bioihbjkbjnl/mcl2 huggingface dataset:
Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
Condition: Anesthesia
Intervention: Clonidine
Intervention description: Clonidine 1 µg/kg plus 2% lidocaine
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 30 Years
Maximum age: 86 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clonidine; Sub-Tenon's and Peribulbar block; IOP; OPP; OPA

Summary:

      Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure
      (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate
      the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and
      ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and
      peribulbar anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between 30 and 86 years old

          -  Both genders

          -  Physical status ASA (American Society of Anesthesiologists) I and II

          -  Cooperative patients undergoing cataract surgery by phacoemulsification

        Exclusion Criteria:

          -  Patients with communication difficulties

          -  Allergic to any medication protocol

          -  Chronic therapy with clonidine

          -  In use of antihypertensive medication

          -  Diabetes

          -  Glaucoma

          -  Previous surgery in the same eye

          -  Abnormalities in coagulation
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Condition: Mucositis; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis
Intervention: Ketamine; Placebo
Intervention description: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mucositis; head and neck; cancer; radiation therapy; chemoradiation; oral; pain

Summary:

      -  The primary objective is to determine the reduction in pain score by ketamine mouthwash
           compared to placebo in head and neck cancer patients with refractory mucositis.

        -  The secondary objectives are to describe the duration of analgesia and adverse effects
           associated with ketamine and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with head and neck tumors (any histology) receiving ongoing
             chemoradiation or radiation therapy

          -  Subjects with mucositis pain refractory to topical management, defined as any
             self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of
             topical agents as prescribed

          -  Age ≥ 18 years

          -  Ability to understand and willingness to consent and to sign consent form

        Exclusion Criteria:

          -  Active substance abuse at time of registration (alcohol, drugs, non-prescription use
             of controlled substances)

          -  Subjects with history of allergic reactions to ketamine

          -  Persistent oral bleeding: > 15 mL (estimated) per day

          -  Pregnancy or breast feeding
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Condition: Trichomonas Vaginitis
MeSH terms: Trichomonas Infections; Trichomonas Vaginitis; Vaginitis
Intervention: oral metronidazole; neo penotran forte; neo penotran forte once a day
Intervention description: 2 gm oral once; neo penotran forte intravaginal twice a day for 7 days; neo penotran forte intravaginally once a day for 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No
Keywords: trichomonas

Summary:

      The investigators are trying a combination vaginal product of higher dose metronidazole
      combined with miconazole to see if it is effective in treating vaginal trichomonas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  presence of trichomonas

        Exclusion Criteria:

          -  pregnant or nursing

          -  known immunodeficiency

          -  allergy to study drugs

          -  concurrent yeast infection

          -  history of seizures or peripheral neuropathy

          -  unwillingness to abstain from alcohol during treatment period and for 48 hrs after
             concurrent lithium

          -  anticoagulation therapy, and abuse

          -  patient expected to have menses within 8 days of enrollment
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
Condition: Facial Wrinkles and Creases
MeSH terms: Facies
Intervention: Autologous Human Fibroblasts (azficel-T)
Intervention description: Collection of 3 mm biopsies
Two injection treatments of facial wrinkles and creases
Conduct of study assessments
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety profile and the treatment effect of
      autologous human fibroblasts and placebo when administered to facial wrinkles and creases
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age

          -  High Investigator wrinkle severity assessment score

          -  Subject assessment of dissatisfaction of facial appearance

          -  Provide written informed consent and comply with the study requirements

          -  Negative pregnancy test at screening visit

          -  Healthy, non-scarred skin for biopsy

        Exclusion Criteria:

          -  Low Investigator wrinkle severity assessment score

          -  Subject assessment of satisfaction of facial appearance

          -  Physical attributes which prevent the assessment or treatment of the facial wrinkles

          -  Treatment with an investigational product or procedure within 30 days or plans to
             participate in another clinical trial

          -  Previous treatment with Isolagen Therapy

          -  History of active autoimmune disease or organ transplantation

          -  Diagnosis of cancer, receiving active treatment

          -  History of pigmentary disorders which can affect the face

          -  Active or chronic skin disease

          -  Known genetic disorders affecting fibroblasts or collagen

          -  Active systemic infection

          -  Requires chronic antibiotic or steroidal therapy

          -  Use of certain cosmetic treatments & procedures

          -  Use of systemic agents that increase bleeding or clotting, or disorders equated with
             these effects

          -  Pregnant or lactating women or women trying to become pregnant

          -  Known allergic reaction to components of study treatment and/or study injection
             procedure

          -  Excessive exposure to sun or sunburn in the post-auricular area

          -  Subject has any disorder that may prevent compliance

          -  Subject who is part of the study staff, a family member or friend
Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Condition: Kidney Transplantation; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Kidney Transplantation; Bone marrow transplantation; MEDI-507; cyclophosphamide; rituximab; Tacrolimus; corticosteroids; thymic irradiation
Intervention description: Surgical transplantation of donor kidney; During kidney transplant, bone marrow cells donated by the same donor as the kidney are given through a plastic tube placed in a vein in the chest, underneath the collarbone; 0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1; 60 mg/kg infusion on days -5, -4; 375 mg/m^2 infusion on days -7, -2, 5, and 12; 0.05 mg/kg intravenously twice daily starting on day -1, adjusted to trough level of 10-15ng/ml, then tapered (if eligible) on days 1, 7, 14, 21, 28, 42, and 56; 2 mg/kg prednisone on day 4, with an additional 500-mg pulse of methylprednisolone given on days 10, 11, and 12, and then tapered off by day 20; 700 cGy of thymic irradiation administered in a single dose on day -1
Intervention MeSH terms: Prednisone; Methylprednisolone; Cyclophosphamide; Rituximab; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: renal allograft tolerance; mixed chimerism; kidney transplant; bone marrow transplant; antirejection; immunosuppression

Summary:

      In small initial studies, combined kidney and bone marrow transplants from the same donor
      have permitted some individuals to stop taking anti-rejection medicines without rejecting
      their transplant. This clinical trial will study this method in a greater number of people to
      determine if it is indeed effective and safe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Awaiting first or second transplant with a living donor or first transplant with a
             cadaveric donor

          -  For living-donor transplants, must have one or more HLA antigen-mismatched donors
             identified

          -  Serologic evidence of prior exposure to Epstein-Barr virus (EBV)

        Exclusion Criteria:

          -  ABO blood group-incompatibility for a kidney graft of tissue from a donor

          -  Decreased circulating white blood cell count

          -  Positive for HIV-1, hepatitis B and C viruses

          -  Have had prior radiation therapy that could limit dose

          -  Lung capacity <50% of predicted normal

          -  Evidence of insufficient cardiac capacity

          -  Unwilling to use adequate contraception until 2 years after transplant

          -  Lactation or pregnancy

          -  Presence of antibody against the donor
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Condition: Depressive Disorder, Major; Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome; Syndrome; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pioglitazone
Intervention description: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Depressive Disorder, Major; Metabolic Syndrome X; pioglitazone

Summary:

      The goal of this study is to begin to test whether or not pioglitazone, an FDA approved
      medication used to treat high blood sugar, may be safe and effective in treating Major
      Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female between the ages of 18 and 70

          -  DSM-IV diagnosis of major depressive disorder

          -  Currently depressed as confirmed by the MINI-Plus at the screening visit

          -  Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score > 11 at study
             baseline

          -  Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria

        Exclusion Criteria:

          -  Pregnancy or breast feeding

          -  Unstable or inadequately treated medical illness as judged by the investigator

          -  Severe personality disorder

          -  Serious suicidal risk as judged by the investigator or having a score > 2 on item 18
             of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale

          -  Known history of intolerance or hypersensitivity to pioglitazone

          -  Treatment with pioglitazone in the 3 months prior to randomization

          -  Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are
             prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g.
             glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide,
             nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose,
             miglitol).

          -  Diagnosed with dementia

          -  Diagnosed with heart failure

          -  Transaminase elevation >2.5 times the upper limit of normal

          -  Presence of renal impairment
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia
Condition: Relapsed Pediatric ALL; Relapsed Pediatric AML; Refractory Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Daunorubicin
Intervention description: Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
Intervention MeSH terms: Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of
      low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily
      for potential toxicity during those 5 days. Once the patient has received 5 doses of
      daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pathologically confirmed ALL or AML, whose disease is refractory to two
             induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in
             1st relapse or refractory to a single therapeutic attempt but are unable to receive
             intensive therapy at the time of consent.

          -  All prior upfront therapies including bone marrow transplant are acceptable. Pulse
             steroids (of 5 days duration or less in the prior month) administered as part of a
             routine maintenance therapy are acceptable.

          -  Age 1 to 21 years of age, inclusive

          -  Established central catheter IV access

        Exclusion Criteria:

          -  Females who are known to be pregnant or lactating

          -  Any Grade 3 or higher Cardiac Disorder per CTCAE version 5

          -  Patients with echocardiographic evidence of cardiomyopathy (shortening fraction <27%
             or ejection fraction <50%)

          -  Uncontrolled sepsis

          -  Absolute Blast Count >50 x10(3)/mcL at enrollment or on day 1 of study

          -  Direct hyperbilirubinemia >5mg/dL

          -  Grade 3 or higher anaphylaxis to daunorubicin

          -  Non-English speaking

          -  Patients, who in the opinion of the PI, are unable to tolerate any study-specific
             procedures

          -  Patients who have received cyclosporine, tacrolimus or other agents to prevent or
             treat graft-vs-host disease post bone marrow transplant in the last 14 days

          -  Concurrent investigational drugs or other chemotherapeutic agents (excluding
             hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.

          -  Prior cumulative doses of anthracyclines will not be an exclusion regardless of the
             total cumulative dose previously received.
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
Condition: Hepatitis C; Cirrhosis; Portal Hypertension; With or Without Liver Decompensation
MeSH terms: Hepatitis C; Liver Cirrhosis; Hypertension, Portal; Liver Failure; Hypertension; Fibrosis
Intervention: SOF; RBV
Intervention description: SOF 400 mg tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF)
      plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic
      hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to
      receive study drug for 48 weeks or take part in an untreated observational arm for the first
      24 weeks followed by study drug for another 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL

          -  Individuals with cirrhosis with Child-Pugh score < 10

          -  Esophageal or gastric varices on endoscopy within 6 months prior to or at screening

          -  Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg

          -  Body mass index (BMI) ≥ 18 kg/m^2

          -  Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

        Exclusion Criteria:

          -  Have any serious or active medical or psychiatric illness which, in the opinion of the
             investigator, would interfere with subject treatment, assessment, or compliance

          -  HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)

          -  Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the
             last 6 months or during screening

          -  Refractory ascites as defined by requiring paracentesis > twice within 1 month prior
             to screening

          -  Active variceal bleeding within 6 months of screening

          -  Expected survival of < 1 year

          -  History of hepatorenal, or hepatopulmonary syndrome.

          -  Evidence of renal impairment (CrCl < 50 mL/min)

          -  History of major organ transplantation, including liver transplant.
A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: Olesoxime
Intervention description: Participants will receive homogeneous suspension of olesoxime.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this open-label, single arm study is to further evaluate long-term
      tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular
      Atrophy (SMA) who previously participated in one of the following two clinical studies:
      TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study)
      or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind,
      randomized, placebo-controlled, multicenter, multinational study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q
             1275-1)

          -  For women of childbearing potential: agreement to use an acceptable birth control
             method during the treatment period and for at least 28 days after the last dose of
             olesoxime

        Exclusion Criteria:

          -  Female participants who are pregnant or lactating, or intending to become pregnant
             during the study

          -  Participants who, in the opinion of the investigator, are not suitable to participate
             in this open-label study

          -  Participants who have developed study drug hypersensitivity to olesoxime or one of the
             formulation excipients, including sesame oil

          -  Concomitant or previous participation in any investigational drug or device study
             within 90 days prior to screening

          -  Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting
             antisense oligonucleotide study within 6 months prior to screening

          -  History of human immunodeficiency virus infection, history of Hepatitis B infection
             within the past year, history of Hepatitis C infection which has not been adequately
             treated

          -  History of illicit drug or alcohol abuse within 12 months prior to screening, in the
             investigator's judgment

          -  Any serious medical condition or abnormality in clinical laboratory tests that, in the
             investigator's judgment, precludes the participant's safe participation in and
             completion of the study

          -  History or presence of an abnormal electrocardiogram (ECG) that is clinically
             significant in the investigator's opinion