bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3209590 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of LY3209590 when given by injection
      under the skin to participants with type 2 diabetes. It will also investigate how the body
      processes the study drug and the effect of the study drug on blood sugar levels. Information
      about any side effects will be documented.

      This study will last approximately 17 weeks, not including screening. Screening is required
      within 4 weeks prior to the start of the study.
    


Intervention name(s): LY3209590; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute
      [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the
      incidence of hypoxemia.
    

Detailed description: 
      It's a double-blind, randomized trial. The patients'demographic information, such as sex,
      weight, height, smoking status, present illness and history of past illness, were collected.
      After successful peripheral intravenous access, all patients, before sedation, received 20
      min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart
      rate, and blood pressure of the patients were recorded by the investigators.Patients in the
      HFNO group received humidified oxygen at different rates via a high-flow nasal cannula
      (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous
      electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients
      was monitored throughout the procedure. . After bronchoscopy, patients were transferred to
      the post anesthesia care unit (PACU) if their vital signs were stable.
    

Intervention name(s): high flow nasal cannula
Intervention type(s): Device
Intervention description(s): The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: high flow nasal oxygenation; hypoxemia; bronchoscopy; effective flow
Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control Programmes
Condition: Schistosomiasis; Helminthiasis; Anaemia
MeSH terms: Schistosomiasis; Helminthiasis
Study type: Observational

Summary: 
      Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus
      on the school-age population, and school-based treatment delivery programs offer a major cost
      advantages because of the use of the existing school infrastructure and the fact that
      schoolchildren are accessible through schools. However, in many developing countries, large
      numbers of school-age children are not in school and this has raised questions about the
      effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the
      non-formal education sector is providing a growing solution to the problem of poor enrolment
      in basic education, especially in sub-Saharan Africa, and has recently been used to deliver
      praziquantel as part of a national schistosomiasis control program in Uganda. However, it is
      unclear how effective this program has been in reaching children who attend non-formal
      schools and whether the program has been reaching children from the poorest households.
    

Detailed description: 
      This study will compare infection and nutritional status of children enrolled in formal
      schools and non-formal schools, and non-enrolled children in Nakasongola District in Uganda,
      and investigate the process and impact of treatment delivered by the national control
      program. The study will consist of household surveys and cross-sectional parasitological and
      hematological surveys, with follow-up six months later. The evaluation will take place over
      the course of a year and will:

        -  Compare the infection and nutritional status of children enrolled in formal schools and
           non-formal schools, and non-enrolled children in Nakasongola District, Uganda

        -  Compare programmatic process indicators, including enrolment rates, attendance rates,
           access to water and sanitation, treatment coverage in formal and non-formal schools

        -  Investigate the impact of treatment on intensity of infection and reinfection rates in
           formal and non-formal schools.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children enrolled in formal schools and children not enrolled in formal school identified
        by household survey
      
Biospecimen description: 
      faeces blood
    
Keywords: schistosomiasis; helminthes; anaemia
Effect of Ozone Gel on Treatment of Chronic Periodontitis
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional
      periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and
      superoxide dismutase (SOD) activity in patient with chronic periodontitis.
    

Detailed description: 
      In this study, the investigators tested the effect of ozone gel as a local delivery system in
      treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in
      clinical attachment level, a more rise in BD values as well as greater reduction in SOD
      activity compared to scaling and root planing (SRP) alone.
    

Intervention name(s): scaling and root planing; placebo gel; Ozonated olive oil gel
Intervention type(s): Procedure; Drug; Drug
Other intervention name(s): Ozonated olive oil gel = Oxactiv gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ozone gel; Antioxidants; Chronic periodontitis; Superoxide dismutase
Effect of a Carbohydrate-rich Diet in Healthy Subjects
Condition: Lipid Metabolism Disorder
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The present research protocol will analyze whether a short-term modification (one week) of
      dietary habits would have an impact on the postprandial metabolism of dietary fatty acids and
      on their uptake by non-adipose tissues, in healthy subjects.

      Each subject will participate in two protocols randomly determined and separated by a period
      of one month: a 7-day isocaloric diet (Protocol A) and a 7-day carbohydrate-rich diet
      containing +50% of the subject's energy needs. (Protocol B).

      At the end of each diet, the subject will go through a postprandial metabolic study of 8
      hours where different parameters will be measured thanks to PET imaging and perfusions of
      stables isotopes.
    


Intervention name(s): isocaloric diet; Hypercaloric diet; Liquid meal; PET imaging; perfusions of stable tracers; Indirect calorimetry
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Radiation; Other; Device
Intervention description(s): a 7-day isocaloric diet; A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
Condition: Polycystic Ovary Syndrome; Hirsutism; Menstrual Irregularity
MeSH terms: Polycystic Ovary Syndrome; Hirsutism; Syndrome; Menstruation Disturbances
Study type: Interventional

Summary: 
      Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous
      ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our
      study is to investigate the role of folic acid conteined in the inositol preparation. The
      study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and
      subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual
      pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test,
      euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of
      treatment.
    


Intervention name(s): myo-inositol 1500 gr; myo-inositol 2000 gr + folic acid 200 mcg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Folic Acid; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myo-inositol; folic acid
Lung Cancer Diagnosis and Staging Using Ultrasound Guidance
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or
      staging of suspected lung cancer
    

Detailed description: 
      Introduction: Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible
      bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy
      under real-time guidance for the staging of lung cancer or evaluation of enlarged lymph
      nodes. In addition, lung lesions or masses can be visualized and biopsied in the same
      sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible
      bronchoscopy.

      Aim: The data of patients with suspected lung cancer or undiagnosed lymph node enlargement in
      whom bronchoscopy with EBUS guidance is clinically indicated will be collected prospectively.

      Results from EBUS are considered positive if a specific diagnosis is obtained ( eg
      malignancy) or if lymphocytes are present in the lymph node biopsy, indicating accurate
      sampling of lymph node. In patients with non-diagnostic EBUS, the results from other
      procedures will be compared for analysis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected lung cancer
      
Keywords: Endobronchial ultrasound, lung cancer
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Randomized, double blind, parallel study to assess the effect of a dietary supplement
      combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat
      beta-glucans) in obese/overweight subjects.
    

Detailed description: 
      This pilot study intends to select the best combination of beta-glucan and a green coffee
      bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two
      types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green
      coffee bean extract. Blind sachets were prepared containing half the daily dose of the
      supplement.

      60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited
      and randomly assigned to one of the four intervention groups. Volunteers were instructed to
      consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily
      during 6 weeks.

      At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at
      the research center after an overnight fast. Urine and blood samples were obtained, blood
      pressure was measured and anthropometric measurements were performed. Dietary and physical
      activity records were collected.
    

Intervention name(s): Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
Intervention type(s): Dietary Supplement
Intervention description(s): Dose-response study on the effect of two different types of oat beta-glucan with different b-glucan content (35% vs. 70%) in combination with a green coffee bean extract rich in polyphenols. Consumption of 2 sachets/day (providing 3 or 5 g/d beta-glucan plus 600 mg polyphenols) during 6 weeks
Other intervention name(s): 35% oat beta-glucan (PromOat(R)Beta Glucan from Tite&Lile; 70% beta-glucan from Garuda Int. Ltd.; green coffee bean extract from Pharmafoods S-L-
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel, double blind study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hydroxycinnamates; Beta-glucan; Green coffee bean extract; Dietary supplement
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system
      which occurs when T cells, which are part of the immune system, damage the insulin secreting
      cells (islet cells) in the pancreas. Although it is known that T cells are important
      mediators of the disease, progress in the development of reliable T cell assays has been
      modest. The purpose of this study is to learn which T cell assays are most reliable and
      reproducible so that the investigators can improve their understanding about how type 1
      diabetes occurs.
    

Detailed description: 
      The T Cell Validation Study is designed to determine the ability of T cell assays to identify
      differences in responses from participants with type 1 diabetes compared to normal control
      subjects, and to compare four different laboratory tests which examine T cells to determine
      whether the measurements are quantitatively reproducible.

      Antibody assays that confirm the presence of type 1 diabetes will be evaluated including:
      Diabetes Biochemical Autoantibody Assay (anti-GAD65, anti-ICA512, anti-insulin) and Islet
      Cell Autoantibody testing; genetic testing (deoxyribonucleic acid [DNA] and human leukocyte
      antigen [HLA]) will also be done to learn more about the T cell assays.

      The following T Cell Assays will be conducted in individuals with type 1 diabetes, as well as
      those without type 1 diabetes:

        -  Cellular Immunoblot Testing

        -  T Cell Proliferation Assay

        -  Tetramer Assay

        -  Cytokine ELISpot Assay
    

Intervention name(s): T Cell Proliferation and Autoreactivity Assays; Cellular Immunoblot Assays; Tetramer Studies; Cytokine ELISPOT
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Time perspective: Prospective
Keywords: Type 1 Diabetes; Juvenile Onset Diabetes; Insulin Dependent Diabetes; T1D
Sepraspray™ Laparoscopic Myomectomy Study
Condition: Laparoscopic Myomectomy
Study type: Interventional

Summary: 
      The purpose of this research study is to obtain preliminary data of the safety and
      effectiveness of Sepraspray in a limited number of patients who are under going a
      laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity
      following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion
      prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
    


Intervention name(s): Sepraspray
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian
      traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of
      diabetic gingivitis and compare it with chlorhexidine (0.2%).
    

Detailed description: 
      Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical
      Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill
      other inclusion criteria, are randomly assigned to intervention or control groups. All of the
      patients will undergo a training panel about mouth hygiene and receive a pack of a
      toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2
      weeks for the second evaluation and taking tooth bleaching. The demographic and general
      information of all participants are taken and the primary outputs (plaque index and bleeding
      on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the
      examinations are done by one trained person and patients, practitioner and statistical
      analyser are blind to the interventions.
    

Intervention name(s): Punica granatum Pleniflora (Golnaar) mouth rinse; Chlorhexidine (0.2%); Tooth bleaching
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.; All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.; Tooth bleaching for both groups one time after using mouth rinses.
Other intervention name(s): Intervention group; Control group; Bleaching
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; Diabetes mellitus; Medicine, Traditional; Herbal medicine; Punica granatum
Children's Taste Study to Increase Vegetable Intake in Preschoolers
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Studies have shown that when exposed to a variety of food and flavor options people tend to
      consume more than when only one item is presented. This strategy has been used to increase
      vegetable intake in adults and during snacktime in children. Increasing vegetable consumption
      in children is important because higher vegetable intake has been associated with reduced
      risk of disease and because vegetables can help prevent weight gain by lowering the energy
      density of a meal. The purpose of this study was to investigate the effects of using herb and
      spice blends to create flavor variety in carrots as a model vegetable in a laboratory test
      meal. We predict that children will consume more vegetables and that the energy density of
      the meal will be lower when a variety of seasoned carrots are presented in comparison to a
      single flavor. A secondary goal of the study was to determine other influences that may
      predict children's liking and intake of seasoned vegetables, such as previous exposure,
      infant feeding practices, and genetic bitter sensitivity.
    


Intervention name(s): Variety Intervention
Intervention type(s): Other
Intervention description(s): Vegetable flavor variety created with multiple herb and spice blends
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Behaviors; Preschool; Vegetable Intake
Impact of an Intervention Program on Parenting Stress After Preterm Birth
Condition: Preterm Birth; Parenting; Mental Health Wellness 1; Parent-Child Relation; Child Development
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this study was to assess the impact of an early psychological intervention,
      Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental
      health, and preterm infant development in the motor, cognitive, emotional and behavioral
      domains at a corrected age of 18 months.
    

Detailed description: 
      Due to prematurity induced infant-mother separation at birth, sometimes for several weeks,
      and owing to the concerns it generates, preterm birth exposes the parent-child attachment
      link to disturbances, especially the mother-child attachment after discharge. Several
      psychological factors affect infant (distress, dysmaturity ) and parents (psychological
      pain). These can cause lasting parent-child interactions disruption and jeopardize the
      attachment process. These early link distortions may hinder the infant's behavioral-emotional
      and cognitive development. Prematurity psychological consequences may negatively influence
      biomedical risks. Understanding these premature infants' future development modalities and
      support involves taking into account intricate organic and psychological factors - which may
      be combined as well.

      Post-hospital psychological intervention with the family, focusing on parental mental health
      and triadic parent-infant relationship, proves an essential element in these children care,
      whose birth conditions were painful.
    

Intervention name(s): Triadic parent-infant Relationship Therapy (TRT)
Intervention type(s): Other
Intervention description(s): 22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.
Other intervention name(s): TRT
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Intervention program; Parenting stress; Parental mental health; Preterm infant's development