bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness in Mood Dysregulated Youth
Condition: Bipolar Disorder; Mood Disorder; Emotional Disturbance
MeSH terms: Bipolar Disorder; Mood Disorders; Affective Symptoms
Study type: Interventional

Summary: 
      Mindfulness group therapy can help children with mood irregularities and family history of
      bipolar disorder.
    

Detailed description: 
      Mindfulness Based Cognitive Therapy (MBCT) is a manualized psychotherapeutic intervention
      that is a combination of mindfulness techniques and cognitive behavioral therapy. MBCT-C,
      which is mindfulness based cognitive based therapy for children, involves weekly group
      sessions, home practice, and the core curriculum of formal mindfulness practices (e.g. body
      scan, sitting, movement and walking meditations). Group sessions will involve guided
      meditation practices, instructor-led discussion of experiences and psychoeducation. By
      fopstering the ability to pay close attention to thoughts, emotions and body sensations,
      participants learn to make better choices to deal with stress, anxiety, depression, pain and
      other challenges. This can allow them to more effectively use the principles of cognitive
      behavioral therapy.

      Twelve children aged 10-17 with mood dysregulation and a bipolar parent will be in the study
      for 12 weeks. There will be two groups receiving intervention: one group recruited from the
      community and one group recruited from a known high-risk cohort.
    

Intervention name(s): MBCT-C Therapy
Intervention type(s): Behavioral
Intervention description(s): Mindfulness Based Cognitive Therapy for Children is a manualized psychotherapeutic intervention that combines mindfulness techniques with certain features of cognitive behavioral therapy. This particular protocol for youth includes weekly group sessions, regular home practice, and the core curriculum of formal mindfulness practices (e.g., body scan, sitting, movement, and walking meditations).
Other intervention name(s): Mindfulness Based Cognitive Therapy-Children
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amygdala; mindfulness; mood; emotion; bipolar disorder; parental bipolar disorder; adolescence
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to compare functional status and quality of life of a group of
      patients with chronic venous insufficiency treated with manual lymphatic drainage with a
      group not treated with manual lymphatic drainage.

      Investigators hypothesized that manual lymphatic drainage can improve:

        -  quality of life,

        -  functional status,

        -  calf muscle strength,

        -  ankle range of motion,

        -  edema,

        -  severity of disease,

        -  and symptoms.
    


Intervention name(s): Manual Lymphatic Drainage; Education
Intervention type(s): Other; Behavioral
Intervention description(s): Behavioral education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Venous Insufficiency; Physical Therapy Techniques; Manual Lymphatic Drainage
Evaluation of Somatostatin Receptors and GH Receptor Expression on Bone of Acromegalic Patients (ACRO-BONE)
Condition: Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients
Study type: Observational

Summary: 
      Skeletal fragility is a frequent complication in patients with acromegaly. About 30% of
      patients with acromegaly can develop spontaneous vertebral fractures. Preliminary data show
      that patients suffering from acromegaly and treated with second generation somatostatin
      analogues (Pasireotide Lar) are more protected from the risk of vertebral fractures, compared
      to patients treated with other therapeutic lines (such as first generation analogues) . The
      molecular basis of this therapeutic effect on bone metabolism has not been identified. Since
      second generation somatostatin analogues preferentially bind somatostatin receptor subtype 5,
      while first generation analogues bind both subtypes 2 and 5, our work aims to evaluate the
      expression pattern of somatostatin receptors somatostatin on bone tissue of patients with
      acromegaly, comparing it with the bone receptor profile of a control group, composed of
      patients with non-secreting pituitary adenomas and prolactin and ACTH-secreting pituitary
      adenomas and healthy subjects undergoing septoplasty for nasal septum deviation .
    


Intervention name(s): Trans-sphenoidal surgery
Intervention type(s): Procedure
Intervention description(s): Surgical removal of pituitary tumor by trans-sphenoidal approach
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort will consist of 20 cases of patients with acromegaly and a control group
        consisting of 20 patients with non-secreting pituitary adenomas, 20 patients with secretory
        pituitary adenomas (10 cases of prolactinoma and 10 cases of Cushing's disease). and 20
        healthy subjects (patients undergoing septoplasty for deviation of the nasal septum).
Predicting Medication Response in Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      In this study, the investigators hope to study a number of variables the investigators
      believe may help us predict why some people respond better to some medications than others.
      Participants will be randomly assigned to receive one of two typical medications for OCD,
      clomipramine or escitalopram. Individuals who would like to participate but who have
      previously tried one or both of these medications may instead take a newer drug, duloxetine,
      and undergo the identical procedures. The factors the investigators will be studying include
      demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in
      genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes
      involved in several brain chemical systems, such as serotonin), the dimensions of OCD
      symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition
      will be measured transcranial magnetic stimulation and is being studied because deficits in
      this process may be important in the development of OCD. The investigators hypothesize that
      certain pretreatment clinical characteristics will correlate with poor treatment response
      including earlier age of onset, longer duration of illness, increased YBOCS severity and
      presence of significant hoarding symptoms. The investigators expect that increasing degree of
      deficit in CI pre-treatment will predict poor treatment response, but that increase in CI
      from pre- to post-treatment will correlate with a positive treatment response. Differences in
      genetic marker status for cytochrome P450 genes will correlate with tolerability and/or
      response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A
      will correlate with response.
    


Intervention name(s): clomipramine; escitalopram; duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily; oral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily; oral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily
Other intervention name(s): Anafranil; Cipralex; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Clomipramine; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: OCD; pharmacogenetics; cortical inhibition; genetics
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Observational

Summary: 
      The purpose of this study is to assess the indirect effects of a pneumococcal conjugate
      vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7
      years.
    

Detailed description: 
      The purpose of this study is to assess the indirect effects of a pneumococcal conjugate
      vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7
      years.

      This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in
      2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia,
      tympanostomy tube surgery and outpatient antimicrobial treatment.
    

Intervention name(s): PCV GSK1024850A; hepatitis B vaccine or hepatitis A vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380); 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Other intervention name(s): GSK Biologicals' Synflorix TM vaccine; GSK Biologicals' Engerix TM (hepatitis B) vaccine; GSK Biologicals' Havrix TM (hepatitis A) vaccine
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger
        child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial
        (ClinicalTrials.gov Identifier:NCT00861380)
      
Biospecimen description: 
      Nasopharyngeal and oropharyngeal swabs obtained.
    
Keywords: Children; Pneumococcal Vaccines
Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective:

      Efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively.
      Evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis.

      Design:

      Open-study on thirty-six patients with moderate to severe nail psoriasis treated with
      acitretin.

      Participants:

      Patients included 27 men and 9 women (mean age 41) with nail psoriasis. Intervention: Therapy
      consisted of acitretin 0.2 to 0.3 mg/Kg/day for 6 months.

      Main Outcome Measure(s):

      Clinical evaluation, NAPSI and modified NAPSI scores before therapy, every 2 months during
      therapy and 6 months after treatment.
    

Detailed description: 
      The Nail Psoriasis Severity Index (NAPSI) has been designed and successfully implemented to
      grade severity of psoriatic nail disease. Moreover, the utilization of the NAPSI score and a
      modified version of this severity index score as an instrument to monitor response to therapy
      has been recently documented in the medical literature .This open study involves thirty-six
      patients with moderate to severe nail psoriasis treated with low-dose acitretin from January
      2005 to January 2007.Acitretin was given at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.
      Laboratory investigations and clinical evaluation, which included photographic record and
      scoring of NAPSI and modified NAPSI, were performed every 2 months. Investigator evaluation
      was performed using a 0 (no improvement) to 3 (cleared or almost cleared) score Treatment
      satisfaction by patients and tolerability were assessed at each visit. All patients were
      followed for at least 6 months after the end of treatment.
    

Intervention name(s): acitretin
Intervention type(s): Drug
Intervention description(s): Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.
Other intervention name(s): Neotigason
Intervention MeSH terms: Acitretin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: nail, psoriasis, NAPSI,acitretin
Molar Potency Study of HM12470 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to assess and compare molar potency of HM12470 and regular human
      insulin in healthy subjects.
    


Intervention name(s): HM12470
Intervention type(s): Biological
Intervention description(s): HM12470 is a long-acting insulin analogue
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Loss of a Healthy Weight Advantage Among Mexican-American Children
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Observational

Summary: 
      Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage
      relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be
      changing over time. The objective of this study was to examine whether the relationship
      between nativity and overweight/obesity has changed over time among Mexican-American children
      and to investigate the implications of this pattern on overweight/obesity disparities
      relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and
      non-Hispanic white children ages 4-17 years participating in the National Health and
      Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators
      used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by
      nativity status adjusting for age, sex, householder marital status, householder education,
      survey period and a nativity by survey period interaction. The investigators also tested
      another covariate-adjusted model with a 3-level ethnicity-nativity variable that included
      Whites and an ethnicity-nativity by survey period interaction.
    


Intervention name(s): Nativity
Intervention type(s): Other
Intervention description(s): Mexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Data came from the National Health and Nutrition Examination Surveys (NHANES), a series of
        repeated cross-sectional surveys conducted by the U.S. Centers for Disease Control and
        Prevention. The investigators used data from NHANES III (1988-1994) and 5 pooled survey
        cycles from the continuous NHANES (2005-2014) to represent the two survey periods under
        study over 20 years apart. These analyses were restricted to Mexican-Americans and
        non-Hispanic White children aged 4-17 years. Out of the 12,006 Mexican-Americans and white
        children who attended the clinical examination in NHANES III and the continuous NHANES
        (2005-2014), those who reported being pregnant were excluded from analyses (N=19). Our
        final analytic sample included 6,280 Mexican-Americans and 5,707 White children across the
        two survey periods (2,704 Mexican-Americans and 2,014 White children in 1988-1994; 3,576
        Mexican-Americans and 3,693 White children in 2005-2014)
Intervention of Attenuated Psychosis Syndrome With M-Health Technology
Condition: Adolescent - Emotional Problem
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      The investigators will develop a culturally sensitive smart phone application to enhance
      neurocognitive function (memory and attention in particular) of participants with attenuated
      psychosis syndrome (APS).
    

Detailed description: 
      The investigator will conduct a pilot study of 80 APS subjects (age 18-45). Forty subjects
      will be randomly put in the SMART plus routine care (RC) group and 40 to RC group only. At
      baseline and 3-month follow-ups, all subjects will complete questionnaires including Mobile
      App Rating Scale SMART feasibility and engagement. 1:1 in-depth interviews will be conducted
      at the two time points to cross-validate the findings obtained from the questionnaires. The
      questionnaires and in-depth interviews for APS subjects for the RC group seek to explore
      their preference and likelihood to use SMART given the opportunity. Examine Cognitive
      Function Change. In order to prepare for future large scale randomized clinical trials, the
      investigator will examine the effectiveness of SMART in improving working memory and
      attention of APS subjects. At baseline and 3-month follow-ups, all subjects will complete
      MATRICS Consensus Cognitive Battery (MCCB) subtests measuring working memory (Spatial Span)
      and attention (Continuous Performance Test-Identical Pairs). A between and within group
      design allows examining change of outcome variables over time and group differences. Enhance
      mHealth research capacity of SMHC at individual and organization levels.
    

Intervention name(s): specific memory and attention realtime training
Intervention type(s): Other
Intervention description(s): The investigator will conduct a pilot study of 80 APS subjects (age 18-45). The investigator will examine SMART feasibility and user engagement using a randomized control trial research design. Using a simple random method, 40 APS subjects will be randomly assigned to the experimental group to receive add-on SMART intervention for 3 months and 40 APS subjects will just get naturalistic treatment with no SMART intervention. At baseline and 3-month follow-up, subjects will complete questionnaires on app use habits and attitudes towards SMART feasibility and engagement. In-depth interviews will be conducted at both time points to cross-validate the findings obtained from the questionnaires.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Methods for Measuring Insulin Sensitivity
Condition: Obesity; Hypertension; Diabetes-Mellitus, Non-Insulin Dependent
MeSH terms: Hypertension; Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Patients with high blood pressure, diabetes, and who are overweight are known to have defects
      in the way their body responds to insulin. The purpose of this study is to develop better
      methods for measuring the way body tissue responds to insulin and sugar (glucose).

      Researchers are planning to study four groups of patients.

        1. Normal volunteers

        2. Patients who have mild to moderate high blood pressure

        3. Patients who are overweight

        4. Patients who have mild to moderate diabetes controlled with oral medication

      In this study patients and volunteers will undergo two separate tests designed to determine
      how well insulin is working in the body. The first test is called a glucose clamp test.
      Patients will have two needles placed in the veins of their arms. One needle will be used to
      take blood samples, the other needle will be used to inject doses of sugar (glucose) and
      insulin.

      The second test is called the frequently sample intravenous glucose tolerance test. In this
      test patients will have sugar (glucose) injected into their veins followed by a slow injected
      dose (infusion) of insulin. Researchers will periodically take blood samples during the test.

      Patients participating in the study will not directly benefit from it. However, the
      information gained from this study may be useful for improving the diagnosis and therapy of
      diseases such as diabetes, obesity, and high blood pressure (hypertension).
    

Detailed description: 
      We hypothesize that the majority of the information needed to accurately estimate insulin
      sensitivity is contained in the fasting insulin and glucose levels as well as the insulin and
      glucose levels obtained shortly after an intravenous glucose load. We propose to test this
      hypothesis by performing both hyperinsulinemic euglycemic glucose clamps as well as
      intravenous glucose tolerance tests on normal volunteers and groups of patients with
      diabetes, hypertension, or obesity (diseases known to be associated with insulin resistance).
      Data from these studies will be used obtain estimates of insulin sensitivity by the glucose
      clamp method, minimal model method, and a novel analysis that utilizes only fasting and peak
      levels of glucose and insulin. We hope to devise a simpler method for determining insulin
      sensitivity in vivo that is suitable for testing large populations. This method will require
      only a few blood samples, take less than one hour to perform, and correlate with glucose
      clamp estimates at least as well as the minimal model method.
    

Keywords: Insulin Resistance; Obesity; Hypertension; Diabetes; Mathematical Modeling; Normal Volunteer
Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.
Condition: Rhinosinusitis; Headache; Fatigue; CT
MeSH terms: Sinusitis; Fatigue; Headache
Study type: Interventional

Summary: 
      This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic
      sinusitis in a randomized, double-blind, placebo-controlled trial.
    

Detailed description: 
      Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by
      symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common
      presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge
      (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated
      with reductions in patient quality of life (QOL), sleep quality, and daily productivity.

      It has been suggested that low-level laser can be used in treating chronic sinusitis but
      there are limited studies about its usage.

      HYPOTHESES:

      There is no statistically significant effect of laser therapy on headache, fatigue, or CT
      finding in patients with chronic sinusitis.
    

Intervention name(s): Laser theapy
Intervention type(s): Device
Intervention description(s): participants were randomized into either the LLLT group or sham treatment group by a computer-generated random number. The participants were treated using LLLT (904nm and 2.5 J/ sinus). treatment was delivered for one month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the efficacy, safety and tolerability of atogepant in participants with
      chronic migraine. This study included a 12-week treatment period.
    


Intervention name(s): Atogepant 30 mg; Atogepant 60 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets containing 30 mg atogepant; Tablets containing 60 mg atogepant; 30 mg/60 mg tablets containing atogepant-matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment