bioihbjkbjnl/mcl2 huggingface dataset:
Factors Influencing Selective Mutism
Condition: Selective Mutism
MeSH terms: Mutism
Study type: Observational

Summary: 
      The study's goal is to check and verify basic assumptions of a new selective mutism
      developmental model from Melfsen and Walitza through standardized and routinely used patient
      questionnaires. The primary emphasis is the question of a connection between selective mutism
      and high sensitivity, dissociation, emotional regulation, family structure, social anxiety
      and self-esteem.
    


Intervention name(s): Psychometric questionnaire study
Intervention type(s): Behavioral
Intervention description(s): Four groups participate in the psychometric questionnaire study. A group of mute children and their mothers (EG:A), as well as a normal, healthy control group (KG:A) with roughly the same age and sex characteristics fill out one-time questionnaires about current daily life experiences. In addition, another group of formerly mute adults (EG:B) as well as a comparable age/sex normal control group will be retrospectively questioned using the same specifically tailored questionnaire.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The sample consist of pupils with selective mutism aged 8 to 18 years.
Milrinone During Living Donor Hepatectomy
Condition: Hepatectomy
Study type: Interventional

Summary: 
      Maintaining a low central venous pressure during living donor hepatectomy is routine
      practice. The investigators tried to test the hypothesis that using milrinone to maintain a
      low central venous pressure (CVP) during is associated with a superior surgical field and
      less blood loss.
    


Intervention name(s): milrinone; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Milrinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: surgical field condition
Pilot Study of Home Blood Pressure Control Program (eBP Control)
Condition: Hypertension; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This intervention study will evaluate the feasibility,acceptability and effectiveness of an
      e-health enabled model of care by randomly assigning a trained patient navigator and/or a
      blood pressure (BP) self-management web portal to patients with uncontrolled hypertension
      after a run in period with a home BP monitor (HBPM) and comparing the results on blood
      pressure control. We anticipate that patients receiving the combination of a patient
      navigator(PN)with a self-management web portal and home BP monitor will have better BP
      control than when the only received a home BP monitor.
    

Detailed description: 
      The study will demonstrate and evaluate the feasibility and acceptability of an e-health
      enabled model of care for improved hypertension and elevated blood pressure control using a
      home blood pressure monitor (HBPM), a blood pressure (BP) self-management web portal, and a
      trained patient navigator. During the first or the control period, all of the participants
      will have access to the only the HBPM. The control period will be compared to the final or
      the intervention period when the participants will gain access to a trained patient navigator
      and the web portal. This comparison will assist in estimating the effect sizes of the HBPM
      plus PN plus self-management web portal to HBPM alone for each of the outcomes: patient
      activation, self-management activities, medication adherence, reduced clinical inertia, and
      improved BP control. The second of the randomization periods will allocate a patient
      navigator to half of the participants, while the other half will gain access to only the web
      portal. We will compare the effectiveness of the PN plus webportal plus HBPM to webportal
      plus HBPM during this second period. An evaluation of the intervention process will delineate
      the barriers and facilitators by the providers, participants, and patient navigators.
    

Intervention name(s): HBPM+website+patient navigator
Intervention type(s): Behavioral
Intervention description(s): In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.
Other intervention name(s): Good Health Gateway
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Home blood pressure monitoring; Patient activation; Patient-centered care; Community Health Aides; Primary Health Care
Evaluating the Bioequivalence of HIP1302, HGP1406
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence after administration of
      HIP1302 and HGP1406 in healthy male volunteers.
    

Detailed description: 
      A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and
      Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers
    

Intervention name(s): HIP1302; HGP1406
Intervention type(s): Drug; Drug
Intervention description(s): Tenofovir 292mg; Tenofovir 300mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute
      essential components in the complex mechanisms regulating gut hormone secretion and glucose
      homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is
      likely that modification of the enterohepatic circulation of bile acids can lead to changes
      in gut hormone secretion or gut bacteria composition and consequently affect glucose
      homeostasis.

      The current study is a human interventional study with 7-day ingestion of a bile acid
      sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is
      to examine how (and if) bile acid sequestration can influence postprandial glucagon-like
      peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2
      diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a
      phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with
      chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic
      control in patients with chronic kidney disease and type 2 diabetes.

      The investigators hypothesize that higher luminal concentrations of bile acids in the distal
      gut will elicit changes in the postprandial gut hormone secretion and gut bacteria
      composition. The current study will help to clarify this hypothesis and improve our general
      understanding of the association between bile acid circulation and signalling, gut hormone
      secretion, gut bacteria and glucose metabolism.
    


Intervention name(s): Sevelamer 1600 mg TID for 7 days; Placebo 1600 mg TID for 7 days
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive
      deterioration in the function of the pancreatic beta-cells, which are the cells that produce
      and secrete insulin (the hormone primarily responsible for the handling of glucose in the
      body). The investigators propose a randomized controlled trial to determine whether combining
      basal insulin with a new medication called exenatide is a therapeutic strategy that can
      preserve beta-cell function early in the course of type 2 diabetes.
    

Detailed description: 
      In this open-label, parallel-arm randomized controlled trial, adults with T2DM of ≤7 years
      duration on 0-2 anti-diabetic medications will be randomized to 8-weeks treatment with either
      (i) basal insulin glargine, (ii) intensive insulin therapy consisting of glargine and
      pre-meal insulin lispro, or (iii) glargine and the GLP-1 agonist exenatide (twice daily).
      They will then go into a 12-week washout on lifestyle modification only. Beta-cell function
      will be assessed by determining the Insulin Secretion-Sensitivity Index-2 (ISSI-2) on oral
      glucose tolerance test (OGTT) performed at baseline, 4-weeks, 8-weeks, and 20-weeks. The
      primary outcome will be mean beta-cell function (ISSI-2) over the 8-week treatment period.
    

Intervention name(s): Basal insulin and exenatide; Basal insulin only; Basal insulin and bolus insulin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Basal insulin glargine; Exenatide; Basal insulin glargine; Basal insulin glargine; Pre-meal insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Exenatide; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; beta-cell function; GLP-1; insulin
Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
Condition: Mixed Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic
      model and could therefore be well suited when it comes to treating patients with high rates
      of comorbidity. So far, no studies have examined MCT in comparison with the best documented
      and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled
      trial consisting of mixed anxiety disorder sample with high degree of comorbidity.

      The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a
      sample of mixed anxiety disorders as compared to a group receiving existing evidence-based
      single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in
      the two treatments.
    


Intervention name(s): Metacognitive therapy; Cognitive behavioral therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: MCT; Metacognitive therapy; Anxiety disorders; Transdiagnostic
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study in which healthy volunteers and participants with chronic HBV
      infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability,
      pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV
      infection).
    


Intervention name(s): VIR-3434; Placebo
Intervention type(s): Biological; Other
Intervention description(s): VIR-3434 given by subcutaneous injection or intravenous infusion.; Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis
The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
Condition: Transesophageal Echocardiography
Study type: Interventional

Summary: 
      There is no ideal sedation technique that can be used during Transesophageal Echocardiography
      (TEE), and the data concerning the effects of available sedation techniques on Heart Rate
      Variability (HRV) are limited. In this study the investigators aimed at comparing the effects
      of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.
    

Detailed description: 
      Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83
      years. In Group Topical (T) there are 26 patients who had the procedure under topical
      pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive
      midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an
      IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be
      monitored with a non-invasive monitor, blood pressure measurements were taken every 3
      minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be
      performed.
    

Intervention name(s): local anesthesia; hypnosis; Midazolam
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): patients will receive only topical anesthesia with 1% lidocaine; Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method; Before insertion of the probe, the patients will be sedated with midazolam at a dose of 0,.05 mg/kg iv (to achieve a Ramsay Sedation Score of 2-3). If needed, additional iv doses (0.005 mg/kg) were given during the procedure.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: age range of 18-83
To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to calculate the pharmacokinetics (concentration of compound in
      and rate of excretion from the blood) following a very low dose of compound which will not
      have any pharmacological activity and to monitor for the safety and tolerability of each of
      the compounds in the study.
    


Intervention name(s): PF-05186462; PF-05186462; PF-05089771; PF-05089771; PF-05150122; PF-05150122; PF-05241328; PF-05241328
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single intravenous infusion of 100 microgram; single oral administration of 100 microgram; single intravenous infusion of 100 microgram of PF-05089771; single oral administration of 100 microgram PF-05089771; single intravenous administration of 100 microgram PF-05150122; single oral administration of 100 microgram PF-05150122; single intravenous infusion of 100 microgram PF-05241328; single oral administration 100 microgram PF-05241328
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; safety; tolerability; Chronic Pain
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on
      the dopaminergic system by using Positron Emission Tomography (PET) imaging with new
      radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline
      administration will increase dopamine (DA) receptors levels ([11C](+)PHNO) within the human
      brain.
    

Detailed description: 
      Subjects will undergo a pre-treatment PET and MRI scans for baseline [11C](+)PHNO measures on
      Day 1. Subjects will subsequently be provided an initial 2-week supply of study medications
      (varenicline) and directions for use. Any adverse events, compliance to medication and
      smoking patterns will be noted during these two weeks. Varenicline will be used at the same
      dosage regimen as used for smoking cessation. After subjects go through a post-treatment PET
      and MRI scans on Day 10, they will be instructed to set up a quit date. There will then be
      follow-up visits every 2 weeks for the duration of the medication phase (3 months total) and
      a visit at 6 months follow-up.
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): Varenicline will be administered as prescribed: 0.5 mg for the first 3 days then 1 mg for the next 7 days and 2 mg after that. A quit date will be chosen at 11 days after starting Varenicline. Varenicline will be given for 3 months.
Other intervention name(s): Champix
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Varenicline; PET imaging; [11C]-(+)-PHNO PET; neuroimaging in smokers
Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women
Condition: Pregnancy Complications; Covid19
MeSH terms: COVID-19; Pregnancy Complications
Study type: Observational

Summary: 
      SARS-CoV-2 impact on pregnant women is not well known yet. Some authors demonstrated that
      lung ultrasound can give similar results if compared to chest computed tomography and better
      results if compared to chest x-rays without radiations and limited risks for mother and
      fetus.

      The Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of
      lung impairment.

      Some authors described an artifact, the "light beam", as a typical ultrasound sign in
      COVID-19 positive patients.

      With our study we hypothesize to understand the prevalence of this sign and other ultrasound
      signs in pregnant COVID-19 positive patients.
    


Intervention name(s): Lung ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Lung ultrasound signs in Covid 19 positive pregnant patients
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant COVID 19 positive patients admitted at our institution
Taste Assessment of Ozanimod
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the taste characteristics of ozanimod formulations,
      alone and mixed, in order to develop a pediatric oral form of ozanimod.
    


Intervention name(s): Ozanimod
Intervention type(s): Drug
Intervention description(s): Taste assessment
Intervention MeSH terms: Ozanimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ozanimod
Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Coagulation abnormalities after pediatric open-heart surgery are complex and very often
      multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the
      coagulation tests during CPB, the younger age has been the most significant risk factor for
      bleeding and transfusion requirements. In children the volume of pump priming is much higher
      compared with the patient's circulating blood volume. For this reason the CPB tubing system
      is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive
      hemodilution and induced coagulopathy. While this is routinely performed in neonates and
      small infants, the routine priming of CPB system with FFP has been questioned in several
      randomized prospective studies in older infants. However, the results of these studies are
      conflicting. Moreover, they show methodological issues.
    


Intervention name(s): Surgery with CPB; Fresh Frozen Plasma; Plasmalyte
Intervention type(s): Procedure; Other; Other
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and
      by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy
      x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation
      therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether dalteparin, initiated at the time of conventional radiotherapy,
           improves the median survival of patients with newly diagnosed supratentorial
           glioblastoma multiforme.

        -  Determine the time to progression in patients treated with this regimen.

        -  Determine the incidence of thromboembolic events in patients treated with this regimen.

        -  Determine the feasibility and toxicity of dalteparin in this patient population.

      OUTLINE: This is a multicenter study.

      Patients undergo cranial irradiation 5 days a week for 7 weeks. Beginning concurrently with
      initiation of radiotherapy, patients receive dalteparin subcutaneously once daily for up to 2
      years in the absence of unacceptable toxicity. Patients may continue receiving dalteparin
      after year 2 at the discretion of the investigator.

      Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
      after study entry.

      PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
    

Intervention name(s): dalteparin; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Primary purpose: Treatment
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      To estimate the duration of efficacy with continued treatment of double-blind flibanserin or
      placebo over twenty-four weeks of treatment.
    


Intervention name(s): Flibanserin
Intervention type(s): Drug
Intervention description(s): flibanserin flexible dosing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment