bioihbjkbjnl/mcl2 huggingface dataset:
Weight Watchers Online
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial to compare the weight
      losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips
      ActiveLink physical activity system, over a 1-year period, compared to a control group.
    


Intervention name(s): Weight Watchers Online Program; Philips ActiveLink; Eating and Activity Newsletter
Intervention type(s): Behavioral; Device; Behavioral
Intervention description(s): Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.; Provision of a key-chain sized physical activity monitor that interfaces with the Weight Watchers website to promote exercise and give feedback on progress towards exercise goals.; General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible
      contraceptive method. It is also sound safe and cheap contraceptive methods available and is
      nearly maintenance free for up to 10 years.

      The fear and the pain associated with IUDs insertion consider barriers to using this
      contraception method, this is because that the mucosal lining of female genital tract is
      highly sensitive to touch and pain. However; most of small procedures done in this sensitive
      area are performed without analgesia.

      The pain during IUDs insertion is due to application of the tenaculum , traction of the
      cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and
      irritation of the endometrial lining by the IUDs.
    


Intervention name(s): IUD; Uterine sounding; Transvaginal ultrasound
Intervention type(s): Other; Other; Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Lower Extremity Spider Veins With Excel V
Condition: Telangiectasis; Spider Veins
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of a new laser for the
      removal of unsightly spider veins on the legs. The device used in this study is the Cutera
      Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064
      nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received
      510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological
      and vascular conditions, like spider veins.
    

Detailed description: 
      Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
      in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced
      12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser
      treatment). Efficacy will be evaluated by blinded independent physician assessment of
      improvement in treated spider veins using digital photographs taken at baseline and the final
      follow-up visit by a third-party medical photography service. In addition, efficacy will be
      evaluated by the Investigator's mean global assessment of improvement and the subject's mean
      assessment of improvement. Safety will be evaluated by continuous monitoring of adverse
      events (AEs) and measuring pain associated with laser treatment.
    

Intervention name(s): 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Intervention type(s): Device
Intervention description(s): The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows:
Spot Size: 5 mm
Fluence: 13-15 J/cm2
Pulse Duration: 40 ms
Epidermal contact-cooling: 5° Celsius
Other intervention name(s): Excel V laser; ExcelV; KTP; 532nm
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telangiectasis; Spider Veins; Excel V; Cutera; Laser; Leg Veins; Venulectasia; Lower Extremity veins; Laser light; KTP; 532nm
Transcranial Alternating Current Stimulation for Major Depressive Disorder
Condition: Major Depressive Disorder; MDD
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)
      on patients with Major Depressive Disorder (MDD).
    

Detailed description: 
      Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces
      cortical hyperactivity and causes a clinical improvement

      Aim 1: To conduct a pilot clinical trial to establish feasibility and to collect first
      effectiveness data for the use of tACS to renormalize pathological alpha oscillations in the
      dorsolateral prefrontal cortex (dl-pfc) of unmedicated patients with MDD by comparing MADRS
      scores from baseline and one month follow up.

      Aim 2: Compare alpha oscillation power from resting state EEG recordings on the first and
      last day of stimulation. Collect EEG data at the one month follow up visit using this data to
      analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
    

Intervention name(s): tACS (alpha); tACS (gamma)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tACS; Major Depressive Disorder; MDD; mood symptoms; sham
Mechanisms of Inflammatory Liver Injury
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      White blood cells can cause liver damage if they inappropriately accumulate in the liver in
      large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a
      substance released from the cell walls of many species of bacteria. The purpose of this study
      is to isolate neutrophils, an important white blood cell, from the blood of normal
      volunteers, and put them in tissue culture with isolated liver cells. The experiments will
      determine how endotoxin can increase the ability of neutrophils to damage liver cells. All
      studies supported by this grant will be done with isolated cells in tissue culture. This
      experimental model will reveal possible mechanisms that can in the future be evaluated in
      human diseases such as bacterial sepsis.
    

Detailed description: 
      Neutrophils will be isolated from normal human volunteers and placed in cell culture with
      isolated hepatocytes or C3A cells (hepatoblastoma cell line that exhibit many characteristics
      of normal hepatocytes). These experiments will evaluate the mechanisms by which neutrophil
      adhere to the surface of hepatocytes, and the mechanisms by which the attached neutrophils
      can damage or kill the hepatocytes. Mechanisms of adhesion will involve understanding of the
      chemokines released by the hepatocytes that stimulate neutrophil adhesiveness, the cytokines
      that activate hepatocytes to express chemokines and adhesion molecules, the adhesion
      receptors on the neutrophil surface that are able to recognize the adhesion molecules on the
      hepatocyte surface, and the ability of adhesion to enhance and focus cytotoxic chemicals
      coming from the stimulated neutrophils. In addition, the role endotoxin can play in these
      sequence of events is being studies, and the specific cytotoxic mechanisms released by the
      neutrophils are under study. As noted in the brief summary, this grant only supports use of
      human cells in vitro (i.e., all experiments will be done in tissue culture). The purpose of
      working with this experimental model is to define what mechanisms should in future
      experiments be evaluated in patients with endotoxin induced disease.
    

Observational model: Case-Control
Time perspective: Other
Keywords: Liver; Inflammation; Endotoxin; Neutrophils; Hepatocytes
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline
      compared to placebo in the treatment of moderate to severe facial acne vulgaris
    


Intervention name(s): Sarecycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg/kg/day taken orally at the same time each day.; Placebo-matching sarecycline tablets, taken orally at the same time each day.
Intervention MeSH terms: Sarecycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne
To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)
Condition: Rabies Human
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell)
      developed by Hualan Biological in healthy people aged 9 to 65 years with two different
      immunization schedules.
    

Detailed description: 
      The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old
      after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group
      turn antibody positive rate of bad effect on 5 agent in the control group; The safety
      profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were
      noninferior to those of the five-dose regimen at 14 days after the first dose. More people
      aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5
      patients and 5 doses in the control group, four patients and 5 doses group antibody positive
      rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion
      rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course
      of vaccination.
    

Intervention name(s): Control vaccine; Experimental vaccine
Intervention type(s): Biological; Biological
Intervention description(s): A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.; A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Antibody Titer
Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
Condition: Inflammation; Rheumatic Diseases
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Rheumatic Diseases; Collagen Diseases; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that
      primarily affects the spine. It is characterized by inflammation of the spinal joints that
      can lead to severe pain, and in more advanced cases, ankylosis (sections of the spine fuse in
      a fixed, immobile position). The study will be an ascending single and multiple-dose study to
      evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous
      KIN-1901 in healthy subjects and subjects with AS.
    

Detailed description: 
      KIN-1901 is a fully human immunoglobulin monoclonal antibody (mAb) directed towards a
      proinflammatory cytokine that is believed to have a role in inflammation and autoimmunity,
      and is found in synovial fluid from patients with spondyloarthritis. Therefore,
      neutralization of this cytokine activity by specific monoclonal antibodies (mAbs) could be
      beneficial in treating certain spondyloarthropathies such as ankylosing spondylitis (AS).

      The primary objective of the study is to evaluate the safety and tolerability of escalating
      single-dose or once-weekly repeat-dose subcutaneous (SC) administration of KIN-1901 in
      healthy subjects (Cohorts 1 through 4) and in subjects with AS (Cohort 5). The secondary
      objective of the study is to evaluate the pharmacokinetics (PK) of escalating single-dose and
      once-weekly repeat-dose SC administration of KIN-1901 in healthy subjects (Cohorts 1 through
      4) and in subjects with AS (Cohort 5). The following exploratory objectives will also be
      evaluated: (1) To explore the pharmacodynamic (PD) effects of escalating single-dose and
      once-weekly repeat-dose SC administration of KIN-1901 in healthy subjects (Cohorts 1 through
      4), (2) To explore the PD effects and changes in disease activity by Assessment in Ankylosing
      Spondylitis Criteria ASAS 20/40 (and components) and Ankylosing Spondylitis Disease Activity
      Score-CRP (ASDAS-CRP) of once-weekly repeat-dose SC administration of KIN-1901 in subjects
      with AS (Cohort 5), (3) To assess biomarkers of efficacy and safety after once-weekly
      repeat-dose SC administration of KIN-1901 in subjects with AS (Cohort 5).
    

Intervention name(s): KIN-1901; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): KIN-1901 is a fully human monoclonal antibody (mAb).; Saline
Intervention MeSH terms: Gimsilumab
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, double-blind (Sponsor unblind), multi-cohort, placebo-controlled design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spondylitis, Ankylosing
Comparative Atorvastatin Pleiotropic Effects
Condition: Coronary Arteriosclerosis; Hypercholesterolemia
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as
      compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week
      treatment period in subjects with documented coronary artery disease.
    


Intervention name(s): Blood samples; Atorvastatin
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy
Condition: Cardiovascular Disease; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to assess the impact of three months of treatment with an active
      vitamin D analogue on a risk marker for excess overall mortality and cardiovascular
      morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis
      is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and
      mortality in patients with type 1 diabetic kidney disease.
    


Intervention name(s): Paricalcitol
Intervention type(s): Drug
Intervention description(s): capsule, 1-2 micrograms daily for 90 days
Other intervention name(s): Zemplar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular disease and mortality; Plasma NTproBNP; UAER
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
Condition: Hypertension; Left Ventricular Hypertrophy; Overweight
MeSH terms: Hypertension; Essential Hypertension; Hypertrophy, Left Ventricular; Overweight; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of aliskiren in combination with losartan compared to
      losartan on the regression of the increased size of the left ventricle in overweight patients
      with high blood pressure.
    


Intervention name(s): Aliskiren 150/300 mg; Losartan 50/100 mg; Aliskiren placebo; Losartan 50/100 mg placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aliskiren 150 mg tablets; Losartan 50 or 100 mg capsules; Aliskiren 150 mg placebo tablet; Losartan 50/100 mg placebo capsules
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers
Condition: Healthy; Thalamic Pain Syndrome; Fallers
MeSH terms: Stroke
Study type: Observational

Summary: 
      A large proportion of falls in older people occurs when walking. Most studies have recently
      demonstrated correlation between the variations in spatiotemporal gait parameters and fall
      risk in elderly and in several diseases. The investigators objective is to analyse this
      parameters in population with gait stability disorders (post-stroke patients and fallers) to
      identify the most valuable and to develop/test a conglomerate stability score.
    

Detailed description: 
      Temporal-spatial gait parameters will be recorded in subjects aged 65-80 years : 30 healthy
      people, 30 patients at least one year post-stroke, and 30 fallers while walking on an
      electronic walkway GAITRite® at self-selected speed.
    

Intervention name(s): Gait analysis
Intervention type(s): Other
Intervention description(s): walking on an electronic walkway GAITRite® at self-selected speed
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke,
        and 30 fallers
      
Keywords: Gait stability; Spatiotemporal parameters; Walking; Elderly people; Stroke; Fallers
Clinical-genetic Investigations in Children With Early Infantile Epilepsies
Condition: Epilepsy; Seizures, Infantile
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      The project strives to discover novel genetic defects that cause monogenic epilepsy or that
      genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes
      for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral
      malformation, lissencephaly or metabolic disorders and which have a comparatively benign
      prognosis.

      The investigators hypothesize that mutations in genes coding for ion channels or genes that
      modify the action of ion channels might be causative.

      For that the investigators will perform a sequence analysis of the coding exons of a large
      set of genes in all recruited patients and verify found mutations in their parents.
    


Intervention name(s): DNA preparation
Intervention type(s): Genetic
Intervention description(s): Taking blood or saliva from the patient to prepare DNA therefrom
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with infantile seizures without brain malformations, metabolic disorders of
        lissencephaly who had a good outcome and are seizure free (with or without AEDs) after the
        age of 5 years.
      
Biospecimen description: 
      DNA isolated from blood cells or from saliva
Mesenchymal Stem Cells in Knee Cartilage Injuries
Condition: Articular Cartilage Disorder of Knee; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Cartilage Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using
      bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing
      conditions.
    

Detailed description: 
      Fourteen patients from both genders, age range 40-68, will be enrolled according to strict
      inclusion and exclusion criteria, divided into two equal groups based upon receiving
      autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.

      The patients are followed by clinical assessment, laboratory investigations as well as
      magnetic resonance imaging (MRI) of the injected knee.

      The investigators hypothesize that the two groups will give satisfactory clinical outcomes,
      but the investigators are looking forward to assessing the best product that will activate
      chondrogenesis and heal cartilaginous injury.
    

Intervention name(s): Autologous Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bone marrow derived Mesenchymal Stem Cells; Knee articular cartilage injury; Chondrogenesis; orthopedics
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun protection factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation number - SR15-46-Z13-072)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment