bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      This study seeks to provide evidence of the effectiveness and obtain patient reported outcome
      (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir
      (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC)
      in a real life setting across clinical practice patient populations in Romania.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical practice patient populations with chronic infection of HCV Genotype 1 (GT1)
      
Keywords: Chronic Hepatitis C; Paritaprevir; Ombitasvir; Dasabuvir; HCV
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
Condition: Cystitis
MeSH terms: Cystitis
Study type: Interventional

Summary: 
      the aim of this trial is to demonstrate that when caring women with symptoms of acute
      cystitis without any risk of complication, general practitioner may use share decision making
      tool to help patients better understand the stakes of taking antibiotics.
    

Detailed description: 
      Each year, more than 2.000.000 patients visit their general practitioners for a acute
      cystitis. The scientific literature shows that acute cystitis without risk of complication
      cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines
      systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the
      only goal to lowering symptomatology.

      Recent studies show that some informed women would like not to take antibiotics and
      pain-killers could be as effective as antibiotics. Canadian studies assessing share decision
      making tools in patients with acute respiratory infection have shown that matching antibiotic
      treatment with the patient values lower such prescription without any impact on clinical
      outcomes .

      Investigators aim to assess a similar strategy in patients with acute cystitis. This study
      will compare a group following French guidelines versus one using a share decision making
      tool to determine if, after being informed of the benefice and risk of this treatment,
      patient still want an antibiotic. Targeting instead of systematic prescription will reduce
      antibiotic consumption.

      After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if
      they filing all study criteria and ask for authorization to add them to the study. Then
      they'll act following their group instruction, and get information (antibiotic prescription
      or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction
      scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after
      inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical
      outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained
      through National assurance database.
    

Intervention name(s): medical shared decision; Standard medical care
Intervention type(s): Procedure; Procedure
Intervention description(s): The experimental group will use the share decision making tool during consultation to adapt antibiotherapy; control group will act as usual in their practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary health care; share decision making; antibiotics; daily activities
The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      This study will test whether a single dose of Lamotrigine (300mg) exerts significant effects
      on emotional processing, cognitive ability and neural activity in healthy volunteers compared
      to placebo.
    

Detailed description: 
      Glutamate has been implicated in the aetiology of mood disorders and there is current
      interest in developing novel agents targeting this system. However, the role of glutamate in
      human emotional function is relatively unknown. Lamotrigine's pharmacological profile
      involves a blockade of voltage-gated sodium channels, leading to an inhibition in the release
      of glutamate and resulting in a general inhibitory effect on cortical neuronal function.

      The current study plans to investigate the effects of modifying glutamate on emotional
      processing, cognitive function and neural activity. For this, 36 healthy volunteers will be
      recruited to the study and randomised to receive a single dose of lamotrigine (300 mg) or
      placebo. Two hours after drug administration, the effects of emotional processing via the use
      of cognitive tasks will be assessed using fMRI. This will be followed by an emotional test
      battery that will measure aspects of cognitive function as well.
    

Intervention name(s): Lamotrigine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug Capsule; Placebo Capsule
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics
      and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.
    


Intervention name(s): BMS-866949; BMS-866949; BMS-866949; BMS-866949; BMS-866949; BMS-866949; BMS-866949; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): (Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days; (Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days; (Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days; (Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days; (Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days; (Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days; (Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days; (Matching volume) - Oral Solution, Oral, once 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics
Condition: Kidney Transplant Patients
Study type: Observational

Summary: 
      The purpose of this observational study is to analyze the extent and characteristics of drug
      interactions (focusing on azole antifungals and echinocandins) and genetic polymorphisms on
      tacrolimus blood concentrations in renal transplant recipients in order to provide a
      reference for the appropriate adjustment of tacrolimus dosing regimen to reduce the incidence
      of adverse drug reactions and rejection, and to improve the survival of transplanted kidneys.
    

Detailed description: 
      In this study, investigators investigated the effects of CYP3A5 and CYP2C19 gene
      polymorphisms on the trough concentration of tacrolimus after renal transplantation in
      recipients who were on a tacrolimus-based immunosuppressive regimen (tacrolimus + mescaline +
      glucocorticosteroid) after their first renal transplantation; investigators investigated the
      effects of antifungal drugs on the trough concentration of tacrolimus, and investigators also
      analyzed the effects of genetic factors on the drug-drug interactions between antifungal
      drugs and tacrolimus, with the aim of providing a basis of reference for the rational use of
      tacrolimus and antifungal drugs in the clinic.
    

Intervention name(s): Combined with voriconazole; Combined with caspofungin; Tacrolimus-alone treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.; Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.; Renal transplant patients treated with tacrolimus-based triple immunotherapy alone
Other intervention name(s): tacrolimus; methylprednisolone sodium succinate; mycophenolate sodium; tacrolimus; methylprednisolone sodium succinate; mycophenolate sodium; methylprednisolone sodium succinate; mycophenolate sodium
Intervention MeSH terms: Mycophenolic Acid; Voriconazole; Caspofungin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Tacrolimus; Prednisolone hemisuccinate; Prednisolone phosphate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included patients who underwent renal transplantation at our hospital between
        01.01.2015 and 04.01.2023 and were divided into the co-voriconazole group,
        co-carbophenazole group and tacrolimus alone group according to co-administration.
      
Keywords: tacrolimus; voriconazole; C0/D; CYP3A5; drug-drug interactions; caspofungin; kidney transplant
Planned Semi-Elective Lung Tx Study
Condition: Lung Transplantation
Study type: Interventional

Summary: 
      In the current practice of lung transplantation, transplants are performed on a 24/7 schedule
      with a significant amount of procedures occurring overnight in order to minimize organ
      ischemic time. However, transplantation during the day time may lead to several advantages
      related to patient safety, including the presence of rested staff performing optimally,
      larger number of in-house professionals for emergency situations, and professional
      well-being. Advances and refinements in preservation practices have evolved to show that
      extended periods of preservation can be achieved without compromising outcome. Based on this,
      it is hypothesized that the avoidance of nighttime lung transplantation through prolonged
      pulmonary preservation will lead to at least similar patient outcomes compared to the current
      practice of 24/7 transplantation. During the period of this study, overnight transplants will
      be moved to a later start time (earliest 6AM). If lungs meet criteria for direct
      transplantation, they will be preserved with cold static preservation at 10°C within a
      special refrigerator. The maximum preservation time from donor cold flush to recipient
      anesthesia start time will be 12 hours.
    


Intervention name(s): Semi-Elective Lung Transplantation
Intervention type(s): Procedure
Intervention description(s): When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Condition: Post-operative Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as
      two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen
      administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen
      administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental
      pain model following third-molar extractions.
    

Detailed description: 
      This is a single-dose, randomized, double-blind, placebo- and active- controlled,
      parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test
      ACM 1000 mg compared with two commercial products over a four-hour period after third-molar
      extractions. Subjects will undergo dental extraction of three or four third molars.
    

Intervention name(s): Test acetaminophen; Commercial acetaminophen; Commercial ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose of 2 Test acetaminophen 500 mg tablets; single dose of 2 acetaminophen 500 mg caplets; Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules; 2 placebo caplets
Other intervention name(s): Test ACM; Commercial ACM; Commercial IBU
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula
Condition: Healthy
Study type: Interventional

Summary: 
      Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in
      routine use in intensive care unit. However, jet nebulizers remain the most frequently used
      nebulizers.

      On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased
      using a vibrating-mesh nebulizer as compared to a jet nebulizer.

      Lung distribution of nebulized particles delivered through a HFNC has never been investigated
      in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers
      through a HFNC by SPECT-CT.
    


Intervention name(s): Technetium-99m - Diethylenetriaminepentaacetic acid; Aeroneb Solo; Jet Nebulizer; Single photon emission computed tomography; Spirometry
Intervention type(s): Drug; Device; Device; Other; Other
Intervention description(s): 99mTc-DTPA solution placed on the nebulizer reservoir; Imaging technique to investigate lung aerosol distribution; FEV1, FVC assessment
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Pulmonary aerosol distribution; SPECT-CT analysis; High flow nasal cannula; Vibrating-mesh nebulizer; Jet nebulizer
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a long-term follow-up study of participants who completed Kythera-sponsored trials
      of ATX-101 (06-03, 07-07, 09-15)
    

Detailed description: 
      No study medication was administered in this study.
    

Intervention name(s): Placebo; ATX-101 (1 mg/cm^2); ATX-101 (2 mg/cm^2); ATX-101 (4 mg/cm^2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple-center, nonrandomized, open label, parallel group, single dose study will be
      conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh
      Class B) hepatic impairment to evaluate the effect of hepatic impairment on the
      pharmacokinetics (PK) of TD-4208.
    


Intervention name(s): TD-4208
Intervention type(s): Drug
Intervention description(s): A single inhaled dose of TD 4208 (175 mcg)
Other intervention name(s): revefenacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment; Hepatitis; Liver Cirrhosis
Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan
      and chlorthalidone.
    


Intervention name(s): Telmisartan 80mg; Chlorthalidone 25mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Chlorthalidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Male
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand whether there is any difference in the
      amount of midazolam (including its breakdown product) in the blood when midazolam is given
      with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the
      blood when rosiglitazone is given with tasimelteon.
    


Intervention name(s): Tasimelteon; Rosiglitazone; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg daily dosing, Days 4-20; 4mg, single dose, Days 3 and 20; 10mg, single dose, Days 1 and 18
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone; Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Drug Interaction
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the
      incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary
      endpoints.
    

Detailed description: 
      The primary objective of this study is to determine the efficacy of the Trexima versus
      placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea
      at 2 hours after treatment as the primary endpoints. Another objective of this study is to
      evaluate the efficacy of Trexima when compared to the individual components (sumatriptan and
      naproxen sodium) using sustained pain-free as the endpoint. It is the intent that this study
      be sufficiently powered to detect differences that are clinically meaningful and
      statistically significant in order to meet both objectives.
    

Intervention name(s): sumatriptan; naproxen sodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: TREXIMA; MIGRAINE HEADACHES; Subjects may be enrolled if they are 18-65 years of age, have a demonstrated history of migraine headaches
Gut Permeability, Sensitivity and Symptomatology
Condition: Irritable Bowel Syndrome; Visceral Hypersensitivity
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity
Study type: Interventional

Summary: 
      To better understand the relationship between gut barrier function and the symptomatology and
      pathophysiology of irritable bowel syndrome (IBS).
    


Intervention name(s): Gastrointestinal Permeability Test; Upper Endoscopy; Rectal Barostat and Infusion of Fats
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): This test will involve ingesting a solution followed by urinalysis; Feeding tube will be placed, as well as a small balloon in the rectum.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IBS; Irritable Bowel Syndrome; Visceral Hypersensitivity; Permeability; Small Bowel; Lactulose; Mannitol
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the relative benefits of daily disposable contact
      lenses versus spectacles in young adults.
    


Intervention name(s): nelfilcon A contact lens; Spectacles
Intervention type(s): Device; Other
Intervention description(s): Commercially marketed, single vision, soft contact lens for daily disposable wear; Spectacles per current prescription
Other intervention name(s): DAILIES AQUACOMFORT PLUS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Condition: Genital Warts; Anal Cancer; Anal Intraepithelial Neoplasia
MeSH terms: Condylomata Acuminata; Anus Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV
      vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV
      efficacy findings in young women to young men based on the demonstration of similar
      immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody
      responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody
      responses in young women.
    

Detailed description: 
      Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for
      immunogenicity 1 month following completion of vaccination. All participants will be followed
      for safety for a total of 12 months.
    

Intervention name(s): 9vHPV Vaccine
Intervention type(s): Biological
Intervention description(s): 9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention