louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05458336: A Randomized Controlled Clinical Trial on the Use of Saline Nasal Irrigations to Eradicate Localized Nasal Infection by SARS-CoV-2
Official title: Saline Nasal Irrigations to Eradicate SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptoms and Signs
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Consecutive adult (\>18 years old) subjects who tested positive for SARS-CoV-2 with nasopharyngeal swab at the local COVID-19 Prevention Centre were included.

Patients were divided into two groups: cases (who performed nasal lavages) and controls (who did not perform lavages), with similar confounding factors (age, comorbidities, vaccination status).

At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to evaluate their symptoms at the moment of diagnosis and of negativization.

Subjects were asked to perform, at a daily time of their choice, a nasal swab provided at the moment of enrolment. When the subjects tested negative for the first time, they had to complete the questionnaire once again.

The study was divided into two phases. In the first phase cases were recruited and were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab. In the second phase controls were recruited and were asked to perform only daily nasal swabs.

Symptoms course and time of negativization were analyzed. Statistic comparisons were made using Kaplan-Meier test. P values \<0,05 were considered to be statistically significant.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* starting participation to the study within the first 48 hours since diagnosis
* ability in self-swabbing
* ability in self-administration of nasal lavages

Exclusion Criteria:

* age \<18 years
* refusal of participation
* starting participation to the study after the first 48 hours since diagnosis
* no ability in self-swabbing
* no ability in self-administration of nasal lavages

Primary outcomes:
measure: Symptoms' course
timeFrame: From date of the first positive swab until the date of to the first negative swab, up to 14 days
Secondary outcomes:
measure: Time of negativization
timeFrame: From date of the first positive swab until the date of to the first negative swab, up to 14 days
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Unit of Otorhinolaryngology of Treviso Hospital
Study officials:
affiliation: Universiry of Padova
name: Giacomo Spinato, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02313636: Narrow Band Imaging in Flexible Cystocopy
Official title: Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narrow Band Imaging in Flexible Cystoscopy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Hospitalsenheden Vest
name: Oslo University Hospital
First posted: 2014-12-10
Enrollment: 955
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Brief summary: Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources.

First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted.

A total number of 896 patients is planned to be included.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Exclusion Criteria:

* Patients not fullfilling the above

Primary outcomes:
measure: change in the clinical decision
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holstebro
country: Denmark
facility: Hospitalsenheden Vest
city: Århus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Jørgen Bjerggaard Jensen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082236: Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Official title: Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Plasma concentrations
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.


Eligibility criteria: Inclusion Criteria:

1. Non-smoking male or female subjects
2. Aged between 18 and 45 years inclusive
3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.

Exclusion Criteria:

1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
2. Female subjects who are pregnant
3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders

Primary outcomes:
measure: Area Under the Curve
timeFrame: 9 days, not including a 30 day screening window
Secondary outcomes:
Other outcomes:
measure: C max
timeFrame: 9 days
measure: T max
timeFrame: 9 days
measure: Context Sensitive Half-Time (CST½)
timeFrame: 9 hours
Locations:
city: Lenexa
country: United States
facility: PRA
state: Kansas
Study officials:
affiliation: PRA
name: Sandra K. Willsie, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05576636: COVID-19 Simulation Education on Nursing Students
Official title: The Effect of Simulation Education as an Approach to Patients With COVID-19 on Nursing Students' Perception and Fear of COVID-19 Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pandemic
Simulation of Physical Illness
Keywords: nursing student
perception of illness
fear of death.
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 86
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effect of simulation education as an approach to patients with COVID-19 on nursing students' perception and fear of the COVID-19 disease. This study was conducted in a randomized controlled trials with 86 nursing students from a university between November 10 and December 10, 2021.


Eligibility criteria: Inclusion Criteria:

* Nursing student and
* Agreeing to participate in the study

Exclusion Criteria:

* Refusing to participate in the study or quitting the study

Primary outcomes:
measure: Approach to COVID-19 Patient Form
timeFrame: 5 Minute
measure: The Fear of COVID-19 Scale
timeFrame: 5 Minute
measure: The COVID-19 Disease Perception Scale
timeFrame: 5 Minute
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Sibel Senturk, PhD
role: STUDY_CHAIR
References:
citation: Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16.
citation: Huang CL. [Impact of Nurse Practitioners and Nursing Education on COVID-19 Pandemics: Innovative Strategies of Authentic Technology-Integrated Clinical Simulation]. Hu Li Za Zhi. 2021 Oct;68(5):4-6. doi: 10.6224/JN.202110_68(5).01. Chinese.
citation: Almomani E, Sullivan J, Hajjieh M, Leighton K. Simulation-based education programme for upskilling non-critical care nurses for COVID-19 deployment. BMJ Simul Technol Enhanc Learn. 2020 Oct 21;7(5):319-322. doi: 10.1136/bmjstel-2020-000711. eCollection 2021.
Clinical trial NCT03561636: Health Literacy in the General Population in Belgium
Official title: Health Literacy in the General Population in Belgium: Associations and Determinants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Literacy
Keywords: Health literacy
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Solidaris
First posted: 2018-06-19
Enrollment: 2535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults affiliated to Solidaris

Brief summary: The aims of the study are:

* To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...)
* To identify potential groups at risk of a lower HL
* To identify the determinants of HL level


Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* Affiliated to Solidaris (health mutual), with a valid phone number
* Consent to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Health Literacy
timeFrame: At the inclusion in the study
Secondary outcomes:
measure: General health
timeFrame: At the inclusion in the study
measure: General health
timeFrame: At the inclusion in the study
measure: Chronic illnesses
timeFrame: At the inclusion in the study
measure: Body Mass Index
timeFrame: At the inclusion in the study
measure: Feeling of stigma associated with the chronic illness
timeFrame: At the inclusion in the study
measure: Satisfaction about health services
timeFrame: At the inclusion in the study
measure: Consumption behaviors
timeFrame: At the inclusion in the study
measure: Physical activity
timeFrame: At the inclusion in the study
measure: Use of the Internet for health purposes
timeFrame: At the inclusion in the study
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
city: Liège
country: Belgium
facility: University of Liège
Study officials:
References:
Clinical trial NCT02574936: Reduction Dead Space Volume With Karydakis Modification
Official title: Effects of Reduction Dead Space Volume With Karydakis Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PILONIDAL SINUS
Keywords: karydakis modification
pilonidal sinus
complication
Lead sponsor: Siverek Devlet Hastanesi
Sponsor class: OTHER
Collaborators: name: Harran University
First posted: 2015-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.

Detailed description: The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* patients who accept the procedure
* chronic p.sinüs disease

Exclusion Criteria:

* previous sinüs surgery
* active infection
* patients who did not accept the procedure
* patients under age of 18.

Primary outcomes:
measure: Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harran University
name: Ali Uzunköy
role: STUDY_DIRECTOR
References:
Clinical trial NCT03594136: New Reference Values for Intracranial Pressure
Official title: Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Pressure
Keywords: Intracranial pressure
ICP
Normal value
Reference value
Hydrocephalus
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2018-07-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Intracranial pressure is a cornerstone in neurosurgical care used in a variety of diseases. However currently, doubts regarding normal intracranial pressure exist. Few studies have investigated normal intracranial pressure in truly normal adults. The aim of this study is to investigate intracranial pressure in adults who have normal intracranial pressure physiology.

In this prospective, multicenter, clinical study, the intracranial pressure of 10 adults requiring surgery for an unruptured aneurysm will be investigated. These patients are thought to be normal in terms of intracranial pressure physiology. At the end of their surgery for an aneurysm, a telemetric intracranial pressure monitoring sensor will be implanted. Afterward, intracranial pressure curves will be obtained non-invasively 1., 14., 30 and 90 days after implantation. The intracranial pressure will be investigated in 5 different positions (supine, lumbar, upright sitting, standing and walking). Furthermore, a 24-hour measurement will be performed in their home environment, thus investigating intracranial pressure under daily activities.


Eligibility criteria: Inclusion Criteria:

* Above the age of 18
* Requiring surgery for a "cold" (unruptured) aneurysm

Exclusion Criteria:

* Current or previous examination or treatment for hydrocephalus
* Current or previous examination or treatment for idiopathic intracranial hypertension
* Previous operation with insertion of cerebrospinal fluid shunt
* Previous trauma with intracranial hemorrhage
* Global cerebral edema
* Increased infection risks
* Surgical complications during the primary operation
* Unable to understand patient information

Primary outcomes:
measure: Normal Intracranial Pressure Values
timeFrame: Each participants will be monitored for three months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Military University Hospital Prague
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen E
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Marianne Marianne, D.M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02871336: Pancreatic Surgical Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasms
Keywords: Cata collection
Pancreatic cancer surgery
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 1500
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: Patient with a pancreatic cancer who has undergone surgery

Brief summary: This data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.


Eligibility criteria: Inclusion Criteria:

* Patient \>18 ans
* Surgery for a pancreatic cancer

Exclusion Criteria:

* Patient refusal to participate in the study

Primary outcomes:
measure: Optimization of the surgical care of the patients
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Olivier Turrini, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Vincent Moutardier
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Jean HARDWIGSEN
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Mehdi Ouassi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228136: Tranexamic Acid and Pediatric Adenotonsillectomy
Official title: Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillectomy
Adenoidectomy
Tranexamic Acid
Keywords: Adenotonsillectomy
Tranexamic acid
Blood loss
Postoperative hemorrhage
Lead sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 95
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.

Detailed description: Tonsillectomy with or without adenoidectomy is the most common major surgical procedure performed in children. Although it's a relatively simple procedure, may present complications as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and 1/27.000 in the literature, with approximately 30% due to hemorrhage.

Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic surgery and menorrhagia.

Eligibility criteria: Inclusion Criteria:

* children with 4 to 12 years
* adenotonsillar hypertrophy
* indication of adenotonsillectomy

Exclusion Criteria:

* patients with blood dyscrasia
* patients with history of bleeding of difficult control or spontaneous hematoma
* patients with coagulation tests altered
* patients with evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or auto immune disease

Primary outcomes:
measure: volume of intraoperative bleeding
timeFrame: one day
Secondary outcomes:
measure: incidence of postoperative bleeding
timeFrame: ten days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital da Criança Santo Antônio
state: Rio Grande do Sul
Study officials:
affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: Marília R Brum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: José Faibes Lubianca Neto, MD
role: STUDY_DIRECTOR
References:
citation: Brum MR, Miura MS, Castro SF, Machado GM, Lima LH, Lubianca Neto JF. Tranexamic acid in adenotonsillectomy in children: a double-blind randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1401-5. doi: 10.1016/j.ijporl.2012.04.028. Epub 2012 Jun 16.
Clinical trial NCT02651636: Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
Official title: Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Menstrual Pattern
Hyperandrogenism
Metabolic Features
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.


Eligibility criteria: Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* past history of cardiovascular disease,
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test),
* hypertension,
* significant liver or renal impairment,
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs),
* neoplasms,
* unstable mental illness.

Primary outcomes:
measure: Number of cycles in six months of therapy
timeFrame: 6 months
Secondary outcomes:
measure: Hirsutism
timeFrame: 6 months
measure: Hyperandrogenism
timeFrame: 6 months
measure: Insulin response to oral glucose tolerance test
timeFrame: 6 months
measure: Lipidic profile
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: