cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France

A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.


Eligibility Criteria:
Inclusion Criteria:

Cohorts 1 \& 2

* Adult participants (at least 18 years of age at time of treatment decision)
* Participants treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy (according to the French current marketing authorization) for the treatment of Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and prior to study participation.
* Participants who provided oral informed consent to participate in the study

Cohort 1 only • Diagnosis of untreated HER2 negative advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma or EAC whose tumor express PD-L1 with a CPS ≥5

Cohort 2 only

• Diagnosis of untreated unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression (TPS) ≥1%

Exclusion Criteria:

Cohorts 1 \& 2

* Participants with a primary diagnosis of a cancer other than advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC, within the past 5 years.
* Participants currently enrolled in an interventional clinical trial for his/her advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC.
* Pregnant women
* Participants under guardianship
Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation

This single-center, parallel-group randomized controlled trial (RCT) will compare two timings for initiating specific exercise therapy after breast cancer surgery. The study tests whether early initiation (within the first postoperative week) versus delayed initiation (at 3 weeks postoperative) results in superior upper limb function at 6 months as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcomes include pain intensity (Visual Analog Scale, VAS) and wound-related complications such as drainage time and hematoma incidence.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65 years.
* Scheduled to undergo breast cancer surgery with axillary node dissection.
* At risk for upper limb morbidity based on preoperative assessment.
* Able to provide informed consent and complete study questionnaires.
* Willing and able to attend scheduled physiotherapy sessions and follow-up evaluations.

Exclusion Criteria:

* Diagnosis of recurrent or metastatic breast cancer.
* Concurrent participation in another rehabilitation intervention or clinical trial.
* Severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic conditions) that preclude safe participation.
* History of previous shoulder surgery or chronic upper extremity musculoskeletal disorders unrelated to breast cancer treatment.
* Inability to understand or complete study materials in English.
* Pregnancy or lactation.
Cytosponge Protocol IRB 11-006429

This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy.

Exclusion Criteria:

* Patients for whom clinically indicated endoscopy is not safe. Patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule.
* Vulnerable populations, such as those with diminished mental acuity, will be excluded.
* Patients with known Lidocaine/Acetylcysteine allergies
Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB

The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most important

Prospective case-control study included patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences. Inclusion criteria is: 1) cardiac output \> 35%; 2) no agents affecting central nervous system; 3) no neuropathology; 5) no multiple organ dysfunction. Patients will have to perform mini mental state examination (MMSE), Trial making, addenbrooke tests before and 7 days after surgery. Brain biomarkers glial fibrillary acid protein (GFAP) and neurofilaments will be taken after induction, 24 and 48 hours after surgery. Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.

After these test, the investigators are going to examine data about patient and operation, recognize factors causing POCD and identify the most important of them.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass grafting or/and heart valve surgery;
* Patients age\>18years
* Cardiac output \>35%

Exclusion Criteria:

* Patient disagreement;
* Diseases causing cognitive dysfunction;
* Multi organic deficiency;
* Agents affecting central nervous system
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine

This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have given written consent.
* Individuals who participated in V98P1 and received the complete schedule of vaccinations.

Exclusion Criteria:

* Individuals who have not given written consent.
* Subjects who did not receive the complete schedule of vaccination in V98P1.
Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites

The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites

This study aims to evaluate the effects of CYP3A5 genotype on pharmacokinetics of maraviroc and its oxidative metabolites. A single oral dose of 300 mg maraviroc will be given to 24 eligible healthy individuals who will be screened and determined to have specific CYP3A5 genotype - 8 homozygous wild type (2 CYP3A5\*1 alleles), 8 heterozygous (1 CYP3A5\*1 allele and 1 mutant allele), and 8 without wild type genotype (2 mutant alleles). Blood samples will be drawn and urine samples will be collected immediately before and during a 32-hr period following the dose. The concentrations of maraviroc and its oxidative metabolites from the blood and urine samples will be measured and the pharmacokinetics of maraviroc and its metabolites will be compared among the three groups with different CYP3A5 polymorphic status.

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Eligibility Criteria:
Inclusion Criteria:

* Healthy with no acute medical illness
* Willing to provide written informed consent
* Age 18-65 years
* Negative serum pregnancy test (females only) at screening and a negative urine pregnancy test (females only) on day of dosing
* HIV seronegative at screening, as determined by any licensed ELISA
* At screening, no evidence of hepatic or renal impairment (LFT's \< 1.5 Upper Limit of Normal (ULN), creatinine clearance \> than 60 ml/min, total bilirubin below ULN, AST and ALT below 1.5 ULN)
* 8 subjects with homozygous CYP3A5 allele \*1 (wild type)
* 8 subjects with 1 CYP3A5\*1 allele and 1 mutant allele
* 8 subjects with CYP3A5 allele other than \*1

Exclusion Criteria:

* Concomitant medication (prescription or over-the-counter) or herbal supplements for which there is a known risk of pharmacokinetic or pharmacodynamic drug interactions, including those that inhibit CYP3A4 as listed on the P450 Drug Interaction Table (http://medicine.iupui.edu/clinpharm/ddis/table.aspx)
* History of postural hypotension or cardiovascular disease
* Active medical or psychological condition that, in the opinion of the investigator, might put the volunteer at undue risk or interfere with the participation of the study
Methadone Versus Placebo in Spine Fusion

What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?

Hypothesis:

1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.
2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I, II, and III, male and non-pregnant female
* English-speaking patients
* Ages 18-75 years
* Undergoing elective one or two level posterior lumbar interbody fusion

Exclusion Criteria:

* Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
* Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).
* history of substance abuse at any time in the past
* known QT prolongation
* Non-elective operations (i.e., cancer or trauma)
* severe hepatic impairment (serum albumin \< 3.0 g/dL in the presence of a history of liver disease)
* pregnancy
* inability to operate a patient-controlled analgesia device
Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

The goal of this study is to: partner with Respiratory Health Association and determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, treatment programs and adults who smoke (AWS) in Chicago. This will be accomplished by establishing a community advisory board (CAB) and pilot testing a community-informed smoking cessation treatment within a community behavioral health organization to determine its feasibility after addressing implementation issues.

The purpose of the proposed study is to determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, behavioral health treatment providers, and community members in Chicago and pilot test a community-informed, targeted rolling smoking cessation treatment within a community organization. The research team and the Respiratory Health Association (RHA) will work together to identify community sites that could derive possible benefit from adopting and implementing the targeted treatment.

Aim 1: Develop a Community Advisory Board (CAB) comprised of providers, community members, and organization leadership.

Aim 2: Use a mixed-methods approach to understand barriers, facilitators, and unmet treatment needs regarding smoking cessation treatment within the community.

Aim 3: Pilot test the targeted smoking cessation treatment across a 3-month period at one community site through partnership with Respiratory Health Association.

Hypothesis: The targeted intervention will demonstrate feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Identify as someone who currently smokes combustible cigarettes (at least 1 cigarette per day) on each day for the past month
* Report interest in quitting cigarettes (at least 6/10 scale in interest of quitting)
* Age 18 or older, ability to understand the English language, willing and able to provide informed consent
* Stable residence and contact information throughout the follow up period

Exclusion Criteria:

* Non-daily or intermittent cigarette use
* No interest in quitting smoking
* Unstable residence/not staying in Chicago for duration of study period
* Current untreated severe substance use disorder (with the exception of tobacco use) or past-year serious untreated psychiatric illness (e.g. schizophrenia, bipolar disorder, obsessive compulsive disorder, unspecified psychosis, past-year suicide attempt)
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth

OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study.

II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity.

III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography, and magnetic resonance imaging; and entry criteria continue to be met.

Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group is treated with oral acyclovir, while the control group receives an oral placebo.

Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease, and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly for at least 4 years.

The study duration is estimated to be 4 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Virologically confirmed herpes simplex virus type 2 (HSV-2) with skin lesions localized to the skin, eyes, and mouth
* No central nervous system or disseminated disease Normal cerebrospinal fluid WBC less than 20 Protein less than 90 mg/dL
* Normal brain computerized tomography or magnetic resonance imaging (MRI) MRI if feasible
* No HSV-1

--Patient Characteristics--

* Age: Under 29 days
* Renal: Creatinine no greater than 1.5 mg/dL
* Other: Birth weight at least 1200 g
* Gestational age greater than 32 weeks
* No breast feeding if mother on acyclovir
5-ALA in Recurrent Glioma

The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.

The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.

Sub-goals:

1. To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
2. To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
3. To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
4. To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.

Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.

Eligibility Criteria:
Inclusion Criteria

* Presumed recurrent glioma
* Age \> 18 years
* Normal bone marrow function (WBC \> 3000, Platelets \> 100,000)

Exclusion Criteria

* Pregnancy
* History of photosensitivity, porphyria, or exfoliative dermatitis
* Hepatic dysfunction in the last 12 months \[defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin \> 2.5 x normal\]
* Serum creatinine \> 180 µmol/L
* Estimated Glomerular Filtration Rate (eGFR)\< 60 ml/min/1.73m2
* Inability to undergo MRI with contrast
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction

The purpose of this registry is to evaluate long-term clinical events in patients with acute myocardial infarction who were treated with percutaneous coronary intervention.

Although numerous articles have been published by using nationwide Korean myocardial infarction registries, such as the Korea Acute Myocardial Infarction Registry (KAMIR), limitation of previous registries is that these have little data beyond the first year of MI. Therefore, current registry was designed to assess long-term clinical events in patients with acute myocardial infarction.

Because most of myocardial infarction patients were treated by revascularization in real world of Korea, this registry limits the inclusion criteria to patients who were treated with percutaneous coronary intervention to reduce the bias.

Cardiovascular center with high-volume percutaneous coronary intervention of following hospitals were participated.

* Seoul St. Mary's Hospital, Seoul, South Korea
* Yeoido St. Mary's Hospital, Seoul, South Korea
* Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea
* St. Paul Hospital, Seoul, South Korea
* Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea
* Incheon St. Mary's Hospital, Incheon, South Korea
* St. Vincent Hospital, Gyeonggi-do, South Korea
* Deajon St. Mary's Hospital, Daejeon, South Korea
* Cheonnam University Hospital, Gwangju, South Korea

  8 hospitals of the Catholic University of Korea already have web-based coronary intervention registry (NCT01239914). And Cheonnam University Hospital is one of leading hospitals to design and manage the web-based previous Korean nationwide myocardial infarction registry, such as such as the Korea Acute Myocardial Infarction Registry (KAMIR) (http://www.kamir.or.kr/).

All consecutive acute myocardial infarction patients had been enrolled in each registries prospectively.

Using these previous data, current registry update new clinical and angiographic variables and assess long-term clinical follow-up data retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction who were treated with percutaneous coronary intervention

Exclusion Criteria:

* Acute myocardial infarction who were managed by conservative strategy
* Acute myocardial infarction who were not treated with percutaneous coronary intervention
Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy

Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the operating room for appendectomy.
* Major or minor patient (higher than 16) affiliated to a social security scheme.
* Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

Exclusion Criteria:

* Pregnant women.
* Childbearing age patient does not have effective contraception.
* Breastfeeding woman.
* Minor patient under 16.
* Major patient subject to a measure of legal protection or unable to consent.
* Persons deprived of liberty by a judicial or an administrative decision.
* Patient with gastric and/or esophagus surgery history.
Ice-pick Intubation With Video Laryngoscopes in a Manikin With Restricted Access to the Airway

To determine whether video laryngioscopes facilitate intubation in ice-pick position in a manikin with restricted access to the airway

To determine whether video laryngioscopes facilitate intubation in ice-pick position (also called inverse intubation) in a manikin with restricted access to the airway

Eligibility Criteria:
Inclusion Criteria:

* anaesthesiologists
* experienced in airway management
* experienced in emergency medicine

Exclusion Criteria:

* no experience in airway management
* missing infiormed consent