louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04294329: Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery
Official title: Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Postoperative
Keywords: Quadratus lumborum block
laparoscopic bariatric surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.


Eligibility criteria: Inclusion Criteria:

Patients included in this study are

* Both genders
* Age between 18-50 years
* Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
* BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.

Exclusion Criteria:

Patients excluded from this study were

* those with obstructive sleep apnoea and/or Pickwickian syndrome.
* if the laparoscopy procedure was converted to laparotomy.
* patients suffering from known coagulation defects.
* known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
* Presence of sepsis at the site of injection.

Primary outcomes:
measure: Postoperative pain severity
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative hemodynamics
timeFrame: 24 hours postoperatively
measure: Postoperative analgesic needs
timeFrame: 24 hours postoperatively.
measure: Total dose of opioids
timeFrame: 24 hours postoperatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesiology department, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Anesthesiology department, Faculty of Medicine, Ain Shams University
name: Ahmed S. Omran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology department, Faculty of Medicine, Ain Shams Unive
name: Doaa M. Kamal El-Din, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology department, Faculty of Medicine, Ain Shams Unive
name: Walid H. Nofal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942929: Lung Function Tests in Adolescents With Anorexia Nervosa
Official title: Lung Function Tests in Adolescents With Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
adolescents
lung function tests
refeeding
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-21
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents 12-18 years old hospitalized to a pediatric ward

Brief summary: The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.

Detailed description: Anorexia Nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. There is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. Based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. To examine our hypothesis we would check lung function by various parameters of adolescents suffering from AN and a control group of adolescents.

Eligibility criteria: Inclusion Criteria:

* Adolescents with anorexia nervosa
* Ability to preform lung function tests
* Parents signing informed concent and adolescents signing informed ascent

Exclusion Criteria:

* A history of a lung disease
* Intercurrent lung illness

Primary outcomes:
measure: Lung function tests at admission of adolescents with anorexia nervosa
timeFrame: On addmission to the pediatric ward
Secondary outcomes:
measure: Lung function tests at discharge of adolescents with anorexia nervosa
timeFrame: On discharge from the pediatric ward
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Centre, Department of Pediatrics
Study officials:
References:
Clinical trial NCT04207229: CERTAS Programmable Valve Registry
Official title: Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
NPH (Normal Pressure Hydrocephalus)
IIH - Idiopathic Intracranial Hypertension
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2019-12-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.

Brief summary: Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

Detailed description: The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.

1) Improvement of the following symptoms related to hydrocephalus:

* Gait disturbances;
* Spatial impairment;
* Cognitive abilities;
* Urinary incontinence;
* Pain caused by headaches;
* Visual acuity.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
2. Patients willing and able to understand and sign informed consent.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Performance Endpoints
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Secondary outcomes:
measure: Device Deficiencies
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Other outcomes:
measure: Safety Endpoints: Incidence and nature of adverse device effects
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: UniversitätsKlinikum Essen
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: München
country: Germany
facility: Klinikum rechts der Isar Technischen Universitat München
city: München
country: Germany
facility: München Klinik Bogenhausen
city: Stuttgart
country: Germany
facility: Klinikum der LandesHauptStadt Stuttgart gKAôR
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Integra LifeSciences
name: Sanja Ilic, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02253329: NMES During the Day and Prior to Sleep
Official title: The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Neuromuscular electrical stimulation
Ageing
Protein ingestion
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 16
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep

Detailed description: In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep

Eligibility criteria: Inclusion Criteria:

* Age 65-85 years
* Male
* 18.5 ≤ BMI ≤ 30.0

Exclusion Criteria:

* Type II diabetes
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
* Use of anticoagulants, blood diseases, allergy for lidocaine
* Use of NSAIDs (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid
* Patients suffering from PKU (Phenylketonuria)
* Presence of implantable cardioverter defibrillator and/or pacemaker
* Performed regular resistance type exercise in the past 6 months
* Use of any tools to assist during walking (cane/ crutches/ walker)
* (Partial) foot/ leg amputation

Primary outcomes:
measure: Incorporation of stable isotope amino acids into skeletal muscle tissue
timeFrame: 4-8 hours in the postprandial phase
Secondary outcomes:
measure: Plasma amino acid enrichment
timeFrame: 4-8 hours in the postprandial phase
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre +
Study officials:
affiliation: Maastricht University Medical Center
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103829: "Quit Smoking on Your Own" Brief Online Study
Official title: "Quit Smoking on Your Own" Brief Online Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Cigarette smoking
Tobacco smoking
Smoking, Tobacco
Lead sponsor: i4Health
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented and actual quit rates one month later.

There are no costs associated with participating in this study and participants will not be compensated for their participation.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The entire study takes place online on an automated website.

Detailed description: Participants will be recruited online using search engine ads (e.g., Google), online association list serves, community websites designed to reach individuals interested in participating in research studies, and social media sites related to smoking cessation efforts.

The entire study will be administered online. Participants may complete it at a time and place of their convenience.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The website will automatically obtain consent, ask 16 brief questions as a pre-test, randomize to 4 very brief interventions, ask 4 post-test questions, and at 1-month follow-up, send an email with a link to a 6-question survey. The initial online session is expected to take between 3 and 8 minutes and the 1-month follow-up survey less than 2 minutes.

Eligibility criteria: Inclusion Criteria:

* Adult (18 years of age or older)
* Smoker who wants to quit
* Access to the Internet

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Percentage of participants who report quitting smoking
timeFrame: 1 month
Secondary outcomes:
measure: Motivation to quit smoking
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University i4Health
state: California
Study officials:
affiliation: Palo Alto University
name: Ricardo F Muñoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331329: Evaluation of NICOM (Bioreactance) for the Non-invasive Determination of Cardiac Output
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Accuracy of NICOM
precision of NICOM
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 41
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: hemodynamically and respiratory stable patients undergoing cardiac magnetic resonance imaging with a clinical indication

Brief summary: Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). Therefore, the aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare this new technique to MRT.


Eligibility criteria: Inclusion Criteria:

* indication for cardiac magnetic resonance imaging

Exclusion Criteria:

* pace maker
* patient unwilling to participate

Primary outcomes:
measure: agreement of NICOM and MRT cardiac output measurements
timeFrame: at time of inclusion
measure: precision of NICOM cardiac output measurements
timeFrame: at time of inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04623229: A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Official title: A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MCS vs ReLACS
Pain Perception Postoperatively First Eye vs Second Eye
Early Anesthesia vs Standard Anesthesia
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
2. Patients who require surgery in both eyes by same surgeon
3. Able to understand English and complete a pain assessment

Exclusion Criteria:

1. Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
2. Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
3. Pre-existing uncontrolled glaucoma/high IOP
4. Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
5. Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
6. Patients under 40, severe obesity (BMI \>35)
7. Chronic pain/narcotics/Recreational/medical marijuana

Primary outcomes:
measure: Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
timeFrame: 1 year
Secondary outcomes:
measure: Effects of Early vs Standard administration of neurolept anesthesia on pain perception
timeFrame: 1 year
measure: Differences in pain perception between first eye vs second eye
timeFrame: 1 year
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Uptown Eye Speicialists
state: Otario
Study officials:
References:
Clinical trial NCT02566629: Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase
Official title: Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: microbiota community
IBS
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who fulfil the Rome III criteria of irritable bowel syndrome in Qilu Hospital outpatient

Brief summary: Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase.

Detailed description: The pathophysiology of IBS is incompletely understood, it may involve an altered intestinal microbiota. Since the microflora composition of IBS is various in different studies, The investigators plan to compare the intestinal microbiota of IBS patients in episodes phase and remission phase with healthy controls,trying to find the difference.

Eligibility criteria: Inclusion Criteria:

* the presence of Rome III criteria for IBS ;
* Patients scheduled for colonoscopy examination or having negative screening examinations
* Aged between 18 and 65 years old

Exclusion Criteria:

* Antibiotic, probiotic or laxative usage within 4 weeks.
* organic gastrointestinal diseases
* Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
* pregnancy or lactation.
* previous major or complicated abdominal surgery.
* severe endometriosis and dementia

Primary outcomes:
measure: microbiota community among IBS patients in episodes phase,remission phase and healthy controls
timeFrame: 5 months
Secondary outcomes:
measure: quality of life in IBS patients
timeFrame: 5 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463629: Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
Official title: Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Multidisciplinary Team
Hispanic adults
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: DHR Health Institute for Research and Development
First posted: 2018-03-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT) approach that incorporates the use of the chronic care model can be an effective method for improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in the Rio Grande Valley. The study will expand the current model of care used and focus on the multidimensional aspects that consist of physical, nutritional, educational and psychological needs of this underserved Hispanic population residing in the Rio Grande Valley.


Eligibility criteria: Inclusion Criteria:

* Have physician-diagnosed type 2 diabetes
* Be self-identified as Hispanic or Latino
* An A1c value between 9-14% within the last three months
* English or Spanish speaking

Exclusion Criteria:

* Type 1 diabetes or gestational diabetes
* Cognitive impairment
* Prisoners or individuals under detention
* Unable to speak or understand English or Spanish
* Medical history of the end-stage renal disease or undergoing dialysis.

Primary outcomes:
measure: Change in glucose level as indicated by HbA1c levels
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)
timeFrame: baseline, 3 months
measure: Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
timeFrame: baseline, 3 months
measure: Change in body mass index (BMI)
timeFrame: baseline, 3 months
measure: Change in weight
timeFrame: baseline, 3 months
measure: Change in blood pressure
timeFrame: baseline, 3 months
Other outcomes:
measure: Glucose level as indicated by HbA1c levels
timeFrame: 3 months
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mayra J Cantu
role: PRINCIPAL_INVESTIGATOR
References: