bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
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 effect of filgotinib on a mixed
      organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer
      resistance protein (BCRP), and OATP substrates using phenotypic probes.
    


Intervention name(s): Atorvastatin; Pravastatin; Rosuvastatin; Filgotinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as single dose tablet orally.; Administered as single dose tablet orally.; Administered as single dose tablet orally.; Administered as tablet orally once daily for 11 days.
Other intervention name(s): GS-6034; GLPG0634; Jyseleca
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
LeMaitre® CARDIAL Dialine II Post Market Study
Condition: Vascular Aneurysm; Vascular Occlusive Disease; Artery Injury
MeSH terms: Aneurysm
Study type: Observational

Summary: 
      This clinical study will capture clinical data specific to the performance and safety of the
      LeMaitre® CARDIAL Dialine II. It is a retrospective, monocenter, post-market safety and
      performance study. Following the new MDR regulation, this study will allow the clinical data
      of the prosthesis to be completed in order to renew its CE marking.
    

Detailed description: 
      The LeMaitre Cardial Dialine® II Vascular Prostheses (Dialine II) is a knitted PET
      (Polyethylene Terephthalate) graft manufactured with multifilament yarns and impregnated with
      bovine origin collagen to achieve a strong and dilatation resistant graft, which eliminates
      the preclotting step. The bovine collagen is then gradually resorbed by the patient. The
      Dialine II comes with black guide lines and crimped construction to facilitate implantation.

      Other design features include:

        -  Thin wall design (0.50+/-0.12mm) with excellent conformability

        -  Special impregnation process for maximum leakage resistance

        -  Water permeability < 10 ml/cm2/min

      The Dialine II is indicated for replacement or bypass procedures in aneurysmal and/or
      occlusive diseases of the abdominal aorta or peripheral arteries. The Dialine II is also
      indicated for arterial reconstruction in patients requiring systemic heparinization. The
      unique collagen impregnation results in exceptional resistance to leakage, even under
      systemic heparinization.
    

Intervention name(s): LeMaitre Cardial Dialine II
Intervention type(s): Device
Intervention description(s): Surgical treatment for the replacement or bypass with LeMaitre Cardial Dialine II
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects who have undergone surgical treatment for the replacement or bypass in
        aneurysmal and/or occlusive diseases and for arterial reconstruction in patients requiring
        systemic heparinization with LeMaitre Cardial Dialine II.
      
Keywords: Vascular prosthesis; Aneurysm; Occlusion; Arterial reconstruction
Study to Compare the Safety and Efficacy of UB-851 and Eprex®
Condition: Renal Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to
      UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure
      receiving hemodialysis.
    

Detailed description: 
      This is a 52-week, phase III trial consisting of two parts:

      Part I is designed as a double-blind, randomized, multicenter, parallel-group study to
      evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal
      anemia on hemodialysis with a treatment period of 24 weeks.

      Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to
      evaluate the long-term safety and immunogenicity of UB-851.
    

Intervention name(s): UB-851; Eprex
Intervention type(s): Biological; Biological
Intervention description(s): UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.; Eprex® is chosen as the comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Condition: Rhabdoid Tumors; INI1-negative Tumors; Synovial Sarcoma; Malignant Rhabdoid Tumor of Ovary
MeSH terms: Neoplasms; Sarcoma; Rhabdoid Tumor; Sarcoma, Synovial; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension)
      and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within
      14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days.
      Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8
      weeks while on study.

      The study has two parts: Dose Escalation and Dose Expansion.

      Dose escalation for subjects with the following relapsed/refractory malignancies:

        -  Rhabdoid tumors:

        -  Atypical teratoid rhabdoid tumor (ATRT)

        -  Malignant rhabdoid tumor (MRT)

        -  Rhabdoid tumor of kidney (RTK)

        -  Selected tumors with rhabdoid features

        -  INI1-negative tumors:

        -  Epithelioid sarcoma

        -  Epithelioid malignant peripheral nerve sheath tumor

        -  Extraskeletal myxoid chondrosarcoma

        -  Myoepithelial carcinoma

        -  Renal medullary carcinoma

        -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor
           approval)

        -  Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to
           enrollment.

      Dose Expansion at the MTD or the RP2D

        -  Cohort 1 - ATRT (closed to enrollment)

        -  Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment)

        -  Cohort 3 - INI-negative tumors:

             -  Epithelioid sarcoma

             -  Epithelioid malignant peripheral nerve sheath tumor

             -  Extraskeletal myxoid chondrosarcoma

             -  Myoepithelial carcinoma

             -  Renal medullary carcinoma

             -  Chordoma (poorly differentiated or de-differentiated)

             -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor
                approval

        -  Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with
           SS18-SSX rearrangement (closed to enrollment)
    


Intervention name(s): Tazemetostat
Intervention type(s): Drug
Intervention description(s): Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
Other intervention name(s): EPZ-6438; E7438
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal
      Healthy Subjects
    


Intervention name(s): Mucinex® ER 600 mg
Intervention type(s): Drug
Intervention description(s): Single dose of Mucinex® 600 mg ER Bi-Layer tablet
Other intervention name(s): guaifenesin
Intervention MeSH terms: Guaifenesin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
Condition: Partial Edentulism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate esthetic outcome of implant supported single crowns
      after alveolar ridge preservation with beta three calcium phosphate with collagen type I in
      aesthetic region in upper jaw.
    


Intervention name(s): preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months; no-preservation of alveolar ridge - 2 months; preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months; no-preservation of alveolar ridge - 4 months; preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months; no-preservation of alveolar ridge - 9 months
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Adenocarcinoma
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Managements for refractory proficient mismatch repair (pMMR) or microsatellite stable (MSS)
      metastatic colorectal cancer (mCRC) were still challenging and controversial. Our study
      sought to investigate the efficacy and safety of anti-PD-1 antibodies plus regorafenib in
      refractory pMMR/MSS mCRC between July 2019 and June 2021 at the Hunan Cancer Hospital.
    

Detailed description: 
      We retrospectively analyzed the efficacy and safety of 103 pMMR/MSS mCRC patients treated
      with at least one dose of anti-PD-1 antibodies plus regorafenib (80 mg once daily for 21 days
      on/7 days off 28 days as a cycle) between July 2019 and June 2021 at the Hunan Cancer
      Hospital. All patients had previously received at least second-line treatment. The patients
      were evaluated by computed tomography every 2 or 3 treatment cycles until progression or
      being lost to follow-up. The primary end point was overall survival (OS).
    

Intervention name(s): regorafenib plus anti-PD-1 antibodies
Intervention type(s): Drug
Intervention description(s): The patients were treated orally with regorafenib (80 mg once daily for 21 days on/7 days off, over a 28-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks
Other intervention name(s): programmed cell death protein 1; immune checkpoint inhibitor
Intervention MeSH terms: Immune Checkpoint Inhibitors; Antibodies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population were the patients treated with at least 1 cycle of anti-PD-1 antibodies
        plus regorafenib between July 2019 and June 2021 at the Hunan Cancer Hospital.
      
Keywords: Colorectal cancer;regorafenib;anti-PD-1 antibodies
Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV
Condition: HPV Infection; Lesion Cervix
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      Clinical Trial phase III, randomized, double-blind, placebo-controlled and parallel-group
      clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions
      caused by HPV.

      The study is divided into two parts. All patients included in the study will be randomized
      (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in
      double-blind conditions.
    

Detailed description: 
      Phase III, randomized, double-blind, placebo-controlled and parallel-group clinical trial to
      evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.

      The study is divided into two parts. All patients included in the study will be randomized
      (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in
      double-blind conditions.

      The study is divided into 2 parts, the first 100 randomized patients will receive treatment
      with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on
      alternate days for 5 months (except for menstruation days). The second part of the study,
      randomized patients from position 101 to 200, will receive treatment with an administration
      regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months
      (except the days of menstruation).

      Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit,
      V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).
    

Intervention name(s): PAPILOCARE; PLACEBO
Intervention type(s): Device; Device
Intervention description(s): Papilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa.
Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera.; The placebo consists of a carrier gel with the absence of the active ingredients of Papilocare®.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone
Condition: Dental Implant; Immediate Implant
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4
      weeks. will be placed in thin buccal bone as immediate implants to determine the resorption
      compared to thick buccal bone
    

Detailed description: 
      With the increased demand for aesthetics and the expectation of immediate tooth replacement,
      improving the treatment options in case with hopeless teeth in the esthetic zone by immediate
      implants is a need by both practitioners and patients.

      Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone
      plates. However, the literature shows that less than 10% of the community have such criteria,
      making it a high risk but needed procedure.

      Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant
      placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005,
      Chen et al. 2009), but implant surface treatment and modifications might enhance the
      maintainability of the supporting structures around the dental implant due to its faster
      integration, better stimulating the vascular components at the site. This could be tested by
      the crestal and buccal bone changes, pink esthetic score and ostell readings.
    

Intervention name(s): immediate implant placement
Intervention type(s): Device
Intervention description(s): Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immediate implant; esthetic zone; buccal plate; SLActive
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  to establish the safety of subcutaneous administration of ceftriaxone at different
           concentrations, with and without HYLENEX recombinant, and to determine the maximum
           tolerated concentration;

        -  and to establish the pharmacokinetic comparability of subcutaneous administration of
           ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX
           recombinant and to IV administration.
    


Intervention name(s): SC HYLENEX and Ceftriaxone; SC Placebo and Ceftriaxone; IV Ceftriaxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes); single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes); single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other intervention name(s): HYLENEX recombinant; hyaluronoglucosaminidase; hyaluronidase; rHuPH20; saline; normal saline; 0.9% sodium chloride injection; ceftriaxone
Intervention MeSH terms: Ceftriaxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ceftriaxone; cephalosporins; pharmacokinetics; subcutaneous; hyaluronoglucosaminidase; hyaluronidase; hyaluronan; rHuPH20
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of our study is to demonstrate the interest of early administration of
      recombinant erythropoietin in trauma patients
    

Detailed description: 
      Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual
      benefice on transfusion savings after traumatic surgery?
    

Intervention name(s): recombinant erythropoietin injection; placebo injection
Intervention type(s): Other; Other
Intervention description(s): Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).; Intravenous injection 0,9% saline solution.
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors
Condition: Remineralization Effect of the Varnish on White Spot Lesions
Study type: Interventional

Summary: 
      Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white
      spot lesions in maxillary primary incisors
    

Detailed description: 
      Early childhood caries (ECC) is a very common and consequential chronic disease affecting
      young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about
      (78%) according to the last Egyptian Report, 2014.

      ECC begins with white-spot lesions, and caries can progress continuously, leading to complete
      destruction of the crown. Calcium and phosphate ions are more readily lost for children
      because lower mineralization of deciduous enamel. The disease usually develops very quickly
      and causes many childhood health problems, such as caries-related toothache and infection.

      Demineralization and remineralization are dynamic processes in caries initiation,
      progression, and reversal. Therefore, regulation of the demineralization- remineralization
      balance is a key to caries prevention and treatment. The ideal method of increasing
      remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the
      same inorganic component as the enamel.

      Fluoride varnishes have been the standard practice for the professional application of
      fluoride.

      Casien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and
      phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.
    

Intervention name(s): MI varnish
Intervention type(s): Other
Intervention description(s): CPP- ACP with 5 % sodium fluoride GC
Other intervention name(s): CPP- ACP with fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early childhood caries; Casein phosphopeptides-amorphous calcium phosphate; fluoride; remineralization potential; varnish
The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives :

        -  To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel
           on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction,
           nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent
           implantation

      Study Design : Prospective, open label, two arm, randomized multicenter trial to test the
      superiority of cilostazol group compared with the control group. Patients will be randomized
      according to the use of cilostazol

      Patient Enrollment: 960 patients enrolled at 5 centers in Korea

      Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic
      follow-up will be recommended to all patient at 6 months after index procedure.

      Primary Endpoint

        -  Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial
           infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months

      Secondary Endpoint

        -  All cause of death, stent thrombosis, and each component of primary endpoint at six
           months

        -  PRU level measured at discharge after the index procedure and after six months

      Safety Endpoint

        -  Bleeding complications according to TIMI criteria

        -  The incidence of drug discontinuation

        -  Heart rate
    

Detailed description: 
      Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was
      performed
    

Intervention name(s): cilostazol
Intervention type(s): Drug
Intervention description(s): Pletaal (Otsuka Pharm.) 100mg bid for six months
Other intervention name(s): Pletaal (Otsuka pharmaceutical)
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cilostazol; clopidogrel; statin; drug-eluting stent