bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Placebo; 5% VDA-1102; 10% VDA-1102
Intervention description: 200 mg applied once-daily for 28 days; 200 mg applied once-daily for 28 days; 200 mg applied once-daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: topical ointment; skin; hexokinase; precancerous conditions; carcinoma, squamous cell

Summary:

      This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled,
      multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of
      VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult
      subjects.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a
             single 25 square centimeter area of skin on their scalp or face

        Main Exclusion Criteria:

          -  Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the
             study, or (d) fertile and they or their fertile partner is unable or unwilling to use
             the required contraceptive methods

          -  Subject is immunosuppressed

          -  Subject has used any of the following topical treatments in the Treatment Field: (1)
             topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser
             ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or
             other topical treatments for AK or that might impact AK within 12 weeks of Screening.

          -  Subject has used systemic retinoid therapy within 6 months of Screening Visit.
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Ofatumumab; Ofatumumab
Intervention description: Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab; followed by 7 weekly infusions of 1000mg ofatumumab
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ofatumumab; rituximab; NHL; CD20; refractory

Summary:

      A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human
      Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to
      Rituximab as Monotherapy or in Combination With Chemotherapy
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient with follicular lymphoma grade 1 - 2

          -  Refractory to rituximab given as monotherapy or in combination with any chemotherapy
             or to rituximab given as maintenance treatment following R-chemo, defined as:

          -  failure to achieve at least PR to rituximab given as monotherapy or in combination
             with any chemotherapy; or,

          -  disease progression while on rituximab (either given as monotherapy or in combination
             with any chemotherapy or during rituximab maintenance treatment following R-chemo);
             or,

          -  disease progression in responders within 6 months of the last dose of rituximab
             (either given as monotherapy or in combination with any chemotherapy or after
             rituximab maintenance treatment schedule following R-chemo)

          -  Tumor verified to be CD20+ positive from excisional lymph node biopsy

          -  CT scan in screening phase (based on local evaluation) showing:

          -  2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or

          -  1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm

          -  ECOG Performance Status of 0, 1, or 2

          -  Age ≥ 18 years

          -  Following receipt of verbal and written information about the study, the patient must
             provide signed informed consent before any study related activity is carried out

        Exclusion Criteria

          -  Previous autologous stem cell transplantation within 6 months

          -  Previous allogeneic stem cell transplantation

          -  More than 1 previous radio immunotherapy regimen

          -  Received radio immunotherapy within 3 months

          -  Received any Anti-cancer treatment within 4 weeks

          -  Received monoclonal antibodies, other than rituximab within 3 months

          -  Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab

          -  Life expectancy less than 6 months
Study of SU011248 in Patients With Advanced Kidney Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: SU011248 capsule
Intervention description: 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Ph2, RCC, SU011248, SUNITINIB

Summary:

      To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally
      once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with
      metastatic Renal Cell Cancer (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven renal cell carcinoma with metastases with a component of clear
             cell histology

        Exclusion Criteria:

          -  Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or
             systemic molecular-targeting therapy for RCC.
Use of Pancreatic Enzymes in Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Pancreatic Enzyme
Intervention description: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 4 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pancreatic enzymes

Summary:

      Patients with short bowel syndrome have a high mortality rate that is mainly attributed to
      complications from central lines and long-term intravenous (IV) nutrition. There are few
      medical therapies to date that improve gut absorption in patients with short bowel syndrome.
      The primary objective of this study is to evaluate if absorption from the GI tract improves
      in subjects with short bowel syndrome following therapy with pancreatic enzymes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of a small bowel resection with subsequent dependence on parenteral nutrition
             for at least three months

          -  age 4 years to 65 years

          -  usual state of health for the past two weeks with no medication changes

          -  able to participate in a study for about four weeks with four study visits

          -  able to take pancreatic enzyme medication orally

        Exclusion Criteria:

          -  significant disease other than short bowel syndrome affecting the gastrointestinal
             tract that impacts absorption or digestions

          -  motility disorder

          -  medications that directly alter fat absorption

          -  cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0
             mg/dL, chronic renal failure, gout, or hyperuricemia

          -  history of a pork allergy

          -  women who are pregnant or lactating

          -  history of fibrosing colonopathy

        Those subjects who are eligible for the malabsorption blood test (MBT) test will be
        excluded if they have a history of a soy or safflower oil allergy.
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Olaparib
Intervention description: Participants will receive capsules of olaparib orally as stated in arm description.
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced breast cancer; Poly(ADP ribose) polymerases; AZD2281,KU-0059436 (olaparib); BRCA1 protein; BRCA2 protein

Summary:

      The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well
      tolerated in treating participants with measurable breast cancer gene (BRCA)1- or
      BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced breast cancer with positive BRCA1 or BRCA2 status

          -  Failed at least one prior chemotherapy

          -  In investigators opinion, no curative standard therapy exists

          -  Measurable disease

        Exclusion Criteria:

          -  Brain metastases

          -  Less than 28 days since last treatment used to treat the disease

          -  Considered a poor medical risk due to a serious uncontrolled disorder
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Administered orally as tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Copper Balance; Molybdenum Balance; Wilson Disease; ALXN1840

Summary:

      This exploratory study will investigate the effects of ALXN1840 on copper balance in
      participants with Wilson disease (WD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of WD by Leipzig Criteria ≥ 4.

          2. Able to reside in the clinical research unit for intensive metabolic monitoring of
             copper and molybdenum.

          3. Participants willing to adhere to copper/molybdenum-controlled diet during the study.

          4. Willing and able to follow protocol-specified contraception requirements.

          5. Capable of giving signed informed consent.

        Exclusion Criteria:

          1. Decompensated cirrhosis or model for end stage liver disease score > 13.

          2. Modified Nazer score > 7.

          3. Clinically significant gastrointestinal bleed within past 3 months.

          4. Alanine aminotransferase > 2 × upper limit of normal.

          5. Hemoglobin less than lower limit of the reference range for age and sex.

          6. Significant medical history (current or past).

          7. Previous treatment with zinc within 30 days prior to the Screening Visit.

          8. Participants in renal failure, defined as in end-stage renal disease on dialysis
             (chronic kidney disease stage 5) or creatinine clearance < 30 milliliters/minute.
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Pemetrexed
Intervention description: 500 mg/m2 IV every 3 weeks for 6 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head and neck cancer

Summary:

      This study will estimate overall response rate of pemetrexed in poor risk patients with
      advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced, metastatic, or recurrent head and neck cancers

          -  Poor risk patients with ECOG performance status of 2

        Exclusion Criteria:

          -  Prior treatment for recurrent or metastatic disease

          -  No clinical or radiological evidence of brain metatases

          -  Patients with bone only disease are not eligible

          -  Patients with pleural or peritoneal effusion as only manifestation of diesase
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Condition: Glioblastoma; Gliomas
MeSH terms: Glioblastoma; Glioma
Intervention: Temozolomide; Temozolomide
Intervention description: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.; Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the
      study to see if it is possible to increase the benefit of temozolomide when given after
      radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer
      when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide
      than patients treated with radiotherapy alone. Patients will receive standard low dose
      temozolomide during radiation. After radiation, they will be randomized to receive either
      more intense temozolomide or continuous low dose temozolomide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic evidence of a malignant glioma.

          -  Tissue block or unstained slides must be available for MGMT analysis.

          -  Age 18-70

          -  KPS > 50

          -  Granulocyte count >1.5 X 109/L

          -  Platelet count >99 X 109/L

          -  SGOT < 2.5X upper limit of normal (ULN).

          -  Serum creatinine < 2X ULN.

          -  Bilirubin < 2X ULN.

          -  All patients must sign written informed consent.

        Exclusion Criteria:

          -  Any prior chemotherapy, radiotherapy and biologic therapy for glioma.

          -  Any prior experimental therapy for glioma.

          -  Other concurrent active malignancy (with the exception of cervical carcinoma in situ
             or basal cell ca of the skin).

          -  Serious medical or psychiatric illness that would in the opinion of the investigator
             would interfere with the prescribed treatment.

          -  Pregnant or breast feeding women.

          -  Refusal to use effective contraception.
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
      paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab.
      Patients will be treated with RA101495 for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH by flow cytometry

          -  Inadequate response to eculizumab defined as having received eculizumab for at least 6
             months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the
             presence of a known C5 mutation conferring resistance to eculizumab

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
Naltrexone in the Treatment of Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Intervention: Naltrexone; Placebo
Intervention description: pill, by mouth, 50mg-150mg/day for the duration of the study; pill, by mouth, daily
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hair pulling

Summary:

      This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 18-75;

          2. current DSM-IV trichotillomania;

          3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as
             pleasurable the majority of time.

        Exclusion Criteria:

          1. unstable medical illness or clinically significant abnormalities on pre-study
             laboratory tests or physical examination;

          2. history of seizures;

          3. myocardial infarction within 6 months;

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          5. clinically significant suicidality;

          6. current or recent (past 3 months) DSM-IV substance abuse or dependence;

          7. illegal substance within 2 weeks of study initiation;

          8. initiation of psychotherapy or behavior therapy from a mental health professional for
             the treatment of trichotillomania within 3 months prior to study baseline;

          9. initiation of a psychotropic medication within 2 months prior to study inclusion;

         10. previous treatment with naltrexone; and

         11. treatment with investigational medication or depot neuroleptics within 3 months, with
             fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
             baseline;

         12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
             other DSM-IV psychotic disorder;

         13. current use of opiates.
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Intervention: Basmisanil; Placebo
Intervention description: Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.; Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition
      and functioning of stable schizophrenia participants treated with antipsychotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia of any type utilizing the Mini International
             Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders,
             fifth edition (DSM-5) direct clinical assessments, family informants and past medical
             records

          -  Evidence of stability of symptoms for 3 months at screening, that is, without
             hospitalizations for schizophrenia or increase in level of psychiatric care due to
             worsening of symptoms of schizophrenia

          -  Participants with schizophrenia clinical symptom severity defined by the following:
             hallucinatory behavior item score less than or equal to (</=) 5 and a delusion item
             score </= 5 of the PANSS

          -  Participants on a stable regimen of antipsychotic therapy for at least 3 months at
             screening and receiving no more than two antipsychotics

        Exclusion Criteria:

          -  Participants with current DSM-5 diagnosis other than schizophrenia including bipolar
             disorder, schizoaffective disorder and major depressive disorder

          -  Clinically significant neurological illness or significant head trauma that affects
             cognitive function, in the judgment of the principal investigator

          -  Full scale intelligence quotient </=65 on the Wechsler Abbreviated Scale of
             Intelligence at screening

          -  Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency
             virus-1 and 2

          -  Moderate to severe substance use disorder (other than nicotine or caffeine), as
             defined by the DSM-5, within the last 12 months

          -  Suicide attempt within 1 year or currently at risk of suicide in the opinion of the
             Investigator