bioihbjkbjnl/mcl2 huggingface dataset:
A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
Condition: Cushing Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Intervention: ATR-101; Placebo
Intervention description: During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.; During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Endogenous Cushing's Syndrome; ATR-101; CS

Summary:

      This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101
      to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous
      Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an
      open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a
      double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets
      randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if
      the subject does not meet randomization criteria).It is anticipated that the overall duration
      of the study per subject will range from approximately 16-22 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of endogenous Cushing's syndrome

          -  Baseline UFC 1.3 to 10 × upper limit of normal (ULN)

          -  If previous pituitary surgery, participants must be at least 3 months since surgery at
             the time of screening

          -  BMI between 18 and 60 kg/m2, inclusive

        Exclusion Criteria:

          -  Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's
             syndrome

          -  Candidates for surgical treatment of Cushing's syndrome, unless surgery is not
             anticipated to occur during the study

          -  Normal late night salivary cortisol or 24-hr urine free cortisol

          -  Radiotherapy of the pituitary within 6 months
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: OPC-6535(Tetomilast)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-6535; ulcerative colitis

Summary:

      The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and
      to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for
      8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients
      with active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active ulcerative colitis

          -  Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a
             fixed dose

          -  Either inpatient or outpatient

        Exclusion Criteria:

          -  Patients who have a history of intestinal resection (other than appendiceal resection)

          -  Patients who have a complication of malignant tumor

          -  Female patients who are pregnant, lactating, or possibly pregnant, or who wish to
             become pregnant during the study period
Cognitive Remediation for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: levodopa/carbidopa; Ropinirole 2 mg/d; Placebo; Ropinirole 4 mg/d
Intervention description: 800/200 mg/d; 2 mg/d; sugar pill; 4 mg/d
Intervention MeSH terms: Levodopa; Carbidopa; Ropinirole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: cocaine; cognition; medication; treatment

Summary:

      The purpose of this study is to evaluate treatments designed to improve cocaine treatment
      success by combining medications that target cocaine-related cognitive impairments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet criteria for cocaine dependence

          -  seeking treatment for cocaine dependence

          -  be in acceptable health based on medical history and physical exam

        Exclusion Criteria:

          -  dependent on drugs other than cocaine, nicotine, marijuana

          -  have a medical condition contraindicating treatment with study medications

          -  having conditions of probation or parole requiring reports of drug use to officers of
             the court
Liposome Bupivacaine Interscalene Total Shoulder
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: liposome bupivacaine; Bupivacaine
Intervention description: interscalene block with liposomal bupivacaine plus bupivacaine; interscalene block with bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized prospective outcomes study comparing two groups of patients. One group
      will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine
      alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the
      study is to determine if LB plus bupivacaine provides superior pain control compared to
      bupivacaine alone when injected in an interscalene block for patients undergoing total
      shoulder arthroplasty surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients aged greater than 18 years of age that are undergoing total or
             reverse total shoulder arthroplasty

        Exclusion Criteria:

          -  Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks
             prior to surgery, patient refusal, patient with coagulopathy, non-english speaking
             patients, and those who do not have access to a telephone.
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
Condition: Rhinitis; Allergic; Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo drops; Placebo tablets matching to levocetirizine; Placebo tablets matching to cetirizine; Levocetirizine drops; Levocetirizine tablets; Cetirizine drops; Cetirizine tablets
Intervention description: Pharmaceutical form: Drops for oral administration
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use; Pharmaceutical form: Drops for oral administration
Concentration: 5 mg/ml
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Concentration: 5 mg
Route of administration: Oral use; Pharmaceutical form: Drops for oral administration
Concentration: 10 mg/ml
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Concentration: 10 mg
Route of administration: Oral use
Intervention MeSH terms: Cetirizine; Levocetirizine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 551.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Levocetirizine; Xyzal; Rhinitis; Allergic; Seasonal; Ragweed

Summary:

      The purpose of the study is to assess the efficacy comparability of cetirizine and
      levocetirizine, by comparing the effects of single intake of the two drugs to placebo in
      reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects
      exposed to ragweed pollen in an Environmental Exposure Unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subject of non-childbearing potential or of childbearing potential agreeing not
             to become pregnant during the study.

          -  Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years

          -  Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as
             defined by protocol

        Exclusion Criteria:

          -  Any clinically significant condition that might interfere with the treatment
             evaluation, both for efficacy and safety

          -  Have used forbidden concomitant medications as defined by the protocol
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Panobinostat
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Cancer; Adenocarcinoma; Prostate-Specific Antigen; metastatic; male; HRPC; DACi

Summary:

      This Phase II single dose study was designed to characterize the safety, tolerability, and
      efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with
      hormone refractory prostate cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Confirmed diagnosis of adenocarcinoma of the prostate

          -  Participants with metastatic hormone refractory prostate cancer

          -  Participants that have had at least one, but not more than two prior cytotoxic
             treatments for prostate cancer

          -  Evidence of disease progression by at least one of the following:

               1. two or more lesions on bone scan

               2. progressive measurable disease

               3. two documented increases in prostate-specific antigen (PSA)

          -  Willing to use contraception throughout the study and for 12 weeks after study
             completion

        Exclusion criteria:

          -  History or clinical signs of central nervous system (CNS) disease

          -  History of other cancers not curatively treated with no evidence of disease for more
             than 5 years

          -  Prior radiotherapy within 3 weeks of starting study treatment

          -  Prior radiopharmaceuticals (strontium, samarium)

          -  Impaired cardiac function

          -  Heart disease

          -  Liver or renal disease with impaired function

        Other protocol-defined inclusion/exclusion criteria may apply.
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
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Carboplatin/Paclitaxel; Trastuzumab
Intervention description: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.; Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Intervention MeSH terms: Paclitaxel; Carboplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Healthy volunteers: No
Keywords: Uterine serous papillary carcinoma; Type II endometrial cancer; HER2/neu; Paclitaxel, Carboplatin, Trastuzumab

Summary:

      The primary objective of this study is to estimate whether the addition of trastuzumab to
      paclitaxel and carboplatin chemotherapy improves progression free survival when compared to
      paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients
      overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence
      in situ hybridization (FISH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC
             with measurable disease.

          -  Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with
             confirmed gene amplification by FISH

        Exclusion Criteria:

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancers, significant history of cardiac disease, uncontrolled
             hypertension, unstable medical issue, brain leptomeningeal, prior therapy with
             trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis,
             hemorrhagic diathesis or requiring supplemental oxygen.
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: T-817MA-H; T-817MA-L; Placebo
Intervention description: 224 mg or 448 mg T-817 MA once daily; 224 mg T-817 MA once 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: 482.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Alzheimer's

Summary:

      The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and
      ADCS-CGIC.

      The secondary objectives are:

        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety
           laboratories, physical examinations, ECGs and solicitation of adverse events.

        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric
           Inventory (NPI) and Mini-mental State Examination (MMSE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (post-menopausal or surgically sterile)

          -  Patients with Mild to moderate Alzheimer's disease who are receiving donepezil
             (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®)
             is allowed only when prescribed in combination with donepezil or rivastigmine
             transdermal system.

          -  Age 55 to 85 inclusive

          -  Patients must be living in the community

          -  Patients must have an eligible informant or study partner (caregiver)

          -  Patients and eligible informant or study partner (caregiver) must be able to read and
             understand English.

          -  Informed consent obtained from both the patient and the caregiver

        Exclusion Criteria:

          -  Patients with clinically significant cardiac, hepatic or renal impairment

          -  Patient have a dementia not of the Alzheimer's type etc (According to the protocol)

          -  Patients who are taking any drug other than donepezil or rivastigmine transdermal
             system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine
             (Razadyne®)
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Condition: ESRD; Hyperkalemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hyperkalemia
Intervention: Patiromer
Intervention description: Patiromer will be orally self-administered by participants.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: End Stage Renal Disease; ESRD; Hyperkalemia

Summary:

      The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With
      Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized,
      crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a)
      2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no
      intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily
      and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects
      will collect stool samples and provide blood and urine samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects on stable hemodialysis for more than 90 days.

          -  Age 18-85 years.

          -  Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than
             2 occasions during the previous 3 months.

        Exclusion Criteria:

          -  Use of pre- or probiotics during the past 2 months

          -  Use of antibiotics within the past 2 months, if the patient received a single course
             of antibiotic.

          -  Presence of chronic wound infection and osteomyelitis

          -  Inflammatory bowel disease, chronic diarrhea, current C. difficile infection

          -  Liver cirrhosis or chronic active hepatitis

          -  Treatment with immunosuppressive medications in the past 6 months or more than a week
             of treatment with prednisone > 10 mg in the last 3 months

          -  Anticipated kidney transplant within 9 months

          -  Expected survival < 9 months

          -  Pregnancy, anticipated pregnancy, or breastfeeding

          -  Incarceration

          -  Participation in another intervention study

          -  severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: LY3454738; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3454738 is safe and effective as
      treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU)
      and that are not controlled with H1-antihistamines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to use appropriate birth control throughout the study

          -  Must have a diagnosis of CSU for at least 6 months

          -  Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines

          -  Must agree to take an anti-histamine every day during the trial

          -  Must be willing to enter information about symptoms in an electronic diary twice a day

        Exclusion Criteria:

          -  Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling
             beneath the skin)

          -  Must not have a current or recent active infection requiring antibiotics

          -  Must not have a history of anaphylaxis (severe, life threatening allergic reaction)

          -  Must not have asthma requiring medications other than short acting beta agonists
             (albuterol, etc.)

          -  Must not have received prior treatment with omalizumab, ligelizumab, or other
             experimental biologic for CSU