bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Condition: Iron Deficiency Anemia; Iron Deficiency Anaemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Iron isomaltoside/ferric derisomaltose
Intervention description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion.
Intervention MeSH terms: Iron isomaltoside 1000
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency Anemia; Iron Deficiency Anaemia; IDA; Intravenous iron replacement therapy; Chronic Kidney Disease; CKD; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Summary:

      Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose
      re-dosing, in subjects who were previously treated with iron isomaltoside/ferric
      derisomaltose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed one of the lead-in trials

          2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in
             trials.

          3. Haemoglobin (Hb) of ≤ 11 g/dL

          4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin
             saturation (TSAT) ≤ 30 %

          5. Willingness to participate and signing the informed consent form (ICF)

        Exclusion Criteria:

          1. Intravenous (IV) iron treatment between the lead-in trial and screening

          2. During 30-day period prior to screening or during the trial period; has or will be
             treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy

          3. Received an investigational drug within 30 days of screening

          4. Decompensated liver cirrhosis or active hepatitis

          5. Pregnant or nursing women.

          6. Any other laboratory abnormality, medical condition, or psychiatric disorders which,
             in the opinion of the Investigator, will put the subject's disease management at risk
             or may result in the subject being unable to comply with the trial requirements
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Intervention: Retzius sparing radical prostatectomy; Vattikuti Urology Institute radical prostatectomy; da Vinci Surgical System
Intervention description: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique; Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique; The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prostate cancer; Urinary continence; robotic assisted radical prostatectomy; Vattikuti Urology Institute (VIP) radical prostatectomy; Retzius sparing radical prostatectomy

Summary:

      To assess and compare the short-term post-operative continence recovery rate in two cohorts
      of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo
      RARP with Vattikuti Institute technique or Retzius sparing technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical
             prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as
             the primary treatment modality

          -  Be able to read and speak English and be able to provide written informed consent

        Exclusion Criteria:

          -  patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a
             pre-operative prostate specific antigen value ≥20 ng/ml.

          -  evidence of clinical nodal involvement (cN1) or metastatic disease (M1)

          -  patients participating in a competing study

          -  patients with pre-operative urinary incontinence.
Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Condition: Glabellar Frown Lines (GL); Lateral Canthal Lines (LCL)
Intervention: botulinum toxin neuromodulator; Placebo
Intervention description: QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL; Placebo will be injected into either the LCL, GL, or both the LCL and GL
Intervention MeSH terms: Botulinum Toxins; Neurotransmitter Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for
      the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe LCL at maximum smile as assessed by the Investigator.

          3. Moderate to severe LCL at maximum smile as assessed by the subject.

          4. Moderate to severe GL at maximum frown as assessed by the Investigator.

          5. Moderate to severe GL at maximum frown as assessed by the subject

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP).
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Nivolumab; Ipilimumab; Pemetrexed; Cisplatin; Carboplatin
Intervention MeSH terms: Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 605.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness and tolerability of the combination of
      Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with
      unresectable pleural mesothelioma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females at least 18 years of age

          -  Histologically confirmed pleural malignant mesothelioma not eligible for curative
             surgery

          -  ECOG Performance status of 0 or 1

          -  Available tumor sample for testing

          -  Acceptable blood work

        Exclusion Criteria:

          -  Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas

          -  Prior chemotherapy for pleural mesothelioma

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody

          -  History of other malignancy unless the subject has been disease-free for at least 3
             years

          -  Active, untreated central nervous system (CNS) metastasis

        Other protocol defined inclusion/exclusion criteria could apply
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Condition: Parenteral Nutrition Associated Cholestasis
MeSH terms: Cholestasis
Intervention: intravenous lipid
Intervention description: intravenous given daily for 6 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.
Enrollment: 40.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No

Summary:

      The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in
      late preterm and term neonates with major GI surgical disorders
    

Eligibility criteria:

        Inclusion Criteria:

        All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis,
        omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal
        atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI
        perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible
        for this study

        Exclusion Criteria:

          1. If does not need TPN by 72 hours;

          2. Direct hyperbilirubinemia within the first 72 hours after birth;

          3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);

          4. Biliary tract disorders leading to direct hyperbilirubinemia;

          5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such
             as Galactosemia, α-1 antitrypsin deficiency, etc
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis; Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21; Sevelamer hydrochloride
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis
      patients with hyperphosphatemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 20 or older, regardless of gender.

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Patients not having changed their phosphate binder agent dose, for 4 weeks or more
             before their observation period start.

