cyrilzakka/clinical-trials huggingface dataset:
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.


Eligibility Criteria:
Inclusion Criteria:

* Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.
* Fixation must require a single non-extensile posterior approach (Kocher-Langenbeck)
* Posterior wall, Posterior column, certain simple transverse and transverse associated with a posterior wall, T-type, and posterior wall-posterior column fracture types
* Ages 18-65
* Patient or family must consent to the research protocol

Exclusion Criteria:

* Not meeting the aforementioned inclusion criteria
* Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)
* Revision surgery
* Surgery occurring more than two weeks post-injury
* History of blood dyscrasias or immunocompromised patients
* Patients with medical conditions requiring anticoagulation or international normalized ratio (INR) above 1.5
* Obese patients (BMI \>35)
* Known ongoing infection (local or systemic)
* Pregnant women
Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine

RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

OBJECTIVES:

Primary

* Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)
* Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)

Secondary

* Evaluate the safety profile as assessed by NCI CTCAE v3.0.
* Evaluate progression-free survival.
* Evaluate overall survival.

OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study.

Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic adenocarcinoma of the pancreas

  * Progressed after first-line or adjuvant gemcitabine-based chemotherapy
* Measurable disease as assessed by RECIST criteria
* No known brain metastasis or symptomatic carcinomatous leptomeningitis

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 2.5 times ULN
* ALT/AST ≤ 5 times ULN
* LVEF ≥ 55%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant comorbidities, including any of the following:

  * Cardiovascular disease
  * Documented history of congestive heart failure
  * Uncontrolled, high-risk arrhythmia
  * Angina pectoris requiring treatment
  * Clinically significant valvular disease
  * Evidence of transmural myocardial infarction by ECG
  * Uncontrolled hypertension
  * Active bleeding
  * Clinically significant active infection
  * Severe dyspnea at rest
  * Oxygen-dependency
* No other malignancy except basal cell carcinoma of the skin
* No severe hypersensitivity to cetuximab or trastuzumab
* No medical or psychological condition that would preclude study completion or giving informed consent
* No legal incapacity or limited legal capacity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior cetuximab or trastuzumab
* No other concurrent experimental drugs or anticancer therapy
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.


Eligibility Criteria:
Inclusion Criteria prior to Surgery:

* Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
* Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
* Treatment naive (no previous systemic treatment)

Inclusion Criteria prior to Treatment Randomization:

* Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
* Must have adequately recovered from surgery at the time of randomization
* Minimal residual disease (MRD) positive results as detected by ctDNA

Exclusion Criteria prior to Surgery:

* Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites)
* Active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Exclusion Criteria prior to Treatment Randomization:

* Must continue to meet Exclusion Criteria prior to Surgery
* Must have no evidence of metastatic disease after surgery
* Received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria apply
PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)

The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process

The aim is to explore the recent experience and views of parents in a qualitative way to assist the development of a questionnaire which can be used with a much larger group of parents. The interview guide with the topics to be covered will include: expectations, concerns and issues relating to the equipment used with their baby, any investigations, including cranial ultrasound and MR imaging and the information provided.

The data collected will then inform the development of a standard instrument or questionnaire which will be used with parents participating in a trial using a randomised design to compare the influence of MR and ultrasound-based information on parental perceptions, stress and coping in association with healthcare usage and costs.

Eligibility Criteria:
Inclusion Criteria:

* Parents of babies born before 33 weeks gestation Parents who are 16 years of age or older Parents who are able to give informed consent Parents who are able to take part in interviews which are conducted in English

Exclusion Criteria:

* Parents who are under 16 years of age Parents who are unable to give informed consent Parents who are unable to take part in interviews which are conducted in English Parents where there are possible or know child protection issues
Effects of Ground-based Walking Training in Pulmonary Hypertension

Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It is recommended that patients with PH should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. Ground-based walking training is a safe and effective method for COPD patients. In the literature, there are no studies evaluating the effects of ground-based walking training in PH patients.

The aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with PH.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Diagnosed with PH
* Followed by the department of chest diseases at least six months
* Not participating in the rehabilitation program in last year

Exclusion Criteria:

* Functional group four due to WHO functional classification
* PH due to left heart diseases, PH due to lung diseases and/or hypoxia
* Treatment and medication change in the last three months
* Cooperation problems
* Patients with successful pulmonary endarterectomy operation
* Smoking
* Patients with uncontrolled cardiovascular diseases
* Patients with orthopeadic and/or neurologic disorders that could limit exercise tests
* Syncope history in recent
Segmental Bronchoalveolar Lavage

Bronchoalveolar lavage (BAL) is a diagnostic and therapeutic procedure conducted by placing a small fiberoptic scope into the lung of a patient, and injecting sterile water (saline) into the lung and removing the fluid. The sterile solution removed contains secretions, cells, and protein from the lower respiratory tract. This sample can be analyzed to provide more information about possible disease processes going on in the lungs.

This protocol will be used to perform BAL, bronchial brushing, and bronchial wall biopsy in normal volunteers and patients with pulmonary disease. The samples collected during the study will be used to examine biochemical processes in the lung that may contribute to lung disease

This protocol proposes to perform bronchoalveolar lavage, bronchial brushing and bronchial wall biopsy in research volunteers and in patients with pulmonary disease to evaluate the cellular components of normal and diseased lungs. This research study will help to improve our understanding of pathogenic mechanisms in the lung during progression of pulmonary disease.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients and research volunteers will be accepted for bronchoscopy and bronchoalveolar lavage only if their heath status will not be compromised by the procedure. Examples of disease that may be studied under this protocol include alpha-1 antitrypsin deficiency; lymphangioleiomyomatosis and the cystic lung disease; pulmonary fibrosis; and sarcoidosis.

EXCLUSION CRITERIA:

Patients or research volunteers with abnormalities that contraindicate, or increase the risk of, fiberoptic bronchoscopy and bronchoalveolar lavage, including a history of allergy to atropine, lidocaine, or other topical anesthetics or premedications; FEV(1) less than 0.8 liters; PaO(2), on supplemental 02, of less than 70 mmHg or PaCO(2) greater than 45 mmHg; presence of uncorrected clotting disorder, uncontrolled hypertension, significant cardiac disease, renal or liver failure; metastatic disease; hematologic disorders such as severe anemia (hemoglobin less than or equal to 7 g/ml), granulocytopenia, or platelet disorders.

Patients or research volunteers with a positive serum test for human immunodeficiency virus or hepatitis B or C. The rationale for excluding participation on the basis of HIV seropositivity is because of the known effects of HIV on the lungs.

Patients or research volunteers who are pregnant or lactating.

Patients or research volunteers incapable of giving informed consent.
Derivation and Validation of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease. Therefore, the aim of this study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

Nodule is generally defined as a small, approximately spherical in morphology, circumscribed focus of abnormal tissue on computed tomography (CT) and no greater than 3cm in maximum diameter. Pulmonary nodules are not uncommon. A systematic review of CT screening lung cancer trials noted that a lung nodule was detected in up to 51% of study participants. More than 95% of detected nodules are benign and have a wide variety of causes, including infections, granulomatous disease, hamartomas, arteriovenous malformations, round atelectasis, and lymph nodes.

Pulmonary cryptococcosis is caused by Cryptococcus spp., a ubiquitous budding yeast-like basidiomycete that is endemic in many countries. Previously, Pulmonary cryptococcosis was thought to be an important opportunistic invasive mycosis in immunocompromised patients, such as AIDS, immunosuppressor used after organ transplantation, but it is also common in immunocompetent patients. Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease.

Therefore, the aim of this multicenter observational study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary nodules
* Evidence of pathological diagnosis for cryptococcosis or adenocarcinoma
* Data on high-resolution computed tomography (HRCT)

Exclusion Criteria:

* Pulmonary nodules greater than 3cm in maximum diameter
* Lack of data on HRCT
Effect of Breathing Exercise During Peripheral Intravenous Catheter

This study was carried out to determine the effect of breathing exercise performed during peripheral intravenous catheter (PIVC) application on pain, anxiety and patient satisfaction.

The study was completed as a randomized controlled experimental study with a total of 130 individuals who met the inclusion criteria. The Descriptive Characteristics Questionnaire, the State-Trait Anxiety Inventory, and the Numerical Rating Scale were used to collect the data of the study. In addition, Algometer (66 Lb/30 Kg) device was used to evaluate the pain pressure threshold in determining the individuals to be included in the research sample. The individuals in the intervention group were given diaphragmatic breathing exercise while applying the catheter, and the individuals in the control group were inserted without any application.

This study was carried out to determine the effect of breathing exercise performed during peripheral intravenous catheter (PIVC) application on pain, anxiety and patient satisfaction.

The study was completed as a randomized controlled experimental study with a total of 130 individuals who met the inclusion criteria, 65 of whom were in the intervention group and 65 in the control group. Ethics committee approval, institutional permission, and written informed consent from individuals were obtained in the study. The Descriptive Characteristics Questionnaire, the State-Trait Anxiety Inventory, and the Numerical Rating Scale were used to collect the data of the study. In addition, Algometer (66 Lb/30 Kg) device was used to evaluate the pain pressure threshold in determining the individuals to be included in the research sample. The individuals in the intervention group were given diaphragmatic breathing exercise while applying the catheter, and the individuals in the control group were inserted without any application.

Eligibility Criteria:
Inclusion Criteria:

* able to speak and understand Turkish,
* between the ages of 18-65,
* having orientation to place and time,
* without any psychiatric disease and hearing problems,
* not using central nervous system drugs,
* people who having PIVC indication,
* no analgesic or anesthetic agent was applied 24 hours before PIVC application,
* not have any pain in any part of the body that may affect the results of the study,
* no PIVC experience in the last month,
* 20-G catheter will be applied,
* pressure pain threshold mean of 8-16 pounds (Lb), (11) individuals who volunteered to participate in the study.

Exclusion Criteria:

* Infection in the area where PIVC will be applied, -having previous operation, scarring, psoriasis, active dermatitis in the area - -
* where PIVC will be applied,
* with peripheral nerve disease,
* no catheter applied to the forearm veins,
* having diabetes,
* with peripheral neuropathy,
* diagnosed with cancer,
* receiving cancer treatment,
* with respiratory disease,
* who have an obstacle to breathing exercise,
* in the post-surgical period,
* individuals who did not volunteer to participate in the study
The Effectiveness of Influenza Vaccine Among Health Care Workers in a Hospital Setting.

The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of the influenza vaccine in health care workers (HCW).

The study will be held in the winter of 2005-2006. Groups of vaccinated HCW and not vaccinated HCW will be followed for symptoms suggestive of influenza. For each event a quick through test for influenza A or B will be done and if positive will be confirmed by viral study. Data regarding days of illness, absence from work, therapy etc., will be collected. Effectiveness will be calculated as well as cost/effectiveness of vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Previously healthy health care worker vaccinated or not

Exclusion Criteria:

* Immunocompromised state
A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must sign the Informed Consent Form.
2. Patients must be between 18 and 60 years of age.
3. Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
4. Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
5. Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
6. Patients will preferably be polysensitized to Phleum pratense. Polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by:

   1. Overlapping seasonal pollens which are cross-reactive with Phleum pratense and Olea europaea.
   2. Pollens whose seasons do not overlap with Phleum pratense or Olea europaea and which are not expected to produce symptoms during the study period.
   3. Other allergens which are not expected to produce symptoms during the study period.
7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
8. Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

Exclusion Criteria:

1. Patients who received immunotherapy in the previous 5 years for Phleum pratense and Olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
2. Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
3. Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
4. Patients with a previous history of anaphylaxis
5. Patients with chronic urticaria,
6. Patients with moderate to severe atopic dermatitis
7. Patients who have participated in another clinical trial within 3 month prior to enrolment.
8. Patients under treatment with tricyclic antidepressives, phenothiazines , β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
9. Female patients who are pregnant or breast-feeding
10. Patient who does not attend the visits
Study to Evaluate the Interaction Between Aspirin and Nexium

The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision informed consent prior to any study specific procedures.
* Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
* Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
* Continuously practice abstinence during screening and throughout the duration of the study
* Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
* Have a body mass index (BMI) between 19 and 30 kg/m2
* No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
* Previous enrolment or randomisation in the present study.
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
* History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness within 4 weeks of the first administration of investigational product.