bioihbjkbjnl/mcl2 huggingface dataset:
BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then
      applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management -
      IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure
      monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e.
      without IHM) during a 6 months intensive treatment program.
    

Detailed description: 
      Early BP control in hypertensives guarantees the best prevention of cardiovascular events on
      the long term (2007 ESH-ESC Guidelines on the Management of Hypertension; VALUE study).
      However, in spite of education efforts and antihypertensive drugs, blood pressure control
      rates remain low. The most common cause of uncontrolled BP is inadequate pharmacological
      treatment, because the selection of antihypertensive agents is often done independently of
      the hemodynamic status of the patient (volemia, peripheral resistance, cardiac inotropy,
      heart rate).

      Several studies confirmed the value of using impedance cardiography (ICG)-derived hemodynamic
      data as an adjunct to therapeutic decision-making in the treatment of hypertension.

      Working hypothesis: when it is possible to assess the hemodynamic status, and select
      accordingly the most appropriate pharmacological class of antihypertensive treatment, BP
      reduction occurs to a greater extent and more rapidly.

      In the present study an integrated therapeutic approach (IHM-Integrated Hemodynamic
      Management)was applied, aiming at detecting permanent vasoconstriction and/or hypervolemia
      and/or hyperinotropy through the HOTMAN System, in order to select the most appropriate
      antihypertensive drugs.
    

Intervention name(s): Integrated hemodynamic management (IHM) - HOTMAN System; Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
Intervention type(s): Device; Device
Intervention description(s): Therapeutic approach according to HOTMAN System measurement(ICG)results .; Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HOTMAN System; Hemodynamic integrated management
Adaptive Family Treatment for Adolescent Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric
      disorder. The most promising treatment for adolescents with AN is family-based treatment
      (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up.
      Consequently, providing an alternative therapy early in the treatment course for those not
      responding to FBT may enhance overall outcome. This study aims to develop a new treatment -
      Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged
      12-18 years, who do not show an early response to FBT.
    


Intervention name(s): Family-Based Therapy (FBT); Family-Based Therapy with Intensive Family-Focused treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 sessions of FBT over the course of 6 months.; FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorder; Anorexia Nervosa; Eating Disorder Not Otherwise Specified; Maudsley; Family-Based Therapy; FBT; Family Therapy
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
Condition: Necrotic Pulp; Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      The aim of this prospective, randomized, controlled double-blind study is to evaluate the
      effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of
      teeth after regenerative based non-obturation root canal treatment in mature single canal
      with pulp necrosis and apical periodontitis.
    

Detailed description: 
      • Regenerative endodontic treatment will be performed through two visits: First visit aims to
      clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At
      the end of first visit, canal will be dressed by CaOH as intracanal medicaments.

      Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation,
      evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated,
      according to the random sequence number of the participants, either biodentine or white MTA
      will be placed as pulp space barrier.

      At the end of treatment, the access cavity will be sealed with composite restoration.
    

Intervention name(s): Biodentine; White MTA
Intervention type(s): Other; Other
Intervention description(s): Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.; MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.
Other intervention name(s): white mineral trioxide aggregate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Necrotic pulp,; Apical periodontitis; Regeneration; MTA; Biodentine
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Condition: Premature Ejaculation
MeSH terms: Premature Ejaculation
Study type: Interventional

Summary: 
      The company suggests a new concept of treatment for PE: Transient inhibition of striated
      muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the
      safety of delivering increasing electrical stimulation intensities to the subject's perineum,
      using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
    


Intervention name(s): TENS Stimulator
Intervention type(s): Device
Intervention description(s): Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Other intervention name(s): TensMed S82 ENRAF-NONIUS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
Condition: Healthy Subjects; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is
      consumed as a traditional remedy for several ailments, including the use as a nutritional
      supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue.
      While the elderly use it as a nutritional supplement, students use it for relief from anxiety
      during exam times.

      The present study is conducted in order to assess the effects of BEC on various physical and
      mental parameters including physical fatigue, working memory and attention, mood and stress,
      in comparison to placebo.
    


Intervention name(s): Essence of Chicken; Placebo (Energy matched)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Brand's Essence of Chicken (BEC) is produced via a water extraction process from chicken meat for several hours under high-temperature, followed by centrifugation to remove fat and cholesterol, vacuum concentration to 3- to 4-fold, sterilization by high temperature and pressure before bottling. This kind of chicken essence is rich in protein, and low in sugar and fat, conveniently available and consumable, and easy for household storage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Parents of Young Adults With Type 1 Diabetes: An Exploratory Study
Condition: Type1diabetes; Parents
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this mixed-methods study is to explore the lived experience of parents of
      young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence,
      and to test the preliminary efficacy of a mobile education program to reduce parental
      distress.
    

Detailed description: 
      As young adults with T1D navigate the transition process to independence, they often do so in
      partnership with their parents, who are tasked with providing support and guidance. At this
      time, however, no structured education program exists for these parents. In addition, little
      is known about their learning needs, levels of distress, and readiness to provide appropriate
      guidance for their emerging adult children. This represents a gap in the literature and an
      opportunity to undertake exploratory research to learn more about this population so that
      meaningful education and support can be provided.

      Aim 1. To describe the lived experience and diabetes-specific educational needs of parents of
      young adults with type 1 diabetes who are transitioning to independence.

      Aim 2. To measure the effect of a mobile diabetes education program on diabetes distress
      levels of parents of young adults ages 18 to 25 years who are transitioning to independence.
    

Intervention name(s): T1DToolkit.org mobile diabetes education
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a reminder via text and/or email twice per week to invite them to view diabetes education materials on the study's mobile website, T1DToolkit.org. Topics on this website include, among others, Caregiver Burnout; Your Child is Now an Adult; Sharing Responsibility; Sources of Support; Common Fears for Parents of Young Adults; and Your Child, Your Child's Doctor, and You.
Six weeks after enrollment, participants will complete the Modified Diabetes Distress Scale: Parents of Young Adults.
Intervention model: Single Group Assignment
Intervention model description: Mixed Methods Exploratory Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: mHealth
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
Condition: Fibrodysplasia Ossificans Progressiva
MeSH terms: Myositis Ossificans
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a three period study design consisting of a 6-month, randomized, double-blind
      placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period
      2) and a follow-up treatment period (period 3).

      Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in
      male and female patients with fibrodysplasia ossificans progressiva (FOP).

      Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on
      the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined
      by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of
      HO lesions by computed tomography (CT).

      Key Secondary objectives are:

        -  To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the
           area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS)
           scores

        -  To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as
           determined by the number of new HO lesions identified by 18F-NaF PET or by CT

        -  To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF
           standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET

        -  To assess the effect of REGN2477, between week 28 and week 56, on the number, activity,
           and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from
           placebo to REGN2477 at week 28 versus the same patients between baseline and week 28

        -  To assess the effect of REGN2477 versus placebo on the change from baseline in
           biochemical markers of bone formation

        -  To characterize the concentrations of total activin A at baseline and over time
           following the first dose of study drug

        -  To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in
           patients with FOP

        -  To assess the immunogenicity of REGN2477
    


Intervention name(s): REGN2477; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment periods 1 and 2.; Pharmaceutical form: Liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment period 1 only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study was designed to test the following hypothesis:

      To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type
      distribution.
    

Detailed description: 
      Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease
      (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress.
      Classical training does not improve these features.

      Objectives: To investigate whether electrostimulation program following exacerbation can
      modify muscle structure and function in COPD patients.

      Method: We propose to conduct a controlled and randomized clinical trial comparing the
      efficacy of muscle electrostimulation training of the lower limbs to sham training in 15
      patients with COPD. Patients are included in either 6 weeks of electrostimulation training
      (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes
      in muscle structure, muscle oxidative stress and their relationship with quadriceps force and
      exercise tolerance.
    

Intervention name(s): Electrostimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week; Sham stimulation: 1 h; 5 times/week
Other intervention name(s): NMES; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: COPD
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese
      participants with ankylosing spondylitis (AS) who have had an inadequate response to or who
      are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
    

Detailed description: 
      Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive
      treatment with adalimumab 40 mg every other week (eow) or matching placebo, given
      subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received
      one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching
      placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could
      enter the 12-week open-label (OL) phase, during which all participants received treatment
      with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or
      injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the
      last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new
      adverse events (AEs).
    

Intervention name(s): adalimumab; placebo
Intervention type(s): Biological; Other
Intervention description(s): Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week; Prefilled syringe, matching placebo administered subcutaneously every other week
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; China
A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the cardiovascular safety of paliperidone in patients
      with schizophrenia or schizoaffective disorder, with particular attention to the length of
      the QT/QTc interval, to measure and review other electrocardiogram (ECG) parameters, such as
      QRS and PR intervals, to explore the relationship between the pharmacokinetics of
      paliperidone and ECG parameters of interest, and to explore the safety and tolerability of
      paliperidone
    

Detailed description: 
      This is a multicenter, placebo- and positive-controlled, randomized study consisting of 3
      periods: a screening period of up to 14 days (including a 5-day washout period), a
      double-blind period of 10 days (including the treatment phase [Days 1 to 8] and the
      posttreatment phase [Days 9 and 10]), and an end-of-study evaluation. Eligible patients will
      be randomly assigned to treatment with either paliperidone or moxifloxacin. Patients randomly
      assigned to receive paliperidone will receive placebo on Day 1, paliperidone 4 mg on Day 2,
      paliperidone 6 mg on Day 3, and paliperidone 8 mg on Days 4 through 8. Patients assigned to
      receive moxifloxacin will receive placebo on Days 1 through 7 and moxifloxacin 400 mg on Day
      8. The moxifloxacin treatment group will provide a concurrent active control to confirm that
      the study is adequate to detect a drug effect (i.e., assay sensitivity) on QTc interval.
      Baseline ECGs will be recorded on the last day of the washout period (Day 1). Serial time
      matched 12 lead ECG triplicate readings will be recorded on Days 1, 2, 3, 4, 5 (predose), 8,
      9, and 10. This study is being conducted to thoroughly assess potential QT/QTc interval
      changes following administration of paliperidone. The results from this safety study, along
      with the ECG results from all paliperidone clinical studies, will be used in the evaluation
      of the cardiovascular safety of paliperidone. Paliperidone IR orally once daily: 4 mg on Day
      2, 6 mg on Day 3, and 8 mg on Days 4 through 8; Active control: a single oral dose of
      moxifloxacin 400 mg on Day 8
    

Intervention name(s): Immediate release (IR) Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Mood Disorders; Antipsychotic drugs; Cardiovascular; Immediate release (IR) Paliperidone
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the overall safety and tolerability of ARC1779 in
      healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with
      respect to parameters of platelet function and von Willebrand Factor activity.
    

Detailed description: 
      The purpose of this study is to establish the overall safety and tolerability of ARC1779 in
      healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with
      respect to parameters of platelet function and von Willebrand Factor activity.
    

Intervention name(s): ARC1779
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Condition: Healthy
MeSH terms: Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1
      tablespoon) relative to the same dose given as an intact tablet to healthy subjects following
      an overnight fast. A secondary objective is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. All study subjects will be monitored for adverse events
      throughout the study period.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1
      tablespoon) relative to the same dose given as an intact tablet to healthy subjects following
      an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers
      between 18-55 years of age will be randomly assigned in a crossover fashion to receive each
      of two dosing regimens in sequence with a 14 day washout period between dosing periods. In
      each of the dosing periods, after an overnight fast, subjects will receive one intact
      Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed
      and sprinkled on 1 tablespoon of applesauce (followed by 240 ml of water) according to the
      randomization schedule. Blood samples will be drawn from all participants before dosing and
      for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of
      colchicine. Vital signs (blood pressure, heart rate, respiratory rate and temperature) will
      be measured prior to dosing, 1 hour ± 30 minutes post-dose and upon discharge from the
      clinical facility. Subjects will be monitored throughout their participation in the study for
      adverse reactions.
    

Intervention name(s): Colchicine 0.6 mg tablet; Colchicine 0.6 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): One Colcrys® 0.6 mg intact tablet taken by mouth; One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce
Other intervention name(s): Colcrys®; Colcrys®
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability