bioihbjkbjnl/mcl2 huggingface dataset:
Angelman & Rett Syndrome: Interaction and Communication
Condition: Behavior, Child; Parent-Child Relations; Communication
MeSH terms: Rett Syndrome
Study type: Observational

Summary: 
      We aim to describe the communicative and sensory profile of children with Angelman syndrome
      or Rett syndrome and their use of augmentative and alternative communication. In addition,
      parents are surveyed regarding parent-child interaction and access to communication support.
    


Intervention name(s): Observation; Parental experiences
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Describe communication and sensory profile using standardized tests and observations.; Survey parents' experiences with parent-child interaction and augmentative and alternative communication.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with complex communication needs.
Psychoeducation to Sick-listed Individuals With Mental Health Problems
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick
      leave due to psychiatric sufferings. Mental health conditions are of great consequence not
      only to the sick-listed individual but also to his/her family and to society in general and
      in socioeconomic terms.

      The aim of this project is to systematically compare psychoeducation with the various
      standard offers to sick listed individuals with mental health conditions provided by job
      centers in four municipalities.

      Psychoeducation is employed within the psychiatric healthcare system and is defined as a
      group based treatment by means of educating participants about psychiatric conditions. In the
      present project, the employed psychoeducation focuses on psyche and work life, and its
      purpose is to impart knowledge about psychiatric conditions in order to provide the sick
      listed individuals with qualifications to understand, and, thereby, improve their own
      situation. Among others, there will be information about the symptoms of various psychiatric
      conditions, diagnoses, and treatment options. Furthermore, the participants will learn about
      specific, useful, cognitive tools in regards to the barriers and difficulties they might
      experience when reentering the work force and leave sickness absence behind.

      The project is designed as a randomized clinical trial in which the participants are offered
      either 1) psychoeducation as well as the standard offer to sick listed individuals provided
      by the municipality in which the individual lives or 2) the participants are offered merely
      the standard offer to sick listed individuals provided by the municipality.

      The target group consists of recently sick listed individuals with mental health issues -
      whether diagnosed or not. The individuals must be inhabitants of the municipalities of
      Struer, Lemvig, Skive, and Holstebro.

      The outcome measure is the determined as the duration of the sickness absence, the severity
      of the psychiatric condition, self-reported health, and 'locus of control´. These outcome
      measurements are assessed at baseline and after 3 and 6 months.
    


Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Intervention description(s): 6 x 2 hours of psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Psychoeducation; Stress; Sickness absence; Psychiatric symptoms; Locus of control; Self reported health
Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables (An Intraoperative Study)
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The aim of this research is to apply cardiac tissue characterization in order to assess left
      ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The
      procedures to be used include a retrospective review of transesophageal images obtained
      during conventional intraoperative transesophageal echocardiography (TEE) for cardiac
      surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared
      with hemodynamic data obtained from a pulmonary artery catheter (PAC).
    

Detailed description: 
      Patients included in this study are between the ages of 18 to 99 years of age, who presented
      to the operating room for cardiac surgery, and received both a pulmonary artery catheter and
      a routine intra-operative TEE. We will only be looking at patients whose TEE images were of
      good quality.

      Subjects underwent cardiac surgery and received both a PAC and a routine TEE exam. We will
      review the data from the PAC, the images from the conventional TEE exam, and a secondary
      analysis with Tissue Doppler.

      A potential benefit to society is a novel means for assessing left ventricular function. Our
      research will not benefit our subjects directly. There is no additional risk to our subjects
      beyond the insertion of the PAC and the TEE probe, which are routinely placed in our patients
      under-going cardiac surgery.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing cardiac surgery with general anesthesia.
      
Keywords: Cardiac deformation; Cardiopulmonary bypass; TEE; Cardiac Surgery; Left ventricular function; Pulmonary Artery catheter; Tissue Doppler; Left ventricular function in cardiac surgery
Cytokeratin 8 Level in Age-related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes
      with exudative age-related macular degeneration (AMD) before therapy with intravitreal
      Ranibizumab, and identify associations with visual and anatomical outcome after treatment.
    

Detailed description: 
      In this non-randomized, and open-label study, the investigators will prospectively evaluate
      58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive
      intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be
      taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in
      aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual
      (the best corrected visual acuity change) and anatomical (optical coherence tomography
      parameters) after Ranibizumab injection will be investigated.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention description(s): Three monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed.
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Included patient is required to be least 50 years of age with newly diagnosed exudative
        age-related macular degeneration, with a recent onset of disease.
      
Biospecimen description: 
      Aqueous humor
    
Keywords: Keratin; Ranibizumab
Mandala Intervention on Mental Distress in Nurses Working With Terminally Ill Patients
Condition: Mental Health Issue
Study type: Interventional

Summary: 
      Mandala application intervention of mental distress in nurses working with terminally ill
      patients
    

Detailed description: 
      Questionnaires were applied to the control and experimental groups. Mandala painting was done
      to the experimental group. Questionnaires were applied to the control and experimental groups
      again. Distress, anxiety, depression, death anxiety, death depression and psychological
      well-being of the experimental and control groups were evaluated.
    

Intervention name(s): mandala painting
Intervention type(s): Behavioral
Intervention description(s): nurse painted mandala for relaksing
Intervention model: Single Group Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control grups
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mental health, anxiety, depression
Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of test and
      reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.
    


Intervention name(s): Fluticasone Propionate 0.05% Cream-Reference Product; Fluticasone Propionate 0.05% Cream-Test product
Intervention type(s): Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of two days; Small amount applied and evaluated over the course of two days
Intervention MeSH terms: Fluticasone; Xhance
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Fluticasone Propionate
Preventing HIV/Aids in Drug Abusing Youth
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This project involves two studies focusing on the engagement and treatment of adolescents
      diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based
      engagement intervention, Community Reinforcement Training, designed to facilitate the entry
      of resistant drug-abusing adolescents in treatment. The approach will be compared with an
      Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial
      evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug
      abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are
      successfully engaged in treatment through Study 1 will be randomly assigned to receive either
      family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention.
      Both studies are being conducted in Portland, Oregon.
    


Intervention name(s): IBFT /HIV prevention; IBFT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.; Integrated Behavioral and Family Therapy (IBFT).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: substance abuse; HIV risk; Behavior and Mental Disorders; HIV Seronegativity
A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives are to identify the highest safe and well-tolerated dose and frequency
      of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188
      mcg, when given every other week or every 4 weeks to healthy volunteers (HV).
    


Intervention name(s): BIIB017 (PEGylated Interferon Beta-1a); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each participant will receive BIIB017 every other week or every 4 weeks.; Each participant will receive placebo every other week or every 4 weeks.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
Condition: Type 2 Diabetes
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve
      (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who
      are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The
      safety of this treatment will also be studied.
    


Intervention name(s): Dapagliflozin; Placebo-matching dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks; Oral tablets administered as 0 mg once daily for up to 12 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Hypoglycemic Agents; Pharmacologic Actions; Physiological Effects of Drugs
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations
Condition: Breast Cancer; Colorectal Cancer; Cervical Cancer
MeSH terms: Colorectal Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the
      general practitioner involvement (signature) and a more personalized communication in
      invitation letters to organized screening of breast, colorectal and cervical cancers.

      The hypothesis on which this project is based is that communication is probably more
      effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I
      am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown
      person).
    


Intervention name(s): Normal invitation; revised invitation signed by the coordinating doctor; Revised invitation signed by the attending physician
Intervention type(s): Other; Other; Other
Intervention description(s): No modification and signed by the coordinating doctor as usual; Invitation with revised text and layout and signed by the coordinating doctor as usual; signature typed or typed + handwritten
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: general practitioner; screening; participation; organized screening
Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Condition: Acute Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell
      transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD)
      and haploidentical related donors(HRD) in the treatment of hematologic malignancy.
    

Detailed description: 
      Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only
      curative therapy for a majority of malignant hematologic diseases, especially acute leukemia.
      HSCT from MSD offers the best results for these diseases, but lack of this donor resource has
      restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot
      satisfy all patients due to unsuccessful donor searches. Almost all patients have an
      available related donor with whom they share a single HLA haplotype (ie, haploidentical
      related donor), and it owns the advantage of immediate availability, especially for those who
      urgently need transplantation.The results of transplantation from HRD have improved
      significantly over the past few years. However, the results from such haploidentical
      transplantation have not formally been compared with those of transplantation in patients
      contemporaneously using MSDs and MUDs for hematologic malignancy.
    

Intervention name(s): HSCT from MSD; HSCT from MUD; HSCT from HRD; Cyclosporin A; Methotrexate; Antithymocyte globulin; Mycophenolate mofetil
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.; HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.; HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.; CsA is used in all the patients for GVHD prophylaxis.; MTX is used in all the patients for GVHD prophylaxis.; ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.; MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other intervention name(s): CsA; MTX; ATG; MMF
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methotrexate; Cyclosporins; Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to analyze in a population of obese adolescents, the
      effect of vitamin D3 supplementation in addition to lifestyle and dietary management on
      vascular function assessed by the change between M0 and M3 of endothelium-dependent
      vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).
    

Detailed description: 
      The secondary objectives of this study are:

      A. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation
      on metabolic and vascular function.

      B. To compare the relationships between food intake, metabolic, inflammatory, oxidative
      stress and vitamin D status, and vascular dysfunction between obese and normal weight
      subjects.

      C. To evaluate the effects of sun exposure variations on relationships described in Objective
      B by comparing the observed parameters at baseline and at the end of the three month
      follow-up period, in non-supplemented obese adolescents and adolescents of normal weight.

      D. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin
      D deficiency and vascular function.

      E. To evaluate in obese adolescents, the effects of vitamin D supplementation on the
      metabolome (metabolic signature).

      F. To evaluate the effects of lifestyle and dietary management on these biomarkers (in the
      "control group").

      For these targets (A to F), all teenagers will be classified according to three levels of
      skin pigmentation.

      G. Establish a biobank of samples taken at baseline and at 3 months.
    

Intervention name(s): Vitamin D supplementation; Placebo; 3 months lifestyle and dietary management; Normal control
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.; Patients randomized to this group will receive placebo for 90 days.; Lifestyle and dietary management at the Saint Pierre Institute (Palavas-les-Flots, France) occurs for three months. Nutritionally speaking, each child or adolescent receives a controlled and balanced diet, consistent with the recommendations appropriate for his/her age, slightly hypocaloric or normocaloric. This dietary approach is complemented by a nutrition education program and supervision by a doctor and a dietician. Three hours of exercise training per week are scheduled; these sessions include adapted aerobic activities supervised by instructors and educators at the center.; Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as
      double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14
      consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label,
      continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to
      9000 mcg/day of ITF2984.
    

Detailed description: 
      This was a two part Phase I repeated incremental doses study in male healthy volunteers. The
      study was conducted in two parts. A total of 36 subjects was planned to be enrolled in Part A
      and 36 subjects in Part B. Part A was performed according to a double blind, randomized,
      placebo controlled design and included three sequential dose groups of repeat doses. Each
      group enrolled 12 subjects on ITF2984 or placebo (ratio 9 active: 3 placebo) and received
      ITF2984 s.c. or placebo twice daily for 14 days. For all three groups the last dose was
      planned to be the first dose on Day 14.

      The study started with the Group 1 2000mcg s.c. b.i.d., Group 2 received 3000mcg b.i.d. after
      an interim review of the safety and PK data of the 2000mcg dose level. Group 3 received
      100mcg s.c. to gather data to complete the PK/PD profile of ITF2984. Subjects were screened
      up to 28 days before dosing with ITF2984/placebo that took place on Days 1-14.

      For all Groups, on day -1 and day 13 subjects received the exogenous tests administration
      (GHRH, Arginin and TRH) 30 minutes after the first morning administration of ITF2984/placebo.

      Part B was open label, and planned for six sequential dose groups of 6 subjects each. In each
      group subjects received ITF2984 continuous subcutaneous infusion for 7 consecutive days. The
      dose was escalated, from the starting dose of 900 mcg, by a maximum of three fold or more
      cautiously, if deemed necessary. The decision to test higher dose levels was based on review
      of safety and PK data from the previous dose level(s). After a 28 day screening period,
      subjects were admitted to the clinical unit on the evening of day -2. ITF2984 continuous
      infusion planned from day 1 to day 8 in the morning. On day -1 (the day prior to the start of
      infusion) subjects received the exogenous/challenge test administrations (GH-RH+Arginina and
      TRH). On day 7 the challenge tests were repeated.
    

Intervention name(s): ITF2984 (100, 2000, 3000 mcg bid); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): somatostatin analogues
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: volunteers