bioihbjkbjnl/mcl2 huggingface dataset:
Self-compassion and Nutrition (SCAN) Study
Condition: Obesity; Weight Loss
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility of two approaches for improving
      long-term weight loss success among individuals with severe obesity. All participants will
      receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a
      mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education
      intervention (determined via randomization procedures). Assessments of weight, physical
      activity, and other weight-related and psychosocial factors will occur at baseline, 4 months,
      6 months, and 9 months.
    


Intervention name(s): Behavioral weight loss program; Self-compassion; Nutrition and cooking education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Using a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform.; This 8-week, group-based program will help train individuals on how to handle difficult emotions with greater ease, how to transform difficult relationships, and how to motivate and encourage oneself, rather than being self-critical.; This 8-week, group-based program will help individuals to improve the quality of their diet through nutrition education and basic cooking skills for preparing healthy meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self-compassion; exercise; nutrition; physical activity
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus
Condition: Diabetes
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Observational

Summary: 
      Observing how cocoa effects the cardiovascular and renal system.
    

Detailed description: 
      Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols.
      Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of
      the effects will be studied in healthy normal (including elderly), and also in subjects with
      Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance.
      Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be
      assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by
      plethysmography. Urine and blood samples will be assayed for routine physiologic parameters,
      including hormone assessment, and also for the presence of cocoa metabolites.
    

Intervention name(s): Cocoa
Intervention type(s): Other
Intervention description(s): Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diabetic (Type I and II)
      
Biospecimen description: 
      Whole red blood cells will be retained for DNA analysis. Subjects may "opt-out" of genetic
      testing.
    
Keywords: Cocoa, diabetes, polyphenols
Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial
      stereotactic radiosurgery and to see how well it works in treating patients with solid
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in
           patients with isolated tumors. (Phase I)

        -  Determine the minimum dose required for local control. (Phase II)

      Secondary

        -  Determine the radiographic response rate.

        -  Determine the median time to progression of the treated tumor.

        -  Evaluate the toxicity of treatment.

        -  Evaluate the cause of death.

      OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.
      Patients are stratified according to tumor size.

        -  Phase I: Patients undergo stereotactic radiosurgery to one lesion. Cohorts of 3-6
           patients undergo escalating doses of stereotactic radiosurgery until the maximum
           tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of
           patients experience dose-limiting toxicity within 3 months of treatment.

        -  Phase II: Patients undergo stereotactic radiosurgery to one lesion at the MTD or at the
           dose at which local control at 3 months is ≥ 80%, as determined in phase I.

      After completion of study treatment, patients are followed at 1 month, 3 months, and then
      every 3 months thereafter.

      PROJECTED ACCRUAL: At least 48 patients will be accrued for this study.
    

Intervention name(s): Radiosurgery
Intervention type(s): Procedure
Intervention description(s): single fractionated radiation therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Nicotine Patch - Multidose Bioequivalence Study
Condition: Healthy Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of nicotine following
      repeated applications of a new transdermal formulation to that of a reference formulation.

      Up to day 7
    


Intervention name(s): V0116 transdermal patch (Test treatment ); Nicotine transdermal patch (Reference treatment )
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents
Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients
Condition: Schizophrenia, Undifferentiated Type
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      After an initial screening visit, including an assessment of psychiatric disorders, patients
      stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and
      control subjects will undergo an assessment using functional magnetic resonance imaging
      (fMRI) of the differences of patterns of brain activation during an emotional task
    

Detailed description: 
      This study is: interventional, comparative, open label, multi center, without experimental
      treatment.

      Main objective: To evaluate the effect of aripiprazole and risperidone on brain activation
      during an emotional task of matching patients with schizophrenia, and in reference to control
      subjects.

      Secondary Objective: Comparison of emotional subjective and physiological perception in
      patients with schizophrenia in relation with their treatment. Comparison of brain activation
      in patients during the emotional induction task based on symptomatic dimensions, personality
      traits and performance on cognitive and attentional tests, and for insight capacity .
      Comparison of transcript level of candidate genes in blood mononuclear cells between the
      study groups and study the interactions between the observed differences in brain imaging and
      different levels of transcription of these genes.
    

Intervention name(s): Imagery; pharmacogenetic sampling
Intervention type(s): Other; Genetic
Intervention description(s): All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.; A pharmacogenetic sample will be done with an additional consentment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Schizophrenic Disorders; Schizophrenia; Affect; Emotional Blunting
Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at the safety of substituting exenatide for insulin in patients with
      type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).
    

Detailed description: 
      This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30
      patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin
      and insulin therapy, will be randomized to discontinue insulin and substitute it with
      exenatide or remain on their current diabetes therapy regimen. All patients will continue
      their current diet and exercise regimen during the study.
    

Intervention name(s): exenatide; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.; Insulin will be taken according to the subject's current regimen
Other intervention name(s): synthetic exendin-4; AC2993; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; exendin-4; Amylin; Eli Lilly; diabetes
Evaluation of the Safety and Efficacy of the DeScribe™ Patch
Condition: Tattoos
Study type: Interventional

Summary: 
      This is a prospective study to evaluate the efficacy and safety of an accessory for laser
      tattoo removal in allowing multiple passes within a single treatment session.
    

Detailed description: 
      This is a prospective study to evaluate the efficacy and safety of an accessory for laser
      tattoo removal in allowing multiple passes within a single treatment session. One half of the
      tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half");
      the other half will receive laser treatment without the Device and serve as the control (the
      "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be
      enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such
      that ½ of the tattoo can be covered with a single patch. Each subject will receive a single
      Treatment Session consisting of 5 minutes. Investigators will administer the standard laser
      treatment to both the Device and Control sites using well-established tattoo-removal
      treatment parameters for the laser used. Subjects will return for follow up approximately one
      month post-treatment. The presence of side effects and adverse events will be assessed and
      recorded for both Device and Control sites immediately after treatment and at the 1-month
      follow-up visit.
    

Intervention name(s): Describe patch
Intervention type(s): Device
Intervention description(s): Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: tattoos; laser; whitening; patch
Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems
Condition: Anxiety Disorders; Social Anxiety Disorder; Generalized Anxiety Disorder; Panic Disorder; Persistent Depressive Disorder; Major Depressive Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Panic Disorder; Phobia, Social
Study type: Interventional

Summary: 
      To investigate the efficacy and mechanisms of change of an Internet-delivered transdiagnostic
      REBT intervention for adolescents with internalizing problems.
    

Detailed description: 
      The main objectives of this study are to evaluate the efficacy and mechanisms of change of an
      Internet-delivered Rational Emotive Behavior Therapy for adolescents (12-15 years) diagnosed
      with a principal anxiety or depressive disorder according to DSM-5 criteria. Participants
      will be randomly allocated to one of the two groups: experimental (REBTonAd) and waitlist
      control. The intervention is structured in 8 modules and will be delivered over six weeks.
      Assessments will be conducted at four time points: baseline, post-treatment, 3-month
      follow-up, and 6-month follow-up.
    

Intervention name(s): Transdiagnostic Internet-delivered REBT
Intervention type(s): Behavioral
Intervention description(s): The protocol is based on Rational Emotive and Behavioral Therapy (REBT; Ellis, 1962, 1994). The program will consist of 8 modules, delivered online over six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transdiagnostic; anxiety; depression; REBT; adolescents; Internet intervention
Modafinil, Sleep Architecture and Cocaine Relapse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The medication modafinil has been shown to reduce cocaine use in some cocaine users. The
      investigators have shown that modafinil taken in the morning improves sleep in chronic
      cocaine users. The investigators hypothesize that the beneficial effects of modafinil in
      reducing cocaine use may be related to specific effects modafinil has on sleep. This study
      will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using
      cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.
    


Intervention name(s): Modafinil; Cognitive Behavioral Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Modafinil 400mg PO QDaily following up-titration for ~8weeks; Once weekly cognitive behavioral therapy for cocaine dependence
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the
      endoscopic ablation system in comparison to irrigated radiofrequency current ablation in
      patients with drug-refractory persistent atrial fibrillation.
    


