louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06872333: Allo HSCT for High Risk Hemoglobinopathies
Official title: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Graft Failure
Sickle Cell Disease
Hemoglobinopathies
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 62
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.


Eligibility criteria: Inclusion Criteria:

* Sickle Cell Disease (SCD)
* SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents/patient must be counseled as to the risks and benefits and provide their voluntary informed consent
* Transfusion Dependent Alpha- or Beta- Thalassemia
* Diamond Blackfan Anemia
* Other Non-Malignant Hematologic Disorders
* Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.
* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.

Exclusion Criteria:

* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment
* HIV Positive
* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
* Known allergy to any of the study components
* Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study

Primary outcomes:
measure: Incidence of Graft versus Host Disease (GvHD)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 and 2 years
measure: Grade 3-4 Acute GvHD
timeFrame: 2 years
measure: Chronic Graft versus Host Disease (GvHD) Free
timeFrame: 2 years
measure: Failure Free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
Study officials:
References:
Clinical trial NCT01102933: RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients
Official title: RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.

Brief summary: The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:

Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.

Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.


Eligibility criteria: Inclusion Criteria:

1. Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
2. Treated at the Department of cardiology, Uppsala University Hospital.
3. Ability to attend the scheduled visits for evaluation procedures.
4. Signed Informed Consent.

Exclusion Criteria:

1. Death ≤ 5 days after the myocardial infarction.
2. Not belonging to the catchment area of Uppsala University Hospital.
3. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Primary outcomes:
measure: Death, myocardial infarction, stroke
timeFrame: Five years from study start
Secondary outcomes:
measure: Venous thromboembolism, Arterial embolism, Bleeding
timeFrame: Five years from study start
Other outcomes:
Locations:
city: Uppsal University Hospital
country: Sweden
facility: Cardiology Department
state: Uppsala
Study officials:
affiliation: Cardiology Department, Uppsala University Hospital
name: Christina Christersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00816933: Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Official title: Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Appendicitis
Pain
Complications
Keywords: pain
operative times
complication
time to return for normal life
pain using VAS score
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2009-01-05
Enrollment: 140
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Appendicitis is the most common benign inflammatory disease that requires an operation.

Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.


Eligibility criteria: Inclusion Criteria:

* Appendicitis (clinical or radilogical diagnosis)
* ASA \< 4

Exclusion Criteria:

* Appendicitis with palpable mass( clinical or radilogical diagnosis)
* Patient has bleeding tendency
* Pregnant

Primary outcomes:
measure: post-operative pain
timeFrame: For 7days
Secondary outcomes:
measure: cosmetic effect
timeFrame: for 14days
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea
state: Gyunggi Do
Study officials:
References:
citation: Kye BH, Lee J, Kim W, Kim D, Lee D. Comparative study between single-incision and three-port laparoscopic appendectomy: a prospective randomized trial. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):431-6. doi: 10.1089/lap.2012.0284. Epub 2013 Mar 8.
citation: Lee J, Baek J, Kim W. Laparoscopic transumbilical single-port appendectomy: initial experience and comparison with three-port appendectomy. Surg Laparosc Endosc Percutan Tech. 2010 Apr;20(2):100-3. doi: 10.1097/SLE.0b013e3181d84922.
Clinical trial NCT05699577: Prognostic Value of Some Biochemical Markers in Breast Cancer
Official title: Prognostic Value of Some Biochemical Markers in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: female patients with breast cancer

Brief summary: breast cancer is the most common type of cancer in women and first cause of cancer death among them. in Egypt it constitutes 33% of female cancer cases and more than22000 new cases diagnosed each year. there are many prognostic factors for breast cancer as Tumer size, axillary lymph node status, hormonal receptor status, and tumer markers as Ca15-3 and interferon gamma.


Eligibility criteria: Inclusion Criteria:

* female patients aged more than or equal 18 year diagnosed with breast cancer
* metastatic and non-metastatic cancer premenopausal and postmenopausal female positive and negative hormonal receptors and HER2 receptor taking any systemic treatment taking radiotherapy or not

Exclusion Criteria:

* female patients less than 18 years patients having comorbid disease. patients with double malignancy

Primary outcomes:
measure: serum level of Ca15-3
timeFrame: 6 months
measure: serum level of interferon gamma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
citation: Uygur MM, Gumus M. The utility of serum tumor markers CEA and CA 15-3 for breast cancer prognosis and their association with clinicopathological parameters. Cancer Treat Res Commun. 2021;28:100402. doi: 10.1016/j.ctarc.2021.100402. Epub 2021 May 24.
citation: Jorgovanovic D, Song M, Wang L, Zhang Y. Roles of IFN-gamma in tumor progression and regression: a review. Biomark Res. 2020 Sep 29;8:49. doi: 10.1186/s40364-020-00228-x. eCollection 2020.
citation: Mendoza JL, Escalante NK, Jude KM, Sotolongo Bellon J, Su L, Horton TM, Tsutsumi N, Berardinelli SJ, Haltiwanger RS, Piehler J, Engleman EG, Garcia KC. Structure of the IFNgamma receptor complex guides design of biased agonists. Nature. 2019 Mar;567(7746):56-60. doi: 10.1038/s41586-019-0988-7. Epub 2019 Feb 27.
Clinical trial NCT02843477: Evaluation of Corrected Carotid Artery Flow Time as a Predictor of Fluid Responsiveness in Spontaneous Breathing Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were scheduled to undergo elective neurosurgery for brain tumor

Brief summary: It is still challenging to assess intravascular volume status in spontaneously breathing patients. Recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume change. The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously breathing patients before induction of general anesthesia.


Eligibility criteria: Inclusion Criteria:

* adult patients (19-80 years of age) who were scheduled to undergo elective neurosurgery for brain tumor

Exclusion Criteria:

* BMI \> 35 or \< 15 kg/m2
* the presence of carotid artery stenosis \> 50%
* systolic blood pressure \> 160 mmHg
* cardiac rhythm other than sinus
* intracardiac shunt 6. valvular heart disease
* a left ventricular ejection fraction of \< 50%
* right ventricular dysfunction 9
* chronic obstructive pulmonary disease
* pulmonary hypertension
* chronic kidney disease (eGFR \< 60 mL/min/1.73m2)
* pregnancy

Primary outcomes:
measure: ultrasonographic measurement of corrected flow time in carotid artery
timeFrame: right before fluid loading
measure: ultrasonographic measurement of corrected flow time in carotid artery
timeFrame: 5 minutes after fluid loading
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: Kim DH, Shin S, Kim N, Choi T, Choi SH, Choi YS. Carotid ultrasound measurements for assessing fluid responsiveness in spontaneously breathing patients: corrected flow time and respirophasic variation in blood flow peak velocity. Br J Anaesth. 2018 Sep;121(3):541-549. doi: 10.1016/j.bja.2017.12.047. Epub 2018 Apr 12.
Clinical trial NCT05201677: Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
Official title: Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Myopia
Low Intraocular Pressure
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 60 participants at Eye Hospital of Wenzhou Medical University during October,2021 to January 2022 will be enroll in the investigators' study. And dived them randomly into 2 groups:High myopia with axial length between 26 mm and 28 mm and High myopia with axial length more than 28 mm (30 eyes) .


Eligibility criteria: Inclusion Criteria:

* The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
* Surgery without complications

Exclusion Criteria:

* Patients who had other ocular diseases or had undergone internal eye surgery
* Patients with a history of myopic laser surgery
* Previous history of eye trauma
* Previous use of medications/eye drops that may alter IOP

Primary outcomes:
measure: Intraocular pressure
timeFrame: two minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT05338177: Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients
Official title: Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established.

This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.


Eligibility criteria: Inclusion Criteria:

* Patient has received a kidney transplantation
* \> 18 years of age
* No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
* Maintenance immunosuppression with mycophenolate or azathioprine

Exclusion Criteria:

* acute illness with fever
* Prior documented infection with SARS-CoV-2
* triple anticoagulation therapy
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
* Subject is pregnant or breast feeding
* SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination \> 0.8 BAU/mL

Primary outcomes:
measure: Seroconversion at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Seroconversion at 7 days
timeFrame: 7 days
measure: Antibody levels at 4 weeks
timeFrame: 4 weeks
measure: Donor specific antibodies
timeFrame: 4 weeks
measure: Donor-derived cell free DNA
timeFrame: 4 weeks
measure: Creatinine levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01222377: Endoscopic Breast Surgery in Treating Patients With Breast Cancer
Official title: Endoscopic Breast Surgery Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Male Breast Cancer
Recurrent Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-18
Enrollment: 2
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility criteria: Inclusion Criteria:

* Breast cancer or prophylactic mastectomy requiring axillary nodal staging
* Breast disease (e.g., fibroadenoma, ADH)
* Ability to read and/or comprehend consent form and questionnaires
* Ability to follow-up per protocol
* Not pregnant or breastfeeding

Exclusion Criteria:

* Pregnant or breastfeeding
* Evidence of chest wall or skin\* involvement
* NOTE: \*may be endoscopy-assisted

Primary outcomes:
measure: To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer
timeFrame: 5 years
Secondary outcomes:
measure: To evaluate the safety, breast cosmesis and patient quality of life following EBS
timeFrame: After completion of study treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Dennis Holmes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616377: Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation
Official title: Survival Benefit of Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation: A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Metastases
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital clients from Sun Yat-sen University Cancer Center, Guangxi Medical University Cancer Hospital, The People's Hospital Of Guangxi Zhuang Autonomous Region, and the First Affiliated Hospital of Guangxi Medical University will be selected.

Brief summary: The goal of this observational study is to learn about the survival benefit of local therapy combination with target therapy in lung cancer brain metastases with EGFR mutation. The main questions it aims to answer are:

* Is local therapy performed before or after target therapy would provide survival benefit ?
* What kind of local therapy combining with target therapy would provide survival benefit, neurosurgical resection or radiotherapy?


Eligibility criteria: Inclusion Criteria:

1. Evidence of pathological diagnosis of primary tumor.
2. Brain metastases confirmed by enhanced magnetic resonance imaging.
3. Gene test indicated that EGFR mutation.
4. Complete clinical information.

Exclusion Criteria:

1. If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery.
2. Patients with 2 or more types of tumors.
3. Incomplete clinical information.

Primary outcomes:
measure: OS
timeFrame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months
Secondary outcomes:
measure: PFS
timeFrame: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Other outcomes:
Locations:
Study officials:
References: