louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06591611: Effect of PEEK and Co-Cr Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinial Trial
Official title: Effect of PEEK and Co-Cr Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: All on Four, Marginal Bone Loss, PEEK
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A fixed all-on-four prosthesis will be fabricated for the mandibular arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months


Eligibility criteria: Inclusion Criteria:

* Completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration
* Implant sites must allow for implant placement
* Patients with no systemic conditions that may interfere with implant placement

Exclusion Criteria:

* General contraindications for implant surgery( Poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)

Primary outcomes:
measure: Marginal bone loss
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03948711: Brain Oxygenation During Prehospital Anesthesia
Official title: Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: FinnHEMS
First posted: 2019-05-14
Enrollment: 100
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: Critically ill or trauma patients undergoing prehospital anesthesia and endotracheal intubation for any reason by helicopter emergency medical team providing critical care.

Brief summary: The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.


Eligibility criteria: Inclusion Criteria:

* sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason

Exclusion Criteria:

* Cardiac arrest at the time of intubation
* Physical barrier for NIRS measuring (e.g. forehead laceration)
* HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
* Workload too high to ensure standard level of clinical care during the study
* Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
* Known or evident pregnancy

Primary outcomes:
measure: Disturbance-free time of the total monitoring time
timeFrame: Prehospital phase
measure: Cerebral desaturation events
timeFrame: During prehospital phase after induction of anesthesia
Secondary outcomes:
measure: On-scene time
timeFrame: Prehospital phase
measure: Qualitative feedback from HEMS crews
timeFrame: Prehospital phase
measure: Survival
timeFrame: 30 days, 12 months
measure: Neurologic disability
timeFrame: 30 days, 12 months
measure: Health related quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: FinnHEMS 50 / Oulu University Hospital
city: Vantaa
country: Finland
facility: FinnHEMS 10 / Helsinki Univeristy Hospital
Study officials:
References:
Clinical trial NCT06590311: Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
Official title: Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mechanical Ventilation Weaning
Keywords: mechanical ventilation weaning
heart rate variability
autonomic modulation
PAV+
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated ICU patients ready to be weaned

Brief summary: The aim of the study is to investigate autonomic modulation in terms of heart rate variability (i.e., HRV) in patients undergoing assisted mechanical ventilation in PSV mode, compared to patients assisted in PAV+ mode. The hypothesis is that the greater patient-ventilator synchrony of the latter mode may represent an advantage in reducing the imbalance of autonomic modulation.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU, ≥18 years old, undergoing invasive controlled mechanical ventilation for at least 72 hours, eligible for assisted support but not yet ready for extubation or spontaneous breathing.

Exclusion Criteria:

* Successful completion of a spontaneous breathing trial (SBT) and spontaneous breathing within 24 hours of enrollment
* Acute ischemic heart disease, cardiac rhythm abnormalities, and/or patients with pacemakers and/or treated with anti-arrhythmic drugs
* Hemodynamic instability
* Chest drainage
* Severe anemia (Hb \&lt;7g/dL)
* Pregnancy
* Severe head trauma, dementia
* High spinal cord injury
* Neuromuscular disorders
* Lack of consent

Primary outcomes:
measure: LF dominion
timeFrame: 30 min
Secondary outcomes:
measure: Other domains
timeFrame: 30 min to 72 hours
measure: Clinical outcomes
timeFrame: 28 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: AOU Policlinico Umberto I
Study officials:
References:
Clinical trial NCT01968811: Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
Official title: A Multi-Centre, Post CE Mark, Open Clinical Investigation to Evaluate an Abdominal NPWT (Negative Pressure Wound Therapy) System (Avance® Pump and Avance® Foam Abdominal Dressing Kit) in Subjects With Open Abdominal Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Abdomen
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2013-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.


Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent from subject or family member
2. Subjects with open abdomen suitable for temporary closure with NPWT therapy
3. Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)
4. Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit
5. Male or female, 18 years and above

Exclusion Criteria:

1. Synthetic mesh inserted in the abdomen
2. Non-enteric fistulae or unexplored fistulas
3. Untreated osteomyelitis
4. Malignant wounds
5. Abdominal wall hernia
6. Subjects previously treated with an NPWT abdominal dressing
7. Known allergy or hypersensitivity to any of the components in the dressing
8. Pregnancy
9. Subjects not suitable for the investigation according to the investigator's judgement
10. Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator

Primary outcomes:
measure: To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings
timeFrame: From 1 to 3 visit, depending on each subject/wound, up to 4 days.
Secondary outcomes:
measure: - Fascial/Skin Closure of the Open Abdomen
timeFrame: End of treatment, up to 4 days.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University hospital
Study officials:
References:
Clinical trial NCT00832611: Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Chronic Emphysema
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.

Exclusion Criteria:

* Subject not qualifying because of physical or psychological condition that may put them at risk of participating.

Primary outcomes:
measure: Improvement in exercise capacity.
timeFrame: 12 weeks post-procedure
Secondary outcomes:
measure: Improvement in quality of life.
timeFrame: 12 weeks post-procedure
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Universitätsklinikum Gieβen und Marburg, Standort Marburg
Study officials:
affiliation: Universitätsklinikum Gieβen und Marburg, Standort Marburg
name: Claus Vogelmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
citation: Faul J, Schoors D, Brouwers S, Scott B, Jerrentrup A, Galvin J, Luitjens S, Dolan E. Creation of an iliac arteriovenous shunt lowers blood pressure in chronic obstructive pulmonary disease patients with hypertension. J Vasc Surg. 2014 Apr;59(4):1078-83. doi: 10.1016/j.jvs.2013.10.069. Epub 2014 Jan 28.
Clinical trial NCT04849611: Covid-19 Fear and Compliance With Protective Measures of Students
Official title: Covid-19 Fear and Compliance With Protective Measures of Students Continuing Face-to-Face Education in the Covid-19 Pandemic Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Covid-19
School
Student
Fear
Protective Measure
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 188
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: continued face-to-face education students

Brief summary: This study was carried out to determine the fear of Covid-19 and the compliance with protective measures of students who continue their education face-to-face during the covid-19 pandemic process.

Detailed description: The study was carried out descriptively. The study population of a province pandemic period junior ongoing training to face in Turkey. Sample constituted reached 188 students with snowball sampling method. The data of the study were collected using the "Questionnaire Form" prepared by the researchers and the "Covid-19 Fear Scale". Data collection tools were applied to the participants electronically via Google Forms.

Eligibility criteria: Inclusion Criteria:

Students who volunteered to participate in the study, had their parents' consent, had a web-based smart device, and continued face-to-face education were included.

Exclusion Criteria:

-

Primary outcomes:
measure: Covid-19 Fear
timeFrame: November-March
Secondary outcomes:
Other outcomes:
measure: Information Form
timeFrame: November-March
Locations:
city: Ordu
country: Turkey
facility: Ordu University
state: Ordu Province
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Hacer GOK UGUR, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
citation: Bakioglu F, Korkmaz O, Ercan H. Fear of COVID-19 and Positivity: Mediating Role of Intolerance of Uncertainty, Depression, Anxiety, and Stress. Int J Ment Health Addict. 2021;19(6):2369-2382. doi: 10.1007/s11469-020-00331-y. Epub 2020 May 28.
Clinical trial NCT02057211: Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
Official title: Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.


Eligibility criteria: Inclusion Criteria:

* fasting C-peptide \>0.12 nmol/l
* within three weeks of diagnosis of type 1 diabetes

Exclusion Criteria:

* body mass index (BMI) \>30
* unstable cardiovascular status incl. New York Heart Association (NYHA) class III/IV
* patients with known or previous malignancy
* active infections incl. serological evidence of infection with HIV, Treponema pallidum, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
* immune suppressive treatment
* women being pregnant or nursing, or women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study

Primary outcomes:
measure: ∆-change of C-peptide Area Under the Curve (AUC) (0-120 min) for a mixed meal tolerance test at two year follow-up when compared to pre-treatment values at enrolment.
timeFrame: ∆-change will be assessed as a difference between two years after transplantation/sham transplantation of mesenchymal stem cells when compared to before transplantation/sham transplantation, i.e. at time 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Per-Ola Carlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03006211: The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients
Official title: The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia on Corneal Endothelial in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea
Anesthesia; Reaction
Keywords: nitrogen protoxide
oxygen
corneal endothelial
pediatric
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated under N2O + sevoflurane and O2 + sevoflurane general anesthesia.

Detailed description: 40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry specular microscopy results at before surgery and 1 week and 1 month after surgery will be analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.

Eligibility criteria: Inclusion Criteria:

* 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia

Exclusion Criteria:

* None

Primary outcomes:
measure: Change of corneal endothal number
timeFrame: after surgery at first day, 1th week and 1th month
measure: Change of Cell density rate
timeFrame: after surgery at first day, 1th week and 1th month
measure: Change of Cell variation rate
timeFrame: at before surgery and 1 week and 1 month after surgery
measure: Change of Hexagonality rate
timeFrame: after surgery at first day, 1th week and 1th month
measure: Change of pachymetry specular microscopy results
timeFrame: after surgery at first day, 1th week and 1th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00638911: Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension
Official title: PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 33247
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

Brief summary: The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.

Detailed description: Study 502.465(NCT00638911) was planned and conducted as 6 independent substudies with varying country participation. One study database, a data management plan or a TSAP were not planned and do not exist which precludes baseline and outcome analyses.

Eligibility criteria: Inclusion criteria:

1. Male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic BP more than 90 mmHg and less than 109 mmHg and or mean morning seated systolic BP more than 140 mmHg and less than 180 mmHg

1. newly diagnosed patients
2. patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment

Exclusion criteria:

1. Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
2. Cholestasis and biliary obstructive disorders
3. Severe hepatic impairment
4. Severe renal impairment creatinine clearance less than 30 ml pro min
5. Refractory hypokalaemia hypercalcaemia
6. Known hypersensitivity to any component in the formulation of Micardis/Micardis Plus

Primary outcomes:
measure: Primary Endpoints will be the change from baseline in mean systolic blood pressure.
timeFrame: 4-24 Weeks
Secondary outcomes:
measure: Secondary Endpoints are clinical control of the BP and response rate.
timeFrame: 4-24 Weeks
measure: Other secondary Endpoints will be discontinuations and tolerability.
timeFrame: 4-24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00775411: Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Age-Related Maculopathy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-10-20
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Central retinal thickness ≥ 300 µm
* Visual acuity between 20/400 and 20/32
* Eligible for Anti-VEGF therapy

Exclusion Criteria:

* Previous treatment for CNV due to AMD
* High eye pressure
* Glaucoma
* Uncontrolled systemic disease
* Known allergy to the study medications
* Recent eye surgery or injections in the eye
* Female subjects that are of childbearing potential

Primary outcomes:
measure: Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
city: Sydney
country: Australia
state: New South Wales
city: Manila
country: Philippines
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: