louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05970822: Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
Official title: A Phase 1b Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of BC3402 in Combination With Azacitidine in Subjects With Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Lead sponsor: Biocity Biopharmaceutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)


Eligibility criteria: Inclusion Criteria:

1. MDS and CMML subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0\~2;
4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
5. Subjects should take effective contraceptive measures
6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Prior exposure to anti-TIM-3 therapy at any time
2. Previous HSCT
3. Live vaccine administered within 4 weeks prior to start of treatment
4. Current use or use within 7 days prior to start of treatment of systemic steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed.

Other protocol-defined Inclusion/Exclusion may apply.

Primary outcomes:
measure: Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Zhijian Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03933722: Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
Official title: Comparison of Noninvasive Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Blood Pressure
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 40
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: Adults ages \> 18 who have septic shock and have an arterial line monitor in place.

Brief summary: Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

Detailed description: The aim of this study is to compare blood pressure obtained using routine blood pressure sphygmomanometer, in patients with invasive arterial pressure monitoring that have septic shock, to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Eligibility criteria: Inclusion Criteria:

* Admitted with septic shock, with or without vasopressor support needed.
* Greater than or equal to 18 years of age.
* Have an arterial catheter already in place.

Exclusion Criteria:

* No arterial catheter in place.
* Contraindication to the application of the Caretaker device due to pre-existing finger injury.
* Patients in whom use of a BP cuff is contraindicated.

Primary outcomes:
measure: Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter.
timeFrame: 20 minutes
Secondary outcomes:
measure: Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff.
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Irwin Gratz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00467922: An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
Official title: A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Ulcerative Colitis
Rectal Cancer
Colon Cancer
Colon Polyps
Rectal Polyps
Diverticulitis
Keywords: Hand-assisted colorectal surgery
colorectal disease
Crohn's
diverticulitis
Colorectal resections
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Deltex Medical, Inc.
First posted: 2007-05-01
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.


Eligibility criteria: Inclusion Criteria:

1. Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
2. Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology

Exclusion Criteria:

1. Patients requiring stoma formation as part of the operative procedure
2. Patients undergoing loop ileostomy or colostomy closure thru the stomal site
3. Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values)
4. Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification \>2

Primary outcomes:
measure: Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay
timeFrame: 90 days
Secondary outcomes:
measure: 1. Determine the effects of the three fluid management strategies on post-operative fluid requirements in colorectal surgery. on the incidence and severity of post-operative complications. on return of gastrointestinal function.
timeFrame: 90 days
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Anthony Senagore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02820922: Anesthesia for Emergency Orthopedic Surgery
Official title: Anesthetic Techniques for Emergency Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: Emergency orthopedic surgery
anesthesia
general anesthesia
regional anesthesia
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of all age groups who administered for orthopedic emergency surgery

Brief summary: The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in our clinic for emergency orthopedic surgery at a 1 year period.

Detailed description: This retrospective study included patients of all ages who have undergone emergency orthopedic surgery between January 2015 and December 2015 after approval of the research ethics committee. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery.

Eligibility criteria: Inclusion Criteria:

* all patients who had orthopedic emergency surgery

Exclusion Criteria:

* involvement of incomplete data collection

Primary outcomes:
measure: Number of patients with preferred anesthesia technique for orthopedic emergency surgery assessed by Statistical Package for the Social Sciences (SPSS) v22.0
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of ages and anesthesia technique relation on orthopedic emergency surgery by SPSS v22.0
timeFrame: 3 months
measure: Assessment of orthopedic surgery type and anesthesia relation on orthopedic emergency surgery by SPSS v22.0
timeFrame: 3 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Research and Training Hospital
Study officials:
affiliation: Sakarya University
name: Ali F Erdem, Prof
role: STUDY_CHAIR
References:
citation: Clark L, Robinson M, Varbanova M. Role of regional anesthesia in orthopedic trauma. Anesthesiol Clin. 2014 Dec;32(4):789-808. doi: 10.1016/j.anclin.2014.08.002. Epub 2014 Nov 25.
citation: Stundner O, Ortmaier R, Memtsoudis SG. Which outcomes related to regional anesthesia are most important for orthopedic surgery patients? Anesthesiol Clin. 2014 Dec;32(4):809-21. doi: 10.1016/j.anclin.2014.08.003. Epub 2014 Nov 25.
citation: Campbell VL. Anesthetic protocols for common emergencies. Vet Clin North Am Small Anim Pract. 2005 Mar;35(2):435-53. doi: 10.1016/j.cvsm.2004.10.005.
Clinical trial NCT06061822: Artificial Intelligence Delivered Cardiac Magnetic Resonance - Prospective Validation
Official title: Artificial Intelligence Delivered Cardiac Magnetic Resonance - Prospective Validation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Healthy Volunteers
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Medical Research Council
name: Rosetrees Trust
First posted: 2023-09-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Cardiac MRI (CMR) scanning allows doctors to create detailed images of the heart. However, the need for experienced cardiac radiographers to perform each scan can make CMR's delivery difficult, and some patients in the UK wait more than half a year for a scan. These radiographers must take pictures of different part of the heart, termed "views", each of which must be precisely positioned.

The investigators believe they can revolutionise CMR, by using artificial intelligence to automatically position the views so radiographers can focus on more difficult tasks.

The investigators have used a retrospective database of pseudonymised (anonymised and linked) CMR scans at our hospital to create these artificial intelligence (AI) algorithms, and they have validated them retrospectively on previous studies. The investigators now wish to test the algorithms prospectively.

In this study, the investigators will recruit patients undergoing clinical CMR scans. In addition to the routine images acquired by expert radiographers, the investigators will require a duplicate set of images, positioned and planned by the AI algorithms.

The investigators will then compare, within each patient, the AI-planned and expert-radiographer-planned scanning in terms of both speed and image quality.


Eligibility criteria: Inclusion Criteria:

* Adult (aged at least 18 years)

Exclusion Criteria:

* Children (patients below age 18).
* Pregnant patients.

Primary outcomes:
measure: Time taken to acquire images
timeFrame: During the MRI scan
measure: Image quality
timeFrame: During the MRI scan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: James P Howard, MB BChir PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05710822: QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study
Official title: Very High-Power Short-duration Ablation Utilizing the QDOT Micro Ablation Catheter for Pulmonary Vein Isolation - A Multicenter Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Catheter abaltion, very high-power short-duration, QDOT
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Afib patients with indication to pulmonary vein isolation

Brief summary: PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Suitable for PVI

Exclusion Criteria:

* Non suitable for PVI

Primary outcomes:
measure: Efficacy of the procedure
timeFrame: Periprocedural
measure: Saftey (Cardiac tamponade)
timeFrame: Periprocedural
measure: Safety (Stroke)
timeFrame: Periprocedural
measure: Safety (Bleeding)
timeFrame: Periprocedural
Secondary outcomes:
measure: Procedure time
timeFrame: Periprocedural
measure: LA dwelling time
timeFrame: Periprocedural
measure: First pass isolation
timeFrame: Periprocedural
measure: 12 months follow-up
timeFrame: 91 days - 12 months after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Department of Rhythmology
name: Christian-Hendrik Heeger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940222: Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
Official title: Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The New Treatment in Amblyopia Therapy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.

In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye
* A difference of two BCVA lines of Snellen between the two eyes

Exclusion Criteria:

* A history of penalization one month prior to the study
* Bilateral amblyopia
* BCVA less than 20/200
* Eccentric fixation
* Nystagmus
* Ocular deviation more than 10 prism diopter (pd)
* Organic amblyopia
* Uncooperative children those with
* Mental and physical disability
* Systemic diseases

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamideh Sabbaghi
Study officials:
References:
Clinical trial NCT04755322: Hydroxychloroquine in Prevention of Preeclampsia
Official title: Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women in 1st 6 weeks gestation.
2. History of preeclampsia in previous pregnancies.
3. Women who accepted to participate

Exclusion Criteria:

1. Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
3. Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up

Primary outcomes:
measure: number of cases of preeclampsia
timeFrame: 9 month
Secondary outcomes:
measure: number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema
timeFrame: 9 month
measure: Number of pregnancies with fetal malformation
timeFrame: 9 months
measure: number of live birth
timeFrame: 9 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Abdel-rahman Mahmoud Mohammed
Study officials:
References:
Clinical trial NCT01788722: Regulatory Post Marketing Surveillance Study in Korea
Official title: Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 3223
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women desiring treatment for endometriosis using Visanne (dienogest 2mg)

Brief summary: The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Women diagnosed by a physician as having endometriosis
* Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period

Exclusion Criteria:

- All contraindications according to the local marketing authorization have to be considered.

Primary outcomes:
measure: Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
timeFrame: up to 1 year
Secondary outcomes:
measure: Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population
timeFrame: 6 months and 1 year
measure: Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02566122: Establishment of Normal Muscle Strength for French Population
Official title: Establishment of Normal Muscle Strength Measured by Hand-held Dynamometer and Muscle Mass Assessed by Ultrasonography for French Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Muscle Mass
Muscle Strength
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female volunteers aged 18-90 years

Brief summary: Normal values for muscle strength using hand held dynamometer and muscle mass using echography are largely unknown. The objective of the present study is to establish normal values of these measurements in population living in France.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18-90 years

Exclusion Criteria:

* Patients \< 20 years and \> 90 years,
* Athletes involved in international sport competition
* Rheumatic or neuromuscular disease
* Other decompensated pathological conditions
* Pregnancy

Primary outcomes:
measure: measuring muscle mass using echography
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'exploration fonctionnelle Les Hôpitaux Universitaires de Strasbourg
state: Alsace
Study officials:
References: