louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02961985: Myocardial Infarction Register of the Saarland
Official title: Myokardinfarkt-Register Des Saarlandes (MIR-SL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Ministry of Social Affairs, Health, Women and Family of Saarland
First posted: 2016-11-11
Enrollment: 455
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 admitted to a hospital in the Saarland region with ST elevation myocardial infarction, in the last 24 hours.

Brief summary: The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

Detailed description: The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

In order to obtain representative data for the Saarland, preferably all consecutive patients should be documented comprehensively in the University Hospital of the Saarland, the non-university hospitals with cardiac catheterization laboratory as well as in hospitals without cardiac catheterization laboratory .

MIR-SL is attended by all 22 hospitals in Saarland, that treat patients with acute STEMI. A follow-up will be carried out after three months, 12 months and five years.

Eligibility criteria: Inclusion Criteria:

* signed informed consent

Exclusion Criteria:

* age \< 18 years
* missing informed consent

Primary outcomes:
measure: Rate of reperfusion therapies
timeFrame: 24 hours
Secondary outcomes:
measure: Time before reperfusion therapy
timeFrame: 24 hours
measure: In-hospital mortality
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saarbruecken
country: Germany
facility: Klinikum Saarbruecken
state: Saarland
city: Dillingen
country: Germany
facility: Marienhaus Klinikum Saarlouis-Dillingen
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes
Study officials:
affiliation: Stiftung Institut fuer Herzinfarktforschung
name: Anselm K. Gitt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02705885: IgY Efficacy on Periodontitis Patients
Official title: Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: IgY
Periodontitis
Porphyromonas gingivalis
gingipains
Efficacy
Lead sponsor: Immunology Research Institute in Gifu
Sponsor class: INDUSTRY
Collaborators: name: National Hospital of Odonto-Stomatology
First posted: 2016-03-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8 weeks the patients were examined against. Parameters including probing depth (PD), bleeding on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with chronic periodontitis
* had at least 2 interproximal site with pocket depth between 3 mm to 5 mm
* nonsmokers with at least 20 natural teeth
* bone loss and bleeding on probing
* had not undergone periodontal treatments within 6 weeks before the study

Exclusion Criteria:

* patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
* had allergy to egg proteins

Primary outcomes:
measure: Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
timeFrame: 8 weeks
measure: Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Hospital of Odonto-Stomatology
name: Thi Hong Minh Nguyen, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382285: The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement
Official title: The Effect of a Prolonged Peripheral Nerve Block (Utilazing Continuous Adductor Canal Block on the Level of Pain After a Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Replacement Surgery
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery

Detailed description: Knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. The period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. Peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. After the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. The level of pain greatly affects the success rate of the patient's rehabilitation. Thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Female and male patients between the ages of 18 and 80 who have signed an informed consent form.
* ASA is less than 3
* Spinal anesthesia

Exclusion Criteria:

* Patients with sensitivity to the anesthetic.

Primary outcomes:
measure: Pain level
timeFrame: during hospitalization (1-2 days)
measure: Analgesic use
timeFrame: during hospitalization (1-2 days)
Secondary outcomes:
measure: Physiotherapy
timeFrame: during hospitalization (1-2 days)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01216085: An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints
Official title: An Exploratory Single Center Study of High-dose Treatment of Glivec® in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CML
Imatinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.


Eligibility criteria: Inclusion Criteria:

1. TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
2. Patients who provided written informed consent prior to participation to this study

Primary outcomes:
measure: Major molecular response
timeFrame: 60 months
Secondary outcomes:
measure: progression-free survival
timeFrame: until 60 months
measure: number of adverse events
timeFrame: until 60 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novartis Investigational Site
Study officials:
affiliation: Catholic Medical Center
name: Dong-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03762785: Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine
Official title: Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Abdominal Cancer
Keywords: pharmacokinitics
nebulized
dexmedetomidine
preschool children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.

Detailed description: Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.

Eligibility criteria: Inclusion Criteria:

* child aged 2-7 years
* ASA I or II
* scheduled for abdominal surgery
* with average weight, height, normal serum albumin

Exclusion Criteria:

* patients with allergy to the study drug
* patients with significant organ dysfunction
* patients with cardiac arrhythmia
* patients with congenital heart disease
* use of psychotropic medication and mental retardation.

Primary outcomes:
measure: pharmacokinitics of dexmedetomidine
timeFrame: at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes
Secondary outcomes:
measure: sedation score
timeFrame: baseline and after end of the drug adminstration by 30 mininute
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: Ministry of higher education
name: Shereen M Kamal, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313685: Educational Materials for Hiccups
Official title: A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiccup
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 50
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 who have had hiccups in the preceding four weeks or patients who might be at risk for hiccups based on drug exposure (for example, recent dexamethasone exposure).

Brief summary: This is a research study about hiccup educational materials. The purpose of this study is to learn whether this type of research can be done.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age.
* Hiccups in the 4 weeks prior to phone contact (patient must confirm).
* Able to speak and read English.
* Has an e-mail address.

Exclusion Criteria:

- Individuals \< 18 years of age.

Primary outcomes:
measure: Feasibility of enrollment
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598385: Groin Complications in Open Vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery
Official title: Groin Complications in Open Vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Peripheral cannulation
Open cannulation
Percutaneous cannulation
Minimally invasive cardiac surgery
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 0
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: The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery

Detailed description: The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).

Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* Patients undergoing elective endoscopic cardiac surgery

Exclusion Criteria:

* Patients that do no understand Dutch, French, or English
* Heavily calcified cannula introduction site
* Central cannulation

Primary outcomes:
measure: Number of participants with groin complications
timeFrame: Until 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jessa Hospital
name: Alaaddin Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860585: Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Metastatic breast cancer
high-dose chemotherapy
autologous haematopoietic progenitor cell transplantation
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 235
Sex: FEMALE
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: female patients treated for Metastatic breast Cancer with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation at the Institut Paoli-Calmettesbetween 2003 and 2012

Brief summary: The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Metastatic breast Cancer
* Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012

Exclusion Criteria:

* Lack of follow-up data

Primary outcomes:
measure: Overall Survival according to Immunohistochemical subtypes .
timeFrame: 8 years
Secondary outcomes:
measure: Progression free Survival according to Immunohistochemical subtypes .
timeFrame: 8 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Christian Chabannon, MD,PhD
role: STUDY_DIRECTOR
affiliation: Institut Paoli-Calmettes
name: Anthony Gonçalves, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232985: Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
Official title: An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Pruritus
Keywords: Atopic Dermatitis
Pruritus
Lead sponsor: Oculus Innovative Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.

Detailed description: RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Female or male, 18 to 65 years of age and in good general health
* Clinical diagnosis of stable mild to moderate atopic dermatitis
* Willing and able to follow study instructions and likely to complete all study requirements

Exclusion Criteria:

* Severe or uncontrolled asthma
* Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Primary outcomes:
measure: Investigator Global Assessment
timeFrame: 2 weeks
Secondary outcomes:
measure: Investigator Pruritus Assessment
timeFrame: 2 weeks
measure: Subject Itch Assessment
timeFrame: 2 weeks
measure: Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
Study officials:
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe Draelos, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628185: Pain Assessment in the Intensive Care Unit
Official title: Pain Assessment in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Critical Illness
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive Care Unit patients

Brief summary: Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. Consequently, pain assessment is highly challenging in these ICU patients. This is a prospective observational study assessing 3 behavioral pain scales in the ICU.

The hypothesis of this proposal is that one of the three ICU pain scales has a more important reliability than the others. Such a scale could be recommended to be used to measure pain intensity in ICU patients not able to communicate.

Detailed description: The aims of this observational study are to measure and compare the psychometric properties of Behavioral Pain Scale (BPS), Critical Care Pain Observation Tool (CPOT) and Non Verbal Pain Scale (NVPS) at baseline and following repositioning procedure in the ICU

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* not comatose, defined by a Richmond Agitation Sedation Scale (RASS) ≥ -3, i.e. between -3 and +4
* not able to self-report accurately their pain intensity using a visually enlarged 0-10 numeric rating scale

Exclusion Criteria:

-neurological deficits (acute or chronic) that prevent observation of the muscle tonus or movement. For example:

* Quadriplegia
* Current use of Neuromuscular blocking agents
* Severe brain injuries

Primary outcomes:
measure: pain score reliability
timeFrame: change from time 0 pain assessment to time 30min pain assessment
Secondary outcomes:
measure: pain score validity
timeFrame: change from time 0 pain assessment to time 30min pain assessment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jesse Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanques G, Pohlman A, Kress JP, Molinari N, de Jong A, Jaber S, Hall JB. Psychometric comparison of three behavioural scales for the assessment of pain in critically ill patients unable to self-report. Crit Care. 2014 Jul 25;18(5):R160. doi: 10.1186/cc14000.
Clinical trial NCT00768885: Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.
Official title: Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.


Eligibility criteria: Inclusion Criteria:

* Subject is myopic
* Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using pharmaceuticals that may affect the function of the eyes or lenses.
* Subject possessing corneal infiltrate or corneal ulcers.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kodama Eye Clinic
Study officials:
References: