bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Condition: In Vitro Fertilization
Intervention: Progesterone; Progesterone
Intervention description: 25 mg, s.c., once à day; 90 mg, vaginally, once à day
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 683.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Luteal Phase Support in IVF patients

Summary:

      Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of
      luteal support (S.C.) to an approved comparator (vaginal gel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18- 42 (upon starting COH);

          -  BMI <30 kg/m2;

          -  <3 prior ART cycles (IVF, ICSI and related procedures);

          -  Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;

          -  Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
             hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);

          -  At least 3 retrieved oocytes;

          -  Patient has given written informed consent.

        Exclusion Criteria:

          -  Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;

          -  Stage III or IV endometriosis (endometriomas);

          -  Hydrosalpinx;

          -  History of past poor response to COH resulting in canceling ART;

          -  Use of thawed/donated oocytes;

          -  Use of thawed/donated embryos;

          -  Patients affected by pathologies associated with any contraindication of being
             pregnant;

          -  Hypersensitivity to study medication;

          -  Uncontrolled adrenal or thyroid dysfunction;

          -  Undiagnosed vaginal bleeding;

          -  History of arterial disease;

          -  Patients with hepatic impairment;

          -  Neoplasias (current) or history of neoplasia that may be responsive to progesterone;

          -  High grade cervical dysplasia;

          -  Active thrombophlebitis or thromboembolic disorders, or a history of
             hormone-associated thrombophlebitis or thromboembolic disorders;

          -  History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
             wherein pregnancy developed to a minimum of a gestational sac on TVUS;

          -  Participation in a concurrent clinical trial or another trial within the past 2
             months;

          -  Use of concomitant medications that might interfere with the study evaluation;

          -  Pre-implantation genetic diagnosis/screening.
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Mycophenolate mofetil (MMF); Cyclophosphamide; Azathioprine; Placebo to Azathioprine; Placebo to Mycophenolate mofetil; Corticosteroid
Intervention description: Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.; Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
Dosing was started at 0.75 g/m^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m^2. The target dose was 1.0 g/m^2, but doses were titrated by 0.25 g/m^2 increments to maintain nadir leukocyte count between 2500-4000/mm^3.; 2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.; Placebo capsules matching Azathioprine taken orally once a day.; Placebo tablets matching Mycophenolate mofetil taken orally twice daily.; Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Azathioprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 370.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to
      cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term
      efficacy of MMF compared to azathioprine in maintaining remission and renal function.
      Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide
      (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for
      response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g
      bid) or azathioprine (2 mg/kg/day).
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients, 12-75 years of age;

          -  diagnosis of systemic lupus erythematosus;

          -  kidney biopsy within 6 months of study, with histological diagnosis of lupus
             nephritis;

          -  laboratory evidence of active nephritis.

        Exclusion Criteria:

          -  continuous dialysis starting >2 weeks before randomization into induction phase,
             and/or with an anticipated duration of >8 weeks;

          -  previous or planned kidney transplant;

          -  other clinically significant active medical conditions.
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab
Intervention description: Subjects will receive bimekizumab at pre-specified time-points.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis; Auto-Injector

Summary:

      The purpose of the study is to evaluate the ability of subjects with moderate to severe
      chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study
      start and 8 weeks after training in self-injection technique using a prefilled safety syringe
      or an auto-injector.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study

          -  Subject is considered reliable and capable of adhering to the DV0002 protocol (eg,
             able to understand and complete questionnaires, willing to self-inject, able to use
             investigational device according to the instructions for use (IFU), and able to adhere
             to the visit schedule) according to the judgment of the Investigator

        Exclusion Criteria:

          -  Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790]
             study exclusion criteria are met
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.; Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of the trial is to
      confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in
      controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Current treatment with once daily insulin glargine in vials with a daily dose equal to
             or above 65 U and equal to or below 100 U

          -  Current treatment with a stable dose of metformin plus/minus one additional oral
             antidiabetic drug (OAD) for at least 12 weeks

          -  Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

        Exclusion Criteria:

          -  Current treatment with insulin other than insulin glargine in vials

          -  Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists
             within 12 weeks

          -  Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary
             arterial bypass graft or angioplasty

          -  Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
Condition: Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: 125 µg Ocriplasmin; Placebo
Intervention description: 125µg ocriplasmin intravitreal injection; Placebo intravitreal injection
Intervention MeSH terms: Plasminogen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate the safety and efficacy of intravitreal
      microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm
             Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior
             vitreous cortex) that in the opinion of the Investigator is related to decreased
             visual function (such as metamorphopsia, decreased visual acuity, or other visual
             complaint)

        Exclusion Criteria:

          -  Any evidence of proliferative retinopathy (including Proliferative Diabetic
             Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular
             proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein
             occlusion in the study eye.

          -  Subjects with any vitreous hemorrhage or any other vitreous opacification which
             precludes either of the following: visualization of the posterior pole by visual
             inspection OR adequate assessment of the macula by either OCT and/or fluorescein
             angiogram in the study eye.

          -  Subjects with macular hole diameter > 400 μm in the study eye.

          -  Aphakia in the study eye.

          -  High myopia (more than 8D) in study eye (unless prior cataract extraction or
             refractive surgery that makes refraction assessment unreliable for myopia severity
             approximation, in which case axial length >28 mm is an exclusion).
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Imatinib mesylate; Imatinib mesylate; Imatinib mesylate
Intervention description: 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops; 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops; 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GIST; Gastrointestinal stromal tumors; Exon 9; Gleevec; Imatinib blood levels

Summary:

      The purpose of this study is to determine if escalating the dose of imatinib to keep the drug
      blood level at ≥ 1100 ng/ml leads to better outcomes for patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Unresectable and/or metastatic GIST

          -  Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to
             registration, and for no more than 6 months prior to registration. This must be the
             first time that the patient has been treated for metastatic and/or unresectable GIST

          -  For patients who received imatinib following surgery at the time of an initial
             diagnosis of GIST, there must be a 6 month interval between completion of imatinib and
             the diagnosis of metastatic GIST

          -  Good physical functioning (ECOG Performance Status of 0 or 1)

          -  Generally, good function of organ such as liver and kidneys

        Exclusion Criteria:

          -  Disease progression during adjuvant therapy with imatinib (adjuvant treatment is
             treatment that is given after surgery for GIST)

          -  Known intolerance of imatinib at a dose of 400 mg/day or higher

          -  Prior systemic therapy for advanced GIST with imatinib or those who have been on
             imatinib for longer than 6 months for unresectable and/or metastatic disease

          -  Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered
             from prior surgery

          -  Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)

          -  Patients who have received wide field radiotherapy ≤ 4 weeks or limited field
             radiation for palliation < 2 weeks or who have not recovered from side effects of this
             therapy
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Condition: Cancer and Chemotherapy Related Anemia
MeSH terms: Anemia
Intervention: Injectafer; Normal Saline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III, multicenter, randomized, double-blinded, prospective study with two parallel
      treatment groups. Patients who present to the hematologist/oncologist and satisfy all
      inclusion and exclusion criteria will be eligible for participation in this 18-week study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male of female) ≥ 18 years of age able to give informed consent to the
             study.

          -  Subjects with non-myeloid malignancies

          -  Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of
             treatment remaining.

          -  Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.

          -  Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%

          -  Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of
             0-2.

          -  Life expectancy of at least 6 months.

          -  Demonstrate the ability to understand the requirements of the study, willingness to
             abide by study restrictions and to return for the required assessments.

        Exclusion Criteria:

          -  Previous participation in a ferric carboxymaltose clinical trial.

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose.

          -  Subjects with overt bleeding

          -  Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion,
             or erythropoiesis-stimulating agents).

          -  Subjects on erythropoiesis-stimulating agents.

          -  Requiring dialysis for the treatment of chronic kidney disease.

          -  Any non-viral infection.

          -  Known positive hepatitis with evidence of active disease.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Any other laboratory abnormality, medical condition or psychiatric disorders which in
             the opinion of the Investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements.

          -  Pregnant or actively trying to become pregnant (Female subjects who are of
             childbearing age must have a negative pregnancy test at screening and be practicing an
             acceptable method of birth control during the study).
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; sitagliptin; metformin; sulphonylurea
Intervention description: The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.; The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.; Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.; Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. This trial aims for comparison of
      the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue
      with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for at least 6 months before trial start

          -  Treatment with at least 1000 mg metformin per day for at least 3 months

          -  Insulin-naive (short-term insulin treatment of up to 14 days is allowed)

          -  DPP-4 (dipeptidyl peptidase-4) inhibitor naive

          -  HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis

          -  BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2

          -  Able and willing to take one subcutaneous injection every day

          -  Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements

        Exclusion Criteria:

          -  Known or suspected allergy or intolerance to any of the trial products or related
             products

          -  Severe hypertension

          -  Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues
             within 2 months prior to trial start

          -  Cardiac disease, within the last 12 months

          -  Impaired hepatic function

          -  Impaired renal function

          -  Proliferative retinopathy or macular oedema requiring acute treatment

          -  Female of childbearing potential

          -  Known or suspected abuse of alcohol, narcotics or illicit substances
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
Condition: Urinary Incontinence; Multiple Sclerosis; Neurogenic Bladder
MeSH terms: Multiple Sclerosis; Urinary Bladder, Neurogenic; Urinary Incontinence; Enuresis; Sclerosis
Intervention: OnabotulinumtoxinA; Placebo (Normal Saline)
Intervention description: OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.; Placebo (normal saline) is administered into the detrusor at Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the
      treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 3 episodes of urinary incontinence over a 3-day period

          -  History of Multiple Sclerosis (MS)

          -  Urinary incontinence not adequately controlled by anticholinergic medication

        Exclusion Criteria:

          -  Current use of intermittent catheter or indwelling catheter to manage urinary
             incontinence

          -  Previous or current botulinum toxin therapy of any serotype for any urological
             condition

          -  Previous or current botulinum toxin therapy of any serotype for any non-urological
             condition within the last 12 weeks

          -  Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral
             Sclerosis