bioihbjkbjnl/mcl2 huggingface dataset:
Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with
      atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus
      ointment, evaluated by examination of treated areas, will also be measured.
    

Detailed description: 
      This is a multi-centre, double-blind, randomised phase II pharmacokinetic study in infants (3
      - 24 months old) suffering from atopic dermatitis and requiring treatment with mid potency
      topical steroids. Patients will primarily be stratified into three groups according to
      percentage body surface area to be treated and subsequently randomised into treatment groups
      of once a day (UID) or twice a day (BID) tacrolimus ointment (0.03%) regimens. There will
      ultimately be a total of six groups. The study will be conducted on an out-patient basis,
      with each patient's parent/legal representative administering the ointment at home. However
      all medications on days 1 and 14 will be applied in the clinic by the Investigator or his/her
      designee, as will the morning application on day 4. The ointment application period will be
      two weeks with a follow-up period of four days. All patients enrolled into the study, who
      applied at least one dose of study medication and who benefited from treatment will be given
      the opportunity to enter a long-term study to follow (FG-506-06-33).

      The patient will be entered into one of the following three groups:

      Stratification Group I Application area of 5 - 20% Stratification Group II Application area
      of > 20 - 40% Stratification Group III Application area of > 40%

      Within these groups the patients will be randomised to either UID or BID.
    

Intervention name(s): Tacrolimus Ointment 0.03%; Tacrolimus Ointment 0.03%
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily, 14 days treatment.; Once daily, 14 days treatment.
Other intervention name(s): Protopic 0.03%
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
Condition: Cardiovascular Abnormalities
MeSH terms: Cardiovascular Abnormalities
Study type: Interventional

Summary: 
      This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001,
      R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)
      exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo,
      and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.
    

Detailed description: 
      This study is specifically designed to evaluate the potential effects of ingestion of the
      novel food ingredient on cardiac safety. The objective will be fulfilled by assessing cardiac
      parameters including heart rate, blood pressure, and ECG/QT interval in healthy adult male
      subjects following a single dose oral administration of the test article.

      The primary objective of this study is to demonstrate that a single oral dose of 150 mg of
      the test article does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)
      exceeding 10 milliseconds (msec).
    

Intervention name(s): R,R-monatin; Moxifloxacin; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Each subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods; Each subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods; Each subject consumes placebo in one of 3 treatment periods
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Condition: Ovarian Reserve
Study type: Interventional

Summary: 
      Two group of patients were selected. Group 1 represents 46 patients that received
      ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received
      antioxidant therapy daily for 3 months. Results are noted and analysed.

      Both groups represent patients with procedures already ongoing, and with diagnosed poor or
      depleted ovarian reserve.

      The analysis has been made to compare the efficacy of both procedures.
    

Detailed description: 
      The bioestimulation group received a blood rich platelet therapy monthly for three months,
      with a technique developed by the laboratory. The second group of antioxidants received a
      combination of antioxidants monthly for three months. Both groups were compared to assess the
      results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and
      egg quality, embryo development, implantation rate, and successful pregnancy with healthy
      live birth.
    

Intervention name(s): blood rich plasma platelets; Antioxidant therapy
Intervention type(s): Procedure; Dietary Supplement
Intervention description(s): Injection of blood rich platelet into the ovaries.; Antioxidants:
Q10, DHEA, Vitamina E, Vitamin C, Omega 3
Intervention MeSH terms: Antioxidants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative study
Masking: None (Open Label)
Primary purpose: Treatment
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
Condition: Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Sexual Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to explore patient and partner experiences with sexual
      dysfunction following radical prostatectomy, in order to understand its effects on sexual and
      non-sexual intimacy. This will enable us to provide assistance in the future to individuals
      experiencing similar circumstances.
    

Detailed description: 
      We are studying the impact of sexual dysfunction following radical prostatectomy on patient
      and partners' experiences of intimacy. Research with men in post-radical prostatectomy
      recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety
      and distress related to sexual difficulties. These experiences may progress and result in
      long-term problems in the relationship between patients and their partners. Despite apparent
      levels of effectiveness, up to half of the patients who turn to sexually assistive aids after
      surgical removal of the prostate discontinue use of the aids within one year. Additionally,
      difficulties in communicating about sexual impairments can significantly interfere with the
      couples' ability to achieve successful adaptation. We are interested in studying patient and
      partner experiences with sexual dysfunction in order to understand its effects on sexual and
      non-sexual intimacy.

      Participation in this study will involve completing 6 confidential face-to-face interviews on
      three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each
      occasion, participants will be required to take part in a "couple's" interview with his/her
      partner, as well as an individual interview. The interviews will provide participants with
      the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and
      communication with their partners. Demographic information will be collected at the initial
      interview. As well, at each of the 3 time points, participants will also be asked to complete
      a questionnaire package containing 6 psychological questionnaires. All questionnaires and
      interview material will be kept strictly confidential.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.
      
Keywords: Prostate Cancer; Radical Prostatectomy; Sexual Dysfunction; Intimacy; Adaptation; Psychosocial Oncology
Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional

Summary: 
      The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to
      colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic
      Acid treatment might be associated with changes of the gut microbiota and metabolomic
      profiles in patients with long-standing ulcerative colitis.
    


Intervention name(s): Eicosapentaenoic Acid
Intervention type(s): Dietary Supplement
Intervention description(s): Twenty patients with long-standing ulcerative colitis undergoing the usual colonoscopic surveillance + biopsy sampling will be recruited. At entry six extra biopsy samples will be collected from the colon. We will also collect blood (for serum, plasma and red cells isolation), urine and stools. Subjects will then receive 2 g/day of Eicosapentaenoic Acid (ALFA ™, SLA Pharma AG, Switzerland) as a supplement for 90 days. At the end of the study each subject will undergo sigmoidoscopy for the collection of 6 biopsies. Blood, urine and stools will be obtained prior to the procedure.
Other intervention name(s): ALFA ™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ivabradine for Rate Control in Permanent Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Fibrillation, Persistent
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative
      effects on hemodynamics and inotropy. The objective in this proof of concept study is to
      investigate the hypothesis that ivabradine will slow the ventricular response in patients
      with permanent atrial fibrillation and previously-implanted pacemakers.
    

Detailed description: 
      In a simple cross-over study, the investigators will evaluate the impact of oral Ivabradine
      on exercise treadmill test, percent pacing as stored in pacemaker diagnostics, and 6 minute
      walk test.

      Aim/Hypotheses

      • To determine if the addition of Ivabradine to baseline cardiac medications slows mean and
      maximum heart rates in permanent atrial fibrillation

        -  Ivabradine will lower mean and maximum heart rates on treadmill exercise test, without
           lowering blood pressure

        -  Ivabradine will increase percent pacing, and lower rates over time as shown on pacemaker
           diagnostic data

        -  Ivabradine will improve exertional symptoms and exercise tolerance due to atrial
           fibrillation as measured by the Borg's scale during a six-minute walk test.

      Study Design

        1. Patients with permanent atrial fibrillation will undergo baseline exercise treadmill
           test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6
           minute walk test with symptomatic assessment of dyspnea using the Borg's scale score.

        2. Oral Ivabradine will be started at 5 mg twice daily, and up-titrated to a maximum dose
           of 7.5 mg twice daily at 7 days if percent pacing has not increased significantly or
           rates have not slowed more than 20bpm.

        3. Exercise treadmill test, measurement of heart rates and percent pacing from pacemaker
           diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the
           Borg's scale score will be repeated at 2 weeks.
    

Intervention name(s): Ivabradine
Intervention type(s): Drug
Intervention description(s): Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
    

Detailed description: 
      This open-label trial is composed of two periods: Induction and Extension. All eligible
      patients will be enrolled into the 12-Week Induction period and receive study medication.
      Patients who complete the Induction period may then be eligible to enter the 100-Week
      Extension period where they will continue to receive study medication.
    

Intervention name(s): RPC1063
Intervention type(s): Drug
Other intervention name(s): Ozanimod
Intervention MeSH terms: Ozanimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2)
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to help in the development of safe, effective and
      reversible male contraception. We are examining the impact of the drug Miglustat on sperm
      production in normal men.

      We want to see if Miglustat will inhibit sperm production in men and act as a reversible male
      contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of
      sperm production. We believe Miglustat may have some potential as a safe, reversible male
      contraceptive.
    

Detailed description: 
      Glycosphingolipids (GSL) are a main constituent of the sperm cell membrane in mammals. Male
      mice deficient in enzymes involved in GSL synthesis have severely impaired fertility and
      knockout mice are infertile. Recently, it was demonstrated that administration to mice of an
      inhibitor of ceramide-specific glycosyltransferase, the first step in the biosynthetic
      pathway of GSL formation, resulted in reversible infertility without discernable adverse side
      effects. This inhibitor was Miglustat, which is an alkylated imino sugar. The impact of
      Miglustat therapy on human spermatogenesis is unknown. If the effects on sperm morphology and
      motility are similar to those observed in mice, Miglustat or other GSL inhibitors might have
      potential utility as non-hormonal male contraceptives.
    

Intervention name(s): Miglustat (Zavesca)
Intervention type(s): Drug
Intervention description(s): 100 mg Miglustat BID (twice daily) for six weeks
Other intervention name(s): Zavseca
Intervention MeSH terms: Miglustat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycosphingolipids (GSL)
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response
      and is associated with clinical progression of many diseases. Our aim is to assess influence
      of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs),
      rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon
      based therapy in chronic Hepatitis C patients in Egypt.

      Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism)
      in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be
      assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.
    


Intervention name(s): WT+ Diplotype
Intervention type(s): Genetic
Intervention description(s): 3 or 4 vitamin D binding protein major alleles
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Hepatitis C patients in Egypt
      
Biospecimen description: 
      EDTA blood
    
Keywords: VDBP; single nucleotide polymorphisms (SNPs); interferon based therapy; Egypt
Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Double blinded randomized controlled study
    

Detailed description: 
      Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.

      264 dark colored envelops will be serially numbered containing the corresponding letter of
      the corresponding drug that will be used.

      Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous
      injection at delivery of the anterior shoulder.

      Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous
      injection at delivery of the anterior shoulder.

        -  All patients will receive general anaesthesia.

        -  Operation will be carried out by a three year registrar (at least).

        -  Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.

        -  Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood
           loss will be calculated using the following equation:

        -  The actual blood loss equals the estimated blood volume X difference between the initial
           hematocrit and the final hematocrit / the initial hematocrit

      Secondary endpoints include:

        1. The need for additional uterotonic medication after carbetocin or oxytocin
           administration.

           - Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will
           be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery

           - Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within
           5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg
           by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.

        2. The need for blood transfusion or operative interventions related to PPH

           - The need for blood transfusion or operative intervention (B-Lynch sutures, uterine
           artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.

        3. The change in hemoglobin and hematocrit post versus pre CS

           - The drop in hemoglobin level and hematocrit will be evaluated by comparing the
           hemoglobin concentration on admission and 24 hours after delivery.

        4. The hemodynamic adverse effects and the cost-benefit of both drugs.
    

Intervention name(s): Carbetocin; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): at delivery of anterior shoulder; at delivery of anterior shoulder
Other intervention name(s): Pabal; Syntocinon
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Postpartum Hemorrhage; carbetocin; oxytocin
Study to Evaluate How Patients Regard the Benefits and Risks of Low-dose Aspirin for the Prevention of Heart and Blood Vessels Disease and for the Prevention of Cancer of the Colon and Rectum
Condition: Cardiovascular Disease; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Cardiovascular Diseases
Study type: Observational

Summary: 
      Research shows that low-dose Aspirin prevents diseases of heart and blood vessels as well as
      cancer of the colon and rectum and it is also associated with risk of bleeding. In this
      study, they want to learn how patients regard the benefits and risks of low-dose Aspirin for
      the prevention of these diseases. The researchers also want to learn how patients balance
      these risks and benefits.
    


Intervention name(s): Acetylsalicylic acid (Aspirin, BAYE4465)
Intervention type(s): Drug
Intervention description(s): This study does not involve prescription of the drugs. This study is a cross-sectional survey of patients taking low-dose aspirin or patients who are eligible but not taking low-dose aspirin.
Other intervention name(s): Low-dose Aspirin
Intervention MeSH terms: Aspirin
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who are eligible for and/or taking low-dose aspirin will be recruited for
        qualitative interviews, pilot/cognitive interviews, and the main quantitative survey.
        Medically trained physicians who have experience prescribing low-dose aspirin for CVD
        (cardiovascular disease) and CRC (colorectal cancer) prevention will be eligible for the
        qualitative interviews.
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the gastrointestinal emptying time using the wireless
      motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with
      migraine who are taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP)
      antagonist called galcanezumab or erenumab.
    


Intervention name(s): Galcanezumab; Erenumab
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
Study to Evaluate Potential Food Effects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Half the group will be given a high fat diet and the other half will fast. They will then be
      crossed over.
    

Detailed description: 
      A food-effect study which will be conducted at any time during the MRD study period on one
      single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a
      high fat diet and the other half will fast. They will ten be crossed over.
    

Intervention name(s): PG-760564; PG-760564
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg capsule, single dose,fasted when dosed, duration is 4 days; 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics study