bioihbjkbjnl/mcl2 huggingface dataset:
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101 powder provided in capsules; Placebo powder provided in capsules
Intervention description: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 4 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Allergy; Peanut Allergy; Peanut-Allergic Children; Children; Peanut-Allergic Adults

Summary:

      This is a multi-center, randomized, double-blind placebo controlled study of efficacy and
      safety of characterized peanut oral immunotherapy in peanut allergic individuals.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ages 4 through 26 years, inclusive

          -  Clinical history of allergy to peanuts or peanut-containing foods

          -  Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or
             a SPT to peanut >3 mm compared to control

          -  Experience dose-limiting symptoms at or before the 100mg dose of peanut protein
             (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via
             PRACTALL guidelines

          -  Use of birth control by females of child-bearing potential

        Key Exclusion Criteria:

          -  History of Cardiovascular disease

          -  History of frequent or repeated, severe or life-threatening episodes of anaphylactic
             shock

          -  History of other chronic disease

          -  History of eosinophilic gastrointestinal disease

          -  Severe asthma

          -  Mild or moderate asthma if uncontrolled

          -  Use of omalizumab within the past 6 months or current use of other non-traditional
             forms of allergen immunotherapy

          -  Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)

          -  Pregnancy, lactation

          -  Having the same place of residence as another study subject

          -  Participation in an interventional clinical trial 30 days prior to randomization
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Engerix™-B; Hiberix®; Prevnar™; sulfadoxine-pyrimethamine; amodiaquine
Intervention description: IM injection in the deltoid muscle; IM injection in the deltoid muscle; IM injection in the deltoid muscle; IM injection in the deltoid muscle; 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance; 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1737.0
Sex: All
Minimum age: 33 Months
Maximum age: 69 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium
      falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of
      infants and children living in malaria endemic areas. The vaccine would offer protection
      against malaria disease due to the parasite P. falciparum. The vaccine would also provide
      protection against infection with hepatitis B virus (HBV).

      This phase IIb trial is being carried out following the demonstration of efficacy of the
      candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated
      approximately 30% efficacy against clinical episodes of malaria and approximately 58%
      efficacy against severe malaria disease.

      In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the
      safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period
      commencing 21 months after Dose 1.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      2. During this extension study, no new subjects will be recruited and no vaccine will be
      administered.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041).

          -  Written informed consent obtained from the parent(s) or guardian(s) of the subject

        Exclusion criteria:

          -  Planned use of any investigational or non-registered drug or vaccine during the study
             period.

          -  Simultaneous participation in any other clinical trial
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Condition: Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorder; Pregnancy Complications; Postpartum Blues; PPD; Postpartum Disorder
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Intervention: Ganaxolone; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Postpartum Care; Postpartum Depression

Summary:

      A clinical study to evaluate safety, tolerability and efficacy of oral administration of
      ganaxolone in women with postpartum depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Experiencing a major depressive episode, which started between the start of the third
             trimester and 4 weeks following delivery. The major depressive episode must be
             diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0
             interview

          -  Given birth in the last 6 months

          -  HAMD17 score of ≥ 20 at screening but < 26

          -  Must agree to stop breastfeeding from start of study treatment or must agree to
             temporarily cease giving breast milk to her infant(s)

        Exclusion Criteria:

          -  Current history of any psychotic illness, including major depressive episode with
             psychotic features

          -  History of suicide attempt within the past 3 years

          -  History of bipolar I disorder

          -  History of seizure discorder
Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Intervention: TR intervention; In-home messaging device.; Usual care
Intervention description: The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during weeks 2, 4, 6, 8 and 12. One additional tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. Visit 3 focuses on functional mobility using adaptive strategy component.; The purpose of this aspect of the intervention is to screen for unforeseen problems and to reinforce adherence to the recommended treatment. It will be used to interface with patients daily, but briefly. The in-home messaging device, which resembles a caller ID box is attached to the home telephone line and electrical outlet. Installation of the equipment involves connecting it to the phone line and plugging it into an electrical outlet. The teletherapist receives the clinical data from the in-home messaging device via the internet on a daily basis. It is used to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence.; Routine VA care.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 45 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cerebrovascular Accident; Rehabilitation; Telemedicine

Summary:

      The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that
      uses tele-health technology to improve outcomes of stroke patients after discharge to home.
      The primary aim is to determine the effect of TR on physical function, and secondarily to
      determine the effect on disability, falls-related self-efficacy, and patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have acute ischemic or hemorrhagic stroke within the preceding twenty-four months,
             defined as "a rapid onset event of vascular origin reflecting a focal disturbance of
             cerebral function, excluding isolated impairments of higher function and persisting
             longer than 24 hours";

          -  age between 45-90;

          -  discharge to the community;

          -  cognitively intact (score of 6/10 or greater on the Short Portable Mental Status
             Questionnaire);

          -  discharge motor Functional Independence Measure (FIM) score of 17-88 (i.e., maximal
             assistance on no more than 4 motor activities of daily living (ADLs) as the most
             severe stroke included and modified independence at least 2 motor ADLs as the least
             severe); able to follow 3-step command; signed VHA Medical Media release form;
             concurrence by the patient's physician;

          -  and informed consent

        Exclusion Criteria:

        Unable to provide informed consent
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CP-690,550; CP-690,550
Intervention description: ORAL TABLET, TWICE DAILY; ORAL TABLETS, TWICE DAILY
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      The study hypothesis is to establish the safety and tolerability of long-term open-label (OL)
      CP-690,550 therapy in subjects with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects
             who withdraw early due to A3921084 study treatment failure (see Appendix 5).

          -  Women of childbearing potential must test negative for pregnancy prior to study
             enrolment.

          -  Sexually active females of childbearing potential are required to use adequate
             contraceptive methods during the study period and until completion of the follow-up
             procedures. No specific contraceptive measures are required in male subjects during
             study participation.

        Exclusion Criteria:

          -  Subjects who have been discontinued due to protocol violation(s) (as determined by the
             Sponsor) in the A3921084 study.

          -  Subjects who were discontinued from the A3921084 study due to an adverse event.

          -  Subjects likely to require any non-elective surgery or surgery requiring overnight
             stay (with the exception of minor same day outpatient procedures that will not
             interfere with study drug dosing).
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: CC-5013 (lenalidomide); dexamethasone
Intervention description: Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle; Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Celgene; Revlimid; Lenalidomide; Diffuse Large B-cell lymphoma; Non-Hodgkins lymphoma; CC-5013; Response Rate; Tumor Control Rate; Duration of Response; Time to Progression; Progression-free survival and safety

Summary:

      To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with
      dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma

          -  Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma

          -  Measurable disease on cross sectional imaging that is at least 2 cm in the longest
             diameter

          -  ECOG performance score of 0,1 or 2

          -  Willing to follow the pregnancy precautions

        Exclusion Criteria:

          -  Any of the following laboratory abnormalities.

          -  Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).

          -  Platelet count < 60,000/mm3 (60 x 109/L).

          -  Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).

          -  Serum total bilirubin > 2.0 mg/dL (34 µmol/L).

          -  Subjects who are candidates for and willing to undergo an autologous stem cell
             transplant.

          -  History of active CNS lymphoma within the previous 3 months

          -  Subjects not willing or unable to take DVT prophylaxis

          -  History of other malignancies within the past year

          -  Positive HIV or active Hepatitis B or C
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Condition: Anorexia Nervosa; Osteoporosis
MeSH terms: Osteoporosis; Anorexia; Anorexia Nervosa
Intervention: Placebo; Teriparatide
Intervention description: sc daily for 6 months; 20 mcg sc daily for 6 months
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: Female
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa; Disordered Eating; Osteoporosis; Parathyroid Hormone; Bone

Summary:

      Decreased bone strength is a common and serious medical problem present in many women with
      anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to
      suffer broken bones than women with normal bone strength.

      We are investigating whether a hormone that is naturally produced by the human body --
      parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anorexia Nervosa

          -  Women, age 30-70 years

          -  Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)

        Exclusion Criteria:

          -  Diseases known to affect bone metabolism

          -  Hyperparathyroidism

          -  Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in
             last 1 year)

          -  Pregnant and/or breastfeeding

          -  Diabetes mellitus

          -  History of malignancy involving or affecting the bone, any active malignancy, and/or
             radiation therapy to the bone

          -  Fractures of a bone other than a finger or toe in last 1 year
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Condition: Narcolepsy; Cataplexy Narcolepsy; Excessive Sleepiness
MeSH terms: Narcolepsy; Cataplexy; Sleepiness
Intervention: AXS-12 (Reboxetine); Placebo
Intervention description: Dosed orally, twice daily for up to 3 weeks; Dosed orally, twice daily for up to 3 weeks
Intervention MeSH terms: Reboxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CONCERT; AXS-12; EDS; Cataplexy; Narcolepsy; Axsome; Reboxetine

Summary:

      CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine
      Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter
      trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be
      randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg
      daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo
      for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and
      measures of other symptoms of narcolepsy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects between 18 and 70 years of age, inclusive

          -  Primary diagnosis of narcolepsy with cataplexy

          -  Willing and able to comply with the study requirements

        Exclusion Criteria:

          -  Other clinically significant conditions potentially causing EDS

          -  Clinically significant psychiatric disorders
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Condition: Anemia; Chronic Renal Failure; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: peginesatide; peginesatide; Epoetin Alfa
Intervention description: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).; Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.; Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Summary:

      The purpose of this study is to evaluate the safety and efficacy of peginesatide for the
      treatment of anemia in participants with chronic kidney disease who are on dialysis and are
      not taking any treatment to increase their red blood cell production.
    

Eligibility criteria:

        Inclusion Criteria

          1. On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.

          2. Two consecutive hemoglobin values of ≥ 8.0 g/dL and < 11.0 g/dL within the 4 weeks
             prior to randomization.

        Exclusion Criteria

          1. Females who are pregnant or breast-feeding.

          2. Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior
             to randomization.

          3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.

          4. Known bleeding or coagulation disorder.

          5. Known hematologic disease or cause for anemia other than renal disease

          6. Poorly controlled hypertension.

          7. Evidence of active malignancy within one year.

          8. A scheduled kidney transplant.