bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST),
      IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of
      adolescent depression.
    

Detailed description: 
      Depression is a serious medical illness that is difficult to diagnose and treat, especially
      in children and adolescents. Signs of depression in children may include the following
      behaviors: pretending to be sick; refusing to go to school; clinging to a parent; or worrying
      that a parent may die. Older children may sulk, behave inappropriately at school, act in a
      negative or grouchy manner, or feel misunderstood. Because normal behaviors vary from one
      childhood stage to another, it can be difficult to determine whether a child is going through
      a temporary "phase" or is suffering from depression. This study will compare IPT-AST,
      Enhanced IPT-AST, and Usual Care for the prevention of adolescent depression.

      Participation in this single-blind study will last approximately 21 months. Participants will
      be randomly assigned to receive either IPT-AST, Enhanced IPT-AST, or Usual Care for 12 weeks.
      IPT-AST is a school-based group intervention program that focuses on prevention,
      psychoeducation, and interpersonal skill-building. Enhanced IPT-AST will entail IPT-AST plus
      three parent-adolescent sessions. Usual Care will consist of standard treatments and will not
      include IPT-AST. Study visits will occur before and during the intervention at baseline and
      Weeks 6 and 12. Follow-up visits will occur 6, 12, and 18 months post-intervention. Study
      visit assessments will include depression symptoms, anxiety symptoms, psychiatric diagnoses,
      overall functioning, social adjustment, parent-child conflict, perceived support from parents
      and peers, and service utilization.
    

Intervention name(s): IPT-AST; Enhanced IPT-AST; School counseling
Intervention type(s): Behavioral; Other; Other
Intervention description(s): IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.; Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.; Usual care consists of standard treatments, including individual counseling with guidance counselor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Adolescent
High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders
Condition: Very Long-chain Acyl-CoA Dehydrogenase Deficiency; Trifunctional Protein Deficiency; Carnitine Palmitoyltransferase 2 Deficiency; Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency
MeSH terms: Protein Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study also determines if eating a diet higher in protein alters body composition, energy
      balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.
    

Detailed description: 
      At baseline, the amount of muscle and fat in the whole body and inside the liver and muscle
      will be measured. All subjects will complete a moderate treadmill exercise test and a test to
      determine how they use sugar (oral glucose tolerance test). The amount and type of energy
      burned by each subject will be measured. Subjects will be randomly assigned to follow either
      a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. At the
      end of 4 months, the tests will be repeated.
    

Intervention name(s): Diet counseling
Intervention type(s): Behavioral
Intervention description(s): Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.
Other intervention name(s): low fat diet; high carbohydrate diet; high protein diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fatty acid oxidation disorders
Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)
Condition: Age Related Macular Degeneration
MeSH terms: Vision, Low; Macular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of intravitreal bevacizumab
      injection (IVBI) with respect to simple observation in patients with subfoveal choroidal
      neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at
      baseline with best corrected visual acuity (BCVA) less than 20/200.
    

Detailed description: 
      There is no clear indication regarding the treatment of patients with subfoveal choroidal
      neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at
      baseline with best corrected visual acuity (BCVA) less than 20/200.

      Treatment of eyes with low visual acuity could lead to a waste of resources, without any
      functional and social improvements.

      Aim of the present study is to compare the effectiveness of intravitreal bevacizumab
      injection (IVBI) with respect to simple observation in
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): 1.25 mg intravitreal bevacizumab
Other intervention name(s): avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: age-related macular degeneration; bevacizumab
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Condition: Biochemical Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Outcome Measures:

      Decrease in rate of serum PSA rise

      Secondary Outcome Measures:

      Adherence to treatment regimens

      Quality of life as assessed by FACT-P at baseline and at 12 months of treatment

      Modulation of serum testosterone,isoflavone metabolites, and cholesterol

      Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date:
      February 2007 (Final data collection date for primary outcome measure)
    

Detailed description: 
      -  Pretreatment evaluation included a complete medical history, physical examination
           (including digital rectal examination), serum PSA, free/total testosterone, lipids,
           serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of
           life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).

        -  Whole blood will be obtained prior to initiation of the study to assess for DNA
           polymorphism.

        -  Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months
           after initiation of treatment.

        -  Medical history, physical examination, serum testosterone, lipids, isoflavone, and
           quality of life were assessed at 6 and 12 months after initiation of treatment.
    

Intervention name(s): Isoflavone
Intervention type(s): Dietary Supplement
Intervention description(s): Ingested 47 mg of isoflavone in three 8 oz servings per day
Other intervention name(s): Soy Dream Enriched, Original or Vanilla, soy milk
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Isoflavone, PSA, prostate cancer, recurrent, quality of life
The Role of Stress Neuromodulators in Decision Making Under Risk (Part II)
Condition: Stress
Study type: Interventional

Summary: 
      The aim of the proposed project is to combine precise pharmacological manipulation of the
      noradrenergic system with behavioral modeling of memory processes, and fMRI methods to study
      the effect of a pharmacologically induced blockade of the noradrenergic system on memory
      processes. Behaviorally, the investigators will focus on the effect of the noradrenergic
      blockade on working memory performance, and recognition memory.
    

Detailed description: 
      Affective states like acute stress can influence cognition, i.e., memory processes.
      Physiologically, acute stress elicits an array of autonomic and endocrine responses,
      including a fast release of norepinephrine from the locus coeruleus noradrenergic (LC NA)
      system. Compelling evidence shows that in healthy humans, stimulation of the noradrenergic
      system increases memory performance whereas noradrenergic blockade reduces memory
      performance. Functional magnetic resonance imaging (fMRI) studies have shown that
      manipulations of the noradrenergic system affects responsiveness and connectivity within
      networks that are important for autonomic-neuroendocrine control and temporal and spatial
      attention orientation. So far, no study investigated the neural underpinnings of memory
      processes after a pharmacologically induced noradrenergic blockade. The aim of the proposed
      project is to combine precise pharmacological manipulation of the noradrenergic system with
      behavioral modeling of distinct memory processes, and fMRI methods to study the effect of a
      pharmacologically induced blockade of the noradrenergic system on two distinct memory
      processes. Behaviorally, the investigators will focus on the effect of the noradrenergic
      blockade on working memory performance, and recognition memory. Participants are randomly
      assigned to one of two groups: (A) clonidine, or (B) placebo.
    

Intervention name(s): Clonidin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0,15mg Clonidin orally versus placebo pill; placebo pill
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this 15-week clinical trial is to test the hypothesis that treatment
      with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA),
      has significantly greater efficacy than placebo as an augmentation treatment in bipolar
      depressed patients who display an incomplete response to conventional treatments.
    

Detailed description: 
      The primary objective of this proposed clinical trial is to test the hypothesis that
      treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic
      acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in
      bipolar depressed patients who display an incomplete response to conventional treatments. We
      propose to test this hypothesis by performing a 15-week placebo-controlled, double-blind,
      parallel group, flexible-dose study investigating the use of ALCAR and ALA as an augmentation
      to treatment as usual in depressed bipolar patients. We will compare the efficacy of
      acetyl-l-carnitine (ALCAR) at doses of 1000-3000mg/day and alpha-lipoic acid (ALA) at doses
      of 600-1800mg/day with placebo on symptom improvement in individuals diagnosed with bipolar
      disorder type I, current episode depressed. Improvement will be assessed using the 21-Item
      Hamilton Depression Rating Scale (HAM-D), the Montgomery Asberg Depression Rating Scale
      (MADRS), the Young Mania Rating Scale (YMRS), and the Clinical Global Impression-Severity and
      Improvement Scales (CGI-S and CGI-I).

      Furthermore, we hypothesize that improvement in depression symptoms following treatment with
      ALCAR and ALA will be associated with increases in phosphocreatine (PCr), beta-nucleoside
      triphosphate (β-NTP), and intracellular pH in the anterior cingulate cortex (ACC) both at
      week 1 and week 12 of treatment.
    

Intervention name(s): acetyl-l-carnitine PLUS alpha-lipoic acide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.; Placebo
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Bipolar depression; Natural substances; Depression
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and potential benefits of the interatrial
      septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
    

Detailed description: 
      The study was a multi-center, non-randomized feasibility evaluation of the IASD System at
      three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics
      committee and competent authority approvals were obtained. The study was conducted in
      accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum
      of 5 patients, and allowed up to twenty patients to be enrolled.

      The primary objective of the trial was to evaluate the safety and potential benefits of the
      IASD Device System in the treatment of patients with symptomatic heart failure with preserved
      ejection fraction, despite optimal medical management.
    

Intervention name(s): IASD System
Intervention type(s): Device
Intervention description(s): Implantation of the DC Devices Inc. IASD System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of brief multifamily
      psychoeducation to relieve the psychological distress of families of patients with chronic
      major depression and to improve their family functioning.
    

Detailed description: 
      Major depressive disorder (MDD) is a long-lasting illness with significant effects on the
      patient's family, social life, and work life. Treatment failure results in a low recovery
      rate and frequent relapses.

      Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased
      rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior
      and mood disturbance and relative's emotional distress were associated with the relatives'
      burden.

      Family psychoeducation is recognized as part of the optimal treatment for patients with
      psychotic disorder. This intervention has been shown to reduce the rates of relapse and
      hospitalization among individuals with psychotic disorders and is recognized as an
      evidenced-based treatment for psychotic disorder. Several randomized controlled trials have
      found that family psychoeducation is effective in enhancing the course of bipolar disorder.
      However, there are few studies on psychoeducation of families of patients with MDD.

      The purpose of this study is to examine the effectiveness of brief multifamily
      psychoeducation to relieve the psychological distress of families of patients with chronic
      major depression and to improve their family functioning, in a randomized controlled trial.
    

Intervention name(s): Family psychoeducation
Intervention type(s): Behavioral
Intervention description(s): Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Family psychoeducation; Major depressive disorder; Family burden
Evaluating Pharmacokinetics and Pharmacodynamics of Jusline
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
      after subcutaneous administration, and to compare this profile with Humulin insulin.
    

Detailed description: 
      To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
      after subcutaneous administration in the abdominal, and to compare this profile with Humulin
      insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).
    

Intervention name(s): Jusline
Intervention type(s): Drug
Other intervention name(s): Humulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects
Effect of Whole-Body Vibration on Plasma Sclerostin Level
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin
      level in healthy young adult women.

      Fifteen healthy young adult women are planned to include in this study. All cases will be
      trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week
      period. Training duration will be short at the beginning but progressed slowly.

      The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The
      subjects will be asked to report negative side effects or adverse reactions in their training
      diary.

      Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma
      sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels
      will be measured by human sclerostin ELISA kit.
    

Detailed description: 
      Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the
      bone stimulates the osteocytes.

      Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine
      knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin
      levels have been reported to be reduced by mechanical stimulation.

      The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin
      level in healthy young adult women.
    

Intervention name(s): whole-body vibration (WBV)
Intervention type(s): Device
Intervention description(s): All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
Other intervention name(s): Cyclic mechanical loading
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sclerostin; whole-body vibration
Fluorodeoxyglucose Positron Emission Tomography (FDG PET) Findings in Patients With Phenylketonuria Before and After KUVAN Therapy
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      The aim of this pilot study is to determine if there are any changes in brain glucose
      metabolism in the gray matter of patients with Phenylketonuria (PKU) and whether
      administration of Sapropterin (KUVAN) therapy can improve such deficits.
    

Detailed description: 
      Phenylketonuria (PKU) is an autosomal recessive disorder resulting from a deficiency of
      phenylalanine hydroxylase, which converts phenylalanine to tyrosine. Phenylalanine
      hydroxylase is one of the three aromatic amino acid hydroxylases that utilizes
      tetrahydrobiopterin (BH4) as cofactor. The published reports indicate that there is altered
      energy metabolism in the brain of patients with PKU. Phenylalanine and its metabolites appear
      to impair several aspects of brain energetics including: (1) Inhibition of glucose uptake;
      (2) diminished glycosylation of cytoskeletal proteins; (3) Inhibition of pyruvate kinase; and
      (4) reduced flux through the glycolysis. Studies in vivo with magnetic resonance spectroscopy
      have demonstrated phenylalanine-responsive abnormalities in cerebral energy metabolism.

      Positron Emission Tomography (PET) scanning with fluorodeoxyglucose (FDG-PET) is a
      non-invasive method that measures regional glucose metabolic rate with high resolution and
      absolute quantitation. To date this technology has been used only for single case reports or
      the investigation of white matter abnormalities in small numbers of patients with PKU.

      The aim of this pilot study is to determine if there are any changes in brain glucose
      metabolism in the gray matter of patients with PKU and whether Sapropterin (KUVAN) can
      improve such deficits. This study will also elucidate the relationship between
      hyperphenylalaninemia, phenylalanine intake in diet, altered brain glucose handling and the
      neurocognitive profile of the patients with PKU before and after KUVAN therapy.
    

Intervention name(s): Sapropterin
Intervention type(s): Drug
Intervention description(s): All subjects will receive 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects will be examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects Phe and tyrosine levels will be monitored weekly during the study and subjects will keep 3-day diet records to allow for calculation of Phe intake.
Other intervention name(s): KUVAN; BH4
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PKU; BH4; KUVAN; PET scan; Neurodevelopment