louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03080142: TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery
Official title: Transversus Abdominus Plane (TAP) Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Surgery
TAP Blocks
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.

Detailed description: At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters.

An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks.

With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria:

* Patients under 18 years of age
* Patient over 90 years of age
* Pregnancy
* Prisoners
* Patients unable to provide consent
* Patients on systemic anticoagulation therapy
* Patients with an allergy to local anesthetics

Primary outcomes:
measure: Mean Opioid Consumption in Morphine Opioid Equivalents in mg
timeFrame: 48 hours from start of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
affiliation: UC Davis Health
name: Jon Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06131242: The s100β Levels in Patients With Mild Brain Injury.
Official title: The Application Value of Serum S100β in Acute Mild Traumatic Brain Injury.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Concussion
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy people or patients with mild traumatic brain injury.

Brief summary: Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs.

S100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods.

This study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Study on healthy people: Apparently healthy people \>18 years old who came to our hospital for physical examination.
2. Study of emergency trauma patients: 1) Emergency trauma patients at least 18 years old with suspected brain injury; 2) Glasgow Coma Score 13-15 (patients with mild traumatic brain injury); 3) Closed head trauma; 4) Clinical judgment of patients requiring craniocerebral CT examination.

Exclusion Criteria:

1. Healthy population study: stroke history, trauma, surgery, mental illness, senile dementia, cognitive impairment, and tumor patients within 3 months.
2. Study of emergency trauma patients: 1) neurological or psychiatric history, 2) intellectual disabilities, 3) alcohol or drug addiction (trauma after drinking was eligible for inclusion, but alcohol consumption was recorded), 4) brain tumor patients, 5) time of trauma was not available, and 6) patients whose clinical conditions were deemed unsuitable for participation in the trial.

Primary outcomes:
measure: The serum s100β levels
timeFrame: 2024.6-2026.6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Sumei Lu
role: STUDY_DIRECTOR
References:
Clinical trial NCT07010042: Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
Official title: Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Anxiety
Postoperative Delirium
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 86

Brief summary: Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery

Detailed description: It is known that preoperative anxiety causes postoperative agitation.

In adult patients, preoperative anxiety is assessed with the Beck Anxiety Inventory (BAI) and BAI≥16 is considered 'anxious'. Postoperative agitation is assessed with the Riker Sedation-Agitation Scale (RSAS) and RSAS ≥5 is considered agitated, pain is assessed with the Numerical Pain Scale (NRS) \>4 is considered postoperative pain. Measurements were recorded at 0, 5, 10 and 15 minutes postoperatively.

There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.

Eligibility criteria: Inclusion Criteria:

* - 18-65 years old,
* ASA I-II risk group
* Those who will be operated under general anesthesia under elective conditions.
* Will undergo surgery for Septo/Rhinoplasty
* Patients whose informed consent form was read to their parents was obtained

Exclusion Criteria:

* -Those do not want to participate in the study,
* ASA III -IV-V patients
* Having a history of drug allergy and drug interaction,
* Having a history of systemic disease such as heart, kidney, liver failure,
* Having a history of bleeding diathesis,
* Difficult intubation expected,
* Obese,
* Emergency patients,
* Mental-motor retarded,
* Having psychiatric and neurological diseases,
* Those with chronic drug use

Primary outcomes:
measure: Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
timeFrame: During the first 15 minutes postoperatively
measure: Preemptive Analgesia for Postoperative Agitation in Septo/Rhinoplasty Surgery
timeFrame: During the first 15 minutes postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT03539042: The Epigenetics of Exercise and Physical Activity in COPD
Official title: The Epigenetics of Exercise and Physical Activity in COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Copd
Keywords: DNA methylation
Physical activity
Exercise capacity
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2018-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit from Veterans referred to the VA Boston Pulmonary Rehabilitation Program who have a confirmed diagnosis of COPD.

Brief summary: This study seeks to examine genome-wide DNA methylation patterns associated with physical activity and exercise capacity from peripheral blood collected from participants with chronic obstructive pulmonary disease (COPD) before and after participation in a structured 9-week outpatient pulmonary rehabilitation program.

Detailed description: Individuals who are referred to pulmonary rehabilitation IN THE COURSE OF THEIR USUAL CLINICAL CARE will be invited to participate in this observational study. Participants who enroll in the study will undergo two in-person visits, once before initiating pulmonary rehabilitation classes and once at the conclusion of pulmonary rehabilitation classes. Participation in this study will not alter the course of the participants' usual clinical care.

Eligibility criteria: Inclusion Criteria:

* Age \>40 years
* Diagnosis of COPD (defined as an FEV1/FVC\<0.7 or evidence of emphysema on radiologist's read of a chest CT obtained in the course of patient's usual care)
* Referral to and participation in the VA Boston Pulmonary Rehabilitation program

Exclusion Criteria:

* Active or unstable cardiac disease
* Inability to ambulate \> 1 block
* Recent acute exacerbation of COPD (defined as new or increased dose of systemic steroids and/or antibiotics for pulmonary indications)

Primary outcomes:
measure: Change in DNA methylation patterns
timeFrame: Baseline and 3-month follow up
Secondary outcomes:
measure: Change in 6MWD
timeFrame: Baseline and 3-month follow up
measure: Change in average daily step count
timeFrame: Baseline and 3-month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: Emily S Wan, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044470: Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
Official title: Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of; Cold
Lead sponsor: Mamata Dental College
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy.

METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Healthy patients without any medical conditions

Exclusion Criteria:

* root canal retreatment
* pregnancy
* teeth with open apices
* a history of intolerance to nonsteroidal anti-inflammatory drugs
* immunosuppressed patients
* those under 18 years old
* patients requiring antibiotic prophylaxis
* patients with pacemakers.

Primary outcomes:
measure: Post endodontic pain measure at different time intervals using heft parker visual analog scale
timeFrame: 12,24,48,72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Khammam
country: India
facility: Mamata Dental College
state: Telangana
Study officials:
References:
Clinical trial NCT05010070: The University of Michigan Wellness for Liver Health Study
Official title: The University of Michigan Wellness Education for Liver Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: nutrition
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-08-18
Enrollment: 11
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 goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).

Detailed description: As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.

Eligibility criteria: Inclusion Criteria:

* have regular access to the internet
* MRI with liver steatosis but nor cirrhosis
* Able to consent and follow directions
* No physical limitations
* Physician approval to participate
* Able to attend in-person appointments in Ann Arbor
* Be identified based on information from the Michigan Genomics Initiative (MGI) database
* have elevated liver function tests

Exclusion Criteria:

* non-English speaking
* inability to complete baseline measurements
* a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.)
* pregnant or planning to get pregnant in the next 6 months
* type 1 diabetes
* non-NAFLD causes of elevated liver function tests
* planned or history of weight loss surgery
* vegan or vegetarian
* currently enrolled in a weight loss program or other investigative study that might conflict with this research
* taking medications known to cause weight gain or loss
* recent decompensation/hospitalization
* metal implants/inability to receive MRI

Primary outcomes:
measure: Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
timeFrame: 4 months
Secondary outcomes:
measure: Change in Liver Stiffness
timeFrame: 4 months
measure: Body Weight Change
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05541770: Application of MDT Clinics in Arab World
Official title: Assessment of Multidisciplinary Clinics Implementation in Cancer Patients' Management in Arab Countries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multidisciplinary Communication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology or non oncology physicians across the Arab countries.

Brief summary: Multidisciplinary clinics affect the quality of management of cancer patients. This Questionnaire is for research purposes aiming at exploring the application and implementation of multidisciplinary clinics in managing cancer patients in the Arab countries. The results of this survey will shed the light on the situation; the investigators aim at exploring the status of their implementation and who participates in them, in addition to exploring the challenges that face MDT clinics in Arab world.

Detailed description: Multidisciplinary teams (MDTs) are recommended as a corner stone of best cancer care nowadays. MDTs consist of many professionals such as medical, nursing, and allied professionals and diagnostic experts to determine the optimal treatment pathway for individual patients. They should be well organized and efficient. MDT clinics care is helpful in making clinical decision and improving the quality of patients' care. However, there are many challenges that face the actual implementation and application of MDT clinics in routine cancer patients' care in our Arab countries.

This study aims at describing the situation in our Arab countries and reflecting the pathway \& logistics of referring cancer patients to MDT \& the impact of that on the patients' management \& outcome, in addition to exploring the challenges that face effective implementation of MDT clinics, so that it can lead the improvement in oncology manangement

Eligibility criteria: Inclusion Criteria:

* Healthcare workers/Physicians involved in cancer diagnosis \& management in the Arab countries.

Exclusion Criteria:

* Health care workers/ Physicians who are not entitled for cancer management.
* Physicians who are not working in the Arab counties.

Primary outcomes:
measure: Investigate the rate of discussing the suspected patients in MDT clinics
timeFrame: Two months
measure: Investigate the main challenges to establish effective MDT clinics.
timeFrame: Two months
Secondary outcomes:
measure: Describe the rate of well established and effective MDT in the Arab countries.
timeFrame: Two months
measure: Who usually attend the MDT in the Arab countries?
timeFrame: Two months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06174870: The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension
Official title: The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly
Hypertension
Keywords: Elderly
Hypertension
Inspiratory muscle training
Lead sponsor: University of Phayao
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is:

• Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity

Participants will be random in to 2 group and measure baseline. Control group will advise to maintain normal daily life activity. and Intervention group will receive inspiratory muscle training (IMT) with 60% of Maximal inspiratory pressure. Intervention group will perform IMT 30 breaths/day, 5 days a week for 6 weeks.

after 6 weeks both group will remeasure variable again as post test


Eligibility criteria: Inclusion Criteria:

* Elderly with hypertension
* BMI 18.5 - 29.9 kg/m2

Exclusion Criteria:

* Unstable angina
* Resting heart rate more than 120 bpm
* Resting blood pressure more than 180/100 mmHg
* Other abnormality with contribute to IMT and variable measurement

Primary outcomes:
measure: Maximal Inspiratory pressure
timeFrame: "baseline, pre-intervention" and "6 weeks"
measure: Systolic and diastolic blood pressure
timeFrame: "baseline, pre-intervention" and "6 weeks"
measure: Six-minute walk distance
timeFrame: "baseline, pre-intervention" and "6 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Nai Muang
country: Thailand
facility: University Of Phayao
state: Phayao
Study officials:
References:
Clinical trial NCT02855970: Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke
Official title: Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation.

The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice.

The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older.
* Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort.
* Patients who have provided oral informed consent.
* Patients with national health insurance cover

Exclusion Criteria:

* History of symptomatic stroke.
* Meningeal haemorrhage.
* Severe visual or hearing handicap making it difficult to complete the questionnaire.
* Global severe aphasia and mutism making communication with the patient impossible-.
* Unable to read or speak French.
* Dementia prior to the stroke.
* Psychiatric disorders and dependence on alcohol/drugs.
* Bedridden before the stroke.
* Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.

Primary outcomes:
measure: responses to a quality of life questionnaire
timeFrame: Change compared with baseline score at Day 15, Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References: