVD and in targeting preventive measures most effectively.
      Furthermore, while genetic factors are agreed to play a significant role in the development
      of CVD, most genes contributing to interindividual variation in CVD risk will have relatively
      small effects on risk for any given individual, even though their aggregate effects
      contribute significantly to CVD risk in the overall population. Relatively little is known
      about the effects of genetic variants on the course of CVD risk factor development in
      individuals over time. The Bogalusa Heart Study (BHS), which began in 1973 as a study of CVD
      risk factors in children but evolved to cover the development of CVD risk factors from
      childhood into early middle age, offers an unparalleled resource for investigating the
      genetic factors influencing within-individual changes over time in quantitative factors, such
      as serum lipids and blood pressure, related to CVD risk.

      DESIGN NARRATIVE:

      Approximately 1500 individuals who were examined in the BHS on at least three separate
      occasions over a period of up to 20 years, and who consented to participate in studies of
      genetic factors influencing CVD risk, will have genotypes measured at selected loci either
      known or strongly suspected to affect interindividual variation in CVD risk. Longitudinal
      multilevel regression will be used to measure the effects of variation at these loci on
      quantitative CVD risk factor profiles within individuals and to determine whether some gene
      effects on CVD risk variation are age-dependent.
    

Intervention name(s): Polymorphisms measured
Intervention type(s): Genetic
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community study of schoolchildren in Bogalusa, Louisiana, with follow-up into young
        adulthood. Both whites and African Americans recruited.
This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep
Condition: Sleep
Study type: Interventional

Summary: 
      Thermal comfort and subsequent sleep quality will improve with the use of bedding that
      incorporates thermoregulation technology, in comparison to standard bedding products.
    

Detailed description: 
      Participants will spend nights sleeping in the residential module of the Well Living Lab.
      Participants will cross over from normal sheets to hygro cotton sheets to assess impact of
      different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.
    

Intervention name(s): hygro cotton sheets
Intervention type(s): Other
Intervention description(s): hygro cotton sheets will be utilized to impact microclimate
Intervention model: Sequential Assignment
Intervention model description: Participants will be randomly assigned to sleep in the residential module of the Well Living Lab. One week will be with standard sheets, followed by one week of hygro cotton sheets.
Masking: None (Open Label)
Primary purpose: Other
Effect of Platform Swing Walkway on Locomotor Behavior in Diplegic Children
Condition: Vestibular Rehabilitation
Study type: Interventional

Summary: 
      Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory,
      olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural
      reflexes, creating synchronized eye movements, and visual attention skills, the vestibular
      system is particularly important.
    

Detailed description: 
      Thirty diaplegic cerebral palsied children of both sexes, ranged in age from 3 to 6 years
      enrolled in this study. They randomly assigned into two groups of equal number; control group
      (A), study group (B). Group (A) groups received the conventional physical therapy program
      based on neurodevelopmental approach for such cases. Whereas study group (B) received the
      same conventional physical therapy program given to group (A) in addition to gait training on
      platform swing walkway for 30 minute. All children were assessed before and after the
      treatment program by using 2D video based gait assessment system to measure the percentage of
      swing and stance phase, also GMFM was used to assess standing and walking, running, and
      jumping abilities, domains (D) and (E).
    

Intervention name(s): conventional physical therapy program; gait training on platform swing walkway
Intervention type(s): Other; Other
Intervention description(s): traditional physical therapy program; gait training on platform swing walkway for 30 minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Drug Delivery Devices for Osteomyelitis
Condition: Osteomyelitis
MeSH terms: Osteomyelitis
Study type: Observational

Summary: 
      Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of
      the lower extremities were included in the retrospective investigation. The patients were
      assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate
      and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological
      parameters, eradication of infection, rate of infection recurrence and reoperation rate were
      evaluated during the follow-up.
    


Intervention name(s): antibiotic-loaded calcium sulfate; antibiotic-loaded polymethyl methacrylate; Vancomycin
Intervention type(s): Device; Device; Drug
Intervention description(s): To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.; One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.; Vancomycin powder was added into the combination therapy group and PMMA groups
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Antibiotics, Antitubercular; Polymethyl Methacrylate; Calcium
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Between April 2011 and April 2015, fifty-one patients requiring surgical treatment for
        chronic post-traumatic/postoperative osteomyelitis of the lower extremities were enrolled
        in a retrospective and control study in our hospital.
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug
      Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month
      double-blind period versus sham followed by a 2 month open label period.
    


Intervention name(s): 700 μg Dexamethasone; Sham
Intervention type(s): Drug; Other
Intervention description(s): 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.; Sham administered in the study eye on Day 1.
Other intervention name(s): Ozurdex®
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD
Condition: Anxiety; Obsessive Compulsive Disorder
MeSH terms: Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for
      anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality
      exposures and to make therapy more available and accessible for patients with anxiety
      disorders. The societal benefit of increased access to therapy is that, if successful, it
      will increase the number of patients who receive appropriate treatment for an anxiety
      disorder.
    

Detailed description: 
      Twenty children with CADs or OCD who have received less than 3 treatment sessions and a
      parent will be recruited to pilot the VR system. Participants will be identified through the
      Mayo Clinic Pediatric Anxiety Disorders Clinic. Each patient will participate in a single (up
      to) 2-hour visit. During the first 30 minutes the patient and parent will be introduced to
      the VR system and the rationale for this feasibility study. Next, a therapist will lead the
      patient through exposure exercises using the VR system for up to 30 minutes. During the next
      period, up to 30 minutes, the therapist will go to a different room and the patient, with
      support from their parent, will complete exposure exercises using the VR system that the
      therapist directed them to complete. During the exposures the interviewer will observe, code
      and record the patient's interaction with the VR system. For the remaining time (up to 30
      minutes) the interviewer will interview the patient about his or her experience with the VR
      system and then will ask for observations and opinions from the parent.
    

Intervention name(s): Virtual Reality
Intervention type(s): Other
Intervention description(s): Use of virtual reality to deliver exposure therapy
Other intervention name(s): Google Cardboard
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; OCD; Obsessive Compulsive Disorder; Generalized Anxiety; Social Phobia; Separation Anxiety; GAD; Youth; Teen; Therapy
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients presenting a deterioration of the general state (performance status [PS] 2-3),
      constitute a population which needs an adapted treatment. An analysis was made of the
      evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594
      trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel,
      docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to
      the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end
      of this study, with the analysis of total toxicity, this one was not higher than that noted
      in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been
      noted, but the analysis showed that only 2 were due to the treatment. It was noted that the
      lower survival compared to the others was related to the disease and not to the treatment.
      These patients are often symptomatic and need palliative treatment. The benefit of
      chemotherapy should not be denied. They should profit from a monochemotherapy with the new
      cytotoxic agents, without associated platinum salt.
    

Detailed description: 
      Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22)

      Arm B Gemzar 1250 mg/m² d1 & d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily

      Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily
    

Intervention name(s): Gefitinib; gemcitabine; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mg/day, until progression; 1250 mg/m² D1 and D8 (D1=D28, until progression); 75 mg/m² D1 (D1=D22, until progression)
Intervention MeSH terms: Gemcitabine; Docetaxel; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB/IV NSCLC; patients with performance status 2 or 3.
Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
Condition: Congenital Afibrinogenemia; Congenital Hypofibrinogenemia
MeSH terms: Afibrinogenemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in
      patients with congenital fibrinogen deficiency.
    

Detailed description: 
      The present study is designed as a prospective, open-label, multicentre, phase I/III study
      investigating the 14 day single-dose pharmacokinetic properties, efficacy and safety of BT524
      following intravenous administration in the treatment or prophylaxis of bleeding in patients
      with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
    

Intervention name(s): BT524 (fibrinogen concentrate from human plasma)
Intervention type(s): Biological
Intervention description(s): single intravenous infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibrinogen, bleeding,
Soy Protein in Early Diabetic Nephropathy
Condition: Diabetic Nephropathy; Diabetes Mellitus
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary
      protein has been used to slow down renal disease progression, but patients are often
      unwilling to make these dietary changes. Other research suggests that changing the quality of
      dietary protein may be as effective as reducing the total amount of ingested protein. This
      study hopes to show that soy protein, a plant protein relatively high in essential amino
      acids and with high nutritional value, maye be beneficial to Type I diabetic patients with
      incipient renal disease.
    


Intervention name(s): soy protein
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetic nephropathy; nephropathy; diabetes; diabetes mellitus; type I diabetes; soy protein
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Condition: Varicella; Measles; Mumps; Rubella; Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Diphtheria; Measles; Chickenpox; Herpes Zoster; Poliomyelitis; Rubella; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

        -  To demonstrate that ProQuad® can be administered concomitantly with a booster dose of
           Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the
           antibody response rates to measles, mumps, rubella, varicella, hepatitis B and
           Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days
           following vaccination.

      Secondary Objectives:

        -  To describe the antibody titres and the antibody response rates to measles, mumps,
           rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
           Haemophilus influenzae type b as measured at 42 days following vaccination by an
           Infanrix® hexa primary series schedule and all data are pooled.

        -  To evaluate the safety profile of ProQuad® when administered concomitantly with a
           booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data
           are pooled.
    


Intervention name(s): ProQuad®; Infanrix® hexa
Intervention type(s): Biological; Biological
Intervention description(s): Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose [CCID]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units [PFU]).; Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mumps and Rubella; Haemophilus influenzae type b (Infanrix® hexa)
Monitoring of Lung Sounds of Patients With Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia; Respiratory Sounds
Study type: Observational

Summary: 
      The aim of this study is to investigate if any correlation between lung sounds of pneumonia
      patients and the clinical development or therapy of the pneumonia exists.
    


Intervention name(s): Lung sound analyzer
Intervention type(s): Device
Intervention description(s): Patients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay.
Other intervention name(s): Electronic stethoscope; Model 3200; Littmann 3M
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with ambulant aquired pneumonia
AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control
      in patients with Type 2 Diabetes Mellitus.
    


Intervention name(s): rosiglitazone/metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; AVANDAMET; Type 2 diabetes
Transpelvic Magnetic Stimulation to Improve Urogenital Function
Condition: Prostate Cancer; Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Interventional

Summary: 
      After recruitment, 20 male patients will be assigned 1:1 to either age-matched control (G1:
      sham) or age-matched intervention (G2: pelvic magnetic stimulation; TPMS) groups using
      computer-generated process, and baseline parameters will be established. All patients will be
      instructed by the investigators to perform standard of care pelvic floor exercise for the
      duration of the study. In addition, G2 patients will receive TPMS, while G1 patients will
      undergo sham treatment.
    

Detailed description: 
      The investigators will use a custom TPMS device that targets pelvic muscles. The
      investigators will apply low amplitude (5%) TPMS to improve blood flow, then high amplitude
      (30-50%) to strengthen pelvic muscles. The treatment regimen will involve two 20-minute
      sessions/visit and 2 -visits per week for 12-weeks (final monitoring at 24 weeks). TPMS will
      be administered by a trained clinical coordinator under the supervision of a urologist.
      Symptom scores and hemodynamic changes will be evaluated monthly. MRI for assessing muscle
      thickness will be performed in the beginning (before TPMS) and at the end (after TPMS) of the
      study. The investigators will assess functional improvements using symptom scores.
      Morphological changes will be determined by MRI.
    

Intervention name(s): Sham Magnetic stimulation
Intervention type(s): Procedure
Intervention description(s): Sham Magnetic stimulation for comparison.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention to prevent prostate cancer surgery related urological issues
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: urinary incontinence; hemodynamics
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
Condition: Memory Disorders
MeSH terms: Memory Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study was to explore in a more documented way the relative potential and
      efficacy of piracetam 9600 and 4800 mg daily.
    


Intervention name(s): Piracetam
Intervention type(s): Drug
Intervention MeSH terms: Piracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Piracetam; Nootropil
Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Condition: Acute Bronchial Obstruction, Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide
      plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute
      bronchial obstruction attending emergency services
    


Intervention name(s): Formoterol fumerate; fenoterol/ipratropium bromide
Intervention type(s): Drug; Drug
Intervention description(s): 12 micrograms stat (twice if necessary). Inhaled via aerolizer; 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.
Intervention MeSH terms: Bromides; Fenoterol; Formoterol Fumarate; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children