louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03065309: Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Official title: Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bradycardia
Hypotension
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Adaptative clinical trial, Dixon's Up-And-Down Method
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

Detailed description: Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life.

Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.

Eligibility criteria: Inclusion Criteria:

* Indication of anesthesia induction

Exclusion Criteria:

* Protocol violation
* Monitoring problems

Primary outcomes:
measure: hemodynamic stability during rapid sequence intubation
timeFrame: from anesthesia induction up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital das Forças Armadas
state: Distrito Federal
Study officials:
affiliation: Head of Anesthesiology
name: Gabriel MN Guimarães, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02311309: Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
Official title: Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Blood Loss
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 1439
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)

Brief summary: Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e. cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown. The investigators conducted a prospective study in order to examine the incidence, and risk factors associated with peroperative bleeding and transfusion.

Detailed description: This was a prospective observational including all consecutive patients scheduled for surgery during a 3 month period.

Exclusion criteria were : emergency, cardiac surgery, and pediatric surgery. Patients received an oral information and informed consent was search for all of them.

Throughout the study period (3 months) data were prospectively recorded by members of a specific research team not involved in the care of patients. Preoperative, peroperative and immediate postoperative data (post anesthesia care unit) were collected.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration \< 8 g/dL.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria:

* Cardiac surgery
* Emergency surgery

Primary outcomes:
measure: Unanticipated Bleeding
timeFrame: one day
Secondary outcomes:
measure: Transfusions
timeFrame: one day
measure: Preoperative Anemia
timeFrame: one day
measure: Lowest Hemoglobin
timeFrame: one day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Jean-Luc Hanouz, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01692509: Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort
Official title: Observation of Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort During NIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure Requiring Non Invasive Ventilation
Keywords: Non invasive ventilation
Respiratory failure
Respiratory comfort
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 30
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 patients hospitalized in the CHUV intensive care unit who require non invasive ventilation because of respiratory failure.

Brief summary: The practices and processes related to the administration of noninvasive ventilation (NIV) in the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded by an investigator at the bedside. The effect of the NIV treatment on various respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Respiratory failure
* Therapeutic treatment by NIV required

Exclusion Criteria:

* Age \< 18 years old
* Prophylactic NIV treatment
* Continuous Positive Airway Pressure (CPAP)treatment
* Denied consent

Primary outcomes:
measure: Documentation of practices and processes related to NIV treatment
Secondary outcomes:
measure: Patient's Respiratory comfort
measure: Ventilatory parameters
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Intensive care and burn unit, University Hospital of Lausanne
Study officials:
affiliation: University of Lausanne Hospitals
name: Philippe Jolliet, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02291809: REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Official title: REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Pediatric
Vaccine
HIV-1 Immunogen
Lead sponsor: Immune Response BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ \& CD8+ T cell counts along with increased HIV immunity.

Detailed description: This is a 26 subject Multi Center double-blind randomized, Safety \& Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection \& immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.

Eligibility criteria: Inclusion Criteria:

* Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
* Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs

Exclusion Criteria:

* Truvada
* Triple cocktail HAART drugs
* Healthy subjects

Primary outcomes:
measure: The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
timeFrame: 52 Weeks
measure: The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
timeFrame: 52 Weeks
Secondary outcomes:
measure: The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
timeFrame: 52
measure: The secondary objective is to evaluate & compare the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection
timeFrame: 52 Weeks
measure: The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Site TBA
state: California
Study officials:
affiliation: Immune Response BioPharma, Inc. Chief R&D Officer
name: Richard M Bartholomew, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00175409: Breast Feeding Analgesia in Preterm Infants
Official title: Breast Feeding Analgesia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Pain Response
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: SickKids Foundation
First posted: 2005-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
2. Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

Detailed description: Research Method:

In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Eligibility criteria: Inclusion Criteria:

* born between 30-36 weeks gestational age
* breastfeeding
* mother has fluent English

Exclusion Criteria:

* CNS injury
* congenital anomaly
* active infection
* has had surgeries or analgesics/sedatives in last 72 hours
* history of maternal drug exposure

Primary outcomes:
measure: Videotaped and recorded at Baseline, Lance and Recovery:
measure: Behavioral Indicators of Infant Pain (BIIP) - total score
measure: Heart Rate
Secondary outcomes:
measure: Videotaped and Recorded at Baseline, Lance and Recovery:
measure: Hand Movements
measure: Sleep/Wake States
measure: Samples taken at baseline, lance and recovery
measure: Salivary Cortisol sample
measure: Recorded before the breast feeding intervention and at 24 hours following:
measure: Preterm Infant Breastfeeding Behavior Scale
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital - Special Care Nursery
state: British Columbia
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Liisa Holsti, PhD, OT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01644409: Urgent-SQ in Treatment of Overactive Bladder Syndrome: 9-yr Follow up
Official title: Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Urinary Frequency or Urgency Adverse Event
Urinary Incontinence, Urge
Keywords: OAB
Overactive bladder
Urgency
Incontinence
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 8
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: Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant

Brief summary: Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).

Detailed description: This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The implant is placed via an minimal invasive surgical procedure. The implant can be activated with an external pulse generator.

This study by van de Pal et al. was conducted with the approval of the local Medical Ethical Committee and with a one year systematic follow-up of eight patients. Since then, follow-up up and use of the device was open-label.

This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ implant in these eight patients.

Parameters evaluated were local pain and discomford at the site of the implant, AE's related to the implant or the use of the implant. Current use of the treatment and effectivity of the treatment.

van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.

Eligibility criteria: Inclusion Criteria:

* Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004

Exclusion Criteria:

* Patient who had the implant removed before the first year after implantation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud Unviversity Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Centre Dept of Urology
name: Dick Janssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL. Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.x.
Clinical trial NCT05566509: Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer
Official title: Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balance and Physical Activity Deficits After Breast Surgery
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer

Brief summary: Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed.


Eligibility criteria: Inclusion Criteria:

* patients who had breast cancer surgery

Exclusion Criteria:

* balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease), bone metastasis, patients who have undergone reconstructive surgery

Primary outcomes:
measure: decrease in the physical activity
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02983409: Analysis the Relationship Between the Abdomen CT and Outcomes in Acute Urinary Stone Patients
Official title: A Study of Analysis the Relationship Between the Findings of Abdominal Comptuted Tomography and the Clinical Outcomes in Acute Urinary Stone Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Calculi
Emergency Service, Hospital
Keywords: computerized tomography
Urinary Calculi
Patient admission
Pain
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 862
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A adult (\>18 years) patients who was diagnosed as ureter stone. They had no previous history of ureter stone within recent 1 year. They should not have a uninary congenital or acquired anomaly and chronic renal disease.

Brief summary: This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED).

Detailed description: Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in ureter stone patient in ED.

Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED within 5 days after discharge. Investigators analyzed multiple variables including age, sex, initial clinical findings, and various CT findings to assess their association with outcomes; multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.

Eligibility criteria: Inclusion Criteria:

* ED Patients
* Age \> 18 years
* Confirmed the ureter stone by Abdomen or Urinary CT

Exclusion Criteria:

* Known a uninary congenital or acquired anomaly
* combined other healthy preblem at the ED

  * infection, renal dysfunction et al
* Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al

Primary outcomes:
measure: Multiple-painkiller
timeFrame: within 6 hours after the ED visit
measure: Admission at ED
timeFrame: within 24 hours after the ED visit
measure: Revisit to the hospital within 5 days
timeFrame: within 5 days after the ED discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
name: Sang O Park, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04413409: A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)
Official title: A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: metastasectomy
oligo-metastatic breast cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 172
Sex: FEMALE
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: This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

1. women aged 18-70 years old;
2. ECOG score: 0-2 points;
3. the expected life period is more than 3 months;
4. Histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases;
5. PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm;
6. according to the RECIST 1.1 edition, there is at least one measurable lesion;
7. the main organs are functioning normally, meeting the following criteria: Blood routine: Hb \> 90g/L (no blood transfusion within 14 days); ANC \> 1.5 x 109/L; PLT \> 75 \* 109/L;Liver function: total bilirubin TBIL is less than 1.5 x ULN (upper limit of normal value); ALT and AST are less than 3 x ULN; if there is liver metastasis, ALT and AST are less than 5 x ULN;Renal function: serum creatinine \< 1 x ULN;
8. participants voluntarily joined the study, signed informed consent, and followed up.

Exclusion Criteria:

1. the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection cannot be achieved;
2. with metastatic lesions other than liver or lung
3. patients with local recurrence
4. palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions
5. has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc.
6. pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives;
7. involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study;
8. severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;

Primary outcomes:
measure: Overall Survival
timeFrame: 3-year
Secondary outcomes:
measure: Time To Event (TTE)
timeFrame: From date of randomization at baseline to the time of the first event, assessed up to 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: