bioihbjkbjnl/mcl2 huggingface dataset:
Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application
Condition: Cutaneous Leishmaniasis; Scar
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional

Summary: 
      Primary Objectives:

      Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the
      cosmetic outcome compared with no treatment (natural healing)
    

Detailed description: 
      Secondary Objectives

        1. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no
           treatment (natural healing)

        2. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with
           WR279396

             -  To determine whether CL lesions treated with vehicle improves the cosmetic outcome
                (compared with natural healing)

             -  To determine whether CL lesions treated with vehicle alone provides a cosmetic
                outcome similar to WR279396
    

Intervention name(s): WR 279396
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Paromomycin; Gentamicin
Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of learning support and chat on
      treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for
      adolescents with anxiety.
    

Detailed description: 
      The study is set up as a factorial design with two independent variables: 1: Learning support
      and 2: chat-sessions in real time. The intervention tested is based on cognitive behavior
      therapy delivered over the internet via a secure treatment platform. Participants in the
      study are recruited from the general public via social media. The intervention is in Swedish.
    

Intervention name(s): Guided-ICBT for adolescents with anxiety; Guided-ICBT with chat; Guided-ICBT with learning support; Guided-ICBT with learning support and chat
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.; Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.; Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.; Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Design is a two-by-two factorial randomized trial with four intervention groups: 1, ICBT with therapeutic guidance through mail. 2, ICBT with therapeutic guidance through chat. 3, ICBT with learning support and terapeutic guidance through mail. 4. ICBT with learning support and terapeutic guidance through chat.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Learning Support; Chat; Adolescents
Single Dose of Etomidate and Adrenal Cortex
Condition: Adrenocortical Deficiency; Hemodynamic Instability
Study type: Interventional
Phase: Phase 4

Summary: 
      we aim to evaluate the effects of single dose of etomidate or use of steroid prior to
      etomidate during emergency intubation on hemodynamics and adrenal cortex.
    


Intervention name(s): Etomidate; Midazolam; methylprednisolone
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): etomidate lipuro, BRAUN; Dormicum,Roche; Prednol-L, Mustafa Nevzat
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Midazolam; Etomidate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
Condition: Heart Failure
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a multi-center, prospective, single-armed, study designed to evaluate the
      safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular
      (LV) volume reduction in heart failure (HF).
    

Detailed description: 
      The purpose of this prospective, single-armed, multi-center clinical trial is to further
      establish the feasibility of using the BioVentrix Revivent TC System for the treatment of
      left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

      The objective of this study is to determine the safety and functionality of a device that
      enables left ventricle (LV) volume and radius reduction through scar exclusion in appropriate
      patients suffering from systolic HF. Use of this device replicates the geometric
      reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction
      (LVR), but on a beating heart, and creates the option of eliminating the use of
      Cardiopulmonary Bypass.

      The System utilizes anchors that are implanted into the scarred portion of the heart,
      rendering the ventricle smaller, and is employed in a cardiac surgical setting without the
      use of cardiopulmonary bypass. The Revivent TC anchors may be implanted through a sternotomy
      or through a mini-thoracotomy and jugular access. Eligible subjects will be limited to those
      whose ventricular dysfunction is due to ischemic cardiomyopathy caused, by a previous
      (greater than 90 days) myocardial infarction (MI) with acontractile (akinetic and/or
      dyskinetic) scar located in the antero-septal, apical (may extend laterally) region.
    

Intervention name(s): Revivent TC
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BioVentrix; Revivent; Revivent TC
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine whether the addition of cognitive behavioral therapy can improve the
      efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety
      disorder. Patients with social anxiety disorder will undergo a 12-week open trial with
      paroxetine. Those who complete the open trial having achieved only partial response will be
      randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to
      continue on paroxetine alone for an additional 16 weeks.
    

Detailed description: 
      Social anxiety disorder is a prevalent and disabling condition for which effective long-term
      treatments need to be identified. Paroxetine is effective in treating the acute symptoms of
      social anxiety, but many patients achieve less than optimal response. CBT has also been
      effective in treating social anxiety disorder; thus,it may also be effective in augmenting
      paroxetine response. This study will examine the effects of paroxetine treatment alone and in
      combination with CBT among patients who achieve less than optimal response after an open
      trial with paroxetine.

      Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks,
      participants who have completed this open trial but have achieved some but less than optimal
      response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients
      must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety
      Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these
      criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or
      to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of
      response and remission, fear of negative evaluation, disability and quality of life will be
      assessed.
    

Intervention name(s): Paroxetine; Cognitive behavioral therapy (CBT)
Intervention type(s): Drug; Behavioral
Intervention description(s): Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.; CBT will consist of 16 weekly treatment sessions.
Other intervention name(s): Paxil
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Phobia
Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: ADPKD
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      A mild reduction in food intake significantly inhibits renal cyst growth in mouse models of
      ADPKD. The underlying mechanism was unknown at the time. Recently published data show that
      the beneficial effect is not due to caloric restriction per se but due to the induction of
      the state of ketosis. Dietary interventions leading to ketosis profoundly inhibited renal
      cyst growth in rodent models of PKD. In addition, acute fasting led to rapid regression of
      renal cystic burden in mouse, rat and feline models of PKD. Due to these compelling effects
      in a multitude of PKD animal models, and due to the fact that well-established dietary
      interventions have a tremendous translational potential, KETO-ADPKD will test such
      interventions regimens in ADPKD patients.

      Two well-established ketogenic dietary regimens will be tested in comparison to a control
      group to address the following four questions:

        1. Feasibility: Are ketogenic dietary interventions acceptable to ADPKD patients in
           everyday life?

        2. Safety: Are there adverse events of ketogenic dietary interventions in ADPKD patients?

        3. Efficacy: Do the dietary interventions reach the metabolic endpoints? Do they have a
           short-term impact on kidney volume?

        4. Which of the two diets is the optimal approach?

      These questions will be addressed in an exploratory, randomized, open, single center,
      three-arm dietary intervention study using the following interventions in 21 ADPKD patients
      per treatment arm:

      A) Ketogenic diet B) 3-day water fasting C) Control: ad libitum food intake (no diet)
    


Intervention name(s): Ketogenic diet; 3-days water-fasting; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will follow a classical ketogenic diet for 3 months; Patients will perform water fasting on 3 consecutive days within the first 14 days of each of the 3 months. In one of the 3 months they are - if required - allowed to split the 3 days into periods of 1 and 2 days. On all other days of the intervention period they are allowed to eat ad libitum.; Patients are allowed to eat ad libitum, but will be advised that low salt intake (< 5-7 g/day) and sufficient fluid intake (>3 l/day) which is considered beneficial in ADPKD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ADPKD; Ketosis; dietary intervention; ketogenic diet; 3-days water fasting; fasting
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
Condition: Latent Tuberculosis Infection
MeSH terms: Infections; Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold
      In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will
      allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis
      cases among contacts screened.

      Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for
      the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing
      study.

      Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.

      Study population: 870 subjects, household contacts of patients with culture positive
      pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A
      (standard practice), in which treatment decisions will be based on the TST result, and Arm B
      (experimental), in which treatment decisions will be based on the QFT result.

      Interventions: participants in arm A will undergo TST; participants in arm B will undergo
      TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm
      A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be
      treated with isoniazid for 6 months. All participants will be followed for two years.

      End-points of evaluation: development of tuberculosis and proportion of subjects for whom
      treatment is prescribed in each arm.
    


Intervention name(s): Preventive treatment with Isoniazid.; Preventive treatment with Isoniazid
Intervention type(s): Drug; Drug
Intervention description(s): If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.; If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Latent tuberculosis infection; Tuberculin skin test; Interferon-gamma release assays; Contact-tracing study
Metabolic Impact of Time Restricted Feeding
Condition: Obesity; Diet Modification
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The investigators are interested in how time-restricted feeding will impact weight, sleep
      duration and efficacy, and activity levels in obese adults. Significant advances in digital
      mobile technology allow detailed measures of an individual's habits, permitting the
      opportunity for personalized dietary and lifestyle recommendations. This is especially
      relevant as time-restricted feeding appears to promote weight loss independent of calorie
      intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to
      a time-based perspective.
    

Detailed description: 
      Given the obesity epidemic, there is intense medical and public interest in dietary and
      lifestyle management to mitigate obesity and its associated complications. Although weight
      loss has traditionally focused on restricting calories, it is well described that most people
      are unable to maintain the caloric restriction required to long term weight loss or
      maintenance. This proposal will address whether restricting the timing of food intake, rather
      than restricting calories, may facilitate weight loss and provide metabolic benefits. It has
      been recently shown that the average American eats over the course of 15 hours per day. Such
      an eating cycle dictates that most people are always in a fed metabolic state and likely
      misaligns circadian patterns. Time-restricted feeding (TRF) is the process of limiting food
      consumption to a specific window of time (e.g. 8 hours per day) and is associated with weight
      loss in humans and metabolic improvements in rodent studies. Significant advances in digital
      mobile technology now allow further detailed measures of an individual's habits to facilitate
      this analysis. Thus, the objective of this study is to test the health related effects of 12
      week TRF (8 hour fed and 16 hour fasting cycle) in overweight/obese adults. The investigators
      hypothesize that TRF will 1) improve sleep duration, sleep efficacy, increase activity and
      increase basal metabolic rate, 2) promote weight loss and lower body fat, and 3) improve
      insulin sensitivity and postprandial hyperglycemia. The investigators expect these studies to
      show that TRF is effective and sustainable approach to improving metabolic parameters in
      overweight/obese individuals.
    

Intervention name(s): Dietary Counseling
Intervention type(s): Behavioral
Intervention description(s): Counseling to only eat during a restricted amount of time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, non-blinded, behavioral intervention pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, diet, sleep activity
A Clinical Evaluation of the LensGen Intraocular Lens
Condition: Cataract; Presbyopia
MeSH terms: Cataract; Presbyopia
Study type: Interventional

Summary: 
      A multi-center, open-label, non-comparative clinical trial to assess the safety and efficacy
      of the LensGen IOL (Juvene IOL) for the treatment of aphakia and presbyopia after removal of
      the natural crystalline lens due to cataract.
    

Detailed description: 
      The Juvene IOL is specifically designed to utilize the mechanics of two optics to change the
      focal point in the human eye to correct presbyopia without the side effects experienced with
      other presbyopia correcting lenses. One optic provides the base power of the lens. The other
      contains a central fluid reservoir that utilizes the natural contraction of the ciliary body
      to change the focal point of the eye via the neural-uveal response induced by looking at an
      intermediate or near target.

      The optic material is well characterized and has been safely used as an IOL material.
      Diffractive and refractive multifocal IOLs provide functional distance and near vision, with
      up to 4 diopters of add, yet they have not overcome the known side effects of haloes, glare,
      and reduced contrast sensitivity. Newer presbyopia correcting lenses, such as the Juvene IOL,
      use novel and proprietary changes in lens curvature to bilaterally change the focal point in
      each eye to any given distance the patient is looking.
    

Intervention name(s): Juvene IOL
Intervention type(s): Device
Intervention description(s): Indicated for Implantation in the human eye after removal of a cataractous crystalline lens
Intervention model: Single Group Assignment
Intervention model description: Multi-center, open-label, non-comparative clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 1

Summary: 
      Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
    

Detailed description: 
      This project is a double-blinded randomized Phase I study that will include dose-ranging one
      day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and
      subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes,
      including IFG.
    

Intervention name(s): (+)-Epicatechin
Intervention type(s): Drug
Intervention description(s): The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.
Other intervention name(s): Epicatechin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
Condition: Interdigital Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in
      subjects with interdigital tinea pedis aged 12 years to less than 18 years.
    

Detailed description: 
      Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and
      efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle
      in adults, the current clinical study is being conducted to provide additional
      pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years
      with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in
      this pediatric population. The study also includes clinical and safety endpoints.
    

Intervention name(s): Econazole Nitrate; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Econazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the GI Endobarrier Liner is safe and
      effective.
    

Detailed description: 
      Patients with obesity are at significantly greater risk of developing significant co-morbid
      complications, and are associated with an increased risk in all-cause mortality. The GI
      Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It
      is a minimally invasive endoscopic procedure, which may allow patients to recover faster with
      less morbidity and mortality. This study is investigating the safety and efficacy of the GI
      Endobarrier Liner in patients who are candidates for bariatric surgery.
    

Intervention name(s): Endobarrier Liner
Intervention type(s): Device
Intervention description(s): Medical device placed endoscopically in the duodenum
Other intervention name(s): GI Sleeve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity