louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06084741: Omitting Drains After Repair of Peptic Ulcer Perforations
Official title: Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peptic Ulcer Perforations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: . This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.

Detailed description: Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.

Eligibility criteria: Inclusion Criteria:

- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.

Exclusion Criteria:

* preoperative shock on admission.

  * Delayed presentation more than 24 hours.
  * known malignant gastric ulcers confirmed by histopathology.
  * the presence of neuropsychiatric disease, pregnant and lactating women.
  * predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS.
  * Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.

Primary outcomes:
measure: number of days of hospital stay
timeFrame: Up to 30 days
measure: number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
timeFrame: 30 days
measure: incidence of Post operative repair leak
timeFrame: 30 days
Secondary outcomes:
measure: number of days before frist bowel motion
timeFrame: 7 days
measure: severity of operative pain measured by Visual Analogue Scale (VAS
timeFrame: 7 days
measure: INCIDENCE OF postoperative nausea and vomiting (PONAV
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mohammed ElShwadfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326741: Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis
Official title: Detection of Clonal Mast Cell Disorders Among Patients With Exercise-induced Anaphylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anaphylaxis
Keywords: clonal mast cell disorder
exercise-induced anaphylaxis
hypotension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten adults of either sex

Brief summary: Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some patients experience anaphylaxis is association with exercise, a disorder called exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially those with hypotension during the anaphylactic episodes, have been shown to have abnormal, clonal populations of a certain cell type, mast cells, in the bone marrow. This has been described in at least one patient with exercise-induced anaphylaxis. The investigators would like review the findings in a group of patients with exercise-induced anaphylaxis who have undergone evaluation for the presence of abnormal, clonal mast cells.


Eligibility criteria: Inclusion Criteria:

* Anaphylaxis in association with exercise on at least two occasions
* During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Number of participants with presence of clonal abnormalities in the bone marrow specimen
timeFrame: Baseline
measure: Number of participants with presence of clonal abnormalities in the bone marrow specimen
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Akin C, Scott LM, Kocabas CN, Kushnir-Sukhov N, Brittain E, Noel P, Metcalfe DD. Demonstration of an aberrant mast-cell population with clonal markers in a subset of patients with "idiopathic" anaphylaxis. Blood. 2007 Oct 1;110(7):2331-3. doi: 10.1182/blood-2006-06-028100. Epub 2007 Jul 16.
Clinical trial NCT04441541: Treadmill With Biofeedback on Gait Symmetry After Stroke
Official title: The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Syndrome
Keywords: Gait training
Biofeedback
Treadmill
Gait symmetry
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* Single stroke experience
* Chronic stroke phase: stroke duration ≥ 6 months
* Independent gait: Functional Ambulation Category (FAC) ≥ 3

Exclusion Criteria:

* Cognitive problem (MMSE \< 24)
* Visual or audio deficiency that might affect training
* Severe heart insufficiency or uncontrolled arterial hypertension
* Orthopedic disorders that affecting their gait

Primary outcomes:
measure: Spatial and temporal gait symmetry
timeFrame: Change from baseline at the first day, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Walking speed
timeFrame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: 6 Minute Walk Test
timeFrame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: Timed up and Go test
timeFrame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: Stroke Impact Scale
timeFrame: Change from baseline at the first day, 4 weeks, and 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05891041: New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon
Official title: First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ileostomy - Stoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy patients with an ileostoma

Brief summary: 1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.

Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.

Detailed description: Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.

The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.

Eligibility criteria: Inclusion Criteria:

* Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm

Exclusion Criteria:

Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters

Primary outcomes:
measure: Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
timeFrame: 6 hours
Secondary outcomes:
measure: Pain during interpoc use
timeFrame: 6 hours
measure: Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),
timeFrame: 6 hours
measure: Scale (0-10) score of Discomfort, acid reflux, nausea
timeFrame: 6 hours
measure: InterPoc™ weight before and after insertion
timeFrame: 6 hours
measure: Leakage around the stoma pouch
timeFrame: 6 hours
measure: Fecal output in stoma bag (ml) before and after the trail
timeFrame: 6 hours
measure: InterPoc™ Skin Irritation
timeFrame: 6 hour
measure: Insertion and removal resistance
timeFrame: 6 hour
measure: Food consumption
timeFrame: 6 hour
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael P Achiam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00936416: Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers
Official title: Assessment of Renal Physiology (Glomerular Filtration Rate and Blood Flow) by MRI With Validation by Inulin and Para-Aminohippuric Acid Clearance in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glomerular Filtration Rate
Renal Blood Flow
Keywords: Glomerular Filtration Rate
Renal Blood Flow
MRI
Inulin
Para-Aminohippuric Acid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients with renal disease. Although serum creatinine based GFR and nuclear medicine based estimations are routinely used in clinical practice, GFR estimation by Inulin is the recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome para-aminohippuric acid (PAH) clearance method.

MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH clearance which are ther gold standards . In this study we propose to estimate MRI based GFR estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI is an accurate test of kidney function.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers with no known renal disease
* Ages between 18-65 years
* Normal routine urinalysis
* Estimated GFR (eGFR) \>=90mls/min
* Arterial pressure \< 130/85
* No medications (birth control pills and vitamins are acceptable)

Exclusion Criteria:

* Pregnancy
* Age \<18y or \>65y
* Proteinuria or hematuria as determined by routine urinalysis
* Estimate GFR (eGFR) \< 90 ml/min
* Known history or requirement of treatment for hypertension
* Known allergy to inulin or PAH
* MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.

Primary outcomes:
measure: GFR estimation comparison between results obtained by MRI and Inulin clearance method. Blood flow estimation comparison between results obtained by MRI and PAH clearance method.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kartik Jhaveri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04924816: Awake Prone Position in Patients With COVID-19
Official title: Evaluation of the Response to the Awake Prone Position in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Brazilian Institute of Higher Education of Censa
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of COVID-19, spontaneously ventilating, dependent on supplemental oxygen.

Brief summary: Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.


Eligibility criteria: Inclusion Criteria: patients with a confirmed diagnosis of COVID-19, through tests based on PCR and chest tomography with suggestive findings, spontaneously ventilating, dependent on supplemental oxygen. The study included patients with: (1) age ≥ 18 years, (2) peripheral oxygen saturation less than 92% under supplemental oxygen administration equal to or greater than 6 L / min through a nasal catheter or reservoir mask; (3) no use of NIV or high-flow nasal catheter; (4) continuous monitoring with pulse oximeter; (5) mental status that allowed to follow the instructions; and (6) able to tolerate PP with minimal assistance.

-

Exclusion Criteria:

* hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP

Primary outcomes:
measure: ICU admission rate
timeFrame: Patients were followed up for up to 15 days of hospitalization.
Secondary outcomes:
Other outcomes:
Locations:
city: Campos Dos Goytacazes
country: Brazil
facility: Luciano M Chicayban
state: RJ
Study officials:
References:
Clinical trial NCT01296724: PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
Official title: PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 54
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH) associated with a new organ failure. The occurrence of this syndrome is not well known in infants. Preterm birth is frequently associated with gastrointestinal complications, particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra abdominal pressure (IAP) increases and can participate in the occurrence of organ failures. Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis, could themselves be suffering from this syndrome. It would be interesting to make early diagnosis in order to optimize the management of these children. This requires reliable measurements methods and standards. Intravesical Pressure (IVP) is the most reliable validated indirect method to measure intra-abdominal pressure. In order to measure the IVP, the bladder must contain a minimum of liquid. However, using inappropriate volumes could give erroneous IAP readings. The optimal amount of saline to inject in older children, determined from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether this quantity is sufficient to obtain reliable and reproducible measurements of IVP in preterm and term.


Eligibility criteria: Inclusion Criteria:

* Preterm or term newborn admitted in paediatric intensive care unit
* With an urethral catheter
* Consent signed by parents

Exclusion Criteria:

* Weight \> 4.5 kg
* Urinary tract or bladder pathology

Primary outcomes:
measure: Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology
timeFrame: 2 years
Secondary outcomes:
measure: Determine the normal intravesical pressure in critically ill children, with and without digestive pathology
timeFrame: 2 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
affiliation: Rennes University Hospital
name: Olivier Tirel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816124: The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
Official title: The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
radiofrequency ablation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with knee osteoarthritis with Kellgren-Lawrance scale stage 3-4 will receive radiofrequency ablation to their genicular nerves and will be evaluated before treatment, 3 weeks and 3 months after treatment.
Primary purpose: TREATMENT

Brief summary: In advanced knee osteoarthritis, postural stability is also disturbed. There are some concerns about performing radiofrequency ablation to genicular nerves since this may further decrease the postural stability of the patient. The aim of this study is to see if application of genicular radiofrequency causes a significant change in postural stability.


Eligibility criteria: Inclusion Criteria:

* Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale
* Knee pain more than 3 months

Exclusion Criteria:

* Neurological diseases such as polyneuropathies
* Presence of severe psychiatric disorders
* Hemodynamic instability
* History of any surgery from the knee

Primary outcomes:
measure: Visual analogue scale
timeFrame: 3 weeks and 3 months after the intervention
Secondary outcomes:
measure: Postural stability
timeFrame: 3 weeks and 3 months after the treatment
measure: WOMAC
timeFrame: 3 weeks and 3 months after the treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT05413824: Neutrophil Side Fluorescent Light (NEU-SFL) in COVID-19 Patients
Official title: Neutrophil Side Fluorescent Light (NEU-SFL) in COVID-19 Patients Hospitalized in 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
neutrophil extracellular traps (NETs)
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 2233
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: All adult patients hospitalized for COVID-19 at Nimes Hospital in 2021.

Brief summary: Recently, a study showed that markers of neutrophil extracellular traps formation, a mechanism corresponding to neutrophil activation, were increased in patients who died of COVID 19 compared with survivors.

The investigators propose to analyze the NEU-SFL parameter, obtained automatically on the Sysmex™ blood count machine (Sysmex Corporation, Kobe, Japan) and which is considered as a reflect of neutrophil extracellular traps formation, in these two groups of patients. The aim was to evaluate whether this parameter could be used to predict the risk of death related to COVID 19.


Eligibility criteria: Inclusion Criteria:

* Hospitalization for COVID 19 in 2021

Exclusion Criteria:

* Patients who refused the use of their data

Primary outcomes:
measure: To compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021, according they survived or not.
timeFrame: 3 months
Secondary outcomes:
measure: Compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021 who survived, between entry and discharge from Nimes hospital
timeFrame: 3 months
measure: Compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021 who died, between entry and discharge from Nimes hospital
timeFrame: 3 months
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Nimes
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Anissa MEGZARI
role: STUDY_CHAIR
References: