bioihbjkbjnl/mcl2 huggingface dataset:
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this project is to develop and test a brief protocol designed to systematically
      integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD)
      into behavioral treatment services for adolescent substance users with co-morbid ADHD in
      everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and
      fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services
      utilization, medication acceptance and compliance, and satisfaction with treatment services.
    


Intervention name(s): MIP Protocol
Intervention type(s): Behavioral
Intervention description(s): We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Comorbid; ADHD; SUD; ASU
Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.
Condition: Disorder Related to Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to assess if low pre-transplantation donor specific T-cell reactive patients
      measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with
      Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.
    

Detailed description: 
      Non randomized, pilot, prospective, open-label trial.
    

Intervention name(s): PRE-TRANSPLANT (PRE=before)
Intervention type(s): Drug
Intervention description(s): All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg).
Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter.
Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T-cell lymphocyte allo-recognition; CNI-free immunosuppressive regimen; Enzyme-linked immunospot (ELISPOT)
Reverse Engineering of Exclusive Enteral Nutrition
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce
      remission of active Crohn's disease.

      Secondary: Consuming a whole foods based smoothie will result in measurable changes to the
      microbiome of individuals with Crohn's disease and healthy controls.

      The specific aims of this proposal are:

        1. To develop a whole-food based smoothie, based on principles of the specific carbohydrate
           diet, that is comparable in macronutrients and micronutrients to formulas used for
           exclusive enteral nutritional (EEN) therapy in Crohn's disease.

        2. To evaluate the ability of a whole-food based smoothie to induce remission of active
           Crohn's disease.

        3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a
           whole-food based smoothie diet.
    

Detailed description: 
      This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's
      disease treated with a smoothie designed to emulate formulas used for exclusive enteral
      nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to
      create the smoothies will be given to each participant/family. The smoothies will be based
      upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie
      recipes will involve whole foods that can be blenderized to liquid consistency. Similar to
      the formulas used for EEN, the smoothies will provide calories, protein, fat, and
      carbohydrates in a distribution to support growth and development.
    

Intervention name(s): Nutritional therapy
Intervention type(s): Other
Intervention description(s): Whole-foods based smoothie designed to emulate formulas used in EEN
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exclusive Enteral Nutrition; Nutrition; Diet; Inflammatory Bowel Disease
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees: An Extension
Condition: Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
MeSH terms: Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This research study is designed to investigate the use of a simple cognitive task (a memory
      cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing
      the number of intrusive memories of trauma among young refugees and asylum seekers. The
      design is a single case experimental AB design with optional replication (ABAB). Participants
      will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a
      one-week intervention phase ('B'), including a one-session intervention with a researcher
      comprising the simple cognitive task, followed by instructions to continue to use the
      technique self-guided in the subsequent week. Follow ups are conducted after each week to
      monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is
      predicted that participants will report fewer intrusive memories during the intervention
      phase than during the preceding baseline phase.
    

Detailed description: 
      This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB
      design and adding additional questions e.g. on concentration, emotion and functioning, and
      with the possibility of focusing on 1 intrusive memory at a time with associated distress
      ratings as part of the procedure.
    

Intervention name(s): Brief cognitive intervention
Intervention type(s): Behavioral
Intervention description(s): A one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game play) with instructions to engage in the task self-guided in the subsequent week.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single case experimental AB design with optional replication (ABAB)
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel
      group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate
      the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to
      its vehicle.
    

Detailed description: 
      Study application was performed once daily, 7 days a week for 6 weeks.
    

Intervention name(s): CD5024 0.3% cream; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks.; Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
Other intervention name(s): Ivermectin
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market
      clinical study. The purpose of the study is to provide data demonstrating the safety and
      effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF).
      The study will also provide first in human insights into clinical safety and device function
      of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To
      this end, the clinical study has been designed into phases (Pilot and Pivotal), with each
      phase comprising a separate data set that will be analyzed and reported on per the below
      objectives.
    


Intervention name(s): Medtronic PulseSelect Pulsed Field Ablation (PFA) System
Intervention type(s): Device
Intervention description(s): Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study begins with a Pilot Phase, followed sequentially by a Pivotal Phase consisting of 3 arms enrolling simultaneously: Roll-in, Paroxysmal AF, Persistent AF
Masking: None (Open Label)
Primary purpose: Treatment
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to develop and implement a treatment that focuses on behaviors
      to reduce symptom severity and functional impairment in patients with Attention Deficit
      Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this
      study is to apply the treatment to larger-scale trials to determine its effectiveness and
      generalizability.
    

Detailed description: 
      ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social
      development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type.
      Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable.
      Effective treatments for ADHD-I are still needed.

      Participants are randomly assigned to receive either a behavioral intervention or treatment
      as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill
      development groups, family meetings, and consultation with the child's teacher to address
      attention problems and areas of impairment at home and school. Parent and child interviews,
      teacher and child ratings, and psychoeducational testing are used to assess participants.
      Participants are assessed post-treatment and at a 2-month follow-up visit.
    

Intervention name(s): Psychosocial (behavioral) Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to measure the effect that various doses of LY2409021 have on blood sugar
      levels and on the amount of glucose released by the liver, when glucagon is given to increase
      these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study
      periods, with a minimum 13-day washout between dosing periods. This study is approximately 9
      weeks long, not including screening. A screening appointment is required within 6 weeks prior
      to the start of the study.
    


Intervention name(s): Placebo; LY2409021
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally, single dose; Administered orally, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The aim of the present study is to investigate wether endothelial dysfunction associated with
      stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone
      as potential anti-inflammatory drug versus placebo.

      Additionally we hypothesize that selective aldosterone antagonism reduces systemic
      inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory
      cytokines.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with coronary heart disease
      
Keywords: Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit
IV Lacosamide: The Safety of Intravenous Lacosamide
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
    

Detailed description: 
      The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4
      years to 35 years, inclusive who are unable to take oral medications or require parenteral
      administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at
      LeBonheur Children's Hospital due to the complexity of their condition, or due to a long
      relationship with their physician. These are exceptions which are reviewed on a case by case
      basis and are approved by the hospital administrator for admissions and outpatient testing.
    

Intervention name(s): IV Lacosamide
Intervention type(s): Drug
Intervention description(s): Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy
Psilocybin for the Treatment of Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen
      in cluster headache. Subjects will be randomized to receive oral placebo, low dose
      psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days.
      Subjects will maintain a headache diary prior to, during, and after the pulse regimen in
      order to document headache frequency and intensity before, during, and after the pulse
      regimen. After at least 6 months from the last experimental session, subjects may be invited
      for a second round, in which they will be randomized to receive either low dose or high dose
      psilocybin.
    


Intervention name(s): 0.143 mg/kg Psilocybin or 10 mg Psilocybin; 0.0143 mg/kg Psilocybin or 1 mg Psilocybin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days); 0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days); Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single ascending oral
      doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants.

      This study also evaluate the pharmacokinetics and determine the effect of food on the
      pharmacokinetics of a single oral dose of ASP1617.
    

Detailed description: 
      After a screening period of up to 28 days prior to study drug administration, eligible
      participants will be residential for a single period of 8 days/7 nights in Part 1: single
      ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
    

Intervention name(s): ASP1617; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ASP1617; Food Effect; Pharmacokinetics; Healthy Volunteers
A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, two period crossover study will evaluate the effect of multiple doses of
      activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy
      volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated
      by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with
      the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period
      2, only a single dose of RO4995819 but no activated charcoal will be administered.
    


Intervention name(s): RO4995819; activated charcoal
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; orally 3 times daily, Days 1-7
Intervention MeSH terms: Charcoal
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
Condition: Histamine H1 Antagonists, Non-Sedating
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus
      Claritin Peach Syrup 1mg/mL (ANNA Formula)
    


Intervention name(s): Loratadine oral solution; Loratadine (Claritin peach syrup)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period.; Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period.
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergy
Periodontal Therapy in a Primary Prevention of Cardiovascular Disease
Condition: Periodontitis; Coronary Disease
MeSH terms: Periodontitis; Cardiovascular Diseases; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity
      all over the world. In the last years, efforts have been made to define more effective
      therapeutic and preventive strategies.Periodontal diseases have been considered a probable
      risk factor for CVD with a great amount of evidence from observational studies. Although
      there are some interventional studies evaluating the systemic effects of periodontal therapy,
      there is little information regarding the impact of periodontal treatment on the prevention
      of cardiovascular events. To the best of our knowledge, there are no randomized controlled
      trials published to date assessing the effect of periodontal therapy in primary prevention of
      CVD.
    


Intervention name(s): Integrated Care Group; Standard Care Group
Intervention type(s): Behavioral; Other
Intervention description(s): The group (TG) consisted of periodontal treatment comprising one session of supragingival scaling and personalized oral hygiene instructions, followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. Individuals were be followed monthly during the first 6 months. In the follow-up sessions, professional plaque removal, oral hygiene instructions, cardiac support along with counseling reinforcement were be provided.; The group (TG) comprising one session of supragingival scaling followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the protective effect, safety and immunogenicity of
      a live attenuated varicella vaccine in healthy children.
    

Detailed description: 
      This study is a randomized, blind, controlled phase III clinical trial. The purpose of this
      study is to evaluate the protective effect, safety and immunogenicity of a live attenuated
      varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control
      is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co.,
      Ltd. All participants are healthy, and will be randomly assigned into experimental group or
      control group in the ratio 1:1.
    

Intervention name(s): Investigational live attenuated varicella vaccine; diluent of lyophilized vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.; The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated varicella vaccine; protective effect; safety; immunogenicity; child