bioihbjkbjnl/mcl2 huggingface dataset:
68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga RM2; 68Ga-PSMA-11; Investigational PET scanner coils and software
Intervention description: PET radiopharmaceutical; PET radiopharmaceutical; GE Healthcare non-approved PET scanner coils and software
Intervention MeSH terms: Gallium 68 PSMA-11; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for
      biopsy guidance in patients with suspected prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected prostate cancer

          -  Planned prostate biopsy

          -  Able to provide written consent

          -  Karnofsky performance status of 50 (or ECOG/WHO equivalent)

        Exclusion Criteria:

          -  Patients not capable of getting PET study due to weight, claustrophobia, or inability
             to lay still for the duration of the exam

          -  Metallic implants (contraindicated for MRI)
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Umbralisib
Intervention description: Ublituximab IV infusion; Umbralisib tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to provide the opportunity to the participants who progressed
      on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab
      (TG-1101) treatment in combination with umbralisib (TGR-1202).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior treatment in clinical trial UTX-TGR-304

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Participants refractory to ublituximab + TGR-1202

          -  Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's
             Lymphoma (NHL) (Richter's transformation)
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
Condition: Obstructive Sleep Apnea; Excessive Sleepiness
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Driving

Summary:

      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 21 to 65 years inclusive

          2. Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep
             Disorders (ICSD-3)

          3. BMI 18 to <40 kg/m2

          4. Willing and able to provide written informed consent

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic
             and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria

          4. History or presence of any unstable medical condition, behavioral or psychiatric
             disorder (including active suicidal ideation), or surgical history that could affect
             the safety of the subject or interfere with study efficacy and/or safety assessments
             per the judgment of the investigator

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription
             medications that could affect sleep-wake function
Memantine Treatment of Compulsive Buying
Condition: Compulsive Buying
Intervention: Memantine
Intervention description: 10-30mg, by mouth, daily
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Buying; Shopping; Impulse Control

Summary:

      This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 18-65

          2. current CB using the clinician-administered Structured Clinical Interview for
             Compulsive buying (SCI-CB)

          3. buying behavior within 2 weeks prior to enrollment

        Exclusion Criteria:

          1. infrequent buying (i.e. less than one time per week) that does not meet proposed
             criteria for CB

          2. unstable medical illness or clinically significant abnormalities on laboratory tests
             or physical examination at screen

          3. history of seizures

          4. myocardial infarction within 6 months

          5. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          6. a need for medication other than memantine with possible psychotropic effects or
             unfavorable interactions;

          7. clinically significant suicidality;

          8. current Axis I disorder determined by the SCID and SCID-compatible modules for impulse
             control disorders, except for nicotine dependence

          9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any
             psychotic disorder determined by SCID

         10. current or recent (past 3 months) DSM-IV substance abuse or dependence;

         11. positive urine drug screen at screening

         12. initiation of psychotherapy or behavior therapy within 3 months prior to study
             baseline

         13. previous treatment with memantine

         14. 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
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Condition: Idiopathic Parkinson's Disease; Drug Induced Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias; Dyskinesia, Drug-Induced
Intervention: Topiramate; Placebo; Amantadine
Intervention description: Topiramate as adjunct to amantadine; Placebo control; Existing treatment for all participants
Intervention MeSH terms: Topiramate; Amantadine
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: 30 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Parkinson's disease; dyskinesia; Indonesia; amantadine

Summary:

      The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed
      comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in
      the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on
      amantadine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria

          2. Current age between 30-90

          3. Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity
             (CGI-s) score (see attachment) > 3 (mild) established by clinician's total assessment
             of patient including objective observation during the screening process. *

          4. Stable doses of all antiparkinsonian medications for at least 4 weeks

          5. Stable treatment with at least 200 mg amantadine for at least 4 weeks.

          6. Presence of a caregiver willing to participate in the study

          7. In the opinion of the enrolling investigator, the subject will be able to maintain
             current dosing schedule of antiparkinsonian drugs for the duration of the trial.

          8. Subjects must be free of dementia, depression and psychosis as determined by clinical
             examination.

          9. The subject must be willing to participate in all study related activities and visits.

        Exclusion criteria:

          1. Any subjects with clinical evidence suggestive of an atypical or secondary form of
             Parkinson's Disease

          2. Any subject who, in the opinion of the Principal Investigator, has a concomitant
             medical illness which would preclude them from being treated with amantadine,

          3. Any subject who, in the opinion of the Principal Investigator, will be unable to
             maintain current stable dosing of their anti-parkinsonian medications for the duration
             of the trial,

          4. Any subject with evidence for dementia, depression, or psychosis, as determined by
             clinical examination.

          5. Any subject who has not signed informed consent, or unable or unwilling to participate
             in all of the study related activities.
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
Condition: Glioblastoma Multiforme of Brain
MeSH terms: Glioblastoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: adult glioblastoma

Summary:

      RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma
      Multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed Glioblastoma Multiforme

          -  Subtotal resection or biopsy only of tumor

          -  Measurable tumor by MRI scan performed within two weeks prior to study entry

          -  Tumor must be at least 5 mm

          -  No brain stem tumor

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  More than 4 months

        Hematopoietic:

          -  WBC at least 1,500/mm^3

          -  Platelet count at least 50,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic:

          -  No hepatic failure

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT and SGPT no greater than 5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No history of renal conditions that would contraindicate high dosages of sodium

        Cardiovascular:

          -  No uncontrolled hypertension

        Other:

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy

          -  No concurrent immunomodulatory agents

        Chemotherapy:

          -  No prior chemotherapy

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  Recovered from any prior surgery
Zinc to Treat Tinnitus in the Elderly
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Zinc; Placebo oral capsule
Intervention description: Zinc taken once daily; Placebo capsules taken once daily
Intervention MeSH terms: Zinc; Zinc Sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: placebo pill
Enrollment: 116.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: tinnitus, zinc

Summary:

      There is widespread belief and some evidence to indicate that zinc can successfully treat
      tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of
      this study is to establish the effectiveness of zinc for the treatment of tinnitus in
      individuals 60 years of age and older. Subjects will be randomly assigned to either receive
      zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed
      over to the other group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  Tinnitus for 6 months or more

          -  Normal copper levels

          -  Be generally healthy

        Exclusion Criteria:

          -  Have a treatable otological disorder

          -  Involved in litigation

          -  Have or are suspected of having a serious psychiatric problem

          -  Involved in other treatments for tinnitus

          -  Are taking drugs which might interact with zinc and result in tinnitus

          -  Have copper deficiency

          -  Have Zinc levels above normal

          -  Are cognitively impaired.
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
Condition: Opioid Related Disorder
MeSH terms: Opioid-Related Disorders
Intervention: RBP-6000; Subutex
Intervention description: 18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and given on alternate sides of the participant's abdomen.; Participants were inducted and stabilized over a 14-day period (study days -14 to -1) on SUBUTEX sublingual tablets. Tablets are placed under the tongue until dissolved.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid Dependence, Buprenorphine, Depot, SUBUTEX, RBP-6000

Summary:

      This is an open-label study in treatment seeking opioid-dependent subjects for safety,
      tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of
      subcutaneous injections of depot buprenorphine after induction and stabilization of treatment
      seeking subjects onto Subutex.

      Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28
      days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a
      13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose
      levels of 8-24 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects

          -  Agree not to take any buprenorphine products other than those administered for the
             current study throughout participation in the study

          -  Body mass index (BMI) of >18.0 to < 33.0 kg/m

        Exclusion Criteria:

          -  Participants with a current diagnosis requiring chronic opioid treatment

          -  Participants with a history of risk factors of Torsades de Pointes (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a
             Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females
             at screening

          -  Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Condition: Pain
Intervention: Intranasal sufentanil/ketamine
Intervention description: Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Intervention MeSH terms: Sufentanil; Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Year
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Painful medical procedures

Summary:

      The aim of the study is to investigate the absorption and clinical effect of nasal
      administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to
      medical procedures in hospitalized children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children and adolescents treated at the University Hospital, Rigshospital

          -  Painful medical procedure related to the patients treatment

          -  Patient and/or the parents must be able to understand and speak danish

          -  Negative pregnancy test for girls, when relevant

          -  Signed informed consent

          -  Only a light meals or no meals have been ingested 2 hours prior to inclusion

        Exclusion Criteria:

          -  Allergy to sufentanil or ketamine

          -  Abnormal nasal cavity

          -  Have been treated with sufentanil and/or ketamine during the last 48 hours

          -  Nasal obstruction (rhinitis)
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Bimekizumab; Adalimumab; Placebo
Intervention description: Bimekizumab in different dosages (dose 1 and 2).; Adalimumab in different dosages (dose 1, 2 and 3).; Placebo will be provided matching Bimekizumab.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Bimekizumab; HS; Moderate to Severe HS

Summary:

      Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses
      and scarring on the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at
             least

             1 year prior to Baseline

          -  Stable HS for at least 2 months prior to Screening and also at the Baseline Visit

          -  Inadequate response to at least a 3-month study of an oral antibiotic for treatment of
             HS

          -  Total abscess and inflammatory nodule count >=3 at the Baseline Visit

          -  Subject must agree to daily use (and throughout the entirety of the study) of 1
             pre-specified over-the-counter topical antiseptics on their HS lesions

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception up till
             20 weeks after last administration of study drug and have a negative pregnancy test at
             Visit 1 (Screening) and immediately prior to first dose

          -  Male subjects must be willing to use a method of contraception when sexually active,
             up till 20 weeks after the last administration of study medication

        Exclusion Criteria:

          -  Prior treatment with anti-IL17s or participation in an anti-IL17 study

          -  Previously received anti-TNFs

          -  Subject requires, or is expected to require, opioid analgesics for any reason
             (excluding tramadol)

          -  Subject received prescription topical therapies for the treatment of HS within 14 days
             prior to the Baseline Visit

          -  Subject received systemic non-biologic therapies for HS with potential therapeutic
             impact for HS less than 28 days prior to Baseline Visit

          -  Draining fistula count >20 at the Baseline Visit

          -  Diagnosis of inflammatory conditions other than HS
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Psilocybin
Intervention description: Dose-finding
Intervention MeSH terms: Psilocybin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of TRD

        Exclusion Criteria:

          -  Other comorbidities