bioihbjkbjnl/mcl2 huggingface dataset:
Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers
Condition: Carcinoma, Non-small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention
      of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up
      to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell
      lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence
      aprepitant plasma concentration, which may lead to the individual difference of CINV control
      rate.
    

Detailed description: 
      Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN
      non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum
      based chemotherapy, are randomized divided into two groups, aprepitant group and placebo
      group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at
      day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both
      group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the
      treatment, any grade of nausea and vomiting should be recorded in order to evaluate the
      complete response rate of CINV, other side-effects should be recorded. In aprepitant group,
      plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4
      and NK-1 should be analyzed for all the patients who received aprepitant if possible.
    

Intervention name(s): Aprepitant; placebo
Intervention type(s): Drug; Drug
Intervention description(s): aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.; placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Other intervention name(s): Emend
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aprepitant; non-small cell lung cancer
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study is designed to assess the long term safety and efficacy of zoledronic
      acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301
      (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year
      core study ended. Baseline is the same as Year 3.
    


Intervention name(s): Zoledronic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.; 100 mL physiologic 0.9% normal saline for intravenous infusion.
Other intervention name(s): Reclast, Aclasta; Reclast, Aclasta
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis, Zoledronic Acid
fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
Condition: Healthy
Study type: Interventional

Summary: 
      The study will consist of five occasions with one week in between. BOLD signal intensity of
      the hypothalamus will be measured using fMRI. Measurements will be done before and after
      drinking 300 ml plain water (reference) or water to which different sweeteners will be added.
    

Detailed description: 
      The hypothalamus is known to be important for control of feeding behaviour as well as the
      regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive
      method, which detects transient haemodynamic changes in the brain, using blood oxygen level
      dependent (BOLD) signal differences.

      In order to investigate the role of hypothalamic neural activity in response to different
      sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water
      or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose
      (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

      The study uses a randomized cross-over design in 16 healthy male subjects with a normal body
      weight. There will be an interval of at least one week between the five occasions.

      Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously
      measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after
      drinking).
    

Intervention name(s): Water; Glucose; Fructose; Sucrose; Sucralose
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Water, 300 ml at room temperature; Glucose, 50 grams in 300 ml water at room temperature; Fructose, 50 grams in 300 ml water at room temperature; Sucrose, 50 grams in 300 ml water at room temperature; Sucralose, 0.33 grams in 300 ml water at room temperature
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pediatric Aggression and Violence
Condition: Pediatric Aggression and Violence
MeSH terms: Aggression
Study type: Observational

Summary: 
      Violence and aggression on pediatric psychiatry units has led to staff and patient injuries
      and even deaths around the country. In an effort to improve safety, the investigators have
      developed a method (with the Brief Rating of Child and Adolescent Aggression) of identifying
      children and adolescents at a higher risk for aggression and violence on the units. In order
      to improve this prediction, the investigators plan to study salivary hormones in low risk
      children and high risk children. The salivary hormones to be studied include cortisol,
      testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to improve
      the investigators current ability to predict the severity and type of pediatric aggression
      and violence on the inpatient units by combining information from the Brief Rating of Child
      and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale (Vitiello et
      al., 1990), and salivary hormones.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 24 male subjects (ages 7-11) will be recruited to two groups from inpatient
        units at CCHMC:

          1. Inpatient high aggression: Twelve inpatient males (6 African-American and 6 Caucasian)
             will be recruited based on completion of the BRACHA and the Predatory-Affective
             Aggression Scale.

          2. Inpatient low aggression: Twelve inpatient males (6 African-American and 6 Caucasian)
             will be recruited based on completion of the BRACHA and the Predatory-Affective
             Aggression Scales.
      
Biospecimen description: 
      Saliva specimens will be retained for future research use for particpants who have given
      proper consent.
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.
Condition: Postoperative Bowel Functions
Study type: Interventional

Summary: 
      Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with
      gynecologic cancers.
    


Intervention name(s): walking
Intervention type(s): Other
Intervention description(s): walking and not walking
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: walking preoperatively not walking preoperatively
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: gynecologic cancer; postoperative bowel function; walking; debulking
Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, phase III trial was designed to test the efficacy of a low-dose
      chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered
      following standard chemotherapy in patients with early breast cancer whose tumors are hormone
      receptor negative.
    

Detailed description: 
      PURPOSE:

        -  Evaluate a low-dose cyclophosphamide and methotrexate chemotherapy-maintenance regimen
           in early breast cancer.

        -  Compare the disease-free survival, overall survival, and systemic disease-free survival
           of patients treated with these regimens.

        -  Compare the toxic effects of these regimens in these patients.

      OUTLINE:

      This is a randomized, open-label, multicenter study. Patients are stratified according to
      participating center, menopausal status (pre vs post), and approved induction chemotherapy
      (anthracycline and cyclophosphamide vs other agents). Treatment duration is 12 months of
      low-dose chemotherapy-maintenance regimen (CM-maintenance) vs no chemotherapy-maintenance
      regimen (no-CM) following standard adjuvant chemotherapy. Patients are randomized to one of
      two treatment arms. Patients are followed every 6 months for 5 years, and yearly follow-up
      thereafter.
    

Intervention name(s): Cyclophosphamide; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/day orally continuously for 1 year; 2.5 mg twice/day orally days 1 and 2 of every week for 1 year
Other intervention name(s): Endoxan; Cytoxan; Trexall
Intervention MeSH terms: Cyclophosphamide; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IA breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IB breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer; triple-negative breast cancer; low-dose maintenance chemotherapy; stroma; angiogenesis
Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Condition: COPD
Study type: Interventional

Summary: 
      Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline
      on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and
      acetylation status of nuclear histones are to be studied.Design: controlled, prospective and
      randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To
      determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT)
      activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3
      months later, once stability is achieved. To correlate these measurements with inflammatory
      and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess
      the effect of theophylline on previous molecular, functional and clinical data. Method: 25
      patients with COPD will be recruited during an episode of exacerbation requiring
      hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and
      oxidative stress will be determined with specific assays. These determinations will be
      repeated once the patient is stable and compared with smokers and non smoker controls with
      normal lung function
    


Intervention name(s): Theophylline
Intervention type(s): Drug
Intervention description(s): Theophylline 100 mg bid for 3 months
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: COPD exacerbation; histone; steroid resistance; inflammation; theophylline
Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
Condition: Procedural Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after
      intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years
      of age children scheduled for minor surgery or other procedures requiring sedation or
      anesthesia.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Device
Intervention description(s): A 2-4 µg/kg dose of the study drug, 2 µg/kg of intranasal dexmedetomidine, will be administered using a LMA MAD Nasal™ -device approximately 20 min prior to planned sedation/anesthesia.
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Absolute Bioavailability of Oral PCI-32765 and the Effect of Grapefruit Juice on the Bioavailability of PCI-32765 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and the
      effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known), sequential and 2-way
      crossover design, pharmacokinetic (study of what the body does to a drug) study to assess the
      absolute bioavailability of oral (by mouth) PCI-32765 and the effect of grapefruit juice on
      the absorption of PCI-32765 in approximately 8 healthy adult participants. The duration of
      the study is approximately 45 days (screening, treatment, and follow-up). All patients will
      receive PCI-32765 560 mg (Treatment A) administered by mouth in the first period and
      Treatment B (560 mg administered by mouth without grapefruit juice) and Treatment C (140 mg
      administered by mouth with grapefruit juice) according to a randomization schedule in Periods
      2 and 3. Participants will fast overnight for at least 10 hours prior to study drug dosing.
      Participants will stay in the study center for pharmacokinetic sampling. Serial
      pharmacokinetic samples will be collected before dosing and over 72 hours after dosing and
      safety will be monitored throughout the study.
    

Intervention name(s): PCI-32765 (Treatment A); PCI-32765 (Treatment B); PCI-32765 (Treatment C); 13C6 PCI-32765 (reference)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 560 mg capsules administered by mouth on Day 1, Period 1; 560 mg capsules administered by mouth (without grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule; 140 mg capsule administered by mouth (with grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule; 100 mcg administered intravenously 2 h after study drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; PCI-32765; PCI 45227; 13C6 PCI-32765; Pharmacokinetic; Bioavailability
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of ADX10059 in patients with
      gastroesophageal reflux disease who are partial responders to proton pump inhibitors
    


Intervention name(s): ADX10059; ADX10059; ADX10059; ADX10059 Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration; oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux; Proton pump inhibitor; Heartburn; Regurgitation
Physical Therapy for Functional Constipation in Children
Condition: Physical Therapy in Pediatric Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Children diagnosed with functional constipation are subjected to physical therapy combined
      with conventional treatment
    


Intervention name(s): Polyethylene Glycols; Physical therapy program
Intervention type(s): Drug; Other
Intervention description(s): Polyethylene Glycols syrup (0.7 g/kg daily); The physical therapy program includes exercises and massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Optimal Value Increase of Egg Products
Condition: Healthy; Inflammation; Aging
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The aim of this project is to evaluate daily intake of eggshell membrane taken as supplement
      (capsule), will reduce markers of inflammation in older people.
    


Intervention name(s): Eggshell membrane (ESM); Placebo
Intervention type(s): Other; Other
Intervention description(s): The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.; The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Eggshell membrane; Healthy volunteers; Old volunteers
A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different
      Extended/modified-release formulations and one immediate release formulation of AZD1446. In
      addition the food effect on AZD1446 pharmacokinetics will be investigated.

      Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in
      elderly healthy volunteers.
    


Intervention name(s): AZD1446; AZD1446; AZD1446; AZD1446; AZD1446; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ER Fast, 90mg, p.o. capsule; ER Moderate, 90mg, p.o. capsule; ER Slow, 90mg, p.o. capsule; MR; IR, 90 mg p.o. capsule; IR; ER/MR
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I; Relative bioavailability; Pharmacokinetic study; AZD1446; healthy volunteers
The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
Condition: Appetitive Behavior; Satiety
Study type: Interventional

Summary: 
      The study was carried out once a week on the same day and for three-week duration, with total
      of 17 randomly selected participants with ages between 18 and 24 years. The test foods
      containing different vegetable fiber sources (chickpeas and oats) were given to the
      participants every week as isocaloric, which have been the control food for a week. The
      satiety status was evaluated by visual analog scale (VAS) for total of five times as
      immediately before the test food consumption and at 30, 60, 90 and 120 minutes after
      consumption. Fasting and postprandial blood glucose levels were measured. A 24-hour
      retrospective food consumption record was obtained the next day.
    


Intervention name(s): Yoghurt; Chickpea+Yoghurt; Oat+Yoghurt
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 200 ml plain full-fat yoghurt; 80 ml plain full-fat yoghurt + 70 gr cooked chickpea; 80 ml plain full-fat yoghurt + 100 gr cooked oat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: appetite; fiber; protein; satiety
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic
      properties (the exposure of the trial drug in the body) of faster-acting insulin aspart
      (FIAsp) after different injection regions and routes of administration in healthy subjects.
    


Intervention name(s): Faster-acting insulin aspart
Intervention type(s): Drug
Intervention description(s): Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment