louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00523497: Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia
Official title: Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Community Acquired Pneumonia.
Acute Hypoxemic Respiratory Failure
Keywords: Severe community-acquired pneumonia
Noninvasive mechanical ventilation
Acute hypoxemic respiratory failure.
Lead sponsor: Hospital Privado del Sur
Sponsor class: OTHER
First posted: 2007-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.


Eligibility criteria: Inclusion Criteria:

The criteria for the diagnosis of SCAP included:

* Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg
* RR higher than 30 breaths per minute
* PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)
* Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and
* Use of vasopressor drugs

Exclusion Criteria:

Exclusion criteria included:

* COPD
* Asthma
* Acute cardiogenic pulmonary edema
* Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs
* Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation
* Antecedents of respiratory failure resulting from neuromuscular pathology
* Failure of two or more organs
* Facial deformities; and
* Recent facial, aesophagic and gastric surgeries

Primary outcomes:
measure: The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV
timeFrame: 3 years
Secondary outcomes:
measure: The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange.
timeFrame: 3 years
Other outcomes:
Locations:
city: Bahía Blanca
country: Argentina
facility: Hospital Privado del Sur
state: Buenos Aires
Study officials:
name: S. A Lasdica, Study Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04986397: Cold Therapy for Pediatric Appendectomy
Official title: Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendicitis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 52
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized control trial to evaluate the efficacy of an FDA approved cold therapy device vs. usual care among children undergoing appendectomy at a large children's hospital.


Eligibility criteria: Inclusion Criteria:

* Age of 7 years of older
* Diagnosis of appendicitis and scheduled appendectomy

Exclusion Criteria:

* Neurologic and Decision Impairment
* Chronic opioid dependency
* Planned ICU admission post-operatively
* Reoperation during hospital stay
* Ward of the state
* Non-english and non-spanish speakers

Primary outcomes:
measure: Numeric Pain Intensity Scale
timeFrame: Post operative days 1-3
Secondary outcomes:
measure: Mean Morphine Metabolic Equivalents (MME)
timeFrame: Limited to duration of hospital stay, up to 1 month
measure: Length of Hospital Stay
timeFrame: Duration of stay in hospital post-operatively, up to 1 month
measure: Time to Return of Tolerating Solid Food
timeFrame: Duration of time until beginning to tolerate solid food, up to 1 month
Other outcomes:
measure: Brief Pain Inventory Short Form
timeFrame: Post operative days 1-3
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Rentea RM, Peter SDS, Snyder CL. Pediatric appendicitis: state of the art review. Pediatr Surg Int. 2017 Mar;33(3):269-283. doi: 10.1007/s00383-016-3990-2. Epub 2016 Oct 14.
citation: Cairo SB, Calabro KA, Bowdish E, Reilly C, Watt S, Rothstein DH. Variation in postoperative narcotic prescribing after pediatric appendectomy. J Pediatr Surg. 2019 Sep;54(9):1866-1871. doi: 10.1016/j.jpedsurg.2018.11.015. Epub 2019 Feb 7.
citation: Harbaugh CM, Gadepalli SK. Pediatric postoperative opioid prescribing and the opioid crisis. Curr Opin Pediatr. 2019 Jun;31(3):378-385. doi: 10.1097/MOP.0000000000000768.
citation: Watkins AA, Johnson TV, Shrewsberry AB, Nourparvar P, Madni T, Watkins CJ, Feingold PL, Kooby DA, Maithel SK, Staley CA, Master VA. Ice packs reduce postoperative midline incision pain and narcotic use: a randomized controlled trial. J Am Coll Surg. 2014 Sep;219(3):511-7. doi: 10.1016/j.jamcollsurg.2014.03.057. Epub 2014 May 23.
citation: Chumkam A, Pongrojpaw D, Chanthasenanont A, Pattaraarchachai J, Bhamarapravatana K, Suwannarurk K. Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial. Pain Res Treat. 2019 Mar 4;2019:2405159. doi: 10.1155/2019/2405159. eCollection 2019.
Clinical trial NCT00531297: Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
Official title: Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Neoplasms
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: University of Basel
name: University of Krakau, Department of Visceral surgery
First posted: 2007-09-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy.

In earlier experimental and clinical studies the investigators researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.


Eligibility criteria: Inclusion Criteria:

* Stage T1 (only)
* Over 18 years old
* Patient's consent
* Previous R0 resection of rectal tumor

Exclusion Criteria:

* Metastases (M1)
* Neoadjuvant chemotherapy or radiotherapy
* Meta- or synchronous tumors

Primary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Secondary outcomes:
measure: Morbidity (>= CTCAE grade 3)
timeFrame: 30 days
measure: Perioperative mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Andreas Zerz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04999397: Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South
Official title: Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penetrating Cardiac Trauma
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who sustained a penetrating injury to the heart presenting at a single trauma unit

Brief summary: Retrospective observational study design auditing the outcomes of cardiac injuries in a single centre

Detailed description: retrospective study over a two-year period. The demographics, injury sustained, clinical physiological parameters, mechanism of injury, injury site and patterns, outcomes and in-hospital mortality description of patients who were admitted at a single centre for further management of their cardiac injuries. Investigations performed, and procedures that were undertaken were also documented. Descriptive statistical analysis was performed. P-value of \<0,05 was considered clinically significant.

Eligibility criteria: Inclusion Criteria: All Priority one penetrating cardiac injuries seen at CMJAH in patients who were 18 years and older -

Exclusion Criteria: Dead on arrival

-

Primary outcomes:
measure: List injury patterns
timeFrame: study period (Jan 2018-Dec 2019)
measure: List of Mechanisms seen
timeFrame: study period (Jan 2016-Dec 2019)
measure: outcomes
timeFrame: study period (Jan 2016-Dec 2019)
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johanneburg Academic Hospital
state: Gautheng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Maeyane Moeng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220697: Central Sensitisation and Postoperative Pain
Official title: Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracotomy
Hyperalgesia
Hyperalgesia, Secondary
Central Sensitisation
Electroencephalography
Persistent Postsurgical Pain
Humans
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: One out of 10 patients undergoing surgery develops persistent post-surgical pain (PPSP). Unfortunately, available therapies for treating this pain have limited success. It is therefore of great importance to find strategies to prevent PPSP. The goal of this project is to find new screening tools that identify patients that are at risk for developing PPSP.

Tissue injury and inflammation following surgery increase the excitability of spinal nociceptive neurons ("central sensitisation", CS) with pain hypersensitivity as consequence. It is thought that CS plays an important role in persistent pain.

The first objective of this project is to assess in human patients if the propensity to develop CS manifested as secondary hyperalgesia before surgery is predictive for PPSP.

In addition, we will test if the frequency content of the resting-state EEG reflecting the initial state of the brain will be related to the propensity for developing CS and to the presence of PPSP at two months after surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled for a lateral thoracotomy as treatment for primary lung cancer
* Ability to provide written informed consent

Exclusion Criteria:

* Evidence for a clinically-significant alteration of the skin of the volar forearms
* Pregnancy
* Having a pacemaker or implanted cardiac defibrillator

Primary outcomes:
measure: mechanical pinprick perceived intensity
timeFrame: 1 day before surgery
measure: area of increased mechanical pinprick sensitivity
timeFrame: 1 day before surgery
measure: resting state EEG
timeFrame: 1 week before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Surgery
city: Brussels
country: Belgium
facility: Saint Luc Hospital
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Valérie Lacroix, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321697: A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vulvar Cancer
Keywords: Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar
cancer requiring lymph node evaluation for the ipsilateral or contralateral
groin
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gynecology Oncology Clinic

Brief summary: This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.


Eligibility criteria: Inclusion Criteria:

* Female patients 18-100 years of age.
* All races and ethnicities.
* Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin.
* Willing participation following informed consent process.

Exclusion Criteria:

* Has not had prior groin surgery or radiation to the groins.
* Any condition the PI or study physician determines that will put the subject at risk during the procedure.
* Allergy to blue dye used in lymphatic identification.
* Pregnant or breast feeding.

Primary outcomes:
measure: Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.
timeFrame: at time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT01468597: Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery
Official title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Keywords: Emergent
Cardiac surgery
On-pump
Platelet function
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 167
Sex: ALL
Minimum age (years): 30
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 needing emergent cardiac surgery under dual antiplatelet therapy

Brief summary: The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.

Detailed description: Blood for measuring platelet function is drawn before induction of anesthesia

Eligibility criteria: Inclusion Criteria:

* First time on-pump CABG with or without valve replacement

Exclusion Criteria:

* Redo surgery,
* Renal insufficiency needing dialysis,
* Concomitant medication with warfarin,
* Preoperative fibrinogen \< 150 mg%

Primary outcomes:
measure: Calculated Blood Loss
timeFrame: until postoperative day 5
Secondary outcomes:
measure: BARC Bleeding
timeFrame: until postoperative day 2
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz
Study officials:
affiliation: Department of Anesthesia and Intensive Care Medicine, Medical University of Graz
name: Elisabeth Mahla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahla E, Prueller F, Farzi S, Pregartner G, Raggam RB, Beran E, Toller W, Berghold A, Tantry US, Gurbel PA. Does Platelet Reactivity Predict Bleeding in Patients Needing Urgent Coronary Artery Bypass Grafting During Dual Antiplatelet Therapy? Ann Thorac Surg. 2016 Dec;102(6):2010-2017. doi: 10.1016/j.athoracsur.2016.05.003. Epub 2016 Jul 1.
Clinical trial NCT01296997: Calcium Phosphate and Incretins
Official title: Influence of a Calcium Phosphate Supplementation on the Secretion of Incretins in Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Keywords: calcium phosphate
incretins
human study
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins.


Eligibility criteria: Inclusion Criteria:

* healthy men

Exclusion Criteria:

* intake of dietary supplements and chronic diseases

Primary outcomes:
measure: secretion of incretins
timeFrame: 3 weeks
Secondary outcomes:
measure: concentration of minerals in plasma
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trautvetter U, Kiehntopf M, Jahreis G. Postprandial effects of calcium phosphate supplementation on plasma concentration-double-blind, placebo-controlled cross-over human study. Nutr J. 2013 Mar 8;12:30. doi: 10.1186/1475-2891-12-30.
Clinical trial NCT03826797: Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure
Official title: Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Keywords: Non invasive ventilation
Esophageal pressure
Transpulmonary pressure
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 300
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: See inclusion criteria

Brief summary: This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19).


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Acute hypoxic respiratory failure (P/F \< 200)

Exclusion Criteria:

* Acute pulmonary edema
* Chest wall deformities
* Immediate need for Mechanical Ventilation
* Pregnancy
* Hypercapnic RF

Primary outcomes:
measure: Esophageal pressure impact on non invasive respiratory support (NRS) failure
timeFrame: 24 hours
Secondary outcomes:
measure: Transpulmonary pressure impact on NRS failure
timeFrame: 24 hours
measure: Dynamic compliance impact on NRS failure
timeFrame: 24 hours
measure: Dynamic mechanical power impact on NRS failure
timeFrame: 24 hours
measure: Correlation between nasal pressure (Pnose) and esophageal pressure
timeFrame: 24 hours
measure: Pnose impact on NRS failure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University Hospital of Modena Policlinico
Study officials:
References:
citation: Tonelli R, Cortegiani A, Marchioni A, Fantini R, Tabbi L, Castaniere I, Biagioni E, Busani S, Nani C, Cerbone C, Vermi M, Gozzi F, Bruzzi G, Manicardi L, Pellegrino MR, Beghe B, Girardis M, Pelosi P, Gregoretti C, Ball L, Clini E. Nasal pressure swings as the measure of inspiratory effort in spontaneously breathing patients with de novo acute respiratory failure. Crit Care. 2022 Mar 24;26(1):70. doi: 10.1186/s13054-022-03938-w.
citation: Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.