bioihbjkbjnl/mcl2 huggingface dataset:
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Intervention: Indacaterol 300μg; Placebo
Intervention description: 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device; Matching placebo devices and hard gelatin capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD, Indacaterol Maleate, Exercise testing

Summary:

      This study evaluated the effect of QAB149 on dynamic and static hyperinflation,
      breathlessness, and health status in COPD patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects,

          -  40 to 80 years of age,

          -  with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary
             disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease
             (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1
             ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an
             informed consent form (ICF) prior to the initiation of any study-related procedure
             (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of
             salbutamol)

          -  Subjects who demonstrate a plethysmographic functional residual capacity >120%
             predicted normal

        Exclusion Criteria:

          -  No COPD exacerbations within 6 weeks prior to dosing,

          -  no concomitant lung disease such as asthma,

          -  no requirement for long term oxygen treatment or history of lung reduction surgery.

          -  No medical conditions that would interfere with the performance of spirometry or
             clinical exercise testing.

          -  Any other medical condition that in the opinion of the investigator may cause the
             patient to be unsuitable for completion of the study or place the patient at potential
             risk from participating in the study e.g. uncontrolled hypertension or unstable
             ischemic heart disease

        Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Condition: Interdental Papillary Insufficiency
Intervention: Autologous Human Fibroblasts (azficel-T)
Intervention description: Collection of biopsy from palate
Papillary priming procedure
Seven injection treatments to target sites
Performance of study assessments (investigator and subject)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety profile and the treatment effect of
      Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study
      (IT-G-002, no NCT identification number)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 18-70 years of age

          -  Subject was treated in IT-G-002 (no NCT identification number)

          -  Subject has maxillary interproximal recession defects

          -  Natural teeth must be present on both sides of each area to be treated

          -  Negative pregnancy test and use of acceptable birth control (females of childbearing
             age)

        Exclusion Criteria:

          -  Subjects who participated in other clinical trials within 30 days prior to enrollment

          -  Interproximal spaces including root grooves or furcations must not be involved

          -  Subjects with poor oral hygiene

          -  Subjects with a systemic condition, which would preclude periodontal treatment

          -  Subjects with acute infectious lesions in the treatment areas

          -  Subjects with open interproximal contact at study sites

          -  Subjects who must receive prophylactic antibiotics before dental procedures

          -  Subjects on chronic antibiotic or steroidal therapy

          -  Subjects with interproximal probing depths > 3 mm around study lesions

          -  Subjects who smoke

          -  Subjects taking medications associated with the development of drug induced gingival
             hyperplasia

          -  Subjects with radiographic evidence of pathology

          -  Subjects with tooth mobility exceeding a score of 1

          -  Subjects with parafunctional habits and not wearing bite guard

          -  Subjects with interproximal spaces associated with teeth without an adequate zone of
             keratinized tissue

          -  Subjects where the etiology of the interproximal papillary recession has not been
             controlled

          -  Subjects who have received a crown or pontic on one or both teeth involved in the
             interproximal space to be treated
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: IMRT; DWI MRI; Doxorubicin; Modified Barium Swallow Impairment Profile (MBSImP)
Intervention description: Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC; The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.; Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.; The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Intervention MeSH terms: Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-anaplastic; non-medullary; radiation; IMRT; Doxorubicin; 13-070

Summary:

      The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam
      radiation therapy, has on the patient and their thyroid cancer where surgery is not an option
      or where despite surgery, the disease is still present.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that
             is either grossly recurrent after surgery or unresectable with or without metastatic
             disease.

          -  Age ≥18 years

          -  Karnofsky performance status ≥70%

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months after treatment.

          -  Patients must have ability to understand and the willingness to sign a written
             informed consent document.

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Inability to comply with study and/or follow-up procedures
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Intervention: Peanut SLIT; Placebo SLIT
Intervention description: Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.; Liquid glycerin without peanut which are dosed under the tongue.
Intervention MeSH terms: Glycerol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment.
After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months)
2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Peanut Allergy; Sublingual immunotherapy

Summary:

      The specific aim of this study is to determine if peanut allergen-specific SLIT will cause
      clinical desensitization and tolerance to develop in peanut-allergic young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND

          -  History of significant clinical symptoms within 60 minutes after the ingestion of
             peanuts.

        Exclusion Criteria:

          -  History of severe life-threatening anaphylaxis to peanut, OR

          -  Medical history that would prevent a DBPCFC to peanut, OR

          -  Subjects with wheat or oat allergy (which are used in the placebo), OR

          -  Unable to cooperate with challenge procedures, OR

          -  Unable to be reached by telephone for follow-up
Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab, docetaxel and carboplatin in dose dense regimen
Intervention description: trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dose dense therapy has been shown to increase survival in the adjuvant setting of breast
      cancer. It is unknown if dose dense therapy will improve survival in tumors that express
      her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and
      herceptin when used in a dose dense manner in patients with large breast cancers. The
      endpoint of pathologic complete response is used as a surrogate marker for survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HER-2 overexpressing breast cancer

          -  Clinical stage 2-3B

          -  Normal ejection fraction

        Exclusion Criteria:

          -  Metastatic disease

          -  Low ejection fraction
Topical Treatment of Under Eye Dark Circles and Swelling
Condition: Edema
Intervention: Fexofenadine; Placebo
Intervention description: Fexofenadine 1%; Placebo
Intervention MeSH terms: Fexofenadine; Terfenadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Under eye dark circles; Under eye puffiness

Summary:

      This study examines topical treatment of under eye circles and swelling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Under eye dark circles and swelling

        Exclusion Criteria:

          -  Under age 18

          -  Allergy to tested medicines
An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: ticagrelor; clopidogrel
Intervention description: Drug oral treatment; Drug oral treatment
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Stable Coronary Artery Disease; Platelet Aggregation

Summary:

      The purpose of the study is to determine the drug characteristics of Ticagrelor, and to
      determine if 4 weeks treatment will reduce the blood clotting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any Percutaneous Coronary Intervention, more than 3 months prior to randomization

          -  Previous documented acute coronary syndrome (ACS), more than 3 months prior to
             randomisation

          -  Treatment with ASA

        Exclusion Criteria:

          -  ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to
             randomisation

          -  Known concurrent disease of stroke or TIA with atrial fibrillation

          -  Persons who are being treated with blood clotting agents that cannot be stopped
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Erythema
Intervention: CD07805/47 Gel; Vehicle Gel; CD07805/47 Gel; CD07805/47 Gel; Vehicle Gel
Intervention description: CD07805/47 Gel 0.5% QD; Vehicle Gel QD; CD07805/47 Gel 0.18% QD; CD07805/47 Gel 0.18% BID; Vehicle Gel BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this vehicle controlled study is to evaluate the efficacy and safety of
      CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18%
      applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate
      to severe facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, who is at least 18 years of age or older.

          -  A clinical diagnosis of rosacea.

          -  A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on
             Baseline/Day 1.

          -  A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on
             Baseline/Day 1.

          -  A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on
             Baseline/Day 1.

        Exclusion Criteria:

          -  Three (3) or more facial inflammatory lesions.

          -  Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.

          -  Known allergies or sensitivities to any components of the study medications, including
             the active gel ingredient, brimonidine tartrate.

          -  Intraocular pressure (IOP) measurement less than 10 mm Hg.
Red Blood Cell ATP Release and Vascular Function in Humans
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Fasudil Hydrochloride; Saline
Intervention description: 10 mg/mL vial of fasudil hydrochloride. 6 mL (60 mg) of fasudil hydrochloride are added to a 100 mL saline bag for delivery to subjects.; 100 mL saline bag.
Intervention MeSH terms: Fasudil
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled, crossover study. Approximately 20 young and 20 older adults will be recruited for participation and randomly assigned to either a placebo (saline) infusion or a fasudil hydrochloride infusion. The dose of fasudil hydrochloride is 60 mg/ 60 min.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: A person not associated with any data collection or data analysis is randomizing the treatment and preparing it in a separate room. All data is collected as visit 1 or visit 2.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Previous work demonstrates that the red blood cells of older adults do not release a potent
      vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are
      targeting a pathway within the red blood cell using fasudil hydrochloride to determine if
      both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia)
      and exercise in older adults can be improved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy

          -  Sedentary to moderately active

          -  18 to 30 years old for young subjects

          -  60 to 80 years old for older subjects

        Exclusion Criteria:

          -  Obesity (BMI ≥ 30 kg/m^2)

          -  Cardiovascular disease

          -  Metabolic disease

          -  Use of medications that can influence cardiovascular function

          -  Blood pressure greater than or equal to 140/90

          -  Smoker

          -  Use of hormone replacement therapy
Combined Spinal/Epidural (CSE) Saline Duration/Spread
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Sterile normal saline 0 mls; 15 mls sterile normal saline
Intervention description: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.; After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: labor pain treatment; duration analgesia; Analgesic duration with normal saline injection.; Analgesic duration without normal saline injection

Summary:

      An attempt is being made to see if by injecting a set volume of sterile saline into the
      epidural space during the treatment of labor pain with a combined spinal/epidural (CSE)
      increases the amount of pain relief obtained and makes the labor analgesia lasts longer.
      Subjects are in the study from the time their CSE is placed until they request additional
      pain medication from the spinal dose of numbing medicine wearing off.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age greater than 12 years of age

          -  ASA status 1 or 2

          -  cervical dilation < 6cm

        Exclusion Criteria:

          -  ASA assigned 3 or 4

          -  advanced labor (> 6cm cervical dilated)

          -  distorted epidural anatomy
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: olaparib
Intervention description: 400 mg po bid continuously
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Colorectal cancer; Olaparib; MSI status; Stage IV; Measurable Colorectal Cancer; Stratified by MSI Status

Summary:

      This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively
      and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to
      determine whether olaparib will have a beneficial effect on the patient's cancer by causing a
      response and increasing the time it takes for the cancer to progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will have measurable disseminated colorectal cancer that is incurable by
             surgery

          -  Patients will have had tumor progression following standard combination front-line or
             second-line chemotherapy.

          -  CRC patients who have relapsed or recurrent disease within six months after completing
             adjuvant or neoadjuvant chemotherapy

        Exclusion Criteria:

          -  Previous treatment with PARP inhibitors, including olaparib.

          -  Patients with symptomatic, uncontrolled brain metastases.

          -  Patients receiving any chemotherapy, radiotherapy (except for palliative reasons),
             within 4 weeks from the last dose prior to study entry (or a longer period depending
             on the defined characteristics of the agents used).

          -  Patients who are unable to swallow orally administered medication.