louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06530524: Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
Official title: Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Head Neck Cancer
Xerostomia Following Radiotherapy
Keywords: Head and Neck Cancer
Radiation induce xerostoma
botulinum toxin
salivary glands
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Lady Davis Institute
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2024-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).

Exclusion Criteria:

* Previous radiation to the head and neck
* Previous treatment for head and neck cancer
* Personal history of xerostomia
* Hypersensitivity to onabotulinumtoxinA
* Previous major salivary gland surgery
* Previous exposure to radioactive iodine therapy

Primary outcomes:
measure: Xerostomia-related quality of life
timeFrame: Pretreatment, 6 and 12 months from treatment completion
Secondary outcomes:
measure: Unstimulated salivary function using salivary gland scintigraphy
timeFrame: Pretreatment and 12 months from treatment completion
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
References:
Clinical trial NCT02761824: Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
Official title: Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Quality of Life
Occupation
Lead sponsor: University of the Sciences in Philadelphia
Sponsor class: OTHER
Collaborators: name: Temple University
name: M.D. Anderson Cancer Center
name: Dolfinger-McMahon Foundation
name: Genesis Health System
First posted: 2016-05-04
Enrollment: 71
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life surveys).

Detailed description: This research study focused on developing and implementing eight one-week activity camps in the summer of 2012, 2013, and 2014 for women diagnosed with cancer. Each camp was held in a different geographical location: rural (Renovo, PA), suburban (Gilda's Club in Warminster, PA), MD Anderson of Camden, and urban (University of the Sciences with the Cancer Support Community of Philadelphia). The focus of this programming was to allow women to engage in activities they may not be engaged in since the diagnosis of cancer and to provide them with opportunities to socially interact and communicate with individuals who may have encountered the same difficulties as them. Quality of life information was collected before, during and after implementation of the activity program. The main objective was to demonstrate improved life satisfaction (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life surveys). 77 women were recruited over a three year period. 6 dropped out and 71 completed the entire study.

Eligibility criteria: Inclusion Criteria:

* women diagnosed with cancer
* age of 21 or older
* a clearance from their MD to participate in the activity program.

Exclusion Criteria: Not Applicable (NA)

* none

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure Scores at Day 5 and Week 6
timeFrame: Day 1, Day 5 and week 6
measure: Change in World Health Organization-Quality of Life Brief (WHO-QoL BREF )scores at Week 6
timeFrame: Day 1 and week 6
measure: Change in Short Form 36 (SF 36) at Week 6
timeFrame: Day 1 and week 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sciences
name: Colleen M Maher, OTD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maher C, Mendonca RJ. Impact of an Activity-Based Program on Health, Quality of Life, and Occupational Performance of Women Diagnosed With Cancer. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205040p1-7202205040p8. doi: 10.5014/ajot.2018.023663.
Clinical trial NCT01860924: Vigorous Exercise for Depressed Smokers
Official title: Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Depression
Keywords: exercise
depression
smoking
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this project the investigators will develop and pilot test a supervised, vigorous intensity exercise intervention for depressed female smokers. If the pilot intervention is successful the investigators will have a blueprint for a large randomized controlled trial. The long term objective is to develop interventions for depressed women that will ultimately reduce their risk of tobacco-caused disease and mortality.

Detailed description: This project will be the first to evaluate supervised vigorous exercise for depressed smokers

Eligibility criteria: INclusion Criteria:

1. depressed (CES-D) score 16 or above
2. 18 years of age
3. female gender
4. sedentary
5. current cigarette smoker

Exclusion Criteria:

1. smoking cessation medication
2. Not able to exercise medically

Primary outcomes:
measure: smoking abstinence
timeFrame: 6 months
Secondary outcomes:
measure: depressive symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christi Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Clinical trial NCT01222416: PET/CT Evaluation of Treatment Response in Breast Cancer
Official title: Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.


Eligibility criteria: Inclusion Criteria

* Subjects must have histologically proven breast cancer
* Subjects are being considered for preoperative chemotherapy
* Subjects must be ≥ 18 years old. Sensor Sub-Study Only
* Palpable subcutaneous or known disease with one surface \<1cm below surface of skin.
* A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.

Exclusion Criteria

* Children will be excluded from this study.
* Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
* Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
* Intraluminal lesions will be excluded from the sensor sub-study.
* Non biopsy proven malignancy will be excluded from this study.
* Palpable subcutaneous or known disease with one surface \>1cm below surface of skin will be excluded from the sensor sub-study.
* Draining or exposed malignant tumor will be excluded from the sensor sub-study.

Primary outcomes:
measure: The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
timeFrame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
Secondary outcomes:
measure: Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.
timeFrame: 48 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: A. Bapsi Chakravarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005716: Asthma Partnership for Minority Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the efficacy of a community-based intervention to improve asthma management for parents, children and health care providers.

Detailed description: DESIGN NARRATIVE:

Forty-two (42) elementary schools in urban Baltimore and Washington, DC, served as recruitment sites and approximately 300 students with moderate to severe asthma were enrolled. All participants enrolled in the A+ Asthma Program. Primary care practitioners of these students were randomized to a minimal contact program or to the A+ asthma physician partnership. They were offered a menu of educational offerings to improve their knowledge and skills. The primary outcome measure was emergency care use. Secondary measures included physician practices, hospitalization, health care utilization, restricted activities, medication use, school absences and coping skills.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Allen FC, Vargas PA, Kolodner K, Eggleston P, Butz A, Huss K, Malveaux F, Rand CS. Assessing pediatric clinical asthma practices and perceptions: a new instrument. J Asthma. 2000 Feb;37(1):31-42. doi: 10.3109/02770900009055426.
citation: Butz AM, Eggleston P, Huss K, Kolodner K, Rand C. Nebulizer use in inner-city children with asthma: morbidity, medication use, and asthma management practices. Arch Pediatr Adolesc Med. 2000 Oct;154(10):984-90. doi: 10.1001/archpedi.154.10.984.
citation: Bartlett SJ, Kolodner K, Butz AM, Eggleston P, Malveaux FJ, Rand CS. Maternal depressive symptoms and emergency department use among inner-city children with asthma. Arch Pediatr Adolesc Med. 2001 Mar;155(3):347-53. doi: 10.1001/archpedi.155.3.347.
Clinical trial NCT01871324: The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Behavioral Changes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the influence of an intervention program especially designed to young ultra orthodox men that were diagnosed with diabetes type one.


Eligibility criteria: Inclusion Criteria:

* Young Ultra-Orthodox men diagnosed with diabetes type one.

Exclusion Criteria:

* Psychiatric illness .

Primary outcomes:
measure: the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program.
timeFrame: three months
Secondary outcomes:
measure: the efficacy will be evaluated using behavioral changes related to diabetes questionnaire before and after the program.
timeFrame: three months
Other outcomes:
measure: the efficacy will be evaluated using HbA1c values, glucose levels before and after the program
timeFrame: three months
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT03990324: Cervical Range of Motion and Stretching
Official title: Immediate Changes in Cervical Range of Motion and Myofascial Sensitivity After Standardized Manual Stretches: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Shortening
Keywords: range of motion
muscle sensitivity
muscle stretching
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: University of Indianapolis
name: Nova Southeastern University
name: Long Island University
First posted: 2019-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. After a single session of the manual stretching procedure, participants immediately demonstrated increased cervical ROM and pressure pain thresholds.

Detailed description: Methods: Sixty participants with no history of neck pain or trauma were randomized into one of two groups: stretching group (n = 30), or control group (n = 30). The stretching group received a standardized manual stretching protocol. The control group did not received intervention. Pre and Post-test measurements were recorded for both groups. Within group differences and group by time interactions were evaluated for Cervical range of motion ROM and myofascial sensitivity. The immediate improvement in active ROM of the cervical spine may prompt clinicians to consider the sequencing of treatment. Stretching prior to active exercises may allow for active exercise through a larger ROM. Future research is needed to evaluate the immediate effects of stretching in the symptomatic population.

Eligibility criteria: Inclusion Criteria:

* ages of 18-60
* active cervical flexion, right lateral flexion OR left cervical lateral flexion \<45˚

Exclusion Criteria:

* minors
* prisoners
* individuals with cognitive impairments
* recent neck surgeries
* pre-existing neck injuries

Primary outcomes:
measure: Range of Motion
timeFrame: 1 minute post-intervention
Secondary outcomes:
measure: Pressure pain thresholds
timeFrame: 1 minute post-intervention
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: William J Hanney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653324: A Registry for the Food Allergy Community
Official title: The FARE Patient Registry: A Registry for the Food Allergy Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Food Hypersensitivity
Anaphylaxis
Eosinophilic Esophagitis
Food Sensitivity
Food Intolerance
Food Allergy in Infants
Keywords: food allergy
Lead sponsor: Food Allergy Research & Education
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 23000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes males and females of all ages with one or more food allergy or those who are at risk of food-induced anaphylaxis.

Brief summary: The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.


Eligibility criteria: Inclusion Criteria:

* Individuals with diagnosed food allergy

Exclusion Criteria:

* Individuals without food allergy

Primary outcomes:
measure: Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.
timeFrame: 2023
Secondary outcomes:
Other outcomes:
Locations:
city: McLean
country: United States
facility: Food Allergy Research & Education
state: Virginia
Study officials:
affiliation: Food Allergy Research & Education
name: Jennifer Bufford, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fierstein JL, Brown D, Gupta R, Bilaver L. Understanding Food-Related Allergic Reactions Through a US National Patient Registry. J Allergy Clin Immunol Pract. 2021 Jan;9(1):206-215.e1. doi: 10.1016/j.jaip.2020.08.011. Epub 2020 Aug 22.
citation: Oriel RC, Waqar O, Sharma HP, Casale TB, Wang J. Characteristics of Food Allergic Reactions in United States Restaurants. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1675-1682. doi: 10.1016/j.jaip.2020.12.018. Epub 2020 Dec 15.
citation: Gupta RS, Sehgal S, Brown DA, Das R, Fierstein JL, Casale TB, Nowak-Wegrzyn AH, Bilaver LA. Characterizing Biphasic Food-Related Allergic Reactions Through a US Food Allergy Patient Registry. J Allergy Clin Immunol Pract. 2021 Oct;9(10):3717-3727. doi: 10.1016/j.jaip.2021.05.009. Epub 2021 May 24.
Clinical trial NCT00547924: Transoesophageal Echocardiography in Liver Transplantation
Official title: Transoesophageal Echocardiography in Liver Transplantation: Left Ventricular Function During Reperfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Liver Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients on waiting list for liver transplantation

Brief summary: Severe hypotension during reperfusion in liver transplantation is a frequent adverse event. Rare data exist so far about pathophysiology of this phenomenon. The exact role of left ventricular function, which might be impaired causing hypotension, has not been elucidated during the period of reperfusion.

Goal of this study is to:

* perform transesophageal echocardiography in order to assess systolic and diastolic left ventricular function during reperfusion
* determine inflammatory mediators in the plasma which could cause left ventricular dysfunction


Eligibility criteria: Inclusion criteria:

* Patients on waiting list for liver transplantation.
* Age: 18-75 years.

Exclusion criteria:

* Strictures, tumours and diverticula of the oesophagus.
* History of oesophageal varices with recent bleeding.
* Oesophageal varices and prothrombin time less than 20% or platetlets les than 30000/ml.
* Instable cervical spine.
* Involvement in other studies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute for Anesthesiology
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Marco Zalunardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zalunardo MP, Schlapfer M, Beck-Schimmer B, Seifert B, Spahn DR, Bettex D. Impact of cytokine release on ventricular function after hepatic reperfusion: a prospective observational echocardiographic study with tissue Doppler imaging. BMC Anesthesiol. 2015 Jul 25;15:107. doi: 10.1186/s12871-015-0080-2.