cyrilzakka/clinical-trials huggingface dataset:
Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.


Eligibility Criteria:
Inclusion Criteria:

* Documented Sars-Cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic CT, serology)
* Need of visceral surgery (laparoscopy or laparotomy)
* Signed informed consent
* Social coverage
* Patient who agrees to be included in the study and who signs the informed consent form
* Patient affiliated to a healthcare insurance plan
* Patient willing to comply with study's requirements

Exclusion Criteria:

* Need of another type of surgery during the same procedure
* Mentally unbalanced patients, under supervision or guardianship
* Patient who does not understand French/ is unable to give consent
* Patient not affiliated to a French or European healthcare insurance
* Patient incarcerated
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. Dose Limiting Toxicities (DLTs) and maximum tolerated dose (MTD) of APG1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase Ib. Safety and efficacy of APG1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase II.

The ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. IAPs are an important class of apoptosis-regulating proteins. APG-1387, a potent bivalent SMAC mimetic, small molecule of IAP inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway.

It's an open label, multiple centers phase Ib/II Study. Safety and tolerability of APG1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase Ib in previously-treated, advanced pancreatic adenocarcinoma patients. Efficacy and tolerability will be evaluated in phase II study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be ≥18 years of age at time of informed consent
2. Able to comply with the study protocol, in the investigator's judgment
3. Expected survival ≥ 3 months
4. Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and:

   * Standard treatment failed or intolerant to standard treatment(Phase Ib);
   * First line standard treatment failed (Phase II).
5. ECOG 0-1;
6. Adequate organ function.
7. Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment

Exclusion Criteria:

1. Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug.
2. Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
3. Has received a therapy with TNFα within 28 days of the first dose of study drug.
4. Known active central nervous system involvement.
5. Has received IAP-inhibitor before.
6. Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days.
7. Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive.
8. Pregnant or breastfeeding (lactating) women.
9. Other situations that investigator think not suit for study.
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS

To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.

Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.

Twenty-seven AIDS patients with elevated TNF and less than 300 CD4 cells are given pentoxifylline 3 times a day for 8 weeks. If no significant changes are seen in virologic, immunologic, or related measures, 27 additional patients are given a higher dose of pentoxifylline 3 times a day for eight weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, at current dosage for the 8 weeks of study treatment.
* Prophylaxis (e.g., aerosolized pentamidine, trimethoprim / sulfamethoxazole (TMP / SMX), dapsone for Pneumocystis carinii pneumonia (PCP) if CD4 cell count is \< 200 cells/mm3

Allowed:

* Concurrent maintenance therapy for opportunistic infections.

Prior Medication: Required:

* Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, for at least 2 months.

Patients must have the following:

* Diagnosis of AIDS.
* Documented HIV seropositivity.
* Ability to give informed consent and willingness to comply with visit schedule and all procedures.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Lymphoma or visceral Kaposi's sarcoma.
* Active peptic ulcer or bleeding disorder.
* Hemophilia. Known intolerance to pentoxifylline, theophylline, or caffeine.

Concurrent Medication:

Excluded:

* Warfarin and heparin.
* Biological response modifiers (e.g., erythropoietin, interferon, G-CSF, GM-CSF).

Cytotoxic chemotherapy.

* Megestrol acetate. Corticosteroids.

Concurrent Treatment:

Excluded:

* Radiation therapy. Blood products or transfusions.

Patients with the following are excluded:

* Presence of an active opportunistic infection.
* Major surgery within 30 days of study treatment.

Prior Medication:

Excluded:

* Biological response modifiers (including interferon, interleukin), corticosteroids, or megestrol acetate within 14 days of first (screening) TNF level.
* Erythropoietin dependency or within 30 days of study treatment.

Prior Treatment:

Excluded:

* Transfusion or blood product dependency or use within 30 days of study treatment.
Hemodynamic Survey Cardiac Surgical Scenarios

The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. This will be accomplished through online surveys which have different cardiac surgery scenarios and will be distributed to cardiac fellowship trained anesthesiologists. The online based survey will include a specific scenario and details on the scenario represented in image format and a brief description of the patient to aid with their analysis of the situation.

Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has been widely used in the various clinical situations warranting advance hemodynamic monitoring. It is considered as gold standard but unfortunately there is always risk associated with PA catheter and time lag between the clinical events and interpretation. Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is widely used in the intensive care set up for goal directed therapy but unfortunately there is not enough data to show whether it is useful in various peri-operative clinical conditions. In the online based survey, responses from the participants are recorded in the nominal scale ( 1 to 5 where 3 represents near normal). This survey will help to determine whether Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic monitoring.

No previous study was done to specifically find out the hemodynamic component that differs between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery although there were few studies compared the trend in the cardiac output with difference in opinion on their accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Must be a certified Anesthesiologist with cardiac fellowship training

Exclusion Criteria:

* none
HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm

Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.

The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.

Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L).

If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.

Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.

The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.

310 patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L).

The HeartLogic index will be monitored remotely on a weekly basis for 12 months and in case of HeartLogic index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. A blind and independent committee will adjudicate the events. Blood samples will be collected for biobanking, and quality of life will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with a cardiac defibrillator, with or without resynchronization, enabled with the HeartLogic index (RESONATE family, Boston Scientific)
* History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L)

Exclusion Criteria:

* Concomitant presence of a heart failure device other than cardiac resynchronisation such as a left ventricular assist device or a device for modulating cardiac contractility.
* Heart transplant project, or heart transplant patient
* Glomerular filtration rate \<30 ml/mn/m2 or dialysis,
* Life expectancy ≤ 6 months
* Remote monitoring of HeartLogic is not possible.
* Refusal to take medication for heart failure
* Patient with a mechanical heart valve
Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ

The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are:

• Is there a more effective treatment for this cases?

Participants will answer a questionary about pain and functional limitations.

Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction

Introduction: Temporomandibular joint disc displacement is a disorder in which the articular disc is anteriorly displaced from its correct position in relation to the mandibular condyle and mandibular fossa. Traditionally, the initial treatment of disc displacements involves several conservative measures, among them, the stabilizing interocclusal splint. However, in cases where there is associated opening limitation, such as intermittent lock and closed-lock, arthrocentesis has been suggested as another initial treatment modality due to its faster effect in preventing disease progression to a more advanced stage, in addition to reducing the chances of pain chronicity and central sensitization. Objectives: The present study aimed to compare and analyze the effectiveness and benefits of performing arthrocentesis as the initial treatment in patients with DDWR with intermittent lock and in patients with DDWoR, compared to the stabilizing interocclusal splint. Additionally, it had as secondary objectives to characterize the sample according to demographic, systemic, local and psychosocial factors in both groups and to correlate the clinical characteristics of the included patients with the imaging findings of the MRI scans. Methods: A randomized, prospective, longitudinal pilot study was performed. The sample was obtained by convenience from a demand through consultations and referral, among patients treated at the Oral and Maxillofacial Surgery Service of HCFMUSP, from June 2021 to July 2023. Patients with diagnoses of: DDWR intermittent lock and DDWoR with opening mouth limitation. Study patients underwent an initial assessment using a clinical questionnaire (DC/TMD) and underwent an initial TMJ MRI. Then, they were randomly divided into two groups according to the treatment to which they would be submitted: stabilizing inter-occlusal splint (group 1) or arthrocentesis (group 2). After treatment was instituted, patients were evaluated at 1, 2, 3 and 6 months regarding clinical parameters of pain, functionality and psychosocial status.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old;
* Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
* Availability of clinical follow-up for 6 months.

Exclusion Criteria:

* Pregnant patients;
* Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
* Inability to use a stabilizing occlusal splint;
* Presence of toothache, neoplasms or medical contraindication for study participation.
Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records

To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health.

This is an observational study of clinical outcomes to be conducted in the United States. Patients with a diagnosis of Stage 3-4 advanced cancer who possess specific pathway mutations identified by the Guardant360® test will be eligible to enroll in the study. Patients will be recruited by telephone or email and/or through the Guardant Health Patient Portal to determine interest in the study. Should patients be interested in contributing to this registry study, they will be prompted to consent via a commercial service for patients to request, manage, and view their medical records. Enrolled participants will be requested to release copies of their medical records for review by the principal investigator. Study adminsitrators will abstract participant demographics, cancer-related therapies, and clinical outcomes for analysis.

Eligibility Criteria:
General Inclusion Criteria:

* Adults (≥ 18 years old) with a diagnosis of Stage 3 or Stage 4 cancer (non-hematologic malignancy). Patients with advanced cancers not typically staged 1-4 (such as extensive stage small lung cancer) may be enrolled.
* Results from Guardant360® test
* Patient has previously provided contact information (either email or phone) to Guardant Health.
* Able and wiling to complete the informed consent process.
* Willingness to consent to the release of medical records.
* Willingness to provide Medical Records Release

General Exclusion Criteria:

* Unwilling or unable to provide written informed consent.
* Unable to understand English.
* Diagnosis of NSCLC
* Guardant 360® test results released to the patient's physician no less than 14 days and no greater than 60 days prior to initial patient contact.
Natural History with Focus on Oncological Risk Evaluation in Pediatric Patients with PTEN Pathogenic Variants - Observational Study

This is an observational study in pediatric patientis carryng PTEN pathogenic variants aimed to define oncological risk in children and provide a deeper insight of the clinical course, establishing an updated follow-up protocol.

PTEN is a tumor suppressor gene that was first linked to cancer predisposition syndromes but, in the following years, its phenotypic spectrum has been in continuous evolution and expansion, and nowadays we know that pathogenic variants n this gene may also be found in children presenting with Autism Spectrum Disorder (ASD), and/or DD and macrocephaly, or also with macrocephaly alone. Thus, the term PTEN Hamartoma Tumor Syndrome (PTHS) is now used when referring to PTEN-related conditions.

Nowadays, there is no recognized standard protocol for pediatric follow-up. The screening in mostly single-Centre-based and generally not performed in infancy, with large variability in protocols and timing.

The penetrance, which was previously believed to follow an age-related pattern, nowadays seems rather to be age-specific, as children mainly present macrocephaly and neuropsychiatric problems (DD/ASD), while adults are diagnosed mostly because of gastrointestinal malignancies, breast cancer, thyroid carcinoma or other tumors. However, it is not always true that adult symptoms never occur in PTHS children and, conversely, pediatric signs may also persist through adulthood.

The present study aims to collect PTEN mutated patients and their relatives diagnosed in Italy and followed in different Centers, offering a large pediatric cohort with a full clinical description and trying to provide a deeper insight of the clinical course and oncological manifestations of PTEN-related syndrome; we would like to establish an updated follow-up protocol in order to address all the possible clinical needs of these children.

Eligibility Criteria:
Inclusion Criteria:

* PTEN pathogenic variants (class 4/5 SNV, gene deletion, intragenic duplication/deletion)
* Pediatric patients (\<18 years old) and their affected relatives, male/female, all ethnicities
* The legal representative must agree to follow the screening protocol
* Informed consent signed by the legal representative

Exclusion Criteria:

* Refuse to undergo the exams of the protocol assessment at the diagnosis
* PTEN non-pathogenic variants (VOUS or benign/likely benign vatiants)
* No signed informed consent
A Study to Verify the Sleep-improving Effects of the Test Food Consumption

The goal of this clinical trial is to test in Japanese adults who feel sleepy when they wake up. The question it aims to answer are:

•Does taking plasmalogens reduce sleepiness upon waking?

Participants will be given the following tasks:

* Take 4 capsules daily containing plasmalogens for 12 weeks.
* Answer the questionnaire on sleepiness1 when they wake up.
* Answer the questionnaire on daytime sleepiness2. Researchers will compare plasmalogens and placebo groups to see if plasmalogens reduce sleepiness upon waking.


Eligibility Criteria:
Inclusion Criteria:

1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose Zc score of "sleepiness on rising" is relatively low at screening

Exclusion Criteria:

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment of any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are undergoing medical treatment or have a medical history of any of the following diseases: mental disorders (e.g., depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or valvular heart disease
5. Individuals who have habits of consuming foods or using devices to improve sleep
6. Individuals who have irregular sleeping habits due to lifestyle such as night shifts
7. Individuals who fall under the following sleeping conditions: sleeping in the same room with two or more people, living with preschool-aged children, living with individuals who require nursing care, or having their sleep potentially disturbed by the influence of others
8. Individuals who have nocturia two times or more
9. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
10. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
11. Individuals who are taking medications (including herbal medicines) or supplements
12. Individuals who are allergic to medicines or foods related to the test product, or have a gelatin allergy or sea squirt-induced asthma
13. Individuals who are pregnant, lactating, or planning to become pregnant during this study
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician