louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02294708: The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery
Official title: The Influence of Postoperative Postures on the Incidence and Duration of Persistent Sub-foveal Fluid After Scleral Buckle for Macula-off Retinal Detachment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Detachment
Keywords: macula-off retinal detachment
scleral buckle
persistent sub-foveal fluid
postoperative postures
optical coherence tomography (OCT)
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery

Detailed description: In this study, we are to compare the difference of influence of two postoperative postures on the incidence and duration of persistent sub-foveal fluid after scleral buckle surgery for macula-off retinal detachment

Eligibility criteria: Inclusion Criteria:

* rhegmatogenous retinal detachment (RRD)
* macula off
* treated by successful scleral buckle surgery
* recent onset with symptom within 1 month

Exclusion Criteria:

* with failed previous surgery
* intraoperative or postoperative injection of long-acting gas
* with other eye diseases than RRD

Primary outcomes:
measure: duration of absorption of persistent sub-foveal fluid after surgery
timeFrame: Time from the date of operation until the date of absorption of sub-foveal fluid determined by OCT. The estimated period of time over which the event (absorption of sub-foveal fluid ) is assessed is up to 1 year.
Secondary outcomes:
measure: best corrected visual acuity
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hui-Jin Chen, M.D.
role: STUDY_DIRECTOR
affiliation: Peking University Third Hospital
name: Chang-Guan Wang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02528708: A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
Official title: A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Postpartum Hemorrhage
Keywords: fibrinogen concentrate
coagulation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2015-08-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) \>1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).

Detailed description: The proposed trial targets early detection and treatment of fibrinogen depletion in PPH. A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to an increased use for this indication. The PERFECT PPH aims to provide an evidence-based knowledge for the recommendation of the early use of fibrinogen concentrate in PPH.

Eligibility criteria: Inclusion Criteria:

* Informed consent from participant
* Age ≥18 years and \<50 years
* Primary PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum
* Vaginal delivery or Cesarean delivery (irrespective of etiology of PPH, such as accreta), with EBL \>1000 mL and ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, uterotonic agents)
* FIBTEM®- A10 \<18 mm (corresponding to a MCF value of \<20 mm and to a plasma fibrinogen level approximately \<3 g/L)

Exclusion Criteria:

* Refusal to give written informed consent
* Refusal to receive blood transfusion
* Known inherited deficiencies of coagulation
* Personal history of thrombosis
* Either pre-pregnancy or ante-partum antithrombotic treatment due to increased risk of thrombosis
* Administration of Platelets, FFP or cryotherapy prior to study drug

Primary outcomes:
measure: maximum clot firmness (MCF via FIBTEM A10)
timeFrame: 15 minutes
measure: maximum clot firmness (MCF via FIBTEM A10)
timeFrame: 1 hour
measure: maximum clot firmness (MCF via FIBTEM A10)
timeFrame: 6 hours
measure: maximum clot firmness (MCF via FIBTEM A10)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Michael J Paidas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191408: Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery
Official title: Predictive Ability of PEEP Induced CVP Changes to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Critical Illness
Cardiac Output, Low
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Detailed description: Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated and sedated patients admitted to the ICU after major abdominal surgery

Exclusion Criteria:

* Heart failure NYHA III or more
* Severe obstructive or restrictive lung disease
* Hypotension with MAP \< 60 mmHg
* Tachycardia \> 140 beats / min

Primary outcomes:
measure: Stroke volume increase after passive leg raise
timeFrame: Within 30 seconds after PLR
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
state: Grad Zagreb
Study officials:
affiliation: Anesthesiologist and Intensive care medicine specialist
name: Andrej Šribar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geerts BF, Aarts LP, Groeneveld AB, Jansen JR. Predicting cardiac output responses to passive leg raising by a PEEP-induced increase in central venous pressure, in cardiac surgery patients. Br J Anaesth. 2011 Aug;107(2):150-6. doi: 10.1093/bja/aer125. Epub 2011 May 27.
Clinical trial NCT04667208: Biomarkers for Intestinal Permeability
Official title: Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus: Simplified Method to Assess Intestinal Permeability
Keywords: Gastroenterology
Gut barrier
Intestinal permeability
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.

Detailed description: This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods. In healthy volunteers potential biomarkers for intestinal permeability as well as an established "gold standard" method for intestinal permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using correlation analyses, potential associations will be assessed and potential biomarkers will be addressed and discussed.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* Underweight (BMI \<18 kg / m2) and obesity from grade II (BMI ≥ 30 kg / m2)
* Acute or chronic gastrointestinal diseases
* Chronically consuming diseases (e.g. chronic tumor disease, florid infections, etc.)
* Smokers (12 hours before the test and during the test it is not allowed to smoke)
* Ingestion of intestinal therapeutics, antibiotics, immunosuppressants or similar within the last 3 months
* Simultaneous participation in another clinical study
* Pregnancy / breastfeeding
* Intolerance to the sugar solution
* Occurrence of relevant diseases
* Revocation of consent

Primary outcomes:
measure: Lactulose / mannitol ratio
timeFrame: 1 day (Single measurement)
Secondary outcomes:
measure: Fecal albumin [ng/mg]
timeFrame: 1 day (Single measurement)
measure: Fecal calprotectin [ng/mg]
timeFrame: 1 day (Single measurement)
measure: Fecal zonulin [ng/mg]
timeFrame: 1 day (Single measurement)
measure: Plasma lipopolysaccharide binding protein [µg/ml]
timeFrame: 1 day (Single measurement)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Institute of Nutritional Medicine
name: Stephan C Bischoff, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807508: Leucine Supplementation in Elderly Men
Official title: The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcopenia
Atrophy
Aging
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-12-12
Enrollment: 29
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men


Eligibility criteria: Inclusion Criteria:

* living independently

Exclusion Criteria:

* Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years

Primary outcomes:
measure: muscle mass and body composition
timeFrame: before and after 12 wk intervention
Secondary outcomes:
measure: muscle strength
timeFrame: before and after 12 wk intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Center
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. doi: 10.3945/ajcn.2008.26668. Epub 2009 Mar 25.
Clinical trial NCT02063308: Oxaloacetate Pharmacokinetics and Safety
Official title: Oxaloacetate Pharmacokinetics and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Oxaloacetate
OAA
AD
Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.


Eligibility criteria: Inclusion Criteria:

* Meet criteria for Mild or Moderate AD
* Have a study partner
* Speak English as primary language.

Exclusion Criteria:

* Absence of a study partner
* Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)

Primary outcomes:
measure: Correlation between oral OAA intake and plasma levels
timeFrame: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing
Secondary outcomes:
measure: safety of OAA in study participants
timeFrame: Change from Baseline to Month 1
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Russell Swerdlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04248608: Perioperative Analgesic Modalities for Breast Cancer Surgeries
Official title: Perioperative Analgesic Modalities for Breast Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 75
Sex: FEMALE
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 incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects

Detailed description: One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects

Eligibility criteria: Inclusion Criteria:

* female 18-65 years old patients undergoing modified radical mastectomy

Exclusion Criteria:

* patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions

Primary outcomes:
measure: Visual analogue score
timeFrame: 24 hours
measure: Total morphine consumption
timeFrame: 24 hours
measure: First time to receive morphine
timeFrame: 24 hours
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: 24 hours
measure: heart rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of anesthesia and pain medicine. National Cancer Institute
Study officials:
affiliation: Lecturer
name: walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.
Clinical trial NCT00554008: Comparative Study of Laparoscopic Versus Open Appendectomy in Children
Official title: Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
laparoscopy
randomized trial
children
pediatric
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2007-11-06
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.

The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.


Eligibility criteria: Inclusion Criteria:

* All children under the age of 18 years with diagnosed appendicitis

Exclusion Criteria:

* Refusal of consent
* Primary language other than English or Spanish.

Primary outcomes:
measure: Surgical complications, length of stay, pain medication requirements
timeFrame: within 30 days of intervention
Secondary outcomes:
measure: Patient/family satisfaction
timeFrame: within 7 days of intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Portland
country: United States
facility: Emanuel Children's Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
Study officials:
affiliation: University of Southern California
name: David Bliss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04114708: MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
Official title: MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ruptured Achilles Tendon
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* ACL deficient knee
* skeletally mature (as defined by closed growth plates on plain radiograph)
* at least 13 years of age
* less than 26 years of age
* not pregnant
* two or more of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
* no concomitant lateral meniscus tear

Exclusion Criteria:

* knee with intact ACL
* skeletally immature (as defined by open physis on plain radiograph)
* less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
* pregnant
* less than 13 years of age
* older than age 25
* previous ACL repair
* concomitant lateral meniscus tear
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees

Primary outcomes:
measure: Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
timeFrame: 1 Year
Secondary outcomes:
measure: Graft Failure
timeFrame: 1 Year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Michael Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426608: To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.
Official title: Placebo-Controlled, Randomized, Blinded, Double-Dummy, Crossover Study to Investigate the Attenuation of ACTH Activation Induced by Metyrapone With a Single Dose of GSK561679 or Alprazolam in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder and Anxiety Disorders
Keywords: HPA axis,
Healthy volunteers
hormones,
GSK561679,
cortisol,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol).


Eligibility criteria: Inclusion:

* Healthy male subjects
* non-smoker
* normal ECG

Exclusion:

* shift workers
* vegetarians
* persons who travel distances
* persons participating in a psychology or psychiatry course

Primary outcomes:
measure: Blood levels of ACTH: over 24 hours
timeFrame: Over 24 hours
Secondary outcomes:
measure: Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours
timeFrame: Over 24 hours
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: