bioihbjkbjnl/mcl2 huggingface dataset:
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients at a Dose of 4E13 vg/kg
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Valoctocogene Roxaparvovec
Intervention description: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia A; Gene Therapy; Clotting Disorders; Blood Disorder; Blood Coagulation Disorders; Inherited Blood Coagulation Disorders; Hematologic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases; Inborn; Factor VIII; Coagulants

Summary:

      This Phase III clinical study will assess the efficacy of BMN 270 defined as FVIII activity,
      during weeks 49-52 following intravenous infusion of BMN 270 and assess the impact of BMN 270
      on usage of exogenous FVIII replacement therapy and the number of bleeding episodes from week
      5 to week 52.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as
             evidenced by medical history.

          2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior
             to study entry.

          3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure
             days.

          4. No previous documented history of a detectable FVIII inhibitor of less than 0.6
             Bethesda Units (BU).

        Exclusion Criteria:

          1. Detectable pre-existing antibodies to the AAV5 capsid.

          2. Any evidence of active infection or any immunosuppressive disorder, including HIV
             infection.

          3. Significant liver dysfunction, prior liver biopsy showing significant fibrosis, liver
             cirrhosis of any etiology or history of hepatic malignancy.

          4. Evidence of any bleeding disorder not related to hemophilia A.

          5. Active Hepatitis C.

          6. Prior treatment with any vector/gene transfer agent.
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mesalamine; Placebo
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to investigate the efficacy of mesalamine for the induction of
      clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will
      receive 4 g extended release granules (sachet) once daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 75 years

          -  Mild to moderate UC

        Exclusion Criteria:

          -  Disease limited to proctitis <15 cm

          -  Short bowel syndrome

          -  Prior colon resection surgery

          -  History of severe/fulminant UC

          -  Evidence of other forms of inflammatory bowel disease

          -  Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus
             [HBV], or hepatitis C virus [HCV])

          -  Intolerant or allergic to aspirin or salicylate derivatives

          -  Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days

          -  Women who are pregnant or nursing

          -  History or known malignancy

          -  History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune
             diseases, or mental/emotional disorders, that would interfere with their participation
             in the trial
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Condition: Trauma Injury
MeSH terms: Hemorrhage
Intervention: Cryoprecipitate; Red Blood Cells; Plasma; Platelets; Whole Blood
Intervention description: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).; RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.; Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.; Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.; Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1604.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol
      to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of
      emergency department arrival).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is judged to be an adult (according to local practice, e.g. 16 years or
             older in UK) and has sustained severe traumatic injury. In the event the age is
             unknown, estimated body weight ≥50 kg.

          -  The patient is deemed by the attending clinician to have on-going active hemorrhage
             AND REQUIRES Activation of the local major hemorrhage protocol for management of
             severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood
             component

        Exclusion Criteria:

          -  The patient has been transferred from another hospital

          -  The trauma team leader deems the injuries incompatible with life

          -  More than 3 hours have elapsed from the time of injury

          -  Prisoner (as defined as someone admitted from a correctional facility)

          -  Known "Do Not Resuscitate" orders

          -  Enrolled in a concurrent ongoing interventional, randomized clinical trial

          -  Patients who wear "opt out" bracelet for study

          -  Obvious pregnancy

          -  Severely burned
Evaluation of Preoperative N1539 in Colorectal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: N1539; Placebo
Intervention description: Once Daily; Once Daily
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colorectal surgery; Pain; Analgesia; N1539; Phase 3b

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of
      preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including
      clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and
      incidence of Adverse Events (AEs) and Serious AEs (SAEs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent.

          -  Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal
             surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection
             and/or anastomosis.

          -  ASA physical status category 1, 2, or 3.

          -  Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
             or commits to the use of an acceptable form of birth control for the duration of the
             study.

          -  Have a body mass index <40 kg/m^2

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to any study treatment.

          -  Planned surgical procedure includes a resection beyond the peritoneal reflection, is
             related to an acute bout of diverticulitis, or is associated with an emergency
             procedure.

          -  Have a history of myocardial infarction within the preceding 12 months.

          -  Have, as determined by the investigator or the sponsor's medical monitor, a history or
             clinical manifestations of significant condition that would preclude participation.

          -  Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with
             exception of events related to an ulcerative colitis diagnosis.

          -  Have a known bleeding disorder which may be worsened with the administration of an
             NSAID.

          -  Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
             48 hours prior to surgery.

          -  Have previously received N1539/IV meloxicam or received any investigational product
             within 30 days before dosing with study medication.

          -  Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
             biological therapy for cancer treatment, within 60 days prior to screening through
             last follow-up.
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria Type 1 (PH1)
MeSH terms: Hyperoxaluria, Primary
Intervention: Placebo; Lumasiran
Intervention description: Placebo by SC injection; Lumasiran by SC injection
Intervention MeSH terms: Lumasiran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: PH1; Primary hyperoxaluria; RNAi therapeutic; siRNA; AGT; Oxalate

Summary:

      The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and
      adults with primary hyperoxaluria type 1 (PH1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to provide written informed consent or assent and to comply with study
             requirements

          -  Confirmation of PH1 disease

          -  Meet the 24 hour urine oxalate excretion requirements

          -  If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
             days

        Exclusion Criteria:

          -  Clinically significant health concerns (with the exception of PH1) or clinical
             evidence of extrarenal systemic oxalosis

          -  Clinically significant abnormal laboratory results

          -  Known active or evidence of HIV or hepatitis B or C infection

          -  An estimated GFR of < 30 mL/min/1.73m^2 at screening

          -  Received an investigational agent within 30 days or 5 half-lives before the first dose
             of study drug or are in follow-up of another clinical study

          -  History of kidney or liver transplant

          -  Known history of multiple drug allergies or allergic reaction to an oligonucleotide or
             GalNAc

          -  History of intolerance to subcutaneous injection

          -  Women who are pregnant, planning a pregnancy, or breast-feeding or those of child
             bearing potential and not willing to use contraception

          -  History of alcohol abuse within the last 12 months, or unable or unwilling to limit
             alcohol consumption throughout the study
Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
Condition: Gastric Cancer; Obesity
MeSH terms: Stomach Neoplasms; Obesity
Intervention: Sugammadex Sodium
Intervention description: INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.
DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the impact of muscle relaxation during laparoscopic
      gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary
      endpoint is number of harvested lymph node that is critical point regarding quality of
      surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding,
      surgeons' satisfaction.

      The patients were randomly assigned to two groups using a computer-generated randomization
      table : 196 persons

        -  Deep neuromuscular block group (98persons)

        -  Moderate neuromuscular group (98persons)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gastric cancer patients with laparoscopic subtotal gastrectomy

          -  19-75 years

          -  Body mass index(BMI) > 25kg/m2

          -  American Society of Anesthesiologists I-III

        Exclusion Criteria:

          -  American Society of Anesthesiologists Class IV

          -  End stage renal disease (ESRD) patient

          -  Patients with allergy to muscle relaxants

          -  Patients with diseases that may affect muscle relaxation
Additive Homeopathy in Cancer Patients
Condition: Malignant Tumors
MeSH terms: Neoplasms
Intervention: Additive classical homeopathy; Homeopathic Placebo globules
Intervention description: Homeopathic remedies every 2 to 3 months; Homeopathic placebo globules every 2 to 3 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; additive homeopathy; patients with advanced malignant tumors

Summary:

      The investigators aim to investigate the validity of their previous results in a randomized
      prospective, placebo-controlled, double-blind, multicenter controlled evaluation of
      questionnaires in patients with advanced malignant tumors. The investigators plan to compare
      the treatment outcome (quality of life and survival) in tumor patients, receiving standard or
      "add-on" homeopathic treatment.

      The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for
      cancer patients. In addition the investigators evaluate survival time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC)
             IIIB, IIIC, IV.

        Exclusion Criteria:

          -  sensitizing mutation of the EGFR gene or translocation of the ALK gene

          -  refusal to sign informed consent

          -  pregnancy

          -  hematological, hepatic, or renal pathology

          -  coronary heart disease

          -  history of secondary tumor

          -  major surgery within 4 weeks prior to study entry

          -  active infection and symptomatic peripheral neuropathy

          -  central nervous system metastases unless the metastases were treated and stable

          -  active autoimmune disease

          -  use of systemic immunosuppressive treatment

          -  use of systemic treatment during the previous 2 years

          -  active interstitial lung disease, or a history of pneumonitis for which
             glucocorticoids were prescribed

          -  previous systemic therapy for metastatic disease or previous irradiation

          -  use of any complementary and/or alternative therapy, including homeopathy other than
             the research treatment during the trial
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: OPC-34712; Escitalopram; Fluoxetine; Paroxetine CR; Sertraline; Duloxetine; Venlafaxine XR
Intervention description: Tablet; Tablet; Capsule; Controlled-release tablets; Tablets; Delayed-release capsules; Extended-release capsules
Intervention MeSH terms: Duloxetine Hydrochloride; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2944.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment

Summary:

      To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in
      addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major
      Depressive Disorder (MDD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female outpatients 18-65 years of age

        Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

          -  Subjects who completed participation in the Double-blind Randomization Phase (i.e.
             Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or

          -  Subjects who met criteria for a response, but did not meet criteria for remission at
             Week 14 of either trial

        Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:

        • Subjects who completed the last scheduled visit of the prior Double-blind Randomized
        Phase 3 trial.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving OPC-34712.

          -  Subjects with a major protocol violation during the course of their participation in
             the Double-blind Randomization Phase
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Macitentan
Intervention description: Macitentan tablet, dose of 10 mg, once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension (PAH); psychometric instrument; PAH-SYMPACT

Summary:

      SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,
      Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to
      psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the
      long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure.

          -  Patients with PAH who completed study AC-055-401

          -  Women of childbearing potential must:

          -  Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum
             pregnancy tests.

          -  Agree to use two methods of contraception from Visit 1 until 1 month after study drug
             discontinuation.

        Exclusion Criteria:

          -  Patients who prematurely discontinued study drug in study AC-055-401

          -  Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to
             become pregnant during the study

          -  Known hypersensitivity to macitentan or its excipients or drugs of the same class
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human-cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Healthy volunteers: No

Summary:

      The purpose of the study is to collect long-term data on the inhibitor development rate of
      Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients who completed GENA-05 in accordance with the study protocol

        Exclusion Criteria:

          1. Severe liver or kidney disease

          2. Concomitant treatment with any systemic immunosuppressive drug;

          3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of
             GENA-05 and start of GENA-15 (except emergency cases).