bioihbjkbjnl/mcl2 huggingface dataset:
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Condition: Gastroesophageal Reflux Disease; Heartburn; Regurgitation
MeSH terms: Gastroesophageal Reflux; Heartburn
Intervention: lesogaberan (AZD3355); lesogaberan (AZD3355); lesogaberan (AZD3355); lesogaberan (AZD3355); Placebo
Intervention description: 60 mg, oral, capsules, bid for 4 w; 120 mg, oral, capsules, bid for 4 w; 180 mg, oral, capsules, bid for 4 w; 240 mg, oral, capsules, bid for 4 w; oral,capsules, bid for 4 w
Intervention MeSH terms: Lesogaberan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 661.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD treatment; Acid and non-acid Reflux; Heartburn; Regurgitation; Add-on treatment to PPI

Summary:

      This study is being carried out to see whether AZD3355 is an effective treatment as an add-on
      to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial
      response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another
      goal of the study is to examine which of the investigated doses of AZD3355 is optimal for
      treatment of these patients. This study will also measure levels of drug in the blood and see
      how well it is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Have at least 6 months history of GERD

          -  Continuously treated during the last 4 weeks before enrolment with daily optimized
             unchanged PPI therapy for any GERD indication

        Exclusion Criteria:

          -  Patients that have not experienced any GERD symptom improvement at all during PPI
             treatment

          -  Prior surgery of the upper gastrointestinal tract.

          -  Subject who have any of the following conditions or diseases: Heart disease, Angina,
             Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such
             as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.
Condition: Neoplasms
Intervention: Everolimus
Intervention description: Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAD001, everolimus, roll-over

Summary:

      The purpose of this study was to collect and assess long-term safety of everolimus in
      patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology
      CD&MA study that had reached its study objectives, were not progressing on the current study
      treatment as defined by the parent protocol, and were unable to access everolimus treatment
      outside of a clinical study. Parent studies eligible to participate in the roll-over study
      were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary
      objective of the parent study must have been reached and the parent study must have been in
      the process of being completed and reported.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving
             everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their
             requirements in the parent study

          -  Patient is currently benefiting from treatment with everolimus, as determined by the
             guidelines of the parent protocol.

        Exclusion Criteria:

          -  Patient has been permanently discontinued from everolimus study treatment in the
             parent study.
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
Condition: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous
Intervention: Hypericin
Intervention description: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
Intervention MeSH terms: Hypericin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; MF; Hypericin; HyBryte

Summary:

      To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8
      weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB
             or Stage IIA

          -  CTCL lesions covering ≥ 10% of their body surface area

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to any of the components of HyBryte

          -  Pregnancy or mothers who are breast-feeding

          -  Males and females not willing to use effective contraception

          -  Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g.,
             porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)

          -  Subjects whose condition is spontaneously improving

          -  Subjects receiving topical steroids or other topical treatments (e.g., nitrogen
             mustard) on index lesions for CTCL within 2 weeks of enrollment

          -  Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy
             (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or
             other systemic therapies for CTCL within 3 weeks of enrollment

          -  Subjects who have received electron beam irradiation within 3 months of enrollment

          -  Subjects with a history of significant systemic immunosuppression

          -  Subjects taking other investigational drugs or drugs of abuse within 30 days of
             enrollment

          -  Subjects receiving drugs known to cause photosensitization within 2 weeks of starting
             HyBryte therapy unless they have not had evidence of photosensitization after
             receiving a stable dose of the medication for a minimum of 4 weeks
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Condition: Severe Sepsis or Septic Shock
MeSH terms: Sepsis; Toxemia
Intervention: Calcitriol; Placebo
Intervention MeSH terms: Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Observational studies among critically ill patients have shown strong associations between
      vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and
      mortality. It is unknown whether vitamin D deficiency contributes directly to adverse
      outcomes or whether it is simply a biomarker of severity of illness or overall health status.
      However, vitamin D plays a key role in host defense, largely by stimulating production of the
      anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration
      of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age ≥ 18

          -  Severe sepsis or septic shock

          -  Central venous catheter (for blood drawing)

        Exclusion Criteria:

          -  Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours

          -  Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses
             >1,000 I.U. per day or activated vitamin D at any dose

          -  History of solid organ or bone marrow transplant, primary parathyroid disease,
             metabolic bone disease, or sarcoidosis

          -  Expected to die or leave the ICU within 48 hours

          -  History of hypersensitivity or any allergic reaction to calcitriol

          -  End stage renal disease

          -  Acute Kidney Injury receiving intermittent renal replacement therapy

          -  Enrolled in a competing study

          -  Pregnancy
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Condition: Hematologic Malignancy; Myeloproliferative Disorder
MeSH terms: Hematologic Neoplasms; Myeloproliferative Disorders
Intervention: Isavuconazole
Intervention description: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Intervention MeSH terms: Isavuconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the effects of isavuconazole in preventing fungal
      infections in patients who have had a hematopoietic stem cell transplant (HCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of greater than or equal to 18 years of age of either sex and of any race.

          -  Have received first peripheral blood, marrow or cord blood transplant from a family or
             unrelated donor for hematologic malignancy or myeloproliferative disorder.

        Exclusion Criteria:

          -  Proven or probable aspergillosis or other mold infection or deep mycoses including
             hepatosplenic candidiasis less than 60 days from first dose of ISA.

          -  History of allergy or intolerance to ISA.

          -  Clinically significant elevation of liver function tests prior to the first day of
             dosing (FDD) that at the discretion of the treating physician would preclude the
             administration of an azole antifungal.

          -  Familial short QT syndrome.
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab; Placebo
Intervention description: Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters; Subcutaneous injection using prefilled syringe containing 0.8 milliliters
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Adalimumab; Nodule; Abscess; Fistula; Physicians Global Assessment; Hurley Stage; Sartorius Scale

Summary:

      This study will investigate how well adalimumab works in people with hidradenitis suppurativa
      (HS) in the short and long term.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with stable, moderate to severe hidradenitis suppurativa

          -  Negative Chest X-ray and PPD test at Screening. If participant has had a past
             ulcerative reaction to PPD placement and/or chest X-ray consistent with prior
             tuberculosis exposure, the participant must initiate, or have documented completion
             of, a course of anti-tuberculosis therapy.

          -  Ability to administer subcutaneous injections

          -  General good health otherwise

        Exclusion Criteria:

          -  Prior anti-TNF therapy

          -  Unstable antibiotic therapy for HS

          -  Required medication washouts for other HS treatments

          -  Prior exposure to Tysabri® (natalizumab);

          -  Recent infection requiring treatment

          -  Significant medical events or conditions that may put patients at risk for
             participation

          -  Female subjects who are pregnant or breast-feeding or considering becoming pregnant
             during the study;

          -  History of cancer, except successfully treated skin cancer

          -  Recent history of drug or alcohol abuse
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: therapeutic allogeneic lymphocytes
Intervention description: If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: recurrent renal cell cancer; clear cell renal cell carcinoma; stage IV renal cell cancer

Summary:

      RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the
      patient's immune system kill tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving irradiated
      donor lymphocytes works in treating patients with metastatic kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of clear cell renal cell carcinoma

               -  Metastatic disease

          -  Measurable disease

          -  Previously treated with high-dose aldesleukin OR not eligible for or refused such
             therapy

          -  No brain metastases by MRI or CT scan

          -  HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available

               -  Patients who have no partially matched immediate family member available are
                  eligible if they have a fully HLA-matched donor

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Bilirubin ≤ 2 times upper limit of normal

          -  Creatinine clearance ≥ 40 mL/min

          -  AST ≤ 3 times ULN

          -  Cardiac ejection fraction ≥ 45%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Intervention: Open; Nifedipine; Placebo
Intervention description: Sitaxsentan sodium 100 mg orally administered once daily (double blind arm); Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm); Placebo for sitaxsentan, orally administered once daily (double blind arm)
Intervention MeSH terms: Nifedipine; Sitaxsentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Sitaxsentan

Summary:

      This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes
             Quality Initiative (K/DOQI) with proteinuria, including any of the following
             aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD),
             congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis,
             minimal change nephropathy, and membranous nephropathy.

        Exclusion Criteria:

          -  Required peritoneal dialysis or haemodialysis.

          -  Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus,
             or known renovascular disease; antiglomerular basement membrane disease; or is on
             immunosuppressive medication.
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Condition: Obesity
MeSH terms: Obesity
Intervention: recombinant human growth hormone (rhGH); Placebo
Intervention description: Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.; Placebo will be administered by daily subcutaneous injections. Sham increases will be used.
Intervention MeSH terms: Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 22.0
Sex: Female
Minimum age: 13 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Obesity; Adolescent; Insulin resistance; Growth hormone; Visceral fat; Adolescent obesity

Summary:

      Teenagers and adults who are overweight or obese have an increase in fat in the abdomen,
      which increases their risk for diabetes and heart disease. Reducing abdominal fat is
      important to reduce risk for diabetes and for heart disease. Overweight teenagers also have
      low levels of growth hormone compared to normal weight teenagers, and teenagers with the
      lowest growth hormone levels also have the greatest abdominal fat. In children who are unable
      to make growth hormone for other reasons, giving back growth hormone leads to a decrease in
      abdominal fat. We are studying whether giving growth hormone in small doses to overweight
      teenagers can change body composition. We hypothesize that growth hormone will cause
      abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescent girls 13-21 years old with bone age ≥ 14 years

          -  Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age

          -  Waist/Hip ratio ≥ 0.85

          -  Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal
             stage or age

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) prior to enrollment in the study

          -  Significant weight gain or loss within 3 months of study (more than 5 kg)

          -  Use of medications that affect GH or cortisol levels (such as estrogen including oral
             contraceptive pills, oral glucocorticoids)

          -  Use of medications such as Meridian and Orlistat

          -  Presence of diabetes mellitus

          -  Uncontrolled Thyroid disorders

          -  Chronic renal insufficiency

          -  Participation in another simultaneous medical investigation or trial

          -  Active neoplasm or history of cancer

          -  Prader-Willi syndrome

          -  History of scoliosis if bone age is <15 years

          -  Hypersensitivity to rhGH or constituents of the injections
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
MeSH terms: Polycystic Ovary Syndrome; Endocrine System Diseases; Syndrome
Intervention: AZD4901 (oral); Placebo to match AZD4901
Intervention description: Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo; Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH

Summary:

      To assess the effects of AZD4901 when given in multiple doses to females with Polycystic
      Ovary Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

        Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for
        cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2
        (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined
        as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine
        pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within
        the 6 months prior to screening.

        Exclusion Criteria:

        Perimenopausal or reached natural menopause, defined as FSH > 10 IU/L. Menstruated within
        the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both.
        Clinically relevant disease and abnormalities (past or present), and in particular causes
        of abnormal vaginal bleeding.

        Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested
        within 7 ± 1 days of the baseline visit.