louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04596215: Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults
Official title: Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoxygenation
Keywords: Anaesthesia
Preoxygenation
blood gas analysis
Oxygen Reserve Index
Decarboxylation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult awake patients for elective surgery with indication for an invasive arterial blood pressure measurement

Brief summary: Valuation of the probability for a correct detection of paO2 \< 100 mmHg and paO2 \> 200 mmHg using the Oxygen Reserve Index

Detailed description: As mentioned above

Eligibility criteria: Inclusion Criteria:

* Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients
* written informed consent

Exclusion Criteria:

* Emergency surgery
* Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation
* no written informed consent

Primary outcomes:
measure: Validation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index
timeFrame: preoxygenation of 3 minutes
Secondary outcomes:
measure: Patient characteristics
timeFrame: 48 hours
measure: MAP
timeFrame: preoxygenation of 3 minutes
measure: NIRS (Near-infrared spectroscopy)
timeFrame: preoxygenation of 3 minutes
measure: PI
timeFrame: preoxygenation of 3 minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg - Universität
state: Rhineland Palatinate
Study officials:
References:
Clinical trial NCT05697315: Erector Spinae Plane Block for Postoperative Pain Management
Official title: The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Post Operative Pain
Keywords: Pain
postoperative analgesia
Erector spinae plane block
cesarean section
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.

Detailed description: The study included 54 patients with mild systemic disease (ASA II patients) who would undergo elective CS under spinal anesthesia. They were randomly divided into an ESP block group (Group E) and a control group (Group C). After the surgery, Group E patients underwent ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral decubitus position, while Group C received no intervention. Patients in both groups received parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and other data were assessed using independent samples t-test, Mann-Whitney U test, and Chi-square analysis.

Eligibility criteria: Inclusion Criteria:

* ASA II patients
* 18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia
* agreed to participate in the study

Exclusion Criteria:

* Patients with infection at the injection site
* Coagulopathy Allergy to amide-type local anesthetics
* History of peripheral neuropathy
* Hepatic and/or renal failure
* Refusing the procedure
* patients with heart disease

Primary outcomes:
measure: 24-hour opioid consumption
timeFrame: up to 24 hour
Secondary outcomes:
measure: Visual Analog Scale (Vas)
timeFrame: 0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey
name: Gökçe Gişi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826137: Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
Official title: Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antibiotic-Associated Diarrhea
Keywords: prebiotics
Antibiotic-associated diarrhea
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.

Detailed description: Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.

Eligibility criteria: Inclusion Criteria:

* Healthy children with acute infection.

Exclusion Criteria:

* Hypersensitivity to antibiotics, chronic illness.

Primary outcomes:
measure: Prevention of diarrhea.
timeFrame: During antibiotic treatment+14 days
Secondary outcomes:
measure: Duration of diarrhea.
timeFrame: During antibiotic treatment+14 days
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Zvi Weizman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02135237: Contingency Management for Alcohol Use Disorders
Official title: Contingency Management for Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-05-09
Enrollment: 120
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: Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* current diagnosis of alcohol use disorder and self report of recent alcohol use
* pass an informed consent quiz
* agree to wear a SCRAMx monitor for 12 weeks
* have a standard SCRAMx compatible phone line in their home or agree to attend the clinic weekly for brief research visits/downloads
* agree to sign an off-campus property transfer form and return SCRAMx equipment

Exclusion Criteria:

* serious, uncontrolled psychiatric illness
* in recovery from pathological gambling
* have an unstable address
* intend to participate in activities incompatible with SCRAMx over the next 3 months
* are wearing SCRAMx for legal purposes

Primary outcomes:
measure: longest duration of abstinence from alcohol
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: New Britain
country: United States
facility: The Hospital of Central Connecticut at New Britain General
state: Connecticut
city: New Britain
country: United States
facility: Farrell Treatment Center
state: Connecticut
city: Springfield
country: United States
facility: Behavioral Health Network, Inc.
state: Massachusetts
Study officials:
affiliation: UConn Health
name: Sheila Alessi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02048137: Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 20
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 the study we test whether transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.


Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Pregnancy
* Sever internal or psychiatric condition

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 1 week
Secondary outcomes:
measure: Visual analoug scale - pain
timeFrame: 1 week
Other outcomes:
measure: Quality of life
timeFrame: 3 weeks
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
References:
Clinical trial NCT03363737: Transtheoretical Model of Behavior Change and Anxiety
Official title: Can Facebook Reduce Perceived Anxiety Among College Students? A Randomized Controlled Exercise Trial Using the Transtheoretical Model of Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological
Physical Activity
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Examine the utility of the Transtheoretical Model in influencing anxiety among college students. Employ a randomized controlled intervention including a static and dynamic Facebook intervention. The static group accessed a Facebook page featuring 96 statuses. Statuses were intended to engage cognitive processes, followed by behavioral processes of change per the Transtheoretical Model of behavior change. Content posted on the static Facebook page was identical to the dynamic page. However, the static group viewed all 96 statuses on the first day of the study, while the dynamic group received only 1-2 of these status updates per day throughout the intervention. Anxiety was measured using the Overall Anxiety Severity and Impairment Scale (OASIS). Time spent engaging in physical activity was assessed using the International Physical Activity Questionnaire (IPAQ).


