louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04917614: Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery
Keywords: ObsQoR-10T
recovery
ceserean
postoperative
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.

Detailed description: Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean operation
* Able to give informed consent

Exclusion Criteria:

* Patients with neurological or psychological diseases
* patients with chronic analgesic and antidepressant drug use
* Patients unable to communicate
* Patients previously treated with TEAS or acupuncture,
* Patients with heart failure and have pace-maker,
* patient with local infection in the TEAS area

Primary outcomes:
measure: Quality of Recovery
timeFrame: The first 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References:
Clinical trial NCT05371314: Artificial Intelligence in Categorizing the Severity of Oxygenation by Incorporating the PEEP Into the Definition of ARDS in Ventilated Patients
Official title: Artificial Intelligence in Categorizing the Severity of Oxygenation by Incorporating the PEEP Into the Definition of ARDS in Ventilated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from MIMIC 4 and eICU

Brief summary: Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio


Eligibility criteria: Inclusion Criteria:

1. Intubated patients

Exclusion Criteria:

1. pediatric and neonates
2. DNR patients
3. Non intubated patients

Primary outcomes:
measure: Artificial intelligence in categorizing the severity of oxygenation of ARDS in ventilated patients
timeFrame: Baseline ABG done at (approximately 4 hour after intubation) to ABG done day 2,3 and day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Universty Health System
Study officials:
References:
Clinical trial NCT05760014: Medical Hypnosis and Stress Reduction in Hospitalization
Official title: Interest of Medical Hypnosis in Reducing Stress and Improving the Experience of Hospitalization in Internal Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress
Keywords: hypnosis
perceived stress
place of safety
case control study
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 60
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: Patients hospitalised for their chronic illness

Brief summary: Patients with chronic diseases, especially rare diseases with uncertain diagnoses, have a representation of their disease and an experience of their hospitalization that is sometimes traumatic, distressing and painful. Patients hospitalized can benefit from non-medicinal techniques, such as medical hypnosis, which could improve the perceived stress in these patients and thus optimize the hospitalization experience. The aim of this study is to evaluate the impact of medical hypnosis in reducing stress and improving the experience of hospitalization comparing two groups : a group (cases) benefiting from an hypnotic technic " the place of safety " and a control group without intervention during hospitalization


Eligibility criteria: Inclusion Criteria:

* Patients hospitalised in the internal medicine department of the Lille University Hospital
* Age\>= 18 years
* Patients having expressed their non opposition

Exclusion Criteria:

* Not covered by the social security system
* Person unable to receive informed information
* Persons deprived of liberty
* Persons under legal protection (guardianship / curatorship)
* Psychotic and/or dementia disorders
* Pregnant and breastfeeding women

Primary outcomes:
measure: STAI questionnaire dimension STAI completed at discharge.
timeFrame: At discharge, an average 10 days
Secondary outcomes:
measure: The STAI ETAT (the current emotional state) questionnaire
timeFrame: at baseline and at discharge, an average 10 days
measure: The STAI-TRAIT (the usual emotional state ) questionnaire
timeFrame: at baseline and at discharge, an average 10 days
measure: patient opinion questionnaire
timeFrame: At discharge, an average 10 days
measure: The difference in STAI STATUS score between the questionnaire completed post-hypnotic treatment and the questionnaire at admission
timeFrame: At discharge, an average 10 days
measure: The ordinal severity scale correlated with the STAI ETAT questionnaire score;
timeFrame: At discharge, an average 10 days
measure: Self-rated stress scale correlated with the STAI ETAT questionnaire score.
timeFrame: At discharge, an average 10 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Mereym-Maud FAHRAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01891214: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
Official title: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Inflammatory bowel diseases
Inflammatory Bowel Disease Questionnaire (IBDQ)
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2013-07-03
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: Patient with definite diagnosis of UC or CD for at least 6 months

Brief summary: The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

Detailed description: Importance of measuring subjective aspects of the patient's health, often referred to as quality of life (QoL), become increasingly recognized and integrated into healthcare. For this purpose, The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for QoL assessment specific for patients who suffer from inflammatory bowel diseases. However, the IBDQ was originally developed in a cohort of Canadian patients in English language. Since QoL is impacted by underlying cultural trends, any translation of the IBDQ should be reassessed in relation to its validity, reliability, and sensitivity to detect change in the new language and cultural context. While the linguistic French translation of the original IBDQ has been validated, the French IBDQ has never been tested adequately on a French cohort of patient that we aim to perform.

Eligibility criteria: Inclusion Criteria:

* men and women ≥ 18 years of age,
* patient with definite diagnosis of UC or CD for at least 6 months

Exclusion Criteria:

* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
* inability to comprehend or complete the self-administered questionnaire
* psychiatric diagnosis that prevents participation (many pts will have anxiety or depression and should not be excluded)
* stoma
* malignancy

Primary outcomes:
measure: Internal validity, scale F-IBDQ
timeFrame: Day1 and Month4
measure: External validity, questionnaire SF36
timeFrame: Day1 and Month4
measure: Discriminant ability, disease activity indexes
timeFrame: Day1 and Month4
measure: Reliability, disease outcomes
timeFrame: Day1 and Month4
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
city: Rennes
country: France
facility: Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux
Study officials:
affiliation: Rennes University Hospital
name: Guillaume Bouguen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01680614: The Efficacy of Computerized Alcohol Screening and Intervention (CASI) in At-Risk Emergency Department and Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Consumption
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 2114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Department

Brief summary: The purpose of this research is to examine the effectiveness of computerized alcohol screening and brief intervention in the UC Irvine Medical Center Emergency Department (ED) and Trauma Patients. Brief interventions have a high potential impact in ED and Trauma populations. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI mitigates barriers to proper screening and intervention, including time, availability of trained personnel, patient comfort, and language barriers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT) followed by a brief intervention and customized alcohol intake recomendations for the patient.

The intervention of this study will be the addition of a brief CASI questionnaire to the standard of care for a random subset of subjects. All subjects who screen positive for hazardous alcohol use will be followed up and reassessed for alcohol use. The researchers hypothesize that the addition of CASI will lead to a decrease in alcohol intake within three months. The basis of this research is evidence of the effectiveness in the CASI system, the growing public health issue of alcohol abuse, the need to be able to provide effective screening and brief intervention in the high volume ED settings, and findings that the primary method to reduce traumatic death is prevention.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Trauma and ED patients

Exclusion Criteria:

* Under the age of 18
* Intoxicated
* Psychiatric

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
References:
Clinical trial NCT05384314: A Retrospective Study to Evaluate the Predictability of Abnormal Arterial Blood Gas Measurements Through Novel Observations of Continuous Trends in Electronically Measured Respiratory Rate in a Mixed Cohort of Respiratory Compromised Patients
Official title: A Retrospective Study to Evaluate the Predictability of Abnormal Arterial Blood Gas Measurements Through Novel Observations of Continuous Trends in Electronically Measured Respiratory Rate in a Mixed Cohort of Respiratory Compromised Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
COPD
Pneumonia
Community-acquired Pneumonia
COVID-19
Pulmonary Disease
Keywords: Respiratory Rate
Arterial Blood Gas
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acutely admitted respiratory compromised patients in a hospital setting

Brief summary: A retrospective study to evaluate the predictability of abnormal arterial blood gas measurements through novel observations of continuous trends in electronically measured respiratory in a mixed cohort of respiratory compromised patients.


Eligibility criteria: Inclusion Criteria:

* Respiratory condition is the primary admission diagnosis

Exclusion Criteria:

* Pregnant patients in their 2nd or 3rd trimester

Primary outcomes:
measure: Positive Predictive Value/Precision (PPV)
timeFrame: 12 months
Secondary outcomes:
measure: PPV of an elevated RR for an abnormal ABG - for a mix of disease states
timeFrame: 12 months
Other outcomes:
measure: PPV of elevated RR
timeFrame: 6 months
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
References:
Clinical trial NCT01349114: Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Official title: Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Pre-hypertension
Hypertension
Keywords: aliskiren
endothelial function
hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2011-05-06
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Detailed description: Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* prehypertension or Stage 1 hypertension

Exclusion Criteria:

* Type 1 diabetes
* Stage 2 hypertension
* CKD
* recent MI, revascularization, CVA or TIA

Primary outcomes:
measure: Change in Flow-mediated Dilation
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Mean Central Aortic Pressure at 3 Months
timeFrame: 3 months after start of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David A Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278314: Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis
Official title: Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2017-09-11
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.


Eligibility criteria: Inclusion Criteria:

* Males and females, 12 years of age and older with confirmed diagnosis of CF.

  1. - completed Vertex clinical studies NCT02565914 or NCT03150719, or
  2. - are homozygous for F508del and have (1) discontinued Orkambi within 12 weeks from start of treatment because of the onset of respiratory AEs considered to be treatment related or (2) cannot initiate Orkambi because of chronic treatment with an essential sensitive CYP3A substrate or a CYP3A substrate with a narrow therapeutic index AND who meet at least 1 of the following criteria:

     * the highest percent predicted forced expiratory volume in 1 second (ppFEV1) is \<40 in the 6 months before the date of completion of the request form, or
     * documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications, or
     * rapid and persistent loss of lung function, defined as at least a 20% relative decrease in ppFEV1 in the last 6 months and sustained for at least 1 month despite appropriate treatment.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the treating physician, might pose undue risk in administering TEZ/IVA combination therapy to the patient (e.g., history of advanced liver disease).
* Ongoing or prior participation in an investigational drug study (with the exception of Vertex clinical studies evaluating TEZ/IVA) within 5 terminal half-lives of the previous investigational study drug or 30 days, whichever is longer, of first administration of TEZ/IVA.
* Subjects who are pregnant.
* Patients eligible for participation in ongoing clinical studies evaluating TEZ/IVA or other CFTR modulator therapies.

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00177814: Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit
Official title: Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-negative Bacterial Infections
Keywords: pipercillin
gram negative bacteria infections
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2005-09-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with piperacillin/tazobactam and or piperacillin

Brief summary: The proposed endpoints of the study would be: comparative use of piperacillin versus broader spectrum agents (e.g., piperacillin/tazobactam, etc.) \[measured as defined daily doses per 1000 patient days\]; physician acceptance of piperacillin as part of a streamlining program \[measured as successful occurrences of the use of piperacillin as streamlining therapy\]; changes in susceptibility patterns of broad spectrum antibiotics \[measured as % Gram negative bacilli susceptible to each of the commonly used broad spectrum antibiotics\]; and outcome of patients treated with streamlined therapy.

Detailed description: The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antibiotics once organism is identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history.

Eligibility criteria: Inclusion Criteria:

* Patients with Gram negative infections treated with piperacillin/tazobactam and/or piperacillin

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References: