bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate safety and efficacy of etanercept in patients with
      psoriasis who had an unsatisfactory response to adalimumab and infliximab.
    


Intervention name(s): etanercept 50 mg
Intervention type(s): Drug
Intervention description(s): All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis; etanercept; efficacy; response; anti-TNF alpha; treatment efficacy
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
Condition: Drug-Drug Interaction Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of
      528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of
      midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK
      profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as
      the safety of vapendavir will also be assessed.
    


Intervention name(s): Midazolam 5mg Syrup; Vapendavir 264 mg BID; Vapendavir 528 mg QD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.
On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.; Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.; Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Condition: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of
      single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with
      UC. The relative bioavailability of tofacitinib released from TD-3504 compared to
      co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
    


Intervention name(s): TD-3504; 15N2-tofacitinib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TD-3504; 15N2-tofacitinib; Placebo
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
Condition: Knee Arthroscopy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose
      mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of
      motor blockade.

      It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will
      result in adequate surgical block for knee arthroscopy surgery with faster recovery and
      discharge compared to mepivacaine alone.
    


Intervention name(s): Mepivacaine without fentanyl; Mepivacaine with Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 45 mg 1.5% mepivacaine injection for spinal anesthesia; 10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia
Intervention MeSH terms: Fentanyl; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal anesthesia; mepivacaine; fentanyl; duration of anesthesia; knee arthroscopy; regional anesthesia; Spinal anesthesia for knee arthroscopy
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an
      adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
    

Detailed description: 
      This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101)
      on both cognition and activities of daily living when added to stable donepezil treatment in
      subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment.
      This study will also provide further information on the safety and tolerability of the 35-mg
      dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil
      alone. This study is being conducted under the agreement of a Special Protocol Assessment by
      FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study
      of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's
      disease including memantine will be allowed.
    

Intervention name(s): RVT-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily, oral, 35 mg tablets; once daily, oral, pill manufactured to match RVT-101 35 mg tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; RVT-101; donepezil; intepirdine; dementia
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and
      Radiopaque IMPLANON.
    


Intervention name(s): Radiopaque Implanon; Implanon (etonogestrel implant)
Intervention type(s): Drug; Drug
Intervention description(s): Radiopaque rod for 3 years; Implanon (etonogestrel implant) for 3 years
Intervention MeSH terms: Etonogestrel; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases (Optim'Oils)
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of optimized oil (enriched with
      micronutriments) on the prevention on cardiovascular diseases.

      Randomised crossover dietary intervention study:

      The main objective of the clinical study is to investigate the effect of the consumption of
      an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the
      consumption of a "reference" oil.

      Post prandial study:

      The second objective of the clinical study is to investigate the effect of the consumption of
      an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period
      as compared with the consumption of a "reference" oil.
    

Detailed description: 
      For both studies, sedentary men between 30 and 65 years of age, with a BMI between 25 and 30,
      without cardiovascular disorders, will be selected.

      Randomised crossover dietary intervention study:

      Sixty volunteers will be randomised into 2 groups of 30. The study will last 12weeks. The
      first 3 weeks will be an adaptation period or "run in". Volunteers will have every day20 g of
      the reference rapeseed oil and 20 g of the reference oil-based rapeseed margarine.
      Subsequently, the two groups will follow 2 dietary intervention periods of 3 weeks during
      which the volunteers will have alternatively either the reference oil/margarine or the
      optimized oil/margarine. Three weeks of "wash out" will separate the two dietary
      interventions of the cross over design trial.

      Cardiovascular risk and oxidative stress biomarkers will be assessed in plasma at week 0, 3,
      6, 9 and 12.

      Volunteers will alsoperform dietary surveys at the week 3, 6, 9 and 12.

      Post prandial study:

      16 volunteers will be cast lots among the 60 volunteers. They will be randomised into 2
      groups of 8. The first kinetic study will be done on week 3. 8 subjects will take 66 g of
      reference oil and 8 subjects will take 66 g of the optimized oil. 5 blood samples (20 mL
      each) will be taken.
    

Intervention name(s): Rapeseed Oil (prevention of cardiovascular diseases)
Intervention type(s): Dietary Supplement
Intervention description(s): to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular diseases; Rapeseed oil; Micronutriments; HDL cholesterol; Oxidative stress; Tocopherols; Sterols; Prevention of cardiovascular diseases
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to fulfil regulatory requirements for registration of a new
      chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease
      (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the
      efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase
      III studies.
    


Intervention name(s): Rasagiline
Intervention type(s): Drug
Intervention description(s): 1 mg/day, tablets for 7 days, orally
Other intervention name(s): Lu 00-773; Azilect®
Intervention MeSH terms: Rasagiline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Condition: Post-cholecystectomy Gastrointestinal Spasms
MeSH terms: Muscle Cramp; Postcholecystectomy Syndrome; Spasm
Study type: Observational

Summary: 
      Prospective, multicenter, non-comparative, observational program designed to assess the
      effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID)
      and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms
    


Intervention name(s): Mebeverine
Intervention type(s): Drug
Intervention description(s): Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed
Other intervention name(s): Duspatalin
Intervention MeSH terms: Mebeverine; Alverine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Duspatalin; mebeverine; cholecystectomy; gastrointestinal spasm; abdominal pain; dyspepsia; antispasmodics
Dietary Supplements and Aging Muscle
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether older adults (ages 65-89) who consume the
      dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate
      increases in fat-free mass, muscle volume,and physical function.
    


Intervention name(s): Juven; Juven
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.; Participants in the placebo arm will be asked to consume two packets of an orange-flavored drink mix each day for a period of six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sarcopenia; Aging; Muscle; Dietary Supplement; HMB; Arginine; Glutamine
Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to estimate drug preference of stable schizophrenic patients who
      will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine
      tablets for 6 weeks and vice-versa.
    


Intervention name(s): olanzapine therapy
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PGS on Blastocysts From Vitrified and Fresh Oocytes
Condition: Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing
Study type: Observational [Patient Registry]

Summary: 
      Oocyte accumulation by vitrification is a valid strategy to increase the number of available
      embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation
      genetic testing.
    

Detailed description: 
      In the present study, the investigators considered the hypothesis to accumulate vitrified
      oocytes with a view to increasing the number of oocytes for micro-injection and consequently
      the number of blastocyst to diagnose for patients with normal ovarian reserve and candidate
      for PGT. The partecipants were proposed to undergo several cycles of ovarian stimulation. In
      the first cycles, mature (metaphase II) oocytes were vitrified and consequently accumulated.
      In the last cycle, the freshly produced mature oocytes and the previously accumulated ones
      were micro-injected together with the same partner's semen sample. PGT was performed on
      blastocysts produced from the two sources of oocytes. The comprehensive chromosomal analysis
      of biopsied trophectoderm cells was performed using NGS technology. The number of available
      euploid blastocyst and the proportion of euploid/aneuploidy embryos from fresh and
      vitrified/warmed oocytes were compared. In conclusion the investigators evaluated the
      efficacy of oocyte accumulation by vitrification in increasing the number of available
      embryos for biopsy and the number of viable euploid embryos to transfer after PGT.
    

Intervention name(s): chromosomal status of blastocysts from fresh and vitrified/warmed oocytes
Intervention type(s): Other
Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Infertile women, normal ovarian reserve, with repeated implantation failure or reccurent
        miscarriage
      
Biospecimen description: 
      DNA from trophectoderm cells
    
Keywords: aneuploidy; next generation sequencing; oocyte vitrification; preimplantation genetic diagnosis; preimplantation genetic screening
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Cevimeline 30 mg under fed conditions
    


Intervention name(s): Cevimeline
Intervention type(s): Drug
Other intervention name(s): Evoxac
Intervention MeSH terms: Cevimeline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Made-to-measure Compression Garments
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      The primary objective is to collect real-life data to evaluate the clinical performance and
      safety of innovative, made-to-measure, flat knitted, CE-marked compression garments for
      daytime treatment of leg or arm lymphedema (ISL stage I-II) in daily routine by analysing
      performance parameters and safety parameters reported during the investigation.
    

Detailed description: 
      The secondary objective is to evaluate (1) patients' quality of life QoL before and after
      having tested JOBST Confidence and (2) patient satisfaction focussing on patient reported
      outcomes of previously worn garments and JOBST® Confidence by analysing patient
      questionnaires parameters completed at the beginning and in the end of the wearing period.
    

Intervention name(s): JOBST® Confidence compression garments
Intervention type(s): Device
Intervention description(s): JOBST® Confidence (JC) compression garments will be used for daytime treatment of leg or arm lymphedema. JC compression garments exert a specific therapeutic external, physical compression level and are therefore intended to use for the management of edema. JC comprise non-invasive medical devices with no direct contact with injured skin or mucous membranes and are intended for use on intact skin only.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Observational

Summary: 
      This 6-month prospective outcomes study addresses the association between timing of infusion,
      patient activity levels, and bleeding episodes through patient-reported measurements.
    


Intervention name(s): ADVATE (Antihemophilic Factor [Recombinant]); RIXUBIS (Coagulation Factor IX [Recombinant])
Intervention type(s): Biological; Biological
Other intervention name(s): Octocog alfa
Intervention MeSH terms: Factor VIII
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll
        eligible patients in this study
      
Keywords: Factor VIII Deficiency; Factor FIX Deficiency
CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence
Condition: Adherence
Study type: Interventional

Summary: 
      The study hypothesis: in groups receiving tailored education and feedback in a style that
      matches their psychological profile, will show a higher CPAP adherence rates than groups
      receiving mismatched tailored education / feedback, and groups that receive no tailored
      education and feedback (standard of care).
    

Detailed description: 
      Three group, randomized, controlled clinical trial assessing the extent to which tailoring a
      CPAP intervention entailing education and feedback to the psychological profile of new CPAP
      users can enhance the impact of the intervention in terms of adherence-related behavior.
    

Intervention name(s): Education and feedback
Intervention type(s): Behavioral
Intervention description(s): The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.
Other intervention name(s): Education; Motivational Enhancement technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adherence
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    


Intervention name(s): TC-5214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy
Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      From the obtained results, topical Flutamide 1% gel can be a promising, effective, and safe
      alternative in treating patients with acne vulgaris with minimal side effects.
    

Detailed description: 
      Flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate
      cancer. Due to its anti-androgenic properties can be used in cases of acne, hirsutism, and
      androgenic alopecia with successful outcomes. To minimize the unnecessary systemic side
      effects associated with the oral administration of Flutamide. It has been shown that the
      topical delivery of Flutamide can allow high drug levels at the site of action, decreasing
      the systemic side effects and improving patient compliance.

      The Flutamide group received topical Flutamide 1% gel twice daily on the face for 8 weeks and
      the control group received the same gel components, without flutamide, twice daily on the
      face for 8 weeks
    

Intervention name(s): Flutamide 1% gel; topical gel without flutamide
Intervention type(s): Drug; Drug
Intervention description(s): Group A: Flutamide-treated patients: Consisted of 25 patients with acne vulgaris treated with 1% Flutamide topical gel on the face two times per day for a duration of 8 weeks.; Group B: Consisted of 25 patients with acne vulgaris treated with topical gel with the same component as the other group, except for flutamide, on the face twice per day for a duration of 8 weeks.
Intervention MeSH terms: Flutamide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment