bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Aripiprazole on Cocaine Craving and Self-Administration
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Intervention: Aripiprazole + Cocaine; Placebo + Cocaine
Intervention description: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).; Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Intervention MeSH terms: Cocaine; Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In order to achieve steady-state concentrations, participants (n=8 men) were administered placebo and aripiprazole (15 mg/day) capsules in counter-balanced order for 21 days. A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance.
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aripiprazole; Cocaine abuse

Summary:

      The purpose of this study is to investigate whether aripiprazole will decrease cocaine
      self-administration, subjective effects and cravings compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for current cocaine abuse

          -  Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at
             least $70 per week on cocaine

          -  Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or
             exceed those administered in the study

          -  Age 21-45

          -  Able to give informed consent, and comply with study procedures

        Exclusion Criteria:

          -  Current seizure disorder, heart disease or psychiatric disorders (other than cocaine
             dependence)

          -  Dependence on substances other than cocaine or nicotine

          -  Request for drug treatment

          -  Judged to be noncompliant with study protocol

          -  Current use of any medication that has the potential to interact with aripiprazole
             (i.e., seizure medications, anti-fungal medications, cardiac medications, or
             medication that produces drowsiness)

          -  Clinical laboratory tests outside normal limits that are clinically unacceptable to
             the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for
             women, < 36 for men; pseudocholinesterase deficiency)

          -  Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other
             than transient psychosis due to drug abuse

          -  Current parole or probation

          -  History of significant violent or suicidal behavior
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Condition: Adult T-cell Leukemia-lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Intervention: KW-0761
Intervention description: KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.
Intervention MeSH terms: Mogamulizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC
      chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous
      infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell
      leukemia-lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Positive for serum anti-HTLV-I antibody

          2. Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past

          3. Positive for CCR4

          4. Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy

          5. Received at least one prior chemotherapy

          6. Subjects with an interval of four weeks or more between the last day of the previous
             treatment and the scheduled day of the first KW-0761 treatment

          7. PS of 0 to 2

          8. Negative for HBs antigen and for HBV-DNA by a real-time PCR

        Exclusion Criteria:

          1. A history of transplantation such as hematopoietic stem cells

          2. Positive for HCV antibody or HIV antibody

          3. Active multiple cancers at the time of starting this clinical study

          4. Previous history of allergic reactions after receiving antibody products

          5. Requiring continuous systemic treatment with a steroid

          6. Requiring such radiotherapy after starting this clinical study

          7. Treated with any investigational drug other than KW-0761 within three months
Pharmacokinetics of Advantage Arrest
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: 38% silver diamine fluoride
Intervention description: Topical application of SDF to teeth
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adult; fluoride; silver; silver diamine fluoride; pharmacokinetics

Summary:

      The study aim is to characterize the kinetics of silver and fluoride after topical
      application of silver diamine fluoride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC
             medications

        Exclusion Criteria:

          -  pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known
             sensitivity to silver or fluoride
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Condition: Liver Cancer
MeSH terms: Liver Neoplasms; Neoplasm Metastasis
Intervention: Tomotherapy treatment
Intervention description: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; Metastatic Liver Cancer; Tomotherapy; Stereotactic Body Radiation Therapy

Summary:

      The purpose of this study is to determine the response of liver tumors to radiation therapy
      using Tomotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of solid primary tumor metastatic to liver

          -  Age greater than or equal to 18 years old

          -  Zubrod performance status less than or equal to 1

          -  Negative pregnancy test for women of child bearing potential

          -  Informed consent

          -  Less than or equal to 3 liver metastases

          -  Each lesion must be less than or equal to 6 cm in maximal diameter

          -  No prior radiation to lesions being treated

          -  Patient is not a surgical candidate or refuses surgery

          -  Absolute neutrophil count ≥ 1800

          -  Platelets ≥ 100000

          -  Hemoglobin ≥8.0

          -  Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT

          -  At time of radiation treatment planning, at least 700 cc of normal liver must receive
             less than 15 Gy

        Exclusion Criteria:

          -  Contraindications to radiation

          -  Pregnant or lactating females who chose to breast feed

          -  Patients must have recovered from toxicity of prior therapy

          -  Any co morbid condition that' in the view of the attending physician' renders the
             patient at high risk from treatment complications

          -  Patients currently receiving anticoagulation with coumadin or IV heparin

          -  Liver cirrhosis

          -  Clinical ascites

          -  Bilirubin > 3, Albumin < 2.5, liver enzymes 3 times above normal, Creatinine > 1.8
Anakinra as a Treatment for Hydradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: anakinra
Intervention description: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hidradenitis suppurativa; anakinra

Summary:

      This is an open-label, proof-of-concept research study to assess the effectiveness of
      anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned
      intervention is to provide about 6 HS patients with anakinra 100mg daily injections to
      administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a
      further 8 weeks to monitor for relapse of HS.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with
        moderate or severe disease activity

        Exclusion Criteria:

          1. Use of the following therapies:

               -  Etanercept in the 4 weeks prior to the baseline visit (Day 1)

               -  Adalimumab in the 8 weeks prior to the baseline visit (Day 1)

               -  Infliximab in the 12 weeks prior to the baseline visit (Day 1)

               -  Any other investigational biologics in the 8 weeks prior to the baseline visit
                  (Day 1)

               -  Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in
                  the 4 weeks prior to the baseline visit (Day 1)

               -  Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)

               -  I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)

               -  6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks
                  prior to the baseline visit (Day 1)

               -  Colchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks
                  prior to the baseline visit (Day 1)

               -  Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior
                  to the baseline visit (Day 1)

          2. history of immunocompromise including HIV infection

          3. positive Hep B surface antigen -
Treatment of Hemoglobin SC Disease With Hydroxyurea
Condition: Hemoglobin SC Disease
MeSH terms: Hemoglobin SC Disease
Intervention: hydroxyurea
Intervention description: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores
Intervention MeSH terms: Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 5 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hemoglobin SC disease; hydroxyurea; quality of life; viscosity; red cell density

Summary:

      Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle
      cell disease with typically higher hemoglobin and milder or later disease complications.
      Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This
      can result in painful episodes, serious infections, and damage to body organs. One medication
      used to treat sickle cell disease is hydroxyurea.

      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with
      sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest
      syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but
      HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,
      so less is known about how HbSC patients respond to hydroxyurea.

      The purpose of this research study is to see if hydroxyurea, a medication given to many
      children with the most common type of sickle cell, those who are homozygous for the sickle
      mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by
      giving a questionaire when the medication is started, and then every two months at a clinic
      visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle Cell
      Disease Module version 3.0, measures quality of life. The investigators will also see how
      hydroxyurea changes laboratory test numbers, and blood thickness.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of HbSC disease

          2. Score equal or lower than 80 on the PedsQL™ Sickle Cell Disease Module version 3.0

          3. Have experienced a sickle cell disease related complication

        Exclusion Criteria:

          1. Failure to meet inclusion criteria.

          2. Hydroxyurea usage in the last 3 months.

          3. Chronic RBC transfusion therapy.

          4. Packed red blood cell transfusion in the last 3 months (temporary exclusion).

          5. Pregnancy, or refusal to use medically effective birth control if female and sexually
             active.
Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
Condition: Aging; Skin Abnormalities
MeSH terms: Skin Abnormalities
Intervention: Polypodium leucotomos
Intervention description: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos; Skin Aging and Damage

Summary:

      With this study, the investigators will like to determine if taking a dose of the study
      medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin
      caused by the adverse effects of UVA, a type of ultraviolet light.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects,

          -  18 years of age or older,

          -  with Fitzpatrick skin types II and III.

        Exclusion Criteria:

          -  Pregnancy

          -  Personal history of skin cancer

          -  History of abnormal photosensitivity

          -  Smokers

          -  Patients with history or being exposed to other forms of radiation (other than
             sunlight)

          -  History or current exposure to asbestos

          -  Patients taking any drug that might alter the response of skin to UVR (including, but
             are not limited to, doxycycline, sulfas, psoralens, and amiodarone)

          -  Patients unable to undergo skin biopsies

          -  History of abnormal scarring

          -  History of adverse reaction to local anesthesia
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan
Intervention description: Tolvaptan was supplied as 15 and 30 mg tablets.
Intervention MeSH terms: Tolvaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the trial was to determine the short-term effects of tolvaptan in patients
      with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) by Ravine criteria.

        Exclusion Criteria:

          -  Renal replacement therapy.

          -  Use of therapies for the purpose of affecting polycystic kidney disease (PKD) cysts.

          -  Evidence of significant renal disease, eg, active glomerular nephritides, renal
             cancer, single kidney.

          -  Significant risk-factors for renal impairment, eg, chronic use of diuretics, advanced
             diabetes, use of nephrotoxic drugs.

          -  History of significant coagulation defects or hemorrhagic diathesis.
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Lymphoseek; Single Photon Emission Computed Tomography (SPECT); Indocyanine Green (ICG); Neoprobe Gamma Detection System NPB11L(Model1102)
Intervention description: Radioactive diagnostic agent; Imaging test; Cyanine dye used in medical diagnostics manufactured by Akorn Inc.; Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce
      additional surgical dissection that is needed in case a sentinel lymph node cannot be
      detected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has histological diagnosis of cancer of the endometrium of any histology
             or grade.

          -  The patient should have received no prior treatment for her endometrial cancer.

          -  The patient has clinically uterine confined disease.

          -  The patient is a candidate for minimal invasive surgery, with sentinel lymph node
             assessment with IC-GREEN planned as part of standard of care.

          -  The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.

          -  If age less than or equal to 55 years, the patient has a negative pregnancy test
             within 72 hours before administration of Lymphoseek, has been surgically sterilized,
             or has been postmenopausal for at least 1 year.

          -  The patient has provided written informed consent.

          -  The patient is at least 18 years of age at the time of consent

        Exclusion Criteria:

          -  The patient has clinical or radiological evidence of metastatic disease.

          -  The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or
             cone procedure performed on her cervix.

          -  The patient has participated in another investigational drug study within 30 days of
             scheduled surgery.

          -  The patient has an iodine allergy.

          -  The patient is pregnant or lactating.
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: Revusiran (ALN-TTRSC)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cardiomyopathy; Heart Failure; FAC; Amyloid; Transthyretin; TTR; RNAi therapeutic

Summary:

      The purpose of this study was to evaluate the safety and clinical activity of long-term
      dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being
      followed-up for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the
             ALN-TTRSC-002 study

          -  Adequate liver function

          -  Not Pregnant or nursing

        Exclusion Criteria:

          -  Inadequate renal function

          -  Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac
             arrhythmia

          -  Untreated hypo- or hyperthyroidism

          -  Prior major organ transplant
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Condition: Post-Dural Puncture Headache; Sphenopalatine Ganglion Block
MeSH terms: Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache; Headache
Intervention: Lidocaine
Intervention description: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm, pilot study
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion
      block to alleviate the pain of post-dural puncture headache (PDPH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Complains of symptoms suggestive of post-dural puncture headache

          2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during
             epidural placement) within the previous 7 days

          3. Fluent in written and spoken English

        Exclusion Criteria:

          1. Those with a known history of hypersensitivity to local anesthetics of the amide type
             or to other components of GLYDO

          2. Those with any congenital or acquired, anatomical deformity of the nostril, which
             preclude performing the block

          3. Those who refuse to consent to participate in the study

          4. Patients who have had a failed epidural blood patch

          5. Cognitive Impairment

          6. Prisoner