bioihbjkbjnl/mcl2 huggingface dataset:
Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine
      administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52
      weeks
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function
Condition: Hepatic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety and efficacy of irreversible
      electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free
      Survival (PFS) and Over Survival (OS) will be recorded.
    

Detailed description: 
      Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of
      patients are unsuitable for tumor resection because of factors such as poor hepatic
      reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments
      include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible
      electroporation had been used successful as a therapeutic choice for unresectable patients.
      At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation
      technology, can induce tissue necross by utilizing short pulses of high-voltage electrical
      energy. The technique also had many advantages, including Short ablation time, preservation
      of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete
      ablation with well-demarcated margin and real-time monitoring of IRE ablation.
    

Intervention name(s): NanoKnife LEDC System
Intervention type(s): Device
Intervention description(s): 90 pulses of 70 microseconds each in duration will be administered per electrode pair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate)
      on brain magnetic resonance imaging (MRI) lesions in pediatric participants with
      relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to
      characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to
      evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.
    


Intervention name(s): dimethyl fumarate
Intervention type(s): Drug
Other intervention name(s): BG00012; DMF
Intervention MeSH terms: Dimethyl Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics
Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
Condition: Blood Pressure; Kidney Failure, Chronic; Dietary Modification
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of nutritional supplementation during
      hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover
      design.
    

Detailed description: 
      The consumption of food or nutritional supplements during hemodialysis treatment has been
      shown to improve nutritional status, improve quality of life, and reduce mortality.

      Despite these observations, allowing patients to eat food during hemodialysis treatment is
      sometimes restricted in the United States. The reasons for this restrictive policy are
      multi-factorial, but include concerns related to drops in blood pressure BP or a reduced
      efficiency of solute removal following eating during HD treatment. An alternative to eating
      solid food is to provide patients with liquid nutritional supplements. Clinics in the US are
      more likely to allow the consumption of liquid nutritional supplements, however, little is
      known about the effect that liquid supplements have on blood pressure or treatment
      efficiency. Therefore, the investigators plan to examine the effect of nutritional
      supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a
      crossover design.
    

Intervention name(s): Nepro
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will be asked to consume a single 8 oz can of Nepro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
EPAT: Estrogen in the Prevention of Atherosclerosis Trial
Condition: Atherosclerosis; Postmenopause
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the effects of estrogen replacement therapy (ERT)
      on the progression of early atherosclerosis in healthy postmenopausal women without
      preexisting cardiovascular disease (CVD).
    

Detailed description: 
      The primary goal of this randomized, controlled trial is to determine if ERT stabilizes,
      retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will
      further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in
      the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of
      change in the thickness of the carotid artery. Blood samples will be used for measuring lipid
      and non-lipid mediators of ERT.

      A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be
      randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching
      placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive
      pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo
      ultrasonography at baseline and every 6 months throughout the 2 years of randomized
      treatment. Measurements of lipid and non-lipid biochemical markers will also be done at
      baseline and every 6 months.
    

Intervention name(s): Micronized 17B-estradiol
Intervention type(s): Drug
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: cardiovascular disease; CVD; estrogen; cholesterol; LDL; lipids; postmenopausal
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II clinical trial to analyze safety and efficiency of intralesional application of
      the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic
      melanoma stage III/IV and unresectable metastasis.
    

Detailed description: 
      Phase I/II clinical trial to analyze safety and efficiency of intralesional application of
      the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic
      melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops
      of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with
      dose escalation.
    

Intervention name(s): rM28; autologous PBMCs
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mRNA; vaccination; melanoma
Intravenous Cannulation In Children During Sevoflurane Induction
Condition: Catheterization
Study type: Interventional

Summary: 
      This interventional simple-blind,randomized trial has included 90 children of American
      Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of
      either sex, scheduled for for outpatient minor surgery under general anesthesia. This study
      examined whether one should make iv attempts during the early induction period (at 60
      seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane
      inhalation anesthesia.
    

Detailed description: 
      We conducted a prospective randomized study, after obtaining Institutional review board
      approval, which didn't require written parental consent. Children age 1-12 years, undergoing
      elective general anesthesia via an inhalation induction were randomized to one of three
      groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L)
      following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were
      determined. Difficulty with iv placement was also recorded. Statistical analysis included
      contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered
      significant.
    

Intervention name(s): Difficulty of catheterization in group 60 s; Difficulty of catheterization in group 90 s; Difficulty of catheterization in group 120 s
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized and crossover assignemnt
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sevoflurane, Catheterization, Anesthetics Inhalation, child
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Condition: Hyperparathyroidism
MeSH terms: Hyperparathyroidism
Study type: Interventional

Summary: 
      This study will evaluate whether commonly used blood pressure medications called "ACE
      inhibitors" can lower parathyroid hormone.
    

Detailed description: 
      The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can
      lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of
      primary hyperparathyroidism.

      Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with
      increased PTH. The principal investigator, and other investigators, have previously shown
      that inhibiting the RAAS may lower PTH. The current study will focus on:

        1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH
           in normal individuals?

        2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary
           hyperparathyroidism?

      The results of this study may have important implications for cardiovascular and skeletal
      health, as both the RAAS and PTH have been implicated as mediators of these conditions.
    

Intervention name(s): Lisinopril
Intervention type(s): Drug
Intervention description(s): Each subject will receive one week of lisinopril and return for repeat for blood measurements.
Intervention MeSH terms: Lisinopril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hyperparathyroidism; Renin-angiotensin-aldosterone system; ACE inhibitors
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of the trial is to investigate the safety and
      efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with
      haemophilia A.
    


Intervention name(s): turoctocog alfa pegol
Intervention type(s): Drug
Intervention description(s): For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis
Other intervention name(s): NNC 0129-0000-1003; N8-GP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Daily Mango Intake on Cardiovascular Health
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      In the current proposal the investigators seek to evaluate the acute and short-term effects
      of mango intake on vascular and platelet function in postmenopausal women between 50 and 70
      years old.

      Our aims are 1) to determine if two weeks of daily mango intake will result in favorable
      changes in measures of vascular function, as measured using peripheral arterial tonometry
      (PAT) and platelet reactivity, in overweight and obese postmenopausal women. 2) to determine
      if two weeks of daily mango intake will change the fermentation capacity of gut microbiota.

      Investigators hypothesize that the daily intake of 330 grams of mango (2 cups) will
      significantly increase PAT while reducing platelet aggregation after 2 hours and two weeks of
      daily intake.
    


Intervention name(s): Mango; No intervention
Intervention type(s): Other; Other
Intervention description(s): 330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening; No mango intake for two weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Turmeric on Pruritus in Hemodialysis Patients
Condition: End Stage Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to see whether turmeric can be effective in treatment of
      pruritus in hemodialysis patients.
    

Detailed description: 
      pruritus is a common in hemodialysis patients and many treatment recommended for it . as
      turmeric has anti-inflammatory , anti-cytokine and anti-oxidant effect it may effective in
      treatment of uremic pruritus. thus we compared turmeric with placebo in this study
    

Intervention name(s): turmeric; placebo; turmeric
Intervention type(s): Drug; Drug; Drug
Intervention description(s): turmeric 500 md tid orally for 8 weeks; placebo 3 time orally for 8 weeks; 500 mg tid orally for 8 weeks
Intervention MeSH terms: Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hemodialysis; turmeric; pruritus
Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine
      on metabolic parameters and syndrome in patients with schizophrenia.
    

Detailed description: 
      The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and
      is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are
      twice as likely to die from, and three times as likely to suffer from a heart attack or
      stroke compared to individuals without the syndrome.

      Patients on atypical antipsychotic medication should be considered a high risk group for
      diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics
      and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.
    

Intervention name(s): Sertindole; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days; 10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine; Sertindole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia
Feasibility Study of a Novel Single Use Robotic Colonoscopy System
Condition: Colonic Polyp; Colon Adenoma; Colorectal Cancer
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System,
      followed immediately by a conventional colonoscope (CC). Each trial subject will undergo
      colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this
      study is to obtain observational data on the safety profile, feasibility and usability of the
      NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of
      procedural pain experienced by subjects will also be explored.
    


Intervention name(s): NISInspire-C System
Intervention type(s): Device
Intervention description(s): The NISInspire-C System is a disposable robotic colonoscopy system that consists of a flexible slender insertion tube designed to ensure non-invasive, reliable and safe colorectal screening. It comprises of two components: NISInspire-C Console, and the NISInspire-C Disposable Colonoscope.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Robotic Colonoscopy; Tandem Colonoscopy; NISInspire-C System; Single Use Colonoscope; Colonoscopy
Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
Condition: Moderate to Severe Chronic, Non-malignant Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and
      acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low
      back pain.
    


Intervention name(s): Hydrocodone/Acetaminophen on Extended Release
Intervention type(s): Drug
Intervention description(s): 2 tablets twice daily
Other intervention name(s): ABT-712
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydrocodone/Acetaminophen; Vicodin CR
Effect of Fresh Gas Flow on Emergence Time
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of fresh gas flow on emergence time in
      patients undergoing transurethral resection of bladder tumor.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of fresh gas flow (5 L/min vs. 10 L/min)
      on emergence time in patients undergoing transurethral resection of bladder tumor.
    

Intervention name(s): Fresh gas flow of 5 L/min; Fresh gas flow of 10 L/min
Intervention type(s): Procedure; Procedure
Intervention description(s): A fresh gas flow of 5 L/min is used during emergence from general anesthesia.; A fresh gas flow of 10 L/min is used during emergence from general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to evaluate the long-term safety and tolerability of teriflunomide
      when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with
      multiple sclerosis [MS] with relapses.

      Secondary objectives were to evaluate the long-term effect on relapse rate, disability
      progression and Magnetic Resonance Imaging [MRI] parameters.

      This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865)
      studies. Participants who successfully completed the initial study were offered to continue
      their treatment (same compound, same dose) for 24 additional weeks.
    

Detailed description: 
      The duration of the extension study per participants was 40 weeks broken down as follows:

        -  24-week double-blind treatment period,

        -  16-week post-treatment elimination follow-up period.
    

Intervention name(s): Teriflunomide; Placebo (for teriflunomide); Interferon-β [IFN-β]; Glatiramer Acetate [GA]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablet
Oral administration; Film-coated tablet
Oral administration; Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection; Solution in prefilled syringe for subcutaneous injection
Other intervention name(s): HMR1726; Avonex®; Rebif®; Betaseron®; Copaxone®
Intervention MeSH terms: Interferons; Interferon-beta; Teriflunomide; Glatiramer Acetate; Interferon beta-1b; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Clinical Study to Evaluate the Performance of the Profound System for the Treatment of
      Cellulite.
    

Detailed description: 
      Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from
      up to 3 investigational sites.

      Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to
      evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive
      treatment of the upper thighs and buttocks cellulite appearance.

      The treatment areas of the study subjects will be divided into two arms:

        1. Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a
           single Profound treatment utilizing the Dermal and SubQ Cartridges

        2. Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single
           Profound treatment utilizing the SubQ Cartridge only.

      Methodology described in protocol to evaluate efficacy of treatments will be carried out at
      each visit.
    

Intervention name(s): Profound
Intervention type(s): Device
Intervention description(s): The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (RF) energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment