louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00522704: Correlation Between Access Blood Flow and Extracorporeal Blood Flow
Official title: Correlation Between Access Blood Flow and Extracorporeal Blood Flow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Fistula
Keywords: Arteriovenous fistula
Access blood flow
Extracorporeal blood flow
Dynamic arterial line pressure
Hemodialysis treatment
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
First posted: 2007-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.

Brief summary: The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line Pressure (DALP) in patients with Arteriovenous fistulae in hemodialysis treatment.

Detailed description: Accesses that show a large (\>15%) decrement over time in vascular access blood flow are associated with a high risk of thrombosis. Serial measurements of vascular access blood flow predict access thrombosis. At the moment, the measurement of access flow is time consuming, operator dependent, so that it cannot be done with every treatment. We hypothesized that extracorporeal blood flow at pressure of -200 to -260 mmHg in arterial line has correlation with access blood flow and this can be used to estimate access blood flow.

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Kidney Disease K-DIGO 5d in hemodialysis treatment)
* Permanent vascular accesses with native arteriovenous fistulas (AVF)
* AVF that were at least 12 weeks old

Exclusion Criteria:

* Inflammation and pain in AVF
* Negation to participate in the study

Primary outcomes:
measure: Acces Blood Flow
timeFrame: Acces Blood Flow
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional De Cardiología Ignacio Chávez
state: Distrito Federeal
Study officials:
affiliation: HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3
name: Franklin B Mora, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Luis R Mariscal, M.D.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Guadalupe C De la Cruz, R.N.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Héctor G Pérez-Grovas, M.D.
role: STUDY_CHAIR
affiliation: Hospital Clínica Kennedy, Guayaquil Ecuador
name: Fabián H Ortiz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484104: Cerebral Perfusion in Hypothermic Circulatory Arrest
Official title: Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Circulation
Keywords: Cardiopulmonary bypass
Hypothermic circulatory arrest
Aortic arch surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 40
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: Adult population scheduled for elective aortic arch surgery.

Brief summary: Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Elective cardiac surgery with cardiopulmonary bypass
* Hypothermic circulatory arrest
* General informed consent signed

Exclusion Criteria:

- Severe stenotis in cerebral arteries

Primary outcomes:
measure: TOI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Vmca
timeFrame: through study completion, an average of 1 year
measure: Neurologic accidents
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, University of Bern
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Gabor Erdoes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352104: Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers
Official title: Effectiveness of Guiding Teachers in Individualized Behavioral Intervention Strategies With Preschool Children Indicated for Externalizing Problem Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem of Childhood and Adolescence
Keywords: Externalizing Problem Behaviour in Preschoolers
Lead sponsor: German Research Foundation
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 144
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Investigating effectiveness of the cognitive-behavioral based teacher training under routine care conditions by comparison of a baseline-interval with no special intervention to a following interval of PEP for the kindergarten teachers only each focussing on one child (3-6 years old) that the teacher herself indicated as "needing special attention for externalising behaviour". Effects on child symptoms and teachers behavior and burden within intervention-period are expected to be stronger than those during waiting-period.

Detailed description: Findings of the PEP-efficacy-study based on a randomised controlled sampling ((ISRCTN CCT-NAPN-18918) using combined training-modules for parents and teachers showed positive effects on children's behaviour in the intervention-group. These effects in teacher's view were stronger than in the control-group but could not be proved to be statistically significant. Moreover after this first step of evaluation there remain unanswered questions concerning the stability of effects after transferring the program in routine care. Therefore the study is continued by an effectiveness-study.

Eligibility criteria: Inclusion Criteria:

* teacher's interest in participating in a specific further training
* Identification of a target child (externalizing problem behavior)by teacher
* possibility of participation in at least 4 assessments (pre1, pre2, post,1stFU)

Exclusion Criteria:

Primary outcomes:
measure: Change in children's externalizing behavior
timeFrame: pre1, pre2, post, 3-, 6-, 9- & 12 month FU
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Manfred Döpfner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512304: Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)
Official title: Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.


Eligibility criteria: Inclusion Criteria:

* gastric adenocarcinoma histologically confirmed
* tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
* performance status WHO\<2
* serum albumin \>30 gr/l
* weight loss \< 10% in the next 6 months
* signed informed consent form

Exclusion Criteria:

* metastatic disease
* prior abdominal radiotherapy

Primary outcomes:
measure: feasibility of treatment
timeFrame: at the end of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Rouen
name: MICHEL Pierre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098604: The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty
Official title: The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.

The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.

The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.


Eligibility criteria: Inclusion Criteria:

* osteonecrosis of femoral head
* primary or secondary osteoarthritis of the hips
* femoral neck fracture

Exclusion Criteria:

* previous hemi- or total hip arthroplasty
* highly dislocated or severe ankylosed hip
* patients who are considered potentially unreliable or who may not reliably attend study visits

Primary outcomes:
measure: rate of dislocation in each head size
timeFrame: 6 weeks
measure: rate of dislocation in each head size
timeFrame: 3 months
measure: rate of dislocation in each head size
timeFrame: 6 months
measure: rate of dislocation in each head size
timeFrame: 9 months
measure: rate of dislocation in each head size
timeFrame: 12 months
measure: rate of dislocation in each head size
timeFrame: 24 months
Secondary outcomes:
measure: clinical results using Harris Hip Score
timeFrame: 6 weeks
measure: clinical results using Harris Hip Score
timeFrame: 3 months
measure: clinical results using Harris Hip Score
timeFrame: 6 months
measure: clinical results using Harris Hip Score
timeFrame: 9 months
measure: clinical results using Harris Hip Score
timeFrame: 12 months
measure: clinical results using Harris Hip Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul national University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyung-Hoi Koo, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03589404: Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation
Official title: Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Abdominal Wall
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-07-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, cohort,double blind
Primary purpose: DIAGNOSTIC

Brief summary: During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

Detailed description: The investigators aimed to investigate the effects of pneumoperitoneum administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent laparoscopic cholecystectomy

Exclusion Criteria:

* Previous surgeon surgeon
* Local anesthetic allergy,
* Bleeding is a diathesis disorder
* Mental impairment,
* Allergic to the drugs used,
* Patients who are not reluctant to participate in the study,
* Presence of infection in the block area,
* Patients whose body mass index is over 30

Primary outcomes:
measure: rso2
timeFrame: perioperative
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
measure: analgesic use
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04394104: COVID-19 Wellness Survey
Official title: COVID-19 Health and Wellness Self-Assessment Survey
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Health Behavior
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-selected population

Brief summary: This study will collect data on physical activity, food consumption, stress, sleep, and alcohol consumption habits both before and after the national emergency for COVID-19 was put into place. This will help identify the health behavior changes taking place due to the COVID-19 pandemic in the United States. Data on past and current health behaviors will be self-reported by participants via a single online survey. The retrospective health behavior questions will be the same quantitative questions as the current health behavior questions so a direct comparison can be made. There will be a couple qualitative questions to assess what each participant feels are the greatest barriers or impacts to their current health behaviors. Participants will be recruited via convenient sampling.

Data collected in this study will show a decline in at least one healthy behavior after the United States national emergency for COVID-19.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Under the age of 18 and anyone who does not currently reside in the United States

Primary outcomes:
measure: Health Behavior Change Regression Questionnaire
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT05746104: Second Window Indocyanine Green for All Nervous System Tumors
Official title: Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Nervous System Tumor
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.


Eligibility criteria: Inclusion Criteria:

1. Adult patients 18 years of age and older
2. Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
3. Good operative candidates, as determined by the treating physician and multidisciplinary team
4. Subjects capable of giving informed consent

Exclusion Criteria:

1. Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
2. Subjects with a history of iodide allergies
3. Vulnerable patient populations
4. Patients unable to participate in the consent process
5. Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)

Primary outcomes:
measure: Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
timeFrame: Surgery
measure: NIR Efficiency
timeFrame: Surgery
measure: NIR True Positive Rate
timeFrame: Surgery
Secondary outcomes:
measure: Safety and Toxicity
timeFrame: Surgery
measure: Association Between Resection Decision and Pathology
timeFrame: Surgery
measure: Sensitivity
timeFrame: Surgery
measure: Specificity
timeFrame: Surgery
measure: Positive Predictive Value
timeFrame: Surgery
measure: Negative Predictive Value
timeFrame: Surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03798704: Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
Official title: Comparison of Immunofluorescence Assay (IFA) and Chemiluminiscence Immunoassay (LIAISON®) for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Disease
Keywords: Lyme disease
IFA
LIAISON
children
Slovenia
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 349
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Younger then 18 years

Brief summary: The aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.

Detailed description: Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.

Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis.

Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests.

For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity.

The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia.

The secondary aim is to determine the influence of early antibiotic treatment of early disseminated LB on serological results in children with LB in Slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study.

Eligibility criteria: Children younger than 18 years with early disseminated Lyme disease:

* multiple erythema migrans
* peripheral facial nerve palsy
* lymphocytic meningitis

Primary outcomes:
measure: Sensitivity IFA vs. LIAISON
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University clinical center
Study officials:
References: