bioihbjkbjnl/mcl2 huggingface dataset:
Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the effects of the combined oral
      contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal
      function, and thyroid function.
    


Intervention name(s): NOMAC-E2; Levonorgestrel and Ethinyl Estradiol
Intervention type(s): Drug; Drug
Intervention description(s): Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.; Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Other intervention name(s): SCH 900121; Org 10486-0 (NOMAC); Org 2317 (E2)
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy
      Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg
      (Warner-Lambert) under fasting conditions.
    

Detailed description: 
      This was an open label, randomized, single dose, 2-way crossover, relative bioavailability
      study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty
      five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In
      each period, subjects were housed from at least 10 hours before dosing until after the 36
      hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a
      washout period of 7 days.

      A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out
      of which a total of thirty five (35) subjects (19 males and 16 females) completed the
      clinical phase of the study.
    

Intervention name(s): 120 mg Pseudoephedrine hydrochloride extended release tablets
Intervention type(s): Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Pseudoephedrine hydrochloride 120 mg extended release tablets
IPI-145 ADME and Absolute Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME)
      and absolute bioavailability study in 6 healthy adult male subjects.
    

Detailed description: 
      In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a
      15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of
      radioactivity.

      In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral
      suspension, containing approximately 3.15 MBq of radioactivity.

      There will be a washout period of at least 14 days between Period 1 and Period 2.
    

Intervention name(s): IPI-145
Intervention type(s): Drug
Intervention description(s): Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; healthy male volunteers; ADME; Bioavailability; PI3K inhibitor; Absorption; Distribution; Metabolism; Excretion; safety
A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, two-period study. There will be nine healthy human
      volunteers arbitrarily assigned to one of four groups. The study objective is to compare the
      action of various combinations of BiDil extended-release capsules and commercial BiDil
      Tablets in the body over a period of time.
    


Intervention name(s): Isosorbide dinitrate / hydralazine capsules
Intervention type(s): Drug
Intervention description(s): Group 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid
Other intervention name(s): BiDil tablets; ISDN/HYD
Intervention MeSH terms: Hydralazine; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hydralazine; isosorbide; bidil; volunteers; pharmacokinetic profile
Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties
Condition: Human Microbiome
Study type: Interventional

Summary: 
      Pomegranate extract (Pomella) is well known for its antioxidant properties due to its
      phenolic compounds. It has also been shown to increase the amount of short chain fatty acid
      producing Lactobacillus and Bifidobacteria genera. Short chain fatty acids are thought to
      have an anti-inflammatory effect on the sebaceous glands. Previous studies have concluded
      that pomegranate extract may act as a prebiotic in the body and subsequently increasing the
      gastrointestinal microbial diversity and by producing short chain fatty acids that may have
      systemic beneficial effects especially on the skin.

      Therefore, the aim of this study is to assess how Pomella alters the gut microbiome and the
      blood level of short chain fatty acids in healthy subjects.
    


Intervention name(s): Pomella; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pomella® Pomegranate Whole Fruit Extract containing 75 mg punicalagin in white/white HPMC size "1" capsules packed in white color HDPE bottle of 30 counts; White/white HPMC size "1" capsules each containing 97.67% Maltodextrin, 0.10% Tartrazine color, 0.22% Brown Color, 2.01% Aerosil packed in white color HDPE bottle of 30 counts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: gut microbiome; polyphenols; skin; dermatology; pomegranate extract; punicalagins
A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
Condition: Cervical Cancer; Anal Cancer; Penile Cancer
MeSH terms: Anus Neoplasms; Penile Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to determine the effects of message framing (gain vs. loss) on
      African American parents' acceptance of the HPV vaccine and how such effects are moderated by
      parents' salient beliefs prior to message exposure. Participants are randomized into gain and
      loss conditions in which they view either gain-framed or loss-framed HPV vaccination
      messages. Key outcome variables include parents' attitudes and intentions toward vaccinating
      their children against HPV.
    

Detailed description: 
      The goal of this study is to determine the effects of message framing (gain vs. loss) on
      African American parents' acceptance of the HPV vaccine and how such effects are moderated by
      parents' salient beliefs prior to message exposure. Participants recruited from local
      communities and online panels will complete a computer-assisted survey. In the survey
      participants will first answer questions related to their beliefs about HPV and the HPV
      vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived
      safety, etc.), as well as other background information. Then they will be presented with
      either a gain-framed or loss-framed human papillomavirus vaccination message. After the
      message exposure, they will answer questions related to their attitudes toward HPV
      vaccination, intentions to vaccinate their children, as well as other message response
      measures. Eligible participants are at least 21 years old, self-identify as African American,
      and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated
      the HPV vaccine series.
    

Intervention name(s): HPV vaccination messages
Intervention type(s): Behavioral
Intervention description(s): Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
Condition: Blood Glucose; Insulin Sensitivity; Dietary Fiber
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This randomized, crossover study will include four clinic visits: one screening (day -7) and
      three test visits (days 0, 2, 4). The objective of this study is to assess the effects of
      dietary fiber-containing bars, at two doses of fiber, compared to a control product, on
      postprandial glucose and insulin responses in healthy adult men and women.
    


Intervention name(s): Medium-fiber bar; High-fiber bar; Control bar (0 g fiber)
Intervention type(s): Other; Other; Other
Intervention description(s): Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.; Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.; Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Postprandial glucose; Meal tolerance test
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The
      amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken
      with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be
      measured. Information about any side effects that may occur will also be collected.

      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.

      Screening will be undertaken within 45 days prior to enrollment.
    


Intervention name(s): Lanabecestat; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3314814; AZD3293
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Oligofructose on Appetite in Overweight Subjects
Condition: Appetite Regulation; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study seeks to look into the effects of oligofructose supplementation on appetite,
      energy intake, and body weight and body composition in overweight subjects. Compared to a
      placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby
      reduce food intake moderately leading to a decrease in body weight.
    

Detailed description: 
      Appetite regulation plays an important part in energy balance. Suppressing appetite by
      manipulating the diet is a safe way of reducing energy intake and body weight compared to
      drug therapy and obesity surgery. How various nutrients affect appetite is not fully
      understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to
      differences in physio-chemical properties.

      This project will look into how two different NDC affect appetite and energy intake in
      overweight individuals in a randomised, double-blinded, placebo controlled parallel study.
      The NDC under investigation are oligofructose and cellulose, both natural compounds of plant
      origin. The former is broken down (fermented) in the large bowel by friendly bacteria
      producing various compounds that may affect appetite and the metabolism of the host.

      Volunteers will consume one of the two NDC for eight weeks (including a two week run-in
      period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be
      conducted before and after the supplementation with NDC (or during the supplementation in the
      case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite
      regulating centres will be investigated. Appetite questionnaires and dietary records will
      completed under free-living conditions at baseline and during the supplementation to explore
      the effect on subjective appetite feelings and energy intake, respectively.

      It is hoped that this project will enhance the understanding of how NDC affect appetite and
      provide further information on how fermentation of NDC, gut hormone release, body
      composition, and appetite regulation are linked.
    

Intervention name(s): Oligofructose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.; Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Appetite regulation; Oligofructose intake
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Condition: Alzheimer's Disease and Related Dementias
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional

Summary: 
      The purpose of this project is to evaluate the preliminary effects of home-based M1-SO
      applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over
      the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's
      disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO
      applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to
      evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain
      management in persons with early-stage AD.
    


Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.; The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Relationship Between Pelvic Tilt and Sit to Stand Task in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purpose of this study is to assess and determine the influence of pelvic inclination on
      sit to stand task in stroke patients.
    

Detailed description: 
      There is a crucial need to have a better understanding of effect of pelvic inclination on sit
      to stand activity and to know the important factors to be considered to improve the patients'
      treatment and performance. Forty five participants are recruiting to assess the pelvic tilt
      angles in stroke patients during sitting position and to analyze the influence of pelvic tilt
      angles on ability to perform sit to stand task during rising from a chair in stroke patients.
    

Intervention name(s): Sagittal pelvic tilt assessment
Intervention type(s): Other
Intervention description(s): Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients were recruited from the Out-patient clinic for Neuromuscular Disorders and Its
        Surgery, Faculty of Physical Therapy, Cairo University and Out- patient clinic of El-kasr
        El-Aini Hospital, Faculty of Medicine, Cairo University
      
Keywords: Pelvic Inclination; Sit to Stand; Stroke; Anterior pelvic tilt; Posterior pelvic tilt
Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is on one hand to verify the measurement conformity of the IRAP
      dosage and on the other hand to obtain normal values of the blood IRAP concentration on
      healthy volunteers.
    

Detailed description: 
      This study consists of two visits, from two to five days apart.

      The first visit :

        -  Healthy volunteers will be on an empty stomach.

        -  they will have a clinical examination, blood tests and blood samples will be taken to
           constitute a blood collection. the IRAP concentration will be measured with those
           samples.

      The second visit : This visit will take place in an interval from 2 to 5 days after the first
      visit.

        -  Subjects will be on an empty stomach

        -  An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will
           be taken three time 15 minutes apart at Baseline (before taking the glucose). And then
           after the glucose intake, blood sample will be taken every 15 minutes to measure
           insulinemia, blood glucose, and IRAP concentration.
    

Intervention name(s): Blood sample collection during an OGTT to assess IRAP blood concentration
Intervention type(s): Other
Intervention description(s): Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects distributed according to 3 age groups (40-49 years old , 50-59 years old,
        60-70 years old). Every age bracket will be balanced in sex.
      
Keywords: IRAP; Insulin Regulated Amino Peptidase; Diagnostic biomarker; Type 2 diabetes
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this trial is to assess the safety,
      pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the
      effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp)
      preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male
      subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar
      to the proposed commercial formulations.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart 30; insulin degludec/insulin aspart 45; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days; Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days; Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days; Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander
Condition: Horizontal Ridge Deficiency
Study type: Interventional

Summary: 
      The objective of this study will be to assess and compare between sub-periosteal self-
      inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge
      augmentation and periosteal releasing incision using autogenous onlay block bone graft.

      The assessment and comparison will be based on:

        1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar

           ridge augmentation.

        2. Quantity of the soft tissue obtained after soft tissue expansion.
    

Detailed description: 
      -  Sixteen patients will be selected from the outpatient clinic of the department of, Oral
           medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.

        -  Three surgeries will be carried out for group I patient; the first is placement of soft
           tissue expander, the second surgery is bone grafting and placement of collagen membrane
           for ridge augmentation while the third (re-entry surgery) is implant placement in a
           routine fashion.

      two surgeries will be carried out for group II patient; the first is surgery is bone grafting
      for ridge augmentation while the second (re-entry surgery) is implant placement in a routine
      fashion.

      -Measurements and evaluation of edentulous ridge will be done by CBCT
    

Intervention name(s): soft tissue expansion
Intervention type(s): Procedure
Intervention description(s): Three surgeries will be carried out for group I patients:
Soft tissue expansion (1st surgery); at baseline
Alveolar ridge augmentation (2nd surgery); after five weeks
Implant surgery (3rd surgery); after six months
Other intervention name(s): osmed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: expander