louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01413724: Survey of Postoperative Pain and Pain Management in Norwegian Hospitals
Official title: Survey of Postoperative Pain and Pain Management in Norwegian Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Administered analgesic therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Pain Association
First posted: 2011-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had surgery the previous day and still are hospitalized. Patients must give informed consent to participate.

Brief summary: The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.


Eligibility criteria: Inclusion Criteria:

* Surgery previous day

Exclusion Criteria:

* Declined participation
* Unable to communicate (delirious, sedated, intubated)
* Does not read and speak Norwegian
* Patient not available (for instance having physiotherapy og examinations during data collection)

Primary outcomes:
measure: pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Olav M Fredheim, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fredheim OM, Kvarstein G, Undall E, Stubhaug A, Rustoen T, Borchgrevink PC. [Postoperative pain in patients admitted to Norwegian hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1763-7. doi: 10.4045/tidsskr.10.1129. Norwegian.
citation: Fredheim OM, Borchgrevink PC, Kvarstein G. [Post-operative pain management in hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1772-6. doi: 10.4045/tidsskr.10.1184. Norwegian.
Clinical trial NCT03179124: Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
Official title: Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
trunk control
upper extremity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 62
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that limit activity and participation and are attributed to non-progressive disturbances in the developing fetal or infant brain

Brief summary: Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.

Detailed description: 30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper Extremity Skills Test was used to assess upper extremity functions (QUEST).

Eligibility criteria: Inclusion Criteria:

* spastic hemiparetic and / or diparetic CP
* co-operative enough to understand test directives
* between 5 and 12 years of age
* Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)
* GMFCS I, II and III

Exclusion Criteria:

Have had previous orthopedic surgery to the upper extremity

Primary outcomes:
measure: Quality of Upper Extremity Skills Test
timeFrame: 30 minutes
Secondary outcomes:
measure: Pediatric Balance Scale
timeFrame: 20 minutes
measure: Trunk Control Measurement Scale
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: study chair
name: Bülent Elbasan
role: STUDY_CHAIR
References:
Clinical trial NCT06537024: Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
Official title: Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Universität Münster
First posted: 2024-08-05
Enrollment: 32953
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were grouped into two treatment groups: LPF (reference group) or RTSA depending on which therapy was performed first. If RTSA and LPF were coded at the same day, patients were assigned to RTSA group. Two different analysis sets were defined as follows:

* Short-term set: including all patients.
* Long-term set: including all patients, which were discharged alive and had an index surgery before 2022 (to guarantee a possible follow-up time of a least one year).

Brief summary: The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.

Detailed description: see Protocol

Eligibility criteria: Inclusion Criteria:

- all patients will be included, who had an inpatient coded treatment using LPF or RTSA

Exclusion Criteria:

* Incomplete insurance status within two years before index
* Incomplete basic information
* Age\<65 years
* Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
* Previous surgical treatment (RTSA, LPF or other fracture fixation)
* Coded polytrauma
* Bone tumors/ bone metastasis
* Both sides or missing information of surgery side
* COVID-19 infection during index hospitalization

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: Overall survival (OS)
timeFrame: up to 12 years
measure: Major adverse events during index case
timeFrame: through hospital stay, an average of 16 days
measure: Major adverse events after discharge
timeFrame: up to 12 years
measure: Thromboembolic events during index
timeFrame: through hospital stay, an average of 16 days
measure: Thromboembolic events (or death) after discharge
timeFrame: up to 12 years
measure: Surgical complications during index case
timeFrame: through hospital stay, an average of 16 days
measure: Surgical complications after discharge
timeFrame: up to 12 years
Secondary outcomes:
measure: Implant-associated complication during index
timeFrame: through hospital stay, an average of 16 days
measure: Non-Implant-associated complication during index
timeFrame: through hospital stay, an average of 16 days
measure: Minor outpatient complications after discharge
timeFrame: up to 12 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01810224: Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
Official title: Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.


Eligibility criteria: Inclusion Criteria:

* Patients with stable angina, unstable angina or NSTEMI candidate to CABG
* Significant LAD and/or LM lesion - proved by FFR or Angiography AND
* At least one more, angiographycally intermediate lesion

Exclusion Criteria:

* Significant valvular disease with indication to surgical replacement
* Severe left ventricular dysfunction (EF\<35%)
* Acute STEMI
* Atrial fibrillation, if Maze procedure is planned

Primary outcomes:
measure: Rate of occluded bypass grafts
timeFrame: 1 year
Secondary outcomes:
measure: a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst OLV Hospital
city: Brno
country: Czech Republic
facility: Department of Internal Medicine and Cardiology, University Hospital Brno
city: Budapest
country: Hungary
facility: Hungarian Institute of Cardiology
Study officials:
affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
name: Emanuele Barbato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Piccoli A, Van Mieghem C, Penicka M, Mates M, Nemec P, Van Praet F, Stockman B, Degriek I, Barbato E. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019 Dec 6;15(11):e999-e1005. doi: 10.4244/EIJ-D-19-00463.
citation: Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Van Mieghem C, Penicka M, Mates M, Van Praet F, Degriek I, Barbato E. Study Design of the Graft Patency After FFR-Guided Versus Angiography-Guided CABG Trial (GRAFFITI). J Cardiovasc Transl Res. 2018 Aug;11(4):269-273. doi: 10.1007/s12265-018-9818-9. Epub 2018 Jul 19.
Clinical trial NCT00479024: Follow-up Study to Previous CARE Trial
Official title: CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Chronic Kidney Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 294
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: Primary care clinic

Brief summary: To determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as \>25% increase in SCr or \>25% increase in cystatin C).


Eligibility criteria: Inclusion Criteria: (from previous CARE trial)

* • Screening eGFR between 20 and 59 mL/min/1.73m2

  * Baseline SCr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
  * At least one post dose blood sample available
  * Received randomized contrast agent
  * Underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by PCI was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
  * Provides written Informed Consent and is willing to comply with protocol requirements;
  * Was included in the patient list provided by Bracco;
  * At least 1 year has passed since the patient's participation ended in the original CARE trial, as determined from the list provided by Bracco

Exclusion Criteria:

* • Screening eGFR outside the range of 20 and 59 mL/min/1.73m2

  * Unstable kidney disease or requiring dialysis upon enrollment
  * Prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
  * Did not receive randomized contrast agent per CARE protocol
  * Did not undergo a cardiac angiography procedure per CARE protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates
state: Alabama
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Steven Sireci, M.D.
role: STUDY_CHAIR
References:
citation: Solomon RJ, Mehran R, Natarajan MK, Doucet S, Katholi RE, Staniloae CS, Sharma SK, Labinaz M, Gelormini JL, Barrett BJ. Contrast-induced nephropathy and long-term adverse events: cause and effect? Clin J Am Soc Nephrol. 2009 Jul;4(7):1162-9. doi: 10.2215/CJN.00550109. Epub 2009 Jun 25.
Clinical trial NCT01694524: Nervous System Infections Among Patients With Febrile Seizure
Official title: Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizure
Febrile Seizure
Meningitis
Encephalitis
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
Collaborators: name: Hopital Universitaire Robert-Debre
name: Hôpital Jean Verdier
name: Centre Hospitalier Intercommunal Creteil
name: Versailles Hospital
name: Centre hospitalier Lagny Marne la vallée
name: Centre hospitalier intercommunal de Poissy
First posted: 2012-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective cohort review of consecutive patients admitted in 7 pediatric emergency departments in Ile-de-France between 2007 and 2011. All clinically well-apparent children 3 to 11 months of age with a first simple febrile seizure were included in the study. All children between 3 months and 5 years with a complex febrile seizure were included

Brief summary: Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous.

The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.


Eligibility criteria: Inclusion Criteria:

* febrile (\>38°)
* Seizure

Exclusion Criteria:

* previous non febrile seizure
* known trauma
* immunodeficiancy status
* Underlying illness

Primary outcomes:
measure: Bacterial meningitis
timeFrame: 7 days after emergency visit
measure: Herpes simplex virus meningitis/encephalitis
timeFrame: 7 days after emergency visit
Secondary outcomes:
measure: emergent intracranial processus
timeFrame: 7 days after emergency visit
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hopital Jean Verdier
city: Creteil
country: France
facility: Centre hospitalier intercommunal de creteil
city: Lagny-Sur-Marne
country: France
facility: Centre hospitalier Lagny-Marne la Vallée
city: Le chesnay
country: France
facility: Centre hospitalier de Versailles
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hopital Robert Debré
city: Poissy
country: France
facility: Centre hospitalier intercommunal de Poissy
Study officials:
affiliation: Hôpital Armand Trousseau, Paris
name: Ricardo Carbajal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05987124: Defibrotide Dose-escalation for SOS Post-HSCT
Official title: A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients With Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated With Either Renal and/or Pulmonary Dysfunction With Either Refractory or Progressive Disease Following Defibrotide Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sinusoidal Obstruction Syndrome
Veno-occlusive Disease
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses of defibrotide.


Eligibility criteria: Inclusion Criteria:

* HCT recipients (Auto or Allograft)
* SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I).
* Unresponsive to standard defibrotide therapy as defined by at least one of the following:
* Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
* Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
* Age 1 month - 75 years

Exclusion Criteria:

* Patients who did not receive HCT.
* Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH).
* Active bleeding and/or hemorrhage of at least grade 2 and above.
* History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide.
* Female patients who are pregnant or breast feeding.

Primary outcomes:
measure: To determine the incidence of grade 3 or 4 adverse events related to defibrotide
timeFrame: 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242124: Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy
Official title: Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Esophageal Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.


Eligibility criteria: Inclusion Criteria:

* Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
* Received no previous treatment for esophageal cancer
* Adequate bone marrow, liver and kidney function
* Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion Criteria:

* Age \< 18 years
* History of significant heart disease
* Inoperable on the basis of co-existent medical problems

Primary outcomes:
measure: Long and short outcome related with anastomoses
timeFrame: 3 year
Secondary outcomes:
measure: Quality of life and function outcomes
timeFrame: 3 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: YU zhen tao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: