bioihbjkbjnl/mcl2 huggingface dataset:
Asthma With Hypersecretion-associated Gene for Cystic Fibrosis
Condition: Asthma
MeSH terms: Cystic Fibrosis; Asthma; Fibrosis
Study type: Observational

Summary: 
      The combination of asthma and being a carrier of genetic variants (mutations and / or
      polymorphisms) in the CFTR gene variant would cause bronchial asthma with mucus
      hypersecretion. This phenotype is characterized by a more severe disease, in terms of
      control, quality of life, exacerbations and lung function, and a different asthma the
      bronchial hypersecretion without inflammatory phenotype.
    

Detailed description: 
      Primary objective:

      Determine the presence of genetic variants (mutations and / or polymorphisms) of the CFTR
      gene in patients with asthma with or without bronchial mucus hypersecretion.

      Secondary objectives:

      To identify genetic variants (mutations and / or polymorphisms) of the most common CFTR gene
      in the asthmatic population. -To define the inflammatory phenotype of asthma with bronchial
      mucus hypersecretion. -To compare the severity, control, quality of life and frequency of
      exacerbations of asthma patients with or without bronchial mucus hypersecretion
    

Intervention name(s): Asthma patients
Intervention type(s): Genetic
Intervention description(s): Patients with inclusion criteria, following examinations: a study of lung function measurement of the fraction of nitric oxide in exhaled air, induced sputum, sputum, and extraction of peripheral venous blood for Study of genetic variants in the CFTR gene,skin prick test . The number of eosinophils in peripheral blood by automated cell counting and Total IgE by ELISA were measured. Furthermore, the level of asthma control be assessed by validated symptom questionnaire Asthma Control Test, quality of life is determined by the MiniAQLQ questionnaire.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 100 asthmatic patients of both sexes, aged between 18 and 80 years will be
        included in the study. They have not a respiratory infection in the last month. Of the 100
        patients, 50 will be hypersecretory asthmatic patients and 50 non- hypersecretory asthmatic
        patients. Both groups have an even distribution regarding sex, age, level and disease
        control. Asthma patients were defined according to the criteria of the GEMA 2015 -GINA 2014
      
Biospecimen description: 
      From peripheral blood samples, the DNA extraction following the protocol saline method. From
      the DNA samples obtained CFTR gene analysis to detect genetic variants by sequencing or mass
      Next Generation Sequencing (NGS) in Miseq team Illumina platform (available in the Hospital
      de la Santa Creu i Sant be held Pau).
    
Keywords: asthma; cystic fibrosis
HD Mapping of Atrial Fibrillation in Asia Pacific
Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF)
      ablation after, and the utility of, electroanatomical mapping with the market-released HD
      mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with
      the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the
      real-world environment of the Asian population.
    


Intervention name(s): Catheter ablation
Intervention type(s): Device
Intervention description(s): Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The analysis population used for all endpoints will include all subjects who have signed
        the Informed Consent Form and have undergone the electroanatomical mapping procedure using
        one of the specified HD mapping catheters and received RF ablation as specified in the
        protocol. If any device used during the procedure is used off-label, the subject will be
        excluded from non-safety related endpoint analysis and any additional evaluations
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
Condition: Hepatitis C, Chronic; Liver Cirrhosis
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to evaluate the efficacy and safety of combination therapy with
      peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks
      in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants
      who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment
      will be discontinued from therapy.
    


Intervention name(s): Peginterferon alfa-2b; Ribavirin
Intervention type(s): Biological; Drug
Intervention description(s): Administered at 1.0 µg/kg/week SC for 48 weeks; Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL; treatment duration is 48 weeks
Other intervention name(s): SCH 054031; SCH 018908
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C
Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Condition: Liver Transplantation; Organ Preservation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot trial of centrifugal machine preservation of donor livers for transplantation
      using a novel preservation solution.
    


Intervention name(s): Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Intervention type(s): Device
Intervention description(s): Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation
Other intervention name(s): Vasosol Solution; Medtronic Portable Bypass System
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Transplantation; Organ Preservation; Liver Preservation; Machine Perfusion; Vasosol; Machine Preservation
Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the protocol is to evaluate the efficacy of olanzapine compared with
      Aripiprazole in patients with schizophrenia.
    


Intervention name(s): Olanzapine; Aripiprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Uterocervical Angle in Idiopathic Polyhydramnios
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature; Polyhydramnios
Study type: Interventional

Summary: 
      To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor
      in isolated polyhydramnios
    


Intervention name(s): uterocervical angle
Intervention type(s): Other
Intervention description(s): uterocervical angle is the angle between lower segment of uterus and cervix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar.
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization
Study type: Interventional

Summary: 
      A randomized clinical trial to compare silver modified glass ionomer restorations to non
      silver glass ionomer restorations in hypo-mineralized first permanent molars in children and
      to measure the amount of wear of restoration in both groups along with detecting changes in
      hypersensitivity in hypomineralized molars in both groups after one year follow up.
    


Intervention name(s): Silver Diamine Fluoride 38%; fluoride varnish
Intervention type(s): Other; Other
Intervention description(s): silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar; fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MIH, silver diamine fluoride, children, glass ionomer
A Pilot Study of the Cala ONE Device for Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      Prospective, multi-center, randomized, controlled study designed to evaluate safety and
      repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent
      patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized
      to the TAPS and sham arms will be blinded to their randomization assignments for the first
      two weeks of participation (controlled phase). After the first two weeks, all subjects will
      be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all
      subjects are to remain on a stable dosage of medications prescribed for the treatment of
      essential tremor, if applicable.
    


Intervention name(s): Cala ONE device
Intervention type(s): Device
Intervention description(s): The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first two weeks are a 3-arm parallel design (treatment, sham, and 'no intervention'). The second two weeks are open-label (all subjects cross-over to treatment arm).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study was to investigate how Brazilian fruits peel affect
      acute/postprandial glucose and insulin responses, inflammatory markers, appetite control
      peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue
      scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a
      standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers
      in healthy volunteers, compared with a similar meal without the corresponding plant
      materials.
    


Intervention name(s): Control drink; Brazilian fruit peel flour; Negative control drink
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Brazilian fruit peel; Functional food; Cardiometabolic risk; Metabolic syndrome; Inflammation; Appetite; Gut hormone
Replication of the Teen Outreach Program in the Pacific Northwest
Condition: Teenage Pregnancy
Study type: Interventional

Summary: 
      The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program
      (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon,
      and Washington. The purpose of this study is to measure: at the end of the program year, were
      TOP students less likely than control group students to report ever being pregnant or causing
      someone to be pregnant?
    


Intervention name(s): The Teen Outreach Program
Intervention type(s): Behavioral
Intervention description(s): Students received the Teen Outreach Program as described previously.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive
      functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering;
      (2) psychosocial functions, how someone interacts with his/her social environment; and (3)
      the relationship between these two functions, in people who have major depressive disorder, a
      severe form of depression.
    

Detailed description: 
      People who have difficulties with concentration and/or cognition as part of their depression
      will be treated with duloxetine for 12 weeks and their cognitive performance will be assessed
      before and after treatment using cognitive tests. Eligible participants will have eight
      clinic visits.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Approximately 30 participants with major depressive disorder and concentration and/or cognition difficulties, recruited from the community and physician referrals, will be treated with duloxetine for 12 weeks. Their cognitive performance will be assessed pre- and post-treatment with a cognitive testing battery.
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Cognitive Function; Psychosocial Function
Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors
Condition: Thrombocytopenia
MeSH terms: Neoplasms; Thrombocytopenia
Study type: Interventional

Summary: 
      To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced
      thrombocytopenia in patients with malignant tumors.
    

Detailed description: 
      Tumor is one of the malignant diseases that people face. In 2015, the incidence of malignant
      tumors was about 3.929 million, and the annual growth rate is about 3.9%. Chemotherapy is
      currently the most commonly used treatment for patients with tumor, but chemotherapy also
      brings many other problems, such as thrombocytopenia which can leads to increased medical
      costs, chemotherapy cycles delayed, and chemotherapy doses reduced. Studies have found that
      the reduction of the chemotherapy dose and the delay of the chemotherapy cycle will affect
      the survival rate of patients. So it is an important to solve the problem of
      chemotherapy-induced thrombocytopenia.

      Currently, there are some methods to treat thrombocytopenia such as platelet transfusion,
      rhTPO, rhIL-11 and other methods. However, these methods have some defects, platelets are at
      risk of ineffective transfusion, rhTPO may produce neutralizing antibodies and rhIL-11 has
      serious side effects. Therefore, there is an urgent need for safer and faster methods to
      treat chemotherapy-induced thrombocytopenia. As a new generation of TPO receptor agonist,
      avatrombopag has the advantages of being taken with food, no hepatotoxicity, good safety, and
      rapidly increase platelet count. Therefore, avatrombopag has great research value in the
      treatment of chemotherapy-induced thrombocytopenia.
    

Intervention name(s): Avatrombopag
Intervention type(s): Drug
Intervention description(s): 10×109/L<PLT<75×109/L, avatrombopag tablet 60 mg once a day for 5-10 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemotherapy; rh-TPO; avatrombopag
Machine Learning for Reclassification of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The goal of this study is to employ or develop computational modeling techniques for the
      precise reclassification of obesity into subgroups. Clinical features, risks of
      noncommunicable diseases, as well as weight loss effects of bariatric surgery will also be
      studied and compared within the subgroups.
    


Intervention name(s): AI classification of patients with obesity
Intervention type(s): Diagnostic Test
Intervention description(s): Computational modeling techniques will be used for the precise reclassification of obesity into four subgroups, several variables according to the clinical experience and the modeling results will be selected for the cluster analysis.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with overweight/obesity.
      
Keywords: Obesity; Machine learning; Metabolic classification; Clustering; Bariatric surgery
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index
      (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will
      also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis
      in this population.
    

Detailed description: 
      To validate culturally the WOMAC tool in mainland China and observe the different response of
      meloxicam and placebo in a patient population with osteoarthritis of the knee
    

Intervention name(s): Meloxicam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7.5mg x2 once a day for 12 weeks; Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.
Other intervention name(s): Mobic
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors
Condition: Time Constraints During School Meals
Study type: Interventional

Summary: 
      Recent peer-reviewed observational evidence suggests that school children receive anywhere
      from 10-33 minutes of seated lunch time and that students with less time to eat discard
      higher amounts of milk, entrée (i.e. protein items), grains, and vegetables. This waste is a
      missed nutritional and food security opportunity and also negatively impacts the environment.
      The purpose of this study is to estimate the impact that lunch time constraints have on child
      food selection, consumption and waste behaviors using a crossover trial design, where the
      duration of seated lunch times are randomly allocated to be either 10 minutes or 20 minutes
      each day.
    


Intervention name(s): Lunch period length
Intervention type(s): Behavioral
Intervention description(s): We are randomly allocating a 10 minute or 20 period of seated lunch time.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending
      dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety,
      tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean
      subjects.
    


Intervention name(s): C1K; C1K; Placebo; C1K; C1K; C1K
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing
      medication and identify the dose or doses that may effectively reduce axillary sweating in
      hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
    


Intervention name(s): WL8713, 6 mg; WL8713, 12 mg; WL8713, 18 mg; WL8713, 24 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment