louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05861635: The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
Official title: Union Hospital Affiliated to Huazhong University of Science and Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Neoadjuvant Therapy
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

Detailed description: Studies have shown that vidicizumab has good efficacy and safety in advanced HER-2 low expression breast cancer. Vidicizumab combined with immunotherapy may be a new adjuvant treatment option for HER-2 low expression breast cancer patients. Therefore, we plan to carry out a clinical study to evaluate the efficacy, safety and tolerance of vidicizumab combined with tirelizumab during neoadjuvant therapy, in order to provide new treatment options for patients with breast cancer with HER-2 low expression in neoadjuvant therapy, improve their prognosis and improve their quality of life

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 75 years old, male or female;
2. Early or locally advanced breast cancer confirmed by pathology;
3. Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5;
4. ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;

Exclusion Criteria:

1. Stage IV breast cancer;
2. Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
3. At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended.
4. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery;
5. Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Primary outcomes:
measure: Pathological complete remission (pCR) rate
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WuhanHU
state: Hubei
Study officials:
affiliation: Xiehe Hospital
name: Jing Yao
role: STUDY_DIRECTOR
References:
Clinical trial NCT00597363: Neptune Pad ® Compared to Conventional Manual Compression
Official title: Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Hemorrhage
Keywords: vascular access site
arterial puncture
femoral pseudoaneurysm
Lead sponsor: Vienna General Hospital
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: BACKGROUND. Arterial access site complications remain the most frequent adverse events after percutaneous transluminal procedures. We investigated the safety and efficacy of the pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for access site management after peripheral percutaneous interventions.

METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´ and physicians´ discomfort were measured using a visual analogue scale.


Eligibility criteria: Inclusion Criteria:

* All inguinal punctures (common femoral, superficial femoral and deep femoral artery, antegrade and retrograde access) were included.
* No specific limitations of anti-platelet or anti-coagulant medication were specified.

Exclusion Criteria:

* Patients with extreme obesity (BMI above 35 kg/m2) were not included according to the manufactures' recommendations.
* Furthermore, patients with known hypersensitivity to components of the device were not eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna
Study officials:
affiliation: Professor
name: Martin Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mlekusch W, Dick P, Haumer M, Sabeti S, Minar E, Schillinger M. Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: a randomized controlled trial. J Endovasc Ther. 2006 Feb;13(1):23-31. doi: 10.1583/05-1679.1.
Clinical trial NCT04224935: The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
Official title: The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Gingival Recession
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I \& II) in comparison with the use of connective tissue graft

Detailed description: Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.

Group 1(10 patients) :

Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues

Group 2 (Control group)(10 patients) :

Coronally repositioned flap will be done with sub epithelial connective tissue Parameters

* Clinical evaluation of percentage of root coverage and keratinized tissue width
* Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include

Both evaluations will be done at 3, 6 and 9 months

Eligibility criteria: Inclusion Criteria:

* Systemically free patients (American Society of Anesthesiologists I; ASA I).
* Age range (20 -40) years.
* Good compliance with the plaque control instructions following initial therapy.
* Patients diagnosed with Miller class I or II in anterior and premolar teeth
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Patient suffering from periodontitis
* Presence of smoking habit.
* Presence of occlusion interference.
* Pregnant and lactating females.
* Vulnerable group of patients (handicapped, mentally retarded and prisoners).

Primary outcomes:
measure: recession treatment
timeFrame: 9 months
Secondary outcomes:
measure: soft tissue thickness (Volumetric assessment)
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: faculty of dentistry ain shams university
name: ahmed abdel aziz, co professor
role: STUDY_CHAIR
References:
Clinical trial NCT01273935: Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke
Official title: Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Test the Efficacy of Antiplatelet Regimes in Acute Stroke
Keywords: Aspirin, Acute Cerebrovascular Ischemia, Platelet Function
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the stroke unit

Brief summary: The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Detailed description: Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Eligibility criteria: Inclusion Criteria:

* suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated

Exclusion Criteria:

* severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders

Primary outcomes:
measure: Result of platelet function test
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Neurology, St. Josef - Hospital, Ruhr-University
state: NRW
Study officials:
affiliation: Department of Neurology, St. Josef - Hospital, Bochum, Germany
name: Saskia H Meves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409835: Effect of Ramosetron on Post-discharge Nausea and Vomiting
Official title: Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

Exclusion Criteria:

* American Society of Anesthesiologists physical statue 3 or more
* Planned admission after surgery
* Intravenous anesthesia
* During chemotherapy
* Pregnancy or breastfeeding
* Abnormal liver or kidney function

Primary outcomes:
measure: The change in the occurrence of postoperative nausea
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
measure: The change in the occurrence of postoperative vomiting
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Secondary outcomes:
measure: The change of postoperative pain score
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
measure: The change in the number of postoperative administration of rescue analgesic drug
timeFrame: Postoperative 30 minute and 3 hour
measure: The change in the number of postoperative administration of rescue antiemetic drug
timeFrame: Postoperative 30 minute and 3 hour
measure: The change of patient's satisfaction score
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT00991835: Plaque Registration and Event Detection In Computed Tomography
Official title: Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 3015
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients reffered to cardiovascular hospital

Brief summary: Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.


Eligibility criteria: Inclusion Criteria:

* patients with known or suspected coronary artery disease.

Exclusion Criteria:

* irregular heart beat,
* known allergy towards the contrast agent,
* renal dysfunction,
* uncontrolled heart failure,
* previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
* impossible breath-hold, OR
* end-stage cancer.

Primary outcomes:
measure: Major cardiac events (Cardiac death and acute coronary syndrome)
timeFrame: 2 years after the CT-scan
measure: All-cause death
timeFrame: 2 years after the CT-scan
Secondary outcomes:
measure: All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)
timeFrame: 2 years after CT-scan
measure: All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)
timeFrame: 2 years after the CT-scan
Other outcomes:
measure: Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics
timeFrame: 2 years after CT
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine
Study officials:
affiliation: Hiroshima University
name: Yasuki Kihara, MD,PhD
role: STUDY_CHAIR
References:
citation: Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.
Clinical trial NCT01026935: The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
Official title: The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Primary
Unilateral
Keywords: open mesh repair
sutured
non-sutured
pro-grip
postoperative pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2009-12-07
Enrollment: 398
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: For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.


Eligibility criteria: Inclusion Criteria:

* primary unilateral inguinal hernia

Exclusion Criteria:

* not willing to participate
* not capable to understand or fill in the questionnaires

Primary outcomes:
measure: postoperative complaints
timeFrame: One year
Secondary outcomes:
measure: Recurrence rate
timeFrame: One year
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: HUCH Jorvi Hospital, department of Surgery
city: Helsinki
country: Finland
facility: HUCH Surgical Hospital, Dept of Surgery
Study officials:
affiliation: HUCH Jorvi Hospital
name: Jaana Vironen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pierides G, Scheinin T, Remes V, Hermunen K, Vironen J. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg. 2012 May;99(5):630-6. doi: 10.1002/bjs.8705. Epub 2012 Feb 23.
Clinical trial NCT03480035: Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand
Official title: Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Disease
Trismus
Tooth Abnormalities
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an adult patient who is 18 years of age or older who undergoes general anesthesia requiring intubation.

Among them, patients who are unable to extend their necks, have trismus or have weak teeth are selected.

Brief summary: If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful device when endotracheal intubation is necessary.

Therefore, if the appropriate position of the light beam is determined and the distance of the light source suitable for intubation using the lightwand is obtained from anatomical structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because it can prevent unnecessary deep insertion or shallow insertion that can cause damage to anatomical structures during intubation.

Detailed description: Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.

However, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.

The prodcedure is as follows.

1. FOB examination and check position of light below 1cm from vocal cord
2. lightwand intubation aimed at checkpoint
3. measurement of distance from thyroid cartilage/cricoid cartilage to light point

Eligibility criteria: Inclusion Criteria:

* impossibility of neck extension
* trismus
* weak teeth

Exclusion Criteria:

* previous history of larynx or neck surgery
* no informed consent

Primary outcomes:
measure: distance from lightbeam of the FOB to thyroid cartilage
timeFrame: before intubation
measure: distance from lightbeam of the FOB to cricoid cartilage
timeFrame: before intubation
Secondary outcomes:
measure: distance from lightbeam of the FOB to sternal notch
timeFrame: before intubation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dongsan medical center
Study officials:
affiliation: Dongsan Medical Center
name: Jiwon Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho E, Kim HC, Lee JM, Park JH, Ha N, Hong JH, Lee J. Evaluation of transmitted glow point at a priori chosen depth (1 cm below vocal cords) for lightwand intubation: a prospective observational study. J Int Med Res. 2020 Dec;48(12):300060520974249. doi: 10.1177/0300060520974249.
Clinical trial NCT03768635: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center
Official title: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: otitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center between 01/01/2006 and 31/01/2018

Brief summary: The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.


Eligibility criteria: Inclusion Criteria:

* patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of necrotizing external otitis
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: Duration of antibiotics
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan Ferry, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: