bioihbjkbjnl/mcl2 huggingface dataset:
An Open Label Extension Study of the Efficacy of MORAb-003
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: MORAb-003
Intervention description: Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.
Intervention MeSH terms: Farletuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extension study; Epithelial ovarian cancer

Summary:

      An open label extension of the MORAb-003-002 study in order to continue the active patients
      in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of Informed consent.

          -  Subjects must have been enrolled in and have met the inclusion/exclusion criteria of
             the MORAb-003-002 study.

          -  Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or
             stable disease and an investigator's assessment of a clinical benefit) after MORAb-003
             in combination with standard chemotherapy and have not yet met the criteria for
             disease progression during participation in the MORAb-003-002 study.

          -  Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

        Exclusion Criteria:

        • Subjects that discontinued the MORAb-003-002 study for any reason.
Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder
Condition: Very Long-chain acylCoA Dehydrogenase (VLCAD) Deficiency; Carnitine Palmitoyltransferase 2 (CPT2) Deficiency; Mitochondrial Trifunctional Protein (TFP) Deficiency; Long-chain 3 hydroxyacylCoA Dehydrogenase (LCHAD) Deficiency
Intervention: Triheptanoin
Intervention description: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: fatty acid oxidation; triheptanoin; long-chain fatty acid oxidation disorders; LCHADD; VLCADD; CPT2; TFP

Summary:

      Humans eat long-chain fat in their diet and use it for energy during exercise and during
      periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use
      dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with
      exercise or illness. They can also develop a heart that does not function properly. These
      patients are tired and expend less energy than people who do not have a long-chain fatty acid
      oxidation disorder. However, they can use a supplement oil called medium chain triglyceride
      or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease
      the muscle pain and increase the heart function and the amount of energy in patients with
      long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Very long-chain acylCoA dehydrogenase (VLCAD) Deficiency,
             Carnitine Palmitoyltransferase 2 (CPT2) Deficiency, Mitochondrial Trifunctional
             Protein (TFP) Deficiency, or Long-chain 3 hydroxyacylCoA dehydrogenase (LCHAD)
             deficiency

          -  > 7 years

          -  Ability to travel to CRC to participate

          -  Ability to follow protocol

        Exclusion Criteria:

          -  Hgb < 10 g/dl

          -  Peripheral neuropathy that limits ability to complete treadmill studies

          -  Inclusion in another research study that alters macronutrient intake

          -  Pregnant females

          -  history of myocardial infarction or cardiovascular disease
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Condition: Colon Staining in Preparation for Colonoscopy
Intervention: Methylene Blue MMX 25 mg modified release tablets
Intervention description: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
Intervention MeSH terms: Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, staining efficacy exploratory study.
Masking: None (Open Label)
Masking description: None. Open label
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after
      total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various
      reasons.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sex: males and females;

          2. Age:18 to 70 years;

          3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult
             blood test positive colorectal cancer screening, polypectomy follow-up and
             inflammatory bowel disease check;

          4. Contraception: either sterile subjects or subjects practising at least one reliable
             methods of contraception or in post-menopausal status for at least 1 year;

          5. Informed Consent: signed written informed consent prior to inclusion in the study.

        Exclusion Criteria:

          1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;

          2. Allergy: known or suspected hypersensitivity to the active principle and/or
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in
             general;

          3. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic
             megacolon, major colonic resection, inflammatory bowel diseases in active phase,
             severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious
             cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other
             relevant disease that might interfere with the aim of the study.

          4. Comprehension: inability to comprehend the full nature and purpose of the study and
             unwillingness to co-operate with the Investigator and to comply with the requirements
             of the entire study.
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Pamidronate; Thalidomide; Zometa
Intervention description: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.; All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met.
Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose); Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
Intervention MeSH terms: Pamidronate; Thalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myeloma; Thalidomide; Pamidronate; Aredia; Bisphosphonate; Anti-Angiogenesis; Smoldering/Indolent Myeloma; Zometa

Summary:

      The purpose of this research is to study how helpful the combination of thalidomide and
      Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any
      side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of Smoldering or Indolent myeloma

          -  All patients must be informed of the investigational nature of this study and must
             sign a written informed consent in accordance with UAMS Human Research Advisory
             Committee and federal guidelines.

        Exclusion Criteria:

          -  Prior bisphosphonate therapy within 30 days prior to study entry.

          -  Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl.

          -  Prior plicamycin or calcitonin within 2 weeks of study entry.

          -  Severe cardiac disease, unstable thyroid disease, or epilepsy.

          -  Prior radiation therapy to > 20% of the skeleton.
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Condition: Advanced Ovarian Carcinoma; Primary Peritoneal Carcinoma; Ovarian Carcinosarcoma
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinosarcoma; Mixed Tumor, Mullerian
Intervention: Avastin; Paclitaxel; Cisplatin
Intervention description: Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles; Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles; 75mg/m2 IP day 2 every 21 days x 6 cycles
Intervention MeSH terms: Paclitaxel; Bevacizumab; Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Gynecologic Cancer; Ovarian Carcinoma; Peritoneal Carcinoma; IP chemotherapy; Intraperitoneal; Avastin; Bevacizumab

Summary:

      The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with
      intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete
      6 cycles of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal
             carcinoma, or ovarian carcinosarcoma.

          -  Adequate bone marrow, renal, and hepatic function

          -  Patients must be entered no more than twelve weeks postoperatively

        Exclusion Criteria:

          -  Patients with epithelial ovarian carcinoma of low malignant potential (borderline
             carcinomas).

          -  Stage IV or suboptimally debulked disease following primary cytoreductive surgery

          -  Patients who have received prior radiotherapy or chemotherapy.
Nitrites, Exercise, and Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training; Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Intervention description: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.; The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Exercise; Functional Capacity

Summary:

      The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high
      nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised
      exercise training at the limb ischemic threshold (SET) will produce a greater clinical
      benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic
      threshold (PET).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peripheral Arterial Disease (ABI of less than 0.9)

          -  Intermittent Claudication for 3 or more months

        Exclusion Criteria:

          -  Individuals with known alcohol or drug abuse problems

          -  Individuals who have suffered a heart attack or stroke, or have changes on a resting
             ECG, in the last 3 months

          -  Those classified as American Heart Association Class D

          -  Gangrene, impending limb loss or osteomyelitis

          -  Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months
             of enrollment

          -  Severe peripheral neuropathy

          -  Any condition other than PAD that limits walking

          -  Chest pain during treadmill exercise which appears before the onset of claudication,
             or >3mm ST depression during exercise

          -  Subjects taking nitrates or nitroglycerin products

          -  Must not be taking protein pump inhibitor medications
Nicotinic Receptors and Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: DMXB-A-SR; Placebo
Intervention description: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR); Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random allocation to a treatment and placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Trial; Smoking; Smoking Cessation; Cognition; Mental Focus

Summary:

      The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene
      anabaseine sustained release) will provide clinical improvement in cognition in patients with
      schizophrenia who are smokers and who are non-smokers. The study drug may also maintain
      abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be selected to be 18 to 65 years old and in good general health.

          -  Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR)
             criteria for schizophrenia or schizoaffective disorder.

          -  Smokers will smoke at least 20 cigarettes per day.

          -  Non-smokers will also be enrolled.

          -  Subjects will have normal:

               -  vital signs,

               -  hematology,

               -  serum chemistries,

               -  EKG, and

               -  urinalysis with a negative drug screen before entry into the study.

          -  Subjects will be fluent in English.

          -  Smoking subjects will be interested in stopping smoking in the near future and not
             interested in nicotine replacement therapy.

        Exclusion Criteria:

          -  Subjects with histories of:

               -  neurological illness,

               -  liver disease,

               -  severe hypertension (cut-off blood pressure 160/100) or

               -  cardiac disease, or

               -  renal failure (cut-off creatinine above 1.4).

          -  Subjects who currently meet DSM-IV-TR criteria for substance dependence other than
             nicotine, cannabis, or alcohol will be excluded.

          -  Women who are capable of pregnancy and not on acceptable forms of birth control will
             be excluded.

          -  Subjects being treated with Clozapine will be excluded.
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301-1 NS (QD); GSP 301-2 NS (BID); GSP 301 Placebo NS; Olopatadine HCl-1 NS (QD); Olopatadine HCl-2 NS (BID); Mometasone Furoate-1 NS (QD); Mometasone Furoate-2 NS (BID)
Intervention description: GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril; GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril; GSP 301 placebo NS administered as 2 sprays/nostril; Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril; Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril; Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril; Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
Intervention MeSH terms: Mometasone Furoate; Olopatadine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1111.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in
      treatment of seasonal allergic rhinitis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Aged ≥12 years and older inclusive of either sex.

          2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the study
             season for the mountain cedar pollen

          3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for
             the AM assessment at the Screening Visit (Visit 1).

        Key Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Plans to travel outside the known pollen area for the investigative site for > 24
             hours during the last 7 days of run in period.

          3. History of nasal polyps of other clinically significant respiratory tract
             malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery,
             atopic dermatitis or rhinitis medicamentosa.

          4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          6. Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          7. Subjects with an active pulmonary disorder or infection.

          8. Subjects with posterior subcapsular cataracts or glaucoma.
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: D9421-C, 9mg; D9421-C, 15mg; Placebo
Intervention description: D9421-C 9 mg was given once daily for 8 weeks.; D9421-C 15 mg was given once daily for 8 weeks.; D9421-C matching placebo was given once daily for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: gastrointestinal; GI; Crohn's disease; Japan; Japanese

Summary:

      The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in
      Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of
      Crohn's disease and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male aged ≥ 18 and ≤ 65 years

          -  Diagnosis of Crohn's Disease

        Exclusion Criteria:

          -  Having ileostomy or pouch and/or colostomy

          -  Having previous gastric surgery

          -  Having a known or suspected systemic infection
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
Condition: Chronic Ulcer of Lower Extremity
MeSH terms: Leg Ulcer; Ulcer
Intervention: Nitric Oxide
Intervention description: Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
Intervention MeSH terms: Nitric Oxide
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: chronic cutaneous ulcers; Nitric Oxide; topically applied; Biofilm; Colonized chronic non-healing ulcers

Summary:

      To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the
      reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by
      measurements of wound size and wound culture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound
             containing a local margin of erythema, edema or tenderness; presence of exudates;
             and/or presence of a malodorous smell)in their lower extremity (below the knee)
             resulting from either diabetes or venous stasis disease.

          -  Are 18 years of age or older.

        Exclusion Criteria:

          -  Have had a change in their topical treatment during the last 4 weeks

          -  Have evidence of Clinical Infection

          -  Have a transcutaneous oxygen tension <30mmHg

          -  Have evidence of the ulcer or infection extending to the underlying muscle or bone.

          -  Are pregnant.

          -  Are less than 18 years of age.