louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04267900: 99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer
Official title: 99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: SPECT/CT
HER2 imaging
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 34
Sex: FEMALE
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: DIAGNOSTIC

Brief summary: This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed description: 99mTc-HPArk2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-HPArk2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-HPArk2 SPECT/CT in stratifying breast cancer.

Eligibility criteria: Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.

Primary outcomes:
measure: Standardized uptake value of 99mTc-HPArk2 in breast tumor
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Zhaohui Zhu, MD,PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05445700: The Effects of Frailty on Opioid Consumption
Official title: The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Opioid Use
Knee Arthropathy
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Groups will be determined according to frailty status.
Primary purpose: TREATMENT

Brief summary: The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Demographic data and intraoperative data of the patients will be recorded. Patients will be transferred to the post-operational post-operative care unit (PACU) and patient-controlled analgesia (PCA) will be applied to each patient with a standard protocol. In the postoperative period, the need for analgesics will be recorded for 24 hours, and if additional analgesics are needed, they will be recorded. Pain scores of the patients will be evaluated for 24 hours.


Eligibility criteria: Inclusion Criteria:

* patients who will undergo unilateral, primary total knee arthroplasty
* Patients who will be operated with spinal anesthesia

Exclusion Criteria:

* Patients with ASA IV and above physical status
* Uncooperative patients
* Patients who do not speak Turkish
* Patients on routine opioid use

Primary outcomes:
measure: Opioid consumption
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Visual analog pain scores (VAS)
timeFrame: 6,12 and 24 hours
measure: Nausea and vomiting questionnaire
timeFrame: Postoperative for 24 hours
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty Hospital
Study officials:
References:
Clinical trial NCT06214000: Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney
Official title: Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Kidney Cancer
Keywords: Prostate Cancer
kidney cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (≥18 years old) operated on for localized prostate or kidney cancer during the period from 01/01/2015 to 12/31/2021

Brief summary: In France, the second cancer plan of 2009-2013 aimed to strengthen the role of MT by putting it back at the center of patient monitoring, in particular by asking "regional health agencies to encourage and support local experiments" which aim for better coordination between the city and the hospital. The third cancer plan for 2014-2019 insists on this measure because it had proven to be unproductive, and recommends, in addition to the creation of a nurse dedicated to the coordination of care between community medicine and the hospital, the creation of a direct telephone line to reach the hospital medical team. This measure is mainly aimed at the follow-up of certain cancers that do not require the technical support of the hospital, as is the case in the post-operative follow-up of RCC and CaP, where the additional examinations carried out during follow-up are carried out in the city.

The research hypothesis is that this new method of monitoring had a positive impact on care in terms of quality, accessibility, organization and costs.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (≥18 years old)
* Patient operated on for localized prostate or kidney cancer
* Patient followed at the HUS during the period from 01/01/2015 to 12/31/2021
* Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Patient under active therapy (hormonotherapy, systemic treatment) for the pathology studied
* Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
* Subject under judicial protection
* Subjects under guardianship or curatorship

Primary outcomes:
measure: Evaluation of the economic impact of the treatment of patients operated on for localized prostate or kidney cancer
timeFrame: The period concerned is from January 1, 2015 to December 31, 2021.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Urologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02822300: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03638700: Comparison of Two High Performance Guidewires in ERCP
Official title: Comparison of the Use of Two High Performance Guidewires in Patients With Stenosis of the Bile Ducts in ERCP: A Randomised Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis of Bile Duct
Keywords: stenosis
bile duct
guidewire
ercp
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Klinikum Stadt Hanau
name: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
name: Robert Bosch Medical Center
First posted: 2018-08-20
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation.

The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire

Detailed description: This is a randomized, multicentric study.

Eligibility criteria: Inclusion Criteria:

* Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data

Exclusion Criteria:

* Operatively alternated anatomy of the patient

Primary outcomes:
measure: Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Duration of ERCP session
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Robert Bosch Krankenhaus Stuttgart, Germany
name: Jörg G Albert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04634500: The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
Official title: Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Detailed description: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Eligibility criteria: Inclusion Criteria:

1. Subjects with T2DM aged 19 to 80 years
2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 60 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV)

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT03958500: The Problem of Colorectal Anastomosis Safety
Official title: Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Carcinoma
Colorectal Neoplasms
Colorectal Adenocarcinoma
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
name: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
First posted: 2019-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.


Eligibility criteria: Inclusion Criteria:

* patients over 18 year
* signed written consent
* a colorectal anastomosis lower 15 cm from anal verge
* elective surgery

Exclusion Criteria:

* allergy to indocyanine green dye
* pregnancy

Primary outcomes:
measure: Rate of anastomotic leakage
timeFrame: 0 to 60 days
Secondary outcomes:
measure: Quality of life before and after the operation
timeFrame: 0 to 60 days
measure: Quality of life before and after the operation
timeFrame: 0 to 60 days
measure: Reoperation rate
timeFrame: 0 to 60 days
measure: Intraoperative test leakage
timeFrame: 0 to 600 minutes
measure: Time of anastomosis testing
timeFrame: 0 to 600 minutes
measure: Operation time
timeFrame: 0 to 600 minutes
measure: 90 days mortality
timeFrame: 0 to 90 days
measure: Timing of anastomosis leakage
timeFrame: 0 to 60 days
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute, Vilnius, Lithuania
city: Vilnius
country: Lithuania
facility: Vilnius University hospital Santaros klinikos
Study officials:
affiliation: Vilnius University, Vilnius, Lithuania
name: Eligijus Poskus, prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kryzauskas M, Poskus E, Dulskas A, Bausys A, Jakubauskas M, Imbrasaite U, Makunaite G, Kuliavas J, Bausys R, Stratilatovas E, Strupas K, Poskus T. The problem of colorectal anastomosis safety. Medicine (Baltimore). 2020 Jan;99(2):e18560. doi: 10.1097/MD.0000000000018560.
Clinical trial NCT00447200: Study of the Natural Variation in Strokevolume
Official title: Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Volume Variation
Keywords: Stroke volume
SV variation
Esophagus Doppler
Goal Directed Therapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Detailed description: We would like to investigate the natural variation in the strokevolume(SV) of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.

Eligibility criteria: Inclusion Criteria:

* Planned abdominal surgery

Exclusion Criteria:

* Oesophageal pathology,
* Age \>90 yr or \<18 yr,
* Alcohol abuse,
* Aneurism in thoracic aorta

Primary outcomes:
measure: Strokevolume variation before fluid optimization
measure: Strokevolume variation after fluid optimization
measure: Number of cycles needed in order to detect a 10% strokevolume increase after fluid bolus of 200ml Voluven.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Seeland
Study officials:
affiliation: Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
name: Christoffer Jorgensen, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06555900: Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence (PREDICT-CE)
Official title: Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any neuro-injured patient admitted to intensive care

Brief summary: The investigators wish to build up a database of clinical data and physiological signals with a view to developing a predictive algorithm based on continuous analysis of the intracranial pressure waveform and other parameters commonly used in intensive care to predict the occurrence of an episode of intracranial hypertension (HTIC). This algorithm will be designed using supervised learning statistical methods based on innovative statistical analysis methods (artificial intelligence). These methods are classically used to exploit massive data such as sensor data.


Eligibility criteria: Inclusion Criteria:

* More than 18 years
* admission to intensive care for less than 3 days for a neurological lesion
* Sensor placement for intracranial pressure monitoring

Exclusion Criteria:

* patient under judicial protection
* refusal to participate
* patients under 18 years of age

Primary outcomes:
measure: Creation of a database of clinical data and physiological signals to develop a predictive algorithm based on continuous analysis of the intracranial pressure waveform to predict the occurrence of an episode of intracranial hypertension.
timeFrame: 30 minutes
Secondary outcomes:
measure: Predict long-term functional outcome using intracranial pressure wave signal modeling and other parameters collected in real time
timeFrame: 28 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: