louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05195515: The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life
Official title: The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life - What is the Cost of the Cure?
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bladder Cancer
Keywords: Quality of Life
Bladder Cancer
Late effects
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: National Research Center for Survivorship and Late Adverse Effects Following Pelvic Organ Cancer, Denmark
First posted: 2022-01-19
Enrollment: 2000
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 over 18 years of age, referred due to hematuria

Brief summary: Bladder Cancer prognosis, treatment, and subsequent morbidity and mortality vary between the different stages, thus resulting in a different impact on patients' lives. There are some well known late effects of the treatments for bladder cancer, but the knowledge of their impact on patients Quality of Life is sparse. This study aims to determine the prevalence of late effects impact on Quality of Life and potential risk factors for impairment.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible if they are referred to a hospital in the Central Region Denmark, due to hematuria between 01/01/2022 and 01/01/2023
* Ability to understand written and oral Danish

Exclusion Criteria:

* Known Alzheimers disease
* Diagnosed other causes explaining the hematuria

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: 5 years from baseline inclusion
Secondary outcomes:
measure: Prevalence of late effects
timeFrame: 5 years from baseline inclusion
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Urology, Aarhus University Hospital
city: Gødstrup
country: Denmark
facility: Department of Urology, Regional Hospital Gødstrup
city: Horsens
country: Denmark
facility: Department of Urology, Regional Hospital Horsens
city: Randers
country: Denmark
facility: Department of Urology, Regional Hospital Randers
city: Viborg
country: Denmark
facility: Department of Urology, Regional Hospital Viborg
Study officials:
affiliation: Department of Urology, Aarhus University Hospital
name: Jørgen Bjerggaard Jensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04281615: Examining Perceptions of the 24-Hr Movement Guidelines
Official title: Examining Perceptions and Brand Approaches for the Canadian 24-Hour Movement Guidelines for Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Self Efficacy
Keywords: Movement Behaviors
Physical Activity
Sedentary Behaviour
Sleep
Knowledge Translation
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of the proposed research is to experimentally test and inform the most effective brand attributes that is to be featured in the forthcoming Canadian 24-Hour Movement Guidelines for Adults. Specifically, there are two main objectives. The first objective is to determine the most preferred tagline associated with the new Guidelines among a sample of Canadian adults. The second objective is to experimentally test if this new attribute fosters stronger perceptions of self-efficacy among an adult sample, when compared to previous threshold-based approaches.


Eligibility criteria: Inclusion Criteria:

* between 18-64 years
* Canadian

Exclusion Criteria:

* cannot read/write in English
* already self-reported meeting Guideline recommendations for all three behaviours (physical activity, sedentary behaviour, and sleep)
* self-reported medical condition and/or sleep condition that would prevent individual from meeting the Guideline recommendations

Primary outcomes:
measure: Change in participants self-efficacy to meet Guidelines measured using the Multi-Dimensional Self-efficacy for Exercise Scale (adapted, scale 0-10; 0=not at all confident, 10=extremely confident) following pre and post exposure to promotional materials.
timeFrame: 3 time points: measuring change from baseline, immediately after viewing message, 2-week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: School of Kinesiology and Health Studies
state: Ontario
Study officials:
affiliation: Queen's University
name: Amy E Latimer-Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853515: Goal-directed Fluid Resuscitation in Acute Pancreatitis
Official title: A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
First posted: 2009-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.

Detailed description: Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.

Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

* acute pancreatitis diagnosed by at least 2 criteria
* adult patients at least 18 years of age

Exclusion Criteria:

* history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
* concurrent metabolic or physiologic derangement requiring specific fluid management
* pregnancy
* patients transferred from acute care hospital

Primary outcomes:
measure: Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
timeFrame: first 24 hours of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Bechien U. Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06859515: A Long-term Follow up Study of EXG102-031 in Participants With wAMD
Official title: A Long-term Follow-up Study to Evaluate the Injection of EXG102-031 Ophthalmic Injection in Participants With Wet Age-related Macular Degeneration (wAMD).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Wet Age-related Macular Degeneration
Keywords: AAV
wAMD
Lead sponsor: Hangzhou Jiayin Biotech Ltd
Sponsor class: INDUSTRY
Collaborators: name: Peking University People's Hospital
First posted: 2025-03-05
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: wAMD patients who have previously been treated with EXG102-031 injection in the study (EXG102-031-111).

Brief summary: This is a long-term, safety and efficacy follow-up study of patients in the EXG102-031-111 gene therapy clinical trial for wAMD. Patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.

Detailed description: This study will enroll patients with wet age-related macular degeneration (wAMD) who have previously be treated with EXG102-031 injection, those patients will Voluntary join this long-term follow-up study to be evaluated the long-term safety and efficacy.

The first two years of long-term follow-up will be conducted every 2 months; From 3 years to 5 years after administration,follow-up visits will be conducted every six months.

Eligibility criteria: Inclusion Criteria:

1. Previously received treatment with EXG102-031 in the study (EXG102-031-111);
2. Paticipantes are informed consent and willingness to follow protocol procedures.

Exclusion Criteria:

1. Paticipantes are unwilling or unable to participate in long-term follow-up

Primary outcomes:
measure: long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).
timeFrame: 4 years
Secondary outcomes:
measure: Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA)
timeFrame: 4 years
measure: Change from baseline after treatment by EXG102-031：central retinal thickness (CRT)
timeFrame: 4 years
measure: The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Mingwei ZHAO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641315: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
Official title: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rabies
Keywords: rabies
rabies immunoglobulin
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

Detailed description: * Controlled trial study
* All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.

group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers age 18-60 years.

Exclusion Criteria:

* received prior rabies immunization
* pregnancy
* immunocompromised conditions

Primary outcomes:
measure: Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
timeFrame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
Secondary outcomes:
measure: Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
timeFrame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292615: Application of Integrated MR-PET in Patients With Gynecologic Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MR-PET Imaging
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220.

Brief summary: In this prospective cohort study, patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220. Patients will undergo image study before and after treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor treatment response and predict treatment outcome will be investigated.


Eligibility criteria: Inclusion Criteria:

1. Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
2. Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).
3. Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.

Exclusion Criteria:

1. Age \<20 or \>90 years old
2. Contraindication for MRI:
3. Contraindication for MR contrast medium (Cre \> 2.0)
4. History of other malignancy
5. Prior arthroplasty of hip or pelvic bone surgery with metallic fixation (may cause artifacts on MRI)
6. Pregnant or lactating women

Primary outcomes:
measure: The imaging biomarkers determined by MR-PET
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Medical Imaging, National Taiwan University Hospital
name: Tiffany Ting-Fang Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04523415: Researches About Proximal Humerus Fractures
Official title: The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proximal Humeral Fracture
Keywords: Proximal Humeral
Fracture
Classifications
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 800
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: proximal humeral fractures without Pathological fracture

Brief summary: Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. Furthermore, CT and 3-D CT construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. Edelson proposed a new three-dimensional classification for fractures of the proximal humerus. The results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability.

It could be hypothesized that patients with proximal humeral fractures would benefit from this 3D classification, but there is a scarcity of application of the classification in large samples. T


Eligibility criteria: Inclusion Criteria:

* Whole imaging data ;
* Clear record of demographic data;
* Three dimensional construction with mimics (with CT of B30);
* Patients older than 17 years with displaced PHF occurring less than 3 weeks before allocation and treatment.

Exclusion Criteria:

* Patients with the presence of neurological disease (syringomyelia and);
* Open fractures;
* Pathological fracture (other than osteoporotic);
* Not a resident in the hospital catchment area

Primary outcomes:
measure: classification based on Edelson classifications
timeFrame: 2019.01-2022.12
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the Third Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT01627015: Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Official title: Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: Fully formula fed
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Beneo GmbH
First posted: 2012-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.

After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.


Eligibility criteria: Inclusion Criteria:

* generally healthy infants born
* weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
* age between 5 - 7th month of life at study entry
* fully formula fed for at least 4 weeks before intervention start
* parents/caregivers understand the German language and are able to fill out questionnaires
* parents/caregivers agree to study participation and sign the informed consent form

Exclusion Criteria:

* acute or chronic illness of infant or mother
* drug and/or alcohol abuses of mother
* chronic medication
* participation of the infant in another intervention study
* gestational diabetes of the mother

Primary outcomes:
measure: metabolic response
timeFrame: After 4 week intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Study officials:
affiliation: Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
name: Berthold Koletzko, Prof.
role: STUDY_DIRECTOR
affiliation: Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
name: Berthold Koletzko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B. Effects of a Follow-On Formula Containing Isomaltulose (Palatinose) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial. PLoS One. 2016 Mar 17;11(3):e0151614. doi: 10.1371/journal.pone.0151614. eCollection 2016.
Clinical trial NCT01668615: Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia
Official title: Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenic Purpura
Keywords: idiopathicthrombocytopenic purpura
all-trans retinoic acid
regulory T cells
Lead sponsor: First Affiliated Hospital of Suzhou Medical College
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 35 patients of RITP who do not response to prednisone,immunosuppressive agents and/or splenectomy were observed in our study .

Brief summary: The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).

Detailed description: Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of refratory idiopathic thrombocytopenic purpura
* Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

* Other autoimmune diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
name: zhaoyue wang, doctor
role: STUDY_DIRECTOR
References: