louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05017896: Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model
Official title: Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm, Dissecting
Acute Kidney Injury
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients sufferred acute type A aortic dissection.

Brief summary: Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. It has been a hot topic in clinical research for a long time. Previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. The purpose of this study is to further clarify the risk factors by studying the relationship between preoperative CT renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative CT renal perfusion imaging and CT angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old
2. Acute type A aortic dissection diagnosed by CT angiography
3. Sign informed consent

Exclusion Criteria:

1. History of chronic kidney disease
2. History of cardiovascular operation
3. Acute kidney injury has occurred before operation
4. Pregnancy status

Primary outcomes:
measure: Acute kidney injury after operation
timeFrame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of cardiac surgery, Qilu Hospital, Shandong University
name: Xin Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977196: The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Official title: Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DTB/HB/Hib vaccine
Infants
Phase I
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed description: This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility criteria: Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighting more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion Criteria:

* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 minggu)
* Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Primary outcomes:
measure: Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
timeFrame: 30 minutes
Secondary outcomes:
measure: Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
timeFrame: 28 hours, 48 hours, 72 hours, 28 days
measure: To asses the immunogenicity
timeFrame: 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine UNPAD
name: Kusnandi Rusmil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00223496: 12- Week Open Label Treatment of Refractory Bipolar Depression
Official title: 12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar Depression
Refractory
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-22
Enrollment: 32
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: 1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Detailed description: )Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks

2) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Eligibility criteria: Inclusion Criteria:

* diagnosis of bipolar disorder I or II according to M.I.N.I.
* patient has signed informed consent
* male, or female who is using effective birth control if of child bearing age
* age 18 and above
* currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
* score of more than 19 on the MADRS
* history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant

Exclusion Criteria:

* current liver disease,
* illness precluding the use of depakote er
* patients who have been treated with a DEP and AZP combination in the past
* Alcohol/drug dependence in the past one month
* CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
* history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
* thyroid dysfunction
* unstable general medical condition
* require antipsychotic other than abilify

Primary outcomes:
measure: Primary Measure:Reduction in Depression Symptoms
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Univ of Texas Helath Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas
name: Vivek Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Charles L Bowden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03455348: Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care
Official title: Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunctions Arterial Catheter
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dysfunctions radial arterial catheter are frequent. This was a prospective, randomized observational study monocentric in ICU in France. Patients are randomized in 2 groups : One to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B). The primary outcome was the incidence of catheter dysfunction (defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve). Investigators compared also the incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter and the cause of withdrawal.


Eligibility criteria: Inclusion Criteria:

* all patients admitted in ICU, older than 18 years and who required an arterial catheter are include

Primary outcomes:
measure: the incidence of dysfunction motivating catheter removal as a function of the distance from the carpal radio joint.
timeFrame: through study completion- 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05860348: Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence
Official title: Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients who have been implanted with a CRT device and are planned for a de novo Barostim System implantation.

Brief summary: The purpose of this study is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that are symptomatic despite having received CRT.

Detailed description: This is a non-randomized, prospective, multicenter complementary-study of the REBALANCE Registry. Patients who have been implanted with a CRT device at least 6-months prior to enrollment are eligible for this complementary-study. Up to 150 subjects will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the study.

Eligibility criteria: Inclusion Criteria:

* Patients can be included if they were implanted with a cardiac resynchronization therapy (CRT) device at least six months (180 days) prior to informed consent and are planned for a de novo Barostim System implantation. Patients must sign an informed consent form before implantation with the Barostim System in order to participate in this study.

Exclusion Criteria:

* Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.

Primary outcomes:
measure: Change in Six Minute Hall Walk
timeFrame: 36 months post-implant
Secondary outcomes:
measure: Change in Minnesota Living with Heart Failure Quality of Life
timeFrame: 6 months post-implant
measure: Change NYHA Class
timeFrame: 6 months post-implant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists
state: Florida
city: Hackettstown
country: United States
facility: Advanced Cardiology
state: New Jersey
Study officials:
References:
Clinical trial NCT04109248: Clinical Pattern of Stroke and Transient Ischemic Attack Mimics
Official title: Clinical Pattern of Stroke and Transient Ischemic Attack Mimics in Patients Attending Neuropsychiatry Department in Assuit University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Transient Ischemic Attack
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient presented with an acute neurological symptom or focal neurological deficit that lasted for few minutes up to 24 hours or more in Neuropsychiatry department will be included in the study . These patients will be recruited

Brief summary: wide range of diagnoses may present like stroke, called stroke mimics as well as transient ischemic attacks .


Eligibility criteria: Inclusion Criteria:

* Male or female
* aged above 18 years
* Accept all requirements of the study

Exclusion Criteria:

.Refuse participation in the study

Primary outcomes:
measure: True estimation of frequency of stroke and TIA mimics in patients attending Neuropsychiatry department in Assuit University Hospital.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03316248: The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation
Official title: Investigation of the Effect of Visual Feedback on Function, Stability and Quality of Life in Individuals With Transtibial Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Traumatic Amputation
Keywords: Transtibial amputation
visual feedback
rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 24
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: This study was conducted to examine the effect of visual feedback on function, stability and quality of life in transtibial amputees. A total of 24 subjects who had unilateral transtibial amputations, used prosthesis with total surface bearing socket (TSB) for at least 1 year and volunteered to participate in the study were included. Before and after Treatment subjects were evaluated with "LASAR Posture" for prosthetic weight bearing (PWB), "Berg Balance Scale (BBS)" and "Timed Up\& Go Test (TUG)" for balance and functional mobility, "2-Minute-Walk-Test (2MWT)" for physical performance, "Satisfaction with the Prosthesis Questionnaire (SATPRO)" for prosthetic pleasure and "Nottingham Health Profile (NHP)" for health- related quality of life. Participants were randomly divided into two equal groups as study and control groups. After the evaluations the same exercises; PWB exercises, balance exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different grounds were applied to the the study group with visual feedback methods and control group.

Detailed description: Inclusion criteria:

1. had transtibial amputation
2. \>18 years old
3. had total surface bearing socket at least one year

Outcome measures:

* Prosthetic weight bearing
* Berg Balance Scale
* Timed up \&go Test
* 2 Minute Walk Test
* Satisfaction of prosthesis questionnare
* Nottingham health profile

Eligibility criteria: Inclusion Criteria:

* had unilateral transtibial amputations,
* used prosthesis with total surface bearing socket (TSB) for at least 1 year
* volunteered to participate in the study

Exclusion Criteria:

* had any neurological disorders
* had any cognitive problems

Primary outcomes:
measure: Prosthetic Weight bearing
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Elif Kırdı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044148: The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
Official title: The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Persistent Albuminuria
Lead sponsor: Chromaderm, Inc.
Sponsor class: INDUSTRY
First posted: 2002-08-21
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2) Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that may be associated with it.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Greater than or equal to 30 years of age
* Albumin to Creatinine ratio (greater than 200 mg/g and less than 2000 mg/g) 4)Without language barrier.

Exclusion Criteria:

* Serum Creatinine greater than 2.0 mg/dl males or greater than 1.7 mg/dl females
* B/P greater than 150 systolic and greater than 90 diastolic
* Hemoglobin Alc greater than 11%
* Liver Function Tests 2 times upper limit of normal
* Poor medical or psychiatric risk.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Waltham
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: St Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT02195648: Sub-occipital Muscle Inhibition in Tension Type Headache
Official title: Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Tension-Type Headache
Physical Therapy Modalities
Musculoskeletal Manipulations
Sub-occipital muscle inhibition technique
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy.

Detailed description: This study is based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy improves symptoms in patients with tension type headache and cervicogenic headache.

The purposes of this study are:

* Evaluate the effectiveness of treatment based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy in patients with tension type headache.
* Evaluate the effects of treatment caused in upper cervical movement.
* Evaluate the effects of treatment caused in neck pain.
* Evaluate the effects of treatment caused in headache.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with tension type headache
* In prophylactic regimen and with medical control

Exclusion Criteria:

* Patients with neurological or cognitive impairments that prevent understanding the questionnaires
* Patients diagnosed with other types of headaches
* Patients who have not signed the informed consent document

Primary outcomes:
measure: Pain
timeFrame: Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)
measure: Anxiety
timeFrame: STAI will be assessed at baseline and after 4 weeks.
Secondary outcomes:
measure: Headache Disability
timeFrame: HDI will be assessed at baseline and after 4 weeks.
measure: Headache Impact Test
timeFrame: HIT-6 will be assessed at baseline and after 4 weeks.
measure: Range of Motion
timeFrame: ROM will be assessed at baseline and after 4 weeks.
measure: Neck Disability Index
timeFrame: NDI will be assessed at baseline and after 4 weeks.
measure: SF-36 Health Survey
timeFrame: SF-36 will be assessed at baseline and after 4 weeks.
measure: Depression
timeFrame: BECK II will be assessed at baseline and after 4 weeks.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Guadalupe
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Javier Meroño-Gallut, PhD
role: STUDY_DIRECTOR
References: