bioihbjkbjnl/mcl2 huggingface dataset:
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Condition: Urinary Bladder Neoplasm; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Urinary Bladder Neoplasms
Intervention: Bempegaldesleukin; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder; Bladder Cancer; CD122; Cisplatin Ineligible; Immuno-oncology; Immunotherapy; Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer; mUC; Natural Killer Cells; Nivolumab; NKTR-214; Opdivo®; PD-L1; Urothelial Cancer; Urothelial; Metastatic Urothelial Carcinoma; Urothelial Carcinoma; Bempegaldesleukin; BEMPEG; CPI Combination; IL-2

Summary:

      The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin
      (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in
      cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written, informed consent to participate in the study and follow the study
             procedures

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

          -  Measurable disease per RECIST 1.1 criteria

          -  Histologically or cytologically documented inoperable, locally advanced or metastatic
             urothelial cell carcinoma (also termed TCC)

          -  Fresh biopsy or archival tissue

          -  No prior systemic chemotherapy or investigational agent for inoperable locally
             advanced or mUC

          -  Ineligible for cisplatin

        Key Exclusion Criteria:

          -  Patients who have an active, known or suspected autoimmune disease

          -  Patients must not have received prior IL-2 therapy

          -  Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte
             associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any
             other antibody or drug specifically targeting T-cell co-stimulation or immune
             checkpoint pathways

          -  Patients with hypertension must be on a stable antihypertensive regimen for the 14
             days prior to Cycle 1 Day 1

        Additional protocol-defined inclusion/exclusion criteria applied
A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: CP-601,927; Placebo
Intervention description: CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.; Matching placebo tablets, taken orally, twice per day, for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 297.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Antidepressant Augmentation

Summary:

      The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared
      to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major
      Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2)
      Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically healthy males or females aged 18-65 (inclusive).

          -  Patients must have a primary current diagnosis of MDD without psychotic features.

          -  Patients must be receiving ongoing antidepressant therapy at the time of screening.
             Duration of the current episode of MDD must be at least 8 weeks prior to enrollment
             without adequate response to treatment.

        Exclusion Criteria:

          -  Patients with other psychiatric disorders.

          -  Patients who use tobacco products.

          -  Alcohol or substance abuse or dependence.

          -  Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.

          -  Pregnancy or breastfeeding.

          -  Clinically significant abnormalities on laboratory tests, electrocardiogram, or
             physical or neurologic examination.
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: UNR844; Placebo
Intervention description: Ophthalmic solution for topical ocular administration; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 45 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: loss of elasticity in lens; lens; lens disorder; loss of near vision; Presbyopia; UNR844; farsightedness

Summary:

      Study of safety and efficacy of UNR844 in subjects with presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Impaired near vision in each eye and when using both eyes, without any near correction

          -  Need a certain level of near correction

        Exclusion Criteria:

          -  Impaired distance vision in either eye, with distance correction (if any)

          -  Severe short- or long-sightedness

          -  Any significant medical or clinical conditions affecting vision, the eyes or general
             health
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; Botulinum Toxins; Analgesics
Intervention MeSH terms: Morphine; Narcotics; Analgesics; Bupivacaine; Botulinum Toxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain; breast cancer; breast implant; breast reconstruction

Summary:

      The investigators hypothesize that in mastectomy patients with breast reconstruction, the
      addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the
      acute and chronic setting, compared to traditional pain management techniques which rely
      almost exclusively on opioid analgesics and sedatives like diazepam (valium). This
      expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will
      produce muscle relaxation, the combination of which will target different sites of pain
      generation, thus producing better analgesia. We also hypothesize that additional benefits may
      accrue from this regimen including decreased nausea and vomiting, sedation and constipation
      as a result of diminished opioid use1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing immediate unilateral or bilateral tissue expander breast
             reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy
             requiring postoperative expansions

          -  Women undergoing immediate bilateral tissue expanders breast reconstruction following
             risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring
             postoperative tissue expansions.

        Exclusion Criteria:

          -  Subjects who are unable to read or speak English;

          -  Breast reconstruction using the latissimus dorsi flap combined with a tissue expander;

          -  Documented diagnosis of chronic pain, chronic migraine, upper limb spasticity,
             cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;

          -  Hypersensitivity to any botulinum toxin (BT) preparation or to any of the components
             in the formulation;

          -  Infection at the proposed site of injection;

          -  Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis,
             Eaton-Lambert syndrome, or amyotrophic lateral sclerosis);

          -  Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the
             effect of BT);

          -  Women who are pregnant or breast feeding.
Maintenance of Platelet Inhibition With Cangrelor
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome
Intervention: cangrelor; Placebo
Intervention description: Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
Intervention MeSH terms: Cangrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that patients receiving cangrelor infusion before
      coronary artery bypass grafting have an acceptable safety profile and can undergo surgery
      without excessive bleeding peri-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  18 Years of Age

          -  Non emergent coronary bypass graft surgery

          -  Received a thienopyridine within 48 hours prior to enrollment

        Exclusion Criteria:

          -  Confirmed or suspected pregnancy

          -  Cerebrovascular accident within one yar

          -  Intracranial neoplasm

          -  History of bleeding diathesis

          -  Thrombocytopenia
Nigella Sativa in COVID-19
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Nigella sativa oil
Intervention description: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, open-label, controlled clinical study
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COVID-19; SARS-CoV-2; Nigella sativa; Herbal

Summary:

      Natural products with immunomodulation and antiviral activity showed a promising improvement
      in the outcomes of some viral infectious diseases both in preclinical and primitive clinical
      studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil
      towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study
      will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be
      supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary
      outcome will be the proportion of patients who clinically recovered on day 14. The secondary
      outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes
      occurred, NS supplementation may be recommended as an add-on to standard care protocol to
      enhance the recovery from COVID-19 disease in the current emerging situation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mild COVID19 upper respiratory tract infection and with no evidence of
             pneumonia

          -  Adult (18 Years and above)

          -  Written informed consent prior to initiation of any study procedures by the patient
             (or legally authorized representative).

          -  Understands and agrees to comply with planned study procedures.

          -  Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
             polymerase chain reaction (PCR) available at KAUH.

        Exclusion Criteria:

          -  Patients with pneumonia or severe illness requiring admission to ICU.

          -  Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30)
             or end stage renal disease requiring dialysis

          -  Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5
             times the upper limit of normal).

          -  Pregnancy or breast feeding.

          -  Anticipated transfer to another hospital which is not a study site within 72 hours.

          -  Allergy to any study medication.
Improving Treatment Adherence in HIV-Infected Individuals
Condition: HIV Antiretroviral Therapy (ART) Adherence; Health Behavior
Intervention: LifeWindows Intervention Sessions; Control
Intervention description: At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.; At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 594.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Antiretroviral Medication Adherence

Summary:

      This study will develop and evaluate the efficacy of an individualized, interactive, computer
      software program delivered in conjunction with clinical care in increasing and supporting
      antiretroviral therapy adherence in HIV-infected individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected

          -  English-speaking

          -  Currently receiving treatment at one of the participating sites

          -  Currently receiving antiretroviral therapy

        Exclusion Criteria:

          -  Marked cognitive impairment
Treatment of Acute Migraine Headache in Children
Condition: Migrainous Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Metoclopramide; Placebo
Intervention description: Intravenous bolus administration.; Standard care including intravenous fluid, but no metoclopramide.
Intervention MeSH terms: Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Migraine is common in children and is one of the most common etiologies of headache leading
      to emergency room presentation in children. Despite this, few studies have investigated the
      treatment of acute migraine headache in the emergency room. We will perform a prospective,
      double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of
      acute migraine headache. The primary outcome will be the number of subjects headache free at
      two hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or Females age 8-18 years

          2. Girls 11 years or older must have a negative urine/serum pregnancy test.

          3. Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine
             headache based on the most recent ICHD criteria are listed below. The requirement of 5
             attacks (A) will not be required for this study, this making the diagnosis migrainous
             headache. As described elsewhere in the protocol, this change is required to make the
             study applicable to ED patients who require treatment before five attacks have
             occurred.

        Exclusion Criteria:

          1. Evidence that headache is due to a secondary underlying disorder based on history or
             physical examination.

          2. Pregnant or lactating females.

          3. Any investigational drug use within 30 days.

          4. Known to have a contraindication to metoclopramide or valproic acid such as pregnancy,
             liver disease, hematologic disease, or metabolic disease.

          5. Have used metoclopramide (or other antidopaminergic medications) or valproic acid
             within two days of presentation.

          6. Severe developmental disorders or mental retardation if insufficient information can
             be obtained to make a clear diagnosis of migraine or judge headache severity.

          7. If patients re-present to the ED, they can not be re-enrolled.
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: Moxifloxacin
Intervention description: 400mg daily for 8 weeks
Intervention MeSH terms: Moxifloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and
      then two drugs for 4 months. New drug regimens that are shorter and effective against
      drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin
      (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively
      treat TB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry.
             Patients with both pulmonary and extrapulmonary disease are eligible.

          -  Documentation of HIV infection status. If HIV status is unknown at study entry, the
             participant must consent to testing and results must be available prior to study
             participation.

          -  Agree to use acceptable methods of contraception

        Exclusion Criteria:

          -  History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB

          -  Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated

          -  History of more than 14 days of continuous antituberculosis therapy during the
             previous 2 years or more than 2 months of antituberculosis therapy ever

          -  Active AIDS-related opportunistic infection or malignancy

          -  Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside
             reverse transcriptase inhibitors in the first 2 months after study entry

          -  Silicotuberculosis

          -  Central nervous system TB

          -  Pregnant or breastfeeding

          -  Unable to take oral medication

          -  Electrocardiogram (EKG) QTc interval greater than 450 msec

          -  Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone,
             sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or
             tricyclic antidepressant

          -  Diseases or conditions for which treatment with other drugs with antituberculosis
             activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the
             study
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006)
Intervention description: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Liver Cancer; Hepatocellular carcinoma (HCC)

Summary:

      Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response
      or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular
      carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)

          -  Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery

          -  Measurable disease

          -  At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography
             (CT) scan or magnetic resonance imaging (MRI)

          -  Presence of at least 1 of the following:

          -  Alpha-fetoprotein greater than the upper limit of normal (ULN)

          -  Hepatitis C antibody positive

          -  Hepatitis B surface antigen positive

          -  Child's Pugh class A or B

          -  Candidate for systemic therapy

        Exclusion Criteria:

          -  Fibrolamellar disease mixed histology

          -  Metastatic brain or meningeal tumors
N-Acetyl Cysteine in Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Intervention: Placebo; N-Acetyl Cysteine
Intervention description: daily; 600mg capsules in varying doses for 12 weeks.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Trichotillomania; Hair-pulling

Summary:

      This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of
      trichotillomania
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and women age 18-65;

          -  current DSM-IV trichotillomania

        Exclusion Criteria:

          -  unstable medical illness;

          -  history of seizures;

          -  myocardial infarction within 6 months;

          -  current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          -  any thoughts of suicide;

          -  lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
             other DSM-IV psychotic disorder;

          -  previous treatment with N-Acetyl Cysteine;

          -  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;

          -  9) diagnosis of asthma