louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02429440: Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
Official title: Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Renal Cell Cancer
Advanced Renal Cell Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 40
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: Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).


Eligibility criteria: Inclusion Criteria:

* Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
* N+, M0
* M1 (after complete metastasectomy)
* ECOG performance status 0 or 1
* age \>18 years
* at least 4 weeks since last administration of radiation- or chemotherapy
* Serum levels of bilirubin \<2 mg/dl, creatinine\<2mg/dl

Exclusion Criteria:

* detectable distant metastasis in radiological imaging (M1)
* patients unable to consent
* severe cardiopulmonary disorder (NYHA \>= 3)
* presence of secondary malignancy
* Immunosuppressive medication (last application of glucocorticoids \> 4 weeks)
* seizure
* pregnancy
* simultaneous participation in other active or passive immunisation treatment

Primary outcomes:
measure: Tolerability
timeFrame: Day 0-365
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 60 Months
measure: Progression-free Survival
timeFrame: 36 Months
measure: Immune Response
timeFrame: Day 0-365
Other outcomes:
Locations:
Study officials:
affiliation: University of Tübingen, Department of Urology
name: Arnulf Stenzl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710240: Indocyanine Green for Central Nervous System Tumors
Official title: A Pilot/Feasibility Study of Intraoperative Image-Guided Surgery of CNS Tumors With Indocyanine Green and MR Spectroscopic Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Suspected Central Nervous System Tumors
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. Subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. The primary goal is to observe what tissues fluoresce in the OR, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.


Eligibility criteria: Inclusion Criteria:

Adult patients 18 years of age and older Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process (children and neonates) Patients with non-MRI compatible implanted metallic foreign bodies Patients who due to severe claustrophobia cannot tolerate MRI scanning Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium

Primary outcomes:
measure: Sensitivity (SBR)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: John Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho SS, Sheikh S, Teng CW, Georges J, Yang AI, De Ravin E, Buch L, Li C, Singh Y, Appelt D, Delikatny EJ, Petersson EJ, Tsourkas A, Dorsey J, Singhal S, Lee JYK. Evaluation of Diagnostic Accuracy Following the Coadministration of Delta-Aminolevulinic Acid and Second Window Indocyanine Green in Rodent and Human Glioblastomas. Mol Imaging Biol. 2020 Oct;22(5):1266-1279. doi: 10.1007/s11307-020-01504-w.
Clinical trial NCT04570540: Obesity in Sleep Medicine - Focusing on OHS Phenotypes
Official title: Obesity in Sleep Medicine - Focusing on OHS Phenotypes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity Hypoventilation Syndrome (OHS)
Keywords: Obstructive Sleep Apnea
Sleep Hypoventilation
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Philips Respironics
First posted: 2020-09-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patient routinely admitted to sleep lab

Brief summary: This study focuses on a comprehensive examination of obese patients with sleep-related breathing disorders including patients with OSA, sleep hypoventilation and OHS. The aim of this study is to (1) evaluate characteristics of and differences between severity levels of obesity-related breathing disorders, (2) discuss pathophysiological variables associated with hypoventilation during sleep or at daytime and (3) find functional parameters indicating sleep hypoventilation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* BMI ≥ 30 kg/m²
* Indication for sleep lab admission or indication for BiLevel or non-invasive ventilation therapy initiation due to existing hypoventilation/OHS

Exclusion Criteria:

* Age \<18 years
* Pregnancy, Lactation
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent.
* Missing informed consent
* Participation in another clinical study

Primary outcomes:
measure: Hypercapnic ventilatory response
timeFrame: Within 48 hours of sleep lab admission
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
state: Nordrhein-Westfalen
Study officials:
affiliation: Chief Physician
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herkenrath SD, Treml M, Hagmeyer L, Matthes S, Randerath WJ. Severity stages of obesity-related breathing disorders - a cross-sectional cohort study. Sleep Med. 2022 Feb;90:9-16. doi: 10.1016/j.sleep.2021.12.015. Epub 2022 Jan 4.
Clinical trial NCT03469440: Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery
Official title: Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
C.Surgical Procedure; Cardiac
Keywords: lactate
central venous saturation
Pediatric Cardiac Surgery
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2018-03-19
Enrollment: 65
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

Detailed description: Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery with cardiopulmonary bypass
* Written informed consent

Exclusion Criteria:

* Cardiac arrhythmia
* Emergency operation
* Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
* Neoplasia
* Heart transplant
* Participation in another study

Primary outcomes:
measure: Lactate clearance
timeFrame: at the beginning of surgery up to 24 hours after surgery
Secondary outcomes:
measure: Length of Mechanical ventilation
timeFrame: within 30 days after cardiac surgery
measure: Vasopressors and inotropic therapy
timeFrame: within 30 days after cardiac surgery
measure: Cardiac complications
timeFrame: within 30 days after cardiac surgery
measure: Renal complications
timeFrame: within 30 days after cardiac surgery
measure: Infection
timeFrame: within 30 days after cardiac surgery
measure: Length of ICU stay
timeFrame: within 30 days after cardiac surgery
measure: Length of hospital stay
timeFrame: within 30 days after cardiac surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
affiliation: HCFUSP
name: Flavio M Ferreira, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03641040: The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Official title: The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Exotropia
Strabismus
Keywords: Video-oculography
Intermittent exotropia
ocular deviation
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Fifteen subjects with intermittent exotropia were included. The subjects were asked to fixate on a black-on-white optotype at 1 m, which subtended a visual angle of 50 min of arc, equating to a Snellen optotype of 20/200. The video files and data about ocular deviations were obtained using VOG with alternate cover test. Investigators analyzed angles of ocular deviations in dominant and non-dominant eyes, compared with values of VOG and deviation angles of the alternative prism cover test.


Eligibility criteria: Inclusion Criteria:

* Visual acuity \>= 1.0/1.0
* Intermittent exotropia
* Cooperative

Exclusion Criteria:

* Other eye disease
* Have hyperopia, myopia \> 2 diopter
* Have horizontal strabismus \> 50 prism diopter
* Not cooperative, no agree

Primary outcomes:
measure: The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
timeFrame: 2 weeks after approval
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik hospital
Study officials:
References:
Clinical trial NCT03494140: Viscontour® Serum Med in Hydration of Facial Skin
Official title: Viscontour® Serum Med in Hydration of Facial Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sodium Hyaluronate
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a Viscontour® Serum Med therapy recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream)

Brief summary: The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.


Eligibility criteria: Inclusion Criteria:

1. Females ≥ 18 years of age and in good general health condition
2. Signed informed consent
3. Existing Viscontour® Serum Med recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream)

Exclusion Criteria:

1. Known hypersensitivity to one of the Viscontour® Serum Med components
2. Known pregnancy or lactating females
3. Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
4. Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

Primary outcomes:
measure: Change of Skin Parameters compared to Baseline
timeFrame: 20 Minutes, Day 7 and Day 28
measure: Change of Subjective Therapy Evaluation (Questionnaire) compared to Baseline
timeFrame: 20 Minutes, Day 7 and Day 28
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis Dr. Dirk Gröne
Study officials:
References:
Clinical trial NCT02517840: Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia
Official title: Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 53
Sex: ALL
Minimum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Critical Limb Ischemia aged 90 year-old or above

Brief summary: The rise in life expectancy implies an increased number of nonagenarian patients who need evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether revascularization techniques in these patients fulfill a set of security and efficacy criteria generated from surgical results in a validated historical cohort.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Critical Limb Ischemia aged 90 year-old or above

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence at 30 days of major adverse cardiovascular events (MACE)
timeFrame: 30 days after the procedure
measure: Incidence at 30 days of major adverse limb events (MALE)
timeFrame: 30 days after the procedure
measure: Incidence at 30 days of limb major amputations (MA)
timeFrame: 30 days after the procedure
Secondary outcomes:
measure: Limb salvage (LS)
timeFrame: 12 months after the procedure
measure: Survival
timeFrame: 12 months after the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04215640: Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
Official title: Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Supraventricular Tachycardia
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 136
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
* Give written informed consent for the study

Exclusion Criteria:

* Unable to induce supraventricular tachycardia during electrophysiologic study.
* Cognitive impairment to understand study procedure

Primary outcomes:
measure: RF time (seconds) to successful ablation
timeFrame: At the end of radiofrequency ablation procedure
measure: RF application number
timeFrame: At the end of radiofrequency ablation procedure
Secondary outcomes:
measure: Total ablation time (seconds)
timeFrame: At the end of radiofrequency ablation procedure
measure: Presence of either acute reconnection or reinduction
timeFrame: At the end of radiofrequency ablation procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong-Seog Oh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi Y, Kim SH, Kim H, Park JW, Ha YW, Hwang Y, Kim JH, Jang SW, Oh YS. The advantage of the mini-electrode-equipped catheter for the radiofrequency ablation of paroxysmal supraventricular tachycardia. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2164-2171. doi: 10.1111/jce.15639. Epub 2022 Aug 24.
Clinical trial NCT00110240: Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-05-05
Enrollment: 594
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 study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 20-40
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
Secondary outcomes:
measure: Change from baseline in HbA1c at 24 weeks for subset of Chinese patients
measure: Overall adverse event profile after 24 weeks of treatment
measure: Gastrointestinal side effect profiles after 24 weeks of treatment
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c <7% after 24 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pan C, Yang W, Barona JP, Wang Y, Niggli M, Mohideen P, Wang Y, Foley JE. Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial. Diabet Med. 2008 Apr;25(4):435-41. doi: 10.1111/j.1464-5491.2008.02391.x. Epub 2008 Mar 13.