bioihbjkbjnl/mcl2 huggingface dataset:
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Cetuximab; 5-Fluorouracil; Radiation
Intervention MeSH terms: Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 5-FU; cetuximab; radiation; adenocarcinoma of the rectum; neoadjuvant therapy

Summary:

      The standard treatment for rectal cancer is to receive the chemotherapeutic drug
      5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal
      cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is
      to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given
      with 5-FU and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the
             anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of
             distant metastatic disease. A complete colonoscopy to the cecum is recommended prior
             to initiating protocol therapy.

          -  Staging with transrectal ultrasound or endorectal coil Magnetic resonance imaging
             (MRI) to confirm clinical stage of T3 or T4 or lymph node positive rectal
             adenocarcinoma

          -  Tumor is K-ras wildtype by method of choice at respective institution (testing codons
             12 and 13)

          -  Performance status: Eastern Cooperative Oncology Group Performance Score (ECOG PS)
             less than or equal to 2

          -  18 years of age or older

          -  No evidence of metastatic disease by abdominal/pelvic (Computed tomography) CT and
             chest imaging

          -  Adequate bone marrow, renal,and hepatic function as outlined in protocol

          -  All patients will be evaluated by a surgeon and considered a candidate for definitive
             surgery

          -  Coumadin or heparin management for line care of other indications is permitted. The
             International Normalised Ratio (INR) will be monitored weekly in patients taking
             coumadin.

        Exclusion Criteria:

          -  Prior treatment for this malignancy

          -  Prior history of pelvic radiation therapy

          -  Prior history of 5-FU based or EGFR receptor inhibitor therapy

          -  Prior history of an allergic reaction to a monoclonal antibody

          -  Uncontrolled serious medical or psychiatric illness

          -  Significant history of uncontrolled cardiac disease

          -  Sexually active women of childbearing potential must use an effective method of birth
             control during the course of the study

          -  Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Condition: Allogeneic Stem Cell Transplant; Viral Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Intervention: Viral Specific T-cells (VSTs)
Intervention description: VSTs will be infused into stem cell transplant recipients
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this research study is to learn more about the use of viral specific
      T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell
      transplant. Allogeneic means the stem cells come from another person. VSTs are cells
      specially designed to fight viral infections that may happen after a stem cell transplant
      (SCT).

      Stem cell transplant reduces your ability to fight infections. Viral infections are a common
      problem after transplant and can cause significant complications. Moreover, treatment of
      viral infections is expensive and time consuming, with families often administering prolonged
      treatments with intravenous anti-viral medications, or patients requiring prolonged
      admissions to the hospital. The medicines can also have side effects like damage to the
      kidneys or reduction in the blood counts, so in this study we are trying to find a way to
      prevent these infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient must be at least 21 days after stem cell infusion

          -  Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other
             steroid equivalent

        Exclusion Criteria:

          -  Patients who have developed viral infection or reactivation will be ineligible for
             prophylactic infusions of VSTs

          -  Active acute GVHD grades II-IV

          -  Uncontrolled relapse of malignancy

          -  Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in
             patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab
             levels will be collected in the second week following stem cell infusion. The level
             must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level
             greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is
             obtained. They would become eligible for prophylactic VST infusion at that point if
             there is still no evidence of viral infection at that time.
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Ecopipam; Placebo
Intervention description: Ecopipam HCI tablets administered PO to establish 2 mg/kg/day; Matching Placebo
Intervention MeSH terms: Ecopipam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of ecopipam tablets in children and adolescents in the
      treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam
      tablets, while the other half will receive matching placebo tablets
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 6 and < 18 years of age

          -  ≥ 18 kg (~ 40 lbs.)

          -  TS diagnosis and both motor and vocal tics that cause impairment with normal routines

          -  Minimum score of 20 on the YGTSS-Total Tic Score

          -  May not be taking any medications used to treat motor or vocal tics for at least 14
             days prior to Baseline.

          -  Effective contraception during the study and 30 days after last study dose for
             sexually active subjects

        Exclusion Criteria:

          -  Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,
             schizophrenia, major depressive disorder)

          -  Unstable medical illness or clinically significant lab abnormalities

          -  Risk of suicide

          -  Pregnant or lactating women

          -  Moderate to severe renal insufficiency

          -  Hepatic insufficiency

          -  Positive urine drug screen

          -  Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity
             Disorder

          -  Certain medications that would lead to drug interactions

          -  Recent behavioral therapy
Lidocaine as an Endotracheal Tube (ETT) Cuff Media
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: 1.8% lidocaine plus 0.76% sodium bicarbonate; Air
Intervention description: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water. This solution will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.; At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Surgery

Summary:

      Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing
      tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air
      is the traditional method used to inflate the breathing tube cuff. Researchers wish to find
      if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased
      coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for
      this particular surgical intervention.
    

Eligibility criteria:

        Patients who meet the inclusion criteria below and are expected to require ventilatory
        support for a period of less than 5 hours post-operatively in the cardiac ICU will be
        enrolled.

        Inclusion Criteria:

          -  All patients > 18 years of age (male and female) who will receive general anesthesia
             for cardiac surgery at St. Mary's Hospital (SMH) in Rochester, Minnesota

          -  Cardiac surgery includes: single valve repair, myectomy, cabbage, pericardectomy.

          -  American Society of Anesthesiologists (ASA) physical status I-III

        Exclusion Criteria:

          -  Age < 18 years old at time of surgery

          -  Patients who are not sent to the cardiac ICU post-operatively

          -  Patients who are anticipated to have a difficult tracheal intubation

          -  Patients having risk factors of postoperative aspiration of gastric contents

          -  Patients who have respiratory disease or recent respiratory tract infection

          -  > 1 attempt to secure an airway

          -  Patients undergoing transcatheter aortic valve replacement (TAVR) procedures or any
             form of "robotic" procedures
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with
      chronic hepatitis C virus (HCV) who have received a liver transplant.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  History of chronic HCV infection (≥ 6 months)

          -  HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate

          -  Liver transplant ≥ 3 months prior to screening

          -  Male and nonpregnant/ non-lactating female individuals without cirrhosis or with
             compensated cirrhosis

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol,

          -  Co-infection with HIV or hepatitis B virus

          -  Known hypersensitivity to study medication,

          -  Use of any prohibited concomitant medications as within with window before the Day 1
             visit.

          -  De novo or recurrent hepatocellular carcinoma posttransplant

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Condition: Iron Deficiency; Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Citrate; Placebo
Intervention description: Dose depends on serum phosphorus levels collected at each study visit.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD; Chronic Kidney Disease; Phosphorus; Iron Deficiency; Iron Deficiency Anemia; Elevated Phosphorus

Summary:

      The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and
      effective treatment for the management of serum phosphorus levels and iron deficiency in
      anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of
      treatment is approximately 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage III to V Chronic Kidney Disease

          -  Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization

          -  Ferritin 300 ng/mL or less

          -  Transferrin Saturation (TSAT) 30% or less

          -  Hemoglobin >9.0 and <12.0 g/dL

          -  Must consume a minimum of 2 meals per day

        Exclusion Criteria:

          -  Parathyroidectomy within 24 weeks of study

          -  gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study

          -  Requirement for dialysis or kidney injury within 8 weeks of study

          -  Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating
             Agent, blood transfusions, and Sensipar during the study

          -  Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals

          -  Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins

          -  History of hemochromatosis

          -  Allergy to iron products

          -  History of malignancy in last 5 years
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Condition: Advanced Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab; Relatlimab; BMS-986205; BMS-813160
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness and safety of various nivolumab
      combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Renal Cell Carcinoma

          -  Must have at least 1 lesion with measurable disease

          -  Life expectancy of at least 3 months

          -  Karnofsky Performance Status (KPS) must be =>70%

        Exclusion Criteria:

          -  Patients/subjects with suspected or known central nervous system metastases unless
             adequately treated

          -  Patients/subjects with autoimmune disease

          -  Patients/subjects who need daily oxygen therapy

        Other protocol defined inclusion/exclusion criteria apply
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
Condition: Acute Cough
MeSH terms: Respiratory Tract Infections; Cough
Intervention: Gefapixant; Placebo
Intervention description: Gefapixant 45 mg will be administered orally.; Placebo tablet matching gefapixant will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant
      (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Susceptible to human rhinovirus type 16 (HRV-16)

          -  Male or non-pregnant and non-breast feeding female

          -  If female of reproductive potential, agrees to use 1 form of acceptable birth control

        Exclusion Criteria:

          -  Donated blood within 56 days or donated plasma within 7 days prior to dosing

          -  History of significant multiple and/or severe allergies

          -  Recent history of respiratory tract infection

          -  History of cancer

          -  Body mass index <18 kg/m^2 or ≥40 kg/m^2

          -  History of major surgery or loss of 1 unit of blood

          -  History of allergic reaction to sulfonamides

          -  Received medications within 14 days prior to randomization

          -  Significantly abnormal laboratory tests at Screening

          -  Current smoker, smoked within 5 years of Screening, or significant past smoking
             history

          -  History of alcohol or drug abuse
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
Condition: Diabetic Retinopathy; Posterior Vitreous Detachment; Disease Progression
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Vitreous Detachment; Disease Progression
Intervention: ocriplasmin 0.0625mg; ocriplasmin 0.125mg; Sham injection
Intervention description: Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart; Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart; 3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Intervention MeSH terms: Fibrinolysin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal
      injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe
      non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment
      (PVD) in order to reduce the risk of disease progression to proliferative diabetic
      retinopathy (PDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years or older

          -  Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent
             of 20/50 or better) in the study eye

          -  HbA1c ≤ 12%, as assessed by the central laboratory

          -  Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field
             stereo colour fundus photograph

          -  Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on
             non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic
             macular oedema

          -  No evidence of total PVD in the study eye

          -  Written informed consent obtained from the subject prior to screening procedures

        Exclusion Criteria:

          -  History of or current ocular condition in the study eye that may interfere with the
             assessment of the progression to PDR

          -  Presence of epiretinal membrane in the study eye

          -  Presence of foveal ischemia in the study eye

          -  Presence of pre-retinal or vitreous haemorrhage in the study eye

          -  Presence of iris or angle neovascularisation in the study eye

          -  Any active ocular / intraocular infection or inflammation in either eye

          -  Aphakic study eye

          -  Uncontrolled hypertension in the opinion of the Investigator

          -  Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the
             Investigator's opinion suggesting lens / zonular instability