cyrilzakka/clinical-trials huggingface dataset:
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer

RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.

PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.

OBJECTIVES:

I. Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.

II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.

III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.

IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.

V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.

OUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.

GROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.

GROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.

After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.

Eligibility Criteria:
Inclusion Criteria:

* The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
* Patients having been accrued to project 1 or project 2
Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients

This prospective observational study aims to evaluate predictive factors for spinal anesthesia-induced hypotension (SASH) in hypertensive patients undergoing elective surgery. Parameters such as internal jugular vein collapsibility index, carotid intima-media thickness, and flow-mediated dilation will be assessed using ultrasonography to determine their association with SASH. Demographic, anthropometric, and hemodynamic data will also be analyzed. The findings may improve perioperative management strategies for hypertensive patients receiving spinal anesthesia.

This study aims to investigate the relationship between carotid intima-media thickness (CIMT) and spinal anesthesia-induced hypotension (SASH) in hypertensive patients. SASH is a common side effect of spinal anesthesia, with an incidence ranging from 15% to 33%, and is associated with significant clinical consequences such as increased morbidity and mortality. CIMT is a well-established marker of atherosclerotic burden and cardiovascular risk. This study hypothesizes that CIMT may be an independent predictor of SASH in hypertensive patients. Participants will undergo preoperative CIMT measurements and standardized spinal anesthesia procedures, with hemodynamic variables and potential risk factors recorded for analysis.

Eligibility Criteria:
Inclusion Criteria:

Adult hypertensive patients classified as ASA II-III risk group. Patients scheduled for elective surgeries requiring spinal anesthesia.

Exclusion Criteria:

Presence of severe renal or hepatic failure, or severe respiratory or cardiovascular diseases.

Contraindication to spinal anesthesia. Failure of spinal anesthesia. History of carotid surgery or presence of carotid plaques. Presence of anxiety.
Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment

To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice. With a significant number of women undergoing this procedure annually, studying its impact on future reproductive capacity has become increasingly important.

The prevalence of cesarean deliveries is rising and constitutes about one-third of all births in both the USA and Italy. As the use of cesarean delivery increases, so do the associated complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean section scar dehiscence and rupture.

Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele) and are characterized by thinning of the myometrium or a uterine scar dehiscence, often appearing as a triangular shape within the endometrial cavity.

The exact prevalence of symptomatic Cesarean scar defects varies due to factors like population differences and lack of standardized criteria. Clinical presentations of Cesarean scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia, and pelvic pain.

Women with a history of Cesarean section are considered high-risk during pregnancy and require specialized assessments to ensure scar integrity. Saline-infused sonography (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal ultrasound (TVS) is more accessible and commonly used.

Experts generally agree that a niche should be defined by an indentation at the CS scar site with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or complex with multiple branches. Additional measurements, such as the distances between the niche and the vesicovaginal fold, are useful for surgical planning.

Given the increasing frequency of cesarean deliveries, healthcare providers will encounter related complications more frequently. Cesarean scar defects are common yet often go undiagnosed. Encouraging vaginal birth after cesarean (VBAC) can help reduce cesarean rates and raise questions about future obstetric practices, especially in developing countries.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 45 years
* Previous 1-3 cesarean sections
* The duration from the last cesarean section ranging from 6 months to 5 years.

Exclusion Criteria:

* Pregnancy (Positive pregnancy test)
* Recent pelvic infection.
* Active pelvic infection.
* Recent surgery on the tubes or the uterus.
* Active vaginal bleeding.
* Menstruation.
* Suspected malignancy.
* Intrauterine device in situ.
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
* Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
* Meet criteria for stage I or II hypertension
* Currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

* Secondary hypertension
* Are taking three or more antihypertensive agents
* Have uncontrolled or poorly controlled diabetes mellitus type I or type II
* Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
* Participation in any investigational study within 30 days of Screening (Visit 1).
* Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
Text Message Reminders for Influenza Vaccine in Pregnancy

Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Woman
* Ages 18 and over
* Working cellular telephone with the ability to receive text messages
* Ability to speak or understand English

Exclusion Criteria:

* Age less than 18
* Inability to speak or understand English
* Not possessing a working cellular telephone with text messaging capability
* Presence of any contraindications to vaccination (such as egg allergy or prior adverse reaction to the vaccine)
* Women who have already received the vaccine during this influenza season
Effect of KT Taping on Waist-to-hip Ratio, Abdominal Strength and Body Image Concerns in Postpartum Females.

This study is aimed at determining the effect of kinesio taping on waist to hip ratio, abdominal muscle strength and body image concerns in postpartum females.

Post Caesarian section there is abdominal weakness and an increase in fat ratio. There is a significant decrease in strength of abdominal muscles and an increase in fat ratio after the C section. Common increase in abdominal circumference in postpartum females and its long term outcomes like women health orders change in body shape and dissatisfaction is arising very commonly in society. Body Image Concern Inventory scale is used to assess dysmorphic concern of body. This study will work on the effects of Kinesiotaping which will be easily applicable and increase muscle activation along with abdominal exercises to regain lost muscle strength and tightening of loose skin. This tapping technique has a therapeutic effect on muscles and easily available in the rehabilitation department. Nowadays it is becoming very common, easily available, and regarded by physiotherapists as a method to support, rehabilitate and stimulate some physiological processes. This study aims at determining rehabilitative treatment to reduce waist circumference in post partum females.

Eligibility Criteria:
Inclusion Criteria:

* Prima parous females, eight weeks post-partum.
* Females with both vaginal delivery and C section.

Exclusion Criteria:

* Females who received previous abdominal or spinal surgeries.
* Females having infection in sutures.
* Females having abdominal hernia, skin sensitivity
* Females having moderate to severe Diastasis Recti (IRD more than 3 finger width).
* Neurological impairment affecting muscle performance.
Goalsetting in Patients With Chronic Pain: a European Survey

The aim of this survey is to get insight in the individual goals of chronic pain patients according to the ICF framework.


Eligibility Criteria:
Inclusion Criteria:

* patients who are suffering from chronic pain

Exclusion Criteria:

* healthy participants or patients with acute pain
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.


Eligibility Criteria:
Inclusion Criteria:

* DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
* Diagnosis of DCIS by minimally invasive needle biopsy
* No prior history of DCIS or invasive breast cancer in the same breast
* No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
* Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
* Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
* No history of breast radiation in the same breast
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.

Primary Objectives:

• To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize \>30% of patients e-referred to SHARE-S will enroll.

Secondary Objectives:

* To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity).
* To describe service outcome variability to inform future studies. Investigators will assess service outcomes relevant to Commission on Cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. We will also assess safety and perceived patient-centeredness of care.
* To describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care).
* To evaluate the Implementation Program we will assess key milestones and processes for this pilot study of the Implementation Stage measured at the clinic level.
* To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded.
* To examine how study results vary by cancer type.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Documented or planned cancer survivorship visit
* Have a texting enabled telephone
* Cognitively able to complete study procedures as judged by the study team
* Able to understand, read and write English

Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.

Exclusion Criteria

- Declined participation in the study
Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults

This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Homogenized and pasteurized milk causes stomach problems (self-reported)
* unhomogenized and unpasteurized milk does not cause stomach problems (self-reported)
* age 18-65
* BMI 18,5 - 30
* hemoglobin under normal range
* fasting plasma alanine aminotransferase ALAT \< 60 U/l (normal liver function)
* fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* fasting plasma creatinine \< 118 umol/l (normal kidney function)

Exclusion Criteria:

* pace maker
* Crohn's disease or other disease of the intestinal tract
* intestinal operation within the last 3 months
* difficult dysphagia
* smoking
* constipation
Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States

This is a prospective, observational trial evaluating the "real world" use of Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical experience. The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject) of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. According and dependent on clinical practice, the investigators expect that subjects will be seen by the investigator for an average of 3 visits (two treatment cycles).

The primary objective of this trial is to collect, evaluate, and report observational data about the clinical use of Xeomin® in a "real world" setting to determine which muscles are injected, the dose used, and how doctors administer the injection.

The secondary objectives of this trial are: To collect and evaluate information about the efficacy of Xeomin®. To collect and evaluate information about the effect of Xeomin® on work productivity and quality of life. To monitor for any serious side effects and non-serious related side effects of Xeomin®

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older.
* The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study.
* Subjects who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon the physicians' clinical experience. There are no restrictive subject entry criteria.
* Subjects who are able to read, speak and understand English.

Exclusion Criteria:

* Subjects who are enrolled in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol are not eligible for this trial.
* Any subject for whom botulinum toxin treatment would be contraindicated; see Xeomin® Prescribing Information for further details.
Flemish Inguinal and Femoral Hernia Prospective Registry

Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.

The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.

The secondary objectives are:

* Surgical Site Occurrence (SSO) after 30 days
* Scope and incidence of pre- and postoperative pain (NRS 0 to 10)
* The difference between pre- and postoperative NRS scores (relative NRS score)
* Presence of pain and impact of pain on daily life activities
* Satisfaction and quality of life
* Sexual function
* Anxiety and depression
* Catastrophizing
* Recurrence
* Development of a predictive model for chronic pain.

Eligibility Criteria:
Inclusion criteria

* Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018.
* Male and female
* 18 years or older
* Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of a hospital, but by specific surgeons)
* Elective and emergency surgery
* Primary and recurrent hernia
* Metachronous and synchronous hernia
* Signed informed consent form

Exclusion criteria

* Younger than 18 years
* Not operated or supervised by participating surgeon
* Pregnant at inclusion in the registry
* No signed informed consent form
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM

The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2DM
* Male and female subjects ages 10-17
* Body weight ≥50 kg
* Glycosylated hemoglobin (HbA1c) 6.5 to 10%

Exclusion Criteria:

* Fasting plasma glucose (FPG) \> 240 mg/dL at screening
* Abnormal renal function
* Active liver disease and/or significant abnormal liver function