bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Tranexamic acid injection; Normal saline placebo
Intervention description: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section; 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.
Masking: Double (Participant, Care Provider)
Enrollment: 1226.0
Sex: Female
Healthy volunteers: No
Keywords: Postpartum hemorrhage; Tranexamic acid; Caesarean section; Prevent

Summary:

      This study seeks to determine if the using tranexamic acid prophylactically at caesarean
      section will prevent postpartum haemorrhage which is a major cause of maternal mortality in
      Zimbabwe and globally.
    

Eligibility criteria:

        Inclusion Criteria: Women undergoing elective or emergency caesarean section with:

          -  Estimated gestational age of 37 weeks or more

          -  Live intrauterine foetus

          -  Elective or emergency caesarean delivery

          -  Signed informed consent

        Exclusion Criteria:

          -  History of coagulopathies or conditions predisposing them to thromboembolic phenomena,

          -  seizure history,

          -  autoimmune disease,

          -  placental abruption,

          -  placenta praevia,

          -  abnormally adherent placentae if identified on prenatal ultrasound,

          -  eclampsia or HELLP syndrome,

          -  known hypersensitivity to TXA,

          -  planned general anaesthesia,

          -  caesarean delivery for the second twin or second/third triplet(s) after vaginal birth
             of the first twin,

          -  poor understanding of English/Shona languages,

          -  those who have received anticoagulants in the week before delivery

          -  persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19
             positive women
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Condition: Compensated Cirrhosis; Nonalcoholic Steatohepatitis
MeSH terms: Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Intervention: Obeticholic acid (10 mg); Obeticholic acid (10 mg to 25 mg); Placebo
Intervention description: Tablets administered orally once daily.; Tablets administered orally once daily.; Tablets administered orally once daily.
Intervention MeSH terms: Chenodeoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 919.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Compensated Cirrhosis; Nonalcoholic Steatohepatitis; Fatty Liver Disease; NASH

Summary:

      The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747)
      can lead to histological improvement in fibrosis with no worsening of NASH in adults with
      compensated cirrhosis due to NASH.
    

Eligibility criteria:

        Key inclusion criteria:

        1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
        NASH CRN scoring system determined by central reading

        Key exclusion criteria:

          1. Current or past history of a clinically evident hepatic decompensation event, such as
             ascites, hepatic encephalopathy (HE), or variceal bleeding

          2. Current or past history of CP score ≥7 points

          3. Model for End-stage Liver Disease (MELD) score > 12

          4. ALT ≥ 5 X ULN

          5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method

          6. Hemoglobin A1c (HbA1c) ≥ 9.5 %

          7. Evidence of other known forms of chronic liver disease such as alcoholic liver
             disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
             iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
             suspected hepatocellular carcinoma (HCC)

          8. History of liver transplant, or current placement on a liver transplant list
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Intervention: Pegylated-Interferon-lambda; Ribavirin; Daclatasvir
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective for this study is to evaluate the proportion of subjects who achieve
      SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects
      with Genotype(GT)-1b, -4 and GT-2, -3
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Severe hemophilia (defined as < 1% factor activity level)

          -  Infection with the hepatitis C virus (HCV) with underlying hemophilia

          -  Males 18 years of age and above

          -  Have not been previously treated with an interferon

        Exclusion Criteria:

          -  Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Chronic liver disease caused by any disease other than chronic HCV infection

          -  Presence of Bethesda inhibitor

          -  Current evidence of or history of portal hypertension
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543 matching placebo; CTP-543
Intervention description: Administered as tablets.; Administered as tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alopecia; Hair loss; Hair disease; CTP-543

Summary:

      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Willing to comply with the study visits and requirements of the study protocol.

        Exclusion Criteria:

          -  Treatment with other medications or agents within 1 month of Baseline or during the
             study that may affect hair regrowth or immune response.

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or other scalp condition that
             may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the
             body at Screening and/or Baseline.

          -  Treatment with systemic immunosuppressive medications within 3 months of Screening or
             during the study, or biologics within 6 months of Screening or during the study.

          -  Females who are nursing, pregnant, or planning to become pregnant while in the study,
             and for 30 days after last dose of study drug.

          -  Clinically significant medical condition, psychiatric disease, or social condition, as
             determined by the Investigator, that may unfavorably alter the risk-benefit of study
             participation, adversely affect study compliance, or confound interpretation of study
             results.
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA; Placebo (matched to ELX/TEZ/IVA); Placebo (matched to IVA)
Intervention description: Fixed-dose combination tablet for oral administration qd in the morning.; Tablet for oral administration qd in the evening.; Placebo matched to ELX/TEZ/IVA for oral administration once daily (qd) in the morning.; Placebo matched to IVA for oral administration qd in the evening.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) /
      ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic
      fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF
      genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for the F508del mutation (F/MF)

          -  Forced expiratory volume in 1 second (FEV1) value greater than equal to(≥) 70%

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX; SOF/VEL
Intervention description: 400/100/100 mg tablet administered orally once daily with food; 400/100 mg tablet administered orally once daily with or without food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 943.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection

Summary:

      The primary objectives of this study are to compare the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC)
      for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive
      participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory parameters outside the acceptable range at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole 2%
Intervention description: Crisaborole 2% ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 7 Months
Healthy volunteers: No
Keywords: Eczema; Crisaborole

Summary:

      This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies
      C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate
      Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants;

          -  Who were patients with mild to moderate AD aged 2 years old or older and met
             eligibility criteria for study C3291032 at the time when entering Study C3291032, and
             completed treatment period in Study C3291032 without safety issues. Or

          -  Who were patients with mild to moderate AD aged 1 months to <24 months and met
             eligibility criteria for Study C3291031 at the time when entering Study C3291031, and
             completed treatment period in Study C3291031 without safety issues

        Exclusion Criteria:

          -  Has other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Condition: Fractures, Open
MeSH terms: Fractures, Bone; Fractures, Open
Intervention: Tobramycin; Placebo: normal saline
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate the effectiveness of local antibiotic
      versus placebo in the prevention of infections in open fractures. The study will assess
      whether local treatment of open fractures with the antibiotic tobramycin (in addition to
      standard systemic antibiotics) will decrease the risk and rate of infection, and rate of
      re-operation. This will be studied using a randomized controlled clinical trial design in
      adult population of age 18-70 years who present with open fractures. About 133 subjects will
      be recruited in this study at UVA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18 - 70 years

          -  Gustilo Type I,II,IIIa open fracture (s)

          -  Ability to provide informed consent (or proxy consent in cases where subject is
             temporarily impaired when intubated and sedated)

          -  Subject should be able to follow up at the scheduled times following surgery

          -  Subjects who may have compartment syndrome, renal insufficiency, and those who are
             immunosuppressed regardless of antibiotic administration will also be included in the
             study

        Exclusion Criteria:

          -  Closed fracture

          -  Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson
             Type IIIB and C respectively)

          -  Aminoglycoside allergy

          -  Presentation greater than 48 hours after injury

          -  Pathologic fracture

          -  Preexisting infection in bone with an open fracture

          -  Patients with multiple trauma involving liver, kidney, or brain

          -  Pregnancy (self-reported)

          -  Current status as prisoner
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: NPSP558
Intervention description: All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PTH 1-84; Hypoparathyroidism; Parathyroid Hormone 1-84; NPSP558

Summary:

      This study is a long-term, open-label study using NPSP558 for the treatment of adult patients
      with Hypoparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or
             previously completed the rhPTH[1-84] REPLACE study (Visit 18).

          -  Able to perform daily SC self-injections of study medication (or have a designee
             perform injection).

          -  Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing
             potential with a negative pregnancy test and who consent to use two acceptable methods
             of contraception for the duration of the study.

          -  Males who have female partners of childbearing potential must use two acceptable forms
             of contraception for the duration of the study.

          -  Serum creatinine <1.5 mg/dL at enrollment.

          -  Total serum calcium less than or equal to upper limit of normal (ULN) based on local
             laboratory result prior to enrollment.

          -  Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within
             approximately 16 weeks prior to enrollment.

        Exclusion Criteria:

          -  Any condition that, in the investigator's opinion after consultation with the sponsor,
             would preclude the safe use of parathyroid hormone (PTH).

          -  Pregnant or lactating women.

          -  Any disease or condition which has a high probability of precluding the subject from
             completing the study or where the subject cannot or will not appropriately comply with
             study requirements.
Efficacy and Safety of RTH258 Versus Aflibercept - Study 2
Condition: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Brolucizumab ophthalmic solution; Aflibercept ophthalmic solution
Intervention description: Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose; Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose
Intervention MeSH terms: Aflibercept; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1048.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; CNV; IVT

Summary:

      The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for
      intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2
      mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to
      age-related macular degeneration (AMD) in the study eye.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written informed consent;

          -  Active CNV lesions secondary to AMD that affected the central subfield in the study
             eye at Screening;

          -  Total area of CNV > 50% of the total lesion area in the study eye at Screening;

          -  Intraretinal and/or subretinal fluid affecting the central subfield of the study eye
             at Screening;

          -  Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study
             eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS)
             testing.

        Key Exclusion Criteria:

          -  Any active intraocular or periocular infection or active intraocular inflammation in
             either eye at Baseline;

          -  Central subfield of the study eye affected by fibrosis or geographic atrophy or total
             area of fibrosis ≥ 50% of the total lesion in the study eye at Screening;

          -  Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the
             study eye at Screening;

          -  Any approved or investigational treatment for neovascular age-related macular
             degeneration (nAMD) in the study eye at any time;

          -  Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or
             current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within
             4 weeks prior to Baseline;

          -  Pregnant or nursing women; women of child-bearing potential;

          -  Stroke or myocardial infarction in the 6-month period prior to Baseline.