cyrilzakka/clinical-trials huggingface dataset:
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.

OBJECTIVES:

* To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
* To determine the prevalence of candidate biomarkers in lung cancer progression.
* To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions.
* To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients.

OUTLINE: This is a multicenter study.

Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC).

Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results.

Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Known or previously diagnosed lung cancer
  * Suspected lung cancer, including the following:

    * Completely resected stage I lung cancer (with no evidence of metastatic disease) for which patient is at risk for developing secondary disease
    * Suspected of having lung cancer due to clinical symptoms, such as positive sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and positive x-ray
  * Healthy volunteer

PATIENT CHARACTERISTICS:

* WBC ≥ 2,000/mm³ but ≤ 20,000/mm³
* Platelet count ≥ 50,000/mm³
* Not pregnant
* No uncontrolled hypertension (i.e., systolic blood pressure \> 200 mm Hg, diastolic blood pressure \> 120 mm Hg)
* No unstable angina
* No known bleeding disorder
* No other contraindications for white light bronchoscopic examination
* No other contraindications for fluorescence examination

PRIOR CONCURRENT THERAPY:

* More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin derivatives)
* More than 3 months since prior and no concurrent chemopreventative drugs (e.g., tretinoin)
* More than 6 months since prior ionizing radiation treatment to the chest
* More than 6 months since prior systemic cytotoxic chemotherapy
* No concurrent anticoagulant therapy
Investigation Into the Pathophysiology and Treatment of Varicose Veins

Chemical sclerotherapy is commonly used to treat varicose veins which affect superficial veins in the leg. Sclerotherapy is injected directly into veins where it causes damage to the vein wall. If sufficient damage occurs, the vein is transformed into a fibrous cord which does not re-open. This study will investigate the structural changes caused to the wall of veins following injection with sclerotherapy ex vivo. Vein samples will be obtained from the Whiteley Clinic in Guildford from patients undergoing phlebectomy operations. These will then be injected with sclerotherapy and the extent of damage will be investigated. Samples will also be used for laboratory analysis into the pathophysiology of varicose veins.

Varicose veins affect up to 40% of the population and are associated with significant discomfort, skin damage, and complications including ulceration and perforation. In recent years, there has been a move towards minimally invasive treatment, including chemical sclerotherapy. Despite their widespread use,the fundamental effects of sclerosants have not been fully characterised. Furthermore, their use is associated with significant rates of re-canalisation and clinical recurrence. There is therefore significant scope for researching the effects of sclerosants on the vein wall and the mechanisms of cell death. Furthermore, the pathophysiology of varicose veins has not been fully characterised. It is the aim of this study to research a number of themes related to the use of sclerotherapy and the pathophysiology of varicose veins in order to provide information which will both further scientific knowledge and further develop clinical practice by optimising the use of sclerotherapy. This research will be conducted by a PhD student based at the University of Surrey, in conjunction with the Whiteley Clinic in Guildford. Veins and blood samples removed following varicose vein surgery at the Whiteley Clinic will be provided for laboratory-based research at the university. A range of methodologies will be employed to analyse cellular responses to sclerosants to determine the precise structural and biochemical changes which lead to destruction of the vein and clinical efficacy, and to investigate a number of key themes implicated in the pathophysiology of varicose veins.

Eligibility Criteria:
Inclusion Criteria:

* Gives consent
* Over 18 years
* Undergoing phlebectomy operation

Exclusion Criteria:

* Does not give consent
REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
* At least one of the following forms of psoriatic arthritis (PsA):

  * Distal interphalangeal (DIP) involvement (inflammatory)
  * Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
  * Arthritis mutilans
  * Asymmetric peripheral arthritis or
  * Spinal involvement
* Active psoriatic arthritis at the time of the study enrollment
* Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
* Greater than 18 years of age at the time of consent
* Able to start etanercept therapy per the approved product monograph
* Informed consent must be provided before any study specific procedures are performed

Exclusion Criteria:

* Active infections at time of initiating Enbrel® therapy
* Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
* A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
* Known hypersensitivity to etanercept or any of its components
* Patients receiving, or who have received:

  * Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or
  * Kineret® (anakinra) in the previous 15 days
* Patients receiving or who have received etanercept
* Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
* Active guttate, erythrodermic or pustular psoriasis at the time of screening
* Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
* Sepsis or at risk of septic syndrome
* Patients not available for follow-up assessment
* Concerns for subject's compliance with the protocol procedures
IFACT: Incidental Findings in Advanced Cancer Therapy

The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this research gap by examining MSK patients' attitudes, preferences, and information needs regarding incidental findings arising from tumor genomic profiling.

Part 1, the investigators will recruit 40 participants from those already enrolled in existing MSK IRB protocol #12-245 (PI: David Hyman, MD) including male and female patients who have been diagnosed with late-stage breast, colorectal, bladder, and lung cancer (some of the most common cancers in this study population).

Part 2, the investigators will recruit 20 participants from those who have actually received incidental germline findings from MSK IRB protocol #12-245 Consent Part C in order to cognitively test novel survey items about their knowledge and perceived utility of their incidental findings (note that the content of these items will be derived from the data collected in Part 1)

Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Patient enrolled on MSK protocol #12-245
* Living patient age 18 or older
* Patient diagnosed with breast cancer, colorectal cancer, bladder cancer, or lung cancer
* Patient residing in New York metro-area

Part 2:

* Living patient age 18 or older
* Consented to Part C of IRB#12-245 and has received results regardless if thereir was a pathogenic variant
* Patient diagnosed with cancer type approved for IRB#12-245 Part C (which are currently breast cancer, gynecological cancer, prostate cancer, and GU non-prostate cancer)breast cancer, colorectal cancer, bladder cancer, or lung cancer
* Patient residing in New York metro-area

Exclusion Criteria for Part 1 and 2:

* Non-English speakers because we do not have the resources to conduct and translate the interviews into other languages.
* Patient unwilling or unable to provide informed consent.
Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)

Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80 years old;
2. Patients with blood pressure\<160/100mmHg, 5.6\<blood glucose\<11.2mmol/L, major organs function normally: (1) Goldman index between grade 1 and 2; (2) Predicted forced expiratory volume in 1s (FEV1) \>= 40 % and diffusing capacity of the lung for carbon monoxide (DLCO) \>= 40 %; (3) total bilirubin \<= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) \<= 2.5 upper limit of normal; (5) creatinine \<= 1.25 upper limit of normal and creatinine clearance rate (CCr) \>= 60ml/min;
3. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
4. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor \<= 5cm and short diameter of mediastinal lymph node \<= 1cm in thin layer CT;
5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
6. All relevant examinations were completed within 28 days before the operation;
7. Patients who understand this study and have signed an approved Informed Consent.

Exclusion Criteria:

1. Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
2. Patients with the previous history of other malignancies;
3. Patients with secondary primary cancer when enrolled;
4. Patients diagnosed as pure ground glass opacity (GGO) before surgery;
5. Patients diagnosed as mixed GGO whose solid part \<= 50% and Maximum diameter of tumor \<= 2cm;
6. Patients with small cell lung cancer;
7. Patients with prior unilateral open thoracic surgical procedures;
8. Woman who is pregnant or breastfeeding;
9. Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
10. Patients with an active bacterial or fungal infection that is difficult to control;
11. Patients with serious psychosis;
12. Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Subjects with FEV1/FVC ratio of \<0.70 and FEV1 \<80% predicted normal and ≥750 mL if FEV1 \<30% of predicted normal value.
* Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

* Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
* Current diagnosis of asthma or alpha-1 antitrypsin deficiency
* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
* Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
* Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
* Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
* Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
* Congestive heart failure (CHF NYHA Class III/IV)
* Clinically significant abnormal 12-lead ECG
* Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
* Cancer not in complete remission for at least five years
* History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Different Body Position on Intraabdominal Pressure in Mechanically Ventilated Patients

Measuring intraabdominal pressure in the semi-recumbent position and supine position.

Each set of measurements of intraabdominal pressure included intra bladder and intragastric pressure in the supine position followed by the semi-recumbent position at head of bed 30. All four measurements were taken over a period of 5 to 10 min or less to reduce the possibility of changes in intraabdominal pressure over time. Three sets of readings were taken at least 4 h apart over a 24-h period.

Eligibility Criteria:
Inclusion Criteria:

older than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place

Exclusion Criteria:

* recent oesophageal, gastric or bladder surgery; patients who were moribund and unlikely to survive 24 h; patients who were pregnant and patients who were unable to lay flat for any reason.
Work-related Stress Among Recently Graduated Midwives Practicing in the Delivery Room

Work stress results from an imbalance between the worker's hopes and work's conditions.

Midwifes are exposed to emergency situations (newborn distress, neonatal resuscitation, foetal abnormal heart rythm, delivery hemorrhage, ...), which can cause stress and sometimes lead to burnout.

the aim of the study is to describe Work-related stress among recently graduated midwives practicing in the delivery room

Eligibility Criteria:
Inclusion Criteria:

* Midwives graduated for less than three years in France
* Practicing in the delivery room
* Whatever the duration of exercise in the delivery room
* Agreeing to participate in the study

Exclusion Criteria:

* No Agreeing to participate in the study
9-valent HPV Vaccine in Postpartum Women

This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.

Women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent HPV vaccine. For clarification, women who are pregnant are eligible to sign consent, but the first vaccine will not occur until after delivery. Vaccine # 1 must occur within seven days of delivery.

The main objective of the study is to determine the immunogenicity of the vaccine in postpartum women. The immunogenicity results will be compared to that of non-postpartum women of the same age, 16-45.

Women will participate for approximately 12 months and will complete a total of 4 visits during that time frame.

Eligibility Criteria:
Inclusion Criteria:

* Female between the ages of 16 and 45 years of age at enrollment
* Postpartum (Day 1 vaccination to occur within 1 week of delivery)
* Judged to be in good health on the basis of medical history and physical examination
* Able to fully understand study procedures, alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent
* Able to read, understand, and complete the questionnaires

Exclusion Criteria:

* Has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™
* Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies (including rituximab), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. The use of inhaled, nasal, or topical steroids are considered eligible for the study
* Has received any immune globulin product (including RhoGAM™) or other blood- derived product within 3 months prior to Day 1 vaccination or plans to receive such product during the study
* Has received a marketed HPV vaccine
* Has had a fever of \> 100° within 24-hour period prior to the Day 1 vaccination
Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer [Companion to CALGB-9781]

RATIONALE: Questionnaires that measure quality of life during treatment may improve the ability to plan treatment for patients with esophageal cancer.

PURPOSE: This clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer.

OBJECTIVES: I. Evaluate the quality of life of patients with esophageal cancer randomized on protocol CALGB C9781 to treatment with surgery alone vs trimodal therapy combining preoperative chemotherapy and radiation therapy in addition to surgery. II. Examine the incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer. III. Examine the incremental cost per quality-adjusted life year (QALY) of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer.

OUTLINE: This is a companion study to CALGB C9781, a phase III randomized study. Prior to treatment on CALGB C9781, patients complete forms assessing quality of life, psychological functioning, specific areas of dysfunction, resource use, and time lost from work; subsequent assessments are completed by telephone interview at 1, 2, 6, 12, 18, and 24 months after the initiation of study treatment, regardless of disease status (patients with hearing impairment and those speaking only a translatable foreign language may mail responses). Patients also keep a diary of medical resource utilization at sites other than the treating institution.

Eligibility Criteria:
1. Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction and with less than 2cmdistal spread into the gastric cardia eligible for C9781.
2. There could be no evidence of distant metastatic disease by history and physical examination; upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies were all required.
3. Tumors had to be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases.
4. Patients with supraclavicular lymph nodes measuring ≤1.5 cm by CT (not palpable) were eligible, as were patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤ 1.5 cm by CT.
5. Patients could not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. Patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence.
6. There could be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent.
7. Patients with uncontrolled or severe cardiovascular disease, pulmonary disease, or active infections were excluded, as were pregnant patients.
Potential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction

The purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior CMV exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior CMV exposure.

The purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior CMV exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior CMV exposure.

Eligibility Criteria:
Patients who are being evaluated to determine if they have CAD or those who have already been studied and the presence or absence of CAD has been ascertained.

No patients who have not been evaluated for CAD.