bioihbjkbjnl/mcl2 huggingface dataset:
Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
Condition: Porphyria Cutanea Tarda
MeSH terms: Porphyria Cutanea Tarda; Porphyrias, Hepatic; Porphyria, Erythropoietic; Porphyrias
Intervention: Hydroxychloroquine; Phlebotomy
Intervention description: 100 mg by mouth twice weekly; 450 mL every 2 weeks
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Porphyria, rare disease, orphan disease, iron metabolism

Summary:

      Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by
      phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are
      limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of
      time to remission. Patients with well documented PCT are assigned to treatment by
      randomization if specific criteria are met. All patients are followed until remission -
      defined as achieving a normal plasma porphyrin concentration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented porphyria cutanea tarda (PCT)

          -  Willing to give informed consent

          -  Age 18 or greater

        Exclusion Criteria:

          -  Blistering skin lesions due to another condition
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: N-Acetylcysteine; placebo; Contingency Management
Intervention description: 1200 mg twice daily for 8 weeks; 2 capsules twice daily for 8 weeks; rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 13 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will
      reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is
      hypothesized that marijuana dependent adolescents who are treated with NAC will use less
      marijuana during treatment when compared to adolescents who receive a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13-21 years

          -  Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking
             marijuana cessation treatment

        Exclusion Criteria:

          -  Allergy or intolerance to NAC

          -  Pregnancy or lactation

          -  Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if
             taken with NAC) within 14 days of study participation

          -  Current enrollment in treatment for cannabis dependence

          -  Current substance dependence, other than cannabis or nicotine

          -  Significant medical or psychiatric illness that may place the participant at increased
             risk in the judgement of the study physician
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F
      18 uptake over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

        Exclusion Criteria:

          -  Current clinically significant cardiovascular disease, ECG abnormalities, risk factors
             for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session

          -  Have received or participated in a trial with investigational medications in the past
             30 days
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Roux-en-Y Gastric Bypass (RYGB); Caloric Restriction; Exendin-9,39; Normal Saline
Intervention description: Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.; Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.; A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.; subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bariatric Surgery; Weight loss

Summary:

      What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2
      diabetes outside of weight loss alone?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20-65 years of age.

          -  Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.

          -  Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested
             in surgery but are interested in supervised caloric restriction.

        Exclusion Criteria:

          -  Previous treatment with thiazolidinediones.

          -  Chronic antibiotic therapy.

          -  Active microvascular or macrovascular complications of diabetes.
Genistein in Treating Patients With Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: genistein; placebo; therapeutic conventional surgery
Intervention description: Given orally; Given orally; Radical prostatectomy for treatment of prostate cancer
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This randomized phase II trial is studying how well genistein works in treating
      patients with prostate cancer.
    

Eligibility criteria:

        Inclusion

          -  Participants must have a pathologic diagnosis of prostate cancer within the past 6
             months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have
             elected to undergo radical prostatectomy; those found to have detectable circulating
             prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to
             proceed onto the treatment phase of the protocol; pathology slides used for diagnosis
             will be submitted to the SPORE tissue pathology core for review

          -  ECOG performance status 0-1

          -  Hemoglobin > 9.0gm/dl

          -  Platelets >= 100 K/uL

          -  ANC > 1000/uL

          -  AST (SGOT)/ALT (SGPT) < 3X upper limit of normal

          -  Creatinine < 2.0 mg/dl

          -  Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a
             familial defect in bilirubin metabolism will be considered on an individual basis)

          -  Participants must agree not to take soy supplements

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to take study agent for at least 2 weeks prior to radical prostatectomy

        Exclusion

          -  History of venous thrombosis within past year

          -  Participants must not be receiving active therapy for neoplastic disorders (including
             hormone or radiation therapy for prostate cancer)

          -  Participants may not be receiving any other investigational agents

          -  Known soy intolerance

          -  Medical conditions that, in the opinion of the investigators, would jeopardize either
             the patient or the integrity of the data obtained
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: JKB-121: 5 mg twice daily; JKB-121: 10 mg twice daily; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily
      and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in
      patients with biopsy-proven nonalcoholic steatohepatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years

          2. Provision of written informed consent

          3. Biopsy-proven NASH within 12 months or at screening

          4. ALT > 40 U/L for women and > 60 U/L for men at screening and at least once in the
             previous 12 months.

          5. HBA1C of ≤ 9.0

        Exclusion Criteria:

          1. Any chronic liver disease other than NASH

          2. Cirrhosis, as assessed clinically or histologically

          3. Presence of vascular liver disease

          4. BMI ≤ 25 kg/m2

          5. Excessive alcohol use (> 20 g/day) within the past 2 years

          6. AST or ALT > 250 U/L.

          7. Type 1 diabetes mellitus

          8. Bariatric surgery in the past 5 years.

          9. Weight gain of > 5% in past 6 months or > 10% change in past 12 months.

         10. Contraindication to MRI

         11. Inadequate venous access

         12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C
             virus (HCV) RNA positive.

         13. Receiving an elemental diet or parenteral nutrition

         14. Chronic pancreatitis or pancreatic insufficiency

         15. Any history of complications of cirrhosis

         16. Concurrent conditions:

               -  Inflammatory bowel disease

               -  Significant cardiac disease

               -  chronic infection or immune mediated disease

               -  Any malignant disease

               -  Prior solid organ transplant

               -  Any other concurrent condition which, in the opinion of the investigator, could
                  impact adversely on the subject participating or the interpretation of the study
                  data.

         17. Concurrent medications which may treat NASH

         18. HbA1C > 9.0%

         19. Pregnancy or breastfeeding.
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: tisagenlecleucel
Intervention description: Tisagenlecleucel is single infusion.
Intervention MeSH terms: Tisagenlecleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory or relapsed Follicular Lymphoma; Refractory; Relapsed; Follicular lymphoma; CTL019; Tisagenlecleucel; Chimeric antigen receptor; CAR19; CAR-T

Summary:

      This is a multi-center, phase II study to determine the efficacy and safety of
      tisagenlecleucel in adult patients with relapsed or refractory FL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)

          -  Radiographically measurable disease at screening

        Exclusion Criteria:

          -  Evidence of histologic transformation

          -  Follicular Lymphoma Grade 3B

          -  Prior anti-CD19 therapy

          -  Prior gene therapy

          -  Prior adoptive T cell therapy

          -  Prior allogeneic hematopoietic stem cell transplant

          -  Active CNS involvement by malignancy

        Other protocol-defined Inclusion/Exclusion criteria may apply.
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: VESANOID; Ipilimumab
Intervention description: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).; Ipilimumab is current standard of care treatment for melanoma.
Intervention MeSH terms: Ipilimumab; Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Melanoma; Malignant Melanoma

Summary:

      The purpose of this study is to assess the safety and efficacy of combined treatment with
      Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 year.

          -  Patients diagnosed with advanced melanoma.

          -  Patients that are considered candidates for ipilimumab therapy.

          -  Patients able to understand and willing to sign a written informed consent documents.

          -  Patients willing to have regular blood draws, one before treatment and four during or
             after treatment.

        Exclusion Criteria:

          -  Patients under the age of 18.

          -  Patients with Stage I or II, melanoma who are not candidates for Ipilimumab.

          -  Patients that have received systemic treatments within four weeks prior to the
             beginning of treatment.

          -  Women that are pregnant or nursing.

          -  Patients taking immunosuppressive medications.

          -  Patients with active autoimmune disease.

          -  Patients with known sensitivity to retinoic acid derivatives.

          -  Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
             bilirubin > 2.5 × ULN.
To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.
Condition: Primary Bile Acid Diarrhea
MeSH terms: Diarrhea
Intervention: LJN452; Placebo to LJN452
Intervention description: Capsules containing LJN452; Capsules containing placebo to LJN452
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary bile acid diarrhea,; FXR agonist,; bile acid malabsorption.

Summary:

      The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid
      diarrhea and to assess its safety and tolerability profile in patients with primary bile acid
      diarrhea (pBAD) to guide decision-making regarding further clinical development in this
      indication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool
             frequency of at least 2 per day when off therapy AND Average stool form of >5 on
             Bristol Stool Chart.

          -  Previous laboratory or radiological confirmation of bile acid malabsorption with
             either fecal bile acid loss OR 7 day 75Selenium homocholic acid taurine (75SeHCAT)
             retention.

          -  Age ≥ 18 years.

        Key Exclusion Criteria:

          -  Patients with other diagnoses leading to diarrhea, including colorectal neoplasia,
             ulcerative colitis, Crohn's disease, celiac disease, chronic pancreatitis,
             drug-induced diarrhea or active infection AND Patients who have not been investigated
             by standard clinical assessments to exclude these disorders.

          -  Treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2
             weeks before the first dose of LJN452. A washout of 14 days for these agents will be
             allowed before first dosing.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  A positive Hepatitis B surface antigen or Hepatitis C test result.

          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western
             blot) test result.
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and
      insulin degludec. The reason for this study is to evaluate the amount of time with glucose
      values within target range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have type 1 diabetes and have been treated with insulin therapy for
             at least 1 year

          -  Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2
             months in the prior 6 months

          -  Participants must have been on the same type of short acting insulin (Humalog U-100,
             Novolog, Admelog, or Apidra) for at least 30 days prior to screening

          -  Participants must have been treated with long-acting insulin degludec U-100 for at
             least 30 days prior to screening

        Exclusion Criteria:

          -  Participants must not have had more than 1 emergency room visit or hospitalization due
             to poor glucose control within 6 months before screening

          -  Participants must not have had more than 1 episode of severe hypoglycemia within the
             last 90 days prior to screening

          -  Participants must not be taking certain diabetes medications that are not allowed for
             study participation
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Condition: Jet Lag Disorder
MeSH terms: Jet Lag Syndrome
Intervention: Tasimelteon; Placebo
Intervention description: capsule; capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With
      Jet Lag Disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and acceptance to provide written consent

          -  Men or women between 18-75 years

          -  Body Mass Index of ≥ 18 and ≤ 30 kg/m2

        Exclusion Criteria:

          -  History (within the 12 months prior to screening) of psychiatric disorders

          -  Major surgery, trauma, illness or immobile for 3 or more days within the past month

          -  Pregnancy or recent pregnancy (within 6 weeks)

          -  A positive test for drugs of abuse at the screening visit

          -  Any other sound medical reason as determined by the clinical investigator