cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

OBJECTIVES:

* Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
* Determine the treatment-related toxicity in patients treated with this therapy.
* Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.

OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of malignant non-small cell lung cancer (NSCLC)

  * Intraoperative needle biopsy confirmation allowed
* Resectable disease (stage I or II)
* All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
* Medically fit to undergo lung resection

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior or concurrent biologic therapy

Chemotherapy:

* No prior or concurrent chemotherapy

Endocrine therapy:

* No prior or concurrent endocrine therapy

Radiotherapy:

* No prior or concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No other prior therapy for NSCLC
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease

As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria:

1. Patients with non-malignant disease.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Hemodynamic Optimization Based on a Dynamic Elastance Protocol

In this study investigators explore the effects of a dynamic elastance guided protocol compared to a stroke volume variation fluid therapy on lactate levels during major abdominal surgery. Hence investigators created two groups: in the intervention group fluids are given in fluid-responders (SVV \> 13%) based on high value of dynamic elastance (ie. Eadyn \> 0.9). In the standard group fluids are administered when SVV \> 13%.


Eligibility Criteria:
Inclusion Criteria: patients enrolled for major abdominal surgery

-

Exclusion Criteria:

1. end-stage renal disease
2. severe heart dysfunction
3. heart rhythm alterations
Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral \[14C\]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of \[14C\]PF-06882961 in reference to intravenous \[14C\]PF-06882961 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Male participants between 18 to 54 years of age
* Healthy and capable of signing informed consent document
* Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures
* Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).

Exclusion Criteria:

* acute or chronic medical or psychiatric condition including recent (within the past year)
* Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements
* Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.
* Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.
* Known prior participation in a trial involving PF-06882961 or known intolerance to a GLP-1R agonist.
* A positive urine drug test on screening or Day -1.
* Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
* Participants with abnormalities in clinical laboratory tests including ECGs, vital signs, liver function tests, myocardial infarction
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
* History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug use or dependence within past 6 months.
* Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy

The purpose of this study is to determine which of the methods of colonoscopy viz. water insufflation or air insufflation or carbon dioxide insufflation is better in detecting the adenomas in colon and also which of these methods is best tolerated by patients.

Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods

Significance:

ADR is an independent predictor of risk of post screening colonoscopy colon cancer. A simple method solely controlled by the colonoscopist that enhances proximal ADR holds the promise of rectifying some of the unresolved shortcomings of screening colonoscopy in failing to reduce the occurrence of post screening incident cancers in the proximal colon and the associated cancer mortality.

Hypotheses \& Specific Aims:

Primary Hypothesis:

In patients undergoing first time screening a higher ADR will be found in the proximal colon in those randomized to the water method compared to those randomized to the air method or CO2 method.

Secondary Hypotheses:

The examination method but not co-variables, procedure-related or patient-centered outcomes, is an independent predictor of proximal colon ADR.

Specific Aims:

This is a prospective, randomized, single-blinded controlled study to compare the study (water) and control 1 (air) method and control 2 (CO2 method) to aid insertion of the colonoscope. The proximal colon ADR, total ADR, co-variables, procedure-related and patient-centered outcomes and adverse event during and within 30 days of colonoscopy will be recorded and compared between the study and control methods.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled.

Exclusion Criteria:

* decline to be randomized
* unable to give consent
* non-screening (surveillance or diagnostic) colonoscopy
* current participation in other colonoscopy studies
* a medical condition that could increase the risk associated with colonoscopy
* pregnancy
* those with a known family history of polyposis syndromes or a family history of colon cancer
Fixed Combination for Lipid and Blood Pressure Control

The aim of this study is to compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.


Eligibility Criteria:
Inclusion Criteria:

Patients with uncontrolled arterial hypertension (the average 24h blood pressure in the range 130/80 - 180/110 mmHg and / or daytime average blood pressure in the range 135/85-180/110 mmHg) and one of the following:

1. a very high cardiovascular risk and LDL-cholesterol\> 1.8 mmol / l
2. a high cardiovascular risk and LDL-cholesterol\> 2.5 mmol / l
3. Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin

Exclusion Criteria:

1. hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins
2. angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors)
3. severe hypotension, shock, including cardiogenic shock
4. hemodynamically unstable heart failure
5. Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal
6. Women of childbearing age without reliable contraception
7. pregnancy
8. breastfeeding
9. Patients with contraindications listed in the currently valid SP
Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

Pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. Early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population

Hormonal changes in a woman's menstrual cycle and changes during pregnancy affect the respiratory system. These changes especially during pregnancy and peripartum complicate the critical care management of the female patients. In addition to the effect of different pregnancy-related as sepsis, and preeclampsia which directly or indirectly predispose to pulmonary complications.

The presence of difficulty in the transfer of critically ill patients mandates point of care modality. Avoidance of fetal exposure to hazardous radiation demands safe technology. Ultrasound arises as a screening method that can be performed rapidly and enables healthcare providers to make timely decisions with no radiation exposure. Thus it facilitates the management of critically ill obstetric and gynecological patients.

When compared to other imaging techniques; X-ray imaging is preferably restricted in parturient because of the ionizing risk on the fetus, and CT is not feasible in critically ill if there is a risk of transfer. Thus ultrasound emerged as a bedside imaging technique.

Yet, the prevalence of the specific ultrasound signatures in that population is not clearly defined and its relation to poor outcome was not tested, This trial is the first trial to determine frequency, timing concerning admission, type of pulmonary abnormalities detectable by LUS, and their associations with poor outcome in patients whether obstetrics or gynecology admitted to the ICU specialized in women's intensive care

Eligibility Criteria:
Inclusion Criteria:

* Any patient admitted to the obstetrics and gynecology intensive care unit

Exclusion Criteria:

* Patient's refusal
* inability to do a lung ultrasound examination during the first 24 hours of admission
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women

Primary Objectives:

* To assess the excretion balance after oral and IV administration of \[14C\]-SAR439859
* To assess PK of total radioactivity, \[14C\] -SAR439859 and its metabolite (M7) after IV administration of \[14C\]-SAR439859 and, PK of radioactivity, SAR439859 and M7 after oral administration of SAR439859 alone or with \[14C\]-SAR439859
* To assess IV clearance and absolute bioavailability of SAR439859 using microdose of \[14C\]-SAR439859 tracer on top of a single tablet oral dose.
* To assess relative bioavailability of SAR439859 given as tablet or solution

Secondary objectives:

* To collect samples in order to assess metabolic profile in plasma and excreta of SAR439859 after oral administration of \[14C\]-SAR439859 as solution, contribution in plasma of SAR439859 and metabolite relative to total radioactivity and identify metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report).
* To assess safety and tolerance of SAR439859

Total study duration is 3 to 10 weeks, including a screening period of up to 27 days, treatment period of up to 16 days and a follow-up and end of study of up to 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

Female participants (age between 40 and 75 years old) who are postmenopausal or had post-bilateral surgical oophorectomy not linked to a history of cancer.

Participants who are overtly healthy. Body weight within 40.0 and 95.0 kg and body mass index (BMI) within the range 18.0 and 30 kg/m2 (inclusive).

Capable of giving signed informed consent.

Exclusion Criteria:

Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.

Subject who had severe course of COVID-19 (i.e., hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).

Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).

Blood donation, any volume (usually approximately 500 mL), within 2 months before inclusion.

Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.

History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).

Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).

Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).

Subjects who are occupationally exposed to radiation as defined in the Ionizing Radiation Regulations 2017.

Participation in a trial with \[13C\] or \[14C\] radiolabeled medication in the 12 months preceding the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Performance of a Conventional Blood Gas Analyser With the Proxima System

This clinical investigation is being undertaken to examine the performance of the CE marked Proxima System - a patient attached blood gas analyser.

The study forms an element of the Post Market surveillance plan for the Proxima system and will also generate method comparison data to allow Sphere Medical to submit the Proxima for FDA regulatory clearance.

The PROX006 study is an open and non-randomised study that will be conducted to assess the performance of the Proxima (a CE marked Medical Device)on a wide range of patients with a variety of conditions. This study will allow the performance of the Proxima and the institution's conventional blood gas analyser to be compared when used in the Intensive Care Unit and Operating Theatre.

The PROX006 investigation is an observational method comparison study - the results obtained from the Proxima will be compared with those obtained on the institution's conventional blood gas analyser (BGA). The potential for bias by the user will be negated in this study by directly comparing the results from the BGA and Proxima.

The data/results documented in the Case Report Form (CRF) will be verified during monitoring visits.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years old
* Patients who have (or will have) an arterial line, which was (will be) inserted for clinical need, will be considered for inclusion in this study
* Patients who give informed consent (or their personal/nominated consultee) to participate in the study
* Patients who are likely to have an arterial line for at least 48 hours.

Exclusion Criteria:

* Patients not indicated or contraindicated for an arterial line
* Refusal of consent by a patient or their personal/nominated consultee to participate
* Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
* The patient is considered by the investigator to be unsuitable for the study

Arterial line location/placement is not dictated by this study, however the following criteria should be considered when deciding if arterial catheter placement is suitable, including but not limited to:

* peripheral vascular disease,
* history of placement site neuropathy or chronic pain,
* history of placement extremity coagulopathy or clot formation,
* history of vascular surgery on same extremity as catheter placement (and/or vascular grafts)
* patients with a plan for perioperative anticoagulation. These patients are at increased risk of known complications such as bleeding and arteriospasm and should be excluded in order to mitigate patient study risk.
Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

Rationale: Bladder tumours are often not visible on X-ray based image-modalities during planning and treatment of Radiotherapy.

Purpose: To determine if a single contrast (Lipiodol) demarcation of the bladder tumour before treatment is feasible and visible on multiple X-ray based image-modalities during Radiotherapy.

To exploit the potential of modern Radiotherapy (RT), it is important to localize and follow the target precisely during treatment. Since the bladder tumour can usually not be identified on conventional CT-scan, a fiducial or contrast marking system is warranted.

The iodized oil, Lipiodol is a well-known contrast media used mainly for lymphography and Hysterosalpingography. Local Lipiodol demarcation has been used for localisation of tumours in the lung, prostate and seminal vesicles visualised on Computed Tomography (CT) and fluoroscopy.

Purpose: To evaluate the feasibility of tumour demarcation using the contrast agent Lipiodol in adaptive Image-guided RT of bladder cancer. Visibility on CT, Cone-Beam CT, MRI and on-board imaging will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary muscle invasive transitional cell carcinoma of the Bladder. T1-4a, N0-1, M0.
* Non-operable or refuse operation.
* Eligible for curative Radiotherapy.
* Oral and written informed consent.
* Fertile women must have a negative pregnancy test before inclusion or use contraceptive pills or intrauterine device.
* Ongoing beta blocker treatment is paused before Lipiodol injection.

Exclusion Criteria:

* Known metabolic disorder (hyperthyroidism, goiter)
* Allergy towards iodine.
* Pregnancy / breast-feeding
* Performance status ECOG \> 2
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study

This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.

Primary objective: This study was purposed to compare and assess immunogenicity of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.

Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.

Eligibility Criteria:
Inclusion Criteria:

* Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
* Healthy male and female infants at the age of 12 to 15 months from birth
* The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
* The parents/legally acceptable representative signed the written consent form.

Exclusion Criteria:

* Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
* Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
* Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
* Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
* There is a clear or suspected immune function disorder
* Systemic corticosteroid (prednisolone or equivalent \> 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used