cyrilzakka/clinical-trials huggingface dataset:
Dosimetry Using a CZT-camera Following LUTATHERA® Therapy

The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.

177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with \[177Lu\]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with \[177Lu\]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.

Eligibility Criteria:
Inclusion Criteria:

* Major adult subject
* ECOG ≤ 2
* Subject receiving treatment with Lutathera®
* Subject having given written, free and informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Contraindication to treatment with Lutathera®
* Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
* Pregnant woman, parturient or nursing mother.
* Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
* Subject unable to express consent.
* Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L.3213-1
Gastrointestinal Bleeding Management

Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists for the emergency management of patients with acute gastrointestinal bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms for the management of acute upper and lower gastrointestinal bleedings.

Acute upper gastrointestinal bleeding is a common medical emergency. Up to 15% of patients still die worldwide. The gastroduodenal ulcer disease is the most common cause of gastrointestinal bleeding. Even lower gastrointestinal bleeding occurs especially in patients of older age.

The goal of our data acquisition and evaluation is to learn whether existing diagnostic or therapeutic procedures are of relevance in the management of acute gastrointestinal bleedings. Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists on patients with acute gastrointestinal bleedings. The aim of our study is to develop optimal diagnostic and therapeutic algorithms of acute gastrointestinal bleeding. Therefore our prospective data registry should answer different questions:

When is the right time for a gastroscopy or colonoscopy? Should every patient with a suspected gastrointestinal bleeding receive endoscopy? Which clinical und laboratory findings influence the success of therapy? Does endoscopic procedures have an influence on the length of hospital stay?

Against this background we will record treatment findings separately. This includes clinical (e.g. age, sex, date of admission, department of admission, onset of symptoms), laboratory (e.g. blood count), history of medications (e.g. new anticoagulation's) and endoscopic findings (e.g. active bleeding). Furthermore the length of inhospital stay will be recorded.

Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* All patients with suspicion or symptoms of gastrointestinal bleeding.

Exclusion Criteria:

* Patients younger than 18 years
The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children

In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer of any kind.
* Patients receiving inpatient chemotherapy at SLCH on the general pediatric oncology service
* Patients admitted for a course of inpatient chemotherapy scheduled to last at least 24 hours and but no more than 7 days.
* Patients who have received any prior cancer treatment, including radiation therapy, and/or surgery.
* Patients ages 4 to 12 years of age.
* Patient with a guardian who has the ability to understand English and the willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Any patient who is not undergoing inpatient chemotherapy on the general pediatric oncology service, including patients undergoing chemotherapy as conditioning for hematopoietic stem cell transplantation or other cellular therapy.
* Any patient who is receiving their first cycle of inpatient chemotherapy (however, they can be included during a future cycle).
* Any patient who is blind or unable to communicate by speaking or pointing.
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
* Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer \[AJCC\]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
* Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
* Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
* Adequate hematological, hepatic, and renal function as defined in the protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
* Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
* Existing need of a hearing aid or greater than or equal to (\>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
* Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
* Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
* Other protocol defined exclusion criteria could apply
Predicting Symptom Trajectories After Thoracoscopic Lung Cancer Surgery Using an Interpretable Machine Learning Model

Patients suffer from a variety of symptoms after thoracoscopic surgery. However, there is a lack of validated predictive tools to identify potentially high-risk patients. This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery. Latent class mixed modeling (LCMM) will be used to dentify subgroups of patients with similar symptom trajectories. Machine learning models were developed to predict postoperative symptom trajectories based on collected information. Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.

Thoracoscopic lung cancer surgery is a widely utilized approach for treating early and locally advanced lung cancer. Despite the advantages of thoracoscopic surgery, such as minimal invasion and rapid recovery, patients still suffer from a variety of symptoms such as pain, shortness of breath, sleep disorders or fatigue after surgery, which seriously affects the quality of life. However, there is a lack of validated predictive tools to identify potentially high-risk patients. This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery. Patients are invited to fill out the MD Anderson Symptom Inventory-Lung Cancer module after thoracoscopic surgery. Symptoms of interest include pain, shortness of breath, sleep disturbance, and fatigue. Moderate to severe symptoms were defined as a score of ≥ 4. Latent class mixed modeling (LCMM), a clustering technique, can identify subgroups of patients with similar symptom trajectories based on longitudinal patient-reported outcome (PRO) data. Machine learning models were developed to predict postoperative symptom trajectories based on collected information including demographic and clinical information, and operative data. The machine learning models mainly include Random Forest, Support Vector Machines, Neural Networks, XGBoost, etc. The most appropriate model is selected, and model interpretation is performed using the SHAP method. Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old;
* Pathologically diagnosed lung cancer;
* Undergo thoracoscopic surgery, including video-assisted thoracoscopy and robotic-assisted thoracoscopic surgery;
* no prior history of malignancy or lung surgery;
* Have the ability to complete the scale.

Exclusion Criteria:

* Converted to thoracotomy during thoracoscopic surgery;
* Unable to complete the postoperative scale at least two times;
* Missing data values exceeding 30 percent.
Effect of WB-EMS on Parkinson's Disease

The aim is to establish adequate and suitable protocols for PD patients and to determine the WB-EMS effects on muscle strength, balance, walking, cognitive functions,neurotrophic factors and alpha-synuclein. Thirty-six PD patients, aged from 50 to 80 years, will be recruited and randomly assigned to two experimental groups (EGs and EGc) and one control group (CG), in order to perform dynamic movements with WB-EMS. EGs will undergo to 12-20 minutes of progressive supervised WB-EMS (4 sec. 85 HZ and 4 sec. rests) combined to light dynamic movements, two-time per week for 12/24 weeks. EGe will undergo to 12-20 minutes of progressive supervised WB-EMS 7 Hz) combined with cardiovascular training with rowing machine. CG will not perform any type of physical activity. Pre and post intervention assessment will be carried out on the following areas: physical assessment, neurocognitive, neurotrophic factors and alpha-synuclein assesments. A 3 months follow-up will be performed.


Eligibility Criteria:
Inclusion Criteria:

* age from 50 to 80 years old
* clinical diagnosis of parkinson's disease from 1 to 3 of Hoehn and Yahr Scale
* no partecipation to other physical activity program

Exclusion Criteria:

* MMSE values \< 24
* inability to walk 6 minutes without assistance
* use of medications and other things that may affect cognitive and motor functions
* presence of contraindications in the use of WB-EMS
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery

Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow the surgeon to perform heart operations. However, these processes can cause injury to the heart which may worsen post-operative outcomes. In fact, the effects of these injuries may continue after surgery, and lead to a long-term decrease in heart function. Neonates and young infants are at particular risk for this occurrence.

While much research has been done in adults looking for medicines that might protect the heart during surgery, few studies have been conducted in neonates and young infants. The investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric cancer patients, in the hope that it may lessen cardiac injury during and after congenital heart surgery, and thereby improve outcomes in the neonatal and young infant population.

In order to accomplish this, the investigators must first determine how Dexrazoxane can be safely administered to young children with congenital heart disease.

Neonates and infants undergoing heart surgery with cardiopulmonary bypass and cardioplegic arrest experience both inflammation and myocardial ischemia-reperfusion \[IR\] injury. These processes provoke myocardial apoptosis and oxygen free radical formation which result in cardiac injury and dysfunction. Dexrazoxane \[DRZ\] is a derivative of EDTA that is approved for prevention of anthracycline-related cardiotoxicity. It provides cardioprotection through reduction of toxic reactive oxygen species \[ROS\], and suppression of apoptosis.

The investigators propose a 12-patient pilot to determine DRZ pharmacokinetics, and to collect additional safety data in the neonatal and infant population. Efficacy of cardioprotection will not be evaluated in this preliminary investigation, though the investigators will determine postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, laboratory indices of myocardial injury and systemic inflammation, and echocardiographic cardiac dysfunction for safety purposes, and as a run-in to the larger, randomized, placebo controlled trial. Conducting this pilot could optimize team execution of the study protocol. In addition, results could further establish the safety of DRZ in the neonatal and infant populations.

Eligibility Criteria:
Inclusion Criteria:

* age ≤ 1 year
* open heart surgery requiring CPB and use of cardioplegia
* parent/guardian consent for study obtained
* surgery planned Monday-Friday

Exclusion Criteria:

* gestational age \<36 weeks at time of enrollment
* known syndrome or genetic abnormality, except Trisomy 21
* single ventricle physiology
* concurrent enrollment in another research protocol
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.


Eligibility Criteria:
Inclusion Criteria:

* Woman ≥ 18 years
* Signed and written informed consent.
* Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib - IVa, T1b or higher, any N, M0.
* Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply;

  * T1b or larger tumour with (irresectable) groin metastases
  * T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter
* World Health Organization performance status of 0-2
* Adequate haematological function defined by platelet count \>100x10E9/L, absolute leukocyte \>3X10E9/L or neutrophil count (ANC) \>1.5x10E9/L, and hemoglobin \>6.0 mmol/L
* Adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit of normal (ULN) range and ASAT and ALAT levels ≤2.5x ULN for all subjects
* Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
* Beta HCG level of 14 mIU/mL or below for women of childbearing potential
* Highly effective contraception for patients if the risk of conception exists

Exclusion Criteria:

* Patients with highly suspicious or positive metastases to the pelvic lymph nodes

  \* Patients eligible for radical local excision without involvement of other organs
* Any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
* Existing neuropathy which will hinder the intake of chemotherapy
Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders

The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.

We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.

Eligibility Criteria:
Inclusion Criteria:

* Patient's physician has ordered a preventive screening test
* Patient has not completed this test in 3 months
* Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.

Exclusion Criteria:

* Patient has been given a more recent order for the same screening test.
* Patient has significant life stress as noted in the Electronic Health Record (EHR)
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan

A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan.

The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Non-traumatic in-hospital or out-of-hospital cardiac arrest
2. Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
3. Patient is at least 20 years of age and less than 80 years of age with consent is given
4. In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
5. Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
6. Written consent can be obtained from a legally acceptable representative

Exclusion Criteria:

1. Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
2. Accidental hypothermia with core body temperature less than 35.0°C
3. Pregnant or of child bearing potential
4. Patient has given or indicated a Do Not Resuscitate (DNR) order
5. Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
6. An inferior vena cava filter is in place
7. Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
8. Intracranial hemorrhage as confirmed by CT scanning
9. Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
10. Heparin hypersensitivity
11. Serious systemic infectious diseases (sepsis, etc.)
12. Platelet count less than 30,000/mm3
13. Serious hepatic dysfunction
14. Serious renal impairment
15. Using percutaneous cardiopulmonary support (PCPS)
16. Using continuous hemodiafiltration (CHDF)
17. Therapeutic hypothermia has been otherwise implemented between ROSC and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander)
18. The patient's core body temperature cannot be monitored
19. Currently participating in another clinical trial or has participated in another clinical trial within the past six months
20. in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient
Investigation of the Effect of Massage Application on Functional Status and Depression in Postpartum Mothers

Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their babies feel more negatively. Symptoms usually start to appear from the 2nd or 3rd week after birth. At the same time, most people focus on the physical characteristics of the mother after birth, such as her reproductive system, while ignoring her full functionality. Full functionality is a multidimensional concept that includes personal care, baby care, family care, social and professional activities. In the first weeks after discharge, the functional status of the mother may differ as a result of the roles she assumes at home. Since the breastfeeding period will begin in new mothers, different treatment methods are preferred instead of drug treatment, one of which is massage therapy. It is thought that massage therapy relaxes the muscles and changes psychological factors. Previous studies conducted on postpartum women show that massage has a positive and healing effect on mothers. While previous studies frequently mention its effects on depression, it has also been observed that there are few studies mentioning its functional status. In light of this information, the aim of this study is to investigate the effects of massage on functional status and depression in postpartum women. For this purpose, there will be 2 groups randomized as intervention and control groups. The intervention will be performed as a 45-minute massage once a week for 4 weeks. Data will be collected before the first intervention and after the last intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being within the first 6 months postpartum

Exclusion Criteria:

* Having a health condition that prevents lying face down (having stitches from a cesarean section, hypertension, etc.)
* Not being cooperative
* All conditions that contraindicate massage