bioihbjkbjnl/mcl2 huggingface dataset:
Lutropin Alfa in Women at Risk of Poor Response
Condition: Ovarian Stimulation
Intervention: r-FSH; r-hLH; Analogous GnRH antagonist; r-hCG; Progesterone
Intervention description: r-FSH will be administered as specified in the arm description.; r-hLH will be administered as specified in the arm description.; Analogous GnRH antagonist will be administered as specified in the arm description.; r-hCG will be administered as specified in the arm description.; Progesterone will be administered as specified in the arm description.
Intervention MeSH terms: Cetrorelix; Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Maximum age: 38 Years
Healthy volunteers: No
Keywords: Lutropin alfa; Fertilization in vitro; Intracytoplasmic sperm injection; Reproductive techniques, assisted

Summary:

      Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone
      [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at
      risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating
      Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro
      fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of
      oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who were at risk of poor response by at least one of the following
             criteria: a) <3 follicles in last cycle, or less than or equal to (</=) 2 metaphase II
             oocytes, or estradiol (E2) <600 pg/mL; b) Cancellation of previous cycle; c) Early
             follicular serum Follicle-Stimulating Hormone (FSH) >8.5 milli IU/L

          -  Participants with normal baseline luteinizing hormone and E2 levels

          -  Regular menstrual cycles of 25-35 days

          -  Presence of both ovaries and uterus able to withstand pregnancy

        Exclusion Criteria:

          -  Participants who had any clinically significant disease including known human
             immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV)
             positivity

          -  Participants with more than 3 previous assisted reproductive techniques (ART) cycles

          -  Participants with polycystic ovaries or cyst of unknown etiology; unexplained
             gynecological bleeding

          -  Participants who had any contraindication to being pregnant

          -  Active substance abuse

          -  Participants who had simultaneously participated in another clinical drug trial
68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
Condition: Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma; Stage IV Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma
Intervention: Computed Tomography; Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Laboratory Biomarker Analysis; Positron Emission Tomography
Intervention description: Undergo PET/CT; Given IV; Correlative studies; Undergo PET/CT
Intervention MeSH terms: Gastrin-Releasing Peptide; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor
      (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed
      tomography (CT) works in detecting regional nodal and distant metastases in patients with
      intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller
      tumors than the standard of care CT or magnetic resonance imaging scan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate adenocarcinoma

          -  Planned prostatectomy with lymph node dissection

          -  Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage
             [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)

          -  Able to provide written consent

          -  Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
             [ECOG]/World Health Organization [WHO] equivalent)

          -  Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to
             the 68Ga-RM2 PET

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time (approximately 30 minutes)

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AMG 827; Placebo
Intervention description: SC injection.; SC injection.
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Amgen; chronic inflammatory disease; wheezing

Summary:

      The purpose of this study is to determine if AMG 827 is effective compared to placebo as
      measured by change in Asthma Control Questionnaire (ACQ) composite scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 to 65 years of age

          -  Percent of predicted FEV1 ≥ 50% and ≤ 80%

          -  At least 12% reversibility over pre-bronchodilator FEV1

          -  Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent

          -  Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

        Exclusion Criteria:

          -  Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit

          -  History of chronic obstructive pulmonary disease or other chronic pulmonary condition
             other than asthma

          -  Any uncontrolled or clinically significant systemic disease (eg, uncontrolled
             diabetes, liver disease)
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: Pomalidomide
Intervention MeSH terms: Pomalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Soft Tissue Sarcoma; CC-4047; Pomalidomide

Summary:

      The purpose of the study is to determine the safety and efficacy of single agent CC-4047
      (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are
      refractory to prior anticancer therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be > 18 years of age

          -  Must have histologically confirmed soft tissue sarcoma

          -  Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have
             failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer
             therapy regimens

          -  Must have measurable or evaluable disease determined as per Response Evaluation
             Criteria in Solid Tumors (RECIST) criteria

          -  Must have documented disease progression (PD) determined as per RECIST criteria within
             3 months prior to study enrollment

          -  Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Prior therapy with thalidomide or lenalidomide

          -  Prior use of experimental/investigational drug therapy < 3 months prior to treatment
             initiation

          -  Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment initiation

          -  Prior radiotherapy < 3 weeks prior to treatment initiation

          -  Prior major surgery < 3 weeks prior to treatment initiation

          -  Absolute neutrophil count (ANC) < 1.5 x 109 cells/L

          -  Platelet count < 100 x 109cells/L

          -  Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and
             alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) > 3.0 x upper
             limit of normal (ULN) or > 5.0 x ULN in the presence of demonstrable liver metastases

          -  Known active central nervous system (CNS) metastases
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Condition: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Intervention: Silodosin 8 mg; Placebo; Silodosin 4 mg
Intervention description: Silodosin 8 mg daily; Placebo; Silodosin 4 mg daily
Intervention MeSH terms: Silodosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 153.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostatitis, chronic pelvic pain

Summary:

      The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with
      placebo in the treatment of subjects with moderate to severe abacterial chronic
      prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary
      objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, at least 18 years of age

          -  Has a total NIH-CPSI total score of 15

          -  Has a NIH-CPSI pain score of 8

          -  Has had pain in the pelvic region for at least 3 months prior to screening

        Exclusion Criteria:

          -  Has previously participated in a Watson study with silodosin

          -  Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain
             syndrome or is currently receiving α-blocked therapy for any condition

          -  Has experience ≥2 urinary tract infections within the previous 12 months

          -  Has any medical condition that in the opinion of the investigator precludes safe
             participation in the study

          -  Has any medical condition that could confound the efficacy evaluation

          -  Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or
             any medication in the opinion of the investigator that precludes safe participation in
             the study

          -  Is receiving any medication that in the opinion of the investigator that could
             confound the efficacy evaluation

          -  Has participated in a study involving the administration of an investigational agent
             within the past 30 days
Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD); Doxazosin 4 mg every day (QD)
Intervention description: Study group; Control group
Intervention MeSH terms: Celecoxib; Doxazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Benign prostatic hyperplasia (BPH); Lower urinary tract symptoms (LUTS); Prostatic specific antigen (PSA); Cyclooxygenase-2 (COX-2)

Summary:

      To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the
      potential predictive value of the absence of prostate cancer in the treatment of patients
      with LUTS/BPH and an elevated serum PSA level.

      Patients who meet all eligible requirements for entry into the study will be randomized into
      one of the two treatment groups for 3 months in 2:1 ratio as shown below:

        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)

        2. Doxazosin 4mg every day (QD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male adults aged ≥ 40 years with LUTS/BPH, IPSS ≥ 8

          -  Free of active urinary tract infection

          -  Free of neurogenic voiding dysfunction

          -  No history of previous prostate biopsy within 6 months

          -  No treatment of BPH by alpha-blocker or 5-alpha-reductase inhibitor within 6 months

          -  Patient or his legally acceptable representative has signed the written informed
             consent form

        Exclusion Criteria:

          -  Patients with severe cardiopulmonary disease and such as congestive heart failure,
             arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

          -  Patients with acute r chronic urinary retention and urodynamically proven detrusor
             underactivity

          -  Patients with postvoid residual > 250 mL

          -  Patients have laboratory abnormalities at screening including:

               1. Aspartate aminotransferase (AST) > 3 x upper limit of normal range

               2. Alanine aminotransferase (ALT) > 3 x upper limit of normal range

               3. Patients have abnormal serum creatinine level > 2 x upper limit of normal range

          -  Patients with any other serious disease or condition considered by the investigator
             not suitable for entry into the trial

          -  Patients participated investigational drug trial within 1 month before entering this
             study
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: ENV515-3 Travoprost XR; ENV515-1 Travoprost XR; ENV515-3-2 Travoprost XR
Intervention MeSH terms: Travoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multiple cohort study that will evaluate the safety and efficacy of ENV515
      travoprost XR in patients with open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.

          -  Are currently treated with topical PGA for ocular hypertension in both eyes.

          -  Patients who in the opinion of the Investigator: have an IOP in both eyes that is
             considered to be adequately controlled, can be safely withdrawn from IOP medications
             in both eyes during the washout period, and who are not considered to be at
             significant risk for disease progression throughout the trial.

