louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02596672: Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.
Official title: Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Aging
Health Behaviour
Social Isolation
Keywords: physical activity
older adults
retirement homes
walking
feasibility study
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (\>6months) physical activity behaviour change in older adults living in independent living communities.

Detailed description: The proposed study is a cluster randomized controlled feasibility trial of a multi-level peer-led walking intervention. The socio-ecological model and social cognitive theory provides the framework that will help inform and test the feasibility of a multi-level peer-led walking intervention for inactive older adults living in independent living communities in Northern Ireland. The behaviour change techniques identified and extracted from a previous systematic review on the effectiveness of peer-led physical activity interventions helped guide the decision-making process of which behavior change strategies should be included in this study. The logic model helped inform the design and development of the 12 week peer-led walking programme.

Eligibility criteria: Inclusion Criteria:

1. Adults over the age of 60 years recruited from fold housing associations, dependent on site; those receiving nursing care will not be included.
2. Inactive/not regularly walking (less than 30 minutes
3. Have the ability to read, write, understand and speak English.
4. Can walk freely without human assistance (residents will be included they use a walking stick/walking aid.)

Exclusion Criteria:

1. If they have fallen in the last 6 months
2. Have regular nursing assistance/care within the fold
3. Residents with dementia or other cognitive challenges will be excluded.

Primary outcomes:
measure: Moderate-to-vigorous physical activity (MVPA)
timeFrame: Baseline, 12 weeks and 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline, 12 weeks and 6 months
measure: Self-efficacy
timeFrame: Baseline, 12 weeks and 6 months
measure: Physical and Mental Health
timeFrame: Baseline, 12 weeks and 6 months
measure: Social Engagement
timeFrame: Baseline, 12 weeks and 6 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Centre for Public Health, Queen's University Belfast
Study officials:
affiliation: Queen's University, Belfast
name: Mark A Tully, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02058472: Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
Official title: An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2014-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I


Eligibility criteria: Inclusion Criteria:

* healthy volunteers between the ages of 19 to 55 years old
* 19 ≤ BMI ≤ 27
* having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
* doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

* Hypersensitivity(or history of hypersensitivity) to amlodipine and olmesartan
* Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
* Excessive drinking(exceed alcohol 140g/week)
* Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
* Smoking over 10 cigarettes per day

Primary outcomes:
measure: AUClast, Cmax
timeFrame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
Secondary outcomes:
measure: tmax, t1/2, AUCinf, CL/F, Vz/F
timeFrame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
measure: ΔAUEC24, ΔEmax, tEmax
timeFrame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: JW Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044472: Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead
Official title: Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi-site Left Ventricular Pacing
Keywords: CRT-D
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard CRT-D indications

Brief summary: The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.

Detailed description: To evaluate the hemodynamic impact of different pacing MSLV configurations.

Eligibility criteria: Inclusion Criteria:

* Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
* Patients have signed an informed consent form indicating their willingness to participate to this study.

Exclusion Criteria:

* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
* Patients with second or third degree AV Block
* Patients with intrinsic atrial rhythm \< 40 bpm
* Patients with a previously implanted left ventricular pacing lead.
* Patients who are pregnant.
* Patients currently participating in a clinical investigation that includes an active treatment arm.
* Patients under 18 years of age.
* Patients with a life expectancy of less then 6 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum
city: Bad Nauheim
country: Germany
facility: Kerckhoff - Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermannklinik
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
city: Ludwigshafen
country: Germany
facility: Städt. Klinikum
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Dudley
country: United Kingdom
facility: Russells Hall
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St Thomas
Study officials:
References:
Clinical trial NCT06546072: Deep Learning With MRI-based Multimodal-data Fusion Enhanced Postoperative Risk Stratification of Breast Cancer
Official title: Deep Learning With MRI-based Multimodal-data Fusion Enhanced Postoperative Risk Stratification of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: deep learning
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 1199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study's initial phase, 1199 patients were randomly allocated at a ratio of 8:2 to training and testing datasets for automatic tumor segmentation. Subsequently, we randomly assigned 569 patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH; Guangzhou, China) at a ratio of 3:1 to training (n = 456) and internal-validation (n = 113) cohorts for DFS prediction. The remaining patients were divided into two independent external-validation cohorts: 432 from Sun Yat-sen University Cancer Center (SYSUCC; Guangzhou, China) into external testing cohort 1, and 198 from Dongguan Tungwah Hospital (DTH; Dongguan, China) and Shunde Hospital of Southern Medical University (SDHSMU; Guangzhou, China) into external testing cohort 2.

Brief summary: Breast cancer poses a significant global health challenge, especially among women, with high rates of recurrence and distant spread despite early interventions. The timely identification of metastasis risk and accurate prediction of treatment strategies are critical for improving prognosis. However, the complex heterogeneity of breast tumors presents challenges in precise prognosis prediction. Therefore, the development of innovative methods for tumor segmentation and prognosis assessment is essential.

The research conducted is a multicenter study that enrolled 1,199 non-metastatic breast cancer patients from four independent centers. Our study leverages the advancements in artificial intelligence (AI) to address this challenge. This study is the first successful application of MRI-based multimodal prediction system to precisely identify the risk of postoperative recurrence in breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage I-III invasive BC
* Age ≥ 18 years
* The patient having undergone surgery
* The existence of MRI scans

Exclusion Criteria:

* Lacked pathological results
* Had other, simultaneous malignancies
* Had MR imaging issues were excluded

Primary outcomes:
measure: DFS
timeFrame: The time from surgery to tumor recurrence, including local and/or distant recurrence, disease progression, or death, assessed up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01388972: Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City
Official title: Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Physical Activity
Keywords: Community nutritional environment
Physical activity
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 2924
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A community sample of Recoleta, Almagro and Constitucion neighborhoods of Buenos Aires, Argentina has been conveniently selected by major representation of different socioeconomic stratus. The value of the square meter of the property (2 rooms apartments) was used as indirect indicator of socioeconomic level.

Brief summary: Several environmental factors have contributed to the growing pandemic of obesity. It has been described that some characteristics of food and built environment have an influence on patterns of food consumption and physical activity of people in a certain place.

We have designed a cross-sectional study to describe some aspects of the food environment (community and consumer) and the frequency, distribution and characteristics of the space available to perform physical activity in three neighborhoods of Buenos Aires city.

Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic strata, will be selected by convenience to conduct this study.

The study will consist on three stages: first, the generation of the sampling frame of food stores, public and private spaces available for carrying out physical activity, and the development of a tool designed to evaluate the availability of healthy foods in supermarkets and grocery stores. Finally, a sample of those stores will be randomly selected for assessing the availability of selected foods.

In Argentina, the knowledge of the food environment is limited. We believe that the information obtained in this study will contribute to a better understanding of the subject.


Eligibility criteria: Inclusion Criteria:

* Stable Places and ambulant stands (only those that are located habitually in the same place) of food sale and / or drinks of any type.
* Public or private spaces destined for the accomplishment of physical activity.

Exclusion Criteria:

* Places and stands of food sale and / or drinks and spaces for the accomplishment of physical activity not opened the public in general (as those who are inside schools, places of work, centers of health, etc.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
Clinical trial NCT01517672: Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder
Official title: Neurobiology of Severe Psychological Trauma in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
domestic violence
intimate partner violence
functional MRI
neuroimaging
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2012-01-25
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help elucidate reasons for variable treatment response and identify novel treatment targets. Exposure-based therapies have been associated with decreased amygdala and increased cingulate cortex response during emotional processing. The current study examined whether cognitive therapy for PTSD in women reduces activation in insula and amygdala and enhances activation in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation predicts treatment response.


Eligibility criteria: Inclusion Criteria:

* Female.
* Intimate partner violence (IPV) trauma defined as physical and/or sexual abuse committed by a romantic partner, occurring within five years of, but having ended at least one month prior to, enrollment in the study.
* Seeking treatment for posttraumatic stress disorder (PTSD) symptoms and meeting full or partial Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for PTSD prior to treatment, verified through the Clinician-Administered PTSD Scale (CAPS).

Exclusion Criteria:

* Substance abuse in the past year
* History of \>2 years of alcohol abuse
* Use of psychotropic medications within 4 weeks prior to the study, bipolar disorder or schizophrenia, irremovable ferromagnetic bodily material, pregnancy, or claustrophobia.

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: After 10 sessions of cognitive behavioral therapy (CBT) (10-14 weeks)
Secondary outcomes:
measure: CAPS 3 months post-treatment
timeFrame: 3 months post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: University of California, San Diego
name: Murray B Stein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00779272: Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases
Official title: Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Liver Metastases
Keywords: neoadjuvant chemotherapy
clinically postoperative outcome
liver regeneration after liver resection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Records from 184 consecutive patients undergoing liver resection due to colorectal metastases between 2003 and July 2008 were reviewed from a prospective database

Brief summary: The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection.


Eligibility criteria: Inclusion Criteria:

* Liver resection due to colorectal liver metastases between 2003 and 2007

Exclusion Criteria:

* Incomplete assessment of preoperative chemotherapy

Primary outcomes:
measure: Postoperative Complications and liver regeneration
timeFrame: 2003- July 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Departement of Visceral and Transplantation Surgery of the University of Zurich
Study officials:
References:
Clinical trial NCT00281372: Sexual Dysfunction and Dental Care
Official title: Association Between Sexual Dysfunction in Adults and Behavioral Dysfunctions in Achieving Proper Dental Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspareunia
Hypoactive Sexual Desire Disorder
Erectile Dysfunction
Vaginismus
Keywords: sexual dysfunction
male
female
dental care
need of control
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-24
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women, over 18 years old, who come for sexual therapy/ counseling to the Sexual Medical Center, in Sheba Medical Center, Israel Partners or spouses of the above.

Brief summary: Evaluation of sexual functioning of patients at the Sexual Medical Center, at Sheba Medical Center in Israel. Sexual functioning shall be compared with their dental behavior.

Hypothesis: a positive association will be found.

Detailed description: Patients, male and female, age over 18, who apply to the Sexual Medical Center, at Sheba Medical Center will fill a battery of questionnaires regarding their sexual function and dental treatment.

Eligibility criteria: Inclusion Criteria:

* Men and women, over 18 years old, who come for sexual therapy/ counseling to the Sexual Medical Center, in Sheba Medical Center, Israel Partners or spouses of the above.

Exclusion Criteria:

* Patients who are already in the middle of treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Obstetricts and Gynecology, Sheba Medical Center, Israel
name: Eyal Shif, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293072: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Official title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
ANCA Associated Vasculitis
Keywords: Rituximab, ANCA, vasculitis, lupus,
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2006-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of SLE or ANCA associated vasculitis
2. Active disease refractory to 6 months conventional therapy with cyclophosphamide, prednisolone and at least one other immunosupressive agent ( or a lesser period if this therapy cannot be tolerated)
3. Age 18-70

Exclusion Criteria:

1. HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
2. Pregnancy, inadequate contraception or lactation
3. Malignancy
4. Current enrolment in pother clinicla trials -

Primary outcomes:
measure: 1. Clinical remission at 6 or 12 months
measure: 2. Absence of a severe life threatening adverse event
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Cambridge Institute for Medical Research, Addenbrooke's Hospital
name: Ken Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Lupus and Vasculitis Service, Addenbrooke's Hospital
name: David Jayne
role: PRINCIPAL_INVESTIGATOR
References: