cyrilzakka/clinical-trials huggingface dataset:
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers

The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with caregivers of older adults with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study will enroll 20 dyads of caregivers and older patients with advanced cancer and 20 dyads of caregivers and patients with advanced cancer and Mild Cognitive Impairment (MCI).


Eligibility Criteria:
Patient Inclusion Criteria:

* Age ≥ 65
* Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score \>14.5 will define ability to independently provide informed consent.
* Eligible patients have Stage III or IV cancer of any type
* Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of \<26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
* Able to read and understand English

Patient Exclusion Criteria:

* Patients scoring \<14.5 on the UBACC
* Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

* One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
* Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
* Age 50 or older
* Ability to provide consent
* Proficient in English

Caregiver Exclusion Criteria

* Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene

Individuals with low copy numbers of salivary amylase gene have lower salivary amylase levels and might therefore have decreased capacity to metabolize starch into glucose. We will in a randomized crossover meal study examine the postprandial response of high-starch meals in individuals with either low or high copy number of the salivary amylase gene.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the Malmö Offspring Study
* Genotyped for AMY1 copy number variation and selected for having either low (2-4) or high (10 or above) copy number of AMY1
* Gender: both males and females
* Completed information on dietary habits

Exclusion Criteria:

* Allergic to wheat, gluten intolerant or on a low-carbohydrate diet
* Inability to eat up to 4 slices of white bread in 15 minutes
* Use of medication known to influence glucose metabolism, appetite or saliva flow
* Diagnosed diabetes or high fasting plasma glucose (above 6.1 mmol/L)
* Smoking
Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images

The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:

Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?

Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?

Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?

Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary breast cancer
2. Positive sentinel lymph node biopsy and axillary lymph node dissection.
3. No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
4. MRI within 3 weeks prior to surgery.

Exclusion Criteria:

1. recurrent breast cancer or history of surgery or radiation therapy in the axilla
2. Inflammatory breast cancer
3. Bilateral breast cancer or metastatic breast cancer
4. previous or current history of other malignant tumors
5. Sentinel lymph node count \> 5
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer

chlorpromazine displays a series of remarkable bio-molecular effects in cancer cells, as inhibition of cell growth, nuclear aberrations, inhibition of the phosphoinositide 3-kinase/mammilian target of rapamycin (PI3K/mTOR) axis, induction of cytotoxic autophagy, inhibition of glutamate and DRD2 receptors. This study will evaluate the addition of chlorpromazine to the first-line therapeutic protocol in colon cancer stage III.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥18 years old.
* Patients with histologically confirmed surgically resected stage III colon cancer
* No rectal cancer
* Stage III disease (any pT, N1-2, M0)
* Patients should have a good performance status according to Eastern Cooperative Oncology Group (ECOG) score (ECOG 0-2).
* Patients with normal organic function as defined for the following criteria:

  * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL);
  * Total serum bilirubin ≤ 2.0 x ULN-LL;
  * Absolute neutrophil count ≥ 1,500 / mm3;
  * Platelet count ≥ 100,000 / mm3;
  * Hemoglobin ≥ 8.0 g / dl;
  * Serum creatinine ≤ 1.5 x ULN-LL
* Patients should undergone curative-intent complete surgical resection
* Patients have at least one month from any major surgery to start of intervention
* Written informed consent before enrollment

Exclusion Criteria:

* Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)
* Patients with metastatic disease
* Patients who scheduled to receive any form of further adjuvant cancer therapy (A malignancy currently under active therapy
* Pregnant or breast-feeding patients
* Patients with known hypersensitivity or intolerance to CPZ
* Patients with serious illness or psychiatric condition.
* Patients have current participation in other protocols with experimental drugs.
* Patients with no ability to ingest food orally.
* Patients who have familial adenomatous polyposis, hereditary non-polyposis rectal cancer, or inflammatory bowel disease
* Patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances

Interventional crossover study on healthy volunteers aimed at evaluating the effect of the composition and timing of ingestion of different types of water on the urinary excretion of lithogenic substances; the study will also analyze the effect of potassium citrate on urine pH and lithogenic substances


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years

Exclusion Criteria:

* Chronic malabsorption
* Recurrent urinary tract infections
* History of kidney stones
Modified Antegrade Stenting in Laparoscopic Pediatric Pyeloplasty; an Optimized Approach

Background and Rationale For decades, the use of transanastomotic stents following dismembered pyeloplasty has been controversial. However classically, many surgeons used to insert an indwelling DJ stent to secure the ureteropelvic anastomosis. During the laparoscopic pyeloplasty, the DJ can be inserted using different approaches. Neither of these approaches has absolute benefits , nor is free from drawbacks.

Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.

Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.

Methods: Between March 2013 and August 2021, 75 patients less than 15 years of age candidate for laparoscopic pyeloplasty were included in the study. All cases were done by the same surgeon in our institute. At first, a retrograde study was done, and an open-tip ureteric catheter was inserted just below the pelviureteric junction. Putting the ureteric catheter just below the pelviureteric junction makes the whole procedure easier. After proper dissection, the anterior wall of the pelvis is incised and continuing the ureteric spatulation on its lateral aspect. Before the complete division of the ureter, the first stitch is taken between the angle of ureteric spatulation and the lower angle of the pelvis. After completing the posterior wall anastomosis, a guide wire is introduced through the ureteric catheter, grasped gently, and pulled out through the uppermost port, and the ureteric catheter is then removed. With the proximal end of the guide wire passing through the upper port and its distal end coming outside the urethra, the DJ is passed in an antegrade manner while pulling on the urethral catheter balloon to close the bladder neck.

Eligibility Criteria:
Inclusion Criteria:

* all pediatric patients (less than 15 years old) candidates for laparoscopic dimembered pyeloplasty.

Exclusion Criteria:

* • patiens who have any contraindications for pneumoperitoneum.

  * Children more than 15 y old
  * Children undergoing stentless pyeloplasty
  * Patients undergoing pyeloplasty other than dismembered type.
Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.

The purpose of this study is to evaluate the safety and effectiveness of the Bausch \& Lomb Technolas 217z laser with the investigational Zyoptix Aspheric Algorithm when used for LASIK treatment of myopia and myopic astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were of legal age (at least 18) and had full legal capacity to volunteer.
* Subjects must be willing to have both eyes treated with the laser.
* Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction.
* Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions.

(Manifest subjective refractions adjusted for optical infinity were used.)

* High contrast, manifest best spectacle-corrected distance logMAR visual acuity correctable to at least 0.3 in both eyes, and must not differ between eyes by more than 1 line (5 letters).
* Contact lens wearers must have 2 Orbscan measurements and 2 manifest subjective refractions taken preoperatively at least 1 week apart.
* Contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 2 weeks prior to the preoperative evaluation.

Exclusion

* Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR
* Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study.
* Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension.
* Subjects who demonstrated evidence of retinal vascular disease.
* Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation.
* Subjects who were at risk for angle closure or who had a potentially occludable angle, as evidenced by a shallow anterior chamber on slit lamp exam, confirmed by gonioscopy as deemed necessary by the study Investigator.
* Subjects who had undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes.
* Subjects who were taking systemic medications likely to affect wound healing such as corticosteroids or anti-metabolites or any other medications that may increase the risk to the subject or confound the outcomes of this study.
* Subjects for whom the combination of their preoperative corneal thickness and the planned operative parameters for the LASIK procedure could have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
Surgical vs. Lifestyle in Obese Older Adults

The study aims are

1. to demonstrate the feasibility of recruiting and enrolling 10 subjects aged 55-75 planning to undergo sleeve gastrectomy and enrolling 10-20 (1-2 per surgical patient) matched subjects to the described intensive lifestyle intervention.
2. to collect preliminary data on the comparative effectiveness of the two interventions on physical function, weight loss, body composition, bone density and QOL.

The investigators propose a 1-year pilot feasibility study to examine the comparative effectiveness of sleeve gastrectomy compared to an intensive lifestyle intervention of a high protein low carbohydrate, hypocaloric weight loss diet combined with exercise training among older adults aged 60-75. For pragmatic and ethical reasons, the investigators are employing a nonrandomized design. The investigators will recruit 10 older patients undergoing sleeve gastrectomy and match, recruit, and enroll 1-2 subjects to the lifestyle intervention for each surgical subject. The investigators will assess physical function, weight loss, body composition, bone density, QOL and adverse events/health utilization at baseline and 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged 55-75 at the time of recruitment,
* speak English,
* meet medical eligibility criteria for WLS (i.e. BMI of \>40 or \>35 with a major obesity comorbidity),
* and be willing and able to participate in study procedures including the physical activity intervention and complete follow-up.

Exclusion Criteria:

The investigators will exclude participants for whom

* intentional weight loss might be inappropriate (e.g. patients with serious life-limiting illness)
* or who might be psychologically unstable (e.g. moderate to severe depression on the PHQ-9)
* or who have contraindications to a high protein diet or the physical activity intervention (e.g. recent MI/CVA in last 6 months, uncontrolled congestive heart failure, serum creatinine \> 2.0 mg/dl/on dialysis, h/o celiac disease/crohn's disease/ulcerative colitis.)
* or patients whose weight exceeds 450 lbs (weight limit of DXA).
* The investigators will withdraw bariatric subjects who do not undergo weight loss surgery and his or her matched lifestyle subject. The investigators will withdraw subjects in the lifestyle group who do not attend at least attend two of the first three nutrition and physical therapy visits. The investigators will recruit additional subjects to replace lifestyle subjects who are withdrawn from the study for this reason.
An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
* Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
* American Society of Anesthesiologists (ASA) score \< 3;
* No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed);
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 18 years of age

Exclusion Criteria:

* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
* Pregnancy;
* Physical or psychological condition which would impair study participation; or
* The subject is judged unsuitable for study participation by the Investigator for any other reason.
Exercise and Noninvasive Ventilation in Heart Failure Patients

Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF) subjects, hampering performance in activities of daily living. In this context, noninvasive ventilation (NIV) has been used to minimize such impairment, increasing functional capacity Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A randomized crossover clinical trial with allocation concealment consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes, 18-60 years
* body mass index (BMI) \<30 kg/m2
* functional class II-III according to the New York Heart Association
* of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45% - echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)\> 55mm
* Diameter Systolic left Ventricular (LVSD)\> 45mm )
* optimized from the point of view of drug and (6) clinical stability

Exclusion Criteria:

* (1) unstable angina, myocardial infarction or heart surgery three months before the beginning of the research

  (2) chronic orthopedic, infectious or metabolic diseases

  (3) FEV1/FVC \<70% predicted characterizing obstructive respiratory disorder; (4) active smokers

  (5) Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) \<60 bpm, recent trauma, nausea and vomiting face
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity

The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.

The present study will compare the nutritional response to the realisation of an acute exercise right before or right after lunch in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized right before lunch; iii) one session with an acute exercise realized right after lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

The objective of this study is to investigate the role of transvaginal ultrasound in detecting endometrial hyperplasia and endometrial cancer in women aged more than 35 presenting with abnormal uterine bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged over than 35
* Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
* Accept transvaginal examination (pelvic examination and ultrasound)
* Informed consent

Exclusion Criteria:

* Severe uterine bleeding resulting in unstable vital signs
* Pregnancy
* Current medications: anticoagulants, selective serotonin reuptake inhibitor (SSRI), antipsychotics, corticosteroids, hormones, herbs
* Intrauterine device
* Genital tract pathologies: infection, submucous myoma distorting uterine cavity
* Systemic diseases that may cause coagulopathies: Thyroid disease, liver disease, pituitary/ hypothalamus diseases
* Not able to retrieve endometrial tissue
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)

This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
* Subjects must be between 18-65 years of age, of either sex and any race
* Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
* Subjects must be mometasone furoate naïve.

Exclusion Criteria:

* Significant comorbid medical condition.
* Respiratory tract infection.
* Any contraindications according to mometasone furoate product monograph.
* Patients who have received antihistamine treatment within the last 5 days.
* Patients who have received corticosteroid treatment within the last 30 days.
* Patients who are likely to require the administration of systemic steroids during the course of this program.
* Any condition which in the doctor's opinion could interfere with the patient completion of this program.
* Pregnant or lactating patients.
* Patients with local infections involving the nasal mucosa.
* Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
* Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
* Patients who are prone to nose bleeding.
Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Directly following cardiac surgery for congenital heart disease; patients are not receiving routine turning every two hours to prevent pressure ulcers, because a negative influence on hemodynamic parameters is assumed. Investigators have suggested that lateral position may have clinically significant effects on oxygenation in cardiac surgery patients.

Sixty pediatric congenital heart disease patients were randomly assigned to two equal intervention groups

Eligibility Criteria:
Inclusion Criteria:

* Age within 10 years with a cyanotic congenital heart disease
* Hemodynamic stability with no compromising arrhythmia
* No respiratory arrest
* Not connected with mechanical ventilation

Exclusion Criteria:

* Cyanotic congenital heart disease
* Hemodynamic instability