bioihbjkbjnl/mcl2 huggingface dataset:
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Condition: Metastatic Seminoma
MeSH terms: Seminoma
Intervention: Carboplatin AUC-10
Intervention description: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve
      (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron
      emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of
      patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A
      PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a
      complete response patients received 3 cycles of treatment. If the PET - CT scan did not show
      a complete response patients received 4 cycles of treatment. After treatment, patients were
      followed up for 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG)
             good prognosis.

          2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance
             over 25 ml/min.

          3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.

          4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate
             dehydrogenase are acceptable).

          5. Males aged ≥18 and ≤75 years.

          6. Able to give written informed consent prior to study entry.

          7. Patients must be sterile or agree to use adequate contraception during the period of
             therapy.

        Exclusion Criteria:

          1. Metastatic seminoma with any non-pulmonary visceral metastases.

          2. Raised Alpha-fetoprotein.

          3. Any previous chemotherapy or radiotherapy.

          4. Currently enrolled in any other investigational drug study.

          5. Other malignancy except basal cell.
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
Condition: Parkinson Disease; Neurodegenerative Diseases; Central Nervous System Diseases; Movement Disorders; Brain Diseases
MeSH terms: Parkinson Disease; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases
Intervention: Preladenant; L-dopa; Other Parkinson's Disease treatments
Intervention description: 5 mg BID capsules; Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).; Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.
Intervention MeSH terms: Levodopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in
      participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa
      decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in
      the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose
      Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814
      Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations
      and Dyskinesias."
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have participated in P04501.

          -  Participants must be >=30 years of age, with a diagnosis of moderate to severe
             idiopathic Parkinson's disease.

          -  Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.

        Exclusion Criteria:

          -  Participants who discontinued from Study P04501 because they experienced a serious
             adverse event (SAE)

          -  Participants with any form of drug-induced or atypical parkinsonism, cognitive
             impairment, or psychosis

          -  Participants taking tolcapone

          -  Participants who are participating in any other clinical study
Cannabidiol Treatment in Patients With Early Psychosis
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Cannabidiol; Placebo
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations
      in cannabis extracts. CBD has been shown to produce central effects including hypnotic,
      anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that
      treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the
      Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a
      reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)
      Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning
      Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,
      subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)
      followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)
      under double-blind conditions. The 2 study periods will be separated by a washout of at least
      2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or
      placebo) for a period of 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Primary psychotic disorder

          -  Ages 18-65 (inclusive)

        Exclusion Criteria:

          -  Current significant medical condition or other comorbidities

          -  Current substance depdendence

          -  Women who are pregnant or breastfeeding
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
Condition: Metastatic Colorectal Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: MORAb-004; Placebo; Best supportive care
Intervention description: MORAb-004 8mg per kg IV once a week; Placebo - normal saline IV once a week; Best supportive care to improve quality of life
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mCRC; chemorefractory metastatic colorectal cancer

Summary:

      The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe
      in the treatment of metastatic, colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females >18 years old

          -  Diagnosis of metastatic, colorectal cancer

          -  Significant medical conditions must be well-controlled and stable for at least 30 days
             prior to the first treatment infusion

          -  Be willing and able to provide written informed consent

        Exclusion Criteria:

          -  No prior treatment for metastatic colorectal cancer

          -  Other serious systemic diseases (bacterial or fungal)

          -  Clinically significant heart disease or an arrhythmia on an ECG within the past 6
             months

          -  Known allergic reaction to monoclonal antibody therapy
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of tirzepatide in participants with
      type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing
             Type 2 Diabetes Mellitus (American Diabetes Association 2017).

          -  Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

          -  If on metformin, have been treated with stable doses of metformin for at least 3
             months.

          -  Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D).

          -  Have used any glucose-lowering medication other than metformin within 3 months prior
             to study entry or during screening/lead-in period or have used any glucagon-like
             peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke).

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry.

          -  Have any condition that is a contraindication for use of the GLP-1 RA class (per
             country-specific labels) at study entry or develop such condition between study entry
             and randomization.
Study of MAP0010 in Asthmatic Children and Adolescents
Condition: Asthma
MeSH terms: Asthma
Intervention: MAP0010 low dose; MAP0010 high dose; Placebo
Intervention description: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks; a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks; Placebo delivered by nebulization twice daily for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics
      of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female asthmatic children/adolescents

          -  1 to 18 years of age

          -  FEV1 greater than or equal to 50% predicted normal (where obtainable)

          -  Stable but symptomatic

          -  Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR
             documented exacerbation or worsening of asthma or symptoms suggestive of asthma
             including nocturnal asthma, within 6 months of screening OR documented SAB use more
             than or at least once for symptom relief during the 4 days of run in with a total
             symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed
             due to asthma symptoms in previous month.

        Exclusion Criteria:

          -  Any other significant childhood illness.

          -  Participated in any investigational clinical trial within the 30 days prior to
             screening.

          -  Use of any corticosteroid within 2 weeks of screening.

          -  Use of oral corticosteroid within 30 days of screening or prolonged use of oral
             corticosteroids within 12 weeks of screening.

          -  Use of inhaled long acting bronchodilators.

          -  Presumptive or documented history of upper or lower respiratory infection within 2
             weeks before screening.

          -  Any history of acute or severe asthma attack requiring ICU admission or ventilatory
             support.

          -  History suggestive (or diagnosis) of other concomitant lung disease.
Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; Bevacizumab; Infusional 5-Fluorouracil
Intervention description: 1000 mg/m2 over 100 minutes every 2 weeks.; 10 mg/kg every 2 weeks.; 2400 mg/m2 over 48 hours every 2 weeks.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Pancreatic Cancer

Summary:

      This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine
      then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients'
      response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response
      Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor
      marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females age >=18 years.

          -  Established histological confirmation of adenocarcinoma of the pancreas.

          -  Stage III and stage IV will be allowed.

        Exclusion Criteria:

          -  No prior chemotherapy or radiotherapy allowed except for that given as part of an
             adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior
             treatment with antibodies to VEGF.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to starting the study.

          -  Pregnant or lactating women.
Treatment of Rett Syndrome With Recombinant Human IGF-1
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Intervention: Recombinant Human Insulin Growth Factor 1 (rhIGF-1); Placebo
Intervention description: Subjects will receive twice daily subcutaneous injections of IGF-1.; Subjects will receive twice daily subcutaneous injections of a saline solution (placebo).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Mitogens; Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Rett syndrome; RTT; IGF-1; autism spectrum disorder

Summary:

      Investigators are recruiting children for a clinical trial using the medication recombinant
      human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with
      Rett syndrome (RTT). While IGF-1 is approved by the Food & Drug Administration (FDA) for
      certain use in children, it is considered an investigational drug in this trial because it
      has not previously been used to treat RTT. Information from this study will help determine if
      IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a
      treatment for RTT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of "classic" (or "typical") Rett Syndrome

          -  Genetic documentation of MECP2 mutation

          -  Subject must be post-regression (Hagberg Stage 2)

          -  Subject and caregiver's primary language must be English

          -  Subject must reside in North America (US and Canada)

          -  Caregiver must have internet access and be able to complete questionnaires online and
             communicate via email

          -  Subject is stable on current medications for at least 4 weeks

          -  Subject's regimen of non-pharmacological interventions (physical therapy, speech
             therapy, etc.) is stable for at least 90 days

        Exclusion Criteria:

          -  Severe scoliosis (curvature >40 degrees)

          -  Bone-age greater than 11 years

          -  Cardiomegaly (enlarged heart)

          -  Tanner stage 2 or higher breast development

          -  Allergy to IGF-1

          -  Prior use of IGF-1, growth hormone, or sex steroids
Effect of Paracetamol on the Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Paracetamol hot drink; Paracetamol tablets
Intervention description: Hot drink containing paracetamol; Paracetamol tablets
Intervention MeSH terms: Acetaminophen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paracetamol; Common cold

Summary:

      The aim of this study is to subjectively assess symptoms in subjects suffering from the
      common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of the common cold of no more than 120 hours duration

          -  Self-rating congestion of at least moderate severity

          -  Suffering from at least four symptoms of common cold or flu
Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
Condition: Adrenoleukodystrophy
MeSH terms: Adrenoleukodystrophy
Intervention: glyceryl trierucate/glyceryl trioleate
Intervention description: Administration of glyceryl trierucate/glyceryl trioleate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: Male
Minimum age: 18 Months
Maximum age: 8 Years
Healthy volunteers: No
Keywords: adrenoleukodystrophy; inborn errors of metabolism; rare disease; sphingolipidoses

Summary:

      OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl
      trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.

      II. Compare the frequency and severity of neurological disability of study patients with
      untreated historical controls.
    

Eligibility criteria:

        Inclusion criteria.

          1. Boys between the age of 18 months and 8 years of age

          2. Biochemically proven asymptomatic X-linked adrenoleukodystrophy determined by
             elevation of very long chain fatty acids or DNA analysis.

          3. Platelet count in normal range

        Exclusion criteria.

          1. Abnormal MRI consistent with childhood cerebral disease

          2. Boys who have undergone bone marrow transplantation

          3. Other medical condition which in the opinion of the investigator prevents evaluation
             or treatment
High Dose Vitamin D vs Standard Dose Vitamin D Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 800 IU Vitamin D Supplement; 50,000 IU Vitamin D supplement
Intervention description: Standard Dose; High Dose
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Hormone Receptor Positive; Vitamin D

Summary:

      This study is being done to look at the difference, if there is a difference between two
      different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is
      caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients.
      The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent
      aromatase inhibitor arthralgia (AIA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All participants must be female and at least 21 years of age

          -  Signed informed consent

          -  Patients must have had histologically confirmed stage I-III breast carcinoma that is
             positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR).

          -  Post-menopausal

          -  Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6
             weeks

          -  Bisphosphonates are allowed at the treating investigator¡¦s discretion

          -  Performance status (WHO/ECOG scale) 0-2.

        Exclusion Criteria:

          -  History of kidney stones

          -  Hypercalcemia at baseline, defined as any corrected calcium greater than the
             laboratory's normal parameters

          -  History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating
             investigator's discretion

          -  Baseline Vitamin D level greater than 50 ng/mL

          -  Inability or unwillingness to comply with, or follow study procedures.

          -  Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or
             orlistat

          -  Malabsorption syndrome, such as Crohn's disease

        Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the
        study medications. Patients who are on cholestyramine or orlistat will not be allowed on
        the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the
        trial either because of interaction between Vitamin D and anti-epileptic medications.