cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria

* Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study
* ALK-positive as confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor
* Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment
* Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment
* Able to be followed-up by participating site
* Participants with advanced NSCLC who have CNS metastases are eligible for inclusion

Exclusion Criteria

* Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information
* Participants not receiving the Roche studied medicinal product
* Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed aggressive \[de novo or transformed\] NHL according to REAL/WHO classification.
* At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
* Relapse after 2 or more prior regimens of chemotherapy
* ECOG performance status of 0, 1, or 2
* Adequate hematologic, renal and hepatic function
* LVEF ≥50% determined by MUGA scan

Exclusion Criteria:

* Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
* Prior allogenic stem cell transplant
* Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
* Active CNS lymphoma or HIV-related lymphoma.
* Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
* Pregnant women or nursing mothers
DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants who have provided ICF with age ≥ 18 yrs
2. ECOG performance 0-2, no deterioration in the past 2 weeks
3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
4. Adequate bone marrow reserve and organ system functions
5. Participants willing to comply with contraceptive restrictions

Exclusion Criteria:

1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
2. Prior history of allogeneic hematopoietic stem cell transplantation
3. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
4. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
6. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
7. Participants with infectious disease:
8. Clinically significant cardiac disorders or abnormalities
9. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
10. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
11. Women who are breast feeding
12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Switzerland \& Austria.

Venetoclax is a drug approved to treat acute myeloid leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 120 participants will be enrolled in the study in approximately 15 sites in Switzerland \& Austria.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed AML and eligible to receive venetoclax as per local label.
* Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion Criteria:

- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access

Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.

This is a retrospective cohort study of consecutive patients receiving suture-mediated closure of the femoral vein following catheterization. All patients undergoing cardiac or arterial catheterization by the Interventional Cardiovascular Medicine Service at The Brigham and Women's hospital from 3/1/02 to the onset of the study and who had femoral venous access during that time were considered for closure of the venous site; however, the decision to use the closure device was left to the discretion of the physician. Contraindications to using the closure device include a groin hematoma that had developed during the procedure and/or difficult access due to extensive scar tissue from surgery or multiple prior vascular accesses.

All in-hospital endpoints have been collected in the pre-existing Catheterization Laboratory Database. Patient's data will be extracted from this database as indicated in the procedure below. Each patient will be reviewed for clinical follow-up and the presence of adverse events including but not limited to hematoma, thrombosis, blood loss, vascular imaging, the need for additional procedures, and re-admissions within 30 days of closure. If necessary, further data will be collected via a phone interview with the patients. Univariate and multivariate analysis will be performed to determine the factors that predict inadequate or incomplete closure or the development of complications mentioned in the section above. A predictive model based on the identified risk factor will be developed and tested prospectively in the next phase of this ongoing investigation.

Eligibility Criteria:
Inclusion Criteria:

* All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization

Exclusion Criteria:

* Pt.s who are unable to give consent.
* Pts. whose participation in research is contraindicated for medical reasons are excluded.
Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication

An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.

Eligibility Criteria:
Inclusion Criteria:

* age ranged between 20 and 50 years old,
* American Society of Anesthesiologists (ASA) physical status classification I
* came for abdominoplasty operation

Exclusion Criteria:

* anemia or hemoglobin levels below 11g/dl
* bleeding problems
* cardiovascular disorders
* restrictive and obstructive respiratory disease
* abdominoplasty without plication.
A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.

Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.

Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer

Exclusion Criteria:

* Age younger than 18 years
* History of psychiatric illness
* Preoperative radiotherapy
Ovarian Hyperstimulation Syndrome Using Calcium Infusion

the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART

Among assisted reproductive technologies (ART), ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication affects up to 30% of women undergoing ART and caries high risks of morbidity and mortality. Women with age younger than 35 years, those with history of polycystic ovary syndrome (PCOS), or having a history of previous OHSS are more susceptible to develop OHSS

Eligibility Criteria:
Inclusion Criteria:

- infertile women aged 20 to 38 years. BMI ranged from 18 to 40. serum FSH within normal limits( 1-12IU /l) presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion Criteria:

* endocrinopathies. a systemic disease. and Insulin-dependent diabetes Thyroid disease using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists. patients need coasting for high risk of OHSS. patients need cycle cancellation. severe male infertility requiring testicular sperm extraction.
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity and mortality before, during, and after liver transplantation. A common mechanism for the reduced muscle and fat mass in cirrhosis is an increased expression of the TGF (transforming growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. The present study will examine the expression of myostatin, its receptor and intracellular signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients undergoing liver transplantation as compared to healthy controls undergoing planned abdominal surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy controls from outpatient surgery lists. Nutritional assessment will be performed, including anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray absorptiometry (DEXA), and bioelectrical impedance analysis (BIA). Rectus abdominis muscle tissue and omental fat tissue will be harvested in the operating room, and the expression of signaling proteins involved in skeletal muscle protein synthesis will be quantified. The investigator will also quantify the expression of genes involved in lipolysis and lipid synthesis. The investigator anticipates that the expression of myostatin will be higher in the skeletal muscle and adipose tissue of cirrhotics as compared to controls. There will be a reduction in the expression of the signaling proteins that regulate skeletal muscle protein synthesis, as well as the expression of genes regulating lipogenesis. The increased expression of myostatin will also correlate with reduced anthropometric and DEXA measurements of lean body mass and fat mass.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Patients undergoing abdominal surgery (liver transplantation or other surgery)

Control

1. non liver transplant donor
2. Elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of exclusion criteria)

Exclusion Criteria:

* Exclusion criteria (all subjects)
* Average daily alcohol intake \> 20 g in women and \> 30 g in men
* Diabetes or a fasting serum glucose \> 100 mg/dL
* Hyper- / hypo- thyroidism
* Renal disease with serum creatinine \> 1.4 mg/dL
* Folate or vitamin B12 deficiency
* Active intravenous drug use
* History of bowel surgery or gastric bypass surgery
* Medications/supplements that affect fat mass or protein mass (creatine, glucocorticoids)
* Pregnancy
* Chronic diseases that result in cachexia (renal, cardiac, pulmonary, hematologic, cancer)
* Hepatocellular cancer

Exclusion criteria (controls)

* Evidence of malnutrition as quantified by triceps skinfold thickness, mid arm muscle area and creatinine height index)
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia

Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of this prospective observational study is to examine the perioperative changes in ventilation inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath washout and forced oscillation techniques.

Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. These alterations lead to a ventilation/perfusion mismatch which is potentiated by a decrease in functional residual capacity (FRC). These effects explain why pregnant women are more prone to the occurrence of hypoxemia, particularly in the third trimester of their pregnancy. The importance of the ventilation inhomogeneity can be estimated from the lung clearance index (LCI) measured by the non-invasive nitrogen multiple breath washout (N2 MBW) technique. Moreover the loss in lung volume is associated with reduction in respiratory system compliance, which can also be assessed non-invasively by the forced oscillation technique (FOT).

To our knowledge, there is no existing data on LCI or FRC using the aforementioned techniques in pregnant women. Furthermore, existing data on respiratory function in pregnant women is largely restricted to spirometric and body plethysmographic measurements taken primarily in the 1970s-1980s. As such, the important roles of lung ventilation inhomogeneity as well as the potential changes following birth after caesarean section have yet to be completely characterised.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Pregnant woman in the third trimester (37-40 weeks gestational age)
* Scheduled for elective caesarean section under regional (spinal or combined spinal-epidural) anaesthesia

Exclusion Criteria:

* Pregnant women outside 37-40 weeks gestational age
* Non-singleton pregnancy
* Previous history of ≥2 caesarean sections
* History or clinical signs of cardiopulmonary disease in the last 12 months (chronic hypertension, gestational hypertension, preeclampsia, asthma, acute or chronic bronchitis, others)
* Positive current smoking status
* Pre-pregnant body mass index (BMI) \>30 kg/m2 (based on booking records)
* Respiratory infection \<2 weeks prior to surgery
* Inability to perform the respiratory function tests
A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer

The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).

This is an open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with metastatic castrate-resistant prostate cancer. The trial consists of 3 phases: screening period, treatment period of approximately 4 months, and a follow-up period (Week 1, 4, 8 and 12 after the last dose) of up to 12 weeks after the administration of last dose. The participants will receive carlumab at the dose of 15 milligram/kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression. Efficacy of the participants will be primarily evaluated by composite response. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of adenocarcinoma of the prostate
* Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
* Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
* Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
* At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent

Exclusion Criteria:

* Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
* Known or symptomatic Central Nervous System metastases
* Residual toxicities resulting from previous therapy that are Grade 2 or more (except for alopecia)
* Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
* Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
RISE RCT for Nurse Leaders

The purpose of this study is to determine whether RISE for Nurse Leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Licensed as an RN
* Unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Celebration, Daytona Beach, DeLand, East Orlando, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
* Able to speak, read, and understand English fluently
* Able to provide informed consent
* Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

* Employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader)
* A study participant of IRBNet #1504917 titled A Pilot Study of RISE for Nurse Managers