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.
Preoperative Alpha Blockade for Pheochromocytoma
Condition: Pheochromocytoma; Paraganglioma
MeSH terms: Pheochromocytoma; Paraganglioma
Intervention: Phenoxybenzamine; Doxazosin
Intervention description: Non-selective alpha blocker; Selective alpha blocker
Intervention MeSH terms: Doxazosin; Phenoxybenzamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires
      preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby
      reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a
      non-selective alpha blocker that is significantly more expensive and is associated with
      increased adverse effects in comparison with selective alpha blockers such as doxazosin.
      Retrospective studies show minimal differences in hemodynamic instability and no differences
      in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.
      This study is a randomized controlled trial that will compare hemodynamic instability,
      morbidity, mortality, cost, and quality of life between patients blocked with
      phenoxybenzamine vs. doxazosin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with pheochromocytoma / paraganglioma undergoing surgical resection

        Exclusion Criteria:

          -  Children < 18 years
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
Condition: HIV-1 Infection
Intervention: E/C/F/TAF; E/C/F/TDF; ATV; RTV; FTC/TDF; B/F/TAF
Intervention description: 150/150/200/10 mg FDC tablet administered orally once daily with food; 150/150/200/300 mg FDC administered orally once daily with food; ATV 300 mg capsules administered orally once daily with food; RTV 100 mg tablets administered orally once daily with food; 200/300 mg tablet administered orally once daily with food; 50/200/25 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 472.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose
      combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir
      alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
      (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil
      fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
    

Eligibility criteria:

        Key Inclusion Criteria

        Medically stable HIV-1 infected women who meet the following criteria:

          -  Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE
             visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or
             any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the
             Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104
             or GS-US-292-0111.

          -  Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or
             ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit

          -  Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the
             Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA

             ≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed

          -  HIV-1 RNA <50 copies/mL at screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to
             the Cockcroft-Gault formula at the Screening visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DSXS; Placebo
Intervention description: Active treatment; Placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to
      Severe Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

        - male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of
        moderate to severe atopic dermatitis (AD)

        Exclusion Criteria:

        - Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic
        dermatitis.
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: lanreotide (Autogel formulation); Pegvisomant
Intervention description: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.; Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
Intervention MeSH terms: Lanreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main aim of this study is to assess the efficacy of the co-administration of lanreotide
      Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant
      (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a
      week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the
      percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the
      end of the co-treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must have had documentation supporting the diagnosis of acromegaly,
             including elevated GH and/or IGF-1 levels

          -  The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN
             when treated with somatostatin analogue, on a daily basis for at least 3 months and
             has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of
             normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated
             with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at
             the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the
             last injection

          -  At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN,
             or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L
             (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR
             the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the
             3rd injection of lanreotide Autogel 120 mg

        Exclusion Criteria:

          -  The patient has undergone pituitary surgery or radiotherapy within 6 months prior to
             study entry, or it is anticipated that it will be done during the study

          -  The patient has already been treated with a somatostatin analogue associated with a GH
             antagonist

          -  The patient has received dopamine agonist within 6 weeks prior to the study entry

          -  The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT,
             alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)

          -  The patient is at risk of pregnancy or is lactating
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Condition: Heart Failure; Respiratory Insufficiency; Stroke Acute; Infectious Diseases; Rheumatic Diseases
MeSH terms: Communicable Diseases; Infections; Rheumatic Diseases; Respiratory Insufficiency; Heart Failure; Collagen Diseases
Intervention: Rivaroxaban, 10 mg; Rivaroxaban, 7.5 mg; Placebo
Intervention description: Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.; Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from >=30 to less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.; All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 12024.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Heart Failure; Respiratory Insufficiency; Stroke Acute; Infectious Diseases; Rheumatic Diseases; Medically ill Patient; Rivaroxaban; Thromboembolism; Prophylactic Anti-Coagulation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with
      placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related
      death post-hospital discharge in high-risk, medically ill patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The duration of the index hospitalization must have been at least 3 and no more than
             10 consecutive days

          -  Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE
             Risk Score of: greater than or equal 4, or 3 with D-dimer > 2* upper limit of normal
             (ULN), or 2 with D-dimer > 2*ULN

        Key Exclusion Criteria:

          -  Any serious bleeding within 3 months prior to randomization or occurring during index
             hospitalization

          -  Serious trauma (including head trauma) within 4 weeks before randomization

          -  History of hemorrhagic stroke at any time in the past

          -  Any medical condition that requires chronic use of any parenteral or oral
             anticoagulation