bioihbjkbjnl/mcl2 huggingface dataset:
Dose Confirmation Efficacy Study (V260-007)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and
      the efficacy to prevent Rotavirus Gastroenteritis.
    

Detailed description: 
      The duration of treatment is 10 months.
    

Intervention name(s): RotaTeq™, rotavirus vaccine, live, oral, pentavalent; Comparator: Placebo matching RotaTeq™
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of RotaTeq™ administered 28 to 70 days apart.; Placebo matching RotaTeq™ administered 28 to 70 days apart.
Other intervention name(s): V260
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
    

Detailed description: 
      This is a multicenter, controlled, randomized, monocular trial evaluating the safety and
      effectiveness of the Bausch & Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT®
      dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two
      treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
    

Intervention name(s): Bausch & Lomb DVisc40; Alcon VISCOAT®
Intervention type(s): Device; Device
Intervention description(s): Ophthalmic viscosurgical device; Ophthalmic viscosurgical device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Iota-Carrageenan Nasal Spray in Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on
      cold symptoms. The effect of treatment on the duration of the cold and the patients viral
      load plus cytokine level indicating the inflammatory response will be analyzed.
    


Intervention name(s): Placebo; Iota-Carrageenan
Intervention type(s): Device; Device
Intervention description(s): Nasal spray saline; Nasal spray containing 1.20 g/l Iota-Carrageenan in saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the pharmacokinetics of perampanel following single
      and multiple oral doses in Chinese healthy male and female participants.
    


Intervention name(s): Perampanel
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): E2007
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Perampanel; Pharmacokinetics; E2007; Chinese
Study of the Effects of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent Provirus
Condition: Hiv
Study type: Observational

Summary: 
      The Farnesoid X receptor (FXR) is a nuclear receptor that controls the transcription of many
      genes involved in lipid and glucose metabolism. A recent study opens the hypothesis that
      Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and
      possibly in the fight against cell invasion by foreign genomes. This hypothesis implied that
      modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus
      replication. The results of in vitro studies with Human Immunodeficiency Virus-infected cell
      lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands
      induces stimulation of virus production rapidly followed by cell death; the overall effect is
      therefore antiviral. Farnesoid X receptor ligands have also shown an effect on the
      reactivation of proviruses in cellular models of viral latency studies. This last data raises
      the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus.

      It is therefore crucial to confirm on quiescent CD4 + T lymphocytes of patients whose viral
      load is controlled by antiretroviral treatment combining several antiretrovirals the results
      obtained with the in vitro models.

      Providing proof of concept that Farnesoid X receptor agonists can reactivate latent
      proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency
      Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency
      Syndrome. The objective of the study is to confirm ex vivo the data obtained in vitro with
      cellular models and laboratory viral strains. It is therefore necessary to show that
      Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in
      quiescent CD4 + T circulating lymphocytes prepared from venous blood of HIV-positive patients
      under cART. Human Immunodeficiency Virus-positive patients will be any patients, irrespective
      of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of
      antiretrovirals, away from primary infection, when they already had a complete western blot,
      indicating an evolution of the infection without treatment and constitution of an already
      evolved reservoir. Patients will have had an undetectable viral load since initiation of
      treatment with a follow-up of at least one year and will have at least 500 CD4 + T
      lymphocytes / mm3.
    


Intervention name(s): Blood sampling
Intervention type(s): Biological
Intervention description(s): Peripheral venous blood collection of 56 mL during a sampling required by routine monitoring of human immunodeficiency virus infection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        human immunodeficiency positive patients under cART.
Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients
      will be treated with docetaxel or docetaxel-gemcitabine.

      Aim of the study is to assess the optimal dosage and safety in this setting.
    


Intervention name(s): Gemcitabine; docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure; A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
B: 80 mg/m2, IV, q 21 days until treatment failure
Other intervention name(s): LY188011; Gemzar
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer
Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
Condition: Gingival Pocket
MeSH terms: Gingival Pocket
Study type: Interventional

Summary: 
      To achieve harmony between restoration and surrounding periodontium, soft tissue management
      plays a pivotal role. Various Gingival displacement techniques show varying results in
      achieving the goals of displacement. The most preferred method of displacement by dental
      practitioners is through conventional retraction cord made up of cotton, which besides its
      advantages, poses certain drawbacks, including low tear strength, high friction, and fiber
      remnants within the sulcus.

      Polytetrafluoroethylene (PTFE) retraction cord, is a fluoropolymer, known for its high tear
      strength, low friction, and bio-compatibility.

      This study aims to determine the difference of horizontal gingival displacement between PTFE
      and conventional retraction cord.

      Participants inducted in this study will be assessed for eligibility. qualifying subjects
      will receive crown preparation for Porcelain-fused to-metal crown. subjects will then be
      randomly allocated to either of the two arms of intervention. After making a pre-displacement
      impression, Retraction cord will be applied for 3 minutes, then removed to record
      post-displacement impression.

      the difference in pre and post-displacement mean gingival sulcus width will be assessed by a
      stereomicroscope using image analysis software.
    


Intervention name(s): PTFE Retraction Cord
Intervention type(s): Device
Intervention description(s): Polytetrafluoroethylene (PTFE) Retraction cord will be gently applied in gingival sulcus with minimal pressure. The intervention will be applied for three minutes in gingival sulcus, followed by a two stage addition silicone impression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Polytetrafluoroethylene; Retraction; Soft tissue Management; Retraction cord
Cost-effectiveness of Reduction Mammaplasty
Condition: Breast,Hypertrophy; Cost-effectiveness
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and
      decrease of the functional capacity and of the self-esteem. The economical evaluations are
      destined to esteem the costs in alternative ways of attendance to the health, comparing, for
      instance, clinical strategies with surgical strategies.

      OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.
    

Detailed description: 
      1. Design: This is a primary, prospective, analytical, controlled study in humans.

        2. Settings: Data will be collected at the Plastic Surgery and Orthopedic and Traumatology
           Outpatient Clinics of the Samuel Libânio General Hospital (Hospital das Clínicas Samuel
           Libânio, HCSL), Pouso Alegre, MG, Brazil, in july/2008-december 2009.

        3. Participants: Fifty women with breast hypertrophy (25 study group and 25 control group)
           according to the Sacchini index,12 aged 18 to 59 years, were consecutively selected to
           participate in this study.

           Pregnant women, and patients who gave birth or were breastfeeding less than one year
           before the beginning of the study, as well as patients with uncontrolled systemic
           diseases, acute diseases, breast asymmetry, who had undergone breast or spine surgery,
           and who had body-mass index (BMI) lower than 18.5 kg/m2 (low body weight) or greater
           than 30 kg/m2 (obese women) were excluded from the study.

        4. Instruments: Pain intensity in the cervical, dorsal and lumbar regions of the back has
           been assessed using a visual analogue scale (VAS). also will be used SF36, HAQ 20 and
           SF-6D.
    

Intervention name(s): reduction mammaplasty
Intervention type(s): Procedure
Intervention description(s): patients submitted to reduction mammaplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Quality-Adjusted Life Years:A measurement index; Cost-Benefit Analysis:A method of comparing costs; Mammaplasty; QALY; Health-related quality of life; Cost-effectiveness; Breast
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
Condition: Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Observational

Summary: 
      Chronic kidney disease (CKD) and hypertension are two closely related common chronic diseases
      that have serious implications to human health. Hypertension is a major cause for progression
      of renal disease and a risk factor for cardiovascular disease (CVD). Control of Blood
      Pressure (BP) to target is now considered to be the main goal in the treatment of patients
      with CKD.

      In clinical practice, it is difficult for CKD patients with hypertension to achieve systolic
      BP (SBP) or diastolic BP (DBP) goal; oftentimes, calcium channel blocker (CCB) class of
      drugs, for example, nifedipine gastrointestinal therapeutic system (GITS), is used in such
      patients. Previous data have demonstrated nifedipine to be having a significant dose-response
      relationship; that is, nifedipine 60 mg provided better BP reduction than 30 mg. However,
      there are limited studies that have evaluated the efficacy and tolerability of nifedipine
      GITS 60 mg in Chinese CKD patients with hypertension. Hereby, the objective of this study was
      to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large
      cohort of CKD patients with uncontrolled hypertension.
    


Intervention name(s): Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)
Intervention type(s): Drug
Intervention description(s): Nifedipine GITS 60 mg (once per day)
Intervention MeSH terms: Nifedipine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are prescribed 60-mg nifedipine GITS (once per day) and meet the
        inclusion/exclusion criteria will be enrolled into the study.
Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered
      alone or in combination with Fostamatinib.
    

Detailed description: 
      An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the
      Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects when Administered Alone
      and in Combination with Fostamatinib 100 mg Twice Daily.
    

Intervention name(s): Fostamatinib; Rosuvastatin; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100-mg tablet; 20-mg tablet; 40-mg tablet
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fostamatinib,; simvastatin,; rosuvastatin,; Phase I,; Healthy Subjects,; Pharmacokinetics
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized study evaluating the safety and efficacy of elagolix in the management of
      moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
    

Detailed description: 
      The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of
      up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment
      Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed
      and training provided to record endometriosis-associated pain, uterine bleeding, and
      analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy
      testing will be performed monthly throughout the study. Subjects will be required to use
      nonhormonal dual contraception during the study, and will be counseled on appropriate and
      effective forms of birth control to promote pregnancy prevention.
    

Intervention name(s): placebo; Elagolix
Intervention type(s): Other; Drug
Other intervention name(s): ABT-620; elagolix sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Menstrual Pelvic Pain (NMPP); Dysmenorrhea (DYS); Elagolix; Endometriosis Associated Pain; Gonadotropin-Releasing Hormone Antagonist
Study of PBI-0451 in Healthy Subjects.
Condition: Covid19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of PBI-0451
      in healthy subjects. PBI-0451 is a new chemical entity and inhibitor of the main protease of
      coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. The study is designed
      to evaluate the safety, tolerability and pharmacokinetics of PBI-0451 after single and
      multiple ascending doses and also to explore drug-drug interaction potential of PBI-0451.
    

Detailed description: 
      Combined Three part, double blind, (sponsor open) study. Part 1: Single ascending dose study.
      Part 2: Multiple ascending dose study. Part 3: Drug-drug interaction study.
    

Intervention name(s): PBI-0451 Dose 1; PBI-0451 Dose 2; PBI-0451 Dose 3; PBI-0451 Dose 4; Ritonavir; Midazolam; Placebo; PBI-0451; PBI-0451 Dose 5
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1 of PBI-0451; Dose level 2 of PBI-0451; Dose level 3 of PBI-0451; Dose level 4 of PBI-0451; Ritonavir will be co-administered with the study drug in Treatments J and K; Midazolam will be co-administered with the study drug in Treatment L; Placebo to match; Dose level of PBI-0451 with a projected exposure; Dose level 5 of PBI-0451
Other intervention name(s): PBI-0451; PBI-0451; PBI-0451; PBI-0451; Norvir; PBi-0451
Intervention MeSH terms: Ritonavir; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to measure the concentration levels of mezigdomide in the blood of
      participants with mild, moderate, and severe hepatic impairment, and in matched healthy
      control participants with normal hepatic function.
    


Intervention name(s): Mezigdomide
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986348; CC-92480
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mezigdomide; BMS-986348; CC-92480
Phase I Study of GW642444M in Healthy Japanese Male Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose
      study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.
    


Intervention name(s): GW642444; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Long acting Beta 2 agonist; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Rivaroxaban Hypericum Trial
Condition: Drug Interaction Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, open-label, sequential treatment study to investigate the influence of the
      combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and
      pharmacodynamics of rivaroxaban in healthy volunteers.
    

Detailed description: 
      Each session (one with and one without preceding CYP induction) will start with phenotyping
      using 25 mg fexofenadine orally for P-gp phenotyping and 2 mg midazolam orally for cytochrome
      P450 (CYP) 3A4 phenotyping. After a washout period of 5 days, subjects will receive a single
      oral dose of 20 mg rivaroxaban, a dose currently approved for human use in clinical routine.
      The same procedure will be repeated after pretreatment with St. John's wort extract (Jarsin®)
      twice daily 450 mg po (dose usually used in clinical routine) for 2 weeks.
    

Intervention name(s): St Johns Wort Extract; Rivaroxaban
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg rivaroxaban after supplementation with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks.; 20 mg rivaroxaban.
Other intervention name(s): Inducer of CYP3A4 and P-gp
Intervention MeSH terms: Rivaroxaban
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Dipole Density Mapping of Typical Atrial Flutter
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional

Summary: 
      Study to determine the feasibility of the Acutus Medical System in obtaining data to create
      Dipole Density Maps of electrical activation in the right atrium in patients with typical
      atrial flutter.
    


Intervention name(s): Acutus Medical System Mapping
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic