louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05154877: Evaluation of a New Generation of PET-CT OMNI
Official title: Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Institut Claudius Regaud
First posted: 2021-12-13
Enrollment: 45
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: Subjects having an indication for FDG or 18F-FDG PET/CT examination according to current clinical practice standards will be enrolled in this study. These subjects are representative of the general population that is expected to use the device in clinical practice.

Brief summary: The overarching purpose of the study is to provide supporting evidence to the value proposition of OMNI, that offers global access to an affordable hybrid PET/CT system similar in performance to that of systems utilized by world-class academic centers. Specifically, the study will collect a library of oncology 18FDG PET image data from the OMNI system and evaluate the images as compared to the standard of care PET/CT systems.

This evaluation is being performed as a necessary part of product development in order to obtain user feedback on device performance, user preference, image quality (IQ), workflow, and new device features. This study will also help to inform protocol development in reducing both scan time and radiologic tracer dose.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. A clinical indication for Fluorodeoxyglucose (FDG or 18F-FDG) PET/CT examination according to current clinical practice standards;
3. Have ≥ 1 WHO Karnofsky index \< 70;
4. Are able to maintain a supine position twice;
5. Are affiliated with a Social Security scheme in France; AND,
6. Are able and willing to provide informed consent for participation in this study, per the EC approved policy.

Exclusion Criteria:

1. Have uncontrolled diabetes;
2. Have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.)
3. Are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; OR,
4. Are known to have any psychological, family, geographic, or sociological condition that does not allow compliance with the medical monitoring and/or the procedures provided for in the study protocol.

Primary outcomes:
measure: Evaluation
timeFrame: through study completion, an average of 1 year
measure: Lesion Detectability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: GE Healthcare
name: Brian W Thomsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT07024277: Study of ZG006 in Participants With Neuroendocrine Prostate Cancer
Official title: A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Neuroendocrine Prostate Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.


Eligibility criteria: Inclusion Criteria:

* Male Participants aged 18 to 80 years (inclusive);
* Advanced metastatic neuroendocrine prostate cancer;
* disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;
* Measurable disease according to RECIST v1.1 criteria;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

* Known positive test for human immunodeficiency virus (HIV) or hepatitis；
* Patients were deemed unsuitable for participating in the study by the investigator for any reason.

Primary outcomes:
measure: Modified Best Overall Response（mBOR）
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Baseline to 12 months
measure: Overall Survival (OS)
timeFrame: Baseline to 12 months
measure: Disease Control Rate (DCR)
timeFrame: Baseline to 12 months
measure: Adverse Events（AE）
timeFrame: Day 1 to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan university shanghai cancer center
state: Shanghai
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT00551577: Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial
Official title: Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: Ovarian neoplasms,
Neoadjuvant Therapy,
Docetaxel,
Neoplasm, Residual
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-10-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.


Eligibility criteria: Inclusion Criteria:

* histological confirmed ovarian neoplasm
* Figo stage IIIC (2cm extrapelvic disease) or Figo IV
* more than 500 ml ascites volume (measured by sonography)
* age \> 18 years old
* ECOG \<= 2
* adequate hepatological, renal and haematological function
* informed consent

Exclusion Criteria:

* concomitant or previous malignant diseases
* debulking procedures on initial surgical approach
* existing peripheral sensoric neuropathy \>= grade 2
* acute infections
* mental disorders, cerebral metastasis
* bowel obstruction

Primary outcomes:
measure: Preoperative reduction of ascites volume
timeFrame: preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)
Secondary outcomes:
measure: Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL
timeFrame: 6 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Gynaecolgy and Obstetrics, University hopsital
city: Hamburg
country: Germany
facility: Department of Gynaecology, University hospital
Study officials:
affiliation: University of Bonn
name: Walther C Kuhn, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polcher M, Rudlowski C, Friedrichs N, Mielich M, Holler T, Wolfgarten M, Kubler K, Buttner R, Kuhn W, Braun M. In vivo intratumor angiogenic treatment effects during taxane-based neoadjuvant chemotherapy of ovarian cancer. BMC Cancer. 2010 Apr 13;10:137. doi: 10.1186/1471-2407-10-137.
citation: Polcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kubler K, Buttner R, Kuhn WC, Hernando JJ. Foxp3(+) cell infiltration and granzyme B(+)/Foxp3(+) cell ratio are associated with outcome in neoadjuvant chemotherapy-treated ovarian carcinoma. Cancer Immunol Immunother. 2010 Jun;59(6):909-19. doi: 10.1007/s00262-010-0817-1. Epub 2010 Jan 20.
Clinical trial NCT01711177: Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Official title: Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: primary open angle glaucoma
retinal oximetry
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glaucoma is the second leading cause of blindness among seniors in Canada. It is often associated with an elevated intraocular pressure (IOP), but its exact mechanism is still largely unknown. Some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. This instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside.

The groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten patients will be recruited into each group for a total of 30 patients in this study. All patients for the suspected or diagnosed groups will be recruited from the Jewish General Hospital. Subsequently all testing will be done at the École d'optométrie, Université de Montréal


Eligibility criteria: Inclusion Criteria:

* good systemic health
* irido-corneal angle open
* intraocular pressure more than 18 mmHg

Exclusion Criteria:

* having cardiovascular problem
* Hypertension or diabetes
* under systemic medication for high blood pressure
* had an ocular surgery in the past

Primary outcomes:
measure: Blood Oxygenation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: University of Montreal
state: Quebec
Study officials:
References:
Clinical trial NCT01269177: Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
Official title: Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Edema
Respiratory Insufficiency
Keywords: ACPE
Acute respiratory failure
Non invasive ventilation
acute cardiogenic pulmonary edema
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 1000
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: Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema

Brief summary: The purpose of this study is to define the current treatment of patients ospitalized with acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency Department will used to investigate the primary outcome (mortality) and risk factors related to the primary outcome.

Detailed description: ACPE is a common cause of presentation to the Emergency Department (ED). Early recognition of high-risk patients could help in better locating human and technical resources and in deciding adequate treatment and site of care.

The investigators planned a real life, multicentric, prospective, web-based observational study performed in Italian Emergency Departments.

The investigators enroll consecutive patients admitted to the Emergency Department with acute cardiogenic pulmonary edema, that is defined as all the following: respiratory distress, bilateral rales and congestion on chest X-ray.

Demographic, clinical and laboratory findings are collected on admission and during hospitalization to evaluate mortality and risk factors related to mortality.

Eligibility criteria: Inclusion Criteria:

all of the following:

* age ≥ 18
* acute-onset dyspnea
* widespread pulmonary rales
* pulmonary congestion on chest X- ray plus one of the following:
* respiratory distress
* respiratory rate ≥ 30
* emogasanalysis: pH \< 7.35 and pCO2 \> 45 mmHg in Venturi-Mask 50%

Primary outcomes:
measure: mortality
timeFrame: Discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena
Study officials:
affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
name: Roberto Cosentini, MD
role: STUDY_CHAIR
References:
citation: Cosentini R, Aliberti S, Bignamini A, Piffer F, Brambilla AM. Mortality in acute cardiogenic pulmonary edema treated with continuous positive airway pressure. Intensive Care Med. 2009 Feb;35(2):299-305. doi: 10.1007/s00134-008-1281-7. Epub 2008 Sep 20.
Clinical trial NCT04331977: Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
Official title: Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Maxillary Expansion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.


Eligibility criteria: Inclusion Criteria:

* Mixed dentition stage;
* Both males and females;
* Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
* Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
* Permanent first maxillary molars present;
* Good periodontal health;
* No previous orthodontic treatment; and

Exclusion Criteria:

* Presence of a syndrome in companion with the present cleft defect.
* Previous secondary alveolar bone grafting.
* Taking medications affecting growth.

Primary outcomes:
measure: Maxillary Expansion
timeFrame: 6 months
measure: Maxillary Expansion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
state: Giza
Study officials:
References:
Clinical trial NCT00282477: Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls
Official title: Prospective Controlled Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Azoospermia
Keywords: cyclist
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-26
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.


Eligibility criteria: Inclusion Criteria:

* Males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week.

Exclusion Criteria:

* History of prostatic surgery, testicular surgery, or single testis,
* Patients after chemotherapy,
* Patients receiving hormonal therapy,
* Patients receiving alpha blockers for any indication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Igael Madgar, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738877: Cardiovascular Effects of Marathon Running
Official title: FEIDIPIDIS Study: Cardiovascular Effects of Marathon Running
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes Heart
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Marathon runners aiming to paricipate in a marathon running race

Brief summary: The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.


Eligibility criteria: Inclusion Criteria:

* Marathon runner

Exclusion Criteria:

* Chronic disease, Drugs

Primary outcomes:
measure: Baseline left ventricular (LV) systolic function
timeFrame: Evaluation of athletes within 3 weeks before the marathon running race.
measure: Baseline LV diastolic function
timeFrame: Evaluation of athletes within 3 weeks before the marathon running race.
measure: Baseline basal right ventricular (RV) function
timeFrame: Evaluation of athletes within 3 weeks before the marathon running race.
measure: Baseline global RV function
timeFrame: Evaluation of athletes within 3 weeks before the marathon running race.
measure: Post-exercise LV systolic function
timeFrame: Evaluation of athletes immediately after the completion of the marathon running race.
measure: Post-exercise LV diastolic function
timeFrame: Evaluation of athletes immediately after the completion of the marathon running race.
measure: Post-exercise basal RV function
timeFrame: Evaluation of athletes immediately after the completion of the marathon running race.
measure: Post-exercise global RV function
timeFrame: Evaluation of athletes immediately after the completion of the marathon running race.
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
References:
citation: Christou GA, Pagourelias ED, Deligiannis AP, Kouidi EJ. Exploring the Anthropometric, Cardiorespiratory, and Haematological Determinants of Marathon Performance. Front Physiol. 2021 Sep 3;12:693733. doi: 10.3389/fphys.2021.693733. eCollection 2021.
Clinical trial NCT05690477: Corrective Osteotomy of the Distal Radius Without Bone Grafting
Official title: Corrective Osteotomy of the Distal Radius With Palmar Locking Plate Osteosynthesis Without Bone Grafting and Without Cortical Contact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with extraarticular corrective osteotomy of the distal radius without cortical contact and without the use of bone graft due to a malunited distal radius fracture

Brief summary: The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy.

The goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.


Eligibility criteria: Inclusion Criteria:

* malunited distal radius fracture
* extraarticular corrective osteotomy
* palmar approach
* no bone graft used
* no cortical contact after dorsal open wedge osteotomy
* signed informed consent

Exclusion Criteria:

* others reasons for malunion
* intraarticular corrective osteotomy
* use of a bone graft
* cortical contact after open wedge osteotomy
* lost to follow up

Primary outcomes:
measure: Secondary fracture dislocation
timeFrame: 1 year
measure: complete bone healing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Hand, Plastic and Reconstructive Surgery
Study officials:
References:
Clinical trial NCT05860777: Harnessing Health IT to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs
Official title: Harnessing Health Information Technology to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence
Keywords: Limited English Proficiency
Machine Learning
Language Barrier
Complex Medical Needs
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 1923
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a pragmatic clinical trial-a stepped wedge cluster randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use


Eligibility criteria: Inclusion Criteria:

* Adults with limited English proficiency and requiring an interpreter and having complex medical care needs (includes admitted to the ICU, prolonged hospital stay, requiring palliative care)
* Have research authorization

Exclusion Criteria:

- Do not require an interpreter

Primary outcomes:
measure: Number of interpreters
timeFrame: 12 months
Secondary outcomes:
measure: Change in time to interpreter use
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brian Pickering, MB, B.Ch
role: PRINCIPAL_INVESTIGATOR
References: