cyrilzakka/clinical-trials huggingface dataset:
Quality of Life in Lymphoma Patients One Year Post-chemotherapy

Malignant lymphomas are considered as among the most chemo-sensitive cancers. ML are cured in more than 85% of patient, the majority with complete response. After this active phase of treatment, patients are in "after cancer period". Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient. Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life. The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.

Quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy. Care cancer pathway will be also evaluated. Self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.

Eligibility Criteria:
Inclusion Criteria:

* Patients being in complete response after a first therapy for lymphoma
* Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation
* Patients informed of the study and not opposed to the research

Exclusion Criteria:

* Patients under legal guardian .
* Patients unavailable to formulate non-opposition to the study
Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients

This clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. Ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.

PRIMARY OBJECTIVES:

I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.

SECONDARY OBJECTIVES:

I. To measure the severity of patients' memory of distress from cancer treatment.

II. To assess the relationship between anxiety to actual distress and to remembered distress.

III. To assess the relationship between optimism-pessimism personality to actual distress and to remembered distress.

IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered distress.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or without chemotherapy.

GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring a bell in the clinic.

After completion of study, patients are followed up for 7 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Definitive radiation treatment with or without concurrent chemotherapy with curative intent; treatment prior to radiation therapy is acceptable (e.g. surgery, chemotherapy)
* Ability to understand and the willingness to sign a written informed consent; consents will be provided in English or Spanish
* Able to speak English or Spanish (questionnaires will be in English and Spanish)

Exclusion Criteria:

* Patients with either a malignant central nervous system (CNS)-primary cancer or with brain metastases; patients do not need to undergo brain imaging unless indicated per standard workup and management (e.g. advanced stage lung cancer receiving definitive therapy)
* Patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment
* Patients with widespread metastatic disease (\> 3 distant metastases); patients with oligometastatic disease (=\< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (RT) with or without chemotherapy
Longitudinal Surveillance Registry

Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).

The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads).

The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include:

I. To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system
* Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician)
* Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator
* Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR

Exclusion Criteria:

* Patient who cannot be followed on the LATITUDE Patient Management system
* Patient who is unable or unwilling to comply with the protocol requirements
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency. Specifically, the investigators will assess the consistency of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and outflow (inferior vena cava differential flow). According to the mass conservation physical property, blood inflow must equals blood outflow. The relative gap between the measured values will characterize the consistency of the acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Participants have fasted for 6 hours before examination
* Adult participants

Exclusion Criteria:

* Anyone with a classic contraindication to MRI
* Recanalized umbilical vein
* Severe obesity
* Gadolinium chelate allergy
Relevance and Efficiency of SecOnd Line Workup for Uveitis

The first-line etiological workup is currently poorly codified, and some patients undergo sequential investigations. However, the reason which lead the clinician to perform subsequent exams, and the relevance of such exams, remain to be determined. The main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.

The first-line etiological workup is currently poorly codified, with some patients undergoing extensive investigations, and other minimal etiological workup. In addition, some patients undergo sequential investigations. However, the reason which lead the clinician to perform subsequent exams, and the relevance of investigations performed after a first line workup remain to be determined. The main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.Secondary objectives were to describe the reasons of these second-line workups, and to determine which exams were the most relevant, and the determinants of its realization.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* at least one etiological workup in our center

Exclusion Criteria:

* only episode of acute anterior uveitis quickly responding to topical treatments
* diagnostic ophthalmologically obvious
* opposition to collection of data
Comparative Tests of Flu Vaccination Phone Messages

This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Patient of client organizations of Emmi Solutions
* Provided a phone number to their care team

Exclusion Criteria:

-
Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers

A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer, age 19\~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who judged ineligible by the investigator.
The Effects of Patient Features on Opioid Induced End-Tidal CO2

Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.

Emergency department patients receiving opioid pain medicine such as morphine, fentanyl, or Dilaudid are eligible. After receiving the pain medication, a small soft plastic tube will be placed between the upper lip and nose. This tube is used to measure the amount of carbon dioxide the patient is breathing out. It can also be used to deliver oxygen if the provider feels the patient needs it. The carbon dioxide breathed out is measured and collected. Other information collected are height, weight, and vital signs. Patient participation time is approximately 2 hours during the emergency department visit.

Eligibility Criteria:
Inclusion Criteria:

* non intubated patients receiving intravenous opioid medications

Exclusion Criteria:

* mechanically ventilated patients
* patients with physiologic shock
A Phase Ia Safety and Tolerability Study of BL-001

To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.

This is a Phase 1a randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose study to evaluate the safety and tolerability of BL-001.

Eligibility Criteria:
Key Inclusion criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: men/women, 18-55 years old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the protocol defined and reliable methods of contraception

Key Exclusion criteria

1. Electrocardiogram 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Bowel movements: on average ≥3 stools per day or \<3 stools per week
4. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
5. Allergy: ascertained or presumptive hypersensitivity to the formulation's ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
6. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study
7. Gastrointestinal: evidence of acute or chronic gastrointestinal disorders
8. Medications and probiotics: probiotics, nutraceuticals, and medications, including over the counter medications and herbal remedies for 2 weeks and antibiotics for 3 months before the start of the study. Hormonal contraceptives for women will be allowed
HFNC Versus SOT During EBUS

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam. During the EBUS procedure, oxygen supplementation can either be provided using low flow or high flow through a nasal cannula.

The investigators hypothesize that the use of high flow nasal cannula (HFNC) for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors plan to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. The procedure is performed either under conscious sedation or using general anaesthesia. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam.During the EBUS procedure, oxygen supplementation is provided to prevent desaturation events. However, despite oxygen supplementation previous studies have reported fall in pulse oximetric saturation (SpO2) below 90%.

The high-flow nasal cannula (HFNC) is a novel device for providing oxygen supplementation. It delivers a flow of 10-70 litres/min of humidified, warmed 100% oxygen through a nasal cannula. The device has been used extensively in intensive care setting in adults with hypoxemic respiratory failure. In a study conducted on patients undergoing EBUS-TBNA, the use of HFNC led to a significant reduction in the number of subjects experiencing clinically significant hypoxemia (SpO2 ≤90%) compared to conventional oxygen supplementation. However, the study conclusions were limited by a small sample size. Another study demonstrated lesser episodes of hypoxemia with HFNC compared to the conventional oxygen supplementation. This study also had a small sample size (n=40). The investigators that the use of HFNC for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors intend to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

Eligibility Criteria:
Inclusion Criteria:

1. All adult (aged between 18 and 80 years) subjects undergoing the EBUS-TBNA procedure and pulse oximetric SPO2 ≥95% at room air will be eligible for this study

Exclusion Criteria:

1. oxygen supplementation required to achieve SPO2 \>95%;
2. subjects who have altered mentation;
3. pregnancy
4. failure to provide informed consent
The Effect of Diet on Learning Abilities for Children in Kindergarden

The main aim of this intervention study is to test the effect of diet on improvement in cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group.

Positive effects of n-3 long chain polyunsaturated fatty acids (PUFAs), as provided by fatty fish intake, on cognitive functions are widely accepted, but so far there is no clear evidence from randomized intervention studies in children and young adults, although fish intake has been positively associated with cognitive functions in observational studies. The main aim of this study is to test the effect of diet on improvement in cognitive performance in kindergarden children aged 4-6 years. In the intervention study, children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group. The children (n=200) will consume the prepared meals three times a week. Cognitive performance of the children will be tested at study start and end using the the Wechsler Preschool and Primary Scale of Intelligence (WPPSI_III) and nine hole peg test. Children will be screened for mental health problems in the Strengths and Difficulties Questionnaire (SDQ), which is a global measure of children's mental health. Compliance will be monitored by documentation of study fish intake and measuring fatty acid status. For a more detailed investigation of effects of increased herring and mackerel intake, before and after intervention blood and urine will be collected for lipidomic analysis (metabolites), vitamin D and iodine determination and genotyping (fatty acid metabolism and inflammation).

Eligibility Criteria:
Inclusion Criteria:

* Being 4-6 years old.
* Sufficient command of the Norwegian language of child to participate in cognitive testing and of child and parents to comply with study requirements according to investigators estimation.

Exclusion Criteria:

* Known food allergies
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad.
* Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml).
* Conventional imaging within 1 month
* Signed written consent
* Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study)

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Renal function: serum creatinine \> 3.0 mg/dl
* Known allergy against exendin-4
* Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
A Regional Partnership to Improve Outcomes Through Fatherhood Engagement

Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.

Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.


Eligibility Criteria:
Inclusion Criteria:

* (i) is a custodial or non-custodial father,
* (ii) who has at least one child under the age of 18,
* (iii) someone in the family is identified as at-risk for substance use

Exclusion Criteria:

* The placement of all children in the family in foster care