louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03686540: Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center
Official title: Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ExtraCorporeal Membrane Oxygenation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who benefited from an ECMO at Rennes University Hospital Center

Brief summary: The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.


Eligibility criteria: Inclusion Criteria:

All patients ≥18 years old who have benefited from an ECMO (no type, no indication) between 2004 and 2016 at the Rennes University Hospital, identified in the database of the Rennes University Hospital Center will be included in this study.

Exclusion Criteria:

Neither

Primary outcomes:
measure: Average net costs
timeFrame: 1 day of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
Study officials:
References:
Clinical trial NCT01176110: Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
Official title: A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcomes
Body Temperature
Keywords: hypothermia
minimal invasive valve replacement
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is known that perioperative hypothermia can influence the postoperative outcome negatively.

The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound infection rate.

The thermal redistribution after the induction of anesthesia is on of the reasons for perioperative hypothermia. Another reason is negative heat balance during surgery.

Further negative side effects of hypothermia are an increase of blood viscosity and thus a higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.

The aim of the study is to evaluate if patients with a perioperative active thermal management during an interventional minimal invasive valve replacement have a significantly higher body temperature at the end of the operation than patients without an active thermal management. Secondary outcome variables are complication rates, length of mechanical ventilation and length of ICU treatment.


Eligibility criteria: Inclusion Criteria:

* Patients, who need an interventional minimal invasive valve replacement
* Age ≥ 18 years
* scheduled general anesthesia during intervention
* no participation on another interventional study
* signed informed consent

Exclusion Criteria:

* pregnant or breast feeding women
* non-elective intervention
* conversion to HLM
* implantation of IABP
* pre-existing decubitus
* patients who are not able to sign informed consent

Primary outcomes:
measure: Temperature at the end of the intervention
timeFrame: average 2 hours
Secondary outcomes:
measure: hospital stay
timeFrame: max 28 days
measure: mechanical ventilation time
timeFrame: maximum 28 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Study officials:
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Michael Sander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Claudia Spies, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03460210: Bariatric Surgery and Pharmacokinetics of Atomoxetine
Official title: Bariatric Surgery and Pharmacokinetics of Atomoxetine: BAR-MEDS Atomoxetine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Atomoxetine hydrochloride
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on atomoxetine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Atomoxetine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01194310: Phaco vs. Phaco-ELT vs. Phaco-Trabectome 12m
Official title: Longtime Efficiency of Combined Cataract-Surgery and Excimer-Laser-Trabeculotomy or Trabectome in Glaucoma Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Cataract
Keywords: glaucoma
cataract
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs. combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.

Detailed description: Glaucoma is one of the most common reasons for blindness. Usually an elevated drain resistance is the reason, while aqueous humor production is normal. Medical reduction of intraocular pressure (IOP) is first line therapy in most cases. The gold standard of surgical treatment still is trabeculectomy (TE) but TE has a lot of drawbacks. In particular when glaucoma and cataract coexists, the investigators therefore prefer the combined procedure cataract extraction plus excimer laser trabeculotomy (ELT) or plus Trabectome. Indication is cataract and a moderate elevated IOP without medical therapy or a moderate cataract and elevated IOP with medical therapy.

The ELT is performed by an AIDA XeCl-Excimer Laser System (TUI-Laser AG, Germering, 1,2 mJ per burst, burst duration 16 ns, wave length 308 nm, spot diameter 200 µm). 10 foramina were made over 90 degrees of the anterior chamber angle. Trabectome procedure is performed with the Trabectome unit from Neomedix.

* Trial with medical device
* Trial with surgical intervention

Eligibility criteria: Inclusion criteria:

* All patients, which had Phaco, Phako/ELT, or Phaco-Trabectome from 01/2008 until 12/2011, where screened 12 month after surgery

Exclusion criteria:

* IOP \>35 mmHg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Toteberg-Harms M, Hanson JV, Funk J. Cataract surgery combined with excimer laser trabeculotomy to lower intraocular pressure: effectiveness dependent on preoperative IOP. BMC Ophthalmol. 2013 Jun 24;13:24. doi: 10.1186/1471-2415-13-24.
Clinical trial NCT05993910: Prospective Hyperthermia Database in Cancer Patients (HT Register)
Official title: Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperthermia
Cancer
Keywords: Hyperthermia E02.565
HTRegister
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned to include the first 1.000 patients in this prospective database. Because of the characters in the database is a certain gender distribution not laid down . Confinement are capable of all patients in the Charité , which has a hyperthermia treatment , regardless of age or gender

Brief summary: This monocentric study registry records all cancer patients at the Charité which are treated with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the general application and to obtain an accurate risk-benefit balance

After confinement in this database are the patients prospectively in order to complications, disease status and survival status tracked.

Furthermore there is the possibility in the course of this study to an optional take part in translational accompanying research with the aim of prognostic factors for response to hyperthermia treatment.

Detailed description: A total of 1000 patients with various diseases with the indication for hyperthermia in addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy) will be included in this registry protocol.

Eligibility criteria: Inclusion Criteria:

* Contrazeption with female patients at the capable of bearing children age
* Written agreement is present (DvH, ICH-GCP)
* Patients, who participate at the same time in a interventional study, can nevertheless in this register study participate if this none Exclusion criterion for the interventional study represents.
* With children must the treatment with one of the GPOH agreed Pattern take place

Exclusion Criteria:

* Exclusion criteria for the hyperthermia (such as hip prosthesis in the therapeutic area, metal implants/marker, patients with cardiac pacemakers)
* mental disease, what the proper study participation does not allow.

Primary outcomes:
measure: Effectivity
timeFrame: Through the study completion, up to 10 years
measure: Toxicity
timeFrame: Through the study completion, up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Clinic for Radio - Oncology and Radiotherapy
city: Berlin
country: Germany
facility: Clinic for Radio - Oncology and Radiotherapy
Study officials:
References:
Clinical trial NCT01122212: Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital
Official title: Introduction of Protein S100 in the Routine Diagnostics in Patients With Minor Head Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Keywords: intracerebral hemorrhage
ct scans
protein s100
inpatient treatment
Lead sponsor: Kantonsspital Münsterlingen
Sponsor class: OTHER
Collaborators: name: Roche Diagnostic Ltd.
First posted: 2010-05-13
Enrollment: 128
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients older than 3 years entering the ED of the Kantonsspital Münsterlingen with the history of a MHI during the last 6 hours and after getting informed consent

Brief summary: In Patients with minor head injury measurement of protein S100 will be introduced to the emergency departement as another tool to rule out intracerebral bleeding.

Detailed description: Severe intracerebral bleeding is still a complication even in obvious minor head injury (MHI) that makes the use of CT scanning necessary in patients with only few signs of intracerebral injury. To reduce the number of cerebral CT scans without pathologic findings measurement of protein S100 level in serum will be used in the emergency departement (ED) at our hospital.

Our hypothesis: with measurement of S100 levels cCT scans and inpatient treatment can be reduced, radiation and costs can be reduced.

From January 1st 2010 for 3-6 months all patients with head injury (all GCS) will be tested for their initial S100 level. Cut off level is set at 0,105ng/ml. During this period test results will be blinded. Decisions for further diagnostics (x-ray, cCT) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. The test results will be monitored and compared with clinical cases. Sensitivity, specificity, positive and negative predictive values will be measured.

The aim is to identify patients without risk for intracerebral bleeding (ie S100 level lower than 0,105ng/ml). Those can be managed in an outpatient way. All other patients will be diagnosed and treated as it is now.

If the test will not miss one intracranial bleeding and will save cCT scans and inpatient treatment, measurement of protein S100 will become a routine diagnostic in our ED for patients with MHI.

Eligibility criteria: Inclusion Criteria:

* history of MHI during last 6 hours
* older than 3 years

Exclusion Criteria:

* more than 6 hours after MHI
* younger than 4 years
* informed consent not given

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
state: Thurgau
Study officials:
affiliation: Kantonsspital Münsterlingen
name: Martin Blay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702312: A Bengali Dietary Salt Study to Control Blood Pressure
Official title: A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Blood pressure
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: St. Bartholomew's Hospital
First posted: 2008-06-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.

Detailed description: We conducted an exploratory study initially to learn about the East London Bangladeshi (ELB) kidney patients salt intake. Furthermore, we assessed their educational needs to inform the development and implementation of an educational programme to reduce dietary salt intake in line with the Department of Health recommendations for a good blood pressure control. The educational programme will be tested in a randomized controlled trial. We are interested in salt because studies have shown that salt is one of the causes of high blood pressure. Scientific studies have also shown that the longer a person has high blood pressure the more the damage to the kidneys.

Eligibility criteria: Inclusion Criteria:

* Adult Bengali kidney disease hypertensive patients

Exclusion Criteria:

* Non-hypertensive Bengali patients and those on dialysis therapy

Primary outcomes:
measure: Reduction in blood pressure
timeFrame: Six months
Secondary outcomes:
measure: Reduction in dietary salt intake
timeFrame: Six months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
affiliation: Barts and The London NHS Trust
name: Ione Ashurst, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
citation: de Brito-Ashurst I, Perry L, Sanders TA, Thomas JE, Dobbie H, Varagunam M, Yaqoob MM. The role of salt intake and salt sensitivity in the management of hypertension in South Asian people with chronic kidney disease: a randomised controlled trial. Heart. 2013 Sep;99(17):1256-60. doi: 10.1136/heartjnl-2013-303688. Epub 2013 Jun 13.
Clinical trial NCT03502512: REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction
Official title: A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammoplasty Patient
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.

SECONDARY OBJECTIVES:

I. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.

II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.

III. To measure patient reported outcomes (PRO, BREAST-Questionnaire \[Q\], Body Image Survey).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo reconstructive surgery with REVOLVE technique.

ARM II: Patients undergo reconstructive surgery with PureGraft technique.

After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.

Eligibility criteria: Inclusion Criteria:

* Previous breast surgery, either mastectomy or partial mastectomy
* Patients with available harvest sites for fat grafting
* Patients with body mass index (BMI) \> 20
* Anticipated harvested fat volume \> 100 cc
* Patients are willing and able to give consent

Exclusion Criteria:

* Patients with active cancer, including primary cancer, recurrent cancer and locally or distantly metastatic cancer
* Patients who are unable to provide consent
* Patients who are suspected or known to be pregnant

Primary outcomes:
measure: Fat graft retention rate
timeFrame: At 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gregory Reece, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04727112: Asthma and Allergy Screening AA2000 (Cross Sectional)
Official title: Asthma and Allergy Screening AA2000 (Cross Sectional)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
airway hyperresponsiveness
asthma management
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 493
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Population based asthma study

Brief summary: Asthma screening of 493 asthma patients

Detailed description: Questionnaire, and testing

Eligibility criteria: Inclusion Criteria: respiratory symptoms suggestive for asthma -

Exclusion Criteria:COPD

-

Primary outcomes:
measure: ACQ
timeFrame: 2004
measure: AQLQ
timeFrame: 2004
Secondary outcomes:
measure: FEV1
timeFrame: 2004
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864212: Development of a Methodology to Design a High Order Sliding Mode Controller for Drug Dosage
Official title: Development of a Methodology to Design a High Order Sliding Mode Controller for Drug Dosage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Hypertension
Anesthesia
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery in the Cardiology Hospital CMNSXXI or treated with fast-acting insulin in the Cardiology Hospital CMNSXXI

Brief summary: The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.

Detailed description: The aim of this observational study is to create a database to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.

The observed drugs in this study are fast acting insulin, propofol and sodium nitroprusside.

The effect of insulin will be measured by a continuous glucose monitor, the effect of propofol by a bispectral index monitor and the the effect of sodium nitroprusside by a invasive blood pressure monitor.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II, II

Exclusion Criteria:

* Impossibility to measure depth of anesthesia or invasive blood pressure. Impossibility of using glucose monitor.

Primary outcomes:
measure: Glucose
timeFrame: Every 5 minutes during 3 days.
measure: Bispectral Index
timeFrame: Every second during surgery
measure: Invasive blood pressure
timeFrame: Every 5 minutes during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Unidad de Investigación Médica en Enfermedades Metabólicas IMSS
state: Mexico City
Study officials:
affiliation: Investigator
name: Ana Gallardo, Dr
role: PRINCIPAL_INVESTIGATOR
References: