bioihbjkbjnl/mcl2 huggingface dataset:
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of this study is to see if giving LDX to children and adolescents aged 6-17
      years with ADHD decreases symptoms of ADHD.
    


Intervention name(s): Lisdexamfetamine Dimesylate (LDX); Methylphenidate Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30, 50 or 70mg capsule once per day (Overencapsulated); 18, 36, or 54mg tablet one per day (Overencapsulated); Placebo capsule once per day (Overencapsulated)
Other intervention name(s): Vyvanse™; Concerta®, OROS MPH
Intervention MeSH terms: Methylphenidate; Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of behavioral treatment, drug
      treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder
      (ADHD). This study will also examine the interactions between different levels of behavioral
      and drug treatments.
    

Detailed description: 
      Participants attend a summer treatment program each Monday-Friday for 9 weeks. They
      participate in group recreational and classroom activities, with 12 children and 5 staff per
      group. Three behavioral conditions (no behavioral modification, low-intensity behavioral
      modification, and high-intensity behavioral modification) are delivered in random order, with
      each condition lasting 3 weeks. Along with the behavioral treatment conditions, children
      receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg
      methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily
      and repeated 3 or 4 times within each behavioral treatment condition.

      Measures include frequency counts of positive and negative behaviors, academic productivity
      and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and
      side effects. Parents attend training sessions and implement behavioral programs at home.
    

Intervention name(s): Methylphenidate 0.15 mg/kg; Low-Intensity BMOD; Methylphenidate 0.3 mg/kg; Placebo; Methylphenidate 0.6 mg/kg; High Intensity BMOD
Intervention type(s): Drug; Behavioral; Drug; Drug; Drug; Behavioral
Intervention description(s): 0.15 m/kg/dose immediate-release methylphenidate; Lower-intensity behavioral treatment package.; 0.3 mg/kg/dose immediate-release methylphenidate; 0.3 mg/kg/dose immediate-release methylphenidate; Comprehensive high-intensity Summer Treatment Program (STP)
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
Condition: Moderate Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple-center, nonrandomized, open label, parallel group, single dose study will be
      conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh
      Class B) hepatic impairment to evaluate the effect of hepatic impairment on the
      pharmacokinetics (PK) of KBP-5074.
    


Intervention name(s): KBP-5074
Intervention type(s): Drug
Intervention description(s): KBP-5074 tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Moderate Hepatic Impairment; Healthy; KBP-5074
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew
      tablet taken without water and with water compared to the Famotidine/Antacid tablet taken
      with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.
    


Intervention name(s): famotidine (+) calcium carbonate (+) magnesium hydroxide tablet; Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water; Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods; A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods; A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Magnesium Hydroxide; Famotidine; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this study were to estimate the absolute bioavailability of
      ravulizumab/rHuPH20 subcutaneous (SC) and to assess the safety and tolerability of
      ravulizumab/rHuPH20 SC.
    


Intervention name(s): Ravulizumab; rHuPH20
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion or injection, as applicable; Solution for infusion
Other intervention name(s): Ultomiris; ALXN1210; Recombinant human hyaluronidase PH20
Intervention MeSH terms: Ravulizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN1210; Pharmacokinetic; Pharmacodynamic; Safety; Immunogenicity; Ravulizumab; rHuPH20
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Condition: QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis; Potential Effect of Selenium
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from
      weight loss, increased heart rate and stress intolerance. Some patients have difficulties in
      regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin,
      suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory
      antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in
      western Europe. This compound has important function in thyroid hormone metabolism and on the
      immune system. It is not known whether addition of selenium affects the well being of
      patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
    

Detailed description: 
      In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are
      treated with methimazole and thyroxin, and randomised to selenium or placebo.
      Neuropsychological investigation is performed, before medical treatment is commenced and
      repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and
      selenium are followed.
    

Intervention name(s): selenium; placebo
Intervention type(s): Other; Other
Intervention description(s): 200 ug selenium once daily
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: selenium; neuropsychological testing; autoantibodies
Phototherapy Applied in Association With Muscular Training
Condition: Muscle Adaptation
Study type: Interventional

Summary: 
      The effects of phototherapy has been widely studied by some research groups. The
      investigators know that there are positive results with light application to improve muscle
      performance and delay fatigue. However, there are few studies showing its´ effects on
      muscular training. Therefore, the aim of this study was to assess the effects of phototherapy
      applied at different times during 12 weeks of strength training. For such, 48 volunteers,
      healthy male, from 18 to 35 years old were recruited to perform a strength training protocol
      for the anterior muscle of the thigh development. Volunteers performed the training protocol
      three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic
      dynamometer, concentric peak torque, 1-repetition maximum test in the leg extension and leg
      press machines and bilateral thigh perimetry.
    

Detailed description: 
      This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight
      participants performed muscular training protocol. Subjects practiced a protocol training
      with 60% of the load followed by 80% of the load, measured through 1-repetition maximum test,
      in all sessions of the training protocol. The training protocol consisted in performing 3
      sets of 7 repetitions with 60% of 1-RM, and 4 set of 7 repetitions with 80% of 1-RM. This
      protocol was performed in every sessions, three times a week, employing leg press and leg
      extension machines.

      Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the
      thigh before and after each training session. Only one investigator, that did not participate
      in any phase of the assessments and trainings sessions, knew about what program is active or
      placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B,
      C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the
      program used, active or placebo. Either strength training lasted 12 weeks and assessments
      were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary
      contraction (MVC), concentric torque, bilateral thigh perimetry and 1-repetition maximum test
      (1-RM).
    

Intervention name(s): Active or Placebo Phototherapy (MR4)
Intervention type(s): Device
Other intervention name(s): MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: phototherapy; photobiostimulation; muscle training; muscular adaptation
Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The
      management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs)
      are insufficient, while opioids are avoided by their adverse effects and regional techniques
      are hampered by a premature discharge. In this context, the investigators seek an
      intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus
      magnesium to significantly decrease postoperative pain.
    


Intervention name(s): Saline; Ketamine; Ketamine + magnesium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h; 50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h; 50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ketamine; Magnesium; Analgesia; Liposuction; Lipoabdominoplasty; Preemptive analgesia
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      To identify the high-risk patients who might have in-stent thrombosis after PCI with
      thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic
      strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with
      the standard antiplatelet therapy.
    

Detailed description: 
      Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with
      evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography
      reveals stenosis lesions; discovery of ADP induced platelet inhibition rate < 50% and MAADP >
      47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for
      stent thrombosis formation); is able to understand the objective of the trial, takes part
      voluntarily and signs the written informed consent form.
    

Intervention name(s): Clopidogrel 75mg; Clopidogrel 150mg; Aspirin 100mg; Cilostazol 100mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCI; platelet function monitoring; Thrombelastography; clopidogrel; cilostazol; in-stent thrombosis
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Condition: Pulmonary Hypertension; Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial
      hypertension, a life threatening disease of the lung blood vessels. Unfortunately,
      treprostinil is irritating to the skin and many patients experience intense pain at the
      infusion site for the first 7-10 days after placing a new subcutaneous infusion site.

      Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of
      post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that
      pretreatment of an area of skin with Qutenza would decrease the pain associated with a new
      treprostinil infusion site. The investigators hope that Qutenza will decrease both the
      intensity of the pain and the duration of the pain after patients place a new treprostinil
      infusion site.

      In this initial study, the investigators will provide Qutenza in open-label, unblinded
      fashion and ask patients to rate their pain using a diary tool with which they are already
      comfortable.
    


Intervention name(s): Qutenza (8% capsaicin)
Intervention type(s): Drug
Intervention description(s): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Other intervention name(s): Qutenza; Capsaicin
Intervention MeSH terms: Capsaicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Qutenza; Capsaicin; Remodulin; Treprostinil
Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Background: Preventive drug therapy in migraine aims to reduce the attack frequency, severity
      and duration of headache. Flunarizine and topiramate are widely used in the prevention of
      migraine attacks. Greater occipital nerve block (GONB) is an alternative treatment option for
      the prophylactic treatment of migraine. In this study, investigators compared the
      effectiveness of GONB, topiramate, and flunarizine in terms of reduction in post-treatment
      VAS scores and attack frequencies in patients with episodic migraine in a four-week period.

      Material and Methods: At least one hundred and twenty migraine patients are aimed to be
      randomly divided into three treatment groups, namely flunarizine (n=40, estimated),
      topiramate (n=40, estimated) and GONB (n=40, estimated). The patients will be followed up for
      four weeks and the attack frequencies and VAS scores will be recorded weekly. At the end of
      the fourth week, the response rates based on 50% and 75% or more reduction in the VAS scores
      and attack frequencies will be calculated. Group-wise comparisons will be assessed
      statistically.
    


Intervention name(s): Greater Occipital Nerve Block; Topiramate; Flunarizine
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): An enjection to paralyze the occipital nerve.; An antiepileptic agent used for migraine prophylaxis.; A calcium overload blocker agent used for migraine prophylaxis.
Intervention MeSH terms: Topiramate; Flunarizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Greater Occipital Nerve Block; Topiramate; Flunarizine
Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in
      chronic hepatitis C patients
    


Intervention name(s): VGX-6150
Intervention type(s): Biological
Intervention description(s): Plasmid DNA delivered via IM injection with electroporation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; DNA Vaccine; Electroporation; Intramuscular (IM) Injection
Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function
      impairment after single intravenous (IV) infusion of POL7080
    


Intervention name(s): POL7080
Intervention type(s): Drug
Intervention description(s): Intravenous infusion
Intervention MeSH terms: Murepavadin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: POL7080; Pharmacokinetics
COMEX Study for Dialysis Patients
Condition: ESRD
Study type: Interventional

Summary: 
      The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility,
      tolerability and adherence of this novel video-based intra-dialytic chair exercise program
      for hemodialysis patients over 3 months.
    

Detailed description: 
      The investigators incorporated patient-provider preferences of the key stakeholders, and used
      a multi-disciplinary team with experts in physical therapy, psychology and nephrology to
      develop a comprehensive exercise program for HD patients. Aim of this pilot study is to
      assess the feasibility, tolerability and adherence to COMEX over 3 months and inform design
      of future randomized controlled trial. A secondary goal is to explore molecular mechanisms in
      muscle and blood of exercise adaptation in HD patients
    

Intervention name(s): COMEX intervention
Intervention type(s): Other
Intervention description(s): Comprehensive Exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults
Condition: Healthy State
Study type: Interventional

Summary: 
      In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a
      high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
    

Detailed description: 
      Investigational drug# Oral magnesium Study title# To explore the regulatory effect of
      magnesium on intestinal flora in healthy adults # A Single-center, Prospective,
      Self-controlled trial.

      Principal Investigator# Professor Yu Chen, Department of Gastroenterology, The Seventh
      Affiliated Hospital, Southern Medical University.

      Professor Peng Chen, Department of Pathophysiology, School of Basic Medical Sciences,
      Southern Medical University.

      Study subjects# Healthy adult, Age 20-30 years Study phase# Investigator Initiated Trial(IIT)
      Study objectives# The objective of the study is to explore the regulatory effect of magnesium
      on intestinal flora in healthy adults Study design# A Single-center, Prospective,
      Self-controlled trial. Medication method# Subjects should avoid high magnesium diet for 1-3
      weeks, and take magnesium supplement (food grade magnesium citrate: 1 capsule, 400mg/
      capsule, three times a day, after meals) in 4-6 weeks. Peripheral blood and stool samples
      were collected from 60 subjects on day 0, day 21, and day 42 of the study period for routine
      blood tests, blood biochemical tests, and 16s rDNA sequencing analysis of gut microbiota.

      Course#42days Sample size#60.
    

Intervention name(s): Magnesium Citrate
Intervention type(s): Dietary Supplement
Intervention description(s): Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
Intervention MeSH terms: Magnesium citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: magnesium, gut microbiota, healthy adult