cyrilzakka/clinical-trials huggingface dataset:
Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil

Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.

Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications.

The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with lung nodules;
2. Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.

Exclusion Criteria:

1. Lung nodule \< 5 mm;
2. Calcification nodules;
3. Lung nodule which decreased in size at time of follow-up;
4. Patients with distant metastases or other severe comorbidities.
Occupational Therapy in Palliative Care

The goal of this research study is to learn if inpatient occupational therapy can help patients in the Palliative Care Unit (PCU).

Caregivers Consent:

If you agree to take part in this study, you will complete a questionnaire about your opinion on the inpatient occupational therapy session the patient (person you are caring for) received. It should take about 10 minutes to complete the questionnaire. You will be left alone in a room to complete the questionnaire.

Length of Study:

Your participation on this study will be over after you complete the questionnaire.

This is an investigational study.

50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.

Patients Consent:

If you agree to take part in this study, you will complete a questionnaire about your opinion of the inpatient occupational therapy session you just had. The questionnaire should take about 10 minutes to complete. You will be left alone in the room to complete the questionnaire.

Length of Study:

You participation on this study will be over after you complete the questionnaire.

This is an investigational study.

50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have an inpatient occupational therapy (OT) order and be able to tolerate an OT session as judged by the attending physician
2. Patients with cancer admitted to inpatient acute palliative care unit
3. Caregiver participation is optional, but must be identified as the primary caregiver in order to complete the Caregiver Satisfaction Survey.
4. Caregiver (if participating) must be present during the session.
5. Patient (and caregiver (if participating) must be 18 years of age or older.
6. Both patient (and caregiver if participating) must be able to understand, read, write and speak English.
7. Both patient and caregiver (if participating) must sign an Informed Consent Form.

Exclusion Criteria:

1. Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and survey.
2. Patients or caregivers who the attending physician deems unable to participate due to poor cognitive capacity or acute physical distress.
PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial

CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity.

PROBODY is a trademark of CytomX Therapeutics, Inc.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
2. Agreement to provide mandatory archival tissue or fresh biopsy.
3. At least 18 years of age.

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.
4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.
5. History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications.
6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.
Gamification and Energetic Behavior Changes

Obesity \[Body mass index (BMI kg/m2 ≥ 95th percentile)\] affects 1 in 5 adolescents in the United States, with 13 million suffering from severe obesity (BMI ≥ 120% \> 95th percentile or ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and physical activity, but change in these behaviors requires self-monitoring and support, and weight loss is not always successful.

Parent involvement and parent weight-loss can help their children to lose weight and successfully change their behavior. Guidance from pediatricians can also help to facilitate weight loss among obese adolescents. That said, treatment of obesity through behavior change within the time constraints of a Pediatric practice visit is limited by treatment adherence and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep adolescents with severe obesity engaged in therapy outside of standard practice is a critical need.

The effects of monetary incentives through games (gamification), and a comprehensive remote digital monitoring system on sleep, physical activity, and dietary intake, has been successful in adults, but has not been tested in adolescents with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Child Subjects age 10 - 16
* Obese as defined by body mass index (BMI)
* Computer access and data plan with text messaging
* SSB intake of 2 or more servings per day (1 serving=12oz)

Exclusion Criteria:

* Active substance abuse.
* Syndromic or secondary obesity.
* Any developmental disorder.
* Eating disorder (with the exception of binge eating disorder).
* Psychosis.
* Untreated depression.
* Use of medications (prescription or otherwise) known to effect body weight.
* Weight loss of more than 5% body weight in the past 3 months.
* History of bariatric surgery.
Is There Any Correlation Between Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava?

Intravascular volume assesment is important for the management of the patients in the intensive care unit. Respiratory variation ratio of the inferior vena cava (IVC) can be determined by ultrasonography (USG) and is a useful tool for hemodynamic evaluation of the patient.

Aim of this study is to search for correlation between respiratory variation ratios of the internal jugular vein (IJV) and the IVC before and after passive leg raise. Another aim of this study is to search for variability between ultrasonographic measurements of different doctors.

The investigators measure the internal jugular vein (IJV) diameter in the short axis by using the linear probe (12-5 MHz) and M-mode of the ultrasound device in the junction of cricothyroid membrane level and midclavicular line. The inferior vena cava (IVC) is visualized in the subxiphoid long axis by using the convex probe (5-1 MHz). Diameter of the IVC is measured 2 cm caudally to the junction of the hepatic vein in M-mode. All measurements are done separately by 3 different doctors; one senior anesthesiology resident, one anesthesiology and critical care medicine fellow and one professor in anesthesiology and critical care. The first measurements of the IVC and the IJV are done in the supine position and the second ones are done after passive leg raise. Passive leg raise is done for 1 minute in the first group and for 3 minutes in the second group. Then distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices are calculated. No fluid therapy or medication are given to the patients according to these measurements.

Oxygen saturation, hearth rate and blood pressure levels are recorded before and after the measurements. The investigators also record age, gender, weight, height, body mass index, causes of admission, comorbidities, ventilator settings, vasoactive and diuretic medications, fluid intake and output volumes, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-Related Organ Failure Assessment (SOFA) scores in the day of admission, Acute Physiology Score (APS) and SOFA scores in the day of measurement and length of stay in the intensive care unit.

Patients with infection or surgical sutures in the site of measurement areas, intraabdominal hypertension, severe aortic regurgitation or lower extremity amputation history are excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated
* Over 18 years of age

Exclusion Criteria:

* Infection in the site of measurement areas
* Surgical sutures in the site of measurement areas
* Intraabdominal hypertension
* Severe aortic regurgitation
* Lower extremity amputation
Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)

Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated.

Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre.

In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Weight ≥ 37,5 kg
* Patients operated for
* complex endovascular aortic aneurysm repair
* deep vein recanalization
* complex arterial revascularization (TASC D lesions)
* Patient informed of the study details and who didn't opposed to participate in this research

Exclusion Criteria:

* Known allergy to heparin
* Known hepatic insufficiency with repercussion on coagulation
* Thrombocytopenia
* Known hemostasis disorders
* Anemia defined HB\<8 g/L
* Pregnant women
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥ 37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Coagulation or renal function disorders
* Known allergy to hydroxyethyl starch
* Fetal distress, or known fetal developmental anomaly
Hull Airway Reflux Questionnaire Scores Following Cough Treatment

The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.


Eligibility Criteria:
Inclusion Criteria:

1. Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
2. Willing and able to comply with study procedures
3. Able to provide written informed consent to participate

Exclusion Criteria:

1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.
Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines made from a tumor antigen gene may make the body build an immune response to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cell to kill melanoma cells. Combining vaccine therapy with interleukin-12 may kill more melanoma cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus interleukin-12 in treating patients who have metastatic melanoma.

OBJECTIVES: I. Determine the safety and maximum tolerated dose level of the vaccine consisting of MAGE-3 or Melan-A (human tumor antigen genes) peptide-pulsed autologous peripheral blood mononuclear cells plus interleukin-12. II. Determine if the procedure results in successful immunization. III. Assess the response of the tumor to the vaccine.

OUTLINE: This is an open label, nonrandomized, single institution study. Patients receive 3 initial courses of treatment consisting of 21 days each. Treatment consists of an immunization with MAGE-3 or Melan-A peptide-loaded autologous PBMC and interleukin-12 (IL-12) on the first day, IL-12 on days 3 and 5, and 16 days of rest. The first cohort is not administered IL-12 and the next cohorts are given escalating doses of IL-12. The Phase II dose will be one dose level below the MTD. Patients who have a tumor remission response or stable disease may continue treatment for up to one year. Phase I completed as of 04/1999. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma Patient must express HLA-A2 (a human leukocyte antigen) Tumor must express MAGE-3 or Melan-A by polymerase chain reaction (PCR) analysis No untreated brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70%-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater 1.5 times upper limit of normal (ULN) SGPT no greater than 2 times ULN Renal: Calcium no greater than 11 mg/dL Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiovascular disease or cardiac arrhythmia requiring medical intervention Other: Hepatitis B surface antigen negative HIV negative No serious concurrent infection No clinically significant autoimmune disease No active gastrointestinal bleeding or uncontrolled peptic ulcer disease No history of inflammatory bowel disease No psychiatric illness that may interfere with compliance in study Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunosuppressive drugs At least 4 weeks since biologic therapy Chemotherapy: At least 2 weeks since chemotherapy Endocrine therapy: No concurrent systemic corticosteroids (except physiologic replacement doses) Radiotherapy: At least 2 weeks since radiotherapy Surgery: At least 2 weeks since surgery
Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma

Retinoblastoma is an unusual cancer of early childhood involving tumor is both eyes or, in certain circumstances, one eye only. This condition is the result of an abnormal gene which makes both retinas (the back of the eye) vulnerable to develop multiple tumors. Growths in the eye impair vision temporarily or permanently. These tumors are malignant, which means that they can grow within the eye, spread outside of the eye, and be fatal if untreated.

Standard therapy for bilateral retinoblastoma includes removal of one eye if vision cannot be save and radiation treatment of either eye in which vision might be saved. Radiation controls tumor growth in the majority of cases. Another standard method is cryotherapy (freezing a tumor to kill it). Chemotherapy (medicines used to kill tumor cells) has been used in the past for tumor in or outside the eye, but is not standard. Hyperthermia, increasing the temperature of a tumor to kill it, is widely performed, and can be done to a retinoblastoma tumor by a laser; this method is not standard.

The problem with removal of an eye is that any hope of vision is lost. The problems with radiation include incomplete control of tumor, injury to the eye or surrounding tissue with decreased growth, and that (due to the abnormal retinoblastoma gene) children are very susceptible to develop other tumors, especially in the tissue which was given radiation.

The doctors at Children's Memorial Hospital are using a newer form of treatment, including laser hyperthermia, chemotherapy and cryotherapy to decrease retinoblastoma tumors. Some may be controlled indefinitely, reducing the number of eyes that need radiation or removal.

OBJECTIVES

1. To find out how well chemotherapy plus cryotherapy and laser hyperthermia work on retinoblastoma tumors.
2. To find out whether vision can be saved and tumors controlled without radiation or removal of the eye.


Eligibility Criteria:
Eligibility Criteria:

* Initial clinical diagnosis of Retinoblastoma, with Bilateral tumors, OR Unilateral tumor with hope for salvage of vision AND Multiple primary tumors, or positive family history for retinoblastoma, or age \< 12 months
* No prior antitumor therapy (except enucleation of one eye)
* At least one tumor exceeds 6 mm in diameter
* No evidence of dissemination outside the globe
* Signed IRB-approved informed consent
* Patient/family available for follow-up