bioihbjkbjnl/mcl2 huggingface dataset:
NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The study will evaluate the effectiveness of a standardized EEG method with the intended
      clinical users in the intended clinical settings with the intended population (patients who
      would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined
      to provide a sample of patients across numerous communities with different demographics. The
      goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a
      widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended
      use population as evaluated by Best Estimate Diagnosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study focuses on individuals who have consecutively presented to participating clinics
        with suspected attention and/or behavior concerns and would receive a clinician's
        comprehensive evaluation for ADHD. The study population includes male and female
        participants aged 6-17.99 years regardless of race, ethnicity, and socioeconomic origin.
        Because of inclusion of patients with consecutive presentation to provide a representative
        clinical sample, the exact numbers for sub-groups will not be controlled. The study
        population will include patients with comorbid conditions. The non-ADHD subgroup will
        include patients with other causes of attentional concerns, which may include other common
        psychiatric disorders, organic causes of attention problems (such as poor hearing, vision
        disturbances, remote head injury, substance abuse), and/or no diagnosis.
      
Keywords: ADHD, Attention Deficit Hyperactivity Disorder
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female
      subjects with hair loss.
    


Intervention name(s): Autologous cultured mixed population of dermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to investigate the influence of several anti-diabetic
      regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in
      patients with recently diagnosed type 2 diabetes.
    


Intervention name(s): rosiglitazone; metformin; Anti-diabetic medications
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Rosiglitazone; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rosiglitazone; metformin
Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,
      docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Giving more than one drug
      (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination
      chemotherapy is more effective when given together with zoledronic acid in treating patients
      with breast cancer.

      PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride
      together with cyclophosphamide and docetaxel to see how well it works with or without
      zoledronic acid in treating patients with large resectable or locally advanced breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the value of neoadjuvant chemotherapy comprising doxorubicin hydrochloride,
           cyclophosphamide, and docetaxel with or without zoledronic acid in patients with
           HER2-negative large resectable or locally advanced breast cancer.

      Secondary

        -  To correlate clinical response with pathological responses in both treatment arms.

        -  To evaluate the disease-free survival and overall survival of patients treated with this
           regimen.

        -  To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant
           chemotherapy.

        -  To evaluate heterogeneity of the ER/PR and HER2 measurement in core biopsy and the
           surgical specimen.

      OUTLINE: Patients are randomized between 2 treatment arms.

        -  Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel
           IV on day 1. Patients also receive zoledronic acid IV over 15 minutes on day 1.
           Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or
           unacceptable toxicity.

        -  Arm II: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and
           docetaxel IV as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence
           of disease progression or unacceptable toxicity.
    

Intervention name(s): cyclophosphamide; docetaxel; doxorubicin hydrochloride; zoledronic acid; neoadjuvant therapy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Zoledronic Acid; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER2-negative breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
Condition: Obesity
Study type: Observational

Summary: 
      This research study is designed to validate the precision and accuracy of body measurement
      and composition results from a novel 2D imaging device that operates through a smart-phone
      application. Measurement references will be obtained through DXA, BodPod, BIA, manual
      anthropometry, and previously validated 3D optical scanners.
    

Detailed description: 
      Participation in this study will require a single 3-hour visit to complete. Each person will
      be asked to arrive at PBRC wearing easily removable gym-style clothing. Upon checking in,
      they will first complete the informed consent process, then have their vital signs checked,
      and then women of child-bearing potential will also have a urine sample taken. Outpatient
      clinic procedures will be followed by a series of body size and composition assessments that
      will require an outfit of minimal clothing. Clean spandex shorts, sports bras, and lycra caps
      will be provided.

        -  Anthropometric measurements including hip, waist, arms, and thighs circumferences will
           be collected by a trained observer using a calibrated tape measure.

        -  Body shape will be measured digitally using 2D and 3D optical devices that optimize
           light patterns to calculate depth.

        -  Bioelectrical Impedance Analysis measures the amount of fat and lean mass in the body
           using electrodes positioned close to the feet and hands.

        -  Whole body dual-energy X-ray absorptiometry measures the amount of bone, muscle, and fat
           mass in the body using low energy X-rays.

        -  BodPod estimates whole body volume, fat mass, and fat-free mass of the body using
           variations in air pressure
    

Intervention name(s): VBC
Intervention type(s): Device
Intervention description(s): Body Composition will be measured using the VBC system that takes under 60 seconds per scan. Image capture for VBC will include taking a series of four photos using a smartphone camera. Data from the camera will be downloaded to a local computer and then securely sent to the cloud for automated analysis and results generation. We will conduct two consecutive scans (image captures) for each research participant.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants will be community dwelling and have no life-threatening conditions or
        diseases that would alter their body composition from what is typical for their age, sex,
        ethnicity, and BMI. Overall, participants must be ambulatory, able to withstand lying flat
        on the DXA table for up to 10 minutes, stand without aid for 2 minutes, weigh less than 440
        lbs and be of generally good health.
Cocaine/Crack and Reduction of Compulsion With Biperiden
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Considering the effects of the cholinergic system on the drug reward and self-administration
      mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process.
      Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in
      attenuate compulsion, one o the main symptoms of the drug dependence.
    

Detailed description: 
      Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15
      and 64 years old. The drug dependence has been described by many authors as a dysfunction of
      the brain reward system. Considering the effects of the cholinergic system on the drug reward
      and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine
      dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic
      antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To
      accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be
      study. This is a double-blind controlled and randomized placebo study. All the patients will
      be treated with brief intervention therapy (BIT), and half of them will receive biperiden
      (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated
      through the comparison between the values obtained on the following measures before and after
      the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and
      the presence of the cocaine metabolite (benzoylecgonine) on urine.
    

Intervention name(s): Biperiden; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.; Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Other intervention name(s): Group psychotherapy; Group psychotherapy
Intervention MeSH terms: Biperiden
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; crack; treatment; dependence; biperiden
Durolane Versus Methylprednisolone in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine whether Durolane is non-inferior to methylprednisolone,
      as assessed by level of pain, when each are given as single intra-articular injections for
      the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.
    


Intervention name(s): Durolane is a device, methylprednisolone in a drug
Intervention type(s): Device
Intervention description(s): single intraarticular injection
Other intervention name(s): Durolane and Depo-Medrol are the brand names
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: comparative; randomized; double-blind; non-inferior; knee OA
An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)
Condition: Bronchiolitis
MeSH terms: Bronchiolitis; Signs and Symptoms, Respiratory
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at whether an investigational drug can treat the
      breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.
    


Intervention name(s): montelukast sodium; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 6 months; Duration of Treatment: 6 months
Other intervention name(s): MK0476
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RSV Bronchiolitis
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain
Condition: Chronic Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Previous studies have shown that chronic pain after hysterectomy is common. The aim of this
      study is to investigate the incidence of chronic pain after vaginal or laparoscopic
      hysterectomy for benign reasons. The aim of this prospective study is also to study the role
      of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.
    


Intervention name(s): vaginal or laparoscopic hysterectomy
Intervention type(s): Procedure
Intervention description(s): vaginal hysterectomy or laparoscopic hysterectomy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein
      to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age
      after a 12-month treatment by epicutaneous immunotherapy (EPIT).
    


Intervention name(s): Viaskin Peanut 250mcg; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Peanut extract cutaneous patch; Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract
Other intervention name(s): DBV712
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Plasma Lipoprotein Response to Glucagon-like Peptide-2
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This
      triglyceride can then be released into the blood when another meal is consumed or in response
      to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride
      from the gut is not known. The research team in this study is interested in finding out how
      teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut
      by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.
    

Detailed description: 
      The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper
      advertisements. Each subject will be their own control, receiving both placebo and
      teduglutide, administered on separate occasions. A member of the study team will explain the
      study in detail on visit 1, and if the individual is interested in participating, informed
      consent will be obtained and preliminary screening will occur on visit 2. On visit 3 & 4
      participants will receive a high fat liquid meal after an overnight fast. Hourly blood
      samples will be taken for 5 hours, followed by randomized assignment to receive either
      subcutaneous placebo or teduglutide at visit 3 and the opposite treatment at visit 4.
      Following the injection, blood samples will be taken every 15 minutes for the first hour and
      every 30 minutes for the subsequent 3 hours.
    

Intervention name(s): Teduglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Teduglutide; Placebo
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: On visits 3 & 4, participants will receive either teduglutide or placebo, in random order, 5 hours after a high-fat drink
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intestinal lipoprotein; Gut Peptide; Chylomicrons
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Prospective non-randomized parallel-assignment multi-center clinical investigation. The study
      design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2)
      Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study
      cohorts are to be treated using the full range of ablation power settings in the Instructions
      For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of
      the recommended ablation power settings (40-50 Watts).
    

Detailed description: 
      This clinical investigation is intended to demonstrate the safety and effectiveness of the
      TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating
      drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will
      be conducted under an investigational device exemption and is intended to support market
      approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects
      will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is
      sponsored by Abbott.
    

Intervention name(s): TactiFlex SE; TactiFlex SE - High Standard Power
Intervention type(s): Device; Device
Intervention description(s): Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.; Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Other intervention name(s): TactiFlex Sensor Enabled Ablation Catheter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
Condition: Siderosis
MeSH terms: Siderosis
Study type: Observational

Summary: 
      This protocol intends to detail investigations necessary to evaluate the ocular safety of
      subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot
      8716-098).
    


Intervention name(s): Observational Trial
Intervention type(s): Other
Intervention description(s): No intervention is being used in this study.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A subset of subjects enrolled in study A4321001 and who have received formulated drug
        product.
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Condition: Stroke; Spasticity
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow.
      The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique
      to reduce spasticity and hypertonia and improve function in patients with CNS injury. The
      main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor
      function in patients between 45 and 80 in a chronic state after a stroke. Methods:
      Double-blinded randomized clinical trial. There will be an intervention group (DNHS®
      technique) and a sham control group. The intervention will be 2 sessions, one per week, in
      biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis
      and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and
      Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ±
      (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit)
      in the selected variables will be calculated.
    


Intervention name(s): DNHS ® (Dry Needling for Hypertonia and Spasticity); Sham Dry Needling
Intervention type(s): Device; Device
Intervention description(s): Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei; Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; spasticity; dry needling; upper motor neuron syndrome; motor function