cyrilzakka/clinical-trials huggingface dataset:
S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer

RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer.

OBJECTIVES:

* Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer.
* Determine the impact of sociodemographic, clinical, and psychosocial predictors of well-being in these patients.
* Determine the changes in well-being over time since disease recurrence in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), time since initial diagnosis (less than 2 years vs 2 years or more), and recurrence site (soft tissue without bone vs soft tissue with bone vs visceral). Patients are randomized to one of two study arms.

* Arm I (control arm): Patients receive the standard level of support by continuing to use existing resources. Patients receive written materials from the counseling group at 6 months.
* Arm II (intervention arm): Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions. Patients receive written materials from the counseling group after the first session.

In both arms, quality of life is assessed at baseline and at 3 and 6 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per study arm) will be accrued for this study within 30 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Received prior definitive surgical treatment for stage I-IIIa breast cancer with or without adjuvant chemotherapy, hormonal therapy, and/or radiotherapy
* No more than 56 days since diagnosis of first recurrence

  * Any distant metastatic site, chest wall recurrence, scar recurrence, or nodal recurrence
  * No ipsilateral breast tumor recurrence after lumpectomy or isolated contralateral new primary breast tumors
* Receiving or planning to receive first therapy for recurrence

  * No prior therapy for this recurrence except surgical treatment for in-breast relapse after lumpectomy or local palliative radiotherapy
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No psychiatric diagnosis that would preclude study
* Must be able to read and understand English

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels and Postoperative Patient Outcomes in Pediatric Cardiovascular Surgery

Low flow anesthesia; It is an anesthesia practice in which, after absorbing at least 50% of the exhaled air and carbon dioxide (CO2) using a semi-closed rebreathing system, the unused anesthetic gases are mixed with a certain amount of fresh gas and then completely or partially returned to the patient in the next inspiration. Theoretically, when low flow anesthesia is compared to high or normal flow anesthesia; it is known to have advantages such as using less inhalation agent, preserving mucociliary activity, preventing microatelectasis, preserving the amount of moisture, and reducing temperature loss.

In studies conducted in different fresh gas flows, it has been observed that CO, which is thought to accumulate in the body by rebreathing in a closed circuit, increases as a result of the chemical interaction and dry CO2 absorbent. However, there is no evidence in these studies that low-flow anesthesia increases CO accumulation and alters hemodynamics.

In our clinic, low-flow and high-flow anesthesia technics are both being used. In this study, we aimed to evaluate the effects of high- and low-flow sevoflurane anesthesia applied with a closed system on perioperative carboxyhemoglobin (COHb) levels and hemodynamic system in pediatric cardiovascular surgery cases.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 2 months and 7 years undergoing elective cardiac surgery
* American Society of Anesthesiology (ASA) score II ve III patients

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients who need mechanical ventilation or any respiratory support before the operation
* Patients with left to right shunt
* cyanotic patients
* Patients younger than 2 months and older than 7 years
Incidence of Complications of Brain Death

The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* confirmed brain death
* organ donor

Exclusion Criteria:

- age under 18 years
Detection of Spinal Cord Lesions Using the MP2RAGE Sequence in Inflammatory Diseases of the Neuraxis

Since the last revision of the MRI guidelines in multiple sclerosis (MS, MAGNIMS) and the McDonald criteria in 2017, all spinal cord lesions must be counted to increase the sensitivity and specificity of the diagnosis of MS. Focal lesions of the spinal cord are more frequently located in the cervical segments than in the lower segments of the spinal cord and occupy the lateral and posterior columns, although the central grey matter may not be spared. Cervical involvement is difficult to study because of the small size of the lesions and the loss of signal in the cervical region. As a result, the detection of cervical lesions on MRI is sub-optimal.

In this context, standardised acquisition protocols have been proposed.

For MRI of the spinal cord, at least two of the following sagittal sequences are recommended: T2, STIR, double inversion recovery, T1 with gadolinium injection, and/or T2 axial acquisitions.

Recently, our team validated the superiority of 3D PSIR and 3D FGAPSIR sequences, which offer better detection performance than T2 and STIR on 3 Tesla MRI.

Other studies have also shown the contribution of the MP2RAGE sequence to the detection of spinal cord lesions in MS, compared with the set of sequences classically recommended. The MP2RAGE sequence is a T1 sequence, which creates a composite image, limiting field inhomogeneity bias while providing a quantitative T1 map. It has recently been optimised for the spinal cord, and has been only minimally evaluated in the context of MS.

The aim of this study is to evaluate the effectiveness of the MP2RAGE sequence in comparison with the set of conventional sequences recommended for the detection of spinal cord lesions in MS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years
* scheduled to undergo 1.5T or 3T MRI of the spinal cord as part of an initial assessment or reassessment of inflammatory neuraxial disease.
* Express consent to participate in the study
* Member or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant women
* Absolute or relative contraindication to 1.5T or 3T MRI
The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial

Rationale:

In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in blood supply, will largely become necrotic. The only way to limit final infarct size, is timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can also damage myocardial tissue and contribute to the final infarct size ("reperfusion injury"). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size. Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop metformin before major surgery for the presumed risk of lactic acidosis, which is a rare complication of metformin. However, here is no evidence that this practice benefits the patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial injury in patients undergoing elective CABG surgery


Eligibility Criteria:
Inclusion Criteria:

* Acceptation for CABG with or without concomitant valve surgery
* Informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Diabetes mellitus
* Renal dysfunction (MDRD \< 60 ml/min)
* Elevated liver enzymes (ALAT \> 3 times upper limit of reference range)
* Treatment with dipyridamole or xanthine derivatives
* Recent myocardial infarction (\<2 weeks before inclusion)
* Off-pump surgery
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)

This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an Asian Indian male between 18 to 45 years of age
* Subject is in good health
* Subject is a nonsmoker or has not used nicotine-containing products for six months
* Subject is willing to avoid strenuous activity

Exclusion Criteria:

* Subject has a history of stroke, seizures, or major neurological disorders
* Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
* Subject has a history of high blood pressure requiring treatment
* Subject has history of cancer
* Subject has a history of diabetes
Epilepsy Birth Control Registry

Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.

Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest information about birth control for women with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Women with Epilepsy between 18 and 47

Exclusion Criteria:

* Women without epilepsy
* Women under 18
* Women over 47
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* angiographic evidence of coronary atherosclerosis

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid.
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
Clinical and Radiological Evaluation of Two Mastoid Filling Products

to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

Primary objective: To compare the radiological aspect in the petrous bone of two obliteration products in adults, one year after surgery (Bioactive Glass S53P4 and biological Hydroxy apatite) secondary objective : To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 and biological hydroxy apatite when used in the mastoid and epitympanic obliteration for chronic otitis surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up

Exclusion Criteria:

* patient less than 18 years old
Role of High Frequency RTMS in Management of Opioid Use Disorder

This study aims to evaluate the role of repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing pain, decreasing craving, alleviating withdrawal symptoms, lowering relapse rates, reducing impulsivity, and improving cognitive function in patients with Opioid Use Disorder, while also evaluating associated factors.

Addiction is a complex, chronic brain condition influenced by genes and the environment that is characterized by substance use or compulsive actions that continue despite harmful consequences. For a long time, addiction meant an uncontrollable habit of using alcohol or other drugs as opioid. More recently, the concept of addiction has expanded to include behaviors, as well as substances, and even ordinary and necessary activities, such as exercise and eating.

Speaking of opioid addiction, Opioid addiction is a long-lasting (chronic) disease that can cause major health, social, and economic problems. Opioids are a class of drugs that act in the nervous system to produce feelings of pleasure and pain relief. Some opioids are legally prescribed by healthcare providers to manage severe and chronic pain. Commonly prescribed opioids include oxycodone, fentanyl, buprenorphine, methadone, oxymorphone, hydrocodone, codeine, and morphine. Some other opioids, such as heroin, are illegal drugs of abuse.

Opioid addiction is characterized by a powerful, compulsive urge to use opioid drugs, even when they are no longer required medically. Opioids have a high potential for causing addiction in some people, even when the medications are prescribed appropriately and taken as directed. Many prescription opioids are misused or diverted to others. Individuals who become addicted may prioritize getting and using these drugs over other activities in their lives, often negatively impacting their professional and personal relationships. It is unknown why some people are more likely to become addicted than others.

Eligibility Criteria:
Inclusion criteria:

* Male
* Age 18- 40
* Opioid use disorder

Exclusion criteria:

* Individuals with mental disorders (such as primary psychosis, schizophrenia, mental retardation, and brain damage induced mental disorder),
* History of epilepsy
* History of cardiovascular complications.
* History of contraindications to TMS (e.g. metal implants in the head).
Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interferences of the ICD when BIA is done.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Implantation with a wireless-enabled ICD

Exclusion Criteria:

* Age \<18yrs
* Inability to sign an informed consent
* Pacemaker dependancy
TX2® Low Profile TAA Endovascular Graft

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.


Eligibility Criteria:
Inclusion Criteria:

* Descending thoracic aneurysm with diameter ≥ 5.0 cm
* Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
* Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Less than 18 years of age
* Life expectancy less than 2 years
* Pregnant or breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Less than 30 days beyond primary endpoint for other investigative drug or device study
Flash Open Trial With Therapists In Training

This study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. Participants will use the subjective units of distress scale (SUDS) to rate distress pre- and post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Therapist trained by Trauma Institute \& Child Trauma Institute in EMDR or PC
Managed Access Program for Momelotinib in Myelofibrosis

Compassionate use access to Momelotinib/GSK3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent can be obtained from the patient or legally authorised representative as per local regulations
* Diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia
* 18 years or older (at the time consent is obtained)
* The patient is willing to abide by the contraception requirements.
* No known hypersensitivity to momelotinib, its metabolites, or any of the formulation excipients

Exclusion Criteria:

* Pregnant or breastfeeding female
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"

"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"

Hemiplegic shoulder pain is a common symptom. Our aim in this study is to investigate the relationship between hemiplegic shoulder pain and balance and upper extremity functions.

Eligibility Criteria:
Inclusion Criteria:

* Having had a cerebrovascular accident
* Ages ranging from 40 to 75
* Right or left hemiplegic
* Without mental problems
* Cooperative
* According to Brunnstrom staging, upper extremity stage 1-2-3-4-5

Exclusion Criteria:

* who do not want to be evaluated
* Under the age of 40 and over the age of 75
* Non-cooperative
* Another orthopedic shoulder problem
* Newly operated patients will not be included in the study.
Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

The objective is to treat elderly AML and MDS patients with sapacitabine.

The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Eligibility Criteria:
Inclusion Criteria:

* A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
* Age 70 years or older for AML and 60 years or older for MDS
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
* Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
* Life expectancy reasonably adequate for evaluating the treatment effect
* Patient must be able to swallow capsules
* Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
* All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* AML is of the sub-type of acute promyelocytic leukemia
* Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
* Patients with known central nervous system (CNS) involvement by leukemia
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
* Known to be HIV-positive