bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo
      After 19 Days of Tiotropium Treatment
    


Intervention name(s): Ipratropium - unit dose vial; Tiotropium - inhalation capsule; Placebo matching tiotropium; Placebo matching ipratropium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Tiotropium Bromide; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.
      Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg
      tablets (Bristol-Myers Squibb, USA) in 48 + (2 standby) healthy, adult, human subjects under
      fed conditions.

      To monitor adverse events and to ensure the safety of subjects.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two-sequence, single
      dose,crossover bioequivalence study with at least 07 days of washout period between each drug
      administration under fed conditions.
    

Intervention name(s): Metformin; Glucophage
Intervention type(s): Drug; Drug
Intervention description(s): Metformin Tablets 1000 mg; Glucophage 1000 mg tablets of Bristol-Myers Squibb
Other intervention name(s): Glucophage Tablets 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Condition: Pressure Ulcers, Bedsores, Decubitus Ulcer
MeSH terms: Pressure Ulcer
Study type: Observational

Summary: 
      Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin
      and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas
      exposed to pressure, shear and friction. Shear- force is an important contributing factor and
      wound dressing are possibly capable to reduce shear force at the skin. At this moment there's
      no good marker to detect the effect of shear- force at the skin. A potential marker could be
      cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study
      have shown a significant increased level of IL-1α after the application of pressure. We want
      to investigate if these cytokines are significant increased after the application of shear-
      force at the skin.

      Objective: The objective of this study is to gather knowledge about cytokine concentrations
      (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to
      use this knowledge in the future to investigate if different prophylactic wound dressings are
      capable to reduce shear force at the skin. This could be interesting in the prevention of
      pressure ulcers.

      Study design: With the use of a special developed shear- force model are we going to
      administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy
      volunteers for 30 minutes. As a control we ware going to put the shear- force model at the
      other arm without the application of shear- force. Before the use of the shear- force model
      we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb
      cytokines from the skin. After the use of the shear force- model we will perform cytokine
      measurements again. Then we will extract the cytokines from the Sebutape with the use of
      ELISA.

      Study population: 10 Healthy volunteers Age 18- 30 years

      Primary outcome: IL-1 α concentration (pg/ml)
    


Intervention name(s): Shear- force model
Intervention type(s): Other
Intervention description(s): Shear- force model
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 healthy volunteers
      
Keywords: IL-1 alpha, Sebutape, shear- force
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study is designed to evaluate the long-term safety and tolerability of
      colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.
    


Intervention name(s): Colesevelam hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open label, Diabetes Mellitus; Long term safety study, extension study
The Effects of Respiratory Muscle Strength Training (RMST) on Inspiratory and Expiratory Muscle Strength in Adults and Children With Pompe Disease
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Study type: Observational

Summary: 
      The purpose of the study is to determine if respiratory muscle strength training will be
      beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe
      disease.
    

Detailed description: 
      Respiratory muscle weakness results in substantial morbidity and mortality in individuals
      with almost all forms of neuromuscular disease (NMD), including both the infantile and adult
      phenotypes of Pompe disease. Although individual patterns of involvement vary, respiratory
      weakness in Pompe disease typically affects both the inspiratory and expiratory muscle
      systems. Our pilot data in two individuals with late-onset Pompe disease suggest that RMST
      may be a treatment for the progressive respiratory weakness encountered in this condition.

      Purpose of the Study

        -  Determine the effect of respiratory muscle strength training on maximum inspiratory
           pressure, maximum expiratory pressure, upright % predicted forced vital capacity, and
           aspects of cough function.

        -  Determine the effect of RMST on functional outcome measures of gross motor function
           appropriate for individual participants in terms of age and motor skills.
    

Intervention name(s): respiratory muscle strength training
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults and children with Pompe disease
      
Keywords: Pompe respiratory
Immune Response in Celiac Disease on In-vitro Gluten Challenge
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The main purpose of this study is to see how cells taken from the lining of the intestine
      behave in the laboratory with exposure to gluten and other substances that act on the immune
      system. The cells lining the intestine of a person with celiac disease should be different
      than a person without celiac disease. The study doctors would like to see how the cells react
      after coming in contact with gluten and if substances that act on the immune system can
      prevent gluten related inflammation. Examples of these substances include steroids. The cells
      should produce chemicals of their own in response to the gluten. These other chemicals will
      be measured and the results compared between those with:

        -  celiac disease that does not respond to a gluten-free diet (refractory celiac disease)

        -  celiac disease which is controlled by a gluten-free diet

        -  uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a
           gluten-free diet

        -  gluten-sensitivity

        -  disorders other than celiac disease.
    

Detailed description: 
      The primary purpose of this study is to determine the effect of in-vitro introduction of
      gluten on inflammatory response primarily Interferon-γ and other cytokines, such as IL-15,
      IL-18 and IL-21, in cultures obtained from small intestinal mucosal biopsy samples of
      subjects who underwent upper endoscopy.

      Secondary goals include comparing the inflammatory response to immunosuppressants and
      cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken
      from RCD I subjects with intestinal mucosal biopsies taken from subjects with CeD controlled
      on a Gluten-Free Diet (GFD), uncontrolled CeD, Gluten sensitivity and Non-celiac Controls.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be selected from patients undergoing a clinically indicated upper endoscopy
        at Beth Israel Deaconess Medical Center
      
Biospecimen description: 
      Duodenal biopsy samples
    
Keywords: celiac disease; refractory celiac disease; gluten sensitivity
Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein With Disease Severity in Pediatric Sars-CoV2
Condition: SARS CoV-2 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      There were many studies in the literature discussing the effects of vitamin D deficiency and
      the role of vitamin D supplementation in SARS-CoV-2 patients. Combined with the possible
      impact of vitamin D on the pathogenesis of SARS-CoV-2 infection, it is concluded that
      VDBP-regulated bioavailable and free vitamin D concentrations modulate the human immune
      system response to viral infections. Because of the gap in the literature, it was emphasized
      that studies should focus on vitamin D binding protein (VDBP) and gene polymorphism. In this
      study, it was aimed to investigate the relationship between SARS-CoV-2 infection severity and
      free and bioavailable vitamin D levels.
    

Detailed description: 
      It was aimed to investigate the relationship between SARS-CoV-2 infection severity and free
      and bioavailable vitamin D levels. This study was planned as a case-control study with
      patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection
      Service. A total of 82 children, including at least 20 patients in each group were included
      in the study. The study group was divided into three groups according to COVID-19 WHO
      clinical progression Scale: unaffected (Group 1), mild (Group 2) and moderate (group 3). In
      order to investigate the relationship between disease severity and free and bioavailable
      vitamin D; 25OH vitamin d (μg/L), albumin (g/l) and VDBP levels (ELISA) were used. Vitamin D
      metabolites were calculated by using Bikle and Vermeulen methods (free Vitamin D BIKLE, free
      vitamin DVERMEULEN, bioavailable vitamin D). And these three vitamin D parameter levels were
      compared between groups.
    

Intervention name(s): Vitamin D Binding protein
Intervention type(s): Diagnostic Test
Intervention description(s): Vitamin D-free and bioavailable metabolites were calculated by using Bikle and Vermeulen methods with using albumin, 25-OH vitamin D, vitamin D binding protein (ELİSA kit) levels
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sars-CoV-2 diagnosed children aged between 1-18 years old and whose parents sign the
        informed consent form to participate in the study.
      
Biospecimen description: 
      to investigate the free and bioavailable vitamin D, 25OH vitamin d (μg/L), albumin (g/l) and
      VDBP levels, a 5 ml blood sample was collected from patients
    
Keywords: Sars Cov-2; Vitamin D Binding protein; free vitamin D; bioavailable vitamin D; children
Effects of Muscle Trainins Inspiratory Linked to Cardiac Rehabilitation Post-operative of CABG Surgery
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Heart surgery procedures are still widely used worldwide for the treatment of patients with
      heart problems, and rates of complications in the postoperative period related to them remain
      high. In these patients, physical conditioning programs result in improved functional
      capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle
      training is also emerging as a valuable strategy in the treatment of cardiac patients. The
      study of the interaction between cardiac rehabilitation and high intensity IMT about these
      changes is not yet understood in this population. The aim of this study is to assess the
      effects of inspiratory muscle training high intensity associated with cardiac rehabilitation
      exercise performance of patients in the postoperative period of CABG surgery.
    

Detailed description: 
      It is a controlled, randomized clinical trial in which patients were randomly assigned
      randomly after referral to cardiac rehabilitation: Group 1 IMT-HI, group 2 - IMT-HI control.
      The evaluator of outcomes is blinded as to groups. The study protocol lasts 36 sessions for
      both groups. The group 1 patients performs cardiac rehabilitation protocol for 40 minutes
      with cardio and stretching and also inspiratory muscle training protocol of high intensity
      with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of MIP
      in third and fourth week, 70% of MIP in the fifth and sixth week and 80% MIP in the seventh
      and eighth week. The group 2 patients only perform the cardiac rehabilitation protocol for 40
      minutes with aerobic exercise and stretching.
    

Intervention name(s): IMT - POWERbreathe Plus Light Resistance®, SP, BR
Intervention type(s): Device
Intervention description(s): POWERbreathe Plus Light Resistance®, SP, BR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201
      and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
    


Intervention name(s): AGN-199201 ophthalmic solution; AGN-190584 ophthalmic solution; AGN-199201 Vehicle; AGN-190584 Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; 1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.; Vehicle to AGN-199201; Vehicle to AGN-190584
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Condition: Sleep
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Sleep disturbances may contribute to impairments in mood, occupational and
      intellectual performance, and social relationships, as well as being associated with
      cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been
      associated with poor sleep quality and hypertension; regular exercise has been studied as a
      coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare
      sleep pattern of active and inactive patients with arterial hypertension, as well as to
      evaluate complaints of depression and anxiety, and the mood profile. Material and Methods:
      Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to
      assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI),
      Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS).
      The level of physical activity will be recorded by the number of steps taken (pedometer).
      Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30).
      Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and
      fewer complaints of depression and anxiety when compared to physically inactive hypertensive
      patients.
    


Intervention name(s): No intervantion. It´s a Cross-Sectional Study
Intervention type(s): Other
Intervention description(s): No intervential
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participating in the study will be 60 males hypertension patients (ACTIVE, n=30; INACTIVE,
        n=30) with age between 30 and 60 years old. All participants should be under
        antihypertensive drug treatment.
      
Keywords: Hypertension; Exercise; Sleep
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD
      MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent
      asthma.
    

Detailed description: 
      This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment,
      incomplete block, cross-over, multicenter study to assess the efficacy and safety of four
      doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult
      subjects with mild to moderate persistent asthma.
    

Intervention name(s): BD MDI 320 µg; BD MDI 160 µg; BD MDI 80 µg; BD MDI 40 µg; Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Placebo MDI administered as 2 inhalations BID
Other intervention name(s): PT008; PT008; PT008; PT008
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild; moderate persistent; Adult
NICU Parent Education Program
Condition: Language Development; Premature Infant; Neurodevelopmental Outcomes
Study type: Interventional

Summary: 
      The purpose of this study is to adminster one of two education programs to parents of preterm
      infants in the NICU to evaluate language and cognitive outcomes of their infants.
    

Detailed description: 
      The long term goal of this research is to determine the language environment necessary in the
      NICU for very preterm infants to optimize their long-term language and cognitive development.
      This study will pilot an early language intervention with parents of preterm infants in the
      NICU the purpose of which is to provide a structured curriculum for the family to guide their
      language interactions with their infant. The aim is to increase the adult word counts and
      conversational turns in the NICU and to improve Bayley III language and cognitive scores at
      12 months and 24 months corrected age.

      The hypotheses is that increasing early language exposure in the NICU will result in improved
      lanugage and cognitive scores. The investigators plan on testing the hypothesis by the
      following specific aims.

        1. Determine the effectiveness of a structured language curriculum with parents of preterm
           infants in the NICU on increasing the amount of early language exposure.

        2. Test the the hypothesis that increased early language exposure will result in higher
           Bayley III language and cognitive scores.
    

Intervention name(s): Know Your Baby Language Curriculum; Reading Aloud Language Curriculum; Sing A Long Language Curriculum; Mimicking First Sounds Language Curriculum; Language Games and Narrating Your Day Language Curriculum; Feeding Safety; Car Seat Safety; Bath Safety; Back to Sleep/SIDS prevention; Taking a Temperature and Signs of Infection; Infection Control Measures and Vaccine Information
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Early language activities that parents can do with their infants; Early language activity that parents can do with their infants; Early language activity that parents can do with their infants; Early language activity that parents can do with their infants; Early language activity that parents can do with their infants; Part of Health and Safety Curriculum; Part of Health and Safety Curriculum; Part of Health and Safety Curriculum; Part of Health and Safety Curriculum; Part of Health and Safety Curriculum; Part of Health and Safety Curriculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
DNA Cytometry for Cervical Cancer Screening in China
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Very few screenings of any kind will be possible during a woman's lifetime in most
      low-resource regions, where 80% of the half-million global cases of cervical cancer occur
      every year. Although a single round of human papillomavirus (HPV) testing was associated with
      a significant decline in the rate of advanced cervical cancers and associated deaths, whether
      other methods like as DNA image cytometry can be used as an more accurate means than others
      in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both
      DNA image cytometry and conventional cytology is not well known. The investigators
      hypothesized that DNA image cytometry was superior in screening cervical cancer than
      conventional cytology.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy women
      
Biospecimen description: 
      Cervical samples were taken through cervical brush. Feulgen method is used to determine the
      amount of DNA.
    
Keywords: DNA cytometry; Cytology; Diagnosis accuracy
Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2)
      sequential applications.
    

Detailed description: 
      Revance is conducting this Phase 2 clinical study to establish the safety of two (2)
      sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of
      moderate to severe LCLs at rest.
    

Intervention name(s): RT001
Intervention type(s): Drug
Intervention description(s): RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles