bioihbjkbjnl/mcl2 huggingface dataset:
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Intervention description: Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin
      pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the
      curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven prostate cancer, locally advanced or
             metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and
             the patient scheduled to receive androgen deprivation therapy

          -  Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured
             by any laboratory or on site within the previous 6 months or at study start

          -  Karnofsky performance index > 70

          -  Expected survival ≥ 9 months

        Exclusion Criteria:

          -  Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone
             (GnRH) agonists or antagonists within the last 12 months preceding the study or
             concomitant treatment with one or more of these substance(s)

          -  Any current use or within 6 months prior to treatment start of medications which are
             known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,
             aminoglutethimide, oestrogens and progesterone

          -  Patient at risk of spinal cord compression or ureter obstruction

          -  Prior hypophysectomy or adrenalectomy
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: Placebo; TrIP-2D; TrIP-2SS; TrIP-2D; TrIP-2SS + Foradil
Intervention description: Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
Intervention MeSH terms: Triptorelin Pamoate; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; pulmonary; inhalation

Summary:

      The purpose of this study was to evaluate the efficacy, safety, and tolerability of single
      doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive
      pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female COPD subjects between the ages of 40 and 80 years

          -  Body mass index between 18 and 35

          -  Medically healthy (other than COPD)

          -  FEV1/FVC less than or equal to 0.70

          -  Current non-smoker or able to abstain from smoking for at least 8 hours postdose

          -  Within the previous 6 months, demonstrated improvement in FEV1 (greater than or equal
             to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs)

          -  Females of childbearing potential must agree to use an acceptable method of
             contraception for the duration of the study

        Exclusion Criteria:

          -  Asthma in the last 10 years

          -  Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis

          -  Bladder neck obstruction, including urinary retention or known symptomatic prostatic
             hypertrophy not controlled with medication

          -  Narrow angle glaucoma

          -  Tachyarrhythmia

          -  Alcohol dependence or illicit drug abuse within the past year

          -  Using long-term oxygen therapy

          -  Female subjects who are pregnant or breastfeeding

          -  Participating in another clinical trial
Lactoferrin Treatment in HIV Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Recombinant Lactoferrin; Placebo
Intervention MeSH terms: Lactoferrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin
      (1500mg bid) for reducing inflammation among HIV positive participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year

          2. HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)

          3. Age >40 years

        Exclusion Criteria:

          1. Prior cardiovascular disease or stroke

          2. Diabetes

          3. Rheumatologic Diseases

          4. Pregnancy

          5. Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)

          6. Cirrhosis or end-stage liver disease
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
Condition: Breast Cancer
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: Tamoxifen; Lumpectomy; brachytherapy
Intervention description: Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient; A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.; Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ductal breast carcinoma in situ; breast cancer in situ

Summary:

      RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor
      to kill tumor cells. Giving internal radiation therapy using a special radiation therapy
      device may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy
      works in treating women with ductal carcinoma in situ.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy

          -  Size: < 3 cm on mammogram

          -  Unicentric disease

          -  Ability to place MammoSite device at time of lumpectomy or within 4 weeks of
             lumpectomy

          -  Patient Age: ≥ 18 years, no upper limit

          -  Life expectancy > 5 years

        Exclusion Criteria:

          -  Prior history of cancer other than basal or squamous cell skin cancer or in situ
             cancer of the cervix

          -  Pregnant or breast feeding

          -  Multicentric disease

          -  Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis,
             scleroderma, or dermatomyositis
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Potassium chloride powder; Potassium citrate powder; Potassium magnesium citrate powder; Placebo
Intervention description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks; 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks; 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks; 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Intervention MeSH terms: Potassium Citrate; Magnesium citrate; Citric Acid; Sodium Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood
      pressure among patients with pre- or Stage I hypertension on their customary diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women > 21 years of age

          -  Any Race/Ethnicity

          -  Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Renal impairment (serum creatinine > 1.4 mg/dL)

          -  Any heart diseases such as congestive heart failure or sustained arrhythmia

          -  Chronic NSAID use

          -  Treatment with diuretics

          -  Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents
             or antacid more than once a week

          -  Esophageal-gastric ulcer

          -  Chronic diarrhea

          -  Hyperkalemia (serum > 4.6 meq/L for patients on angiotension-converting-enzyme (ACE)
             inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient
             not on ACE inhibitors or ARBs)

          -  Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase
             (ALT) above upper limit of normal range)

          -  Subjects who require any potassium supplement on a regular basis from any reasons

          -  Pregnancy

          -  History of major depression, bipolar disorder, or schizophrenia
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: MUC1 Dendritic Cell Vaccine (Cvac)
Intervention description: The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).
Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cvac

Summary:

      The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian
      cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer
      eligible for study participation due to disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients ≥ 18 years old with histologically confirmed Stage III or IV
             epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in
             CAN-003

          -  Able and willing to undergo mononuclear cell (MNC) collection (if required for
             patients who do not have available Cvac doses)

          -  Were enrolled in CAN-003 and met protocol criteria for progressive disease

          -  Wish to remain in the study and, in the investigator's judgment, the potential benefit
             of Cvac treatment outweighs the risk

          -  Must be non-pregnant and, if of childbearing potential, must use adequate birth
             control (hormonal or barrier method of birth control or abstinence) for the duration
             of the study and for 3 months after study completion

          -  Able to provide written informed consent

          -  White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL,
             hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Other medical conditions which preclude study participation, in the opinion of the
             investigator

          -  Receiving treatment with any other investigational product
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo
Intervention description: Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.; Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.; Matching placebo capsule will be taken orally, before the first meal of the day.
Intervention MeSH terms: Canagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 352.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 1; Canagliflozin; Continuous Glucose Monitoring

Summary:

      The purpose of this study is to assess the effects of administration of canagliflozin 100 mg
      and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type
      1 Diabetes Mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have type 1 diabetes mellitus (T1DM) for at least 1 year

          -  Must have have inadequate glycemic control (as defined by glycosylated hemoglobin
             level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening

          -  Must have body mass index 21 to 35 kg/m2 inclusive

          -  Must be on a total daily dose of insulin >= 0.6 IU/kg at screening

          -  Must be on a stable insulin regimen for at least 8 weeks prior to screening

        Exclusion Criteria:

          -  History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to
             pancreatitis or pancreatectomy

          -  Severe hypoglycemia (defined as an event required assistance from another person, or
             which resulted in seizure or loss of consciousness) within 6 months prior to study
             start

          -  Diabetic ketoacidosis within 6 months prior to study start

          -  History of hereditary glucose-galactose malabsorption or primary renal glycosuria

          -  An ongoing, inadequately controlled thyroid disorder
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention
Condition: Adherence, Medication
Intervention: Vaginal Renewal Program
Intervention description: Therapeutic vibrating wand.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Prospective Simon two-stage study design
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Breast cancer patients commonly take medications to reduce the risk of recurrence, including
      aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient
      adherence. Early discontinuation of AI therapy results in an increased risk of cancer
      recurrence and increased risk of breast cancer-related death. Common side effects include
      vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI
      adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP)
      aimed at stimulating nitric oxide production to consequently increase vaginal lubrication,
      and improve the symptoms of vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed active primary treatment

               -  defined as surgery chemotherapy and/or radiation for the treatment of breast
                  cancer

               -  Does not include immunotherapy or other targeted therapies such as trastuzumab,
                  CDK 4/6 or mTOR inhibitors

          -  Have been receiving AIs for at least 6 months prior to enrollment

          -  Plan to continue AIs for an additional 3 months

          -  Amenorrhea for at least 12 months at enrollment

          -  Participants must be able to read and write in English

          -  Participants must have < 2% superficial vaginal cells on cytologic evaluation

        Exclusion Criteria:

          -  Pre-existing hypertonic pelvic floor dysfunction identified in the medical record

          -  Unresolved or recurrent vaginismus identified in the medical record

          -  Aversion to touching one's own body, including genitals, or using vibration therapy on
             the genitals

          -  Currently receiving estrogen therapy, including topical and/or systemic estrogens

          -  Have received estrogen therapy within 6 months of study enrollment, including topical
             and/or systemic estrogens

          -  Any surgical procedure to the vagina or vulva, excluding office biopsies, within the
             previous 12 months

          -  Receipt of pelvic or vaginal or vulvar radiation therapy within the 12 months prior to
             enrollment or if the subject is anticipated to receive radiation targeted to any of
             these 3 locations within 6 months following enrollment

          -  Any use of the VRP off study within the last 6 months
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
Condition: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: ABT-493; ABT-530; ABT-450/r/ABT-267, ABT-333; Ribavirin (RBV)
Intervention description: Tablet; Tablet; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Cirrhosis; Child Pugh A; Hepatitis C virus; Compensated Cirrhosis; Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; Cirrhotic

Summary:

      The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of
      ABT-493 and ABT-530 in adults with genotype 1 HCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV infection prior to study enrollment.

          -  Screening laboratory result indicating HCV genotype 1-infection.

          -  Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

          -  Per local standard, subject is considered to be non-cirrhotic or to have compensated
             cirrhosis.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any drug.

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency Virus antibody (HIV Ab).

          -  Prior therapy for the treatment of HCV.

          -  Any current or past clinical evidence of Child Pugh B or C classification of clinical
             history of liver decompensation including ascites (noted on physical exam), variceal
             bleeding or hepatic encephalopathy.

          -  Any cause of liver disease other than chronic HCV infection.