louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03776825: Permacol Paste in Perianal Crohn's Disease
Official title: Use of Permacol Paste in Perianal Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Perianal Fistula
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perianal Crohn's Disease Patients

Brief summary: The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.

Detailed description: This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.

Eligibility criteria: Inclusion Criteria:

* Age \> 18, any sex
* Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
* Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
* Non-active or mildly active luminal CD defined by a CDAI \< 220

Exclusion Criteria:

* CDAI \> 220
* Dominant luminal active CD requiring immediate surgical or medical therapy
* Fistula with \> 3 external openings and \> 2 internal openings
* Severe active proctitis and/or rectal stenosis
* Abscess or pelvic collection \> 2 cm diameter
* Concomitant rectovaginal fistulas
* Concomitant steroid treatment or treated with steroids in the last 4 weeks

Primary outcomes:
measure: Perianal fistula closure rate
timeFrame: 12 months
Secondary outcomes:
measure: Patients quality of life
timeFrame: 12 months
measure: Patients continence
timeFrame: 12 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968525: The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
Official title: The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Anemia
Keywords: anemia
non-hypoxic apnoea
tracheal intubation
anesthesia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction.
2. Building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an unanticipated difficult airway.
3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.
4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb while arterial oxygenation and oxyhemoglobin saturation remain high.
5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.
6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.
7. The aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.

Detailed description: After breathing for 3 minutes, anesthesia induction was conducted. The endotracheal tube position was confirmed after anesthesia induction. Patients were left apneic with the endotracheal tube open to room air. The non-hypoxic apneic period was recorded as the time (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min elapsed, whichever was earlier.

Eligibility criteria: Inclusion Criteria:

1. patients scheduled to undergo general anesthesia
2. American Society of Anesthesiologists Performance Status 1-2
3. adults

Exclusion Criteria:

1. Individuals with significant cardiorespiratory or cerebrovascular disease,
2. difficult intubation
3. history of epilepsy
4. body mass index \>25 kg/m2,
5. and those who had smoking history in past 6 months

Primary outcomes:
measure: duration of non-hypoxic apnoea
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan university
state: Shanghai
Study officials:
affiliation: Department of anesthesiology, obstetrics and genecology hospital, FuDan university
name: Guiqi Geng, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00374725: Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
Official title: Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Probiotic
Placebo controlled trial
Lactobacillus rhamnosus
Lactobacillus acidophilus
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Crohn's and Colitis Foundation
First posted: 2006-09-11
Enrollment: 130
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: In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

Detailed description: In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.

In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy.

The trial is double-blind, randomised and controlled.

Eligibility criteria: Inclusion Criteria:

* Patients with known ulcerative colitis
* At least one prior flare of the disease
* Clinically and endoscopically active disease
* Age: 18 and above

Exclusion Criteria:

* Changes in azathioprine dosage within the last three months
* Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding
* Known immunodeficiencies
* On-going infectious disease
* On-going treatment with NSAID or cholestyramine
* Pregnant og lactating women

Primary outcomes:
measure: Number of patients in remission in the two groups at the end of the treatment period
Secondary outcomes:
measure: Difference in time to relapse in the two treatment groups
measure: Number of patients successfully obtaining remission
measure: Time to remission in the two groups
measure: Time ro relapse after study treatment is discontinued
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lone G Klinge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Jens Kjeldsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Karsten Lauritsen, MD, Dr.med.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Lisbeth Ambrosius, MD,Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06089525: Treatment of Complex Pilon Fractures
Official title: Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pilon Fracture
Keywords: Pilon Fracture
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2023-10-18
Enrollment: 30
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: Individuals over the age of 18 that have undergone an ORIF or PA surgery for an acute pilon fracture at either KUMC or Emory University Hospital.

Brief summary: This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.


Eligibility criteria: Inclusion Criteria: Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital.

Exclusion Criteria: Anyone under the age of 18 years. Pregnant women.

Primary outcomes:
measure: Ankle range of motion
timeFrame: Collected only once; from 6 months post-op up to date of death from any cause
measure: Walking cadence
timeFrame: Collected only once; from 6 months post-op up to date of death from any cause
measure: Timed up-and-go
timeFrame: Collected only once; from 6 months post-op up to date of death from any cause
measure: Foot and ankle Outcome Score (FAOS)
timeFrame: Collected only once; from 6 months post-op up to date of death from any cause
measure: 12 Item Short Form Survey (SF-12)
timeFrame: Collected only once; from 6 months post-op up to date of death from any cause
Secondary outcomes:
measure: Presence of infection and/or post-traumatic arthritis
timeFrame: From the date of surgery up until the date of death from any cause
measure: Need for secondary operation
timeFrame: From the date of surgery up until the date of death from any cause
measure: Return to work time
timeFrame: From the date of surgery up until the date of death from any cause
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT06382025: Preoperative Information With Storybook for Pediatric Anesthesia
Official title: The Effect of Storybook vs Standart Information on Anesthesia Anxiety in Preoperative Period in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 168
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.


Eligibility criteria: Inclusion Criteria:

* Pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy.
* without having previous emergency surgery and anesthetic experience,

Exclusion Criteria:

* Their parents reported developmental delays, mental retardation, or chronic illnesses of the children
* Emergency surgery

Primary outcomes:
measure: preoperative anxiety scale
timeFrame: baseline ( before induction of anesthesia)
measure: State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents
timeFrame: baseline ( before induction of anesthesia)
measure: Children's Hospital of Eastern Ontario Pain (CHEOP) Scale
timeFrame: Postoperative 0-24 hours
measure: Pediatric Anesthesia Emergence Delirium (PAED) scale
timeFrame: Postoperative 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Edi̇rne
Study officials:
References:
Clinical trial NCT06504225: EVEROLD LONG TERM FOLLOW-UP
Official title: Long-term Evaluation of the Value of Using an MTor Inhibitor (everolimus) for the Minimisation of Anticalceurins in Old-for-old Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant; Complication, Failure
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 260 patients previously included in the EVEROLD study

Brief summary: Long Term Follow up of EVEROLD study


Eligibility criteria: Inclusion Criteria:

* Informed patients participating to the EVEROLD study
* Patient having completed the EVEROLD M12 follow-up visit
* Patient agreeing to participate in the observational study

Exclusion Criteria:

* Opposition to the use his medical data
* Patient under legal protection

Primary outcomes:
measure: Patient survival
timeFrame: up to 12 years
measure: Graft survival
timeFrame: up to 12 years
Secondary outcomes:
measure: Rejection rate
timeFrame: up to 12 years
measure: Infection rate
timeFrame: up to 12 years
measure: Major cardiovascular events
timeFrame: up to 12 years
measure: Cancer rate
timeFrame: up to 12 years
measure: Hospitalization
timeFrame: up to 12 years
measure: eGFR
timeFrame: up to 12 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: Chu Brest
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Nice
country: France
facility: CHU Nice Pasteur 2
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Hôpital Necker
city: Poitiers
country: France
facility: Chu Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU Brest
name: Yannick LE MEUR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04088825: Validation of the CONUT Software Tool for Screening Clinical Malnutrition in the University Hospital La Paz
Official title: Validation of the CONUT Software Tool for Screening Clinical Malnutrition in the University Hospital La Paz
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 233
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional study in which the nutritional status of patients will be assessed in the first 72 hours of entry.

Brief summary: Nutrition Department of University Hospital La Paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. Due to the large size of our centre, with about 1,500 beds and the few human resources in our unit, we chose to use the CONUT system (Nutritional Control), a 100% automatic method based on analytical parameters, very easy to use, low cost and whose validity is confirmed, characteristics that fulfilled our needs. The implementation of this nutritional screening method has led to a change in the ìnutritionafi culture of our centre respect to DRM in most of our professionals: doctors and nurses and even in the management team, so all of them understand the importance of the process and know about the available tools and knowledge to indicate an adequate and early nutritional support.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* Patients older than 15 years
* Patients admitted to the General Hospital or Traumatology area
* Patients who have signed the informed consent to participate in the study
* Patients who do not meet any exclusion criteria.

Exclusion Criteria:

* Pregnant women.
* Patients whose physical and / or psychic capacity prevents them from providing all the data collected by the evaluated methods or who do not have a caregiver.
* Non-collaborating patients in data collection
* Patients in whom a hospital stay of less than 48 hours is expected.
* Patients who at the time of performing the analyzes are in the ICU and OER

Primary outcomes:
measure: To detect as many patients with malnutrition risk as possible
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gómez Candela, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975725: Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
Official title: Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Illnesses
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose is to demonstrate the usefulness of WitCard and WitDisplayer in the diagnosis of AF but more generally in the qualification of the heart rhythm and the diagnosis of cardiac arrhythmias.

The main objective is therefore to demonstrate that at least 90 +/- 0.03% of ECGWs are interpretable by a physician and the primary endpoint will therefore be the ratio of the number of ECGWs that allowed a physician to make a diagnosis. rhythmic (ECGW interpretable) and the total number of ECGW recorded and viewed.

The clinical trial as part of the CE medical device certification process for secondary objectives and ancillary studies will be required to assess the diagnostic performance of the WitCard + WitDisplayer system, the quality of the ECGW recorded by the WitCard, the the safety of using the WitCard, the technical performance of the WitCard ECG recorder, the ergonomics of the WitCard, and finally the performance of automatic cardiac rhythm classification algorithms.

Detailed description: Monocentric, prospective, interventional study

Eligibility criteria: Inclusion Criteria:

Patient, male or female, over 18 years of age, presenting to the cardiology-rhythmology department (consultations and hospitalizations) or to the emergency department of the Timone 2 Hospital for the management of suspicion of disorder heart rate in front of:

* Palpitations
* Dyspnoea, acute pulmonary edema, non-ischemic heart failure
* Malaise, lipothymia, syncope

Exclusion Criteria:

* Patients with clinical criteria that do not warrant the use of WitCard:
* Immediate vital risk whatever its nature
* Rhythmic urgency requiring treatment without delay: respiratory, circulatory or neurological distress
* Acute Coronary Syndrome
* Pregnant women
* Non-beneficiaries of a social security scheme
* Persons deprived of their liberty
* Patient participating in another study
* Patient in a period of exclusion determined by a previous study
* Patient under the protection of justice, under guardianship or under guardianship

Primary outcomes:
measure: the ratio between the number of ECGWs that allowed a physician to make a rhythmic diagnosis (ECGW interpretable) and the total number of ECGWs recorded and visualized.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean-olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02911025: Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Official title: Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
sleep
antiepileptic drugs
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 13
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: Adults with Epilepsy who have recently been started on Clobazam (Onfi)

Brief summary: The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.

Detailed description: Many studies show that patients with epilepsy frequently have disrupted sleep, as well as a high level of daytime sleepiness. This may be due to a sleep disorder, nighttime seizures that lead to disrupted sleep, and other abnormalities. Sleep complaints are widely reported among patients with various epilepsy syndromes.

Anti-seizure treatments may affect sleep. Effects vary by type of medication and other health issues. Generally, with improvement of seizure control, the sleep cycle improves and becomes more regular. However, some anti-seizure medications have been associated with insomnia. There have been studies that looked at sleep in relation to some anti-seizure medications. However, there are no currently available published reports on the effect of Clobazam (Onfi) on sleep.

Eligibility criteria: Inclusion Criteria:

* adults aged 18 years or older
* diagnosis of epilepsy who are being considered for treatment with Clobazam

Exclusion Criteria:

* known untreated moderate or severe sleep apnea
* major circadian rhythm disorders

Primary outcomes:
measure: Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam
timeFrame: 1 week after reaching effective clobazam dose
Secondary outcomes:
measure: Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam
timeFrame: 1 week after reaching effective clobazam dose
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Milena Pavlova, MD
role: PRINCIPAL_INVESTIGATOR
References: