cyrilzakka/clinical-trials huggingface dataset:
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant)
* Availability of a representative formalin fixed paraffin embedded tumor tissue sample
* At least one measurable or non-measurable lesion
* Age ≥ 18 years
* World Health Organization (WHO) Performance Status ≤ 2
* Good organ (hepatic, kidney, BM) function at screening/baseline visit

Exclusion Criteria:

* Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed).
* Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit
* Patient with peripheral neuropathy NCI-CTC Grade ≥ 3
* Patient with diarrhea NCI-CTC Grade ≥ 2
* Patient with acute or chronic pancreatitis
* Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
* Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
* Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply
Social Determinants of Sleep and Obesity

African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.


Eligibility Criteria:
Inclusion Criteria:

* Not meeting Physical Activity Guidelines
* age range: 21 to 65 years
* body mass index range: 25.0 to 40 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American.

Exclusion Criteria:

* Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
* pregnant or less than 4 months postpartum
* infant living in household less than 1 year old
Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers

The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr) catheters, in coronariography via the right transradial approach.

This was a prospective, randomized, study of paralled design. Consecutive patients with acute coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful cannulation of right artery and informed consent to either Tiger or Judkins catheters.

analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases were performed with conventional catheters (Judkins). The patients of both group were overall well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic angiograms were successfully achieved in all cases via the radial approach.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* indication for coronary angiography

Exclusion Criteria:

* negative Allen´s test
* Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)
* Hemodynamic instability
* coronary artery bypass grafting
Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients

Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. These include the taxanes, which are among the most commonly used class of chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease as defined by the presence of at least one measurable lesion
* Patients must have received at least 3 weeks of continuous therapy with Taxane - patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
* excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant.
* others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Proto-Oncogene, BHLH Transcription Factor (MYC) Protein Expression in Diffuse Large B-Cell Lymphoma

This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.

This is a single center feasibility imaging study in patients with diffuse large B-cell lymphoma (DLBCL) or B-cell Lymphoma, Unclassifiable with features between DLBCL and Burkitt's (BCLU). Study participants will undergo PET/MRI of the whole body with 68Ga citrate.

The study will include at least 5 patients with double hit lymphoma and 5 patients with DLBCL with an additional 5 more patients as expansion once the dose level has been established. Patients with DLBCL will be included once an optimal dose level for the resolution of cancer lesions has been established.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed DLBCL or BCLU.

   * Double hit lymphoma, defined by positive cytogenetic/ fluorescence in situ hybridization (FISH) analysis for translocations involving myc and bcl2 or a double hit score of 2 by immunohistochemistry as described by Johnson et al.
   * DLBCL without myc translocation or overexpression by the above methods
2. Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension.
3. Available prior CT or PET/CT scan done in the last 8 weeks for comparison
4. Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior.
5. Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation)
6. No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia)
7. Ability to sign a study-specific internal review board (IRB) approved consent prior to study entry. Patients must be able and willing to consent and undergo study procedures.
8. Age ≥18 years old

Exclusion Criteria:

1. Any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures
2. Body weight over 300 pounds
3. Female patients who are pregnant or breast-feeding
4. Prior MRI with gadolinium performed \<24 hours before the study scan
5. No red blood cell transfusion or iron administration by any route in the last 7 days
6. Prior hypersensitivity or intolerance to gadolinium or gallium citrate.
Changes in the Treatment of Acute Appendicitis

The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.

This retrospective observational study analyzed routine data provided by the CLINOTEL Hospital Association Germany, covering the years 2010 to 2022. The data was derived from anonymized billing data according to the German Diagnosis-Related Groups (DRG) system for inpatient hospital treatments.

The study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy.

Patients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to Intensive Care Unit, length of stay, and in-hospital-mortality. Cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. Furthermore, all cases with multiple appendectomy codes were removed from the sample. Ultimately, 31988 patients were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Acute Appendicitis

Exclusion Criteria:

* Age under 18 years
* No appendectomy performed
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 19 to 55
* If female, must be of non-child bearing potential or practicing birth control
* Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)

Exclusion Criteria:

* Intolerance towards ethanol
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
* History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
* Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
* Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase
Preoperative Intravenous Fluid Type and Postoperative Nausea

In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.

Fluid management is an integral and important part of perioperative treatment. In order to prevent organ damage, a key components of assuring adequate organ perfusion is to provide adequate volume and appropriate fluid. Types of the fluids, amount of the fluid given and timing of the administration are the main topics that determine the fluid management strategy. Colloids (e.g. albumin or fresh frozen plasma (FFP)) and crystalloids (e.g. ringer lactate, isotonic, 5% dextrose) are types of intravenous fluids that are used for fluid replacement apart from blood transfusion . Crystalloids are low-cost salt solutions with small molecules, which can move around easily when injected into the body.

There are studies reporting that fluid therapy applied in the preoperative period reduces gastric acid secretion and reduces stomach movements and nausea and vomiting. In addition, there are studies reporting that fluids given in the preoperative period have a positive effect on anxiety levels by reducing the feeling of hunger and thirst in patients. There are studies reporting that fluid therapy reduces ATP destruction and oxidative stress, which contributes to the reduction of pain levels.

90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups. Patients in Group 1 were administered 400 ml 0.9% saline infusion within 30 minutes, 2 hours before surgery. Patients in Group 2 were infused with 400 ml 5% Dextrose at the same infusion rate. In groups 1 and 2, 10 ml/kg/h 0.9% saline infusion was applied during the intraoperative period. Patients in Group 3 were administered 200 ml dextrose infusion in the preoperative period and 200 ml dextrose infusion in the intraoperative period. 0.9% saline infusion was applied so that the total intraoperative fluid volume was the same as in the other groups.

Postoperative nausea and vomiting (PONV) , within 24 hours was compared between groups by PONV score. Other outcomes were the antiemetic drugs needed, The NRS Score, The State-Trait Anxiety Inventory , additional analgesic drug requirement.

In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic cholecystectomy
* Patients over the age of 18

Exclusion Criteria:

* Patients who do not accept the study
* Diabetes Mellitus
Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility

SWIFT-CORE-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. Site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. A doctor will review medical history with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
2. Participant is at least 18 years old.

Exclusion Criteria:

1. Participant is pregnant, breast-feeding, or planning to become pregnant.
2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
3. Moderate or severe substance use disorder within 90 days prior to screen
4. Any condition that in the investigator's opinion makes a participant unsuitable for the study.
5. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.
A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months
* Started on tocilizumab, with or without previous history of biological treatment

Exclusion Criteria:

* Pregnant or lactating women
* Treated with an investigational drug within 30 days prior to initiation of study drug
* Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results
BIS of Sedation Depth During Flexible Bronchoscopy.

Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious sedation of FB.

Fentanyl is opioid receptor agonists. It is a fast-acting, short duration and potent analgesics.

Flexible bronchoscopy (FB) is mostly used in the diagnosis and therapy in the respiratory disease. As we know, there has not pain nerve in the lung. People will not feel pain when they are in FB.

If fentanyl will be effective in FB? Our study will observe the effect of conscious sedation in FB with fentanyl or without fentanyl.

Eligibility Criteria:
Inclusion Criteria:

Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy

Exclusion Criteria:

Forced expiratory volume in one second\<1 L severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)
Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant

Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients.


Eligibility Criteria:
Inclusion criteria:

* Patients where the investigator expects to prescribe cyclosporine, mycophenolate mofetil and corticosteroids as base immunosuppressive therapy, regardless of their participation in the study.
* Man or woman aged from 17 to 70 years.
* Patients that receive a first or second renal transplant from a non-living donor
* Patients where allograft biopsies may be performed.
* Patients receiving an identical or compatible ABO graft.
* Patients willing to give their written informed consent to all study issues.
* Women with child-bearing potential should use a medically proven contraceptive method during the study.
* Patients able to meet all study requirements.

Exclusion criteria:

* Patients with pre-transplant cholesterol levels above 240 mg/dl (6.2 mmol/l).
* Positive cross-match of T cells or ABO incompatibility with the donor.
* Recipients of multiorgan transplant.
* Patients with diabetes mellitus.
* HIV seropositive or with surface antigen of Hepatitis B .
* Kidney from a donor aged over 65 years.
* Last panel of reactive antibody (PRA) above 50%.
* Women who plan to get pregnant within 12 months, or who are pregnant and/or nursing.
* Patients with a history of cancer in the previous 5 years, except for patients successfully treated with localized carcinoma of squamous or basal cells of the skin, or cervix cancer in situ treated adequately.
* Patients receiving an investigational drug in the 30 days prior to the transplant and/or who will receive an investigational/non-registered drug during the study, except for the use of erythropoietin-stimulating products
* Patients with myocardial infarction within the 6 months prior to the transplant, uncontrollable cardiac arrhythmia or another severe or unstable medical condition probably affecting the safety of the patient or the study objectives.
* Patients with alcohol dependence or drug abuse not solved, or signs of organic lesion caused by alcohol, mental dysfunction or other factors limiting their ability to fully cooperate with the study.
* Patients where it is planned to perform an induction treatment with preparations containing antilymphocyte antibodies (ALG, ATG or OKT-3).
* Patients scheduled to receive cyclosporine i.v. for over 48 hours.
* Patients with liver dysfunction (ALT or AST values or total bilirubin 2 times above the upper limit of the normal ranges of the laboratory values).
* Other protocol-defined inclusion/exclusion criteria may apply
Intra-abdominal Pressures During the Spontaneous Breathing Trial

Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can also reflect the change of pulmonary dynamics. In this study, we choose patients who received spontaneous breathing trial to answer the hypothesis.

During the weaning process, we tapered down the respiratory support from mechanical ventilation and recruited respiratory muscles to work. Previous study showed that transdiaphragmatic pressure was increasing while pressure support was reducing. However, the transdiaphragmatic pressure required invasive procedure to measure and not used frequently in weaning. IAP reflects the pleural pressure. If the PEEP is not changed, change of IAP is largely due to change of transpulmonary pressure.

Study Aim:

1. To evaluate the patterns of change of IAP during SBT
2. To predict success of SBT by the change of IAP
3. To predict weaning outcome by the change of IAP

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with endotracheal intubation in the intensive care unit
* The clinical condition is considered to prepare for weaning assessment

Exclusion Criteria:

* tracheostomy
* severe heart failure, heart disease or arrhythmia
* upper airway obstruction related respiratory failure
* poor cooperation due to agitation
* no foley catheter in place or had been removed
* baseline IAP above 20 mmHg