Intervention name(s): HeartLight(TM) Laser Balloon; irrigated radiofrequency current ablation
Intervention type(s): Device; Device
Intervention description(s): With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided; The irrigated radiofrequency current ablation is used for pulmonary vein isolation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This is a double blind, randomized controlled trial to evaluate the efficacy of ESPB(Erector
      Spinae Plane Block) on postoperative analgesia in RFA( Radiofrequency Ablation therapy). We
      will include 80 patients, and randomly assign to ESPB(Chirocaine) group and control
      group(normal saline).We deduce Erector spinae plane block can be use as a postoperative
      analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma.
    

Detailed description: 
      Computed tomography guided radiofrequency ablation of hepatocellular carcinoma(HCC) has
      became a popular way to treat HCC. Although the wound is small and the patients can discharge
      on the next day, they have to suffer from moderate to severe pain. Nowadays Erector spinae
      plane block has been applied to many surgery as a postoperative analgesic strategy. We deduce
      Erector spinae plane block can be use as a postoperative analgesic way for patients who
      receive radiofrequency ablation of hepatocellular carcinoma. Besides, we will add contrast
      medium to evaluate the spread area of local anesthetics.
    

Intervention name(s): ESPB group; Control group
Intervention type(s): Drug; Drug
Intervention description(s): ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc; ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc
Other intervention name(s): ESPB group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; radiofrequency ablation; erector spinae plane block
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a
      single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in
      RSV-seronegative infants 6 to 24 months of age.

      This study was a companion study to CIR 311.
    

Detailed description: 
      Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
      respiratory illness in infants and children under 5 years of age worldwide. This study
      evaluated the safety, infectivity, and immunogenicity of a single dose of a recombinant
      live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6 to 24 months
      of age.

      Participants were randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s
      vaccine or placebo (administered as nose drops) at study entry (Day 0).

      Participants could be enrolled in the study between April 1 and October 14 (outside of RSV
      season) and remained on study until they completed the post-RSV season visit between April 1
      and April 30 in the calendar year following enrollment. Participants' total study duration
      was between 6 to 10 months, depending on when they enrolled in the study. Participants
      attended several study visits throughout the study, which included blood collection, nasal
      washes, and/or physical examinations. Participants' parents or guardians were contacted by
      study staff at various times during the study to monitor participants' health.
    

Intervention name(s): RSV LID ΔM2-2 1030s vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10^5.0 PFU; administered as nose drops; Isotonic diluent, administered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Neurodynamic Study
Condition: Sciatic Leg Pain
Study type: Interventional

Summary: 
      Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg
      pain often have a poor recovery and some go onto have spinal surgery. However, in the absence
      of nerve root compression on MRI, no surgical option is viable and patients are often
      discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with
      non-compressive leg pain. To date, there is no research exploring which form of neurodynamic
      sliding technique offers the greatest therapeutic benefit in patients presenting with
      sciatica. The aim of this pilot study is to calculate how many patients would be needed to
      run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the
      overall workability of the study and the feasibility of patient recruitment.
    

Detailed description: 
      Patients who have given informed consent will be randomly allocated to one of three groups in
      a ratio of 1:1:1 (Control Group, Intervention Group 1, Intervention Group 2). Randomisation
      reduces selection bias and controls for unknown variables that may affect the outcome.
      Treatment allocation will occur through the use of sealed, opaque envelopes and will be
      implemented by the Graves Move More reception team as the patient attends the clinic. The
      reception staff will hand an opaque envelope to the subject for them to open. Randomisation
      undertaken by an independent third party improves internal validity. Patients will be treated
      according to the group they have been randomised to.

      Data Collection, Analysis & Statistical Opinion Prior to undertaking the study, baseline
      socio-demographic data will be recorded (E.g. age, sex, weight, height, occupation and
      duration of symptoms). Pre and posttest outcome data will also be recorded for the
      Roland-Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index 2.0 (ODI).
      Long-term data (I.e. 6-12 months post-treatment) will not be recorded as treatment effect is
      not being analysed as part of the pilot study.
    

Intervention name(s): Bilateral Sliding Techniques; Unilateral Sliding Techniques
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral Sliding Techniques; Unilateral Sliding Techniques
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment