bioihbjkbjnl/mcl2 huggingface dataset:
6-Year Follow-up of a Prevention Program for Bereaved Families
Condition: Mental Disorders Diagnosed in Childhood
MeSH terms: Mental Disorders; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Six-years following participation in the Family Bereavement Program (FBP) participants in the
      program as compared to a self-study control group will have lower levels of mental health
      problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower
      use of substances, higher levels of competence at achieving developmentally appropriate tasks
      in academic achievement and social competence, and better self-esteem. The effects of the FBP
      will be moderated by baseline levels of mental health problems and gender. Bereaved
      caregivers who participated in the program will also show lower levels of mental health
      problems as compared with controls.

      Program effects will be mediated by theoretical mediators targeted by the program.
    


Intervention name(s): Self- study comparison group; Family Bereavement Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Caregivers, children and adolescents each received three books about coping with grief following the death of a loved one plus a syllabus to guide reading; 12 session groups for caregivers and bereaved children and adolescents plus two individual sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
Condition: Overweight; Healthy Volunteers
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The research study will investigate the safety and tolerability of ZP8396 in healthy study
      participants. In addition, the study will investigate how ZP8396 works in the body
      (pharmacokinetics and pharmacodynamics).

      Participants will receive 1 single dose either as an injection under the skin (subcutaneous,
      s.c.) or an injection into a vein of one arm (intravenous, i.v.).

      Participants will have 9 visits with the study team. One of these visits consists of 8
      overnight stays at the study site. For each participant, the study will last up to 66 days.
    


Intervention name(s): ZP8396; Placebo (ZP8396)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.; Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety and effectiveness of infliximab in patients
      with plaque psoriasis who have been receiving the drug etanercept for treatment of their
      plaque psoriasis for at least four months, without enough improvement in their psoriasis
      symptoms.
    

Detailed description: 
      The most common form of psoriasis is plaque-type psoriasis, which is characterized by
      recurrent flaring of thickened, red, scaly patches of skin. Although psoriasis is usually not
      life threatening, these physical discomforts combined with the potential psychological
      effects of the disease may interfere with everyday activities and negatively impact an
      individual's quality of life. Many therapies are available for psoriasis; however, with
      limited effectiveness and significant toxicity. Infliximab is an antibody made in a
      laboratory. Antibodies are proteins that fight other substances in the body that may cause
      infections or diseases. A substance called "tumor necrosis factor" (TNF) naturally occurs in
      the body. TNF is related to the itchy patches of skin (or plaques) of psoriasis. Infliximab
      stops the TNF from working. Other studies have shown that stopping the TNF may reduce the
      plaques. To address the unmet medical need for effective chronic therapies, TNFalpha blockers
      have recently been used to treat patients with moderate to severe plaque psoriasis.
      Etanercept also works by stopping the TNF, but in a different way than infliximab. This
      multi-center, open-label study is designed to test whether or not patients with plaque
      psoriasis who have not responded well to etanercept treatment may benefit from treatment with
      infliximab. Key effectiveness measurements will include the time to onset of symptom
      improvement and health-related quality of life. Safety will be assessed throughout the study.
      Two weeks after their last dose of etanercept, all eligible patients will receive open-label
      5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
    

Intervention name(s): infliximab
Intervention type(s): Biological
Intervention description(s): Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Intervention MeSH terms: Infliximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plaque psoriasis; psoriasis; infliximab; remicade; etanercept; enbrel; psunrise; C0168Z04
Discomfort Evaluation During Atraumatic Restorative Treatment in Children
Condition: Dental Caries; Primary Teeth; Post Dental Restoration
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study evaluates the patient 's discomfort when submitted to partial caries removal
      through the atraumatic restorative treatment compared to chemo-mechanical caries removal
      using Papacarie™ gel.
    

Detailed description: 
      This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate
      of the caries) prior to removal of the carious tissue, and when subjected to partial caries
      removal through the atraumatic restorative treatment compared to removal of chemo -
      mechanical caries with Papacarie gel ™.
    

Intervention name(s): Caries removal using only manual instruments; Caries removal using Papacarie gel
Intervention type(s): Other; Other
Intervention description(s): Caries removal using only manual instruments according to Atraumatic Restorative Treatment; Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion
Condition: Parenteral Feeding; Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      The present protocol describes a randomized, open-labelled study in which either SmofKabiven
      Peripheral or a hospital compounded control Parenteral Nutrition (PN) regimen will be given
      to adult surgical patients for 5 consecutive days.

      As serum prealbumin is a well-established surrogate efficacy parameter reflecting the
      patient´s nutritional status, the absolute change of the serum prealbumin level at the day of
      the final study visit compared to baseline will represent the primary efficacy parameter in
      the present study.
    

Detailed description: 
      In addition, other variables will be assessed in this study, i.e., C-reactive Protein (CRP),
      free fatty acids, immunology parameters, taurine, comparison of the time required for Total
      Parenteral Nutrition (TPN) preparation of the two groups, the results of physical
      examination, vital signs, relevant nutrition- and safety-related laboratory parameters in
      venous blood and urine, the results of an Electrocardiography (ECG), and the number,
      severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs).
      The aim of the planned study is to demonstrate that SmofKabiven Peripheral is not inferior to
      the comparative drug (compounded emulsion).
    

Intervention name(s): SmofKabiven Peripheral; Hospital compounded emulsion
Intervention type(s): Drug; Drug
Intervention description(s): Total Parenteral Nutrition; Total Parenteral Nutrition
Other intervention name(s): Study intervention; Investigational Product; Control; Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SmofKabiven; Nutrition; Parenteral; Abdominal surgery
Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method
Condition: Obesity; Type 2 Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Observational

Summary: 
      The main aim of this study is to compare 2 different measurements of visceral fat that can be
      easily used in clinical practice (waist circumference versus bioelectric impedance) in
      relation to known risk factors of coronary artery disease in a large cohort of patients with
      type 2 diabetes and with a BMI range between 20-45 kg/m2
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators will identify and recruit 500 patients. Participants for this study (men
        and women) will be recruited for the diabetes outpatient clinic of the Joslin Diabetes
        Center. Subjects from minority and various ethnic/racial groups will be invited to
        participate in the study at the same proportional to Massachusetts's population, which is
        86.5% white, 6.9 Black, 0.3% American Indian and Alaska, 4.9 Asian, 0.1% Native Hawaiian
        and Other Pacific Islander and 8.2% of Hispanic or Latino origin. The investigators will
        monitor our recruitment by gender and race/ethnicity and modify our recruitment procedures
        if necessary to ensure that there is no selection bias due to these factors.
      
Keywords: Visceral Fat; Waist Circumference; Bioelectrical Impedance; Metabolic Syndrome; Obesity; Type 2 Diabetes
A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the outcome of treatment switch defined as an
      improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects who have undergone a switch in their antipsychotic treatment and fulfill the
        following criteria will participate in the study.
      
Keywords: Schizophrenia; Switch of antipsychotic treatment; Outcome evaluation; monotherapy; Greece
PSA TOOL for Prostate Cancer Screening Discussions
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The study team created a tool to help identify patients who may benefit from shared decision
      making in the primary care setting. This tool is a guide to aid in decision making for
      prostate cancer screening. The team proposes the topics to be discussed in the screening
      conversation include the risk for developing prostate cancer based upon age, race/ethnicity,
      family history of prostate cancer, history of previous digital rectal exam, and history of
      previous prostate specific antigen (PSA) as well as self-reported health status and
      preferences for treatment. The team now proposes 1) testing this tool first for ease of use
      in primary care clinics 2) revising this tool based upon feedback from patients and
      providers, then 3) testing this tool for effectiveness in improving patient knowledge that
      they have an option to be screened for prostate cancer and of specific factors to be
      considered in the screening decision.
    

Detailed description: 
      Objectives:

        1. To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for
           usefulness and ease of use in primary care practices.

        2. To revise the PSA TOOL based upon provider and patient feedback.

        3. To assess patient knowledge about the option to be screened for prostate cancer and
           factors to consider in the prostate cancer screening decision before and after use of
           the tool.

      Study Design:

      This protocol is for field testing of a brief tool to improve prostate cancer screening
      discussions that occur at previously scheduled primary care outpatient visits.
    

Intervention name(s): PSA TOOL; Revised PSA TOOL; Informal Interview
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.; Patients will be given the revised PSA TOOL, after providers have given their initial feedback.; Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Initially, health care providers will give feedback on the tool. The tool will be revised and the second segment of the study will be to give the revised tool to patients with pre- and post-tests which measure changes in prostate cancer screening knowledge.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Screening; Shared Decision Making
Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of the study is to test a food supplement to:

        -  Show that the food supplement is well tolerated and safe to feed to infants;

        -  Find out how often parents/caregivers feed their infants the food supplement;

        -  Find out how parents/caregivers usually add the food supplement to infants' regular
           solid or liquid food; and

        -  Learn what aspects of the food supplement are more or less attractive to infants and to
           parents/caregivers.
    

Detailed description: 
      The study involves parents/caregivers of infants, ≥ 5 months but < 11 months of age. Parents
      who enrolled their infants complete a 1-month blinded placebo run-in period, followed by
      randomization to placebo or the food supplement.

      During the intervention period, infants randomized to the food supplement are fed a once
      daily, individual packet of the food supplement mixed into liquid (e.g., breast milk, infant
      formula) or solid (e.g., applesauce, pureed carrots) foods being fed to the infant. The food
      supplement is a blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat]
      [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon])
      combined with 400 IU of Vitamin D3. Parents complete a daily diary about any reactions or
      symptoms within 2 hours of ingesting the food supplement. Infants randomized to the placebo
      are also fed a once daily individual packet of the placebo mixed into liquid or solid foods
      being fed to the infant. Parents also complete a daily diary about any reactions or symptoms
      within 2 hours of ingesting the placebo.
    

Intervention name(s): Food Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): A powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Japanese P III vs Voglibose and Placebo
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and
      voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with
      insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension
      treatment to 52 weeks.
    


Intervention name(s): BI 1356; BI 1356; voglibose placebo; BI 1356 placebo; voglibose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/daily; 10 mg/daily; three times daily; once daily; 0.6 mg/daily
Intervention MeSH terms: Inositol; Linagliptin; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of the new tipranavir oral solution formulation with the
      current tipranavir oral solution formulation following single-dose administration. In each
      case, 500 mg tipranavir was coadministered with 200 mg ritonavir.
    


Intervention name(s): Tipranavir; Tipranavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): New oral solution (back up) formulation
Other intervention name(s): Current oral solution formulation; Norvir®
Intervention MeSH terms: Ritonavir; Tipranavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Targeting Auditory Hallucinations With Alternating Current Stimulation
Condition: Schizophrenia; Schizo Affective Disorder
MeSH terms: Hallucinations; Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)
      as a treatment for auditory hallucinations in patients with schizophrenia.
    

Detailed description: 
      The investigator's primary objective is to provide further evidence for the effectiveness of
      transcranial alternating current stimulation (tACS) to treat auditory hallucinations and to
      collect preliminary data on whether maintenance stimulation sessions can prolong the duration
      of stimulation-induced clinical benefits. The investigators will be looking into effects of
      tACS to re-normalize pathological alpha oscillations in the dorso-lateral prefrontal cortex
      (dl-PFC) of patients with schizophrenia or schizo-affective disorder by comparing Auditory
      Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session,
      immediately after the last stimulation session, and at the end of the 8 weeks of maintenance
      sessions. As a secondary objective, the investigators will assess the differential clinical
      effects of active sham and 10Hz tACS on electroencephalogram (EEG) measures of alpha
      oscillations. The investigators will also be using source localization techniques in EEG
      analysis, based on individual locations of the scalp electrodes and anatomical structures
      with the use of structural magnetic resonance imaging (sMRI).
    

Intervention name(s): tACS treatment week; tACS sham week; Maintenance tACS; Maintenance Sham tACS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.; 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.; 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.; 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
Other intervention name(s): Neuroconn DC Stimulator; Neuroconn DC Stimulator; Neuroconn DC Stimulator; Neuroconn DC Stimulator
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants will initially be randomized to either sham or 10 Hz tACS for the 5 consecutive days of stimulation. Participants will then be re-randomized to either sham or 10 Hz tACS for the 8 weeks of maintenance stimulation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tACS; Sham; Auditory Hallucinations; Schizophrenia; Schizo Affective Disorder; EEG
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both
      with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in
      smokers after short term deprivation of cigarettes.
    


Intervention name(s): EVT 302, 10 mg; placebo; Nicotine replacement therapy (NRT); NRT placebo
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): 2 X EVT 302, 5 mg tablets; 2 X placebo tablets to match EVT 302 5 mg; NRT patch containing 21 mg of nicotine; Medically inert plaster cut to match the NRT plaster
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking cessation; Craving; Smokers
Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions
Condition: Bioequivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of bicalutamide
      50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under
      fasting conditions
    


Intervention name(s): Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
Intervention type(s): Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment