cyrilzakka/clinical-trials huggingface dataset:
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 \[PD-1\] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them.

The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents
* Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 \[PDL1\] if applicable) or for whom no standard therapy is available for their tumor type
* Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020)
* Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only)
* Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy
* Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Adequate hematologic, renal, and liver functions
* Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria.
* Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2)

Exclusion Criteria:

* Other active malignancy
* Recent major surgery
* Systemic anticancer therapy and chemotherapy within protocol-defined washout period
* Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years
* Current or history of myocarditis or congestive heart failure (New York Heart Association \[NYHA\] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction
* Active or history of interstitial lung disease (ILD)/pneumonitis
* Patients requiring chronic systemic immunosuppressants
* History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy
* Known symptomatic brain metastases requiring steroids
* History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment
* Any prior or planned organ transplant
* Presence of any open, active wound requiring treatment
Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy

Removal of the uterus, or hysterectomy, is a surgical operation that involves partial or total removal of the uterus. It can be done by vaginally, laparoscopically or laparotomically.

Since the first hysterectomy performed by laparoscopy in 1989, this approach has gained popularity to varying degrees depending on the countries. This technique allows a major surgical procedure to be performed by incisions of only a few millimeters, thus reducing parietal pain and visceral in addition to a cosmetic benefit.

Since 2013, more than 200 laparoscopic hysterectomies have been scheduled on an outpatient basis at the Clinique des Cèdres (France). The analysis of this retrospective series of approximately 200 patients would provide elements related to the practice of laparoscopic hysterectomy in ambulatory in France.

Removal of the uterus, or hysterectomy, is a surgical operation that involves partial or total removal of the uterus. It can be done by vaginally, laparoscopically or laparotomically.

Since the first hysterectomy performed by laparoscopy in 1989 (Reich, 1989), this approach has gained popularity to varying degrees depending on the countries. This technique allows a major surgical procedure to be performed by incisions of only a few millimeters, thus reducing parietal pain and visceral in addition to a cosmetic benefit. Thus, when we offer women requiring a two-way hysterectomy first, 84% of them prefer the laparoscopic route to the laparotomy route (Nieboer, 2009). Alongside this surgical advance, an improvement in anesthesy techniques combined with the use of anti-inflammatories and antiemetics made it possible to improve the speed of recovery and therefore the possibility of a departure early, but not premature, from the hospital. In the United States, a study published in 2012 (Schiavone, 2012) reported the hospital stays of more than 128,000 women who underwent a laparoscopic total hysterectomy and reported that 46% of them had been operated on as an outpatient.

Since 2013, more than 200 laparoscopic hysterectomies have been scheduled on an outpatient basis at the Clinique des Cèdres.

The analysis of this retrospective series of approximately 200 patients would provide elements related to the practice of laparoscopic hysterectomy in ambulatory in France.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 or over.
* Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route with or without adnexectomy, for benign or malignant reasons, at the Clinique des Cèdres since 2013.
* Patient having been informed of the research and not objecting to the use of his data as part of this research

Exclusion Criteria:

* None
Effect of Extended Infusion Lines on Pulse Contour-based Measurements

Hemodynamic monitoring of the critically-ill patients is increasingly performed using an arterial pulse contour-based cardiac output device such as the proAQT system.

The aim of this study is to evaluate the effect of extending the pressure lines on the arterial pressure wave and the calculated hemodynamic variables when using the proAQT system.

Hemodynamic continuous monitoring of critically-ill patients is increasingly performed with minimally-invasive methods, such as the proAQT sensor (PULSION Medical Systems SE, Munich, Germany).

The proAQT sensor calculates hemodynamic variables such as the cardiac output, stroke volume (variation), pulse-pressure variation and systemic vascular resistance by pulse contour analysis of the arterial pressure waveform using an arterial radial or femoral catheter. This minimal invasive technique, also permits continuous beat-to-beat assessment.

In patients in who an arterial catheter is placed for clinical reasons, the hemodynamic variables are continuously recorded. An extension line is coupled to a 3-way stopcock, connected to the proAQT sensor. In a neutral position of the 3-way stopcock, the pressure wave travels from the pressure sensor through the standard line. By turning the handle of the stopcock the standard line is bypassed and the pressure wave travels through the extended line.

The hemodynamic registration will be as follows:

* two minutes in the neutral position;
* two minutes with one type of extension line
* two minutes in the neutral position
* two minutes with a second type of extension line
* two minutes in neutral position

The arterial pressure curve and all calculated hemodynamic variables are electronically registered.

The influence of two types of extension lines on the accuracy of the calculated hemodynamic variables will be evaluated by comparing the variables measured in neutral position and variables measured with the extended pressure lines. The changes in the calculated variables will be correlated to possible arterial pressure waveform modifications and used to evaluate different algorithms, which might be used to reconstruct the primary pressure wave.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* arterial catheter necessary for clinical reasons

Exclusion Criteria:

* ≥ASA 3
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
3. Ability and willingness to comply with the treatment and follow up procedures.
4. Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

1. Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent \> 8 diopters), macular degeneration)
4. Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)
5. Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
6. History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
7. History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
8. Any lens opacity which significantly impairs vision, in the opinion of the investigator.
9. Peripheral retinal detachment in prospective area of insertion
10. Participation in another clinical trial within 12 weeks before the screening visit or during the study
A Long-term Trial of OPC-34712 in Patients With Schizophrenia

To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
* Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer

Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.

Exclusion Criteria:

* prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema
Protocol of Management of Major Pediatric Burn in Intensive Care Unit

Decrease mortality and morbidity in major pediatric burns

The goals of initial patient management include preservation of overall homeostasis while appreciating the physiologic challenges that the burn injury poses to the body. Major burn injury not only results in local damage from the inciting injury, but in many cases results in multisystem injury. Initial efforts are focused on resuscitation, maintaining hemodynamic stability, and airway management. Intermediate efforts are focused on managing the multi-organ failure that results from systemic inflammatory mediators that result in diffuse capillary leak and surgical therapy. Finally, efforts shift to issues with chronic wound healing, pain management, restoration of functional capabilities, and rehabilitation.. Burn injury in children continues to be a major epidemiologic problem around the globe. Nearly a fourth of all burn injuries occur in children under the age of 16, of whom the majority are under the age of five This provides a team of pediatricians, surgeons, anesthesiologists, intensivists, nurses, respiratory therapists, and other healthcare providers with a unique opportunity to make a multidisciplinary collaborative effort.

Eligibility Criteria:
Inclusion Criteria:

* age below 18 year
* children with burn between 20% to 50% of total body surface area
* recent burn within 48 hour

Exclusion Criteria:

* old burn over 48 hour after injury -burnt surface area less than 20% of total body surface area - -
* burnt surface area more than 50% of total body surface area
* old age over 18 year
Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

Open-label treatment with MPC-7869 for participants in a previous randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Participation in a previous MPC-7869 randomized protocol
* Have had a diagnosis of probable Alzheimer's disease.
* Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
* Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
* Female subjects must be surgically sterile or postmenopausal for \> 1 year.
* Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

* History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
* Chronic or acute renal, hepatic or metabolic disorder.
* Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI

The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.

The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.

Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* ST segment elevation myocardial infarction, according to the WHO definition.
* \<24 hour from the origin of symptoms.
* Single left anterior descending coronary artery disease.
* Successful revascularization of culprit lesion with PCI.
* Age between 45 and 65 years old.
* Written informed consent.

Exclusion Criteria:

* Previous MI.
* Cardiomyopathy.
* Atrial fibrillation or fluctuation.
* Previous heart surgery.
* Severe valvular heart disease.
* Disease of the hematopoetic system.
* NYHA functional class IV at baseline.
* Severe renal, lung and liver disease or cancer.
* Significant coronary lesion in one or more major coronary vessels, requiring revascularization.
* Intra-cardiac thrombus.
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality.

Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected.

In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biliary obstructive disease (Benign or Malignant)
* 19 year-old and older than 19 year-old

Exclusion Criteria:

* Younger than 19 year-old
* Patients with leukocytosis (WBC ≥ 11,000/mm3)
* Body temperature ≥ 38 °C within 72 hours before ERCP
* History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP
* Pregnancy women
* Patients with allergy to beta-lactam
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.


Eligibility Criteria:
Main Inclusion Criteria:

* Female or male patients ≥ 18 years
* ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
* Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
* Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
* For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
* For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus
* For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis

Main Exclusion Criteria:

* Spasticity of any other origin than stroke
* Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
* Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
* Previous or planned treatment with phenol- or alcohol-injection in the target limb
* Previous surgical treatment of spasticity in the target muscle(s)
* Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
* Severe atrophy of the target limb muscles
Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection

This study is for those who had nontuberculous mycobacterial pulmonary infection with higher a serum inflammatory marker than those who had colonization.

Nontuberculous mycobacteria (NTM), not like Mycobacterium tuberculosis, is ubiquitous in environment including soil and water. Therefore, NTM pulmonary infection is not diagnosed only by microbiology of respiratory specimen but also clinical and radiographical findings.(1) Due to airway NTM colonization is not uncommon in sputum, diagnosis of pulmonary NTM infection is a big challenge in clinical practice. Especially NTM burden is increasing in recent literature.(2,3) Besides, the short-term mortality is reported higher in patients with NTM infection in medical ICU by Shu et al.(4) Early diagnosis and then treatment of NTM infection become important though NTM infection is considered as indolent process before.(1) Inflammatory marker in the patients with NTM being isolated from respiratory specimens is an indicator for differentiating true infection from colonization.(5,6) Those inflammatory factors might include blood white count, C-reactive protein, cytokines, procalcitonin , trigger receptor expressed on myeloid cell-1 (TREM-1) and Toll-like receptor-2. We therefore conduct this prospective study for analyzing

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years
* study group : Satisfied the criteria for NTM pulmonary disease according to the ATS diagnosis guidelines.
* control groups: they had positive sputum culture for NTM but not fulfilled the diagnosis criteria

Exclusion Criteria:

* Those with bleeding tendency
* No inform consent
* Female with pregnancy