cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants

This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple times once daily to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* The participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
* Male and female adults aged 18 to 55 years at screening.
* Healthy participants were determined by pre-study medical evaluation and judged by the Investigator.
* Female participants of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\]) or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone \[FSH\] in the postmenopausal range as confirmed by an FSH test).
* Female participants of childbearing potential who agree to use highly effective method of contraception in the protocol consistently and correctly from screening until the last dose administration of the study intervention.
* Male participants must be unable to procreate (defined as surgically sterile \[had a vasectomy\] ≥6 months prior screening) or must agree to use a highly effective contraception as detailed in the protocol during the intervention period and for at least 90 days after the study completion and refrain from donating sperm during this period.
* Non-smoker (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\<200 ng/mL) at screening and admission.

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder as determined by the Investigator.
* Presence of any disorder that would interfere with the absorption, distribution, metabolism, or excretion of study intervention as judged by the Investigator.
* Serum alkaline phosphatase (ALP) or total bilirubin ≥upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN at either screening or admission.
* Abnormal renal function with estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2 at screening.
* History or presence of clinically significant abnormal cardiac automaticity, heart rhythm, ECG findings, or other relevant conditions that may pose a risk to the participants as judged by the Investigator.
* History of alcohol and/or illicit drug abuse within 2 years before screening or positive urine test for alcohol or positive urine drug test at screening or admission.
* Positive test for HBsAg, HCV RNA, or HIV antibody at screening.
* Currently taking a lipid-modifying medication.
* History of hypersensitivity to CKD-508 or medicinal products with similar chemical structures.
* Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study

Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria:

* AF patients who have severe heart deformations or blood problems.
* The patients who had been performed catheter ablation of atrial ablation.
* The patients who missed out to recording of 3D CT, echo and electrocardiography.
Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery

Evaluate the complement of patient care course in the development of proctology outpatient surgery (CAP) by providing:

* An additional preoperative nurse consultation day hospital
* And a phone call from a nurse at D + 1 of the operation

This corresponds to a reinforced support.

Main objective of the study: help improve the care of patients in CAP including during their exit after surgery. To evaluate the quality of patient care related to this enhanced system is a lever of development assistance outpatient surgical activity.

Secondary Objectives: To evaluate the impact of this new organization

* Satisfaction of patients and caregivers
* The effectiveness of the management of patients' pain

Study period: 3 months extendable a month, no start date announced

Workforce to include 100 patients at 3 months (10 per week), 50 in the "enhanced support" group and 50 in the group "usual care"

Expected results:

The main objective evaluation criteria: Evaluation support the success rate.

Evaluation performed 45 days after the patient's surgery.

Secondary objectives: patient satisfaction (telephone questionnaire to 45 days of operation), caregivers, pain assessment (painkillers booklet completed by the patient during his first consultation), consultation or rehospitalization for emergency patients and finally degree trust the doctor vis-à-vis this new support.

Eligibility Criteria:
Inclusion Criteria:

* Patient man or woman major
* Patient primary surgery and requiring care in CAP
* Patient affiliated to a social security scheme or of such a scheme

Exclusion Criteria:

* Bedridden patient and / or not communicating
* Patient opposing his participation in the study after information
* Patient has already undergone anal surgery
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

* Selection criteria validation
* Patient information and collection of a signed informed consent
* Randomization
* Completion of HADS questionnaire
* Day 1 = Begin of analgesic treatment / brachytherapy
* T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
* T0= end of the operative procedure under general anesthesia
* T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:

  1. paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
  2. paracetamol and morphine (Arms A and B)
* Day 2 to Day 30: At home or during hospital stay:

Pain assessment twice a day by the patient until absence of pain during 2 consecutive days

* Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
* Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire

In any case, pain assessment must be done until absence of pain during 2 consecutive days

Eligibility Criteria:
Inclusion Criteria:

* Patient with a uterine cervical cancer or an upper aero-digestive tract cancer
* Age ≥ 18 years and ≤ 75 years
* Patient who are eligible for brachytherapy treatment associated with or without hospital stay
* With operative procedure under general anesthesia to set up the material needed for brachytherapy
* Performance status ≤ 2
* Creatinine Clearance ≥ 60 ml/min using Cockcroft equation
* No coagulation disorder or anticoagulation therapy at curative dose
* Registered with a social security system
* Patient having dated and signed an informed consent form before initiation of any study procedures

Exclusion Criteria:

* Respiratory pathology (SpO2\< 70 %)
* Severe undernutrition
* Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs
* Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID
* Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage
* Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified)
* Liver insufficiency
* Severe renal insufficiency
* Severe heart failure
* Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors
* Intolerance or hypersensitivity to one of the treatments or excipients
* Inability to swallow
* Pregnant or breastfeeding woman
* Patient under tutorship or guardianship
Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.


Eligibility Criteria:
Inclusion Criteria:

* Children with active myopia treated with ATROPINE 0.01% eye drops
* patient affiliated with a social security organization
* agreement of both parents

Exclusion Criteria:

* non compliance with treatment
A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension

This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis.

The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during your stay in the hospital.

The study is looking at several other research questions, including:

* How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Proven or suspected infection defined as administration or planned administration of antibiotics within the screening period
2. Sepsis-induced hypotension that has not responded to intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol

Key Exclusion Criteria:

1. Unable to obtain informed consent by participant or legally authorized representative (LAR)
2. Clinical status requires vasopressor and/or blood pressure (BP) management inconsistent with the study protocol
3. Receiving continuous neuromuscular blockade during the screening period
4. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
5. Ejection fraction \<20% in the most recent known echocardiogram
6. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
7. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months
8. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
9. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration
10. Chronic mechanical ventilation for any reason or severe Chronic Obstructive Pulmonary Disease (COPD) requiring either continuous daily oxygen use or mechanical ventilation (for acute exacerbation of COPD) prior to hospital admission
11. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia

NOTE: Other Protocol-Defined Inclusion-Exclusion Criteria Apply
the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia

Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.

Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).Secondary Exploratory Endpoints: (1) Rate of granulocyte and platelet hematopoietic recovery. (2) Incidence of toxicity related to the conditioning regimen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for inclusion in this study must meet all of the following criteria: (1) Definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) Age greater than or equal to 16 years.

Exclusion Criteria:

* Subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) Patients with extramedullary infiltration (excluding central nervous system leukemia). (2) Patients undergoing second transplantation. (3) Patients with concurrent malignancies. (4) Patients with malignancies secondary to a second tumor. (5) Patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient\&#39;s life or interfere with the patient\&#39;s completion of this study.
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF

The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective, single-center, non-randomized investigation.

The design for this study involves the sequential enrollment of patients with documented paroxysmal atrial fibrillation who have had two (2) or more AF episodes for at least 30 seconds in length within six (6) months prior to enrollment. Target population shall be selected from the treatable AF population that meets both inclusion/exclusion criteria.It is intended that the Vado Steerable Sheath will be used as part of standard clinical workflow procedures, with no procedural deviations relative to other procedures requiring steerable sheaths. Individual subjects will be studied during mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care.

Eligibility Criteria:
Inclusion Criteria:

* suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
* Eighteen to Eighty years of age
* Signed informed consent

Exclusion Criteria:

* Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
* Severe cerebrovascular disease or history of cerebrovascular event within one (1) month
* Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR \< 29.
* Active gastrointestinal bleeding, infection or fever (\> 100.5/38C)
* Severe co morbidity or Short life expectancy (\<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
* Structural heart disease of clinical significance including

  * Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction \< 40% measured by acceptable cardiac testing
  * Stable/unstable angina or ongoing myocardial ischemia
  * Myocardial infarction (MI) within three months of enrollment
  * Aortic or mitral valve disease \> Grade II
  * Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
* Enrollment in any other ongoing arrhythmia study protocol
* Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
* Active infection or sepsis
* Female patient is pregnant or lactating
* Untreatable allergy to contrast media
* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or warfarin
* Severe COPD (identified by an FEV1 \<1)
Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
* Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
* On a stable medication regimen for IOP reduction one week prior to the screening visit;
* Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
* Sign informed consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
* Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
* Infection in either eye;
* Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
* Risk for visual field or visual acuity worsening, in the opinion of the investigator;
* Women of childbearing potential;
* Pregnant or lactating women;
* Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
* Participation in another clinical study within 30 days before the screening visit;
* Other protocol-defined exclusion criteria may apply.
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee

Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Atraumatic knee pain for at least 3 months;
* Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
* Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
* BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)

Exclusion Criteria:

* Knee pain and functional limitation related to other causes like osteonecrosis
* Fractures or inflammatory arthritis
* Ligamentous instabilities
* Malalignment on the coronal axis greater than 10 degrees in varus/valgus
* Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer

This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. To evaluate the change in percent tumor-infiltrating lymphocytes (TIL) as a continuous variable before and after preoperative boost radiotherapy (RT) in hormone receptor (HR)+/human epidermal growth factor receptor2 (HER2)- breast cancers.

SECONDARY OBJECTIVES:

I. To evaluate the safety of preoperative boost RT administered to patients with HR+/HER2- breast cancer.

EXPLORATORY OBJECTIVES:

* I. To assess the mechanisms of cell death induced by preoperative boost RT.
* II. To assess immunologic and molecular responses to preoperative boost RT.
* III. To assess the correlations between immune markers, cell death markers, and their changes during treatment.
* IV. To determine if magnetic resonance imaging (MRI) can be used to predict breast tumor response to neoadjuvant radiation.

OUTLINE:

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

After completion of study treatment, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

Inclusion:

* Age \>/=18 years at time of study entry
* Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
* Presence of a clip in the primary breast cancer
* Biopsy-amenable residual disease in the breast measuring \>/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Signed written informed consent
* Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon.

Exclusion:

* Women who are pregnant or breast-feeding
* Contraindication to receive radiotherapy