bioihbjkbjnl/mcl2 huggingface dataset:
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vortioxetine (Lu AA21004); Venlafaxine XL
Intervention description: capsules, daily, orally; encapsulated tablets, daily, orally; capsules, daily, orally
Intervention MeSH terms: Vortioxetine; Venlafaxine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment

Summary:

      The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and
      tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive
      Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)

          -  Current MDE duration of at least 3 months and less than 12 months

          -  The patient has a MADRS total score >=30

        Exclusion Criteria:

          -  Any current psychiatric disorder other than MDD as defined in the DSM-IV TR

          -  Any substance disorder within the previous 6 months

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication 2 weeks prior to screening and during the study

        Other protocol-defined inclusion and exclusion criteria may apply.
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Condition: Obesity; Overweight; Craniopharyngioma
MeSH terms: Craniopharyngioma; Adamantinoma; Obesity; Overweight
Intervention: Exenatide
Intervention description: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Exenatide; Byetta; Hypothalamic Obesity; Obesity; Craniopharyngioma

Summary:

      The purpose of this study is to determine whether exenatide can cause weight loss in patients
      with a history of craniopharyngioma or other brain lesion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 40 years old

          -  History of craniopharyngioma or other lesion in the hypothalamic region

          -  Greater than 6 months post-treatment, including chemotherapy, surgery or radiation

          -  BMI >30 mg/m2

          -  Females must be post-menopausal, surgically sterile or using effective birth control
             for at least 12 weeks

        Exclusion Criteria:

          -  HgbA1C >7%

          -  Use of diabetes medications other than metformin in the past 12 weeks, including
             exenatide

          -  Use of weight loss drugs or initiation of a weight loss program in past 3 months

          -  Impaired renal function or history of kidney transplant

          -  History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism

          -  Personal or family history of medullary carcinoma of the thyroid or MEN type 2

          -  History of gastroparesis or other gastric motility problems as exenatide decreases
             gastric motility

          -  History of allergic reaction to exenatide or other medication components

          -  Other significant comorbidities other than pituitary deficiencies

          -  Currently prescribed warfarin (exenatide may alter warfarin metabolism)

          -  Pregnant or lactating females

          -  History of severe hypoglycemia (BG <60 and requiring assistance from another person)
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Condition: Nutrient Deficiency; Pregnancy Related
Intervention: Carotenoid Group; Control Group
Intervention description: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil; Placebo ingredients: Safflower oil
Intervention MeSH terms: Carotenoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a
      period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation
      with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on
      ocular and systemic biomarkers of maternal and infant carotenoid status relative to a
      matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3)
      newborn infants with the highest systemic and ocular carotenoid status will have more mature
      foveal structure.

      Mothers will be enrolled in the study during their first trimester, and will take the study
      carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of
      mothers and infants will be completed within two weeks of the baby's birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated
             obstetric history and plan to deliver either vaginally or by Caesarian section at the
             University of Utah for their current pregnancy.

        Exclusion Criteria:

          -  Women who have regularly taken carotenoid supplements containing more than 0.5 mg of
             lutein and/or zeaxanthin daily during the six months prior to screening

          -  Women who have significant eye disease associated with macular pigment abnormalities
             such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).

          -  Women with conditions associated with high-risk pregnancy such as adolescent
             pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia,
             previous premature delivery, drug abuse or other significant medical illness
The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
Condition: Change in Bone Mineral Density; Change in Bone Marrow Fat Content
Intervention: Rosiglitazone; Placebo pill
Intervention description: one tablet of rosiglitazone 8 milligrams per day for 14 weeks; One encapsulated placebo pill a day for 14 weeks
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: Female
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BMD; Rosiglitazone; Bone marrow fat

Summary:

      Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The
      disease is caused partly by environmental and partly by genetic factors. It is well known
      that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies
      suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the
      drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby
      decreasing bone strength. In a single study healthy volunteers were treated with
      rosiglitazone for 14 weeks and had a decrease in bone mineral density.

      In the present study we wish to investigate the effect of this treatment on bone and fat
      tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks
      and compared with 25 women receiving placebo.

      The effect will be evaluated as follows:

        1. The effect on bone marrow density will be examined by a bone scan prior to and after
           treatment and again after 6 and 9 months.

        2. The effect on bone turnover will be measured in blood- and urine samples at the same
           times.

        3. The effect on fat distribution will be evaluated by an MRI scan after treatment.

        4. The effect on bone marrow cells will be investigated bone marrow sampling immediately
           after treatment

        5. The direct effect on fat will be examined by a biopsy immediately after treatment The
           study hypothesis is that rosiglitazone treatment decreases bone mineral density and
           increases bone marrow fat content. The causal molecular mechanisms will be investigated
           from the bone marrow and fat samples
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women age 60-75 with no rosiglitazone allergy

        Exclusion Criteria:

          -  Osteoporosis

          -  Diabetes

          -  Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism

          -  Treatment with bone active drugs

          -  Low impact fracture

          -  Heart disease

          -  Kidney failure

          -  Liver failure

          -  Anaemia

          -  Ineligibility for MRI-scan

          -  Cancer within last 5 years
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Condition: Breast Cancer; Prostate Cancer; Bone Neoplasms
MeSH terms: Breast Neoplasms; Prostatic Neoplasms; Bone Neoplasms; Bone Diseases
Intervention: AZD0530; Zoledronic Acid
Intervention description: Daily oral dose
Intervention MeSH terms: Zoledronic Acid; Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; prostate cancer; metastatic bone disease; Subjects with breast cancer or prostate cancer with metastatic bone disease

Summary:

      The purpose of this study is to determine the effect of AZD0530 on subjects with breast
      cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone
             Disease Have evidence of recurrence or disease progression

          -  At least one radiographically confirmed metastatic bone lesion

          -  No change of cancer therapy for at least 8 weeks before randomization

        Exclusion Criteria:

          -  Have had any prior exposure to bisphosphonate

          -  Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to
             bone within the past 12 months

          -  Inadequate renal function or low haemoglobin

          -  Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits
             of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate
             aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence of
             liver metastases). If bone metastases are present and liver function is otherwise
             considered adequate by the investigator then elevated ALP will not exclude the
             patient.
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Condition: Severe Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: GRF6019; Placebo
Intervention description: GRF6019 for IV infusion; Placebo for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dementia; Tauopathy

Summary:

      This study will evaluate the safety, tolerability, and potential cognitive benefit of the
      experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's
             Association (NIA-AA) Criteria

          -  MMSE Score 0-10 inclusive

          -  Modified Hachinski Ischemia Scale (MHIS) score of 4 or less

          -  Provided a signed and dated informed consent form (either the subject and/or subject's
             legal representative)

        Exclusion Criteria:

          -  Evidence of clinically relevant neurological disorder(s) other than probable AD

          -  History of blood coagulation disorders or hypercoagulability; any concurrent use of an
             anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
             inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

          -  Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable
             angina in the 6 months prior to dosing.

          -  Moderate to severe congestive heart failure (New York Association Class III or IV).

          -  Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher
             and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3
             months prior to dosing, or treatment refractory high blood pressure, defined as
             treatment requiring 3 or more antihypertensives from different classes.

          -  Prior hypersensitivity reaction to any human blood product or intravenous infusion;
             any known clinically significant drug allergy.

          -  Treatment with any human blood product, including transfusions and intravenous
             immunoglobulin, during the 6 months prior to screening.

          -  History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
             anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

          -  Hemoglobin <10 g/dL in women; and <11 g/dL in men.
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ingenol mebutate; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2
      trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily
      treatment for 2, 3 or 4 consecutive days compared to vehicle gel
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area
        of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

        Exclusion Criteria:

          -  Location of the treatment area (trunk (except chest) or extremities)

               -  within 5 cm of an incompletely healed wound,

               -  within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
                  (SCC)

          -  Prior treatment with ingenol mebutate within the selected treatment area

          -  Lesions in the treatment area that have:

               -  atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous
                  horns) and/or,

               -  recalcitrant disease (e.g., did not respond to cryotherapy on two previous
                  occasions)
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Condition: Diabetes
Intervention: VI-0521
Intervention description: Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 Diabetes; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Glycemic Control

Summary:

      This study is an extension of a study that has been ongoing for 1 year. The purpose of this
      open label study is to see the how well type 2 diabetics respond to
      VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an
      extended period of time. All subjects eligible to enroll into this study will receive study
      drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the qualifying DM-230 trial

          -  If females of child-bearing potential, subjects must be using adequate contraception

          -  Provide written informed consent

          -  Be willing and able to comply with scheduled study visits, treatment plan, lab tests
             and other study procedures

          -  Be greater than 80% compliant in study medication use during the last three visits for
             DM-230

        Exclusion Criteria:

          -  Subjects who have developed one or more morbidities during the DM-230 trial that would
             pose a safety concern
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Methadone; methadone and morphine
Intervention description: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg; Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Analgesics; Retroperitoneal lymph node dissection

Summary:

      This is a randomized Phase II study testing the effectiveness of the combination of morphine
      and methadone versus morphine alone in relieving pain. A second goal is to further evaluate
      any side effects of the combination of morphine and methadone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Retroperitoneal lymph node dissection

          -  Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every
             10 minutes

          -  18 years of age or older

          -  English-speaking

          -  Give informed consent to participate in this study

        Exclusion Criteria:

          -  Known hypersensitivity to methadone or morphine

          -  Patients with past or present history of substance abuse

          -  Patients with a history of methadone treatment

          -  Patients with a history of chronic pain requiring daily analgesic use for more than 3
             months

          -  Patients treated with opioids within one month from the scheduled surgery

          -  Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).

          -  Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise
             data collection
Combination of Danazole With Berberine in the Treatment of ITP
Condition: Corticosteroid-resistant or Relapsed ITP
Intervention: Berberine plus danazol
Intervention description: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Intervention MeSH terms: Danazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: corticosteroid-resistant or relapsed ITP; Danazole; berberine

Summary:

      A prospective, multicenter, open-label, Phase II, single arm, trial performed in 6
      departments of hematology in China
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed

          2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L
             combined with bleeding manifestation

          3. Subject is ≥ 18 years and ≤80years

          4. Subject has signed and dated written informed consent.

          5. Fertile patients must use effective contraception during treatment and observational
             period

          6. Negative pregnancy test

        Exclusion Criteria:

          1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL

          2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL
             and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper
             limit of normal

          3. Have a New York Heart Classification III or IV heart disease

          4. Have a history of severe psychiatric disorder or are unable to comply with study and
             follow-up procedures

          5. Have active hepatitis B or hepatitis C infection

          6. Have a HIV infection

          7. Have active infection requiring antibiotic therapy within 7 days prior to study entry

          8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12
             months of receiving study drug

          9. Previous treatment with rituximab

         10. Previous splenectomy

         11. Had previous or concomitant malignant disease

         12. Not willing to participate in the study.

         13. Expected survival of < 2 years

         14. Intolerant to murine antibodies

         15. Immunosuppressive treatment within the last month

         16. Connective tissue disease

         17. Autoimmune hemolytic anemia

         18. Patients currently involved in another clinical trial with evaluation of drug
             treatment