bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
Condition: Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is designed to compare the pharmacokinetic characteristics of combination
      and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also
      investigate drug interaction between separate and combination administration.

      Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day
      administration, 10 days washout after 5th day of administration.

      All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each
      period.
    


Intervention name(s): Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg)
Intervention type(s): Drug
Intervention description(s): For co-administration,Crestor 1 tablet and Glucodown 1 tablet a day for 5 day.(1 period) For separate administration, Crestor 1 tablet a day for 5 day and Glucodown 1 tablet a day for 5 day.
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Drug interaction; Rosuvastatin; Metformin SR; Pharmacokinetic
Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of
      these multiple births being twin births . Preterm birth defined as birth occurring prior to
      37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in
      the United States.

      Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are
      at increased risk of developing respiratory distress syndrome, sepsis, intraventricular
      hemorrhage, and necrotizing enterocolitis.

      Twin pregnancy is considered one of the important risk factors of preterm birth. Over
      distension of uterus may be one of the etiological factors for preterm birth. However, no
      definite effective interventions have been shown to prevent preterm delivery in twin
      pregnancy.

      Three large randomized trials suggested that progesterone might prevent preterm delivery in
      high-risk singleton pregnancy especially those with previous preterm delivery or short cervix
      might be reduced by antenatal progesterone.

      Fonseca et al (2007) concluded that women with short cervix are less likely to deliver
      preterm ≤34 weeks if they are treated with vaginal progesterone.
    


Intervention name(s): The progesterone vaginal pessary; Tonics group
Intervention type(s): Drug; Drug
Intervention description(s): Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy; Those patients will receive only tonics
Other intervention name(s): Active drug treatment; Placepo
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm birth; Twin pregnancy; progesterone
Impaired Regulation of Energy Balance in Elderly People (Balance Study)
Condition: Anorexia of Ageing
MeSH terms: Anorexia
Study type: Interventional

Summary: 
      Over the past century life expectancy has risen rapidly. As a result, the proportion of
      elderly people continues to grow. Elderly people probably have an impaired regulation of
      energy balance (energy intake versus energy expenditure) whereby the underlying physiological
      mechanisms are not fully understood.

      The first objective of this study is to provide further evidence for an age-related failure
      to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy
      balance in elderly is confirmed then the second objective becomes to elucidate the underlying
      physiological mechanisms of the age-related failure to regulate energy intake in elderly.
    


Intervention name(s): Energy restriction period
Intervention type(s): Other
Intervention description(s): The experiment can be divided in 3 phases, namely (1) run-in phase, (2) energy restriction phase and (3) ad libitum food intake phase. Thus, for all participants the experiment consists of three subsequent phases.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anorexia of ageing; Anorexia of aging; Energy balance; Elderly
Investigation of Oral Microflora of Infants
Condition: Streptococcus Mutans
Study type: Observational [Patient Registry]

Summary: 
      The placement of cariogenic microorganisms in oral microflora is an important factor in
      dental caries. The aim of this study is to research from whom, when and how the cariogenic
      microorganisms are first transmitted to the infant. The investigators investigated of
      colonization of Streptococcus mutans, Lactobacillus spp., and Candida spp. in oral cavities
      of infants and their transmission to the infants.
    

Detailed description: 
      Study sample size and design: When α = 0.05, 1-β (power) = 0.80 were taken to determine the
      sample volume, it was calculated that at least 46 babies should be sampled for 6 months to
      have an average amount of S. mutans change of 1.87 units. Considering the losses that may
      occur during the follow-up, the study was started by taking samples from 60 systemically
      healthy newborns.

      The study commenced with 60 newborns and was completed with 47 infants due to losses during
      the follow-up. Oral swab samples were taken from 47 healthy infants within the first 24 hours
      after birth, at 1 month old and during the first tooth eruption. Saliva samples were taken
      from the mothers of all the infants and from the fathers of 20 of the infants in the last
      meeting.

      Last interview with the parents, their oral examinations were performed, and their findings
      were processed as decayed (D), filled (F) and missing (M) teeth in accordance with the World
      Health Organization criteria, with the DMF (decayed, missing and filled) index being
      calculated. Furthermore, saliva samples were taken from the parents at the last interview. A
      questionnaire form including the sex of the infant, type of delivery, birth weight, and
      nutritional habits of the infant during the follow-up was filled in by gaining information
      from the parents on the first day and during the follow-ups.

      Swab samples taken from infants with sterile swabs were transferred to the laboratory by
      placing sterile saline solution into dispensed 2 ml screw cap tubes. Sterile urine collection
      containers of 50 ml were used to collect saliva samples from the parents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was conducted in two centers - Turgut Özal Medical Center and Malatya Training
        and Research Hospital. Between January and May 2018, healthy newborns born in these two
        hospitals were followed up.
      
Biospecimen description: 
      salivary
    
Keywords: Familial transmission; Candida; Lactobacillus; S. mutans; newborn
A Study Comparing Two Forms of Didanosine in HIV-infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe
      and absorbed by the body as well as the chewable-tablet form of ddI.

      Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the
      stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may
      replace the need for antacids.
    

Detailed description: 
      Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection
      when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to
      protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using
      buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being
      developed.

      Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at
      least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the
      test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are
      performed periodically during the study and at discharge. Serial blood samples are collected
      at specific time points over the 12 hours following dosing, and are used for the
      pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject
      within sequence, period, and formulation. Safety is assessed by monitoring adverse effects,
      vital signs, ECG recordings, and clinical laboratory tests throughout the study.
    

Intervention name(s): Didanosine
Intervention type(s): Drug
Intervention MeSH terms: Didanosine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Didanosine; Tablets; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Therapeutic Equivalency
Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia
Condition: Presbyopia; Refractive Errors; Eye Diseases; Near Vision; Miosis
MeSH terms: Eye Diseases; Presbyopia; Refractive Errors
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with
      Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
    


Intervention name(s): Aceclidine+Brimonidine combination ophthalmic solution; Aceclidine ophthalmic solution; Vehicle proprietary ophthalmic solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LNZ101-combination ophthalmic solution; Aceclidine alone + vehicle; Proprietary vehicle ophthalmic solution
Other intervention name(s): LNZ101; Brimonidine; Aceclidine; Vehicle; LNZ100; Aceclidine; Vehicle; vehicle
Intervention MeSH terms: Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions; Aceclidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmaceutical Solutions; Opthalmic Solutions; Eye Drops; INSIGHT Study; INSIGHT 2
Exercise Testing to Screen for Unknown Coronary Artery Disease in Diabetic Patients: Does it Contribute to a Risk Reduction in Very High Risk Patients?
Condition: Coronary Artery Disease; Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      In the present study a cohort of diabetic patients without any symptoms and without known
      coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients
      services. Those with intermediate or high risk will be asked to participate and enrolled.
      They will be seen and followed by the cardiologists in order to provide the best adherence to
      medical therapy. By mean of a randomization process, a group of patients will undergo an
      exercise electrocardiography (ECG) testing while the other group will continue to be
      regularly seen at the investigators' cardiology service. Those patients with a positive
      exercise ECG test will be study by coronary angiography and treated according to the severity
      of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen
      every six-eight months for the next three years.
    


Intervention name(s): exercise testing - coronary angiography - revascularization
Intervention type(s): Procedure
Intervention description(s): Those patients with a positive exercise ECG test will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery
Other intervention name(s): Exercise tolerance testing as screening; Coronary angiography; Revascularization surgical or pecutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer
Condition: Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer.
      Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive
      inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal
      growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer
      by simultaneous inhibition of these receptors. The purpose of this study is to determine the
      safety and efficacy of Varlitinib in combination with capecitabine for the treatment of
      Biliary Tract Cancer. Eligible patients will receive Varlitinib plus capecitabine.
    


Intervention name(s): Varlitinib; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets, twice daily; oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biliary Tract Neoplasms; Bile Duct Neoplasms; Gallbladder Neoplasms
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to
      assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone
      [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular
      development as part of an assisted reproductive technology (ART) treatment cycle in poor
      ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of
      Human Reproduction and Embryology (ESHRE) criteria.
    


Intervention name(s): Pergoveris®; GONAL-f®; Recombinant human chorionic gonadotrophin (r-hCG)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.; GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.; On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
Other intervention name(s): r-hFSH/r-hLH; Follitropin alfa/Lutropin alfa; r-hFSH; Follitropin alfa; Ovidrel®; Ovitrelle®; choriogonadotropin alfa
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ESPART; Reproductive Techniques, Assisted; Infertility; Pergoveris®; GONAL-f®
Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham
      treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette
      smokers.
    

Detailed description: 
      This is a multi center, randomized, double blind study to evaluate the safety and
      effectiveness of the device as an aid to smoking cessation. Treatment will be administered
      over a 6 week period and follow-up assessments will be conducted at 4 months. The clinical
      study design includes multiple measurements of safety and effectiveness parameters. The
      design is meant to demonstrate that the device shows superiority compared to sham treatment
      over six treatment weeks, at the 4 months follow up.
    

Intervention name(s): Sham Treatment; Active dTMS Treatment
Intervention type(s): Device; Device
Intervention description(s): In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the the brain.; Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions.
Other intervention name(s): Brainsway Sham Treatment; Brainsway Deep TMS Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
Condition: Apnea of Prematurity
MeSH terms: Apnea; Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the present proposed study is to discover whether, in the nursery setting,
      administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can
      make breathing more regular with less apneic time than that observed with administration of
      theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%)
      will reduce apnea more effectively and will have fewer adverse side effects than
      theophylline.
    

Detailed description: 
      1. To discover whether, in the nursery setting, continuous administration of a low
           concentration of inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing
           in preterm infants more regular with less apneic time than that observed with
           theophylline.

        2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged
           apneas (>20 seconds), more effectively than theophylline.

        3. To discover whether short term (during hospitalization) and long term (2 years) adverse
           side effects are less pronounced with CO2 than with theophylline.
    

Intervention name(s): CO2 inhalation; Theophylline
Intervention type(s): Other; Drug
Intervention description(s): Inhalation of CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apnea; premature; infant; prematurity
The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees
Condition: Amputation Balance Prosthesis
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to determine the effect of various
      linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as
      well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.
    

Detailed description: 
      Initial Visit:

        1. Informed consent

        2. HIPAA

        3. Foot Inspection

        4. Review expectations

        5. Take measurements

        6. Casting

      Second Visit: Fitting and adjusting accordingly.

        -  One person will conduct all the measurements, casting, check sockets, etc. to evade
           inconsistencies in data collection.

        -  Begin conducting practice runs on Balance Master at LLU-East Campus.

      Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test)
      *Testing will be video recorded for re-assessment of subjects*

        1. Five times sit-to-stand test (5XSTS).

        2. Activities-Specific Balance Confidence (ABC-16) scale

        3. Balance Master:

           Weight Bearing Squat (WBS) Unilateral Stance (US) Sensory Organization Test (SOT)
           modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Limits of Stability
           (LOS)

        4. A Polar H10 heart rate monitor will be worn while subjects perform each of the various
           tests.
    

Intervention name(s): Neutral Alignment; Anterior Alignment; Posterior Alignment
Intervention type(s): Other; Other; Other
Intervention description(s): Alignment that is a neutral replicate of the participants prescribed prosthesis.; Alignment that is anterior displaced pylon.; Alignment that is posteriorly displaced pylon.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other