bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Condition: Diabetic Macular Edema; Vitrectomy
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone
Intervention description: 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in
      the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be
      followed for 26 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older with diabetic macular edema

          -  History of vitrectomy

          -  Central retinal thickness ≥ 275 µm

          -  Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in
             the other eye

        Exclusion Criteria:

          -  Known anticipated need for ocular surgery during the study period

          -  History of glaucoma or current high eye pressure requiring more than 1 medication

          -  Uncontrolled systemic disease

          -  Known allergy to the study medication

          -  Known steroid-responder

          -  Use of systemic steroids

          -  Female subjects that are pregnant, nursing or planning a pregnancy
Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia
Condition: Anemia; Unexplained Anemia (UAE)
MeSH terms: Anemia
Intervention: iron sucrose; iron sucrose
Intervention description: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.; Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Anemia; Unexplained anemia; elderly; geriatric; older adults; UAE; over 65; iron; pactte; pactee; aging; aged; old; older

Summary:

      The purpose of this study is to determine whether treatment of unexplained anemia in older
      adults with a short course of weekly intravenous iron infusions can improve physical activity
      and therefore quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 65 years old

          -  Hemoglobin concentration ≥ 9.0 g/dL and < 11.5 g/dL (women) or < 12.7 g/dL (men)

          -  Unexplained anemia

          -  Serum ferritin level ≥ 20 and ≤ 200 ng/mL

          -  Able to walk without the use of a walker, motorized device or the assistance of
             another person.

          -  Able to understand and willing to provide written informed consent in the absence of
             dementia

          -  Must be able to understand and speak in English

        Exclusion Criteria:

          -  Red blood cell transfusions within the past 3 months

          -  Use of erythropoiesis stimulating agents (ESA) in the past 3 months

          -  Intravenous Iron Infusions within the past 3 months

          -  Distance on baseline 6MWT (6 minute walk test) above the median for age and sex

          -  History of unstable angina or myocardial infarction in the past 3 months

          -  History of stroke or TIA (transient ischemic attack) the past 3 months

          -  Uncontrolled hypertension (diastolic blood pressure > 100 mm Hg or systolic blood
             pressure > 160 mm Hg on 2 separate occasions)

          -  Positive fecal occult blood test within the screening period

          -  Elevated AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≥ 2x upper
             limit of normal

          -  Documented anaphylactic reaction to iron sucrose infusion in the past

          -  Subjects initiated on oral iron supplementation within the last 6 weeks, or those
             initiated on oral iron within the last 3 months who have had at least a one gram/dL
             improvement in Hb since starting oral iron supplementation
Herbal Treatment for Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Shi-Bi-Lin; Placebo
Intervention description: 4 weeks of treatment, dose of 1 g (two capsules), twice daily; 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Perennial Allergic rhinitis; Traditional Chinese Medicine

Summary:

      Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The
      conventional therapies are effective in alleviating symptoms but the efficacy are limited and
      not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese
      herbal formula, has been used for AR for centries. Our study purpose is to evaluate the
      clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis
      (PAR).

      Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and
      change some immunological parameters in the peripheral blood when comparing with the placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged from 18 to 65 years old

          -  Have typical symotoms of PAR including rhinirrhea, sneezing, nasal obstruction and
             itching in nose and eyes for at least 2 previous consecutive years.

          -  Postive skin prick test(SPT) to hose dust mite, mold, animal dander and cockcroach
             with regular AR medications withould for 3 days prior to the test

        Exclusion Criteria:

          -  Pregnant women and women at risk of conception

          -  Received allergen injections in previous 2 years

          -  Regular medications for AR or cold and other allergic disorder

          -  Seasonal allergic rhinitis, vasomotor rhinitis and rhinitis medicamentosa

          -  Nasal structure deformities, nasal polyps and hypertrophic rhinitis

          -  Systematic cortisosteroid used within recent 3 months or nasal cortisosteroid with 15
             days

          -  Other active respiratory disorders

          -  Active medical disorders: cancer, infection, hematology, renal, hepatic,
             cardiovascular, metabolic and gastrointestinal diseases
A Study of Tasisulam in Treating Participants With Malignant Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: tasisulam
Intervention description: Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine the objective response rate (complete and
      partial response) for participants who receive tasisulam after one prior systemic treatment
      for unresectable or metastatic melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)

          -  Have received 1 previous systemic treatment regimen for unresectable or metastatic
             melanoma. An immunotherapy or antibody-based regimen (including vaccination-based
             treatments) is not counted as a prior treatment regimen for determining study
             eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer
             drug.

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

        Exclusion Criteria:

          -  Serious pre-existing medical conditions

          -  Have received two or more previous treatment regimens for unresectable or metastatic
             melanoma

          -  Have a second primary cancer (unless disease-free to more than 2 years)

          -  Active treatment with Warfarin (Coumadin)

          -  Primary ocular or mucosal melanoma
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
Condition: Lysosomal Acid Lipase Deficiency
MeSH terms: Wolman Disease
Intervention: Sebelipase Alfa
Intervention description: IV infusion of sebelipase alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 8 Months
Healthy volunteers: No
Keywords: Enzyme Replacement Therapy (ERT); Lysosomal Storage Disease; Late Onset Lysosomal Acid Lipase (LAL) Deficiency; Acid cholesteryl ester hydrolase deficiency, type 2; Acid lipase disease; Cholesterol ester hydrolase deficiency; LAL Deficiency; LIPA Deficiency; Wolman disease; Additional relevant MeSH terms:; Cholesterol Ester Storage Disease; Metabolic Diseases; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Infant, Newborn, Diseases

Summary:

      This study evaluated the safety and efficacy of sebelipase alfa in a broad population of
      participants with lysosomal acid lipase deficiency (LAL-D).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Participant was >8 months of age at the time of dosing.

          2. Confirmation of LAL-D diagnosis as determined by the central laboratory or, for
             participants with prior hematopoietic stem cell transplant or liver transplant,
             historical enzyme activity or molecular genetic testing confirming a diagnosis of
             LAL-D.

          3. Participants >8 months but <4 years of age at Screening had at least 1 of the
             following documented clinical manifestations of LAL-D:

               -  Dyslipidemia

               -  Elevated transaminases

               -  Impaired growth

               -  Suspected malabsorption

               -  Other clinical manifestation of LAL-D

          4. Participants ≥4 years of age at Screening had at least 1 of the following documented
             clinical manifestations of LAL-D:

               -  Evidence of advanced liver disease

               -  Histologically confirmed disease recurrence in participants with past liver or
                  hematopoietic transplant

               -  Persistent dyslipidemia

               -  Suspected malabsorption

               -  Other clinical manifestation of LAL-D

        Key Exclusion Criteria:

          1. Participant had known causes of active liver disease other than LAL-D, which had not
             been adequately treated.

          2. Participant received a hematopoietic stem cell or liver transplant <2 years from the
             time of dosing.

          3. Participant with co-morbidities other than complications due to LAL-D, which were
             irreversible or associated with a high mortality risk within 6 months or would
             interfere with study compliance or data interpretation.
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Condition: OCD
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: escitalopram; Placebo ( sugar pill)
Intervention description: Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.; Placebo Comparator in double.blind phase.
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OCD; SSRI; escitalopram; relapse

Summary:

      This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating
      obsessive-compulsive disorder (OCD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of OCD

          -  A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the
             screening and baseline visits

        Exclusion Criteria:

          -  Lifetime history of psychosis or cognitive dysfunction due to a general medical
             condition or substance use

          -  A primary diagnosis of another Axis I psychiatric disorder

          -  Alcohol or other substance abuse or dependence within the last 6 months

          -  Unstable medical condition

          -  Clinically significant laboratory abnormality

          -  Failure of a previous 10-week trial of citalopram of at least 40 mg/day or
             escitalopram 20 mg/day

          -  Active suicidality

          -  History of violent behavior in the past year or current risk of serious violence

          -  A history of sensitivity to citalopram or escitalopram

          -  Use of other investigational drugs within 30 days of baseline or other psychotropic
             drugs or herbs within 14 days of baseline (28 days for fluoxetine)

          -  Need for concurrent psychotherapeutic intervention

          -  Pregnant or lactating females.
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Intervention: ACZ885; Placebo
Intervention description: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects; Monthly doses of placebo to match the administered dose of canakinumab s.c.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 8 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Sickle cell disease; hemoglobinopathy; pediatric

Summary:

      The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric
      and young adult patients with sickle cell anemia (SCA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle
             cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or
             analysis of either hemoglobin or DNA).

          -  Patient's written informed consent from those ≥18 years of age must be obtained before
             any assessment is performed. Parent or legal guardian's written informed consent and
             child's assent, if appropriate, are required before any assessment is performed for
             patients < 18 years of age.

          -  Detectable baseline of background or episodic pain measured by daily e-diary over 1 to
             2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm
             without analgesic use over a period of at least 7 days and/or, At least one episode of
             pain requiring analgesic use during a period of up to 14 days.

          -  History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with
             no other, non-sickle cell identifiable cause that requires analgesia and interferes
             with the patient's normal daily routine.

        Exclusion Criteria:

          -  History of known hypersensitivity to canakinumab.

          -  Ongoing or treatment with the past 3 months with red blood cell transfusion therapy,
             or have evidence of iron overload requiring chelation therapy.

          -  Transcranial Doppler ultrasound in the past year or at screening in patients with an
             accessible transtemporal window, demonstrating velocity in middle or anterior cerebral
             or internal carotid artery ≥200 cm/sec.

          -  Administration of any other blood products within 3 weeks of screening visit.

        Other protocol-defined inclusion/exclusion criteria may apply.
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: SSP-002358 (0.1 mg) + PPI; SSP-002358 (0.5 mg) + PPI; SSP-002358 (2.0 mg) + PPI; Placebo + PPI
Intervention description: 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI; 0.5 mg tablet t.i.d. taken in addition to a PPI; 2.0 mg tablet t.i.d. taken in addition to a PPI; Placebo t.i.d. taken in addition to a PPI
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 480.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor
      agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in
      subjects with GERD who have persistent symptoms while on PPI therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent Form signed voluntarily before the first study-related
             activity.

          2. Aged between 18 and 70 years, inclusive.

          3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and
             regurgitation) prior to PPI therapy.

          4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.

          5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the
             past week with or without heartburn while on PPI.

          6. Subjects have at least some improvement to the symptom of heartburn while on PPI
             therapy.

          7. Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the
             last 4 weeks are on a stable labeled dose for any GERD indication according to the
             country label, where a change of PPI therapy would not impact the symptoms
             (twice-daily dosing of PPI is not allowed in the last 4 weeks)

        Exclusion Criteria:

          1. Subjects who show no response to heartburn while on PPI therapy.

          2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms
             (heartburn and/or regurgitation).

          3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects
             with major GI disorders.

          4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or
             neurologic disease, cancer or AIDS.

          5. Alarm symptoms suggestive of malignancies or organic disease.
GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Condition: Amenorrhea; Premature Ovarian Failure; Ovarian Function Insufficiency
MeSH terms: Primary Ovarian Insufficiency; Menopause, Premature; Amenorrhea
Intervention: Leuprolide Acetate; Questionnaire; Hematopoietic Stem Cell Transplantation
Intervention description: 22.5 mg IM injection 2 months before transplant and 3 months post-transplant.; Questionnaires taking about 15 minutes to complete.; Stem cell infusion on Day 0.
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Hematopoietic Stem Cell Transplantation; GnRH Analogue; Gonadotropin-releasing hormone analogue; GnRH-a; Ovarian Function; Fertility; Leuprolide Acetate; Lupron Depot; premature ovarian failure; POF; Abnormal suppression of menstruation; absence of menstruation

Summary:

      Primary Objectives:

        -  To determine the effectiveness of the 3-month depot leuprolide in inducing and
           maintaining secondary amenorrhea in patients undergo hematopoietic stem cell
           transplantation.

        -  To determine the incidence of regained ovarian function manifested as spontaneous
           restoration of menstruation and normalization of hormonal level in patients after
           transplantation and discontinuation of long-acting leuprolide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hematopoietic stem cell transplantation candidate.

          -  Post-menarche female less than 40 years old.

          -  Premenopausal before the start of transplantation, or the start of oral contraceptive
             pills.

          -  Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing
             hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection
             or the ovarian status is determined by Gynecology Oncology Service.

          -  Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year
             post-transplant

        Exclusion Criteria:

          -  Breast cancer

          -  Ovarian cancer

          -  Pregnancy

          -  Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs