cyrilzakka/clinical-trials huggingface dataset:
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer

Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.

This is an open-label, nonrandomized, uncontrolled Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced KRASmt tumors.

The study will consist of two parts:

* Part 1: Dose-Escalation part to determine the RP2D and dosing schedule of futibatinib in combination with binimetinib in patients with advanced cancer disease
* Part 2: Dose-Expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC

Patients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met.

No patients were enrolled in Phase 2 as the Sponsor decided to not proceed with the dose expansion Phase 2 part of the TAS-120-204 study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2)
* Appropriate candidate for experimental therapy
* For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Adequate cardiac function (Left ventricular ejection fraction (LVEF) ≥50% )
* Adequate organ function
* Must have tumor tissue specimen available (optional for patients in Part 1)

Exclusion Criteria:

* History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
* Current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures.
* Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib
* Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)
Aging, Beta Blockers, and Thermoregulatory Responses

This study will test the hypothesis that the drugs propranolol and metoprolol will result in greater increases in core body temperature during 3 hours of extreme heat exposure in older adults.

Older individuals are more likely to die or become ill during heat waves. During the 1995 Chicago heat wave, there was 35% increase in hospital admissions for individuals older than 65 years of age. Moreover, adults over the age of 65 have a heat-related death rate that is more than double any other age group. Therefore, with an increasing elderly population that is expected to rise by 60% (to 78 million) by 2035, the causes of this excess mortality must be understood to better protect the ageing United States population. It is notable that selective and non-selective beta blocker drugs are commonly prescribed to older individuals with cardiovascular diseases. In younger individuals exposed to a heat stress, beta blocker administration reduced whole-body sweat rate and skin blood flow responses resulting in greater increases in core body temperature. Notably, nothing is known regarding the effects of beta blockers on thermoregulatory responses during heat exposure in older individuals.

This project will evaluate core body temperature responses to selective and non-selective beta blocker drugs during simulated heat wave exposure in older individuals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and free of any significant medical problems
* Normal resting electrocardiogram
* 65+ years of age
* Controlled cholesterol of less than 200 mg/dl
* Controlled blood pressure of less than 140/90 mmHg

Exclusion Criteria:

* Known diseases or other chronic conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia
* Serious abnormalities detected on routine screening
* Taking prescribed medications or over-the-counter medications that have known influences on either cardiac function or sweating
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* body mass index ≥31 kg/m2
Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse


Eligibility Criteria:
Inclusion Criteria:

* major patient
* patient suspected of infection and benefiting from the routine practice of NFS, whatever the indication during his / her visit to the emergency room.
* patient with or without criteria for bacterial infection
* patient affiliated to a social security scheme
* patient (or legal representative) who has agreed to participate in the study

Exclusion Criteria:

* anti tumor chemotherapy
* immunosuppressive treatment
* corticotherapy
* antibiotherapy in progress
* malignant hemopathy
* evolutionary cancer
* refusal to participate in the study
* subjects under safeguard of justice
* subject under guardianship or curatorship
Resistance Exercise, Metabolism and Time of Day

The aim of the current study is to determine the effect of time of day on the muscle and metabolic responses to resistance exercises in obese or overweight adults. To achieve this aim we have the following objectives:

1. Compare the effects of resistance exercise training performed in the morning vs the evening on insulin sensitivity
2. Compare the effects of resistance exercise training performed in the morning vs the evening on gains in muscle mass and strength
3. Compare the acute glucose responses to resistance exercise performed in the morning vs the evening


Eligibility Criteria:
Inclusion Criteria:

* pass the physical activity readiness questionnaire
* body mass index (BMI) \>27kg/m² and limited to 40 kg/m².

Exclusion Criteria:

* Prior surgery for weight loss
* Prior history of heart, lung, cancer, endocrine or liver disease
* Participating in more than 1 hour structured exercise training per week
KF STRIDE to Improve Job Interview Skills

The goals of the current study are to evaluate the preliminary effectiveness and feasibility of Kessler Foundation-Strength Identification and Expression (KF-STRIDE) in an 8-week randomized controlled trial comparing the intervention to services as usual (SAU).

This study will evaluate the acceptability and effectiveness of a strength-based intervention (Kessler Foundation Strength Identification and Expression; KF-STRIDE) that can enhance job interview skills and employment. Despite possessing employable talents, the core social deficits of transition age youth with autism spectrum disorder (TAY-ASD) make it difficult for this group to articulate their individual strengths. This inability to identify and express one's strengths to a potential employer can negatively affect interview performance and lead to difficulty with job obtainment. Thus, the current proposal will examine the effectiveness (Aim 1), acceptability, usability, and feasibility (Aim 2) of a novel strength-based intervention, KF-STRIDE, which is designed to enhance the ability of TAY-ASD to identify personal strengths and effectively discuss them. The goals of the current study are to evaluate the preliminary effectiveness and feasibility of KF-STRIDE in an 8-week randomized controlled trial comparing the intervention to services as usual (SAU). The study will be performed at two private therapeutic schools. Compared to a SAU group, we hypothesize that the KF-STRIDE group will: a) improve the ability to identify strengths (Hypothesis 1), b) improve the ability to express strengths (Hypothesis 2), c) improve other job interview skills (Hypothesis 3) and finally c) improve ability to obtain employment 6-months following the intervention (Hypothesis 4). In this way, the current study is in line with the NIMH's experimental therapeutics model, as we will examine whether the intervention improves employment, as well as identify potential mechanistic targets that could affect outcome. In Aim 2, we will also monitor fidelity, acceptability, usability, and feasibility of the strength-based intervention. The long-term goal of the current research is to collect pilot data that will lead to fully-powered effectiveness and implementation evaluations of KF-STRIDE in other community settings.

Eligibility Criteria:
Inclusion Criteria:

* adolescents with Autism Spectrum Disorder
* Live in the United States of America
* Ages of 14-26
* Speak English fluently and at a 4th grade reading level

Exclusion Criteria:

* History of stroke, Traumatic Brain Injury, or neurological injury or disease in the past (like brain tumor or epilepsy).
* History of significant psychiatric illness
* Uncontrolled seizures or other unstable medical complications.
Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study

The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.

The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.

* Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.
* Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.
* Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis
* The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.
* The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the TAP block.

Eligibility Criteria:
Inclusion Criteria:

* • Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon

  * Part of the ERAS protocol as listed by the surgeon
  * Age 18 years and older
  * Elective procedure

Exclusion Criteria:

* • Patient inability to consent

  * Patient inability to communicate for data collection
  * Conversion from laparoscopic to open case
  * Local anesthetic allergy
  * Weight less than 50 kg
  * Anatomical variation making block visualization unlikely
  * Inability to cooperate with block
  * Surgery posted longer than 6 hours
  * Known preoperative substance abuse
  * Chronic opioid use \> 3 months
  * Patient exhibits dependence on opioids Daily opioid use for pain control
Renal Cancer Detection Using Convolutional Neural Networks

We aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, we are interested in detecting renal tumors from CT urography scans in this project. We would like to classify renal tumor to cancer, non cancer, renal cyst I, renal cyst II, renal cyst III and renal cyst VI, with high sensitivity and low false positive rate using various types of convolutional neural networks (CNN). This task can be considered as the first step in building CAD systems for renal cancer diagnosis. Moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of CT-urography scans.

We aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, we are interested in detecting renal tumors from CT urography scans in this project. We would like to classify renal tumor to cancer, non cancer, renal cyst I, renal cyst II, renal cyst III and renal cyst VI, with high sensitivity and low false positive rate using various types of convolutional neural networks (CNN). This task can be considered as the first step in building CAD systems for renal cancer diagnosis. Moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of CT-urography scans.

Eligibility Criteria:
Inclusion Criteria:

* All patient with RCC, who underwent surgery

Exclusion Criteria:

* Patients with RCC, who did not underwent surgery
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials.

Therefore, this study was planned for review of the safety and efficacy in korean patients.


Eligibility Criteria:
Inclusion Criteria:

* The male and female patients over 18 years
* To participate in clinical trials and voluntary written consent requirement to comply with a patient
* Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation
* Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count \<500/mm3) patients
* Combined antibiotic therapy 72 hours after the expiration of term lasts three patients

Exclusion Criteria:

* Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to
* Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection
* HIV-positive patient serum
* This test within 30 days of assignment to the other patients participating in clinical trials
* Within 72 hours of registration before the patients treated with systemic antifungal agents
Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake

The purpose of this study is to investigate the effect of two weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Caucasian;
2. Male sex;
3. Age: 18-30
4. BMI: 18-25 kg/m2;
5. Normal physical activity levels;

Exclusion Criteria:

1. Not meeting all inclusion criteria
2. Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements)
3. Respiratory diseases (including asthma, bronchitis and COPD);
4. Unstable body weight (weight gain or loss \> 5 kg in the last three months);
5. Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
6. Excessive alcohol and/or drug abuse;
7. Hypokalaemia;
8. Hb \< 8.4 mmol/L;
9. Epilepsy;
10. Smoking;
11. Renal and/or liver insufficiency;
12. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
13. Medication use known to hamper subject's safety during the study procedures;
14. Subjects who do not want to be informed about unexpected medical findings;
15. Subjects who do not want that their treating physician to be informed;
16. Inability to participate and/or complete the required measurements;
17. Participation in organised or structured physical exercise;
18. Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
19. Hyperthyroidism
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.


Eligibility Criteria:
* Age greater than or equal to 18
* Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
* At least one brain metastasis diagnosed within 30 days of randomization
* Brain metastases must not have been previously treated with WBRT or radiosurgery
* No more than 2 sites of extracranial metastases
* May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient
* Appropriate use of effective contraception if of childbearing potential.
* Karnofsky Performance Status KPS greater than 70
* Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)
Diagnosing Respiratory Disease in Children Using Cough Sounds 2

The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).


Eligibility Criteria:
Inclusion Criteria:

* Infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices dated March 24, 2014)
* Presenting to the study site (an outpatient facility, an urgent care center, an Emergency Department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia.
* Onset of symptoms within past 14 days
* Outpatient or inpatient within 24 hours of admission
* Coughing spontaneously or able to cough voluntarily

Exclusion Criteria:

* Lack of a signed consent form from parent or legal guardian
* Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
* Need for mechanical ventilatory support ((including invasive, CPAP, or BiPAP)) or high flow nasal cannula
* History of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
* Any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month
* Too medically unstable to participate in study per treating clinician
* Subject previously enrolled in SMARTCOUGH-C-2 study
* Tracheostomy present or tube placed
Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proved extranodal NK/T cell lymphoma
* No previous anti-cancer treatment
* Measurable lesion on baseline PET/CT and MRI
* Stage I-II
* Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
* ECOG PS 0-1
* Sufficient organ functions

Exclusion Criteria:

* Other mature T- or NK- lymphoma
* Hemophagocytic lymphohistiocytosis
* Primary CNS lymphoma or CNS-involved lymphoma
* History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.

The objective of the study is to evaluate the efficacy and safety of Ibuprofen versus placebo in patients for the treatment of pain related to uncomplicated ankle injuries.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained.
2. Male and female patients, age in the range of 18-45 years (inclusive).
3. Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
4. Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
5. Patients with normal or clinically non-significant findings as determined by baseline history, physical examination and vital signs (blood pressure, heart rate and axillary temperature).
6. Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
7. Negative urine pregnancy test (for females only).

Exclusion Criteria:

1. Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID).
2. Known history of asthma.
3. Known history of gastric or peptic ulcer or bleeding.
4. Known history of malignancy or other serious diseases.
5. Known history of skin allergy.
6. Known history of cardiac, renal or hepatic insufficiency.
7. Presence of bruises or rash on the skin of ankle.
8. Presence of skin lesions like eczema or psoriasis.
9. Arthritis in the same joint.
10. Alcohol use during the study period or within 48 hours before the study enrolment.
11. Patients judged unable to use the VAS for pain reliably
12. Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
13. Other pain killers than rescue medication to be taken during the study.
14. Recurrent sprain at the same joint during the last 6 months.
15. Anticoagulant therapy.
16. Physiotherapy during study period.
17. Open wounds, infected skin or fracture.
18. Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the patient.
19. Pregnant or lactating females.
20. Participation in a drug or device study within 90 days before the study enrolment.