Eligibility criteria: Inclusion Criteria:

* Having an active Facebook account
* Daily access to a Smart Phone
* Current University of Mississippi email account

Exclusion Criteria:

* Outside the age range of 18-35

Primary outcomes:
measure: Changes in Anxiety
timeFrame: At baseline and at the end of the 8-week intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Frith E, Loprinzi P. Can Facebook Reduce Perceived Anxiety Among College Students? Randomized Controlled Exercise Trial Using the Transtheoretical Model of Behavior Change. JMIR Ment Health. 2017 Dec 8;4(4):e50. doi: 10.2196/mental.8086.
Clinical trial NCT04480437: Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
Official title: Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
First posted: 2020-07-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Primary purpose: DIAGNOSTIC

Brief summary: It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others, applied during breast ultrasound (BUS) imaging allows to classify lesions according to its malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the board of experts judging the BUS imaging results if no biopsy is done.

Detailed description: Patients with a palpable lump in the breast or suspicious findings in X-ray mammography typically undergo breast ultrasound examination as a supplemental imaging modality. Findings are then used for tumour classification according the American Collage of Radiology (ACR) Breast Imaging Reporting and Database System (BI-RADS) lexicon. Suspicious findings then undergo ultrasound-guided biopsy, which causes discomfort for the patient and introduces high emotional stress, and may involve - albeit very-small - risk of complications (such as bleeding and infections).

Today conventional breast ultrasound B-mode images do not have the specificity to reliably differentiate malignant and benign tissues in all cases and hence a biopsy intervention or close follow-up is necessitated. Multiparametric imaging bio-markers such as the novel method of speed-of-sound imaging may provide additional indicators to help to better classify lesions prior to biopsy and avoid any further work-up.

The study collects data with an ultrasound device during normal BUS examination which is then retrospectively processed to extract the desired multi-parametric BUS (mp-BUS) information of imaged tissue.

Eligibility criteria: Inclusion Criteria:

* Women who are suspected or suspected of having breast cancer and who are advised to perform a detailed breast ultrasound or tissue sampling (biopsy)
* Classification into groups:

  * Group 1: Foreseen for BUS guided biopsy
  * Group 2: BI-RADS classification I, II and III and foreseen for BUS only based diagnosis

Exclusion Criteria:

* Lactating women
* Women with mastitis
* Vulnerable persons

Primary outcomes:
measure: Speed-of-sound imaging shows malignancy of lesion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
Study officials:
affiliation: Kantonsspital Baden
name: Kubik Rahel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011115: Motivations for Weight Loss
Official title: Weight Loss Motivations and Long-term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: overweight
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2001-02-09
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study tests the effects of emphasizing different motivations for wanting to lose weight on weight loss maintenance in women. At the start of the study, participants will be weighed and will complete questionnaires about their health, weight history, eating and exercise habits, body satisfaction and mood. Participants will then be randomly assigned to 1 of 4 treatments. Participants in all 4 groups will receive information on topics related to eating and exercise, and will receive calorie and fat intake goals, and exercise goals. The 4 treatments will differ in the emphasis given to various reasons for wanting to lose weight. At 6, 12 and 18 months after enrollment, participants will again have weights measured and fill out questionnaires.


Eligibility criteria: Inclusion Criteria:

* Body mass index greater than or equal to 27 and less than or equal to 35
* Rating both physical appearance and health concerns as important motivations for weight loss
* Successful completion of a food and exercise diary over a 5-day period

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine, Dept of Psychiatry
state: Pennsylvania
Study officials:
References:
citation: Kalarchian MA, Levine MD, Klem ML, Burke LE, Soulakova JN, Marcus MD. Impact of addressing reasons for weight loss on behavioral weight-control outcome. Am J Prev Med. 2011 Jan;40(1):18-24. doi: 10.1016/j.amepre.2010.09.019.
Clinical trial NCT02524015: Novel Treatment For Pusher Syndrome Using Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pusher Syndrome
Keywords: stroke
pusher syndrome
contraversive pushing
lateropulsion
rehabilitation
physical therapy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
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 see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."


Eligibility criteria: Inclusion Criteria:

* Recent (within 2 months) unilateral stroke
* Burke Lateropulsion Scale ≥ 2
* Age 21 to 89 years
* Ability to provide informed consent
* English-speaking

Exclusion Criteria:

* Prior stroke within the past 6 months
* Cerebellar stroke
* Stroke-related brain imaging (MRI or CT) unavailable
* Global or receptive aphasia
* Prior documented neurologic disorder (e.g., multiple sclerosis, Parkinson's)

Primary outcomes:
measure: Recovery from pusher syndrome as measured by changes in the Burke Lateropulsion Scale score over time.
timeFrame: Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03305315: Study of Temporomandibular Joint Dysfunction
Official title: Study of Movement of the Pathological Temporomandibular Joint.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diseases of the Temporomandibular Joint
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with temporomandibular joint disorders and asymptomatic subjects

Brief summary: Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.

The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.


Eligibility criteria: Inclusion Criteria:

Patients:

* Patients who have provided verbal consent,
* Patients over 18 years old,
* Patients with mandible dentition compatible with placement of the kinetic measurement device,
* Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).

Asymptomatic subjects:

* Subjects who have provided verbal consent,
* Subjects over 18 years old,
* Subjects with Class 1 occlusion,
* Subjects without dental implants,
* Subjects with no history of joint dysfunction,
* Absence of clicking, popping, or grating sounds during large movements and during palpation of the TMJ with the mouth slightly open (distance between incisors around 1 cm)
* Absence of headache,
* Absence of tinnitus,
* Kinematic curves around the mean.

Exclusion Criteria:

* Adults under guardianship,
* Patients without national health insurance cover.

Primary outcomes:
measure: Mobility of the jaw with regard to the skull during each movement.
timeFrame: Until 6 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: