bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations
      based on sodium salt compared to the present commercial formulation (MicardisPlus®)
    


Intervention name(s): Telmisartan /HCTZ - compression tablet (DC); Telmisartan /HCTZ - dry granulation tablet (DG); Telmisartan /HCTZ - present commercial formulation
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): MicardisPlus®
Intervention MeSH terms: Telmisartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on the microRNA Expression Level in Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Observational [Patient Registry]

Summary: 
      The miRNA plays an important regulation role in gene expression, and also closely related to
      bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin
      deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by
      bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual
      luciferase report system for target validation, aimed at the miRNA levels to explore
      postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.
    


Intervention name(s): osteoporosis
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        outpatient clinic
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a
      number of ascending doses administered once daily for 14 days in healthy volunteers.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; PF-04958242; PF-04958242; PF-04958242; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-04958242 0.05 mg oral solution Q24 hours for 14 days; PF-04958242 0.10 mg oral solution Q24 hours for 14 days; PF-04958242 0.15 mg oral solution Q24 hours for 14 days; PF-04958242 0.25 mg oral solution Q24 hours for 14 days; Placebo oral solution Q24 hours for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-04958242; multiple dose; safety; schizophrenia
Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the changes of cognitive function (as
      measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated
      with and without white matter changes after rivastigmine patch therapy.
    

Detailed description: 
      Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors
      within the brain, and are the primary medications used to treat AD. Alzheimer's disease
      patients are frequently associated with mild or moderate white matter changes on MR imaging.
      The impact of whiter matter changes on the efficacy of cognition, functional abilities,
      behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is
      not well known. There are very few studies for the efficacy of rivastigmine between the
      patients with mild to moderate Alzheimer's disease associated with or without vascular risk
      factors.

      Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of
      rivastigmine capsules, with markedly improved tolerability profile. The investigators
      hypothesized that rivastigmine patch will provide benefits to AD patients with white matter
      changes compared to those without any white matter changes. Possible explanation about
      favorable benefits for AD with white matter changes is that rivastigmine may act on both
      Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment
      effects in patients suffering from both conditions concurrently. To our Knowledge, there was
      no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and
      caregiver burden in two groups of patient with Alzheimer's disease associated with or without
      white matter changes after rivastigmine transdermal patch therapy.
    

Intervention name(s): rivastigmine patch
Intervention type(s): Drug
Intervention description(s): rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Other intervention name(s): Exelon patch
Intervention MeSH terms: Rivastigmine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; rivastigmine patch; white matter change
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized
      by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is
      observed within the left ventricle which is named left ventricular outflow tract obstruction
      (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms
      such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To
      now, medical or interventional treatments such as betablocacker, calcium blockers or septal
      alcoholisation or surgery present with a limited efficiency. Recent studies from
      investigators group revealed new concepts about the role of venous return to the LVOTO.
      Therefore the investigators hypothesis that BX1514M generating a venous vascular
      constriction, could improve symptoms of HCM patients by reducing LVOTO.
    


Intervention name(s): Treatment BX1514M; Placebo; Walk distance test; Exercise echocardiography
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): X mg x 3 /day of BX1514M for 15 days. Dosage will be then adapted, depending on symptoms release and walk distance test results for another 15 days period.; Placebo will be given for 30 days; Walk distance test during 6 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Left ventricular obstruction
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III trial is to assess the long-term safety of intravaginal
      dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal
      atrophy aged 40 to 75 years.
    


Intervention name(s): DHEA
Intervention type(s): Drug
Intervention description(s): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Other intervention name(s): Prasterone, Dehydroepiandrosterone, Vaginorm
Intervention MeSH terms: Dehydroepiandrosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvar/Vaginal Atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa
A Study of Nasal Glucagon in Participants With a Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in
      participants with a common cold, some of whom will also take a nasal decongestant. The study
      will investigate how the body processes NG and the effect of NG on the body. The study will
      last up to 30 days for each participant.
    


Intervention name(s): Nasal Glucagon; Oxymetazoline
Intervention type(s): Drug; Drug
Intervention description(s): Administered intranasally.; Administered intranasally.
Other intervention name(s): LY900018; AMG 504-1
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Glucagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the
      multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive
      metabolisers).
    


Intervention name(s): Lu AE58054 30 mg; Lu AE58054 30 mg + itraconazole 200 mg; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally; Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally; Itraconazole capsules, once daily, Day 12-13, orally
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery
Condition: Postoperative Nausea and Vomiting; Pain
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      There some evidence regarding the effect of lidocaine for the prevention of nausea and
      vomiting in adults.
    

Detailed description: 
      The investigators want to know whether with intravenous lidocaine a adjunct for general
      anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or
      without adenoids has the same effect.
    

Intervention name(s): Lidocaine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h; Sodium Chloride 0.9% infusion
Other intervention name(s): Saline solution
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative; Nausea; Vomiting; Pain; Surgery
Validation of a Noninvasive Automated Blood Pressure Device
Condition: Blood Pressure
Study type: Observational

Summary: 
      The investigator's objective is to validate the novel automated blood pressure device against
      the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented
      study participants.
    

Detailed description: 
      A new prototype blood pressure cuff has been designed for the higi SH llc health stations.
      This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is
      used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring
      BP values in most clinical facilities. The cuff is driven by a motor and gearhead to
      automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP
      measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an
      algorithm developed for use with a fitted cuff; the same module one would expect to find in a
      clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard
      statistical requirements and thus, be considered a valid device for measuring BP it will need
      to meet the standards criteria 1 and 2.
    

Intervention name(s): Blood pressure assessment
Intervention type(s): Device
Intervention description(s): Validation of an automated blood pressure device
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed
        with heart disease.
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Condition: Chronic Hepatitis C (CHC)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in
      patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after
      previous treatment.
    


Intervention name(s): MP-424; RBV; PEG-IFN alfa-2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MP-424: 750mg every 8 hours (q8h) for 12 weeks; RBV: 600 - 1000 mg/day based on body weight for 24 weeks; PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Intervention MeSH terms: Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pegasys
Prediction of Preeclampsia by Comprehensive Markers.
Condition: Pre-Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      Preeclampsia is one of the most serious complications in pregnancy that causes maternal death
      and preterm delivery. Series studies has show that the competing risk model developed by the
      Fetal Maternal FouNdation in early pregnancy has the potential to predict preeclampsia
      effectively but has show crowd difference. We aim to evaluate the performance of various
      screening model based on FMF model in Chinese population.
    

Detailed description: 
      The prospective multi-center observational study aimed to recruit at least 10,000 pregnant
      woman during the first trimester conducted among 12 medical centers in China. The medical
      history of each candidate was recorded , blood pressure was measured , blood sample was taken
      between 11 gestational weeks and 13+6 gestational weeks, to get the PlGF and PAPPA tested.
      Routine ultrasound was taken with measurement of the uterine artery pulsatility index. The
      results of the recruited patients were not released to the patients or the doctor. Pregnancy
      outcome was recorded as to whether the women develop preeclampsia , the SGA babies, or low
      birth Apgar score and other preeclampsia related adverse maternal and neonatal outcomes. The
      basic medical information, the mean artery pressure, the PlGF and PAPPA MOM, the UtA PI were
      used in combination to do the risk stratification, and to develop prediction model for
      Chinese people.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        we aimed to recruit as many as possible the women without discrimination during the study
        periods.
      
Biospecimen description: 
      maternal serum samples.
    
Keywords: preeclampsia prediction; competing risk model; 11~13+6 gestational weeks
Effects of Diet Manipulation on Women in the Curves Program
Condition: Diet, Carbohydrate-Restricted
Study type: Interventional

Summary: 
      The purpose of this study is to look at the effects of a carbohydrate restricted, high
      protein, high fat diet on weight loss and health outcomes in women participating in the
      Curves Fitness and Weight Loss Program.
    

Detailed description: 
      The purpose of this study is to determine if a carbohydrate restricted, high protein, high
      fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in
      weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low
      fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate
      restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).
    

Intervention name(s): Control; American Heart Association plus exercise; Curves Complete - I plus exercise; Curves Complete - II plus exercise
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Use of Honey for Pressure Ulcers in Critically Ill Children
Condition: Bed Sore; Pressure Ulcer; Pressure Sore; Critically Ill Children
MeSH terms: Pressure Ulcer; Ulcer; Critical Illness
Study type: Interventional

Summary: 
      The enrolled children would be randomized to one of the groups 'study group' or 'Honey
      dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known
      as Manuka honey would be used), changed every alternate day for a maximum period of upto 8
      weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is
      earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is
      applied after application of povidone iodine). Randomization will be performed as per
      protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer
      and secondary outcomes will be treatment failure and new onset infection of ulcer.
    

Detailed description: 
      Children admitted to the PICU would be eligible for inclusion. The interventions will be
      initiated within the hospital itself. All children will be managed as per standard treatment
      protocols of the unit for various disease conditions. The enrolled children would be
      randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey
      dressing containing Active Leptospermum Honey also known as Manuka honey would be used),
      changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV
      ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group'
      or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of
      povidone iodine). Randomization will be performed as per protocol. Primary outcome will be
      reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be
      treatment failure rate and new onset infection of ulcer. The investigators ICU is a fully
      equipped 8 bedded ICU with all ventilated beds. There are 2 full time consultants, residents
      and staff with nurse patient ratio of 1:1 to 1:2. Therefore, the investigators are well
      equipped to treat critically ill children. There will be an in-built mechanism of assuring
      quality of processes at different steps.
    

Intervention name(s): Honey (medicated)
Intervention type(s): Other
Intervention description(s): Honey (medicated) dressing will be used in the experimental group
Other intervention name(s): Manuka honey; Leptospermum honey
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Extracorporeal Shock Therapy for Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were
      selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo
      University. Their age ranged from 25-35 years, BMI<30kg/ m².
    

Detailed description: 
      Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic
      low back pain were excluded from the study. They were randomly assigned into two equal groups
      (A& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI
      27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty
      patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham
      technique. A hot pack was used for 15 minutes for both groups (A&B) before the treatment.
    

Intervention name(s): Extracorporeal Shock wave
Intervention type(s): Device
Intervention description(s): Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level
Other intervention name(s): dietary modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment