bioihbjkbjnl/mcl2 huggingface dataset:
Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit
Condition: Diaper Rash; Preterm Neonates
MeSH terms: Premature Birth; Diaper Rash
Study type: Interventional
Phase: Phase 4

Summary: 
      -This study aimed to investigate the effect of colloid oatmeal compared to colloid cream on
      diaper rash among preterm neonates in the NICU.
    

Detailed description: 
      A quasi-experimental study was carried out in the NICU of El-Raml Children's Hospital at
      Wengat in Alexandria. Ninety preterm neonates were randomly assigned to three equal groups.
      The control group received the usual care of NICU for diaper rash, colloidal oatmeal group
      received colloidal oatmeal cream and colloid group received colloid cream (cold which is the
      base for colloid oatmeal)
    

Intervention name(s): Colloidal oatmeal; Cold cream
Intervention type(s): Biological; Biological
Intervention description(s): The colloid oatmeal had the following component: Colloidal Oat (5gm), stearic acid 5, cretoctryl alcohol 2.5, cetyl alcohol 2.5, koh 02, potassium sorbate 1gm, paraffin oil 5ml, and soft paraffin 10gm; It is composed of stearic acid 5, cretoctryl alcohol 2.5, cetyl alcohol 2.5, koh 02, potassium sorbate 1gm, paraffin oil 5ml, and soft paraffin 10gm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colloidal oatmeal; Diaper rash; Preterm neonates
Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of the study is to pilot test the implementation of healthcare provider education
      interventions to improve asthma outcomes in rural youth residing in Bradford County, Florida.
      The investigators propose to assess the feasibility and acceptability of implementing the
      Easy Breathing program a rural, medically underserved county and evaluate changes in
      healthcare provider practices and asthma-related outcomes of rural youth diagnosed with
      asthma.
    


Intervention name(s): Easy Breathing program
Intervention type(s): Other
Intervention description(s): Easy Breathing is a longstanding, nationally recognized program that translates asthma management guidelines into a standardized and usable format for healthcare providers. As part of the program primary healthcare providers will identify children at-risk for adverse asthma outcomes and provide care coordination services. Patients receive a tailored, comprehensive Asthma Treatment Plan with information regarding daily medication use and management of acute symptoms based on asthma severity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Condition: Solid Tumor; Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, dose-escalation, single-center study of ADG106 in subjects
      with advanced or metastatic solid tumors and/or relapsed/ refractory non-Hodgkin lymphoma.
      ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the
      activated human T cells via a T cell receptor CD137. ADG106 administered intravenously (IV)
      over a period of 60-90 minutes.

      Primary objective:

      To assess safety and tolerability at increasing dose levels of single agent ADG106 in
      subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma.

      To determine the recommended dosage and dosage regimen for further study. Secondary
      Objectives To characterize the pharmacokinetic (PK) profiles of ADG106. To evaluate the
      immunogenicity of ADG106. To evaluate the potential anti-tumor effect of ADG106. To
      investigate serum biomarkers related to immune regulation and cytokine releasing.

      Exploratory Objective:

      To identify the potential biomarkers of ADG106.
    


Intervention name(s): ADG106
Intervention type(s): Drug
Intervention description(s): IV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumor; Non-Hodgkin Lymphoma
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and
      to see how safe PS433540 is compared to placebo.
    


Intervention name(s): PS433540; placebo; PS433540
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mg capsule, once daily for 28 days; placebo capsule, once daily for 28 days; 500mg capsule, once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypertension; high blood pressure
Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea
Condition: Erythematotelangiectatic Rosacea; Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88
      subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22
      subjects), and will receive study treatments based on their assigned treatment group.
      Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each
      subject's last study treatment.
    

Detailed description: 
      Clinician Erythema Assessment (CEA) and Patient Self-Assessment (PSA) scores, assessing
      severity of erythema, will be obtained prior to study treatment to confirm subject
      eligibility. Enrolled subjects will receive up to three dual-depth treatments to affected
      areas of the midface (cheeks, chin, forehead, glabella and nose) each treatment provided
      approximately 2 weeks apart. Groups A and B will receive low-density treatment, and Groups C
      and D receive high-density treatment. Groups A and C will receive 2 treatments. Groups B and
      D will receive 3 treatments. Protocol amended Sept 2014: Groups A and C will receive 1
      treatment; Groups B and D will receive 2 treatments.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy® Treatment; Ulthera, Inc.
Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program
Condition: HIV-infection/Aids; Breast Feeding
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months
      followed by continued breastfeeding for the next 6 months with introduction of complementary
      foods among HIV infected women in a resource limited setting.
    

Detailed description: 
      This is a single center, operational research study with two components. A formative
      component and randomized intervention trial. The study aims are to inform, promote and
      evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by
      continued breastfeeding for the next 6 months with introduction of complementary foods among
      HIV infected women in a resource limited settings.

      The primary objective of the qualitative formative research which includes Focus Group
      Discussions (FGD) and Key Informant Interviews (KII) is to explore factors affecting
      decisions on EBF and continued breastfeeding among HIV infected women.

      The primary objective for the Intervention phase is to compare either of two intervention
      strategies against the standard arm using Ministry of Health (MOH) messages aimed at
      promoting EBF for 6 month.
    

Intervention name(s): Family member / peer support; Enhanced intervention with counselor support; standard of care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): supplemental individualized counselling; "hands on" EBF demonstrations; one on one and in-group counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; Breast Feeding
Gestational Diabetes and Sleep-Disordered Breathing
Condition: Gestational Diabetes Mellitus
MeSH terms: Sleep Apnea Syndromes; Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      This study is designed to evaluate the amount of heart rate variability (HRV) for women with
      gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient
      sleep-disordered breathing (SDB) during pregnancy.
    


Intervention name(s): Determining a change in heart rate variability post delivery of the baby
Intervention type(s): Other
Intervention description(s): Determining a change in heart rate variability post delivery of the baby
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with Gestational Diabetes Mellitus (GDM)
      
Keywords: GDM
Abdominal Compression in Orthostatic Hypotension
Condition: Autonomic Failure; Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to assess if abdominal binders that use pull strings to adjust
      compression (non-elastic) are more effective than standard elastic abdominal binders in
      attenuating neurogenic orthostatic hypotension.
    

Detailed description: 
      In 3 protocols, patients will undergo standing maneuvers, measured abdominal compressions,
      continuous BP monitoring and symptoms, ease-of-use and compliance scoring. In protocol 1,
      patients will exert abdominal compression to maximal tolerable and comfortable levels and
      values will be recorded. In protocol 2, patients will perform 3 standing maneuvers following
      a preceding rest period with and without abdominal compression at 20 mmHg (binders used in
      random order). In protocol 3, the standing maneuvers will be extended and the investigator
      will adjust binders to levels of abdominal compression corresponding to what patient gauged
      as maximal tolerable and comfortable levels. Comparison of outcome measures will establish
      which binder achieves higher abdominal compression, is easier to adjust, likely will be used
      in the future, if elastic and adjustable binders are equally effective in attenuating
      Orthostatic Hypotension and its associated symptoms at comparable pressures and which binder
      is more effective in recovering standing BP and improving orthostatic symptoms.
    

Intervention name(s): Abdominal binder; No abdominal binder
Intervention type(s): Other; Other
Intervention description(s): External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.; Standing without abdominal binder for 3 minutes
Other intervention name(s): Elastic abdominal binder; Non-elastic abdominal binder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: orthostatic; abdominal compression
Effects of Continuous Venous Dialysis and Hemodialysis on Fluid Dynamics by Bioreactance Method
Condition: Renal Dialysis
Study type: Observational

Summary: 
      Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are
      widely applied in patients with renal insufficiency. Especially hemodynamically affected
      patients are less affected by hemodynamics as a result of using dialysis methods. It is a
      completely non-invasive method by bioreactance method and it can be done to measure the
      intra-body fluid status with the help of the glued probes. The aim of this study is to
      investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics
      applied at the bedside with bioreactance method. In this way, the patient can develop more
      comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative
      Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or
      hemodialysis will be included in the study. Before the dialysis, body fluid measurements will
      be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in
      dialysis patients 6, 12, 24 and 36 hours.
    

Detailed description: 
      Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are
      widely applied in patients with renal insufficiency. Especially hemodynamically affected
      patients are less affected by hemodynamics as a result of using dialysis methods. Dialysis in
      the hemodialysis unit is a method used in intensive care patients and is preferred especially
      in patients with stable hemodynamics. In dialysis methods, changes occur frequently in the
      body fluids of the patient. It is a completely non-invasive method by bioreactance method and
      it can be done to measure the intra-body fluid status with the help of the glued probes. The
      aim of this study is to investigate the effects of continuous venous dialysis and
      hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. As a
      result of measurements with buioreactans method, fluid balance in patients will be understood
      more easily. In this way, the patient can develop more comfortable hemodynamic changes.
      Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24
      hours of hospitalization and bedside dialysis or hemodialysis will be included in the study.
      Before the dialysis, body fluid measurements will be made with bioreactance, and after
      dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.
    

Intervention name(s): bioreactans tool
Intervention type(s): Device
Intervention description(s): It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the probes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients in need of dialysis treatment
Adolescent Weight Management Study
Condition: Protocol #1:Behavioral Therapy + Placebo or Sibutramine; Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
Study type: Interventional

Summary: 
      Protocol #1:The goals of this study was to examine whether increased weight loss in obese
      adolescent is induced when the weight loss medication sibutramine is added to a family-based,
      behavioral weight control program.

      Protocol #2: This study aims to improve the behavioral treatment of obesity during
      adolescence. A behavioral program using regular foods will be compared to a behavioral
      program using a structured meal plan (a portion-controlled approach with liquid-meal
      replacements [nutritional supplements]). This structured approach may be better for the
      promotion of weight loss compared to a diet of regular foods.
    


Intervention name(s): Sibutramine; Slim Fast
Intervention type(s): Drug; Dietary Supplement
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adolescent; Weight Management; Obesity Treatment; Behavioral Treatment
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of plastic spacers and breath actuated
      spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and
      whether electrostatic charge within plastic spacers has a clinically relevant impact on the
      inhaled steroid delivery.
    

Detailed description: 
      Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which
      can reduce respirable dose delivery especially when used brand new "out of the box". Breath
      actuated integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic device
      with a vortex chamber which is designed to be more patient friendly and free from the effects
      of electrostatic charge. The systemic bioavailability from the lung of inhaled fluticasone
      and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler
      devices can be quantified by measuring the degree of adrenal suppression and fall in serum
      potassium(K) as surrogates for delivered lung dose. This study attempts to compares the
      systemic bioavailability from the lung in real life conditions for Fluticasone/Salmeterol
      combination (measured in terms of relative adrenal suppression and fall in serum K) via the
      breath actuated Synchro-Breathe device, pMDI( Seretide Evohaler), and Aerochamber Plus &
      Volumatic spacer used brand new "out of the box" in healthy volunteers.
    

Intervention name(s): Seretide 250(8puffs) via Evohaler actuator; Seretide 250 (8 puffs)/placebo via Volumatic spacer; Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Seretide 250/placebo via Synchro-Breathe
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 8 puffs of Seretide250/Placebo via Evohaler actuator; 8 puffs of Seretide 250/placebo via volumatic spacer; Seretide 250/placebo 8 puffs via Aerochamber Plus; Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device
Other intervention name(s): Advair; Advair; Advair; Advair
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lung bioavailability; asthma; seretide; Spacer
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
Condition: Obstetric Labour, Premature; Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      A study conducted on healthy volunteers to determine the safety, tolerability and affect on
      the human body by experimental drug GSK557296.
    


Intervention name(s): GSK557296
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Healthy Subjects,; Safety,; Tolerability,; Pharmacokinetics
Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,
      single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with
      persistent asthma. The primary purpose of this study is to compare the efficacy and safety of
      Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose
      levels equivalent to 90 mcg and 180 mcg of albuterol base.
    

Detailed description: 
      The study consists of a screening visit (SV) followed by up to 16 days by a treatment period
      comprising 5 visits (TV1-TV5). The treatment period visits will each be separated by a
      washout period lasting 2-7 days. During each treatment period visit, the forced expiratory
      volume in 1 second (FEV1) will be determined at 30 minutes and again immediately prior to the
      commencement of study medication administration, and 5, 15, 30, 45, 60, 120, 180, 240, 300,
      and 360 minutes after completion of study medication administration.
    

Intervention name(s): Albuterol Spiromax; ProAir HFA; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Albuterol Spiromax® Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose dry powder inhaler (DPI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two DPIs filled with Albuterol Spiromax® were used.; ProAir® HFA Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose metered dose inhaler (MDI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two MDIs filled with ProAir HFA were used.; Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each.
Other intervention name(s): Spiromax®; albuterol; ProAir®
Intervention MeSH terms: Albuterol; Procaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Albuterol Spiromax; ProAir HFA; albuterol sulfate
OCT Pilot in Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      This is a pilot study to test a newly developed optical coherence tomography (OCT) device to
      determine 1) whether adequate tissue contact can be attained to acquire high quality images,
      and 2) to identify if these images can discern whether the imaged tissue is squamous or
      Barrett's Esophagus (BE) epithelium.
    


Intervention name(s): optical coherence tomography
Intervention type(s): Device
Intervention description(s): OCT measurements of 5 locations in the esophagus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of
      nonchildbearing potential and male subjects - to be conducted at a single center in the
      United States.

      The study will consist of a screening phase, a baseline phase, four treatment periods, and a
      follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and
      Period 3 and 4), potentially separated by an intermission during which subjects will be
      discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA)
      estimation, while Periods 3 and 4 support estimation of PPI effects.
    


Intervention name(s): Rabeprazole; CC-92480
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole; CC-92480
Intervention MeSH terms: Rabeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Subjects; CC-92480; Pharmacokinetics