bioihbjkbjnl/mcl2 huggingface dataset:
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Growth hormone; Placebo
Intervention description: growth hormone, Genotropin (Pfizer); placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)
Intervention MeSH terms: Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of
      alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates
      of about 30% of individuals in the United States. A subset of these will develop progressive
      disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis
      and liver failure. NAFLD is expected to be the most common indication for liver
      transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will
      decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy
      (1H-MRS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18 - 65 yr

          2. NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of
             significant alcohol consumption and other causes of hepatic steatosis. If liver
             imaging or biopsy has not been performed clinically, liver ultrasound will be
             performed as part of the screening visit.

        Exclusion Criteria:

          1. Serum creatinine > 2 times the upper limit of normal

          2. History of cancer, except for non-melanoma skin cancers

          3. Active carpel tunnel syndrome

          4. Diabetes mellitus, defined as a hemoglobin A1C >6.5 or use of any medications
             prescribed to treat hyperglycemia. The exception is that the use of metformin is
             acceptable in patients whose HbA1c has been =<6.0 on two visits and whose weight has
             remained stable for six months.

          5. Contraindications to magnetic resonance imaging (MRI).

          6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to
             use contraception.

          7. Breastfeeding

          8. Aspartate and aminotransferase levels >10x upper limit of normal
Varenicline for Methamphetamine Dependence
Condition: Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
MeSH terms: Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).; Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crystal meth dependence; crystal meth; methamphetamine dependence; substance abuse

Summary:

      Methamphetamine (MA) dependence is a source of continuing danger for both individuals and
      society. While there are some behavioral treatments, they are not always effective. To date,
      there are no medications available to treatment methamphetamine dependence. There is some
      early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to
      stop or reduce their use of methamphetamine. Varenicline is already on the market in the U.S.
      for cigarette smoking cessation and shows promise for treating alcohol dependence. In order
      to determine if varenicline can help people stop using methamphetamine, we will enroll 90
      methamphetamine-dependent people who are looking for treatment into the study at the UCLA
      Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and
      half will receive placebo (n=45) which will be determined randomly. Everyone will receive
      talk therapy for methamphetamine dependence. People will take the medication for 9 weeks
      followed by a 4 week follow-up period. Before receiving any medication, participants will
      complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,
      psychological and medical evaluation, and comprehensive assessment of drug use to determine
      study eligibility. If a person is eligible for the study, s/he will receive either
      varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three
      times a week study visits. At the end of the medication phase, subjects will complete a four
      week follow up period for safety monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

        Contact site for additional information.

        Exclusion Criteria:

        Contact site for additional information.
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
Condition: Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: ALD518; 0.9% saline
Intervention description: IV; IV Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the
      course of oral mucositis in subjects with head and neck cancer receiving concomitant
      chemotherapy and radiotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have recently diagnosed (< than 6 months prior to screening visit date),
             pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx,
             hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects
             with a history of surgical management (approximately 4-6 weeks before RT with
             sufficient time for post-surgical healing) are eligible

          -  Have a plan to receive a continuous course of conventional external beam irradiation
             delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
             to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.

          -  Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to
             100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin
             regimen administered weekly (100 mg/m2)

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  CRP < 80 mg/L

          -  Have adequate hematopoietic, hepatic, and renal function at the screening visit

        Exclusion Criteria:

          -  Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor

          -  Metastatic disease (M1) Stage IV C

          -  Any prior history of head and neck cancer

          -  Prior radiation to the head and neck

          -  Have had a major surgical procedure, other than for HNC, or significant traumatic
             injury within 4 weeks prior to the initiation of RT; or anticipation of need for a
             major surgical procedure during the clinical trial

          -  Active infectious disease, excluding oral candidiasis

          -  Have OM at the screening visit

          -  Have a history of hypersensitivity to monoclonal antibody
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: CUROSURF® (poractant alfa)
Intervention description: Three administrations with a 24 hours dosing interval.
Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus:
30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.
Intervention MeSH terms: Poractant alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: acute respiratory distress syndrome; ARDS; Adults; Surfactant; Poractant alfa (porcine surfactant, Curosurf®),; Curosurf®; Coronavirus disease (COVID-19); Coronavirus 2019 Disease

Summary:

      The purpose of this study was to evaluate the efficacy and safety of poractant alfa
      (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients
      diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants were eligible to be included in the study if the following criteria apply:

          1. Male or female ≥18 and ≤ 80 years of age

          2. Informed consent for participation in the study (refer to section 15 for detailed
             inform consent procedure)

          3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before
             randomisation

          4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio <
             150 mmHg

          5. Lung compliance ≤45 ml/cmH20

          6. Intubated and artificially ventilated less than 48 hours before the first poractant
             alfa administration

        Exclusion Criteria:

        Participants were excluded from the study if any of the following criteria apply:

          1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and
             pneumothorax)

          2. Weight < 40kg

          3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate
             (eGFR) < 30)

          4. Pregnancy

          5. Administration of any nebulized surfactant in the 48 hours before the first poractant
             alfa administration

          6. Extracorporeal membrane oxygenation (ECMO)
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; Docetaxel; Standard chemotherapy
Intervention description: 15mg/kg iv on day 1 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle; As prescribed
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of a combination of Avastin and
      docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable
      breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin
      (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each
      cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each
      cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on
      study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age;

          -  primary HER2-negative operable breast cancer;

          -  tumor >2cm in size;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  previous treatment for breast cancer;

          -  metastatic disease;

          -  current or recent (within 10 days of first dose of Avastin) use of aspirin
             (>325mg/day) or full-dose anticoagulants for therapeutic purposes;

          -  clinically significant cardiovascular disease.
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Enfuvirtide
Intervention MeSH terms: Enfuvirtide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 3 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Anti-HIV Agents; pentafuside

Summary:

      This study will evaluate T-20 in children.
    

Eligibility criteria:

        Inclusion Criteria

        Patients may be eligible for this study if they:

          -  Are 3 through 16 years of age and have the consent of parent or guardian.

          -  Have a viral load of at least 5000 copies/ml.

          -  Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.

          -  Have been on stable therapy for at least 4 weeks.
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Condition: Autism; Pediatric Autism
MeSH terms: Autistic Disorder
Intervention: Memantine HCl
Intervention description: Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Namenda; Autism; Memantine; Pediatric; Forest Laboratories

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of memantine
      in the treatment of autism in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed lead-in study MEM-MD-57A (NCT00872898)

          -  A knowledgeable caregiver capable of providing reliable information about the
             patient's condition, able to attend all clinic visits with the patient

        Exclusion Criteria:

          -  Patients with a concurrent medical condition that might interfere with the conduct of
             the study
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: OPC-34712; Placebo; ADT
Intervention description: Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks; Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks; Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Intervention MeSH terms: Fluoxetine; Paroxetine; Sertraline; Desvenlafaxine Succinate; Escitalopram; Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 850.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712, Major Depressive Disorder, Adjunctive Treatment

Summary:

      Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an
      assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an
      incomplete response to a prospective eight week trial of the same assigned open-label
      marketed ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 65 years of age, with diagnosis of major
             depressive disorder, as defined by DSM-IV-TR criteria

          -  The current depressive episode must be equal to or greater than 8 weeks in duration

          -  Subjects must report a history for the current depressive episode of an inadequate
             response to at least one and no more than three adequate antidepressant treatments.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug.

          -  Subjects who report an inadequate response to more than three adequate trials of
             antidepressant treatments during current depressive episode at a therapeutic dose for
             an adequate duration.

          -  Subjects with a current Axis I (DSM-IV-TR) diagnosis of:

               -  Delirium, dementia,amnestic or other cognitive disorder

               -  Schizophrenia, schizoaffective disorder, or other psychotic disorder

               -  Bipolar I or II disorder

               -  Subjects with a clinically significant current Axis II (DSM-IV-TR)

               -  diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or
                  histrionic personality disorder.
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Condition: Metastatic Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: Sm-EDTMP; Autologous Stem Cell Infusion; External Beam Radiotherapy
Intervention description: Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.; Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.; The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.
After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.
Intervention MeSH terms: Samarium Sm-153 lexidronam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 10 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Osteosarcoma; Osteogenic Sarcoma; Sarcoma; Bone Cancer

Summary:

      The primary goal of this study will be to examine tumor response after radiation treatment
      via a combination of Samarium-153 EDTMP and external beam radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be between 13 and 65 years of age, inclusive

          -  Must have unresectable primary tumor or metastases

          -  Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not
             all lesions must be positive on bone scan.

          -  Creatinine clearance >70ml/min/1.73m2

          -  ANC >500/mm3

          -  Platelets >50,000/mm3

          -  Life expectancy > 8 weeks

          -  Karnofsky performance status >50%

          -  Stem cell product collected prior to the infusion of Samarium must be available,
             either by peripheral stem cell mobilization or bone marrow harvest prior to trial
             entry.

        Exclusion Criteria:

          -  Patient may not be pregnant or breastfeeding.

          -  Patients who have received prior radiotherapy to all areas of current active disease
             are not eligible.
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Capecitabine; Cisplatin; Pertuzumab; Pertuzumab; Trastuzumab
Intervention description: 1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle; 80 mg/m2 on Day 1 of each cycle; loading dose of 840 mg, then 420 mg once every three weeks; 840 mg once every three weeks; loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Intervention MeSH terms: Capecitabine; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, multicenter, open-label study will evaluate two different doses of
      pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line
      treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or
      gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment
      arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of
      840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab
      840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both
      treatment arms will receive trastuzumab, cisplatin, and capecitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, greater than or equal to (>=) 18 of age

          -  Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally
             advanced or metastatic disease, not amenable to curative therapy

          -  Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
             (RECIST), v1.1

          -  HER2-positive tumor

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Life expectancy of at least 3 months

        Exclusion Criteria:

          -  Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or
             neoadjuvant therapy at least 6 months before enrollment in the study)

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  Active (significant or uncontrolled) gastrointestinal bleeding

          -  Abnormal laboratory values