bioihbjkbjnl/mcl2 huggingface dataset:
Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at
      high risk to develop alterations of glucose metabolism and definition of new pathogenic
      mechanisms of insulin resistance and atherosclerosis.

      The following classes of subjects at high risk will be considered:First degree relatives of
      patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke,
      patients with heart valve disease. age will be > 30 years, both gender.
    

Detailed description: 
      The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and
      insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of
      endothelial function, of natriuretic peptides and free fatty acids, and inflammation before
      and 2 hours post-glucose load. New candidate genes will be also evaluated.
    

Observational model: Defined Population
Time perspective: Other
Keywords: cardiovascular disease; glucose intolerance; type 2 diabetes; endothelial dysfunction; inflammation; Age> 30 years, male and female; Fasting glucose below 126 mg/dl
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood
      lipid levels
    

Detailed description: 
      A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate
      the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in
      subjects with higher than normal blood lipid levels
    

Intervention name(s): Study Dietary Supplement (Prelipid 500 mg capsules); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.
Other intervention name(s): PreLipid, Natural Cholesterol Supplement, Predisease; Placebo 600 mg capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyslipidemia; High cholesterol; High LDL; Triglycerides
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH
    


Intervention name(s): ALN-CC5; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple doses of ALN-CC5 by subcutaneous (sc) injection; calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PNH; RNAi therapeutic
Safety and Efficacy of DA-9805 for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate
      the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects
      diagnosed with early Parkinson's disease.
    

Detailed description: 
      Parkinson's disease (PD) is recognized as one of the most common neurologic disorders,
      affecting approximately 1% of individuals older than 60 years. There are 2 major
      neuropathologic findings: the loss of pigmented dopaminergic neurons in the substantia nigra
      pars compacta (SNpc) and the presence of Lewy bodies.

      Parkinson's disease affects an estimated 1.5 million persons in the United States, with over
      ten million affected worldwide, and these estimates are expected to increase substantially in
      the next few decades. Despite the increasing prevalence, the approved agents for the early
      management of Parkinson's disease have changed little in the past decade; however, there have
      been advances in drug delivery, dosing, and the use of combination therapy in an attempt to
      reduce adverse events. The most important, unmet medical need in targeting Parkinson's
      disease is developing agents with neuroprotective potential. So far, no drug has been shown
      to reduce or slow down the progression of PD.

      DA-9805 is a botanical drug product composed of three main raw herbal materials. It is
      expected that DA-9805 will help treat PD by prevention of dopaminergic neurodegeneration via
      recovery of mitochondrial dysfunction, anti-inflammatory effect and relief from Endoplasmic
      reticulum (ER) stress and oxidative stress.
    

Intervention name(s): DA-9805 45mg; DA-9805 90mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): DA-9805 15mg tid; DA-9805 30mg tid; Placebo, tid
Other intervention name(s): DA-9805; DA-9805
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone
      intensities have been suggested as a correlative of central serotonergic activity. A strong
      loudness dependence amplitude increase (strong intensity dependence) reflects low
      serotonergic neurotransmission and vice versa. Many researchers assumed that the brain
      serotonergic activity could influence treatment response of highly selective serotonin
      reuptake inhibitors in depression and anxiety disorders. There are a couple of studies
      reporting associations of N1 amplitude intensity dependence with response to Citalopram
      (positive correlation) and Reboxetine (negative correlation) treatment in major depressive
      disorder patients. But so far there have been no reports about associations between ERP N1
      and antidepressant response in GAD patients.

      So, it would be very interesting to explore the correlations between ERP N1 amplitude change
      and the Escitalopram treatment responsiveness in GAD patients.
    


Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): Start with escitalopram 10mg
According to patient's symptoms, stay on 10mg or increase up to 20mg
Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages
Length of washout period will be at least 2 weeks for any psychotropic drugs
Other intervention name(s): lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized anxiety disorder; N100; Central serotonergic activity
Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
Condition: Satiety; Appetite
Study type: Interventional

Summary: 
      This study evaluates the satiating effect of two types of food supplements made from various
      types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of
      hormones
    

Detailed description: 
      This study assessing the effect on appetite satisfaction and short-term satiety of different
      plant compositions in the adolescent age segment wants to assess the satiating effect of two
      types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum
      and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the
      regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the
      mechanisms of satiety
    

Intervention name(s): Fiber product; Control product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fiber product with inulin, maltodextrin, gum guar and plum powder.; Placebo product with maltodextrin and plum powder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was performed on 160 participants, to ensure the impact of multi vitamin and
      mineral to reduce NAFLD
    

Detailed description: 
      This study was performed on 160 participants, to ensure the impact of multi vitamin and
      mineral to reduce NAFLD.

      Participants were randomly selected to participate in the study. Then divided into the groups
      (intervention and placebo). Intervention received supplementation for 12 weeks and placebo
      received same capsule was made for placebo groups.
    

Intervention name(s): Multiviamins and minerals; Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group received multivitamin and minerral
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Of Primary And Secondary Attention-Deficit/Hyperactivity Disorder Among Survivors Of Childhood Cancer
Condition: ADHD; Cancer
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This is a pilot study that will be an exploratory investigation of the rate of occurrence of
      ADHD/S-ADHD in adolescent cancer survivors. The procedures that will be used for identifying
      attention problem symptoms, determining the frequency and severity of such symptoms, and
      characterizing the level of impairment resulting from the symptoms are novel to pediatric
      oncology research.This pilot study will draw from the approach used in traumatic brain injury
      research of post-injury effects to illuminate more clearly the nature of attentional late
      effects experienced by survivors of childhood cancer.
    

Detailed description: 
      1. This study will investigate the feasibility of assessing symptoms of developmental ADHD
           and "secondary ADHD" (S-ADHD) among adolescent survivors of childhood cancer using a
           structured diagnostic clinical interview procedure. (S-ADHD describes an acquired
           clinical presentation that is consistent with the diagnostic criteria of ADHD).

        2. This study will provide preliminary estimates of the rate of occurrence of ADHD/S-ADHD
           among adolescent survivors of childhood cancer as compared to the prevalence of
           developmental ADHD in the general population.

        3. The study will examine the relationship between ADHD/S-ADHD symptoms and laboratory
           measures traditionally used to assess specific components of attention (e.g., CPT) in
           survivors of childhood cancer.

        4. The study will examine the relationship between ADHD/S-ADHD symptoms and smoking
           (including intentions, behaviors, and motivators) among adolescent survivors of
           childhood cancer.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited through consecutive enrollment in the SJCRH Leukemia,
        Neuro-Oncology, Radiation Oncology, and After Completion of Therapy (ACT) clinics.
        Participants will be accrued using a broad stratification process for gender (female, male)
        and age (12-14 years, 15-17 years) for each diagnosis group (brain tumor, ALL).
      
Keywords: ADHD, childhood cancer; ADHD/Secondary ADHD Among Survivors of Childhood Cancer
Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension
Condition: Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is that evaluation of basic and accessory respiratory muscles and their
      relationship of six minute walk test in patient with pulmonary arterial hypertension (PAH)
    


Intervention name(s): patient assessment
Intervention type(s): Diagnostic Test
Intervention description(s): subjective and objective measurement will be performed in patients with PAH
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patient group will be chosen among the admitted to clinic control group will consist of
        invited volunteers
      
Keywords: respiratory muscle strength; exercise capacity; dyspnea; accessory respiratory muscle
Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors
Condition: Obesity; Cancer
Study type: Interventional

Summary: 
      This purpose of this pilot study is to investigate the feasibility of and optimal time post
      cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T),
      as well as assess its preliminary efficacy on specific child health behaviors. The study will
      also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC
      (standard care).
    

Detailed description: 
      Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese,
      which increases their risk for negative long-term physical health complications. Consistent
      with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to
      cancer survivorship and increasing long-term healthy behaviors in these survivors, we
      conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by
      targeting their caregivers as agents for PCS behavior change. We focused on parents'
      behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in
      PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be
      effective for parents of overweight and obese children and adolescents in reducing child and
      adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years
      off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our
      Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the
      preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care
      (EUC) control condition, and 2) factors to consider to improve future adaptations of the
      intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into
      the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre-
      and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we
      hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater
      improvements in dietary intake, physical activity, and in anthropometric health indicators
      over time.
    

Intervention name(s): NOURISH-T; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Overweight/obesity family intervention; Publicly available overweight/obesity materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Association Between Arterial Stiffness and Assessment of Hydration State in Peritoneal Dialysis Patients
Condition: Disorders Associated With Peritoneal Dialysis
Study type: Observational

Summary: 
      Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis
      (PD) patients but so far objective methods for DW assessment have not been established for
      daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a
      body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of
      brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial
      stiffness.
    

Detailed description: 
      We evaluated 60 patients using a new BCM device that implies a validated body composition
      model. This method allows correct quantification of extracellular fluid overload or
      deficiency (normal limits:-1.1 to +1.1L). Patients were assigned to normo and hypervolemic
      groups according to BCM results. Also, normalized calf resistivity (nRho) was calculated from
      resistance at 5 Khz using c-BI and the levels of NT-proBNP were measured in all study
      patients. The analyses of arterial stiffness were performed by using the pulse wave velocity
      (PWV) technique on the patients. All patients underwent conventional echocardiography and
      their left ventricular diastolic functions were evaluated.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We evaluated 60 patients' hydration states were measured by bioimpedance spectroscopy
        methods. Patients were assigned to normo and hypervolemic groups according to Body
        composition monitor(BCM) results. Also, normalized calf resistivity (nRho) was calculated
        from resistance at 5 Khz and the levels of NT-proBNP were measured in all study patients.
        The analyses of arterial stiffness were performed by using the pulse wave velocity (PWV)
        technique on the patients. Additionally, all patients underwent conventional
        echocardiography and their left ventricular diastolic functions were evaluated. The
        patients were grouped using the BCM method because, according to the literature, this
        method is the only one that can classify subjects in terms of volume conditions.
      
Keywords: Peritoneal, Dialysis
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open label intra-patient dose escalation study to evaluate safety and
      tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis
      imperfecta (OI).

      Pharmacodynamic effect will be determined by serological biomarkers and radiologic
      assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.
    

Detailed description: 
      This study was previously posted by Mereo BioPharma and was transferred to Ultragenyx in
      February 2021.
    

Intervention name(s): BPS804
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brittle bone disease; inherited; connective tissue disorder; fracture
Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
Condition: Cardiovascular Diseases; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Study type: Observational

Summary: 
      In which CHD patients with high risk of CV complications are different doses of LIPRIMAR
      used? For this purpose, data on hyperlipidemia will be elicited over and above the basic
      nosographic and demographic data, concomitant diseases and cardiovascular risk factor.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin, 10- 80 mg, once daily, 6 month treatment
Intervention MeSH terms: Atorvastatin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Coronary atery disease, prevention of high risk cardiovascular complications with statins.
      
Keywords: Coronary Artery Disease; Hyperlipidemia; Atorvastatin
Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
Condition: Secondary Prevention
Study type: Interventional

Summary: 
      Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the
      lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer,
      or may appear months later. In the literature there are numerous educational recommendations
      to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With
      the increase of mobile technologies among adults, the mobile devices can be an effective
      method to meet their education.

      Objective: To determine the effectiveness of therapeutic adherence a brief educational
      intervention through a smartphone-based application in the prevention of lymphedema in women
      with mastectomies.

      Method: 100 women survivors of breast cancer will be randomized to a group that will receive
      lymphedema prevention education and an app specific for better adhesion compared to the
      control group will receive education only. They will be monitored for 28 weeks by specific
      measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema
      disability questionnaire and other measures of fatigue, quality of life and mood related to
      cancer.

      Discussion: The lack of adherence to health education is the main cause of failure in
      maintaining these brief educational interventions, whether the program is beneficial, it
      could be successfully implemented in clinical practice.
    


Intervention name(s): health education for lymphedema prevention
Intervention type(s): Other
Intervention description(s): All subjects received a multimodal intervention consist in a multimodal program with an educational approach
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lymphedema, prevention, ehealth, cancer