bioihbjkbjnl/mcl2 huggingface dataset:
Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with
      cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment
      of locally advanced nasopharyngeal carcinoma.
    

Detailed description: 
      All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral
      capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by
      concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with
      radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total
      dose and dose/fraction (Fr) as follows: PTV (planned target volume)_1:70 grays (Gy) at 2 Gy/
      Fr, PTV_2:63 Gy at 1.8 Gy/ Fr, PTV_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response
      was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of
      CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All
      toxicities were gauged based on the Common Terminology Criteria for Adverse Events version
      4.03 (CTCAE 4.03).
    

Intervention name(s): cisplatin, capecitabine
Intervention type(s): Drug
Intervention description(s): Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
Other intervention name(s): chemoradiotherapy
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Intervention model description: All patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasopharyngeal carcinoma; induction chemotherapy; cisplatin; capecitabine; chemoradiotherapy
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Smoking-related cardiopulmonary diseases account for a large number of hospital admissions.
      We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking
      cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks
      after hospital discharge. We compared outcomes with hospitalized patients who received more
      conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on
      their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization
      among patients admitted with a cardiac or a pulmonary diagnosis.
    

Detailed description: 
      Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were
      recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy
      and NRT, and self-quit group. All patients received self-help brochures and in-hospital
      counseling. Intervention groups received more extensive counseling, free NRT supply for a
      month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had
      follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of
      tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and
      urinary Cotinine levels.
    

Intervention name(s): hypnotherapy; Nicotine
Intervention type(s): Behavioral; Drug
Intervention description(s): One 90 minute session within 2 weeks of hospital discharge; free one month supply after hospital discharge
Other intervention name(s): hypnosis; Nicotine replacement therapy
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Tobacco abstinence; hypnotherapy; Nicotine replacement therapy
A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase Ib/III clinical study to evaluate the efficacy and safety of
      recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell
      death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel
      versus placebo in combination with paclitaxel in subjects with small cell lung cancer who
      have failed first-line or above chemotherapies.
    


Intervention name(s): paclitaxel; IBI318
Intervention type(s): Drug; Drug
Intervention description(s): 80mg/m^2,iv,Q4W; 300mg,iv,Q4W
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient
Condition: Neurosurgery
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether a correlation exists between the partial
      pressure of carbon dioxide existing within arterial blood and the gradient between inhaled
      and exhaled fractions of oxygen.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults age 18 to 65 scheduled for a surgical procedure that will last at least two hours
        and for whom arterial cannulation and at least two arterial blood gas analyses are planned
        during the surgery.
      
Keywords: Arterial cannulation; Blood gas; Carbon dioxide; Arterial blood; Oxygen; Oxygen fractions
Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation
Condition: Diabetes Mellitus; Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in
      pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out
      Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance
      and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic
      to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see
      the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.
    

Detailed description: 
      This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics
      and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in
      the study by observing the Helsinki Declaration for clinical trials.

      volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or
      at risk to develop diabetes mellitus type 2.

      On screening, pre-diabetics and early onset diabetics with no previous history of treatment
      etc will be grouped into A and B.

      Biochemical evaluations will be carried out at base line and followed by three weeks
      intervention and evaluation of biomarkers and at sixth week for further evaluation.

      Collected data will be evaluated for primary out comes and secondary out come. statistical
      analysis will be done. One year followup of participants was conducted.
    

Intervention name(s): Polyherbal formulation
Intervention type(s): Dietary Supplement
Intervention description(s): Test candidate will be administered per oral before / with meal in two divided doses
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  community samples will be obtained from the area of Bahawalpur

          -  Model Town A, B, and

          -  remote areas of district Bahawalpur consisting of Khairpur Tamewali city population
      
Keywords: Impaired Fasting Glucose; Impaired Glucose Tolerance; 2hr -75gm Oral Glucose Tolerance Test; Diabetes Mellitus Prevention
Effect of AKB-6548 on the Pharmacokinetics of Celecoxib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when
      administered alone and following multiple daily doses of AKB-6548.
    

Detailed description: 
      To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib
      in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone
      and following multiple daily doses of AKB-6548.
    

Intervention name(s): Celecoxib; AKB-6548
Intervention type(s): Drug; Drug
Other intervention name(s): CELEBREX®
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to assess the general safety and tolerability of the administration of a 3-dose
      prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis
      C virus infection.
    


Intervention name(s): MRKAd5 HIV-1 gag vaccine (V520); Comparator: Placebo; Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed; MRKAd5 HIV-1 gag vaccine (V520)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26; 1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26; 0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only; 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Condition: Dyspnea; Quality of Life; Respiratory Symptoms
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea; Signs and Symptoms, Respiratory
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE
      PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND
      SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
    

Detailed description: 
      PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE WILL BE SUBMITTED TO PASSIVE STRETCHING
      OF RESPIRATORY MUSCLES AND EXERCISE IN TREADMILL DURING 12 WEEKS, TWICE A WEEK. ONE WEEK
      AFTER THE TRAINING PERIOD, THE FUNCTIONAL CAPACITY, THE THORACOABDOMINAL MECHANICS AND LEVELS
      OF ANXIETY AND DEPRESSION WILL BE ASSESSED.
    

Intervention name(s): Stretching Exercises
Intervention type(s): Other
Intervention description(s): The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Thoracoabdominal Mechanics; Functional capacity; Quality of life
Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine
Condition: Anesthesia
Study type: Interventional

Summary: 
      Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal
      dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher
      dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published
      data exist comparing buffered local anesthetics at lower drug concentrations to current
      dosages commonly used in dental and oral surgical procedures
    

Detailed description: 
      Specific Aims:

      Compare clinical depths of pulpal anesthesia for maxillary molar and canine teeth at 30min
      intervals post injection after maxillary field block anesthesia with buffered 1% lidocaine
      with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000
      epinephrine.

      Hypotheses:

      No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for
      maxillary field block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as
      compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

      Study Time Frame: 6 months: Month One Recruit 24 volunteers as subjects, Prepare case-books.
      Months Two-Three Clinical Study. Months Four-Five Analyze Lab data. Month Six Prepare
      Abstracts, Papers Methods: Blinded, Randomized Clinical Design, Recruit subjects with
      Institutional Review Board approved consent at University of North Carolina. Subjects will
      serve as their own controls in a cross-over AB/BA study design which is uniform within
      sequences, uniform within periods, and balanced. Randomized subjects to be injected orally
      for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal sensory nerves)
      alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc
      non-buffered of 2% lidocaine with 1/100,000 epinephrine.

      Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold,
      electronic pulp test at maxillary molar and canine at 30 minute intervals.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Intraoral maxillary field block
Other intervention name(s): xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: lidocaine, jaw
Effect of Combined Morphine and Duloxetine on Chronic Pain
Condition: Chronic Low Back Pain; Chronic Neck Pain
MeSH terms: Low Back Pain; Chronic Pain; Neck Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blind, randomized, and placebo-controlled clinical study examining whether
      duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid
      analgesia and reduce overall opioid use. Positive outcomes will help improve the overall
      effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.
    


Intervention name(s): Morphine; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.; Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.; Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other intervention name(s): Morphine Sulfate Contin, Morphine Sulfate Instant Release; Cymbalta; Sugar pill
Intervention MeSH terms: Morphine; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Pain; Pain Management
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of the study is to develop a nomogram that correlates intraoperative, aphakic
      refraction measurements when the anterior chamber is pressurized with either balanced salt
      solution (BSS) or DisCoVisc; and to understand how suggested IOL power selection may differ.
    


Intervention name(s): BSS; DiscoVisc
Intervention type(s): Device; Device
Intervention description(s): Intraoperative aberrometry measurements for BSS will be performed.; Intraoperative aberrometry measurements for DiscoVisc will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cataract Extraction
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Detailed description: 
      Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy,
      hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject
      compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including
      adhesion).
    

Intervention name(s): AG200-15; Levora
Intervention type(s): Drug; Drug
Intervention description(s): Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.; One tablet of Levora will be taken each day for a 28 day cycle.
Other intervention name(s): Transdermal contraceptive delivery system (TCDS); Hormonal oral contraceptive
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Hormonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraceptive
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Egg Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if children with egg allergy can be desensitized to
      egg protein and if this desensitization can help them outgrow their egg allergy at an earlier
      time than normal. Our hypothesis is that children with egg allergy can be orally desensitized
      to egg protein and that this desensitization will help them outgrow their egg allergy at an
      earlier time than normal.
    

Detailed description: 
      Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and
      peanuts, cause 80% of the food allergy reactions in children in the United States. Children
      have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The
      current therapy for children with egg allergy is to place the child on an egg-free diet until
      the allergy is outgrown. Because egg protein is a part of a significant number of processed
      foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to
      reactions to egg can occur with a bite of a cookie (~70 mg of egg protein) or a bite of a
      cake (~55 mg of egg protein). Children typically do not outgrow their egg allergy for several
      years. Therefore it would be helpful if a specific form of therapy would make children
      outgrow their allergic reactions to egg sooner. Egg protein is given to children in this
      study in small increasing amounts to desensitize them to the egg protein with the goal of
      helping them to outgrow their allergy.
    

Intervention name(s): Egg white protein
Intervention type(s): Drug
Intervention description(s): Egg white protein powder
Other intervention name(s): Egg OIT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Egg allergy
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin
      in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment
      period.

      Secondary objective was to assess the effect of insulin glargine in comparison with
      sitagliptin on:

        -  HbA1c level

        -  Fasting Plasma Glucose (FPG)

        -  7-point plasma glucose (PG) profiles

        -  Percentage of patients with HbA1c <7% and <6.5%

      Safety objectives consisted of:

        -  Hypoglycemia occurrence

        -  Body weight

        -  Overall safety
    


Intervention name(s): Insulin Glargine; Sitagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).; Oral administration. 100 mg film-coated tablets.; Patients continued with metformin as usual oral anti-diabetic treatment.
Other intervention name(s): Lantus®; Januvia®
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GSK1349572 Drug Interaction Study With Protease Inhibitors
Condition: Healthy Subjects; Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to determine whether there is a drug interaction between
      GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir
    


Intervention name(s): GSK1349572; GSK1349572
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg given in combination with lopinavir/ritonavir; 30 mg in combination with darunavir/ritonavir
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: healthy volunteer; darunavir; lopinavir; ritonavir; GSK1349572; integrase; pharmacokinetics