louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03018119: Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
Official title: Implementation of the National Partnership for Maternal Safety Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Hemorrhage
Postpartum Hemorrhage
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage consensus bundle to provide every United States birthing facility consistent, validated practice guidelines. To facilitate implementation of each element of this bundle at the participants large tertiary center, the investigators utilized the Delphi method to identify deficiencies, perceived barriers to implementation, and multidisciplinary consensus on changes with high feasibility and impact on patient care.


Eligibility criteria: Inclusion Criteria:

* ≥ five years of experience on the L\&D unit
* current employment on the L\&D unit \> 20h per week
* prior involvement in clinical obstetric hemorrhage situations

Exclusion Criteria:

* none

Primary outcomes:
measure: Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented
timeFrame: 4 weeks
Secondary outcomes:
measure: Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components
timeFrame: 4 weeks
measure: Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components
timeFrame: 6 months
measure: Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michaela Farber, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869.
Clinical trial NCT01920919: Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sarcoidosis
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Detailed description: The orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. Most patients are diagnosed between the age of 20-40 years. In sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. Sarcoidosis invalidates the lives of most patient for many years.

Although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. These symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. However, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. This wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking.

This project examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis, confirmed by histology or cytology
* Age 18-60 years
* No affected organ requiring high dose immunosuppressive therapy
* Short Form - 36 subscale physical functioning score \< 70 points

Exclusion Criteria:

* Allergy to corticosteroids
* Diagnosis of glaucoma, osteoporosis, history of fractures
* History of gastric ulcera in the past 12 months
* Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor
* Current use of carbamazepin, fenytoin, rifampicin
* Obesity (BMI \> 30)
* Pregnancy of lactation

Primary outcomes:
measure: Change in health-related quality of life versus baseline
timeFrame: 0, 3, 6, 12, 18, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
Study officials:
References:
Clinical trial NCT02912819: Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients
Official title: Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Cancer
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: INCLIVA
First posted: 2016-09-23
Enrollment: 30
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: The study included all patients with ASA status I-III scheduled for elective abdominal laparoscopic surgery.

Brief summary: General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized patients.

Investigators hypothesized that the SpO2 breathing air can personalize the open-lung approach.

Detailed description: Increase in airway pressure until the SpO2 reaches 97% (lung´s opening pressure) during the incremental positive end-expiratory (PEEP) limb. Decrease in the PEEP level until the SpO2 decreases bellow 97% (lung´s closing pressure)

Eligibility criteria: Inclusion Criteria:

* Non-obese patients with ASA physical status I-III undergoing elective abdominal laparoscopic surgery with an expected operating time of less than 2 hours were included.

Exclusion Criteria:

* age of \<18 years,
* preoperative SpO2 ≤97% while breathing room air, and
* patients with previous known cardiac or respiratory disease.

Primary outcomes:
measure: open-lung condition
timeFrame: During the experimental protocol (Intraoperative)
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Study officials:
References:
citation: Tusman G, Groisman I, Fiolo FE, Scandurra A, Arca JM, Krumrick G, Bohm SH, Sipmann FS. Noninvasive monitoring of lung recruitment maneuvers in morbidly obese patients: the role of pulse oximetry and volumetric capnography. Anesth Analg. 2014 Jan;118(1):137-44. doi: 10.1213/01.ane.0000438350.29240.08.
citation: Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
Clinical trial NCT03526419: Exparel PK and Breast Milk Excretion
Official title: Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine After TAP Block in Patients Undergoing Cesarean Section Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Milk Expression, Breast
Keywords: Liposomal bupivacaine
TAP block
cesarean section
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients undergoing scheduled C-section delivery

Brief summary: Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery


Eligibility criteria: Inclusion Criteria:

1. Pregnant women \>18 year old, scheduled for elective Cesarean delivery and who desire to have a TAP block performed after delivery.
2. American Society of Anesthesiologists physical status I, II, and III

Exclusion Criteria:

1. Patient refusal or inability to cooperate.
2. Allergy, hypersensitivity, intolerance, or contraindication to liposomal bupivacaine.
3. Severely impaired renal or hepatic function (eg, serum creatinine level \>2 mg/dL \[176.8 µmol/L\], blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\], serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal \[ULN\], or serum alanine aminotransferase \[ALT\] level \>3 times the ULN).
4. Participants at an increased risk for bleeding or with any coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5) (all contraindications to TAP block).
5. Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
6. Patient membership in a vulnerable population such as a prisoner, mentally unable to provide direct consent etc.
7. Participant has contraindication to breastfeeding or not planning to breastfeed the first 2-3 days after delivery.

Primary outcomes:
measure: milk plasma ratio
timeFrame: 72 hours
Secondary outcomes:
measure: AUC of plasma
timeFrame: 72 hours
measure: AUC of milk
timeFrame: 72 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.
Clinical trial NCT01852019: Cangrelor Prasugrel Transition Study
Official title: A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: CAD
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2013-05-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.


Eligibility criteria: Inclusion Criteria:

1. greater than / equal to 18 and less than 75 years of age
2. stable coronary artery disease defined by the following criteria

   1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q waves on at least 2 contiguous electrocardiogram (ECG) leads.

      OR
   2. Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

      AND
   3. Treatment with aspirin (ASA) 81 mg daily.

Primary outcomes:
measure: Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
timeFrame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
measure: Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
timeFrame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Secondary outcomes:
measure: Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
timeFrame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
measure: Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
timeFrame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
measure: Bleeding Events in Accordance With the GUSTO Scale
timeFrame: Day 1 through Day 8
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: David J. Schneider
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02476019: A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
Official title: A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 (ISIS-FGFR4RX, an Antisense Inhibitor of Fibroblast Growth Factor Receptor 4) Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Energy Expenditure
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 13
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 purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
2. Male or female patients between the age of 18-65 years, inclusive

   * Females: Must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
   * Males: Surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of ISIS 463588 or placebo (Study Drug)
3. Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive
4. Patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures
5. Agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits
6. Agree to maintain current diet and exercise regimen from Screening until End-of-Study

Exclusion Criteria:

1. Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening) or physical examination
2. Positive test for HIV, hepatitis B or C at Screening
3. Hypothyroidism or Hyperthyroidism
4. Weight change \> 5% in the 3 months prior to Screening

Primary outcomes:
measure: Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
timeFrame: From baseline to the average of weeks 14 and 16
Secondary outcomes:
measure: Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.
timeFrame: 33 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
References:
Clinical trial NCT06742619: PERFUSION INDEX, PRONE ,SUPİNE AND SITTING POSITION
Official title: OBESE PATIENTS AND ANAESTHESİA İNDUCTİON: PERFUSION INDEX, PRONE ,SUPİNE AND SITTING POSITION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perfusion Index
Keywords: perfusion index
prone
supine
anesthesia
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will be operated in supine prone and sitting positions

Brief summary: The aim was to investigate the effect of anesthesia management on perfusion index changes in obese patients and different anesthesia positions. The effect of positional intra-abdominal pressure and lung-related variables was investigated.

Detailed description: There may be changes in haemodynamic findings in patients after anaesthesia. The most common of these are hypotension and bradycardia. Many factors play a role on the hypotensive effect of anaesthesia induction1 . Position changes in patients during surgery in obese patients affect these changes.In our study, the changes in haemodimaic findings and the changes in PI and PVI were investigated in patients with BMI 30 and above and in patients with BMI within normal limits after induction of anaesthesia by giving prone position and sitting position.Position changes in patients during surgery in obese patients affect these changes. Hypertension and hypotension after induction of anaesthesia are common in obese patients. In addition, decreased venous return to the heart due to increased intrathoracic pressure during mechanical ventilation may trigger bradycardia and hypotension.

Eligibility criteria: Inclusion Criteria:

* 18-70 years range
* Patients who will be operated in supine prone and sitting positions

Exclusion Criteria:

* Heart Failure
* antiarrhythmic drug use hemodynamic instability uncooperative patients

Primary outcomes:
measure: Group P-S-ST
timeFrame: preoperative 5 minute and after anesthesia induction 10 20 30. mimute Perfusion İndex value)
Secondary outcomes:
measure: Body mass index, age,comorbidities
timeFrame: preoperative perion (10 minutes before anesthesia)
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University Hospital
Study officials:
References:
citation: Hara K, Ichihara K, Yamaguchi M, Takeshita H, Kuroki T. Effect of intraoperative operating table rotation on lower limb perfusion index in patients in the lithotomy position. Medicine (Baltimore). 2022 Sep 23;101(38):e30412. doi: 10.1097/MD.0000000000030677.
Clinical trial NCT00282919: A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Official title: A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Falciparum Malaria
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.


Eligibility criteria: Inclusion Criteria:

* Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

Exclusion Criteria:

* Subjects with severe or complicated malaria. Pregnant or breast feeding women.

Primary outcomes:
measure: Percentage of Participants With Parasite Clearance at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Percentage of Participants With Early Treatment Failures (ETF)
timeFrame: Baseline up to Day 28
measure: Percentage of Participants With Late Treatment Failures (LTF)
timeFrame: Baseline up to Day 28
measure: Percentage of Participants With Resistance to Treatment
timeFrame: Days 7, 14, 21, 28, 35, 42
measure: Percentage of Participants With Clinical Cure
timeFrame: Day 3, 7, 28, and 42
measure: Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42
timeFrame: Day 7, 14, 21, 35, 42
measure: Percentage of Participants With Gametocyte Clearance
timeFrame: Day 7, 14, 21, 28, 35, 42
measure: Fever Clearance Time
timeFrame: Baseline up to Day 42
measure: Parasite Clearance Time
timeFrame: Baseline up to Day 42
Other outcomes:
Locations:
city: San Andres de Tumaco
country: Colombia
facility: Pfizer Investigational Site
state: Narino
city: Bambolim
country: India
facility: Pfizer Investigational Site
state: Goa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: