bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility, safety and efficiency of zero
      ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional
      laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
    

Detailed description: 
      Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors.
      Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was
      developed, but the experience was preliminary. This study aims to evaluate the feasibility,
      safety and efficiency of this technique, particularly its role in the preservation of renal
      function, in comparison with conventional laparoscopic partial nephrectomy.
    

Intervention name(s): laparoscopic microwave ablation-assisted enucleation; conventional laparoscopic partial nephrectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: zero ischemia; microwave; ablation; enucleation; renal cell carcinoma
To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability
Condition: Graft-versus-host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy
      subjects.

      To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.
    


Intervention name(s): SHR0302
Intervention type(s): Drug
Intervention description(s): SHR0302 oral solution 1 time, SHR0302 tablets 1 time
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving Right Ventricular Function in Young Adults Born Preterm
Condition: Infant,Premature
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to evaluate the short-term effects of sildenafil and
      metoprolol on heart function in young adults born premature.
    

Detailed description: 
      The purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and
      metoprolol on right ventricular function in young adults born premature using novel
      4-Dimensional flow Cardiac Magnetic Resonance Imaging.
    

Intervention name(s): Pulmonary Function Testing; Electrocardiogram; Cardiac Magnetic Resonance Imaging; Metoprolol; Sildenafil
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug
Intervention description(s): Subjects will undergo spirometry, Plethysmography, and diffusion capacity.; Subjects will undergo an electrocardiogram to ensure sinus rhythm; Subjects will undergo positron magnetic resonance imaging to detect images of the heart; Subjects will receive intravenous metoprolol. Dose titrated 1-5 mg every 2 minutes to achieve goal heart rate of 55-65 beats per minute, or for subjects with a resting heart rate already at goal, titrated to achieve a 10-15% reduction in heart rate.; Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Other intervention name(s): Lopressor; Metolar XR; Revatio
Intervention MeSH terms: Metoprolol; Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: premature adults; premature; premature cardiac function; MRI; sildenafil; metoprolol; CMR
Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.
Condition: Spinal Muscular Atrophy Type II; Spinal Muscular Atrophy Type III Non Ambulant
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients
      aged 3-25 years
    

Detailed description: 
      This study is a multicenter, double-blind, randomized, adaptive, parallel groups, placebo
      controlled 3-stage study in patients with SMA type 2 or non ambulant type 3.

      Stage 1 DMC 3-month safety assessment: An independent Data Monitoring Committee (DMC)will
      assess the safety of olesoxime every 3 months.

      Stage 2 Efficacy/futility analyses at one year: A first interim efficacy analysis will be
      performed after all patients have been treated for one year (52 weeks) in order to assess the
      need to continue the study to reach the planned objective. In the event of positive and
      significant results in favor of olesoxime, the study will be considered as successful and all
      patients will be switched to olesoxime to allow the assessment of the sustainability of the
      treatment effect and safety. If the results are significantly in favor of placebo, the study
      will be discontinued for failure (futility).

      Stage 3 Efficacy and safety analysis at two years: The expected study duration is of 2 years
      (104 weeks) to show efficacy. If the study is not discontinued for futility or medication
      regimen is changed due to success, the study will therefore continue until planned completion
      i.e. 104 weeks.
    

Intervention name(s): Olesoxime; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid suspension formulation, 100 mg/ml at a dose of 10 mg/kg will be administered once a day with food at dinner; 0.1ml/kg once a day with food at dinner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Smoking, Vaping, and Alcohol Consumption Behavior
Condition: Survey; E-Cig Use; Smoking Behaviors; Alcohol Drinking; Vaping; Food Intake
MeSH terms: Alcohol Drinking
Study type: Observational

Summary: 
      To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the
      population. Further, the objective is to administer additional surveys to assess which
      methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping,
      alcohol intake, and food intake are preferred by the study population.
    

Detailed description: 
      Many smokers believe that smoking helps them to control their weight, and concerns about
      weight gain can interfere with smoking cessation. In fact, nicotine has been shown to
      suppress appetite and increase resting metabolic rate, and smoking also serves as a
      behavioral alternative to eating or a distraction from hunger or food cravings. E-cigarettes
      are frequently marketed as the safer and healthier alternative to smoking, and some
      e-cigarettes are in fact actively advertised for weight management and/or suppression of food
      cravings, encouraging smokers to make the switch. In contrast, alcohol consumption has been
      shown to increase appetite and food intake and at the same time is associated with smoking
      and vaping.

      Therefore, it is possible that participants who smoke or vape for weight control,
      particularly those who also regularly consume alcohol, would benefit from a lifestyle program
      that encompasses dietary counseling and exercise to prevent weight gain after smoking
      cessation. Additionally, methods to assess smoking, vaping, alcohol intake, and food intake
      (i.e., ingestive behaviors) historically relied on self-report, though the investigator's
      group has developed smartphone apps that allow people to capture images of their intake
      and/or self-report their intake in the app. App-based methods offer advantages, including the
      real-time transfer of data, and it is presumed that people will believe that apps are an
      easier and preferred method to capture ingestive behaviors, yet this assumption has not yet
      been thoroughly examined.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Individuals aged 18 to 85 years who regularly engage in one or more of the following
        behaviors:

          -  cigarette smoking

          -  e-cigarette consumption (vaping)

          -  alcohol consumption
Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Condition: Tibia Fracture
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      Two standards of care exist with regards to posterior splinting post-operatively. The
      proponents of splinting feel the additional immobilization decreases the stress on the soft
      tissue, subsequently preventing or limiting pain while improving early range of motion (ROM).
      The opposing belief is that the splinting is without therapeutic benefit and that early
      mobilization is beneficial. With regards to both practices, the surgeon's practice is
      anecdotally based on past experience.

      The purpose of this study is to compare the results obtained with and without posterior
      splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence
      based reasoning to guide future practice.
    


Intervention name(s): Post-Op Splinting; No Splinting
Intervention type(s): Procedure; Procedure
Intervention description(s): Splint will applied post-operatively and will remain on for two weeks; Patient will be discharged post-operatively without a splint on their lower leg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
Condition: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly
      cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half
      will receive clomiphene citrate only.
    

Detailed description: 
      Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.

      Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It
      works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and
      subsequently gonadotropin from the anterior pituitary.

      Vit E is used in treatment of pco due its anti-oxidant effect.
    

Intervention name(s): vitamin E; Metformin; Clomiphene Citrate
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect; Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS); is a medication used to treat infertility in women who do not ovulate
Other intervention name(s): toco 1000; cidophage; clomid
Intervention MeSH terms: Vitamin E; Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled open label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin E; Polycystic ovary
Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM
      Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
    

Detailed description: 
      In this study, a single-center, single-dose, single-administration trial will be carried out
      in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of
      Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of
      single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24
      patients with oral tolerance of this drug.

      In this study, the washout period before administration is designed as a 35-day duration
      before administration of the investigational drug (aripiprazoleIM Depot), screening period a
      4-week duration (28 days) before administration of the investigational drug, observation
      period after administration a 20-week duration after administration of the investigational
      drug and hospital stay a minimum 35-day duration after administration of the investigational
      drug.
    

Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.
Other intervention name(s): ABILIFY MAINTENA
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of a Single Dose of ALXN1210 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics
      (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms,
      physical examination, vital signs, laboratory analysis, and assessment of adverse events
      (AEs).
    

Detailed description: 
      The participants were randomized in a 2:1 ratio (4 active and 2 placebo) to receive a single
      dose of ALXN1210 or placebo in the 200-milligram (mg) dose cohort and in a 3:1 ratio (6
      active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 400-mg dose
      cohort, administered by intravenous (IV) infusion. A 150-day observation period was performed
      for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration.
      Antidrug antibody (ADA) levels were monitored in study participants for the duration of the
      150-day follow-up period.
    

Intervention name(s): ALXN1210; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters [mL]/hour), excluding interruption for safety or technical reason.; All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason.
Other intervention name(s): Ultomiris; Ravulizumab
Intervention MeSH terms: Ravulizumab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ALXN1210; Pharmacokinetic; Pharmacodynamic; Safety; Immunogenicity
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and
      emotional well being of children and adolescents with ADHD and to evaluate whether and in
      what measure the presence of comorbid conditions (internalizing and externalizing disorders)
      influences atomoxetine's ability to improve the quality of life of ADHD subjects.
    


Intervention name(s): atomoxetine
Intervention type(s): Drug
Intervention description(s): 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
tDCS for Treatment Resistant Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      It's a multicentric, randomized, controlled study concerning 100 patients with
      treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to
      evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.
    


Intervention name(s): Active stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).; Patients will receive a Sham stimulation during 30 mn
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OCD; tDCS
Mindfulness and Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to see if mindfulness, a form of mental training, or listening
      to a book alters brain activation in response to raising your leg that may produce the
      feeling of pain. A technique called functional magnetic resonance imaging (fMRI) allows
      scientists to determine which parts of the brain are active during a particular task. This
      study will provide new information about how mindfulness affects the brain.
    

Detailed description: 
      To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP)
      patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC),
      subgenual anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to
      rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and
      twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness
      meditation (n=40) and book-listening-control (n=40). Each participants will be administered
      noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.
    

Intervention name(s): mindfulness training; non-mindfulness training; book-listening
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A well-validated brief mindfulness-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.; A well-validated brief meditation-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.; Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
Other intervention name(s): mental training; mental training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a six session mindfulness meditation, non-mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete two MRI scans over the course of the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mindfulness; fMRI; Pain; Low Back; Radicular
Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Different lowing blood pressure strategies have a different clinical efficacies. Blocking the
      angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial
      fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months
      than 30% compared to Nifedipine( Adalat GITS ).

      A total of 160 subjects will be included in two study groups. The Group 1 will receive
      80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS).
      Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and
      24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial
      fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg.
      Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood
      pressure during the study.
    


Intervention name(s): Nifedipine,; Telmisartan
Intervention type(s): Drug; Drug
Intervention description(s): Nifedipine 30-60mg/day; Telmisartan 80-160mg/day
Other intervention name(s): anti-hypertensive drugs, Atrial fibrillation; anti-hypertensive drugs, atrial fibrillation
Intervention MeSH terms: Telmisartan; Antihypertensive Agents; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: paroxysmal atrial fibrillation, hypertension
FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents
Condition: Physical Activity; Sedentary Behavior; Active Commuting; Psychosocial Factors; Parental Interference
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether an Internet-supported FeetEnergy approach
      and two home works integrated in three health education lessons can increase adolescents'
      active commuting to school and leisure-time physical activity and decrease their screen time.
    


Intervention name(s): Internet-supported FeetEnergy approach; Usual health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three health education lessons and two homework's about increasing physical activity and reducing screen time; Usual health education lessons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: intervention; health education; physical activity; sedentary behavior; health promotion; evaluation; RE-AIM