bioihbjkbjnl/mcl2 huggingface dataset:
OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-dose, parallel group study. The objectives of this
      study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN)
      prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese
      patients with moderate to severe chronic non-malignant pain.
    

Detailed description: 
      It will be conducted to assess the pharmacokinetics of OXN 5/2.5 and OXN 20/10 tablets.
      Subjects will be allocated to a sequence of two strength group in accordance with a random
      allocation schedule (RAS) in a 1:1 ratio.

      Subjects will attend a screening visit within 14 days of the first (OXN) dosing day (Day 1).

      Eligible subjects will then check into the study unit on the day before OXN dosing (Day -2).
      Subjects will be administered their OXN dose the next 2 morning (Day 1), following an
      overnight fast.
    

Intervention name(s): OXN PR tablet
Intervention type(s): Drug
Intervention description(s): Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
Other intervention name(s): Targin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Moderate to severe chronic non-malignant pain
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies
Condition: Polymyositis; Dermatomyositis
MeSH terms: Dermatomyositis; Polymyositis
Study type: Interventional

Summary: 
      The diagnosis of the different forms of inflammatory myopathies (polymyositis,
      dermatomyositis, inclusion-body myositis...) remains difficult which may lead to
      unappropriate patient care.

      Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array
      (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.

      Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to
      distinguish different forms of inflammatory myopathies.
    


Intervention name(s): transcriptome analysis; T cell repertoire analysis
Intervention type(s): Other; Other
Intervention description(s): transcriptome analysis from muscle biopsy; blood T cell repertoire analysis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myositis; cDNA arrays; Genes, T-Cell Receptor beta
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A 10-week study to compare the reduction in cholesterol following treatment with two
      different marketed drugs in patients with hypercholesterolemia.
    

Detailed description: 
      The duration of treatment is 6 weeks.
    

Intervention name(s): MK0653A, ezetimibe (+) simvastatin; Comparator: Rosuvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain
      severity in patient with Systemic Lupus Erythematosus.
    

Detailed description: 
      Duloxetine (Cymbalta) is a reuptake inhibitor of both serotonin and norepinephrine. By
      increasing levels of serotonin and norepinephrine, the descending inhibitory pain pathways
      may function better. These pathways lessen the perception of pain. Results of double blind,
      placebo controlled, clinical trials investigating the effectiveness of Duloxetine (Cymbalta)
      have shown that at doses of 60 mg once a day or 60 mg twice a day, Duloxetine (Cymbalta)
      demonstrated significantly higher rates of treatment response for pain when compared to
      placebo.

      Given the positive findings in other clinical trial studies for Duloxetine (Cymbalta) such as
      Diabetic Peripheral Neuropathy (Raskin et al., 2005) and Fibromyalgia (e.g. Arnold et al.,
      2005), the investigators hypothesize that Duloxetine (Cymbalta) may reduce the pain severity,
      frequency and intensity of exacerbations in patients with SLE.
    

Intervention name(s): Cymbalta
Intervention type(s): Drug
Intervention description(s): Cymbalta 60 to 120 mg PO QD
Other intervention name(s): Duloxetine
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus Pain; Lupus; Pain; Systemic Lupus Erythematosus; Duloxetine; Cymbalta
Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
Condition: Post-operative Pain; Respiratory Depression
MeSH terms: Respiratory Insufficiency; Pain, Postoperative; Depression
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory
      stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients
      undergoing thoracic surgery after discharge from PACU or ICU.
    

Detailed description: 
      Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement
      in post-operative patients, thereby decreasing the chance of post-operative respiratory
      depression that occurs with opioid administration. In addition, patients may be more alert
      with less opioid medication. Currently, dexmedetomidine is not approved for use longer than
      twenty-four hours and must only be administered in the Intensive Care Unit where patients can
      be continuously monitored.

      This is a prospective, double-blinded, control group pilot study. One group (the control
      group) will receive a normal saline infusion and the second group (the treatment group) will
      receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open
      nursing unit (not an Intensive Care Unit).

      During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical
      procedure after an optional loading dose. All patients will receive pain medication using a
      Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the
      physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the
      incision under direction of the surgeon.

      Before discharge from the PACU or ICU, each subject will receive either low-dose
      dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after
      the subject is discharged from either the PACU or the ICU to an open nursing unit. While on
      the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score
      will recorded every two hours until the treatment drug is stopped.
    

Intervention name(s): Dexmedetomidine; Placebo (Normal Saline)
Intervention type(s): Drug; Other
Intervention description(s): Dexmedetomidine titrated over 24 hours
Other intervention name(s): Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Sedation; Opioid; Respiratory depression
Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants
Condition: Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to assess the efficacy, safety and tolerability of a single
      dose of REGN1908-1909 in allergic adult participants, to collect information about how much
      REGN1908-1909 is in blood over time and to collect information about how the body reacts to
      REGN1908-1909.
    


Intervention name(s): REGN1908-1909; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bicycle Ergometer Training in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      The progressive muscle weakness and contractures of the patients adversely affect their gait
      and balance. It is known that the disorder of the patients' balance and gait affects their
      functional capacity. The aim of this study is to examine the effects of bicycle ergometer
      training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four
      children with DMD included in the study will be divided into two groups as home program and
      home program+bicycle ergometer training with block randomization method. Home program
      including stretching, respiratory, range of motion, posture and mild resistance exercise with
      body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be
      performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes
      total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were
      evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be
      applied at pre-training and after 12 weeks of training.
    


Intervention name(s): Bicycle Ergometer Training; Home-based exercise group
Intervention type(s): Other; Other
Intervention description(s): Bicycle ergometer training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group.; Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Block Randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; Bicycle training; Gait; Balance
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
Condition: Orphan Cholestatic Liver Diseases; Progressive Familial Intrahepatic Cholestasis; Alagille Syndrome; Primary Biliary Cirrhosis
MeSH terms: Liver Diseases; Cholestasis; Liver Cirrhosis, Biliary; Cholestasis, Intrahepatic; Alagille Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to assess the mass balance recovery after a single
      dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples
      for metabolite profiling and structural identification in healthy male subjects.
    


Intervention name(s): 3 mg [14C]-A4250 capsule
Intervention type(s): Drug
Intervention description(s): Each subject will receive a single administration of 3 mg [14C]-A4250 capsule for oral administration containing not more than 4.3 MBq (116 μCi), in the fasted state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Guanfacine in Children With Tic Disorders
Condition: Tourette Disorder; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tic Disorders; Tics
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this pilot study is to obtain preliminary information on the tolerability and
      efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette
      Disorder (TD, also called Tourette syndrome).
    

Detailed description: 
      Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but
      neither the immediate release compound nor the new extended release formulation have been
      evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate
      efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather,
      the goal of this trial is to determine whether extended release guanfacine warrants further
      study in a large scale trial. Immediate-release guanfacine is frequently used in children
      with TD, but dosing, time to effect and adverse effects with the new extended release
      guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of
      outcomes because it ensures blindness in the parent and clinician ratings.

      This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled,
      parallel-group study. Subjects who show a positive response to extended release guanfacine in
      the 8-week double-blind phase will continue on the the drug in an 8-week extension phase.
      Subjects who are randomly assigned to placebo and do not show improvement will be offered
      8-weeks of open-label treatment with Intuniv.
    

Intervention name(s): placebo; extended-release guanfacine (Intuniv)
Intervention type(s): Drug; Drug
Intervention description(s): Administered up to 8 weeks.; 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette Syndrome; Tourette Disorder; Tics; Motor tics; Vocal tics; Intuniv; Guanfacine; Medication; Drug; Placebo; Child; Children; Adolescent
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
Condition: High Blood Pressure
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy and safety of Bunazosin with
      Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential
      hypertension accompanied by metabolic syndrome.
    

Detailed description: 
      This clinical study will comprise a 1 to 2-week washout period, a 5-week mono therapy period
      with AngiotensinⅡantagonist, and an 8-week alpha blocker add-on treatment period. Total study
      period will be 15 weeks.
    

Intervention name(s): Bunazosin; Doxazosin; Valsartin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be randomized to the add-on treatment with Bunazosin (Detantol-R) 3 mg once-daily after breakfast for a total of eight weeks.; Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks.; After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks.
Other intervention name(s): Detantol-R; Doxaben XL; Diovan
Intervention MeSH terms: Doxazosin; Bunazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; SBP; DBP
TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery
Condition: Anesthesia
Study type: Interventional

Summary: 
      This study is to observe whether transcutaneous electrical stimulation at specific acupoints
      could improve the quality of emergence in patients undergoing robotic laparoscopic
      gynecologic surgery.
    

Detailed description: 
      During robotic laparoscopic gynecologic surgery, the patients are put in an extremely
      trendelenburg positon. And a long duration of this position could lead to delayed emergence
      or agitation. Stimulation at some acupoints were reported to improve homeostasis. In this
      study we tend to observe whether transcutaneous electrical stimulation at specific acupoints
      could improve the quality of emergence in patients undergoing robotic laparoscopic
      gynecologic surgery.
    

Intervention name(s): acupoint stimulation; non-acupoint stimulation; electrode attached; electrical stimulation
Intervention type(s): Other; Other; Other; Device
Intervention description(s): stimulation is given at acupoints; stimulation is given at acupoints; electrodes are attached to skin; electrical stimulation is given through electrodes attached to th skin
Other intervention name(s): electrode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Clinical & Web-based Diet & Activity Counseling for Men
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion
      program. The study aims to learn more about how to help men lose weight, become more
      physically active, and improve their dietary habits. The study is sponsored by the National
      Institutes of Health.
    

Detailed description: 
      This is a randomized controlled trial that will evaluate the effects of a Web-based
      intervention to improve physical activity and dietary behaviors in overweight and moderately
      obese men age 25 through 55 years. The study will complement our currently funded NCI project
      evaluating a similar intervention among overweight female primary care patients. Overweight
      is related to multiple cancers, CVD, and NIDDM, and the prevalence of overweight is
      increasing rapidly (NIH 1998). Patient-centered Assessment and Counseling for Exercise plus
      Nutrition - Internet (PACEi) targets weight-related behaviors and gives patients a tool for
      addressing these behaviors with their primary care practitioners should they choose to do so.
      PACEi includes a web-based assessment and progress planning tool, and 12 months of tailored
      Internet and telephone contact. The components are integrated through a common theoretical
      framework. Subjects will be randomized to PACEi or to a low intensity intervention.
    

Intervention name(s): Diet and physical activity interventions; Computer technology to tailor, promote and sustain health behavior change & improve health care delivery.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.; Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
Intervention MeSH terms: Sulfamethazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Men; Overweight
A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the new long-acting insulin 287 with the marketed insulin glargine for
      use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long
      it stays there and how the blood sugar is lowered. The participant will get both of the
      insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already
      approved for the treatment of diabetes and can be prescribed by a doctor. The participant
      will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will
      also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you
      start the insulin 287 period. All doses will be injected under the skin. The study will last
      for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
    


Intervention name(s): Insulin icodec; IGlar U100
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks; Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Retrospective Case Series Study for Acute Abdomen in General Surgery Ward
Condition: The Study Was Aimed to Assessing the Clinical Profile of Acute Abdomen and Their Frequency According to Age and Sex
MeSH terms: Abdomen, Acute
Study type: Observational

Summary: 
      The acute abdomen is a clinical situation in which an acute an change in the condition of
      intra-abdominal organ, commonly attached to inflammation or infection need urgent and correct
      diagnosis .
    

Detailed description: 
      A special data collection sheet designed to collect data regarding the diagnosis, age and sex
      from the profile of patients retrospectively. Data entry was performed by using Microsoft
      Excel and all the data were analysed by SPSS.
    

Intervention name(s): surgery
Intervention type(s): Procedure
Intervention description(s): Our study is observational and we use secondary data
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All of patients with acute abdomen that is admitted in general surgery ward of Aliabad.
      
Keywords: Acute abdomen, Abdominal pain, Acute appendecitis, intestinal obstruction
Emergence of Generative Language
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of several applied behavior teaching
      procedures on the use of multi-word utterances by children with autism.
    


Intervention name(s): Mand Training; Matrix; Stimulus Equivalence Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.; The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.; The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASD, Children