cyrilzakka/clinical-trials huggingface dataset:
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients have either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part. Patients in the expansion part were enrolled into two arms depending on whether they had ibrutinib resistance mutations present at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL per the WHO classification
* At least 18 years of age
* Lack of a complete response after receiving ibrutinib for \> 1 year OR presence of known ibrutinib resistance mutation
* Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)

Exclusion Criteria:

* Known history of HIV
* Active hepatitis B or C infection
* Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block.

Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.

Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely.

Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups.

The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects.

The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a social insurance number
* ASA 1-3
* Patients undergoing hand surgery requiring a continuous brachial plexus block
* Elective or urgent surgery
* Effective contraception (HAS criteria)
* Informed consent

Exclusion Criteria:

* Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
* Preexisting neuropathy
* Pregnancy
* Arteriovenous fistula
* Obesity (BMI \>40)
* Another surgical site implicated during the surgery
* Incapacity to abduct the operated arm
* Preoperative use of morphine or equivalent
Topical Raplixa for Surgical Bleeding in Children

The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.


Eligibility Criteria:
Before Surgery Inclusion Criteria:

* Was at least 36 weeks gestational age at birth (if an infant less than 6 months old) and is no older than 17 years at time of treatment
* Has a legal representative (parent or guardian) who signed an institutional review board (IRB)-approved informed consent document
* If at least 7 years old or appropriate age as defined by local regulations, may be required to sign an IRB-approved assent document
* Is scheduled to undergo one of the surgical procedures described in the protocol
* If female and of child-bearing potential, subject has negative pregnancy test on the day of surgery (baseline)
* If a sexually active male or female of reproductive potential, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

During Surgery Inclusion Criteria:

* Has mild or moderate bleeding/oozing
* Has TBS surface area no more than 100 cm\^2
* Has not received any whole blood, fresh frozen plasma (FFP), cryoprecipitate, or platelets within 24 hours prior to study drug (packed red blood cell (PRBC) transfusions are allowed)
* Had no complication during surgery other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety

Exclusion Criteria:

* Has any clinically significant laboratory or vital sign value, chronic disease state, or congenital coagulation disorder (eg, hemophilia A or B) that the investigator determines could interfere with the assessment of efficacy or pose a safety risk to the participant
* Is unwilling to receive blood products
* Has known antibodies or hypersensitivity to porcine gelatine, Raplixa or any of it's components, or other thrombin preparations or coagulation factors
* Has medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety of the participant or compliance with study procedures, including protocol-defined limits on participating in other clinical studies
Outcomes of a Skill-Based Program for Eating Disorders

This study aims to measure the effect of a neurobiologically-guided intensive family based treatment for adults with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of anorexia nervosa
* Illness onset at least 2 years prior to study
* Medically stable
* Identified carer to participate in treatment with participant

Exclusion Criteria:

* Developmental or intellectual disorder
* Diagnosis of substance abuse or dependence in 3 months prior to study
* Current suicidal thoughts
* Severe comorbid psychiatric disorder (e.g., psychotic disorder, bipolar disorder)
A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma

This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC).

From 2009 to 2020, this study analyzed GC patients underwent Radical Gastrectomy at three hospitals, dividing them into training, internal, and external validation cohorts. Twelve blood indicators were analyzed. The POSII Score was developed in the training cohort using the Least Absolute Shrinkage and Selection Operator (LASSO) technique. Additionally, two online nomogram calculators were created based on multivariate Cox regression within the training cohort and subsequently validated in internal and external validation cohorts.

Eligibility Criteria:
Inclusion Criteria:1) histopathologically diagnosed gastric adenocarcinoma, 2) undergoing radical gastrectomy for GC, 3) absence of tumor invasion into adjacent organs or distant metastasis, and 4) availability of complete laboratory data.

Exclusion Criteria: 1) non-adenocarcinoma gastric cancers, 2) gastric stump cancer, 3) receipt of neoadjuvant therapy, 4) a history of other malignancies, and 5) insufficient clinical data or follow-up information.
Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters

Studies have shown that more than 30% of the overall acute decompensated heart failure (ADHF) patients develop renal dysfunction.

Several studies have tried to find a correlation between hemodynamic Parameters (blood pressure , heart rate, central venous pressure CVP) and worsening of renal function in acute decompensated heart failure patients.

Results showed that there were no correlation between baseline hemodynamics or change in hemodynamics and worsening of renal function.

Another study showed that intra-abdominal pressure (IAP) measuring was a better corollary to renal failure status then measuring cardiovascular hemodynamics using pulmonary artery catheterization in ADHF patients.. An increased IAP was associated with worse renal function and that level of IAP far below abdominal compartment syndrome may adversely affect renal function in patients with ADHF.


Eligibility Criteria:
Inclusion Criteria:

* Any ICU(intensive care unit) or CCU(critical care unit) patient older than 18 y.
* Patient diagnosed on admission with pulmonary edema/CHF (fluid in the lungs) - independently from the baseline renal function.
* No subject will be accepted to take part in the study unless they are able to sign or if Health care proxy signs a consent

Exclusion Criteria:

* Pregnant women
* Cognitively impaired patients
* Age\<18 yrs old
* Patients diagnosed on admission with ARDS.
* Patients admitted with a diagnosis of sepsis ( WBC\> 12000, CXR findings consistent with pneumonia, positive blood cultures on admission, UTI)
CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology

This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:

* A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist)
* Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops
* An information booklet "Prepare the work return" The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

Unmet need characterize in 4 points:

* Cancer and survival: challenges for cancer patients who want to work while being treated
* Cancer and career: Job instability for cancer patients
* Difficulties and isolation of patients due to a lack of coordination between healthcare professionals and colleagues/management
* Post-treatment cognitive troubles stress and hindered patient return to employment: chemo brain This research-action will propose and evaluate a concrete device: To maintain a professional activity with the support of CAP'Onco during treatment, to balance between quality of life, managing the "cancer event" and the psychosocial consequences for professional experience, to provide an early, durable and multimodal support to improve work keeping and anticipate return to employment

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Institut Bergonié
* Informed Consent signed.
* Patients affiliated to a French social
* living in Gironde
* Professional activity at the time of diagnosis
* Treated for - breast cancer, Hodgkin's or non-Hodgkin's lymphoma (non-cerebral), testicular cancer
* CURATIVE support
* At any time during treatment (chemotherapy or radiotherapy, or immunotherapy)

Exclusion Criteria:

* Patient deprived of liberty or subject to a legal protection measure
* History of cancers
* Cerebral pathology and / or brain metastasis
Treatment Outcome in Eating Disorders

Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with Anorexia Nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED), or Unspecified Feeding or Eating Disorder (UFED) in this study will self select one of the two treatment groups, FBT or CBT-E.

Additionally, does Family-based Treatment (FBT) modified for Avoidant/Restrictive Food Intake Disorder (ARFID) and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) demonstrate effectiveness for patients with an Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis?

Given a significant number of patients who presented for treatment at the Center for the Treatment of Eating Disorders (CTED) and were enrolled in this effectiveness study met criteria for a diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID), and because there are currently no randomized control trials systematically evaluating children/adolescents with ARFID, a secondary aim was added to this study.

The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) for ARFID patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 6 years of age, attending the CTED clinic for outpatient treatment of a Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosed eating disorder in order to be included in this study.

Exclusion Criteria:

* Participants who are receiving inpatient services only and will not return to CTED for outpatient treatment.
* Participants with a co-morbid medical disorder known to influence eating or weight.
* Participants presenting with a significant psychotic disorder.
* Participants who are acutely suicidal.
* Participants who demonstrate significant substance abuse and/or substance dependence.
Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)

evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.

* Background: Lung cancer is the leading cause of cancer deaths. Patients with pulmonary nodules often undergo multiple computed tomography (CT) examinations for diagnostic and follow-up purposes.
* Purpose: The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.
* Abstract: Despite recent advances, lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer death worldwide because it is often diagnosed at advanced stages that are not surgically curable. Nevertheless, early detection of lung cancer allows surgical resection, offers curative treatment and the best chance of survival. There is currently no screening program in France, but individual screening can be carried out depending on risk factors. Many pulmonary nodules are discovered each year, most of which are benign. The challenge is to distinguish malignant lesions from the multitude of benign lesions. One of the most effective criteria is the doubling time of the nodules which leads to multiple follow-up examinations requiring ionizing radiation to assess the size and growth of the nodules. Great efforts are currently being made by CT manufacturers in order to reduce the radiation with equivalent diagnostic performance. Patients who were referred to our department for an unenhanced low-dose chest CT (LD CT) for pulmonary nodules check-up or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (ULDCT, \<0,25 mSv, similar to standard two-view chest X-Ray) with deep learning-based reconstruction (DLIR). The main objective of this study is to evaluate the diagnostic performance between ULD and LD CT protocols for the detection of pulmonary nodules. The impact of dose reduction will be assessed in this context. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for non-enhanced chest CT for lung nodule check-up or follow-up,
* Affiliation to a social security program,
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age \<18 years old,
* Person under guardianship or curatorship,
* Pregnant woman,
* Any contraindications to CT
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m\^2

Exclusion Criteria:

* Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years (healthy elderly subjects) at screening.
* Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight \>= 50 kg.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.
LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases

The goal of this study is to evaluate the effects of LC-Plasma on the innate and acquired immune systems, including the activation of pDCs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. Researchers will compare LC-Plasma to placebo, participants will take a tablet containing LC-Plasma or placebo daily for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who can provide a signed and dated informed consent form after confirming their willingness to participate.
* Individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular RATs.
* Healthy people living in Australia aged 18-60 (both men and women).
* Individuals who have received at least two doses of a SARS-CoV-2 vaccine, with at least two weeks having passed since the last dose.
* Individuals who are not currently infected with SARS-CoV-2 and, if previously infected, have recovered and have been infection-free for at least four weeks.
* Individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, IBS, IBD, SLE, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment.

Exclusion Criteria:

* Individuals medically prescribed medications that would affect the immune and/or the inflammatory response.
* Individuals deemed unsuitable for participation by Griffith CTU staff and/or the study clinician.
* Active smokers/vapers and/or individuals with nicotine or drug habits.
* Individuals currently participating in (or planning to participate in) other clinical trials.
* Women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding.
* Individuals unable to abstain from alcohol for two days prior to blood and urine sample collection.
* Individuals unable to refrain from consuming other lactic acid bacteria supplements.
* Individuals who are known to be HIV, HTLV-1, or HCV positive (based on answers to the enrolment questionnaire).
Dental Support Device in the Second Stage of Labor

Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve lead to shortened labor by allowing patients to push more effectively.

In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not without risks and may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve maternal valsalva and lead to a shortened second stage of labor by allowing them to push more effectively. Previous studies have been underpowered to find statistically significant results.

The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. The objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use the LaboraideTM, a DSD designed for laboring women, while pushing with contractions in the second stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Non-anomalous fetus
* Singleton fetus
* Vertex presentation
* In the first phase of labor
* Full term gestation (\>=37w0d)
* Maternal age 18-64 years

Exclusion Criteria:

* Multiparity
* History of prior uterine surgery such as cesarean section or myomectomy
* Unexplained vaginal bleeding
* Latex allergy
* Contraindication to vaginal delivery
* Pregestational or Gestational Diabetes
* Fetal growth restriction
* Fetus with suspected macrosomia
* Prematurity (\<37 weeks gestational age)
* Multiple gestation
* Refusal to participate