cyrilzakka/clinical-trials huggingface dataset:
Fludeoxyglucose F 18-PET Imaging for Early Detection of Residual Disease in Patients Undergoing Radiofrequency Ablation of Liver Metastases From Colorectal Cancer

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET imaging, may be effective in detecting residual disease after radiofrequency ablation of liver metastases in patients with colorectal cancer.

PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works for early detection of residual disease in patients undergoing radiofrequency ablation of liver metastases from colorectal cancer.

OBJECTIVES:

Primary

* Determine the sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in detecting residual disease within 48 hours after radiofrequency ablation (RFA) of liver metastases in patients with colorectal cancer.

Secondary

* Determine the findings on day 7 after RFA using FDG-PET imaging in these patients.

OUTLINE: This is a prospective study.

Patients undergo fludeoxyglucose F 18 (FDG)-PET imaging at baseline. They then undergo percutaneous laparoscopic or intraoperative radiofrequency ablation (RFA). Patients then undergo further FDG-PET scans within 48 hours and 7 days after RFA. FDG-PET images are evaluated for residual disease, including focal FDG uptake at the site of ablation. Beginning 1 month after RFA, patients undergo contrast-enhanced MRI for routine post-ablation follow-up. MRI scans are performed at 1, 4, 7, 12, 18, and 24 months after completion of RFA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colorectal cancer

  * Disease metastatic to the liver
* Undergoing percutaneous, intraoperative or laparoscopic radiofrequency ablation for liver metastases at the University of North Carolina Gastrointestinal Oncology Clinic

PATIENT CHARACTERISTICS:

* Not pregnant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No chemotherapy within 7 days after RFA on study
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* genuine stress incontinence

  * asymptomatic cystocele

Exclusion Criteria:

* mixed incontinence
Restoration of Life Role Participation Through Cognitive and Motor Training for TBI

The purpose of this study is to restore life role participation for those with TBI by customizing, applying, and testing integrated cognitive and motor training protocols that were successful in populations with impairments similar to TBI. The treatment protocols are based on principles of brain plasticity and re-learning, required to restore cognitive and motor function. The intervention targets an array of impairments that are obstacles to life role participation. These include cognitive attention and executive control; motor control for upper limb function; balance and gait; and cognitive executive control of simultaneous cognitive and motor tasks required by everyday tasks. The intervention utilizes training specificity, framing the intervention within functional task and life role activity component practice.

The investigators will use an assessment and treatment decision schema that has been successful in restoration of life role participation for stroke survivors and a comparable schema used for cognitive training for TBI patients. The subject assessment and decision schema will be used to identify for each subject, the optimal array of impairment interventions. The proposed treatment will optimize outcome by customizing the intervention and use of technologies, while ensuring the application of the array of impairment interventions required to produce restoration of function and life role participation. The investigators will target an array of impairments preventing participation in life role activities, which will include dyscoordination and weakness of upper limb, impaired balance, gait deficits, and impaired attention and executive function. In treatment, the investigators will use a dual-task paradigm combining motor and cognitive training, with treatment extending to the every day environment. Treatment will be up to 5 times/wk, 5hrs/day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Medically Stable
* Age \> 18 years
* Ability to walk at least with the minimum assistance of one person or an assistive device
* At least 6 months post injury
* Ability to follow 2 stage commands

Exclusion Criteria:

* pacemaker
* Acute medical conditions
* potential subjects will undergo a screening evaluation to determine eligibility for study entry
Characterizing and Comparing the Profile of Microorganisms From Specific Body Sites and Environmental Surfaces in Newly Disinfected Patient Rooms

Overall Aim: To describe and to assess the change in the temporal profile and transmission of microorganisms between patients and environmental surfaces after admission into a newly disinfected room.

Study Activities: Investigators will prospectively and concurrently perform microbiological sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g. bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is already performed in many units of the hospital as standard of care. Infection and readmission related data from enrolled patients will be collected for upto 1 year after enrollment.

Data analysis: Standard surveillance for hospital-acquired infections will be performed by the infection control group of the hospital. The identity and the nature of micro-organisms colonizing the high touch surfaces of rooms and of patient's body sites will be determined and compared. Risks involved is no more than minimal risk.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients who provide informed consent.

Exclusion Criteria:

* Pediatric patients under 18 years of age,
* Patients who cannot or do not provide consent
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe

This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe

This study is a combination of Prospective and Retrospective models.

Eligibility Criteria:
Inclusion Criteria:

* The subject is an adult (aged 18 years or older) of any race or gender and has been referred for a VIZAMYL™ PET brain scan as part of the assessment of his/her cognitive impairment.
* The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial.
* If informed consent is required by the local IEC, the subject, or his/her legally authorised representative, is willing and able to sign consent for use of their de-identified VIZAMYL™ PET images and associated anatomic images (brain CT and/or MRI) used in the interpretation of the VIZAMYL™ images as well as de-identified demographic information.

Exclusion Criteria:

* If informed consent is required by the local IEC, the subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.
The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation

This is a two arm randomized, paired prospective study comparing the percentage of time spent above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the setting of pacing versus non-pacing. This study is designed to compare the percentage of time spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion locations.

Patients will be randomized and proceed to one of two study arms:

1. Pacing during first half of lesions: During each of the 15 pre-specified lesions, pacing will be initiated at a 500ms cycle length from a catheter in the coronary sinus or right ventricle prior to the start of the lesion. Pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Weckebach behavior continues, the pacing catheter will be moved to the right ventricle, which and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.
2. Pacing during second half of lesions: During each of the 15 pre-specified lesions, pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Wenckebach behavior persists, the pacing catheter will be moved to the right ventricle and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AF scheduled for AF ablation with planned pulmonary vein isolation
* Presenting in normal sinus rhythm (NSR) prior to lesion delivery

Exclusion Criteria:

* Previous radiofrequency ablation
* Previous thoracotomy-type AF ablation (MAZE or similar technique)
* In AF prior to lesion delivery
* Evidence of left atrial scarring on voltage map
* Resting heart rate \> 90 bpm
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.

* Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid. The first subject in each dose cohort will receive BPX-603 alone (without rimiducid) in order to assess safety of the CAR-T monotherapy.
* Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-603 persistence and response to temsirolimus as applicable), and clinical activity at the recommended dose for expansion (RDE) identified in Phase 1 in various HER2+ solid tumors.
* During Phase 1 or 2, temsirolimus (single IV dose at 25 mg) may be administered following BPX-603 infusion in response to treatment-emergent toxicity in order to activate the iRC9 safety switch.

Eligibility Criteria:
Inclusion Criteria:

* Documented evidence of HER2 amplification/overexpression by local testing.
* Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
* Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
* Measurable disease (at least one target lesion) per RECIST v1.1.
* Life expectancy \> 12 weeks.
* ECOG 0-1.
* Adequate organ function.

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system metastases.
* Prior CAR T cell or other genetically-modified T cell therapy.
* Impaired cardiac function or clinically significant cardiac disease.
* Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
* Severe intercurrent infection.
* Pregnant or breastfeeding.
* Known HIV positivity.
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.

For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a BMI ≥18.5 and ≤30 kg/m2
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
* The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.

Exclusion Criteria:

* The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.

Other in- and exclusion criteria may apply
Cardiovascular Disease Population Risk Tool

The purpose of this study is to develop, evaluate, and apply a predictive algorithm for assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool (CVDPoRT).

This observational study will use the Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77,251 respondents) to assess risk factors - focusing on health behaviours (physical activity, diet, smoking, and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619,886 person-years of follow-up until 31 December 2011). Socio-demographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Risk prediction models will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid risk prediction models to limit the risk of over-fitting and improve the quality of predictions. Key considerations are fully pre-specifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures that increase the risk of type I error. The 2007 and 2009 surveys (approximately 50,000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.

Eligibility Criteria:
Inclusion Criteria:

* Respondents to the Canadian Community Health Surveys

Exclusion Criteria:

* Not eligible for Ontario's universal health insurance program
* Pregnant
* Prior history of heart disease or stroke
* Younger than age 20
Parental Education and Children's Screen Time

The study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years.

A total of 129 parent-child dyads were randomly allocated to two groups: experimental group (receiving parental education, n=63), and control group (daily activities, n=66). Data were collected before and after intervention. Instruments included screen time, Children's Sleep Habits Questionnaire, and Pediatric Symptom Checklist-17. A linear mixed model analysis was used to examine the efficacy of education intervention.

Eligibility Criteria:
Inclusion Criteria:

* children aged 4\~6 years with screen time of ≥ 2 h/day.

Exclusion Criteria:

* cerebral palsy,
* mental retardation
* psychosis
* Down's syndrome
* chronic disease
* hearing impairment.
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD and standard of care TTE to screen for right to left shunt (RLS) or patent foramen ovale (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.

The objectives of the study is to evaluate the shunt detection rate of the NeuralBot Investigational System (NB-IS) TCD relative to standard of care diagnostic techniques (transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and standard transcranial Doppler ultrasound (TCD) and to assess the safety, accuracy and usability of the NB-IS device.

Eligibility Criteria:
Inclusion Criteria TTE Main Study:

1. Subject 18 years of age and older.
2. Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or transient ischemic attack (TIA) in the differential diagnosis.
3. Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
4. Subject is able to successfully perform a Valsalva Maneuver (VM).
5. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria TTE Main Study:

1. Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure.
2. Female who is pregnant or lactating at time of admission
3. Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months.
4. Subjects who have a physical limitation preventing TCD headset placement

Inclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):

1. Subject 18 years of age and older.
2. Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or TIA in the differential diagnosis.
3. Scheduled for a transesophageal echocardiograph (TEE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
4. Subject is able to successfully perform a Valsalva Maneuver (VM).
5. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):

1. Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure.
2. Female who is pregnant or lactating at time of admission
3. Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months.
4. Subjects who have a physical limitation preventing TCD headset placement.
Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography

This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have been given a drug called regadenoson to widen and expand the blood vessels bringing blood to the heart muscle. The SPECT pictures of the heart are taken about an hour after the regadenoson is put into an arm vein through an IV. In this study, additional echo pictures will be taken and compared to the SPECT pictures.

The aim of the study is to see if the echo pictures work as well as SPECT to measure the blood flow to the heart muscle.

This is a single center, prospective, non-randomized, comparative, same-setting study of Lexiscan MPI SPECT versus state-of-the-art echocardiography. Lexiscan SPECT MPI will be performed per routine clinical protocol with Lexiscan administered as per package insert (0.4 mg in 5 ml IV push over 10 seconds followed by a 5 ml saline flush). Simultaneous echo/Doppler will be obtained immediately before (baseline), during and immediately post (peak vasodilation) using conventional techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to a University of Arizona/Sarver Heart Center/University Medical Center stress imaging laboratory and scheduled to receive a regadenoson SPECT nuclear scan.

Exclusion Criteria:

* Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.
The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO)

The objective of this study was to examine the impact of the intrapartum care model that adheres to the guidelines set forth by the World Health Organization (WHO) on several key outcomes, including the mother's maternal behavior towards her infant postpartum, breastfeeding self-efficacy, the success of breastfeeding, and the mother's readiness for hospital discharge.

The study was a randomized controlled trial. The study was conducted with 128 primiparous pregnant women (intervention group n=64, control group n=64) admitted to the maternity unit of a training and research hospital in a province in the Central Anatolia region of Turkey. Pregnant women in the intervention group were provided with intrapartum care in accordance with the WHO recommendations following the achievement of cervical dilatation reaching 5 cm. The control group was provided with only standard intrapartum and postpartum care. Data were collected using a personal information form, a postpartum parenting behavior scale, a breastfeeding self-efficacy scale, a breastfeeding charting system and documentation tool (LATCH), and a hospital discharge readiness scale.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older,
* History of term pregnancy (38-42 weeks),
* Having a primiparous,
* Single, healthy, vertex positioned fetus,
* Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
* Birth canal dystocia, dystocia related to the mother's psychology),
* Having a partner/husband,
* History of cervical dilatation of 5 cm or more,
* Having a healthy newborn,
* Being able to speak and understand Turkish.

Exclusion Criteria:

* Being under 18 years of age,
* Having a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
* Having a chronic disease (hypertension, diabetes, etc.),
* Having maternal or fetal complications (oligohydramnios and polyhydramnios, placenta previa, pre-eclampsia, premature rupture of membranes, anomalies of presentation, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, cord prolapse, etc.),
* Having any complication that prevents vaginal delivery (head-pelvis incompatibility, etc.),
* Having a history of elective cesarean section,
* Being pregnant with assisted reproductive techniques,
* Being multiparous,and having mastitis in the breast or having inverted nipples.
* The study also excluded women who had undergone a cesarean section due to any complication (e.g., cord entanglement, fetal distress),
* Who experienced complications related to the postpartum period (e.g., uterine atony, hemorrhage),
* And whose infant was admitted to the neonatal intensive care unit for any reason (e.g., respiratory distress).