        Exclusion Criteria:

          -  Eye surgery (including cataract surgery) within the past 3 months.

          -  History of glaucoma related surgery.
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Intervention: Stannsoporfin; Placebo; PhotoTherapy (as needed)
Intervention description: Stannsoporfin administered as a single IM injection; Placebo (sterile saline solution) administered as a single IM injection; PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Intervention MeSH terms: Tin mesoporphyrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential experimental cohorts are run in parallel with placebo controls.
Masking: Double (Participant, Investigator)
Masking description: Clinical personnel at the site (including investigator, study coordinator and central cardiologist) were blinded to treatment group.
The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).
Enrollment: 58.0
Sex: All
Minimum age: 1 Minute
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: Hemolysis

Summary:

      It is a normal process in the human body for red blood cells to die, which makes bilirubin.

      Bilirubin is cleared away through the liver.

      Some babies are born with livers that don't work well enough yet, or their red blood cells
      are dying too fast, so the baby looks yellow (jaundice).

      This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin
      gets too high.

      Phototherapy is what they call the lights they shine on newborn babies to help the liver get
      rid of bilirubin.

      This study tests an experimental drug to see if it can reduce how much bilirubin is being
      made in the first place.
    

Eligibility criteria:

        Inclusion Criteria:

        Babies may only participate if they meet all the following criteria:

          -  Is a term or late preterm baby

          -  Is at risk for protocol-defined hemolytic disease

          -  Weighs at least 2500 g (5.5 lbs)

          -  Has total serum bilirubin (TSB) a specified amount lower than the phototherapy
             threshold for the age

          -  Has parents/guardians who are willing to follow light precautions and sign informed
             consent

        Exclusion Criteria:

        The following criteria will make a baby not eligible to participate:

          -  Needs medications that may prolong the QT interval

          -  Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome,
             or Porphyrias

          -  Has an Apgar score of 6 or below at age 5 minutes

          -  Has abnormalities or infections (in mother or child) that per protocol or in the
             opinion of the investigator may compromise the safety and well-being of the baby or
             analysis of study results
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Condition: HIV Infections
MeSH terms: Infections
Intervention: Abacavir sulfate, Lamivudine, and Zidovudine; Lopinavir/Ritonavir
Intervention description: antiretroviral therapy; antiretroviral therapy
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Abacavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Infection; Treatment Naive

Summary:

      Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in
      transplant patients who receive donor organs. CsA may also help people with HIV. The purpose
      of this study is to determine the safety of and immune response to CsA when given with
      abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT), (ABC/3TC/AZT) and
      lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection.

      Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will
      result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to
      acute infected individuals treated with LPV/r alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute HIV infection with HIV viral load of more than 50,000 copies/ml AND either
             negative ELISA OR Western blot with 5 bands or less within 4 weeks prior to study
             entry

          -  Hepatitis B surface antigen negative within 12 weeks prior to study entry

          -  Hepatitis C antibody negative within 12 weeks prior to study entry

          -  Willing to use acceptable methods of contraception

        Exclusion Criteria:

          -  Prior antiretroviral therapy. A patient who has undergone Post Exposure Prophylaxis
             (PEP) taken at least 6 months prior to study entry is not excluded.

          -  Allergy or hypersensitivity to any study medications or their components

          -  Require certain medications, including those that may alter CsA levels or cause renal
             dysfunction. More information on this criterion can be found in the protocol.

          -  Any medical or psychiatric condition, including alcohol or drug abuse, that may
             interfere with adherence to study requirements

          -  Weight less than 88 lbs (40 kg)

          -  Uncontrolled hypertension

          -  History of pancreatitis

          -  History of cancer. Participants with cancer in remission who have not had treatment
             for at least 3 years may be eligible for this study.

          -  Pregnancy or breastfeeding
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Sufentanil NanoTab 20 mcg; Sufentanil NanoTab 30 mcg; Placebo NanoTab
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a dose-finding study to determine if the sublingual administration of the Sufentanil
      NanoTab is safe and effective in the treatment of post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients scheduled for bunion surgery

        Exclusion Criteria:

          -  daily opioid use

          -  drug or alcohol abuse

          -  pregnant or breastfeeding women