louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04538599: RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Official title: RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Malignancies
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.


Eligibility criteria: Inclusion Criteria:

1. Aged 3 to 70 years.
2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
3. ECOG: 0-2.
4. Life expectancy greater than 12 weeks.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.

Exclusion Criteria:

1. Pregnant or lactating.
2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
4. Participated in other clinical studies within 2 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 4 weeks after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital，College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02026999: Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations
Official title: Phase IV Study of the Use of Sugammadex Versus Neostigmine in Septoplasty Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Septum Deviation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing septoplasty operation

Brief summary: The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation.

Detailed description: Patients undergoing septoplasty operation will be included to this study. After coming to operation room all the patients will have standard monitorisation and induction. After intubation they will have inhalational anesthesia as maintenance. According to the TOF (train of four) measurement all patient will have neuromuscular relaxant if needed. After the operation they will be extubated according to TOF or clinical parameters. And time for extubation, mask assistance need, any complication, mask difficulty, and time spent in postoperative care unit will be recorded. Then the results will be compared, whether sugammadex or neostigmine is better for these patients in means of extubation and postoperative status.

Eligibility criteria: Inclusion Criteria:

ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation

Exclusion Criteria:

* patient refusal
* any allergy to any medication used

Primary outcomes:
measure: easy mask ventilation for septoplasty patients
timeFrame: time between end of surgery and extubation of the patient, approximately 5 to 10 minutes
Secondary outcomes:
measure: Quick and safe transfer from postoperative care unit
timeFrame: time spent in postanesthesia care unit approximately 10 to 60 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: ANKARA UNIVERSITY FACULTY OF MEDICINE
name: CIGDEM YILDIRIM GUCLU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871999: Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Carcinoma
Pain
Keywords: Acupuncture Therapy
Pain degree after surgery
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.


Eligibility criteria: Inclusion Criteria:

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
2. Pathology diagnosed;
3. Brain, heart, lung, liver, kidney are at good condition before surgery;
4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion Criteria:

1. Severely complication after surgery;
2. Contraindication of the acupuncture;
3. Patients with mental disease;
4. Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Primary outcomes:
measure: Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Secondary outcomes:
measure: Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
measure: Prostaglandin E2(PGE2) in blood
timeFrame: day 2,day 7 after surgery
measure: Estradiol(Female) in blood
timeFrame: day 2, day 7 after surgery
measure: Th1/Th2 in blood
timeFrame: day 2, day 7 after surgery
measure: 5-Hydroxytryptamine(5-HT) in blood
timeFrame: day 2,day 7 after surgery
measure: Histamine(HIS) in blood
timeFrame: day 2,day 7 after surgery
measure: Th17/Treg in blood
timeFrame: day 2, day 7 after surgery
measure: Testosterone(Male) in blood
timeFrame: day 2,day 7 after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02375399: New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy
Official title: New Approaches to Echocardiography Assessment of Cardiac Dyssynchrony: Relevance Concerning Response Rate to Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients referred to the University Hospital of Heidelberg with congestive heart failure to undergo the implantation of CRT device

Brief summary: Echocardiography parameters for cardiac dyssynchrony had no predictive value in current multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been analyzed, but their definite value has not been proven yet.

Detailed description: In patients with severe heart failure, delays in the conduction system can result in asynchronous contraction impairing cardiac function. By implantation of pacemaker systems with three leads located in atrium, right ventricle and coronary sinus, tracing back this deranged contraction closer to the physiological excitation propagation is aimed (cardial resynchronization therapy \[CRT\]). Despite patient selection according to the guidelines nearly one-third of the patients do not profit, neither clinically nor echocardiographically, from an implanted CRT-device. In addition, recent studies have shown that no reliable prediction may be achieved with the known echocardiographic parameters of dyssynchrony, regarding the response to such therapy. The aim of this study is therefore to assess new echocardiographic parameters, which may allow to better predict CRT response.

Eligibility criteria: Inclusion Criteria:

* congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC)

Exclusion Criteria:

* persons who are incapable of giving informed consent
* acute heart attack
* arrhythmia during the examination (such as atrial fibrillation and frequent VES)
* state after STEMI with an extended scar
* inotropic drug therapy
* pre-existing permanent pacemaker stimulation

Primary outcomes:
measure: 3D echocardiography
timeFrame: 12 months
measure: 2D strain
timeFrame: 12 months
measure: m-mode echocardiography
timeFrame: 12 months
Secondary outcomes:
measure: NYHA
timeFrame: 12 months
measure: six-min walk test
timeFrame: 12 months
measure: NT-proBNP
timeFrame: 12 months
measure: LV EF
timeFrame: 12 month
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Cardiology, University of Heidelberg
state: BW
Study officials:
affiliation: Heidelberg University
name: Mathias Konstandin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640699: The Effects of Neurophysiological Facilitation Techniques After Coronary Artery Bypass Graft Surgery
Official title: The Effects of Neurophysiological Facilitation Techniques on Cardiopulmonary Parameters After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Disease
Keywords: coronary artery bypass
respiratory function test
ventricular ejection fraction
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of neurophysiological facilitation techniques, applied in addition to Phase I cardiac rehabilitation in the early postoperative period after coronary artery bypass graft (CABG) surgery, on left ventricular function, respiratory functions, and functional capacity.

Detailed description: In this prospective randomized controlled study, participants will be randomly divided into two groups: the control group, which will receive Phase I cardiac rehabilitation, and the treatment group, which will receive Phase I cardiac rehabilitation along with the application of neurophysiological facilitation techniques. The participants' left ventricular function, respiratory functions, and functional capacity will be assessed before and after the interventions.

Eligibility criteria: Inclusion Criteria:

* First-time undergoing open-heart surgery
* Aged between 50 and 85 years
* Full cooperation

Exclusion Criteria:

* Presence of facial, sternum, or rib fractures
* Chronic renal failure
* Development of cerebrovascular events
* Cognitive function impairment
* Development of deep vein thrombosis in the postoperative period
* Presence of neuromuscular disease
* Presence of orthopedic disabilities
* Intubation duration longer than 24 hours
* Staying in intensive care for more than 48 hours

Primary outcomes:
measure: ecocardiography device
timeFrame: 3 months
measure: spirometer
timeFrame: 3 months
measure: 6 Minutes walking test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Okan University
name: Gamze Aydın, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107599: The Feasibility of Florbetapir Quantitation in Europe
Official title: A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.


Eligibility criteria: Inclusion Criteria:

* Readers have undergone Amyvid reader training
* Readers have not more than minimal experience with quantitation of amyloid PET scans

Exclusion Criteria:

* Readers have previously been trained to quantitate amyloid PET scans

Primary outcomes:
measure: Change in Reader Accuracy After Application of Quantitation Software
timeFrame: Scan acquired 50-60 minutes post injection
Secondary outcomes:
measure: Change in Scan Interpretation Reliability After Application of Quantitation Software
timeFrame: Scan acquired 50-60 minutes post injection
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Research Site
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT02693899: Prospective Study on the Feasibility of Plasma FLT3-Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated Intensively for Acute Leukemia
Official title: Monocentric, Biological, Uncontrolled, Prospective Study on the Feasibility of Plasma FLT3 Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated With Intensively for Acute Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en cancérologie Nantes-Angers - CRCNA
First posted: 2016-02-29
Enrollment: 80
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: All adults supported in the Clinical Hematology of the Nantes University Hospital between the beginning of the study and the end of 2017, for the diagnosis and treatment of myelogenous leukemia or acute lymphoblastic requiring intensive chemotherapy and possibly allogeneic haematopoietic stem cells.

Brief summary: Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Some studies have shown that Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an increase of this marker in the blood of patients responding to treatment. The aim of our prospective, non-interventional study is to measure the plasma levels of FLT3-L at different times of the management of patients with acute lymphoblastic leukemia but also myeloid. For this, analyzes of the samples collected in the usual care will be conducted to study the relationship between the plasma concentration of FLT3-L and outcomes. If there is any link, the FLT3-L could serve as a predictor of treatment response.


Eligibility criteria: Inclusion Criteria:

* Acute myelogenous leukemia diagnosis or lymphoblastic
* Patient intensively treated
* Patients who agreed to participate in the study and having signed the consent biocollection

Non-Inclusion Criteria:

* Patient aged under 18

Primary outcomes:
measure: Dosage of plasma FLT3-L in adult patients with acute leukemia
timeFrame: up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Pierre PETERLIN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224899: Surgical Sympathetic Blockade in Heart Failure
Official title: Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systolic Heart Failure
Beta-blockers Intolerance
Beta-blockers Resistance
Keywords: Heart Failure
Sympathetic Nervous System
Sympathectomy
Adrenergic beta-Antagonists
Ventricular Dysfunction, Left
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.


Eligibility criteria: Inclusion Criteria:

* chronic heart failure (at least 1 month of symptoms onset)
* NYHA functional class II or III
* LV ejection fraction 40% or lower
* resting heart rate higher than 65 bpm
* either maximum beta-blocker therapy according to guidelines or no beta-blocker use for intolerance.

Exclusion Criteria:

* NYHA functional class I or IV
* cardiogenic shock
* resting heart rate ≤ 65 bpm
* systolic blood pressure \< 90 mmHg
* sustained ventricular tachycardia
* eligibility to other surgical procedures
* procedure-limiting comorbidity
* presence of ICD or pacemaker
* valvar, chagasic or congenital cardiomyopathy
* age \> 70 years
* patient refusal
* contra-indication to videothoracoscopy
* decompensated thyroid disease
* atrial fibrillation or flutter
* active infection

Primary outcomes:
measure: Perioperative mortality and morbidity
timeFrame: 30 days after operation
Secondary outcomes:
measure: Cardiovascular effects
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Heart Institute (InCor) HC FMUSP
name: Edimar A Bocchi, MD
role: STUDY_CHAIR
affiliation: Heart Institute (InCor) HC FMUSP
name: Paulo M Pego-Fernandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conceicao-Souza GE, Pego-Fernandes PM, Cruz Fd, Guimaraes GV, Bacal F, Vieira ML, Grupi CJ, Giorgi MC, Consolim-Colombo FM, Negrao CE, Rondon MU, Moreira LF, Bocchi EA. Left cardiac sympathetic denervation for treatment of symptomatic systolic heart failure patients: a pilot study. Eur J Heart Fail. 2012 Dec;14(12):1366-73. doi: 10.1093/eurjhf/hfs132. Epub 2012 Oct 25.
Clinical trial NCT00693199: Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Hypertension
Keywords: Amlodipine
Terazosin
Lower Urinary Tract Symptoms (LUTS)
Essential hypertension
International Prostate Symptom Score (IPSS)
Quality Of Life (QOL)
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: The University of Science and Technology of China
name: Peking University First Hospital
First posted: 2008-06-06
Enrollment: 360
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the efficacy and safety of low dose amlodipine alone, or combined with low dose terazosin in male patients with both lower urinary tract symptoms and hypertension.


Eligibility criteria: Inclusion Criteria:

1. Men 50 years or older
2. with LUTS \[defined as International Prostate Symptom Score (IPSS) \>= 10\].
3. Stage 1 or 2 essential hypertension (SBP \>= 140 mm Hg and \< 180 mm Hg and/or DBP \>= 90 mm Hg and \< 110 mm Hg)

Exclusion Criteria:

1. A history of postural hypotension
2. Secondary hypertension
3. Prostate cancer
4. Prostate surgery or other intervention
5. Use of any agents to influence the LUTS symptoms in the last 4 weeks
6. Other severe diseases

Primary outcomes:
measure: The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.
timeFrame: 28th day after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Biomedicine Inistitute of Anhui Medical University
state: Anhui
Study officials:
affiliation: Biomedical Institute of Anhui Medical University
name: Ping Liu, PhD
role: STUDY_DIRECTOR
References:
citation: Liu H, Liu P, Mao G, Chen G, Wang B, Qin X, Na Y, Liu Z, Wang X, Xu X. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. Urology. 2009 Jul;74(1):130-6. doi: 10.1016/j.urology.2008.11.051. Epub 2009 Apr 15.