louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06747533: Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
Official title: Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breathing, Mouth
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over the age of 18 with invasive breast cancer requiring radiation to the left whole breast or treatment of either the right or left breast/chestwall with comprehensive nodal irradiation will be eligible for study. These are the participants with the highest risk of cardiac exposure. Forty participants total are expected to be enrolled on the study, with an estimate of 3-4 participants enrolled per week. We anticipate the study will be able to accrue 40 participants within 3 months based on average treatment numbers in the MDACC Mays clinic.

Brief summary: To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.

Detailed description: Primary Objectives The primary objective is to compare the average daily shift for participant treatment for participant who have had coaching with https://www.thebreathingclass.com/cancer-center/participant versus participant who had standard clinic teaching.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Left sided breast cancer planned for whole breast radiation or any breast cancer requiring treatment of the regional nodes
* Treatment planned at the MDACC Mays Breast Radiation Oncology clinic

Exclusion Criteria:

* Underlying lung issues that may limit ability to achieve ideal breath hold (COPD on oxygen, etc)
* Active pregnancy

Primary outcomes:
measure: Safety and Adverse Events
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT01750333: Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity
Official title: Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OBESITY
Endothelial Dysfunction
Insulin Resistance
Lead sponsor: Montagnani, Monica, M.D., Ph.D.
Sponsor class: INDIV
First posted: 2012-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC

Brief summary: The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity


Eligibility criteria: Inclusion Criteria:

* Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.

Exclusion Criteria:

* presence of renal, liver and/or cardiovascular diseases;
* hypertension;
* metabolic and/or endocrine disorders;
* genetic syndromes;
* histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study

Primary outcomes:
measure: Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari Medical School - Dept Biomedical Sciences and Human Oncology
Study officials:
affiliation: University of Bari Medical School
name: Monica Montagnani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02319733: Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold
Official title: Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulnerable Plaque
Lead sponsor: Canisius-Wilhelmina Hospital
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients between the age of 18 and 80 years
* Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
* Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
* FFR negative lesion at coronary angiogram
* Vessel diameter ≥2.5 mm on visual estimate
* GFR ≥ 45mL/min/1.73m².

Exclusion Criteria:

* High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
* Lesions located in a coronary vessels previously stented.
* Lesions located at a bifurcation
* lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
* the presence of thrombus or another clinically significant stenosis in the target vessel.
* Left main (\>50%) or known three vessel disease.
* Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction \<30%
* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
* Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
* History of stent thrombosis
* Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
* Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)

Primary outcomes:
measure: change in plaque cumulative score of signs of vulnerability on CT
timeFrame: 24 months
measure: nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisuis Wilhelmina Hospital
state: Gelderland
Study officials:
References:
Clinical trial NCT00164333: The Treatment Advocacy Program
Official title: The Treatment Advocacy Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in improving sexual safety and treatment adherence among gay and bisexual men infected with HIV. It is hypothesized that those who are in the intervention group will report reductions in unprotected sex with HIV-negative and unknown-status partners; and will show stricter adherence to their treatment regimens, compared to the individuals in the standard-of-care, control group.


Eligibility criteria: Inclusion Criteria:

* HIV+ men who have sex with other men, age 18 or over, in HIV care at one of the collaborating clinics, any sexual contact within the previous six months.

Exclusion Criteria:

* self-reported low likelihood of remaining in treatment or in the study location for 12 months, inability to comprehend the consent quiz administered during the Consent and Enrollment Visit, or unwilling to provide required locator information

Primary outcomes:
measure: Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative or unknown-status partners.
Secondary outcomes:
measure: Self-reported incidences of missed doses of treatment regimen.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Medical Center
state: Illinois
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Dogan Eroglu, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000333: Evaluation of Benztropine for Cocaine Craving - 2
Official title: Evaluation of Efficacy of Benztropine for Cocaine Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Washington D.C. Veterans Affairs Medical Center
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Stimulated and non-stimulated craving
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA
state: District of Columbia
Study officials:
affiliation: Washington D.C. Veterans Affairs Medical Center
name: Steven Deutsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02861833: Identifying Coping Strategies of Patients With Cancerous Wound After a Specific Nursing Accompaniment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancerous Wounds
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: major patients followed in a cancer ward and holders of a cancerous wound.

Brief summary: This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. How to live then? The literature review shows that there is research on adaptation strategies in cancer pathology and that different factors seem to interact with these strategies. However the investigators have not found written on the theme cancerous wound and adaptation strategies.

the investigators conducted a pilot study of this research in medical oncology, Prof. service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers contacted but also areas for improvement. Indeed, the investigators now were doing a study of adaptation strategies implemented by the patient time T of his life. However, adaptation is a process in constant motion, the investigators want to identify two different time patients coping strategies following a specific charge nurse taking.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient having at least a cancerous wound.
* Patient having read the information leaflet and has given its consent.
* Patient able to meet a French language questionnaire.

Exclusion Criteria:

* History or active psychiatric illness.
* Unable to give informed consent.
* Inability to comply with the protocol procedures for geographical, social or psychological.

Primary outcomes:
measure: Descriptive analysis of the main demographic, clinical, and psychological
timeFrame: one month
Secondary outcomes:
measure: main clinical features
timeFrame: one month
measure: main psychological characteristics
timeFrame: one month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille Hôpital de Timone
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT01836133: An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
Official title: Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1

Brief summary: This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate hematologic, renal and liver function
* Participant initiating treatment with Tarceva according to the Summary of Product Characteristics

Exclusion Criteria:

* Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
* Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
* Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Percentage of Participants With Overall Response
timeFrame: Approximately 3 years
measure: Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia; Institute For Pulmology
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia; Medical Oncology
city: Belgrade
country: Serbia
facility: Military Medical Academy; Clinic for Pulmonology
city: Knez Selo
country: Serbia
facility: Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
city: Sremska Kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05047133: Effect of Early Administration of TXA in Adult Hip Fractures
Official title: Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Postoperative Blood Loss
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.


Eligibility criteria: Inclusion Criteria:

* 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria:

1. Polytrauma patients
2. Previous operation on the ipsilateral hip
3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
4. Patients with \< 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
5. History of seizure disorder
6. Patients on birth control
7. Pregnant Women
8. Prisoners
9. Active thromboembolic disease (DVT/PE, MI, Stroke)

Primary outcomes:
measure: Postoperative Blood Transfusion
timeFrame: Up to two weeks
measure: Overall Blood Loss
timeFrame: Up to two weeks
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Up to two weeks
measure: Postoperative Pain
timeFrame: Up to two weeks
measure: Wound complications
timeFrame: Up to two weeks
measure: Acute DVT/PE
timeFrame: Up to two weeks
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Ascension Genesys Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT01277133: An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Metastatic Breast Cancer (CRONOS 2)
Official title: The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With Metastatic Breast Cancer Treated With First Line Regimens Based On AvaStin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with metastatic HER2 negative breast cancer. First-line treatment with Avastin

Brief summary: This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic breast cancer. Patients will be followed for up to 12 months after progressive disease occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Previously untreated metastatic breast cancer
* Scheduled to start 1st line chemotherapeutic treatment
* ECOG performance status 0-1

Exclusion Criteria:

* Any conditions included in contraindication list for Avastin
* Prior chemotherapy for metastatic breast cancer
* Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic malignancy completed \<6 months prior to treatment start

Primary outcomes:
measure: Correlation between the time from start of chemotherapy to the start of Avastin treatment with progression-free survival
timeFrame: 60 months
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Safety: Incidence of adverse events
timeFrame: 60 months
Other outcomes:
Locations:
city: Cluj Napoca
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02413333: Clear Care® Plus vs. PeroxiClear™
Official title: Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Contact lens solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.

Detailed description: Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Eligibility criteria: Inclusion Criteria:

* Sign informed consent form;
* Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
* Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
* Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Current hydrogen peroxide-based solution user;
* Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Residual Peroxide at Day 30
timeFrame: Day 30, each product
Secondary outcomes:
measure: Mean Osmolality in Lens Cases at Day 30
timeFrame: Day 30, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Vision Care, Global Medical Affairs
role: STUDY_DIRECTOR
References: