bioihbjkbjnl/mcl2 huggingface dataset:
Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Condition: Heart Failure; Pulmonary Disease; Cancer
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Informal caregivers provide a majority of care for patients during serious illness. Lack of
      preparation and completion may leave caregivers less capable of caring for a loved one or
      making crucial decisions influencing care.

      This study will examine whether a preparation and completion intervention reduces caregiver
      anxiety, depression, anticipatory grief, and burden and improves patient quality of life and
      health care use.
    

Detailed description: 
      The investigators propose a randomized control trial to evaluate an intervention of
      preparation and completion with Veterans and their caregivers during serious illness.
      Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on
      caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the
      impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate
      the impact of the intervention session's qualitative content, examining variation associated
      with selected demographic variables, quality of family communication, and stage of illness on
      change.

      Caregivers in the first group ("Treatment", or "Preparation and life completion") will meet
      with a facilitator three times for a period of forty-five minutes each. In the first session,
      subjects will be asked to discuss issues related to relationship life review.

      In session two, participants will be asked to speak in more depth about issues such as regret
      and forgiveness. In the final session, subjects will focus on legacy and celebration.
      Caregivers in the second group ("attention control" or "relaxation meditation") will meet
      with a facilitator three times for a period of forty-five minutes each and be asked to listen
      to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.

      Participants in both groups will receive pre and post-test measures administered by a blinded
      interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy
      - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale,
      Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient
      days at home.
    

Intervention name(s): Preparation and life completion; Attention Control
Intervention type(s): Other; Other
Intervention description(s): Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.; Caregiver subjects will listen to a non-guided relaxation CD with facilitator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: caregiver; end of life; self-disclosure
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
Condition: End-Stage Renal Disease; Kidney Failure
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence
      was found that a single large dose of Thymoglobulin on the day of kidney transplantation
      produced better kidney function than the standard dosing plan, when the same amount is
      divided into smaller doses on 4 days. This new study repeats that dose comparison, but with
      double-blinding and at multiple transplantation centers.
    

Detailed description: 
      This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte
      globulin induction at kidney transplantation, compared to the conventional administration of
      the same overall dose divided into four smaller doses across four days. Two randomized groups
      of kidney transplant recipients will be each administered the drug Thymoglobulin according to
      a different dosing regimen. The control group will receive the usual and traditional regimen
      of a total of 6 mg/Kg divided into 4 doses, 1 on the day of transplantation and 1 each day on
      the next 3 days. The experimental group will receive the same total Thymoglobulin dose, 6
      mg/Kg, but entirely on the day of transplantation.

      The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed
      to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects
      needed to complete the study for adequate evaluation.
    

Intervention name(s): Single-dose rabbit Anti-thymocyte Globulin induction; Divided-dose rabbit Anti-thymocyte Globulin induction
Intervention type(s): Biological; Biological
Intervention description(s): 6 mg of rATG administered in a single dose on the day of kidney transplantation; 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Other intervention name(s): Thymoglobulin; rATG; Thymoglobulin; rATG
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Renal transplantation; Kidney transplantation
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of
      single and multiple doses of rufinamide. The effects of food and sex on the PK properties of
      rufinamide in these Chinese volunteers were also evaluated.
    

Detailed description: 
      This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese
      subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and
      received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition.
      An additional food effect study was performed in the 200-mg dose group by assessing changes
      in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were
      administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS
      method was applied to determine plasma concentration of rufinamide. Tolerability was assessed
      based on investigator inquiries, spontaneous reports, and clinical evaluations such as
      standard laboratory tests, vital signs, physical examinations and 12-lead
      electrocardiography.
    

Intervention name(s): rufinamide
Intervention type(s): Drug
Intervention description(s): comparison of different doses, sex and medication conditions
Other intervention name(s): 106308-44-5
Intervention MeSH terms: Rufinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; food effect; sex effect; tolerability
Eptinezumab in Participants With Episodic Cluster Headache
Condition: Cluster Headache, Episodic
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of eptinezumab in participants with
      episodic Cluster Headache (eCH)
    

Detailed description: 
      Eligible participants will be randomly assigned to receive treatment, in a blinded manner,
      two infusions of either eptinezumab or placebo in a cross-over manner during the
      Placebo-controlled Period and Active Treatment Period of the study.

      The total duration of the study after randomization is 24 weeks, including a safety follow-up
      period of 8 weeks.
    

Intervention name(s): Eptinezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eptinezumab - concentrate for solution for infusion, intravenously; Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare capillary (the smallest of a body's blood vessels)
      and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single
      oral, immediate-release dose to healthy participants.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), open-label (all people know the
      identity of the intervention), parallel-group (each group of patients will be treated at the
      same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts
      (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone
      or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and
      have a capacity to ameliorate thought disorders. Participants will enter the investigational
      site in the morning of Day -1 and stay until the morning of Day 2. Participants will return
      to the study site for subsequent assessments as per study's schedule. The total study length
      for a participant is approximately 26 days, except for participants receiving aripiprazole
      for whom the total study length is approximately 39 days.
    

Intervention name(s): Aripiprazole; Quetiapine; Olanzapine; Risperidone; Paliperidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.; Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast.; Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.; Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.; Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy; Antipsychotics; Aripiprazole; Paliperidone; Risperidone; Quetiapine; Olanzapine
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming
      at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in
      subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant
      to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month
      follow-up period.
    

Detailed description: 
      This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming
      at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in
      subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant
      to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month
      follow-up period.

      Eligible subjects will be randomized according to a 2/1 ratio in two different groups of
      treatment. Randomized subjects who will receive 50 mg ABX464 orally once daily for 56 days.
    

Intervention name(s): ABX464; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): ABX464 is a new Anti-inflammatory drug; Placebo matching with ABX464
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ABX464; Ulcerative Colitis; Refractory
Custom-made Ceramic Barrier vs Titanium Mesh
Condition: Bone Loss
Study type: Interventional

Summary: 
      It is a comparative study between custom-made ceramic barrier and titanium mesh for
      augmentation of atrophic posterior mandible.
    


Intervention name(s): Ceramic barrier; Titanium Mesh
Intervention type(s): Device; Device
Intervention description(s): The use of a ceramic barrier to induce bone formation during GBR; The use of a titanium mesh to induce bone formation during GBR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Quartet™ Bad Oeynhausen Trial
Condition: Congestive Heart Failure; Cardiac Resynchronization Therapy
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Primary objective of this study is to evaluate whether the use of a quadripolar left
      ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower
      non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)
    


Intervention name(s): Application of quadripolar / bipolar LV electrodes
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac resynchronization therapy; heart failure, congestive
Exercise Training in Chagas Cardiomyopathy
Condition: Chagas Disease; Cardiomyopathy; Exercise Training
MeSH terms: Chagas Disease; Chagas Cardiomyopathy; Cardiomyopathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The benefits of exercise training in heart failure are well established. Its effects,
      however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis
      is that the exercise training may improve functional capacity, quality of life (QoL), and
      reduce brain natriuretic peptide (BNP) levels in patients with ChC.
    


Intervention name(s): Exercise training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chagas Disease; Chagas Cardiomyopathy; Exercise Movement Techniques
Quality of Life Among Children With Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Congenital heart diseases (CHD) are the first cause of congenital malformations with an
      incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a
      great impact on CHD prevalence. France was the first country to show the impact of prenatal
      diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart
      syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and
      cardiac catheterization have led to lower mortality and morbidity in this population.
      Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly
      increasing. For all these reasons and as the investigators can also see in other many chronic
      diseases, new questions about the quality of life of these patients arise among patients,
      parents/future parents, doctors, patients associations, and public health organizations. In
      2007 French government promoted a national public health plan for "improvement of the quality
      of life among patients suffering from chronic illnesses". First step of such a program is to
      correctly evaluate this quality of life. Indeed the concept of "quality of life" (QoL)
      remains subjective and difficult to appreciate and measure. Its analysis requires the use of
      validated questionnaires. Few questionnaires are available in Europe, especially in
      pediatrics. Few studies in this population have been led and no comparative study to a
      control randomized group has been published. The investigators study aims to analyze in the
      investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old
      French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to
      same aged healthy children. The investigators secondarily intend to :- validate the French
      version of one reference pediatric QoL questionnaire used in most publications in the USA
      (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative
      score.- compare the QoL to the severity of the CHD using the results of routine exercise
      tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis
      are that :- Quality of life of most common and not severe CHD is close to that of healthy
      children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a
      simple questionnaire which can be used in France in routine follow-up of children with CHD.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  children with congenital heart disease

          -  healthy children
      
Keywords: children with congenital heart disease
ACTIVATE: A Computerized Training Program for Children With ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD.
      ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see:
      www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e.,
      sustained attention, working memory (WM), response inhibition, speed of information
      processing, cognitive flexibility and control, multiple simultaneous attention, category
      formation, and pattern recognition and inductive thinking).
    

Detailed description: 
      In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be
      evaluated to determine its effectiveness in improving symptoms of
      attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a
      computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that
      simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working
      memory (WM), response inhibition, speed of information processing, cognitive flexibility and
      control, multiple simultaneous attention, category formation, and pattern recognition and
      inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD
      and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly
      during treatment, and immediately post-treatment.
    

Intervention name(s): ACTIVATE
Intervention type(s): Other
Intervention description(s): A home-based computerized brain training intervention for youth.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Androgen Effect on Klinefelter Syndrome Motor Outcome
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of low-dose androgen on the motor and
      cognitive development of boys with Klinefelter syndrome.
    

Detailed description: 
      Klinefelter syndrome (KS), a genetic disorder that affects males only, is characterized by
      having an extra X chromosome. The phenotype - or physical and learning features - includes
      testicular failure, tall stature, and specific cognitive and behavioral attributes such as
      diminished motor function, language-based learning difficulties, poor self-image, and
      shyness. The KS phenotype may be the result of androgen deficiency in utero, infancy, and
      childhood. For individuals with KS, androgen replacement is standard treatment in adolescence
      and adulthood but has not been used earlier in childhood or included in the standard medical
      care of KS children ages 4 to 12.

      The purpose of this study is to examine the effects of androgen on learning and development
      in boys with KS. Researchers also want to determine if low-dose androgen replacement at an
      early age will improve some of the learning difficulties associated with the disorder. The
      overall goal of this study is to address questions regarding the relationship of early
      androgen deficiency to learning and motor function.

      Participants in the study will be randomized to one of two treatment groups, receiving either
      oxandrolone (low-dose androgen) or placebo, for two years. All participants will be evaluated
      for safety at the beginning of the study and at 3, 6, 12, 18, and 24 months. Also at the
      beginning of the study and every 3 to 6 months thereafter (for a total of 6 visits), the
      researchers will perform a careful history and physical examination and a bone age X-ray, and
      obtain a blood sample.

      Participation in the trial will last two years and includes 6 clinic visits.
    

Intervention name(s): androgen oxandrolone; placebo
Intervention type(s): Drug; Other
Intervention description(s): Oxandrolone ,06 >mg/kg/day, orally, for 2 years; an inactive substance
Intervention MeSH terms: Androgens; Oxandrolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Klinefelter syndrome; androgen; androgen oxandrolone