bioihbjkbjnl/mcl2 huggingface dataset:
Prolactin Hormone in Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Observational

Summary: 
      Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune
      etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally
      occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone
      that has a role in autoimmune related diseases like systemic lupus erythematosus and ,
      rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of
      this study is to investigate the expression of PRL receptors in tissue biopsies of OLP
      patients.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Egyptian patients with OLP
Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to generate additional data on the immunogenicity and safety of
      revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

      Primary Objective:

        -  To evaluate and describe the safety profile of revaccination with Fluzone ID for all
           participants.

      Secondary Objective:

        -  To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
    

Detailed description: 
      All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT
      00772109), will receive one dose of either the same or the alternative vaccine.
    

Intervention name(s): Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.1 mL, Intradermal; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.1 mL, Intradermal
Other intervention name(s): Fluzone® 2009/2010 Northern Hemisphere Formulation; Fluzone® 2009/2010 Northern Hemisphere Formulation
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Fluzone Vaccine; Intradermal Injections; Adults
The Impact of the COVID-19 Pandemic on Testicular Cancer
Condition: Testicular Cancer; COVID-19
MeSH terms: COVID-19; Testicular Neoplasms
Study type: Observational

Summary: 
      In this study, investigators aim to reveal how the COVID-19 pandemic process affects
      testicular cancer presentations, tumor stages, the time elapsed between diagnosis and
      intervention, tumor recurrence and progression, which are oncological outcomes.
    

Detailed description: 
      The rapid spread of the 2019 coronavirus disease (COVID-19) caused by a novel betacoronavirus
      known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has had dramatic
      effects on individuals and health systems around the world. Beyond those infected with
      SARS-CoV-2,the intense demand for limited health system resources has led to reduced
      capacity, rapid depletion of healthcare systems and hospitals becoming a source of virus
      transmission.

      Urology associations and reference centers have issued recommendations to inform urology care
      during the COVID-19 outbreak. It is essential that urologists give priority to patient
      safety. Potential delays in the diagnosis and treatment of urological conditions and the
      additional burden on healthcare resources must be balanced against the risks of exposure to
      COVID-19. While this situation aims to conserve healthcare resources, it has created the risk
      of delaying cancer treatment. As a result, the transformation of health services and the
      increasing interest of the public in avoiding exposure to the disease has led to a decrease
      in the number of hospital admissions.

      The effects of the pandemic on patients with testicular cancer due to a decrease in emergency
      room and urology clinic admissions are not clear. During theCOVID-19 outbreak, the EAU
      (European Association of Urology) panel of testicular cancer published an evidence-based
      guideline. According to this guideline, four priority groups were formed and a certain period
      of delaying treatment was defined for patients in each group according to their priorities.
    

Intervention name(s): COVID-19 pandemic
Intervention type(s): Behavioral
Intervention description(s): Patients diagnosed with testicular cancer in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with testicular cancer in the urology clinic
      
Keywords: Testicular Cancer; COVID-19; Radical Orchiectomy
Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the
      "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)
    

Detailed description: 
      The aim of this study is to develop and validate a French self-questionnaire to diagnose
      parkinsonian primary : the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ). It
      will allow clinicians to distinguish this pain from the other pain of the parkinsonian
      patient (whether or not related to Parkinson's disease).

      The development and validation of the 3PDQ self-questionnaire will take place in 3 sequential
      steps:

        1. design of the self-questionnaire

        2. appearance validity study

        3. validation of the self-questionnaire

      Participants :

      Appearance validity study: 40 painful parkinsonian patients Validation study: 200 painful
      parkinsonian patients (10 patients per item)

      Duration of the study :

      Duration of the inclusion period:

        -  Appearance validity study : 6 months

        -  Validity study : 20 months

      Duration of participation for each patient:

        -  Appearance validity study : about 30 min

        -  Validity study : 3 days maximum Total duration of the study: (with results analysis): 3
           years
    

Intervention name(s): Self-questionnaire 3PDQ
Intervention type(s): Diagnostic Test
Intervention description(s): Visit 1 : - The patient will have to complete the 3PDQ self-questionnaire. - The investigator will conduct an interrogation and a neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.
Visit 2 : - The patient will have to complete the 3PDQ self-questionnaire.
- An investigator, obligatorily different from the investigator of the visit 1, will conduct to the same interrogation and the same neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.
Visits 1 and 2 can be made on the same day. In this case the patient will fill the 3PDQ self questionnaire only once.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinson Disease; Parkinsonian central pain; Diagnosis; Primary Parkinsonian Pain Diagnostic Questionnaire
Protect and Improve Cluster of Differentiation 4 (CD4) Cells and B Cells Lymphocytes
Condition: HIV-1-infection; AIDS
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a plant-based medication used to increase the amount, protect, and reduce HIV's
      impact on T and B lymphocytes.
    

Detailed description: 
      Dioscorea cirrhosa, impatiens balsamina, eclipta prostrata, phyllanthus urinaria, adenosma
      glutinosum, and ascorbic acid are used to elevate T and B lymphocytes level, protect their
      cells membrane, decrease the damage of HIV on CD4+ T.

      In detail, Diosgenin presented in dioscorea cirrhosa is a precursor of cortisol. Dioscorea
      cirrhosa when combined with ascorbic acid helps to balance cortisol levels which reduces cell
      inflammation. Flavonoids of dioscorea cirrhosa also help to increase CD4+ T levels.

      impatiens balsamina can be used as an antitoxin alternative against bacteria or viruses.
      Flavonoids in impatiens balsamina, such as kaempferol, quercetin, rutin, astragalin, have the
      ability to reduce the virus's impact on T lymphocyte, protect their cell membrane, produce
      antihistamine, protect the cell from inflammation.

      Targeted flavonoids in eclipta prostrata, phyllanthus urinaria, adenosma glutinosum are used
      to cell repair, protect and increase CD4+ T production.

      Ascorbic acid in combination with herbal extracts creates a favorable environment for body
      metabolism, improves the medication's effectiveness.
    

Intervention name(s): Ahah Drug; Ahah Placebo
Intervention type(s): Drug; Device
Intervention description(s): - Composition Ahah containing concentrated extracts of plants: Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg
-Take 1tablet x 2 times / 24 hours. Maintained for 9 months.; - Composition Ahah (not containing concentrated extracts of plants): Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg)
-Take 1tablet x 2 times / 24 hours. Maintained for 9 months.
Other intervention name(s): Ahah; Ahah
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 people were recruited HIV / AIDS positive between the ages of 20 and 60 and divided into 2 groups according to a random distribution.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy, adult Japanese women will characterize the PK, safety and tolerability
      of retosiban at the therapeutic doses planned to be evaluated in Phase 3. The PK data will be
      compared to a sub-set of Caucasian women given the same dose of retosiban. This study has two
      cohorts, cohort 1 will be a double-blind sponsor-open (subjects and investigator blinded and
      sponsor unblinded), randomized, continuous 48 hours (h) infusion study in healthy, adult
      Japanese women of child-bearing potential. Cohort 2 is an open label and continuous retosiban
      48 h infusion study in Caucasian, adult, healthy women of child bearing potential. So, the PK
      can be compared with those of Japanese women. Approximately 32 subjects will be enrolled. In
      cohort 1, approximately 24 subjects will be enrolled and randomized to retosiban and placebo
      (2:1 ratio) to have 18 women with 12 active, 6 placebo completed subjects. In Cohort 2, 8
      subjects will be enrolled to have 6 competed subjects. The total duration of a subject's
      involvement in this part is anticipated to be up to 6 weeks (including the 28 day screening
      period).
    


Intervention name(s): Retosiban solution for Infusion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Retosiban will be supplied as clear, colorless IV solution for infusion in 5 mL vial with a unit dose strength of 15 milligrams per milliliter (mg/mL) (each 5 mL vial contains 75 mg retosiban), dosed at up to 300 mg over 48 h infusion; Placebo will be supplied as a clear, colorless IV solution for infusion with a unit dose strength of 0.9% sodium chloride (NaCl) normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Preterm labor; Retosiban; Pharmacokinetics; Safety; Infusion; GSK2847065
Out-of Pocket Payments in Patients With Lymphedema
Condition: Primary Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      Primary lymphedema is a chronic condition posing a high burden on patients. Clinical
      guidelines emphasize the role of compression therapy by prescription medical devices. Even in
      a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist
      due to the price and reimbursement setting processes. OOPP may threaten the equity of care
      and drive patients to forgo care. The investigators aim was to analyze the distributive
      effects of OOPP for primary lymphedema patients in France.

      A prospective, multicenter study will be conducted in France in 2015 on patients with primary
      lymphedema. Household ability to pay will be specified by net income and OOPP will be
      assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,
      nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory
      and voluntary health insurance reimbursements will be considered. The investigators will
      combine concentration curves and concentration indices to assess the distributive effects.
    


Intervention name(s): Out of pocket payments in patients
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients meeting the inclusion criteria will be included in each
        participating centre during the inclusion phase
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Condition: Urinary Incontinence, Urge
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of three doses of oxybutynin for the
      treatment of urge urinary incontinence.
    


Intervention name(s): oxybutynin; oxybutynin; oxybutynin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dose oxybutynin administered daily; middle dose oxybutynin administered daily; high dose oxybutynin administered daily
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urinary incontinence, urge; urinary urge incontinence; urge incontinence; over active bladder
Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      The total hip replacement, with over 120,000 cases per year in France, provides short term,
      excellent functional results and a significant improvement in quality of life, in almost all
      cases. However, observation showed that the dislocation is not a rare complication (2-4%) and
      the lifetime of the implants is limited due to aseptic loosening.

      The evaluation process used in this study will be the extent of penetration of the metal
      femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA)
      whose precision provides early results (2 3 years), long before wear and migration are
      measurable by conventional radiological means. The main objective will be to compare, 2 years
      after the intervention, the penetration of the metal femoral head in 3 types of inserts: two
      dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure
      (Sunfit®), and a fixed insert (Quartz®).

      This is a randomized controlled trial. 105 patients will be enrolled (35 in each group).
      Patients will be included in each of the two participating centers (Amiens, Caen). The
      analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will
      be made to 3 years if the analysis requires it to 2 years.

      Analysis of pictures will be centralized in Caen and performed with specific software after
      transferring images via a secure network.
    


Intervention name(s): Novae E®; Sunfit®; Quartz®
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib
      and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic
      function relative to matched, healthy controls.
    


Intervention name(s): Filgotinib
Intervention type(s): Drug
Intervention description(s): 100 mg tablet administered orally
Other intervention name(s): GS-6034; GLPG0634
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials
Condition: Healthy
Study type: Interventional

Summary: 
      To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury
      to the skin
    


Intervention name(s): Tetrix; Tetrix
Intervention type(s): Device; Device
Intervention description(s): Twice daily topical application; Twice daily topical application
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Tetrix crea; skin barrier; antigen reaction; prevention; The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major (Also Referred to as Transfusion-dependent β-Thalassemia [TDT]) and Sickle Cell Disease
Condition: Beta-Thalassemia Major; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2, open label, safety, and efficacy study of the administration of
      LentiGlobin BB305 Drug Product to participants with either transfusion dependent
      beta-thalassemia (TDT) or sickle cell disease (SCD).
    


Intervention name(s): LentiGlobin BB305 Drug Product
Intervention type(s): Drug
Intervention description(s): LentiGlobin BB305 Drug Product was administered by intravenous (IV) infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80
      mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 80-mg tablet x 1 dose taken with food.; Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Healthy volunteers
A Food Effect Study of 60mg ER Torsemide
Condition: Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability
      and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in
      healthy volunteers. The study will be conducted as a two-sequence to period crossover study
      to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER
      torsemide is a new strength and dosage form.
    

Detailed description: 
      Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short
      duration of action is a major drawback, which allows significant post-dose sodium retention,
      and as consequence, limits salt loss in patients with heart failure unless dietary salt
      intake is severely restricted. Extended Release (ER) torsemide is being developed to address
      this drawback by prolonging the duration of action to increase sodium excretion even in
      patients who consume high salt diet. Since 60mg ER torsemide is a new strength and dosage
      form, this study will test 60mg ER torsemide for a food effect in healthy volunteers who are
      either fasting or consuming a high-fat meal (fed). The primary endpoint of the study is full
      pharmacokinetics measurements after a single dose of 60mg ER torsemide. The secondary
      endpoints are 24h sodium excretion and total urinary excretion.
    

Intervention name(s): Fed- 60mg ER Torsemide; Fasting- 60mg ER Torsemide
Intervention type(s): Drug; Drug
Intervention description(s): 60mg ER Torsemide will be given after high fat, high-calorie meal; 60mg ER Torsemide will be given after overnight fasting
Other intervention name(s): High fat/high-calorie fed conditions; Fasting conditions
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 60mg ER Torsemide study in fed and fasting conditions
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-63733657 in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following
      single ascending intravenous (IV) dose administration in healthy Japanese participants.
    


Intervention name(s): JNJ-63733657; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.; Participants will receive matching placebo intravenously.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment