cyrilzakka/clinical-trials huggingface dataset:
Pembro With Radiation With or Without Olaparib

This trial will evaluate whether the immune-sensitizing effects of immunotherapy (Pembrolizumab) and radiation with or without a PARP-inhibitor (Olaparib) will increase the effects of immunotherapy in men with high-risk localized prostate cancer.

Immunotherapy and PARP-inhibitor are known to have radio-sensitizing effects when combined with radiation therapy. In addition, the combination with PARP-inhibitor and radiation can increase neoantigen expression, cytotoxic lymphocyte infiltration within the tumor microenvironment and increased immune stimulating cytokine concentration. Thus, there is a potential synergy of combining immunotherapy and PARP-inhibitor.

This is a phase 2 randomized 1:1 study. Subjects will be randomized to one arm (pembro + PARPi + standard of care therapy which is definitive radiation therapy combined with hormonal therapy) vs. another arm (pembro + standard of care therapy). All subjects will receive adjuvant immunotherapy for one year once they are done with definitive radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male participants with histologically confirmed adenocarcinoma of the prostate
* High-risk / very high-risk status per NCCN guidelines
* ECOG performance status 0 to 1
* No pelvic nodes \>2 cm in long axis as established by CT imaging
* Agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
* Ability to understand and the willingness to sign a written informed consent document.
* Adequate organ and marrow function
* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤90 days prior to the date of registration
* Prior 5-alpha reductase inhibitor (for example, finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration.
* Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.

Exclusion Criteria:

* PSA \> 150ng/ml
* Prior hormonal therapy with LHRH agonists (e.g., Lupron) and LHRH antagonists (e.g., Degarelix)for prostate cancer continuously for more than 90-days prior to study enrollment.
* Prior radiation to the prostate. Previous pelvic RT or major surgery (colorectal anastomosis, total cystectomy, radical prostatectomy, TURP, etc.). History of Ulcerative proctitis.
* Concurrent active, additional malignancy in the last 2 years.
* Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
* Patients with distant metastases
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
* Confirmed diagnosis of moderate to severe CD as assessed by Crohn'
NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

Background: Alveolar osteitis is one of the most frequent complications after lower third molar extraction, and is usually accompanied by inflammation, pain and poor wound healing. Several local interventions have been used to reduce these complications with limited effectiveness.

Purpose: To clinically evaluate the use of propolis extract, nanovitamin C and nanovitamin E gel for the prevention of surgical complications related to impacted lower third molar extraction.

Methods: A randomized, triple-blind, split-mouth, pilot study is being performed in patients needing bilateral lower third molar extraction with similar surgical difficulty. Surgical extractions are randomly being performed and NBF gingival gel (TG) or placebo (PBG) are randomly being applied inside postextraction sockets by a blinded surgeon. The patients are being instructed to apply it 3 times/day in the surgical wound for 7 days. One month later, the contralateral wisdom tooth is being extracted and the opposite gel is being applied. Alveolar osteitis (AO) is being diagnosed following Blum's criteria. Swelling is being assessed by measuring the facial perimeter. Wound healing is being evaluated with a semi-quantitative scale as good, satisfactory or insufficient. Postoperative pain is being recorded using a visual analog scale (VAS) for 7 days. Analgesic pill intake is being recorded by each patient. Variables are being registered by a blinded researcher to 3M extractions at one, two, three and seven postoperative days.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria are:

* cooperative adult patients able to fulfil the study protocol,
* needing surgical extractions of both lower third molars,
* with similar surgical difficulty according to Pederson scale.

Exclusion Criteria:

The exclusion criteria are

* refuse to participate in the study,
* failure to attend 24, 48, and 72 hours, as well as, 7 days post-surgical appointment visits,
* smokers,
* systemic diseases as diabetes mellitus or being immunosuppressed,
* patients who take local or systemic antibiotics less than 3 months ago, anti-inflammatory or anticoagulant medication in the previous 4 weeks,
* patients who require antibiotic prophylaxis,
* pregnant or breastfeeding women,
* patients with chronic periodontitis in active phase or
* with history of allergies to any of the components of local anaesthetics, antibiotics, AINEs, or NBF gingival gel.
Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis

The investigators aimed to study the associations between exercise capacity and cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine possible relationships with disease-related variables. Thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. Comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were recorded. A maximal treadmill exercise test by Bruce protocol was administered to all participants.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of axial SpA
* must be able to walk

Exclusion Criteria:

* established cardiac disease including structural heart diseases,
* uncontrolled hypertension,
* cardiac rhythm disorder,
* unstable angina pectoris,
* chronical renal and/or hepatic disease,
* malignancy,
* neuromuscular disease
* musculoskeletal deformity
* the history of an inflammatory arthritis for control group
The Clinical Value of Serum KL-6 Changes on Evaluating Disease Development in Different Diffuse Parenchymal Lung Disease

Diffuse Parenchymal Lung Disease(DPLD) is a chronic progressive fibrosis lung disease that with a highly variable clinical process.Krebs von den Lungen-6 (KL-6) is a high-molecular-weight glycoprotein, classified as human MUC1 mucin, that is produced mainly by regenerating type II pneumocytes.Serum levels of KL-6 have been shown to be elevated in patients with DPLD and could predict progress, but unaware of the differential threshold. The objective of this study was to perspectively and sequentially monitor serum KL-6 levels in patients with different DPLD,then analyze its clinical value and find the differential threshold.

Subjects and Method: Recruiting different DPLD patients in our hospital between 2013 February and 2016 October, including polymyositis/dermatomyositis related interstitial lung disease (PM/DM-ILD), rheumatoid arthritis related interstitial lung disease (RA - ILD), interstitial pneumonia with autoimmune features(IPAF) and idiopathic pulmonary fibrosis(IPF), following up for enery 3 to 6 months. Once condition deteriorated, patient could return at any time if necessary according to our clinical physician judgment. Tumor markers，pulmonary function test(PFT); chest thin-section CT examination and CT scores; serum KL-6 levels were acquired in all patients at baseline and follow-ups. Serum KL-6 was measured on LUMIPULSE G System(FUJIREBIO, JAPAN) by chemiluminescence enzyme immunoassay. All follow-up patients will be respectively divided into improved,stable and deteriotated group according to the official ATS/ERS statement.

Inclusion criteria: (1)patient with PM/DM-ILD, RA-ILD, IPAF, IPF.The diagnosis of patient were according to the official ATS/ERS statement and the American College of Rheumatology/European League standard;(2)18 to 80 years old.

Exclusion criteria: (1)conbination with pulmonary tubenculersis,pulmonary infection,tumor;(2)no serum KL-6 or pulmonary function test or chest thin-section CT examintion ;(3)patient with severe hepatic and renal dysfunction,heart disease or receiving hemodialysis treatment;(4)pregnant or plan to be pregnant

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PM/DM-ILD,RA-ILD,IPAF,IPF

Exclusion Criteria:

* Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.

This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

* Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors.
* No extra-abdominal metastases
* Good general status (American Society of Anesthesiologists Physical Status score \[ASA\] 1 or 2)
* Signed consent

Exclusion Criteria:

* Tumor seedings coming from other origins
* Huge peritoneal carcinomatosis (peritoneal score \> 25, except for pseudomyxomas)
* Peritoneal carcinomatosis progressing rapidly
* Presence of extra-abdominal metastases
* Patients presenting contraindications to the use of oxaliplatin or irinotecan
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas

The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* History of pancreatitis
* Medically stable
* Able to give informed consent

Exclusion Criteria:

* Prior history of pancreatic resection
* Prior history of pancreatic duct drainage procedure
* Presence of a pancreatic stent
* Unstable cardiovascular disease
* Any contraindication to MRI procedure
* Pregnancy
Study of Postoperative ICC Analgesia

This study is to examine the analgesic effectiveness of continuous loco-regional analgesic application (ropivacaine) through surgically placed Intercostal Catheter (ICC) and to establish correctly this method as a possible standard of care in the postoperative analgesia after Video-assisted thoracoscopic surgery (VATS) anatomical lung resection.

Good control of the pain without excessive use of opiates supports the benefits of minimally invasive surgical procedure.

This study is to examine the efficacy of continuously via surgically placed intercostal catheter administered ropivacaine at a flow rate of 6-8 ml/h of 2 mg/ml on post-operative pain (NRS) and pulmonary function (FEV1, PEF) during a maximum of 72 ± 2 hours after skin closure. Patients undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia with confirmed or anticipated Stage I Lung cancer will be included. The study will be conducted as superiority, double-blind, placebo-controlled, randomized. The efficacy of loco-regional administered ropivacaine will be compared to placebo (NaCl, 0.9%) administration. The whole study period per participant is expected to be 6 months. In the follow-up, 6 months after surgery, the impact of ropivacaine on long-term pain (NRS, McGill) and pulmonary function (FEV1, PEF) shall be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Patient undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia for confirmed or anticipated Stage I lung cancer (UICC 8th edition)
* American Society of Anesthesiologists (ASA) physical status classes I to III

Exclusion Criteria:

* NRS while coughing \> 0
* Previous ipsilateral thoracotomy or sternotomy
* Abdominal or contralateral thoracic surgery up to 6 months preoperatively
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
* Contraindications to self-administration of opioids
* Women who are pregnant or breast feeding
* Chronic steroid therapy (e.g. Prednisone \> 10mg/day for more than last 2 weeks before surgery)
* Chronic, daily pain therapy
* Congestive heart failure
* Liver insufficiency
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent person
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction

Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

Randomized to device sequence

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a physician documented history or diagnosis of asthma for at least 6 months
* Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
* Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Female subjects who are pregnant
* Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
* Evidence of lower respiratory tract infection
* Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis
EUROpE-RSI (EURopean Online Evaluation RSI Study)

The investigators want to identify and show differences in standards and procedures of in-hospital rapid sequence induction by collecting data with an online survey for anaesthetist in Europe.

The study is designed as a web-based online survey for anaesthetist in Europe. They will be invited via mail, as members of the European Society of Anaesthesiology (ESA), the participation is voluntary.

The survey contains 30 items about the standards and procedures of in-hospital rapid sequence induction (RSI). There will be a selection of possible answers, only a few items contains free-text answers.

The study collects only personal data to age, country, gender and level of training.

The collected data should identify differences in the procedures of RSI.

Eligibility Criteria:
Inclusion Criteria:

* Emergency physician

Exclusion Criteria:

* None Emergency physician
The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue

This cross-sectional study aims to ascertain the mechanical properties of human carotid/femoral atherosclerotic plaque and abdominal aortic aneurysm tissue and correlate tissue mechanics with novel blood-based biomarkers of cardiovascular calcification.

The study is a non-randomised, controlled, cross-sectional study of diseased human carotid, femoral and abdominal aortic tissue.

Eligibility Criteria:
Inclusion Criteria:

* Patients with arterial plaque undergoing treatment where the plaque tissue will be surgically removed as per the usual peripheral endarterectomy procedure.
* Able to provide informed consent.

Exclusion Criteria:

* Patients that are unable to give informed consent.
* Seriously ill/unconscious patients.
The Performance of Renal Doppler Ultrasound in Predicting Outcome of Dialysis Weaning

Acute kidney injury (AKI) is a frequent problem in the intensive care unit (ICU) affecting more than 50 % of patients. AKI is associated with several adverse outcomes, including increased mortality and increased length of ICU- and hospital stay, in particular in patients requiring Renal Replacement Therapy (RRT).

Choosing the optimal time for attempting liberation from RRT is still unclear. With this study, we will describe the ability of renal ultrasound in predicting the outcome of dialysis weaning.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years admitted to the ICU, Aarhus University Hospital who are treated with dialysis as continuous renal placement therapy (CRRT) and planned to undergo dialysis weaning

Exclusion Criteria:

* Insufficient ultrasonographic imaging of the kidneys
* Known morphological kidney disease
* Previous need of chronic RRT
* Prior participation in the study
* Need of extracorporeal membrane oxygenation (ECMO) or other heart assist device
Fibroscan Study in HCC

In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HCC
* Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery

  1. For TACE cohort, patients undergoing first cycle TACE are eligible.
  2. For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible.
  3. For surgery cohort, patient undergoing surgery are eligible.
* Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed
* Child's A to Child's C liver function

Exclusion Criteria:

* ECOG performance status \> 2
* Poorly controlled ascites
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With Irinotecan

Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with irinotecan. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

OBJECTIVES:

I. Determine the tumor response rate in patients treated with oxaliplatin, fluorouracil, and leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan.

II. Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen.

III. Determine the toxicity of this regimen in this patient population. IV. Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent
* Progressive disease no more than 3 months after completion of a prior weekly irinotecan, fluorouracil, and leucovorin calcium chemotherapy regimen
* At least 1 measurable lesion At least 20 mm in at least one dimension
* No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0-2
* Life expectancy: At least 12 weeks
* Absolute neutrophil count greater than 2,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)
* AST no greater than 5 times ULN
* Creatinine no greater than 1.5 times ULN OR creatinine clearance greater than 60 mL/min
* No unstable angina No symptomatic congestive heart failure
* No serious uncontrolled cardiac arrhythmia
* No active or uncontrolled infection
* No evidence of other serious illness
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No concurrent sargramostim (GM-CSF)
* At least 4 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen for advanced colorectal cancer
* Prior adjuvant chemotherapy allowed
* No prior radiotherapy to more than 25% of bone marrow
* At least 4 weeks since prior major surgery
Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule

This study is a prospective multicenter cohort study that primarily evaluates the impact of traditional Chinese medicine treatment on pulmonary nodules

This study is a multicenter, prospective cohort study that will recruit at least 2244 individuals with chest HRCT findings of pulmonary nodules and recommended follow-up by MDT from four research centers. According to whether patients with pulmonary nodules are treated with traditional Chinese medicine, they are divided into a traditional Chinese medicine cohort and a non-traditional Chinese medicine cohort , and are followed up for at least 2 years. The main outcome measures were pulmonary nodule growth (enlargement or new onset) and nodule regression (reduction or disappearance). To evaluate the efficacy of traditional Chinese medicine treatment for patients with pulmonary nodules, secondary outcome measures include nodule volume, average nodule density, doubling time of volume, internal and external signs of nodules, anxiety self-assessment scale, depression self-assessment scale and SF-36 scale.

Eligibility Criteria:
Inclusion Criteria:

① Patients with pulmonary nodules and recommended for follow-up by MDT; ② Voluntarily sign the informed consent form.

Exclusion Criteria:

①Patients with metastatic pulmonary nodules; ②Patients with benign diseases such as pulmonary lymph nodes, hamartomas, sclerosing alveolar cell tumors, or nodules with obvious benign features such as calcification; ③Patients withserious heart, lung, liver and kidney diseases.