bioihbjkbjnl/mcl2 huggingface dataset:
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Condition: Schizophrenic Psychoses
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Intervention: n-acetylcysteine; Placebo
Intervention description: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM; Placebo tablets are placed in water or juice in the AM and PM
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective; schizophreniform; early schizophrenia spectrum psychosis

Summary:

      The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early
      phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and
      Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur
      during the pre-illness phase and around the transition to psychosis. Therefore, studying new
      treatments that could target changes occurring during this period is of critical importance.

      Aims:

      Does add-on NAC treatment in early psychosis influence:

        -  positive and negative symptoms

        -  extrapyramidal side-effects of other medication

        -  plasma concentration of glutathione

        -  Mismatch Negativity, a physiological marker
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capacity to provide informed consent

          -  DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective

          -  Psychiatric and medical stability

          -  Prescribing clinician's premission to participate, assurance of medical stability

          -  Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at
             Risk Mental States Scale) Psychosis subscale

          -  Up to 12 months of antipsychotic treatment

        Exclusion Criteria:

          -  Severe medical comorbidities

          -  Previous cerebral trauma

          -  Substance induced psychosis or organic psychosis

          -  Mental retardation

          -  NAC allergy

          -  Pregnancy, females and males planning pregnancy

          -  Treatment with antioxidants

          -  Insufficient command of English
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Condition: Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Mouth Diseases; Oral Ulcer
Intervention: Sucralfate; Placebo; Acetaminophen; Ibuprofen
Intervention description: Will receive 20mg/kg/dose up to 1 gram.; Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Sucralfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if sucralfate, a medication commonly used for patients
      with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level
      and improve their ability to drink.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥6 months and ≤5 years old

          -  Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand,
             foot and mouth disease

          -  History of decreased oral fluid intake by parent or guardian

          -  English or Spanish speaking parents or guardians

        Exclusion Criteria:

          -  Severely dehydrated or toxic, requiring immediate resuscitation

          -  Exclusively breastfed

          -  Severe dental disease

          -  Significant mouth trauma

          -  Active Malignancy

          -  Preexisting upper airway obstruction or swallowing difficulties

          -  Received intravenous fluids within 24 hours

          -  Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours
             of enrollment
Treatment of Patients With RAD001 With Progressive Sarcoma
Condition: Progressive Sarcoma
MeSH terms: Sarcoma
Intervention: Everolimus
Intervention description: 2.5 and 5 mg tablets taken orally and starting dose was 10 mg daily for all patients
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: progressive GIST; progressive sarcoma

Summary:

      The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to
      determine the preliminary efficacy and safety of RAD001 in patients with histological
      evidence of progressive or metastatic bone or soft tissue sarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Histological evidence of progressive or metastatic bone or soft tissue sarcoma.

        The following tumor types are included:

          -  malignant fibrous histiocytoma

          -  liposarcoma

          -  synovial sarcoma

          -  malignant paraganglioma

          -  fibrosarcoma

          -  leiomyosarcoma

          -  angiosarcoma including haemangiopericytoma

          -  malignant peripheral nerve sheath tumor

          -  STS, not otherwise specified

          -  miscellaneous sarcoma including mixed mesodermal tumors of the uterus

          -  osteosarcoma

          -  Ewing's sarcoma

          -  rhabdomyosarcoma

          -  gastrointestinal stromal tumor (only after failure or intolerance of imatinib or
             sunitinib in 1st and 2nd line)

          -  alveolar soft part sarcoma (ASPS)

               -  Objective progression of disease may be documented by RECIST criteria. Any of the
                  following would be sufficient according to RECIST:

          -  a 20% increase in the sum of unidimensionally measured target lesions

          -  a new lesion

          -  unequivocal increase in non-measurable disease.

               -  Patients must have disease not amenable to surgery, radiation, or combined
                  modality therapy with curative intent.

               -  ECOG performance status 0 - 2.

        Exclusion Criteria:

        Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy,
        immunotherapy, or radiotherapy.

          -  The following tumor types will not be included:

               -  gastrointestinal stromal tumor (except for patients after treatment with imatinib
                  or sunitinib in 1st and 2nd line)

               -  chondrosarcoma

               -  malignant mesothelioma

               -  neuroblastoma.

          -  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).

          -  Neurotoxicity > grade 2 CTC.

          -  Radiation of the lung.

        Other protocol-defined inclusion/exclusion criteria may apply
Fluid Chloride and AKI in Cardiopulmonary Bypass
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: 0.9% Normal Saline (0.9% Sodium Chloride) injection; Isolyte S injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models,
      excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid
      has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold
      under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI
      outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The
      investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients
      (up to 40 enrolled) into 2 study arms and compare renal outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned on- or off-pump cardiac surgery including: bypass grafting, valvular
             procedures, congenital defect correction, and thoracic aortic procedures or a
             combination of these procedures

        Exclusion Criteria:

          -  Emergency surgery

          -  Pregnancy

          -  Previous renal transplantation

          -  Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or
             RIFLE-F/KDIGO stage 2 or 3)

          -  Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis
             at time of enrollment

          -  Chronic kidney disease without baseline serum creatinine value obtained within 6
             months of enrollment
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Condition: Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: IdB 1016 (Siliphos); Matched placebo
Intervention description: 1 pill 3 times daily x 6 weeks; 1 pill 3 times daily x 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trials; Pilot Projects; Milk Thistle; Liver Function Tests

Summary:

      The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from
      milk thistle, to determine whether it is safe and well-tolerated in adults who have
      non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether
      Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes
      (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in
      people with NASH and will result in a decrease in the liver enzymes ALT and AST.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver biopsy within 12 months demonstrating NASH

          -  Abnormal ALT

        Exclusion Criteria:

          -  Uncontrolled diabetes

          -  Hepatitis B, hepatitis C, or other chronic liver conditions

          -  Abnormal kidney function

          -  Excess alcohol consumption
A Study of Flovent in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Flovent; Placebo
Intervention description: 1760 mcg daily; Placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 3 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Eosinophilic Esophagitis

Summary:

      The purpose of this study is to test the effects (both good and bad) of high dose swallowed
      fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent for study by subject, or parent/guardian if subject is a
             minor. Assent will be obtained from all minors 11 years of age and older.

          -  Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per
             high power field (400x) in the proximal or distal esophagus validated by a pathologist
             at CCHMC.

          -  Allergy evaluation including skin-prick testing with multiple food antigens to ensure
             elimination diet is not indicated.

          -  Have undergone a minimum 3 months of elimination diet as indicated by skin-prick
             testing without detectable resolution by repeat endoscopy with biopsies demonstrating
             persistent EE OR subject/parental refusal to follow elimination diet. If the
             subject/parent refuses the elimination diet, they are eligible for this study.

          -  Treatment with a proton-pump inhibitor for at least two months (rounded to nearest
             month) prior to endoscopy OR failure of histological improvement as defined by < 1
             eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump
             inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to
             rule out the possibility of GERD.

        Exclusion Criteria:

          -  History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple
             episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as
             evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections
             during exposure to Flovent

          -  Unable to cooperate with use of MDI

          -  Pregnant females

          -  Concurrent or recent (within 3 months) use of systemic corticosteroids.

          -  Unable to swallow medicines (i.e., fed only by gastrostomy tube).

          -  Comorbid eosinophilic disorders.

          -  Previously treated with swallowed glucocorticoid for EE within 3 months of the
             screening visit. Nasal glucocorticoids taken for EE are permitted.
Liposomal Bupivacaine in Bariatric Surgery
Condition: Bariatric Surgery Analgesia
Intervention: Liposomal Bupivacaine TAP block; Bupivacaine TAP block
Intervention description: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.; Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bariatric surgery; liposomal bupivacaine

Summary:

      The aim of this study is to perform a randomized controlled trial for patients undergoing
      bariatric surgery, comparing the need for opiates with and without administration of a
      transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal
      bupivacaine (Exparel®). From this study, the investigators will assess whether use of long
      acting local anesthetic can reduce the need for opiates in the bariatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patients undergoing bariatric surgery (LSG or LRYGB)

          -  Patients 18 years of age and older

          -  Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

        Exclusion Criteria:

          -  Patients under the age of 18 years old

          -  Patients taking any opiates within 30 days of enrollment in the trial

          -  Patients with a history of chronic pain.

          -  Patients taking pregabalin or gabapentin.

          -  ASA IV

          -  Prior laparotomy

          -  Body Mass Index ≥ 60 kg/m2

          -  History of cardiac arrhythmia

          -  History of Seizure

          -  Psychiatric Diagnosis currently on antipsychotic medication
Caring Light Project for Family Caregivers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Caring Response App; Traditional Educational/Resources Program
Intervention description: Participants will receive the Caring Light mobile app containing the coping skills training.; Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related
      dementia to cope with the difficulties related to caregiving, reduce stress, and improve
      quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Care for an individual with Alzheimer's Disease or other dementia.

          -  Own a smartphone or tablet and have Internet access.

          -  Minimum age of 18 years old.

          -  Spend at least 8 hours/week caring for a person with dementia.

        Exclusion Criteria:

          -  Severe psychological or physical illness.

          -  Inability to read and follow English instructions.

          -  High level of depressive symptoms.

          -  Unwillingness to participate in all aspects of the study.
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Intervention: perampanel
Intervention description: Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Seizure; epilepsy

Summary:

      The purpose of this trial is to investigate the safety and tolerability of perampanel in
      long- term treatment in the patients with refractory partial epilepsy (uncontrolled with
      other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients who consent to the study entry on their free will before starting any
             trial-related activities.

          2. Patients who participated in Study 231 and completed the required evaluation period
             (10 weeks).

          3. Patients who are certainly and voluntarily able to participate in this study and
             record their seizures by themselves or have family members or caregivers (or nurses,
             if hospitalized) record the seizures. Patients who wish to continue perampanel
             treatment and necessitate receiving the long- term administration judged by the
             investigator or sub-investigator.

        Exclusion criteria:

          1. Pregnant or lactating women, women of child-bearing potential, women willing to become
             pregnant.

          2. Patients who are ineligible judged by the investigator or sub investigator in light of
             medical history or complication at enrollment in treatment period.

          3. Patients who operate heavy equipment or drive should not be recruited into the study.

          4. Patients who are ineligible for study entry judged by the investigator or
             sub-investigator.
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of
      Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who
      are at imminent risk of suicide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major Depressive episode of at least 4 weeks and not exceeding 24 months in
             duration at visit 1

          -  Have current, ongoing suicidality (ideation or behavior) of sufficient severity to
             warrant hospitalization based on the judgment of the investigator

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 1 month before Visit 1.

          -  Lifetime history or currently meet DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study.

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant homicidal ideation or at imminent risk of injuring others or causing
             significant damage to property, as judged by the investigator.

          -  Prior participation in any investigational study of rapastinel/GLYX-13