louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01798147: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Official title: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intrahepatic Cholangiocellular Carcinoma
Keywords: Cholangiocellular Carcinoma
TACE
SIRT
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
* Tumor confined to the liver
* At least one measurable lesion in magnetic resonance imaging (MRI)
* Tumor load ≤ 50%
* Preserved liver function (Child Pugh A and B)
* ECOG performance status ≤2

Exclusion Criteria:

* Patients feasible for curative treatment (e.g. resection or local ablation)
* Previous TACE or SIRT
* Prior Chemotherapy
* Child Pugh stage C
* ECOG Performance Status \>1
* Tumor involvement \>50% of the liver
* Extrahepatic tumor
* Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
* Esophageal bleeding during the last 3 months
* Hepatic encephalopathy
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Infiltration or occlusion of the main portal vein
* Hepatofugal blood flow in the portal vein
* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
* Contraindications against angiography
* Pregnancy

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: at the end of study
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: at the end of study
measure: Time to progression (TTP)
timeFrame: at the end of study
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Diagnostic and Interventional Radiology
Study officials:
References:
citation: Kloeckner R, Ruckes C, Kronfeld K, Worns MA, Weinmann A, Galle PR, Lang H, Otto G, Eichhorn W, Schreckenberger M, Dueber C, Pitton MB. Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial. Trials. 2014 Aug 6;15:311. doi: 10.1186/1745-6215-15-311.
Clinical trial NCT00807547: Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
Official title: A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 149
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: Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing


Eligibility criteria: Inclusion Criteria:

* history of grass pollen induced allergic rhinoconjunctivitis
* positive skin prick test

Exclusion Criteria:

* uncontrolled severe bronchial asthma
* previous treatment with immunotherapy within the previous 5 years
* contraindication for specific immunotherapy

Primary outcomes:
measure: Changes from baseline in Immuno globuline E (IgE)-blocking factor
timeFrame: 9 weeks
Secondary outcomes:
measure: Tolerability
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Center for Rhinology and Allergology
Study officials:
affiliation: Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
name: Ludger Klimek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfaar O, Wolf H, Klimek L, Schnitker J, Wustenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled trial. Clin Ther. 2012 Oct;34(10):2072-81. doi: 10.1016/j.clinthera.2012.09.006.
Clinical trial NCT01401283: GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery
Official title: Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Northern State Medical University
name: Szeged University
name: University of Kiel
name: University of Witten/Herdecke
name: University of Valencia
First posted: 2011-07-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

Detailed description: This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.

Eligibility criteria: Inclusion Criteria:

* major abdominal surgery
* duration of surgery \> 2 hours

Exclusion Criteria:

* age \< 18 years
* scheduled postoperative icu treatment

Primary outcomes:
measure: Postoperative Complications
timeFrame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days
Secondary outcomes:
measure: Hospital Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Daniel A Reuter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
Clinical trial NCT05025683: Analyzing Patient Flows at the Emergency Department by Data Analytics, Simulation, and Optimization
Official title: Analyzing Patient Flows at the Emergency Department by Data Analytics, Simulation, and Optimization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Patients
Keywords: Emergency department
Simulation
Patient Flows
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2021-08-27
Enrollment: 23425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients attended to the Emergency Department of Prince of Wales Hospital in the period of July 2017 to June 2018 will be included in this study.

Brief summary: In this project, investigators apply operations research techniques, more specifically data analytics, system simulation, mathematical modelling, and optimization, for analyzing and improving operations in the Emergency Department at the Prince of Wales Hospital. The long term goals of this project are to demonstrate that integrated approach of data analytics and systems thinking is beneficial to health service planning and to extend present work to applications in other health-service systems.

Detailed description: Design and subjects The current study requires time stamps for which patients start and end activities in the department. Personally identifiable information is not needed in this study. Investigators will collect the data from the computer system of the Department. The data will be used for data analysis and the development of simulation and optimization models. With current models, investigators investigate the effects of queueing policies, study workforce planning, and conduct a cost-effectiveness analysis for strategic planning.

Study instruments Data analytics tools and simulation and optimization softwares are needed in this research.

Interventions With simulation and optimization models, investigators examine the impacts of different operational strategies on the performance of the Emergency Department. The Computational experiments will not disturb the actual operations but will provide insights into the effectiveness of the various intervention policies.

Main Outcome Measures Investigators will derive insights from computational experiments and deliver useful recommendations for managing emergency department operations in Hong Kong.

Eligibility criteria: Inclusion Criteria:

* All the patients attended to the Emergency Department of Prince of Wales Hospital in the period of July 2017 to June 2018 will be included in this study.

Exclusion Criteria:

* No patient will be excluded in this study

Primary outcomes:
measure: Quantitative models
timeFrame: 12 months after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: NT
Study officials:
affiliation: Chinese University of Hong Kong
name: Colin A Graham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000483: Coronary Drug Project Mortality Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: MALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).

Detailed description: BACKGROUND:

Three of the CDP treatments (two doses of estrogen and dextrothyroxine) were stopped prematurely because of toxicity. At the time the treatments were stopped, it was thought that future assessment of the status of patients on those treatments would be important to evaluate long-term sequellae. Another clinical trial evaluating clofibrate for primary prevention found that more patients on that treatment than on placebo had died. This effect persisted even after the treatment was stopped. Therefore, it was considered necessary to follow the CDP patients on clofibrate.

Of the original 834l patients, about 6000 were still alive in March l975. Cause-specific mortality in those patients was assessed through March l980.

DESIGN NARRATIVE:

The vital status of the subjects known to be alive at the end of the CDP in March l975 was assessed as of March l980. This was accomplished through questioning the local investigators, letters to the subjects, and by use of Social Security Administration and National Death Index records.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland
name: Roger Sherwin
References:
citation: Canner PL, Klimt CR. The Coronary Drug Project. Experimental design features. Control Clin Trials. 1983 Dec;4(4):313-32. doi: 10.1016/0197-2456(83)90019-3. No abstract available.
citation: Canner PL, Stamler J. The Coronary Drug Project. Organizational structure of the study. Control Clin Trials. 1983 Dec;4(4):333-43. doi: 10.1016/0197-2456(83)90020-x. No abstract available.
citation: Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986 Dec;8(6):1245-55. doi: 10.1016/s0735-1097(86)80293-5.
citation: Berge KG, Canner PL. Coronary drug project: experience with niacin. Coronary Drug Project Research Group. Eur J Clin Pharmacol. 1991;40 Suppl 1:S49-51.
Clinical trial NCT04413383: Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery
Official title: Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Every year thousands of dermatologic surgery procedures are performed at the University of Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and biopsies. Surgery is known to cause anxiety for patients and with these procedures performed under local anesthetic on awake patients', the sights, sounds, and smells experienced during the procedure can lead to an increase in their anxiety or affect their overall perception of the experience. From performing and assisting with dermatologic surgery the noise associated with the use of the traditional curved Iris scissors provokes an increase in patient awareness to the procedure resulting in increased anxiety, triggering of the vasovagal response, and expressions of annoyance by the patient. However, the modified curved Iris scissors make almost no noise. The Investigators hypothesize that if patients were given the comparative experience of both types of curved Iris scissors during dermatologic surgery, then they will choose the modified curved Iris scissors because the lack of noise will be perceived as more pleasant experience. Our objective is to perform a prospective, single blinded, randomized controlled trial to determine how the noise of traditional curved Iris scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during dermatologic surgery.


Eligibility criteria: Inclusion Criteria:

* Adult (18 years or older)
* non-pregnant
* patients being treated with Mohs micrographic surgery or excision on the head and neck

Exclusion Criteria:

* Patients not meeting above inclusion criteria will be excluded.

Primary outcomes:
measure: Extent that patient notices curved Iris scissors
timeFrame: 3 to 8 hours (length of the patients Mohs Surgery)
measure: Extent that patient is bothered by the curved Iris scissors
timeFrame: 3 to 8 hours (length of the patients Mohs Surgery)
measure: Patients Preference of curved Iris scissor
timeFrame: 3 to 8 hours (length of the patients Mohs Surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: UPMB
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia Dermatology
name: John P Wuennenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270683: Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest
Official title: Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest: the DOTAC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Out-of-hospital cardiac arrest
transcranial Doppler sonography
cerebrovascular circulation
prognosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients resuscitated from out-of-hospital cardiac arrest

Brief summary: Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography (TCD) in comatose survivors after cardiac arrest.

Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit and cardiac intensive care unit in a university hospital.

Patients: all comatose patients older than 18 years successfully resuscitated from an out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic brain injury, no window for TCD measurements, or dead before neurological prognostication are excluded.

Detailed description: The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the right and left middle cerebral artery during the first 12 h after return of spontaneous circulation (ROSC). The highest value of DFV and the lowest of PI will use for the statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital discharge.

Data provided by early TCD after ROSC are associated with neurological outcome. The use of these data could lead to the development of therapeutics improving cerebral perfusion in patient resuscitated from an OHCA.

Eligibility criteria: Inclusion Criteria:

* older 18 years
* out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity

Exclusion Criteria:

* transcranial doppler not done or not interpretable
* associated cranial trauma
* died without neurological assessment

Primary outcomes:
measure: Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of pulsatility index
timeFrame: 12 hours
measure: Entry of doppler parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Adel Maamar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140083: 68Ga-NOTA Evans Blue PET/CT in Patients With Lymphatic System Related Diseases
Official title: 68Ga-NOTA Evans Blue PET/CT in Patients With Lymphatic System Related Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Positron-Emission Tomography
Keywords: Lymphatic System Related Diseases
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 80
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: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-NOTA Evans Blue (68Ga-NEB) positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and efficacy assessment in lymphatic system related diseases.

Detailed description: Subjects with lymphatic system related diseases underwent 68Ga-NEB PET/CT either for a primary diagnosis or for efficacy assessment. Anomalies were detected by visual analysis and quantitative analysis of maximum standard uptake value (SUVmax). To compare the diagnostic sensitivity of 68Ga-NEB PET/CT lymphatic imaging with other lymphatic imaging such as 99mTc-dextran for lymphatic system related diseases.

Eligibility criteria: Inclusion Criteria:

* adult population (aged between18 years and 80 years)
* patients with suspected or new diagnosed or previously treated lymphatic system related diseases
* patients who had scheduled 68Ga-NEB PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Visual analysis of lymphatic patency
timeFrame: through study completion, an average of 3 years
measure: Standardized uptake value (SUV)
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: