louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05516394: National Polish Registry of Minimally Invasive Liver Surgery
Official title: National Polish Registry of Minimally Invasive Liver Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Tumor
Keywords: laparoscopic liver resection
short-term results
long-term results
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: Ludwik Rydygier Memorial Hospital, Cracow, Poland
name: Regional Oncology Center, Białystok, Poland
name: Medical University of Lublin
name: Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland
name: Medical University of Łódź
First posted: 2022-08-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent laparoscopic liver resection in Poland

Brief summary: After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice.

Primary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values.

The National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry.

This study will be the first national report about diffusion of minimally invasive surgery in Poland.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* underwent laparoscopic liver resection

Primary outcomes:
measure: Postoperative complications
timeFrame: 90 days
Secondary outcomes:
measure: Patient survival
timeFrame: 5 years
measure: Postoperative hospital stay
timeFrame: 1 year
measure: Number of patients scheduled for reoperation after laparoscopic liver resection
timeFrame: 30 days
measure: Number of patients readmitted to hospital after discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Wacław Hołówko
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380094: Triage Now: an Observational, Prospective Multimarker Study of Biomarkers in Patients Presenting With Chest Pain
Official title: TRIAGE NOW: Triage in Acute General Chest Pain Patients Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: ACS
NSTEMI
Myeloperoxidase
nonST segment elevation myocardial infarction
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with chest pain and ACE in differential diagnosis.

Brief summary: Study of diagnostic tests for heart attack for patients with chest pain.

Detailed description: Study of multiple biomarkers, including myeloperoxidase, in the evaluation of patients presenting with suspected acute coronary syndrome.

Eligibility criteria: Inclusion Criteria:

* Chest pain and ACS in differential diagnosis
* Age\> 18 years
* Ability to give informed consent

Exclusion Criteria:

* Trauma
* Vulnerable populations
* Known inflammatory condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University of Mainz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Stefan Blankenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585494: Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes
Official title: Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Complications
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Wisconsin orthopedic clinic patients ages 18 and older

Brief summary: This protocol will determine the prevalence of hyperglycemia and diabetes in the elective orthopedic population at the University of Wisconsin. It will also determine if there is a difference in outcomes. The study hypothesizes that at least 10% of patients will have some degree of impaired glucose regulation that has previously been undiagnosed.


Eligibility criteria: Inclusion Criteria:

* Ages 18 years or older
* Undergoing elective total knee, hip or lumbar spinal surgery

Exclusion Criteria:

* Pregnancy
* Unable to give consent

Primary outcomes:
measure: Prevalence of Hyperglycemia in the Elective Orthopedic Population
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.
timeFrame: 1 year
measure: Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.
timeFrame: 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ann M Sheehy, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheehy AM, Benca J, Glinberg SL, Li Z, Nautiyal A, Anderson PA, Squire MW, Coursin DB. Preoperative "NPO" as an opportunity for diabetes screening. J Hosp Med. 2012 Oct;7(8):611-6. doi: 10.1002/jhm.1958. Epub 2012 Aug 7.
Clinical trial NCT00411294: Ergocalciferol in Chronic Kidney Disease
Official title: The Effect of Ergocalciferol Treatment on 25-Hydroxyvitamin D Levels and Plasma Intact PTH in Patients With Chronic Kidney Disease Stage 3 and 4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: ergocalciferol
chronic kidney disease
secondary hyperparathyroidism
vitamin D deficiency
Lead sponsor: Saint Louis VA Medical Center
Sponsor class: FED
First posted: 2006-12-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4


Eligibility criteria: Inclusion Criteria:

* Patient with CKD stage 3 or 4 whose 25-hydroxyvitamin D levels are below 30 ng/ml and plasma intact PTH levels \>70 pg/ml.

Exclusion Criteria:

* Patients who are on any form of active vitamin treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis VA Medical Center
state: Missouri
Study officials:
affiliation: VAMC-Saint Louis
name: Ziyad Al-Aly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Aly Z, Qazi RA, Gonzalez EA, Zeringue A, Martin KJ. Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD. Am J Kidney Dis. 2007 Jul;50(1):59-68. doi: 10.1053/j.ajkd.2007.04.010.
Clinical trial NCT01932060: Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Official title: Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Keywords: Oxytocin
blood loss
Cesarean delivery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Detailed description: Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant patients with uncomplicated pregnancies:
* ASA (American Association of Anesthesiologists) class 1 or 2 patients.
* Singleton pregnancies.

Exclusion Criteria:

* ASA class 3 or 4 patients.
* Known drug allergy to intravenous oxytocin.
* Significant medical or obstetric disease.
* Known uterine abnormality.
* Known placental abnormality.

Primary outcomes:
measure: Total Estimated Blood Loss
timeFrame: immediately at end of surgery
Secondary outcomes:
measure: Hemoglobin Indices After Cesarean Delivery
timeFrame: 24 hr after cesarean delivery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital, Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Alexander J Butwick, F.R.C.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872560: Comparison of 2 NovoFine® Needles on the Reflux of Insulin
Official title: Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.


Eligibility criteria: Inclusion Criteria:

* Children/adolescents with type 1 diabetes mellitus
* Usage of NovoPen® 1.5 for at least 3 months
* Duration of insulin treatment more than 1 year
* Normal weight according to Tanner scales
* The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%

Exclusion Criteria:

* Pregnancy or desire to become pregnant
* Clinical relevant peripheral neuropathy as judged by the investigators
* Pronounced lipodystrophy in accordance with investigator's evaluation
* Use of drugs that can influence the trial
* Coagulation disorders (use of anti-coagulants)
* Serious, chronic diseases, making it highly unlikely that the subject can complete the trial

Primary outcomes:
measure: Weighing of reflux of insulin
timeFrame: 6 seconds after injection
Secondary outcomes:
measure: Pain perception
timeFrame: after 6 weeks of treatment
measure: Number and severity of bleedings
timeFrame: after 6 weeks of treatment
measure: Reactions at injection sites
timeFrame: after 6 weeks of treatment
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02478060: Birch-SPIRE Safety and Efficacy Study
Official title: A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis
Keywords: Allergy
Birch
Rhinitis
Rhinoconjuntivitis
SPIRE
Toleromune
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Quintiles, Inc.
First posted: 2015-06-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 65 years;
* Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
* Birch IgE ≥ 0.35 kU/L
* Positive skin prick test to whole birch allergen

Exclusion Criteria:

* Any past history of asthma
* FEV1 \< 80% of predicted
* History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
* Acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm
* Administration of adrenaline (epinephrine) is contraindicated
* History of severe drug allergy or anaphylactic reaction to food.
* History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Primary outcomes:
measure: Safety of Birch-SPIRE administrations measured by Adverse Events
timeFrame: Up to 16 weeks after start of dosing
Secondary outcomes:
measure: Measurement of IgE as a Pharmacodynamic parameter
timeFrame: Up to 9 months after start of dosing
measure: Conjunctival Provocation Test as a Pharmacodynamic parameter
timeFrame: Up to 9 months after start of dosing
measure: Skin Prick Testing as a Pharmacodynamic parameter
timeFrame: Up to 9 months after start of dosing
Other outcomes:
measure: Allergy symptoms and allergy medication use during next Birch season
timeFrame: Up to 9 months after start of dosing
Locations:
city: Quebec
country: Canada
facility: Centre de Recherche Appliqué en Allergie de Québec
Study officials:
References:
Clinical trial NCT01279460: Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4
Official title: Evaluation of Aortic Stiffness in CKD II to IV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decline in Renal Function
Keywords: chronic kidney disease
CKD
pulse wave velocity
PWV
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Department of Nephrology, Klinikum rechts der Isar, München
First posted: 2011-01-19
Enrollment: 167
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: Patients were enrolled in a prospective study of vascular stiffness and CV risk in patients with CKD stages 2 to 4. They were predominantly recruited from outpatients attending nephrology clinics at the Klinikum rechts der Isar der Technischen Universität München and at a private nephrological clinic in Weissenburg October 2007 to December 2008.

Brief summary: This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* CKD 2-4

Exclusion Criteria:

* pregnancy
* history of malignant disease with a prognostic life expectancy less than 24 months
* missing of written and informed consent

Primary outcomes:
measure: combined renal end-point (>25% decline in renal function or start of renal replacement therapy)
timeFrame: 24 months
Secondary outcomes:
measure: mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
city: Weissenburg
country: Germany
facility: Klinikum Weissenburg
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar of the Technical University Munich
name: Marcus Baumann, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan CR, Roos M, Schmaderer C, Lutz J, Wang JG, Heemann U, Baumann M. Interrelationship between aortic stiffness and proteinuria in chronic kidney disease. J Hum Hypertens. 2010 Sep;24(9):593-9. doi: 10.1038/jhh.2009.108. Epub 2010 Jan 28.
citation: Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.
Clinical trial NCT06558760: Changes in the Treatment of Acute Appendicitis
Official title: Continuous Decline in Open Appendectomies to 0.9% and Conversions to 2%
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: Acute Appendicitis
Type of appendectomy
Lead sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Sponsor class: OTHER
Collaborators: name: CLINOTEL Hospital Association Germany
First posted: 2024-08-19
Enrollment: 31988
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 with acute appendicitis in 68 hospitals in Germany collected by routine data between 2010 and 2022.

Brief summary: The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.

Detailed description: This retrospective observational study analyzed routine data provided by the CLINOTEL Hospital Association Germany, covering the years 2010 to 2022. The data was derived from anonymized billing data according to the German Diagnosis-Related Groups (DRG) system for inpatient hospital treatments.

The study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy.

Patients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to Intensive Care Unit, length of stay, and in-hospital-mortality. Cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. Furthermore, all cases with multiple appendectomy codes were removed from the sample. Ultimately, 31988 patients were included in the study.

Eligibility criteria: Inclusion Criteria:

* Acute Appendicitis

Exclusion Criteria:

* Age under 18 years
* No appendectomy performed

Primary outcomes:
measure: Changes in surgical techniques over time
timeFrame: 2010-2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02086760: Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
Official title: Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hydronephrosis in Children
Keywords: hydronephrosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 0
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.


Eligibility criteria: Inclusion Criteria:

* child of 30 days old or less
* unilateral or bilateral hydronephrosis (pelvis \> 5mm )

Exclusion Criteria:

* complex uropathy
* diuretic administration 6 hours prior to ultrasonography or scintigraphy
* oral feeding trouble

Primary outcomes:
measure: Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
timeFrame: V2 (Age of 6 months)
Secondary outcomes:
measure: Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
timeFrame: Between V0 (age: 30 days ) and V2 (age: 6 months)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Isabelle LACREUSE, MD
role: PRINCIPAL_INVESTIGATOR
References: