bioihbjkbjnl/mcl2 huggingface dataset:
Menstrual Cycle on Injection Pain of Rocuronium
Condition: Pain, Menstrual
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half
      of participants will receive follicular phase, while the other half will receive luteal
      phase.
    

Detailed description: 
      Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal
      phase of menstrual cycle, which are disappeared after menstruation.

      During menstrual cycle, fluctuation in sexual hormones results in attitude change and
      alteration in pain perception.

      Different studies reported some interactions between sex hormones and central nervous system,
      which might be linked to activity of serotonin and beta-endorphin in the brain.

      Pain perception differs during menstrual cycle.

      It has been recommended that estrogens might have an influence on somatic sensory process.

      Some studies reported a significant effect of pain sensitivity with higher levels of
      progesterone and some other studies reported similar patterns for pain perception.

      There are reports of more complaint of pain in luteal phase of menstruation, which is
      suggested as the reason for functional changes in women during menstrual cycle.
    

Intervention name(s): Rocuronium 0,6mg/kg; Rocuronium 0,6mg/kg
Intervention type(s): Drug; Drug
Intervention description(s): patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous was applied; patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied
Other intervention name(s): esmeron; esmeron
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to evaluate the efficacy and safety of AJOVY
      (fremanezumab-vfrm) on interictal migraine related burden in adults.
    

Detailed description: 
      This is a single group, multicenter, open-label study with a study population of patients who
      meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for
      migraine with or without aura and have 4 to 22 migraine days per month. This is a
      single-group supportive care study with one arm and no masking. A maximum of 40 participants
      will be enrolled to study intervention. All participants in this single-group study will
      complete a 4-week run-in period. After the run-in period, eligible participants will be
      enrolled to study intervention and enter a 12-week treatment period.
    

Intervention name(s): Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]
Intervention type(s): Drug
Intervention description(s): 225 MG/1.5 ML Subcutaneous Solution
Other intervention name(s): fremanezumab-vfrm
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Nutraceutical on Hyperglycemia
Condition: Dysglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex
      Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving
      glycemic status in subject with dysglycemia.
    

Detailed description: 
      The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex
      Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving
      glycemic status in subject with dysglycemia.

      The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired
      glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or
      nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3
      months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo
      will be self-administered once a day, 1 tablet during the breakfast.
    

Intervention name(s): Glicoset; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate; Patients will take placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Measurement of Blood Perfusion in Response to Loading in Patients With Wounds
Condition: Wound Formation
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to monitor the skin blood flow in the lower leg, with different
      levels and types of applied loads. These loads will not be placed over the patient's wound
      nor will they be higher than loads the skin normally experiences in daily activities. The
      results of this research will help investigators understand the development of pressure
      ulcers, commonly known as bedsores and stasis ulcers.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with wounds on their legs, wound clinic patients
A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 4

Summary: 
      Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves
      the scalp, nasolabial folds, eyebrows, glabella, and upper eye lids. It presents as an
      erythematous, thin scaly patch with a greasy sandpaper texture that varies depending on
      disease severity. While seborrheic dermatitis most frequently occurs on the face, it can
      involve other areas of the body especially the chest, abdomen, and axilla. Overall incidence
      is thought to be between 2-5% of the general population, though this is likely an
      underestimation. Pruritus is variable, though the signs and symptoms of this disorder are
      certainly worsened by certain external conditions especially weather, personal perspiration,
      stress, and poor hygiene. Patients often complain about the red, scaly patches on the face.

      Antifungal agents are frequently used as monotherapy or in combination regimens in the
      treatment of seborrheic dermatitis. Topical corticosteroids are often used for their
      anti-inflammatory effects. Long term use of topical steroids on the face is not a preferred
      treatment modality due to the risk of striae development and other textural changes that
      occur over time. Therefore, topical crisaborole may be an alternative given its
      non-corticosteroid anti-inflammatory action. Crisaborole is a phosphodiesterase-4 (PDE-4)
      inhibitor that increases intracellular cyclic AMP (cAMP) levels to exert its
      anti-inflammatory effects. While it has not previously been investigated for its effects in
      seborrheic dermatitis, further studies evaluating its role in this disease are warranted.

      Therefore, the investigators propose a proof of concept study using topical crisaborole 2%
      ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and
      its utility in the treatment of facial seborrheic dermatitis.
    


Intervention name(s): Crisaborole
Intervention type(s): Drug
Intervention description(s): Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17
      and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed
      in human healthy female subjects. Only female subjects will be included in the study to reach
      the objectives of the study.
    


Intervention name(s): XM17; Gonal-f®; Zoladex®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 IU corresponds to an injection volume of 0.5 mL.; 300 IU corresponds to an injection volume of 0.5 mL.; 3.6 mg
Other intervention name(s): follitropin alfa; goserelin acetate
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Function and Pharmacogenetics in Renal Transplant Recipients Converted From Tac BID to Tac OD
Condition: Real Function Post Conversion From Prograf to Advagraf; Examin Ethnicity and Pharmacogenetics of the Cohort Requiring Dose Adjustment Post-conversion
Study type: Observational

Summary: 
      In Kidney transplant recipients Once daily Tacrolimus has the poteb]ntial advantage of better
      adnerence, and perhpas improvement in reanl function compred with the twice daily tacrolimus
      formulation.

      Our center has the largest experience in North America with once-daily tacrolimus ( advagraf)
      in Renal transplant recipients.

      Recently we converted ~500 stable patients from the twice daily to once-daily tacrolimus.

      We are interested in:

        1. change in renal function

        2. dose changes based on ethnic diveristy

        3. dose changes based on pharmacogenetics

      This will helpnus understand better ways to utilize this anti-rejection medication
    

Detailed description: 
      The Renal transplant program at St. Michael's is one of the largest in Canada. The CNI of
      choice since 2000 has been tacrolimus based therapy. In 2009 our program decided to switch
      from bid prograf to once daily advagraf for all de-novo renal transplant recipients (RTR).
      Our Advagraf experience is currently the largest in North America. Because of concerns
      regarding generic prograf, we began a conversion of > 600 prevalent transplant patients on
      bid prograf to OD advagraf in January 2012. At present this is nearly completed.

      It has been recognized that dosing of tacrolimus is highly dependent on pharmacogenentic
      differences related to the CYP3A5 genotype. CYP3A%*3 (nonexpressors) require significantly
      higher doses of tacrolimus than CYP3A5*1 (expressers) with heterozygotes being somewhere in
      the middle. Our study will examine the demographics, renal function and tacrolimus dosing and
      Co levels, both pre and post conversion from tac BID, to tac OD in our cohort of converted
      patients.

      Of More scientific interest, will be to retrospectively determine the CYP3A5 genotypes in
      recipients who required significant dose adjustments in the tac OD following conversion and
      compare to a matched cohort of recipients in whom no dose adjustment was needed.

      The hypothesis is that recipients who require dose increase when converted from the BID to
      the OD formulation, will have a different CYP3A5 genotype and will tend towards CYP3A5*3.

      This will be the largest cohort to look at this question. Specifically this may lead to
      better dosing of tac OD, if pre-emptive genotyping prior to transplantation were to be
      employed.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        500 stable renal transplant recipients
      
Keywords: Advagraf, pharmacogenetics, Cyp3A5
Escitalopram in the Treatment of Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as
      monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of
      the study will consist of an 8 week treatment phase. Treatment of eligible participants will
      be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the
      presence of depressive symptoms and side effects up to a maximum of 20mg/day.

      Study objectives are:

        1. to investigate the efficacy of escitalopram in the treatment of PPD.

        2. to assess the effects of escitalopram on patients quality of life.
    

Detailed description: 
      Major Depression Postpartum Onset (PPD) is a chronic relapsing illness which affects not only
      maternal mood but also the baby and family. Therefore, it is critical to aim for timely
      intervention once the diagnosis is made. Studies have shown that antidepressant medications
      are effective in treatment for moderate to severe PPD. Common reasons for noncompliance and
      discontinuation of antidepressant medications in the postpartum period are the side effects
      associated with different antidepressants. To choose an antidepressant medication with proven
      efficacy and a tolerable side effect profile is key in order to maximize adherence to
      pharmacotherapy.

      A number of studies have been published that highlight the efficacy of escitalopram in the
      treatment of Major Depressive Disorder (MDD). However, there has been no research to date
      investigating the effectiveness of escitalopram in the treatment of PPD.

      Based upon the preliminary clinical observations in our tertiary care program (Provincial
      Reproductive Mental Health Program) where a postpartum depressed population is frequently
      treated with antidepressant medications, compliance with escitalopram has been impressive.
      Therefore, we propose to conduct an open-label study with escitalopram in postpartum
      depressed, non-lactating mothers to confirm our clinical observation.

      Hypotheses:

      i) Escitalopram will be effective in the treatment of Postpartum Depression and ii)
      Escitalopram will be effective in increasing the quality of life of participants.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presences of depressive symptoms and side effects up to a maximum of 20mg/day.
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postpartum; postpartum depression; PPD; escitalopram
Creatine Augmentation Treatment in Major Depressive Disorder Subjects
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its
      potential usefulness in improving brain energy metabolism, 3) the reported abnormality in
      brain energy metabolism in MDD subjects, and 4) plausible association between depression and
      inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in
      MDD patients as well as normalize a deficit in brain energy metabolism and that improvement
      of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.

      In this study, we plan to conduct an randomized, double-blind, placebo-controlled
      augmentation study with creatine in addition to escitalopram. We will assess the efficacy and
      safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and
      inflammatory mediators.
    


Intervention name(s): Creatine monohydrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In addition to 10-20mg escitalopram, the subjects will be given total 3 gram of creatine (500mg/capsule) a day in first week and then, 5 gram a day in the rest of the weeks.; In addition to 10-20mg escitalopram, the subjects will be given total 6 capsules of placebo (equal quantities to those of creatine group) a day in first week and then, 10 capsules a day in the rest of the weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Creatine; Augmentation; Major Depressive Disorder; Efficacy; Brain Energy Metabolism
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the efficacy and safety of a single oral dose of
      two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that
      naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than
      either single ingredient alone in subjects with post-surgical dental pain and phase advanced
      sleep.
    


Intervention name(s): Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111); Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111); Naproxen sodium 440 mg (BAYH6689); DPH 50 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose; Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose; Participants received two Naproxen sodium 220 mg tablets orally, single dose; Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Naproxen sodium; Diphenhydramine
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose
      study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196
      in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses
      of VIA-3196 or matching placebo.
    


Intervention name(s): Placebo; VIA-3196
Intervention type(s): Drug; Drug
Intervention description(s): Oral, matching number of placebo capsule(s) with active arm; Oral, capsule(s)
Other intervention name(s): VIA-3196, Resmetirom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development of Pharmacokinetics Model in Pregnancy Women and Fetus
Condition: Preterm Labor; Preterm Premature Rupture of Membrane (PPROM)
MeSH terms: Premature Birth; Obstetric Labor, Premature; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and
      fetus
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        preterm labor, PPROM in pregnant women from tertiary university hospital
Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the effect of food
      on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in
      a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three
      different dosing conditions in healthy subjects.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): For oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects
Condition: Alzheimer Disease; Huntington Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed to confirm, in healthy subjects, the lack of a clinically
      important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial
      dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a
      sensitive P-gp substrate recommended by FDA.
    


Intervention name(s): digoxin; digoxin; dimebon
Intervention type(s): Drug; Drug; Drug
Intervention description(s): digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.; digoxin once daily (0.125 mg QD) for 14 days.; Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: digoxin dimebon drug-drug interaction study