louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06373068: Association Between Resuscitation Orders and Mortality in ICU Patients
Official title: A Retrospective Study of the Association of Different Levels of Resuscitation Orders and Mortality in ICU Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Keywords: Resuscitation orders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the intensive care unit during 2023 and 2024

Brief summary: The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.


Eligibility criteria: Inclusion Criteria:

* Admitted to ICU

Exclusion Criteria:

* Second or subsequent admission to ICU during the study period.

Primary outcomes:
measure: Mortality
timeFrame: 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Stockholm South General Hospital
name: Sandra Jonmarker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02677168: cNEP for the Treatment of Obstructive Sleep Apnea
Official title: Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: obstructive sleep apnea
sleep apnea
OSA
cNEP
continuous negative external pressure
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 71
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 purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea


Eligibility criteria: Key Inclusion Criteria:

* PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
* on that PSG, AHI must be 10 - 50/hr and \>80% of the apneas and hypopneas must be obstructive
* no significant changes in health, medications, or lifestyle since the qualifying PSG

Key Exclusion Criteria:

* previous major surgery, injury or radiation to the neck
* beard or excessive hair on the area of the neck where the collar will be applied
* carotid artery disease
* serious medical conditions
* pregnancy
* use of home oxygen
* silicone allergy
* sleep disturbance other than obstructive sleep apnea

Primary outcomes:
measure: "Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
timeFrame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
measure: occurrence of adverse events
timeFrame: three weeks
Secondary outcomes:
measure: "Initial Response" of AHI at PSG I
timeFrame: up to 12 months after the qualifying PSG
measure: Comparison of AHI at PSG I and PSG II
timeFrame: three weeks
measure: time of SpO2 (oxygen saturation) < 90%
timeFrame: during each of the overnight PSGs
measure: hours of home use of cNEP per night
timeFrame: three weeks after initiation of home cNEP
measure: Three CGI (clinical global impression) subjective measures
timeFrame: three weeks after the initiation of home cNEP
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Sleep Institute
state: Ontario
Study officials:
affiliation: Toronto Sleep Institute
name: Adam Blackman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972868: A Novel Unidirectional Face Mask During NPPV in COPD Patients
Official title: Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Unidirectional mask
NPPV
COPD
respiratory physiology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 0
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 purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).


Eligibility criteria: Inclusion Criteria:

1. Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 \> 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
2. Requiring NPPV as assessed by the managing care team.

Exclusion Criteria:

1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
2. Patients who have claustrophobia and cannot wear the mask;
3. Patients who are hemodynamically unstable;
4. Patients who are disoriented and unable to cooperate with the study procedure;
5. DNI or DNR status or patients in whom intubation is contraindicated;
6. Patients who are currently intubated;
7. Patients who recently (\< 6months) had an MI or stroke;
8. Pregnant woman; There will be no exclusion based on gender, race or ethnicity.

Primary outcomes:
measure: Reduction in anatomical dead space and improvement in ventilatory efficiency
timeFrame: 30 minutes
Secondary outcomes:
measure: Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yandong Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Robert Kacmarek, PhD, RRT
role: STUDY_CHAIR
References:
Clinical trial NCT06630468: Task-Oriented Occupational Therapy Approach in Chronic Stroke: Performance, Balance, Quality of Life
Official title: The Effect of Task-oriented Occupational Therapy Intervention on Occupational Performance, Occupational Balance and Quality of Life Among Individuals with Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Occupational Therapy
Occupational Balance
Upper Extremity
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Medipol University
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic stroke is a neurological disorder that leads to long-term disability and functional impairments in motor, sensory, cognitive, and speech functions, persisting beyond six months after the stroke incident. The purpose of this study was to investigate the effects of task- oriented occupational therapy intervention on occupational performance, occupational balance, and quality of life in individuals with chronic stroke. The study included 30 individuals with chronic stroke aged between 18 and 65, who were divided into two groups:

the task-oriented occupational therapy intervention group (TOOT) (n=15) and the control group (n=15). The participants in the TOOT group received task-oriented occupational therapy intervention in 30-minute sessions, five days a week, for four weeks, while the control group received routine upper-extremity-based occupational therapy intervention in a hospital setting.


Eligibility criteria: Inclusion Criteria:

* aged 18-65 years old,
* completed the acute phase of stroke
* experienced ischemic and/or hemorrhagic stroke
* had \<=21 scores of Montreal Cognitive Assessment (MoCA)
* had \<= 15 scores of the Rivermead Motor Assessment (RMA)
* had a motor stage of the hand and upper extremity motor stage level 3 or higher of the Brunnstrom Stages of Motor Recovery
* had scoring 2 or lower on the Modified Ashworth Scale for muscle tone around the shoulder, elbow, and wrist were included into the study.

Exclusion Criteria:

* Had an orthopedic problem affecting the upper extremity
* had undergone surgery in the past 6 months
* had a diagnosis related to a psychotic disorder.

Primary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Occupational Balance Questionnaire-11 (OBQ11-T)
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Stroke Impact Scale 3.0
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri city hospital
Study officials:
References:
Clinical trial NCT04597268: Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures
Official title: Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation and Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Detailed description: Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for gastrointestinal endoscopic procedures
* ≥ Age 18 years
* ASA I-II

Exclusion Criteria:

* Allergy to any of the used drugs
* impaired renal or liver functions
* hypertensive patients
* patients with cardiovascular
* cerebrovascular disease

Primary outcomes:
measure: Ramsy sedation score (RSS)
timeFrame: 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Lecturer
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Nahla Y Shehab, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04161768: Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Official title: Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Detailed description: Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Eligibility criteria: Inclusion Criteria:

* cirrhotic patients with ascites who had previous episodes of SBP.

Exclusion Criteria:

* 1. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.

Primary outcomes:
measure: Number of bouts of recurrence during treatment.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: Afaf Younes Mohammed Younes, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Medicine
name: Mona Ahmed Helmy Shehata, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Tropical Medicine Department
name: Sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06835868: Neuro-Pain Provides a Dynamic and Interactive Register for the Invasvive Neuromodulatory Therapies for Different Chronic Pain Syndromes. Patients Living in Belgium and Suffering From Persistent Spinal Pain Syndromes Type 2 as Well as Suffering From Complex Regional Pain Syndromes Are Included.
Official title: Nationwide Dynamic Register for Screening, Evaluation and Follow-up of Patients Suffering From Chronic Pain Syndromes and Treated by Means of Invasive Neuromodulation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain Syndromes
CRPS
Keywords: spinal cord stimulation
chronic pain
quality of life
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering from chronic pain syndromes, either persistent spinal pain syndromes or complex regional pain syndromes.

Brief summary: Patients suffereing from chronic pain due to persistent spinal pain syndromes or complex regional pain syndromes and living in Belgium will be included in this register once they are being considered for a treatment with invasive neuromodulation (either spinal cord stimulation either dorsal root ganglion stimulation). The screening process, the multidisciplinary evaluation, the trial therapy and the long-terl follow-up will be monitored through this register.


Eligibility criteria: Inclusion Criteria:

* chronic pain syndromes

Exclusion Criteria:

* acute pain syndromes

Primary outcomes:
measure: Pain intensity after 21 days
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA, multidisciplinary pain center
state: Antwerp
Study officials:
References:
Clinical trial NCT05206968: Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
Official title: Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Idiopathic Arthritis Hip
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General data demographics , disease characteristics \[symptom duration, disease presentation, JIA subtypes, Antigen(HLA) B27 positivity)\], disease activity: Juvenile arthritis disease activity (JADAS), were collected.

All patients underwent a posteroanterior pelvic radiograph

Brief summary: Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. However, radiological scoring was not standardized. This study aimed to compare the two scoring systems previously proposed, examine their repeatability and their intra and inter agreement.


Eligibility criteria: Inclusion Criteria:

* All included patient followed the ILAR criteria of JIA and have a hip involvement. This later was defined as the presence of rang motion limitation, and abnormal findings in pelvic radiographic, or ultrasound or MRI in the coxo-femoral joint.

Exclusion Criteria:

* The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip

Primary outcomes:
measure: intermodality agreement
timeFrame: 6 months
Secondary outcomes:
measure: interreader agreement
timeFrame: 3 months
Other outcomes:
Locations:
city: Manouba
country: Tunisia
facility: Kassab institute of orthopedics
Study officials:
References:
Clinical trial NCT04662268: Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis
Official title: Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis of Montpellier
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Colitis
Keywords: Ischemic colitis
computed tomography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single-center retrospective cohort (center: CHU de Montpellier) of patients admitted between january 2014 and december 2019 at the CHU, over 18 years of age and having presented ischemic colitis during their stay, with completion of an injected abdomino-pelvic scanner within 6 hours of onset of symptoms, then proven by surgery or endoscopy

Brief summary: Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).


Eligibility criteria: Inclusion criteria:

* Age \> or = at 18 years old;
* Performing an abdomino-pelvic scan injected within 6 hours of the onset of symptoms;
* Ischemic colitis proven by endoscopy or surgical data.

Exclusion criteria:

* CT scan performed without injection and / or after 6 hours following the onset of symptoms;
* Unproven ischemic colitis.

Primary outcomes:
measure: Complication rate of ischemic colitis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Patrice TAOUREL, MD-PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01426568: A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
Official title: A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: Multi-Convergent Therapy
Mindfulness Meditation
Functional Abdominal Symptoms
Irritable Bowel Syndrome
Inflammatory Bowel Disease
Psychological Stress
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2011-08-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Inflammatory Bowel Disease
* Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP \<10
* Age 18 to 65 years
* Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score \> 0.44)

Exclusion Criteria:

* Use of steroids within 1 month of entry to study
* Initiation or change in dose of medication within 1 month of entry to the study
* Presence of ileostomy or colostomy
* Diagnosis of dementia or cognitive impairment
* Current psychosis or substance misuse
* Change in psychotropic medication in 3 months prior to entry to study
* Previous psychological interventions
* Pregnancy

Primary outcomes:
measure: Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
timeFrame: Assessed at baseline and at 4 months, 8 months, and 1 year
Secondary outcomes:
measure: Change in Irritable Bowel Syndrome Symptom Severity Score
timeFrame: Assessed at baseline and at 4 months, 8 months, and 1 year
measure: Change in Levenstein Perceived Stress Score
timeFrame: 2 monthly intervals over 1 year
measure: Change in Hospital Anxiety and Depression Score
timeFrame: 2 monthly intervals over 1 year
measure: Abdominal Symptoms Global Improvement Score
timeFrame: 4 monthly intervals over 1 year
measure: Relapse rate in inflammatory bowel disease
timeFrame: 1 year
measure: Feasibility of Treatment
timeFrame: 4 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
state: South Glamorgan
Study officials:
References:
citation: Berrill JW, Sadlier M, Hood K, Green JT. Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. J Crohns Colitis. 2014 Sep;8(9):945-55. doi: 10.1016/j.crohns.2014.01.018. Epub 2014 Feb 13.