louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04468802: Do Childhood Measles and DTaP Vaccination Decrease the Mortality Rate Caused by COVID-19 in OECD Countries?
Official title: Do Childhood Measles and DTaP Vaccination Decrease the Mortality Rate Caused by SARS CoV-2 in OECD Countries?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Measles Vaccine
Mortality
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children vaccinated in OECD countries in northern hemisphere

Brief summary: Mortality rates caused by SARS CoV-2 differ between countries and this difference might be explained by several reasons. Childhood vaccination rate is thought to be one of them. Therefore present study aimed to examine the possible relationship between DTaP (diphtheria, tetanus, pertussis) and measles vaccination rates of Organization for Economic Co-operation and Development (OECD) countries and case fatality rate (CFR) caused by SARS CoV-2.

Detailed description: The mortality rates caused by SARS CoV-2 differ between countries and this difference might be explained by several reasons. Childhood vaccination rate is thought to be one of them. Therefore present study aimed to examine the possible relationship between DTaP (diphtheria, tetanus, pertussis) and measles vaccination rates of Organization for Economic Co-operation and Development (OECD) countries and case fatality rate (CFR) caused by SARS CoV-2.A total of 32 OECD countries, of northern hemisphere, have been included in this study. Statistical analysis performed according to the CFR data of these countries based on SARS CoV-2. The CFR data calculated according to the total mortality count of a specific country for the 3-month period down from the date when first SARS CoV-2 case was observed.

Eligibility criteria: Inclusion Criteria:

* Children vaccinated in OECD countries in northern hemisphere

Exclusion Criteria:

* Non vaccinated children
* Southern hemisphere countries
* non-OECD countries

Primary outcomes:
measure: Case Fatality Rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
References:
Clinical trial NCT00957502: ENTact™ Septal Stapler Shelf Life Extension
Official title: A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deviated Nasal Septum
Lead sponsor: ENTrigue Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.


Eligibility criteria: Inclusion Criteria:

* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
* Patient is able to provide a signed informed consent form.
* Patient will agree to comply with all study related procedures.
* Subject is not pregnant at this time by confirmation of one of the following:

  * subject is male,
  * subject not of child bearing age,
  * subject is surgically sterile,
  * subject is not pregnant per negative hCG test.
* Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

* Patients who have had previous septoplasty
* Patients with uncontrolled diabetes
* Presence of infection at the study site
* Subject is a:

  * smoker,
  * severe drug abuser,
  * severe alcohol abuser.
* Patient with autoimmune disease deemed clinically significant by the Principal Investigator.

Primary outcomes:
measure: Clinical performance of aged ENTact™ Septal Staples
timeFrame: One week post op
Secondary outcomes:
measure: Clinical evaluation of gross tissue appearance at implantation site(s)
timeFrame: One week post op
measure: ENTact™ Septal Staple functionality based on maintained coaptation
timeFrame: One week post op
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: Good Samaritan Hospital
name: Thomas A Tami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793802: Impact of Physiotherapy Session in Cardiac Surgery Patients
Official title: Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Therapy in Cardiac Surgery Patients
Keywords: Physiotherapy
Cardiac surgery
Lung ultrasound score
Noninvasive ventilation
High flow oxygenation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects of the study will be patients who stayed in the Cardiovascular Surgery and Cardiac Transplant Intensive Care Unit at NANCY CHRU from September 15, 2020 to March 15, 2021

Brief summary: This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.

Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.

The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?

Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.

Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.


Eligibility criteria: Inclusion Criteria:

* Person who has received full information on the organization of the research and has not objected to the use of the data.
* Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass
* Patient under high flow oxygenation
* Age ≥ 18 years old
* 18.5 ≤ BMI ≤ 35 kg/m2
* Conscious and oriented patients: Glasgow 15

Exclusion Criteria:

* Surgical emergencies: grafting, dissections...
* Lumbar drainage in progress
* Beating heart surgery
* Refusal to participate in the study
* Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)

Primary outcomes:
measure: Lung ultrasound score
timeFrame: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Jean PAYSANT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830202: Expanded Access to Telisotuzumab Vedotin
Official title: Expanded Access to Telisotuzumab Vedotin
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: Non-Small Cell Lung Cancer (NSCLC)
Telisotuzumab vedotin
ABBV-399
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-04-05
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for a telisotuzumab vedotin clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01610102: PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
Official title: Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long Term Safety of the AMS 1.0
Keywords: clinical follow-up
up to 7 years
all patients enrolled in the main study
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 63 eligible patints previously enrolled in the PROGRESS AMS-1 study

Brief summary: The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0

Detailed description: The first clinical experience with AMS was in infrapopliteal arteries and demonstrated safety and acceptable patency rates up to 12 months post implantation. These encouraging results led to the initiation of the first trial to treat human coronary lesions with AMS named Clinical Performance and angiographic Results of Coronary Stenting with Absorbable Metal Stents (PROGRESS AMS-1). Although an ischemic driven target lesion revascularization rate of 26.7% (16/60) was observed during the PROGRESS AMS-1 study, it demonstrated that biodegradable magnesium stents can be implanted safely in coronary arteries, and the stents degraded as intended without causing stent thrombosis, myocardial infarction or death at one year. No adverse device effects from the absorbable nature of the stents or its constituents were detected. The continued clinical follow-up and retrospective evaluation of all angiographies and IVUS films on all eligible patients enrolled in the PROGRESS-AMS 1.0 will give important information on the long term safety of absorbable metal scaffolds and thus can support improvement of the device.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form available prior to clinical long term follow-up

Exclusion Criteria:

* Patent did not sign the informed consent form prior to clinical long term follow-up

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: up to 7 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin & Repatriation Medical Centre
state: Victoria
city: Aalst
country: Belgium
facility: O.L.V. Ziekenhuis Aalst
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen
state: NRW
city: Eindhoven
country: Netherlands
facility: Catharina Zieckenhuis
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Westdeutsches Herzzentrum Essen
name: Raimund Erbel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Biotronik AG
name: Esther Gerteis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03034902: Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface
Official title: Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2017-01-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research study is to determine whether a combined electroencephalography (EEG) and functional near infrared spectroscopy (fNIRS) recording is able to detect changes in brain activity and blood flow after stroke.


Eligibility criteria: Inclusion Criteria:

* All patients with a subacute ischemic stroke with symptom onset within 8 weeks
* Must have a measurable deficit on the National Institute of Health Stroke Scale (NIHSS)
* Able to give and sign informed consent

Exclusion Criteria:

* Aphasia
* Underlying dementia
* Any chronic neurological disorder
* Malignancy
* Non-ambulatory (ambulation with assistance will be included)
* Modified Rankin Score (mRS) \> 3

Primary outcomes:
measure: Number of participants with abnormal blood flow as assessed by fNIRS
timeFrame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
measure: Number of participants with abnormal neuronal activity as assessed by EEG
timeFrame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Paulina B Sergot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372502: Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
Official title: Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Septic Shock
Keywords: sepsis
shock
emergency department
resuscitation
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2006-09-07
Enrollment: 300
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 purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.


Eligibility criteria: Inclusion Criteria:

1. Suspected infection
2. Any two of four criteria of systemic inflammatory response
3. SBP \< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \> 4 mmol/L (severe sepsis).

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Established "Do Not Resuscitate" orders prior to enrollment
4. Primary diagnosis other than sepsis
5. Requirement for immediate surgery in \< 6 hours from admission
6. Any absolute contraindication to central venous catheterization

Primary outcomes:
measure: Mortality
timeFrame: In-hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Camden
country: United States
facility: Cooper Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Alan E Jones, MD
role: STUDY_DIRECTOR
affiliation: Carolinas Medical Center
name: Jeffrey A Kline, MD
role: STUDY_CHAIR
References:
citation: Puskarich MA, Trzeciak S, Shapiro NI, Albers AB, Heffner AC, Kline JA, Jones AE. Whole blood lactate kinetics in patients undergoing quantitative resuscitation for severe sepsis and septic shock. Chest. 2013 Jun;143(6):1548-1553. doi: 10.1378/chest.12-0878.
citation: Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
Clinical trial NCT00953602: Long Time Metabolic Changes Induced by Genetically Modified Potatoes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism
Hormonal Changes
Satiety
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the effects of genetically modified potatoes on the human metabolism will be observed. Healthy volunteers receive for one week muffins, produced with starch from a genetically modified potato or with a normal available starch, in a randomized trial.


Eligibility criteria: Inclusion Criteria:

* healthy male volunteers

Exclusion Criteria:

* acute oder severe chronic diseases

Primary outcomes:
measure: glucose metabolism
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, Dpt. of Endocrinology, Diabetes and Nutrition
Study officials:
References:
Clinical trial NCT04892602: Fibromyalgia in Rheumatiod and Psoriatic Patients
Official title: Fibromyalgia in Rheumatiod and Psoriatic Arthritis Patients:Relationshipwith Disease Activity and Serum Vitamin Dlevel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia, Secondary
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Those patient who diagnosed as rheumatiod arthritis and psoriatic arthritis..assess serum vitamin D level

Brief summary: the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients


Eligibility criteria: Inclusion Criteria:

- adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old

Exclusion Criteria:

* any other autoimmune diseases

Primary outcomes:
measure: Serum vitamin D level
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT04191902: Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus
Official title: Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus: A Brazilian Case Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Educational Problems
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients from the ward

Brief summary: The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.

Detailed description: Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.

Eligibility criteria: Inclusion Criteria:

* diabetes

Exclusion Criteria:

* non diabetes

Primary outcomes:
measure: differences in glycemic control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: