louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02029261: Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
Official title: Project 4: Molecular Mechanisms in Burn-induced Insulin Resistance in Humans
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Burn
Keywords: Burn
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 0
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: Massachusetts General Hospital (MGH) burn patients from the emergency department, intensive care unit, burn unit, or other MGH inpatient unit

Brief summary: The purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.

Detailed description: Burn injury induces insulin resistance and our investigators have previous shown the importance of insulin receptor substrate 1 (IRS-1)-mediated pathways. This project will establish the inhibitory effects of burn injury on IRS-1 mediated signaling in human skeletal muscle of burn patients.

Eligibility criteria: Inclusion Criteria:

* Burn injury \>=10% total body surface area involvement from any etiology that will require surgical treatment
* Age 18 years or older
* Admitted to the Massachusetts General Hospital within 30 days of burn injury
* Patient or guardian who is capable of giving full informed consent

Exclusion Criteria:

* Decision not to treat due to severity of injury
* Presence of anoxic brain injury that is not expected to result in complete recovery
* Existence of co-morbid conditions of malignancy currently under treatment, medical condition requiring glucocorticoid treatment, insulin dependent diabetes mellitus, morbid obesity defined as body mass index \>= 40

Primary outcomes:
measure: Determination of gene expression profile and protein expression
timeFrame: Time of burn injury up to 24 months postinjury
Secondary outcomes:
measure: Hospital discharge status
timeFrame: From hospital admission to discharge
measure: Presence of clinical complications
timeFrame: From hospital admission to discharge
measure: Intensive care unit (ICU) days
timeFrame: From hospital admission to discharge
measure: Nutritional status at discharge
timeFrame: At hospital discharge
measure: Correlation between protein data and in vivo physiologic measurement data
timeFrame: Hospitalization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ronald G Tompkins, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01972061: Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Official title: Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.

Detailed description: Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.

Eligibility criteria: Inclusion Criteria:

1. 18 year old men and women and older
2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB

Exclusion Criteria:

1. Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.
2. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.
3. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.

Primary outcomes:
measure: Number of Urinary Incontinence Episodes Per Day
timeFrame: Week 1, Week 2, Week 3
Secondary outcomes:
measure: Number of Urinary Urgency Episodes Per Day
timeFrame: Week 1, Week 2, Week 3
Other outcomes:
measure: Bladder Volume as Recorded on CMG for Strong Desire to Void
timeFrame: CMG #1 and CMG#2
measure: Number of Urinary Voids Per Day
timeFrame: Week 1, Week 2, Week 3
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Christopher Chermansky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Dawn McBride, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT03404661: Optical and Biochemical Biomarkers in Early Pancreatic Cancer
Official title: Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreas cancer, controls at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms, and subjects with a familial history of pancreas cancer.

Brief summary: The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

Detailed description: Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. This entire process from secretin injection to sample collection takes an average of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. The top 10 candidate markers from discovery and validation on tissue (AUCs \>0.95) and from pilot pancreatic-juice testing (AUCs \>0.9) will be evaluated in this study. Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods. Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique. Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.

Eligibility criteria: Inclusion Criteria:

* Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.
* International normalized ratio (INR) less than 1.5
* Platelet count \>50,000

Exclusion Criteria:

* Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding
* Pregnant patients

Primary outcomes:
measure: Methylated DNA markers as measured by mean percentage of total human DNA per pancreatic juice volume
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Massimo Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748461: Objective Assessment and Promotion of Physical Activity in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: intervention study in elderly (65+)
cycle ergometer
physical activity
physical fitness
assisted living facility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the present study is to evaluate the short-term and long-term effects of a cycle ergometer program on physical activity and physical fitness in elderly (65+). Therefore, physical activity, physical fitness and functionality are measured at baseline, after 10 weeks (after the intervention period), after 6 months and after 1 year.

Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer program) will also be evaluated. What is the best (coaching) approach for long-term adherence (physical activity)?


Eligibility criteria: Inclusion Criteria:

* 65 yrs
* residents of a service flat
* No frequent use of bike / cycle ergometer

Exclusion Criteria:

* recent cardiovascular event or fracture
* vestibular or thrombotic disorder
* severe dementia
* need for oxygen supplementation during daily activities

Primary outcomes:
measure: Change in objective and subjective measures of degree of physical activity
timeFrame: baseline, 10 weeks, 6 months, 1 year
measure: Change in objective measures of physical fitness
timeFrame: baseline, 10 weeks, 6 months, 1 year
measure: Change in objective measures of functionality
timeFrame: baseline, 10 weeks, 6 months, 1 year
Secondary outcomes:
measure: Change in mental well-being
timeFrame: baseline, 10 weeks, 6 months, 1 year
measure: Change in motivation to be physically active
timeFrame: baseline, 10 weeks, 6 months, 1 year
measure: Change in self-efficacy to be physically active
timeFrame: baseline, 10 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of Kinesiology and Rehabilitation Sciences
Study officials:
References:
Clinical trial NCT06743061: Long-Term Follow-up of Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears
Official title: Evaluation of Arthroscopic Debridement, Subacromial Decompression, and Biceps Tenotomy Without Repair of Rotator Cuff in Chronic Massive Rotator Cuff Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From Oct 2018 to Jan 2021, 23 patients who had chronic massive RCTs received arthroscopic management for their RCTs and were followed as short-term follow-up for 3 months after surgery. Then, patients were asked to attend the Orthopedic outpatient clinic every three months for assessment to get the outcomes of the long-term follow-up. The preoperative, operative, immediate postoperative, and short-term follow-up data were collected from patients' files.

Brief summary: Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing MMRCTs is not fully understood. A comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling.

The study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. By analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. Furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.


Eligibility criteria: Inclusion Criteria:

* Patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears

Exclusion Criteria:

* Patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears

Primary outcomes:
measure: The proportion of patients reported having at least a 50% obtaining the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.
timeFrame: 42 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Kasr Al-Einy
Study officials:
References:
Clinical trial NCT03871283: Anticoagulation and Antiplatelet Management During Perioperative Period
Official title: Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulants and Bleeding Disorders
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 2400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient programed for elective surgery

Brief summary: the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

Detailed description: the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality?

Anticoagulation for prevention of thromboembolic events will not be studied in this study.

The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Able to consent
* Taking anticoagulants or antiplatelet drugs in the long term.

Exclusion Criteria:

* Incapacitated adults
* Minor patients

Primary outcomes:
measure: Ratio of well treated patient
timeFrame: 30 days
Secondary outcomes:
measure: bleeding consequence (volume in mL)
timeFrame: 30 days
measure: Mortality Consequence
timeFrame: 30 Days
measure: Blood Test Consequence
timeFrame: 30 Days
measure: Morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: ERASME Hospital
Study officials:
affiliation: ERASME UH
name: Olivier DURANTEAU, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773483: Quorn in Community Health Experiment
Official title: Quorn in Community Health Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Marlow Foods Ltd
name: NIHR Exeter Clinical Research Facility
First posted: 2021-02-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In overweight individuals (BMI \> 27.5 kg/m2), does daily consumption of mycoprotein containing Quorn Food products lower blood cholesterol compared with daily meat/fish consumption?


Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* BMI \>27.5 kg/m2
* Non allergic to penicillin/mycoprotein
* Moderate levels of physical activity or below (self-identified; NDNS servey)
* Omnivores
* Not currently using cholesterol lowering medication

Exclusion Criteria:

* \<18 or \>70 years old
* BMI \<27.5 kg/m2
* Allergies to penicillin/mycoprotein
* Heavy exercisers (self idenfiied)
* Vegetarian/vegans
* Currently using cholesterol lowering medication

Primary outcomes:
measure: Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations
timeFrame: 4 weeks
Secondary outcomes:
measure: Postprandial blood cholesterol concentration
timeFrame: 3 hours
measure: Fingerprick blood glucose concentration
timeFrame: 4 weeks
measure: Satiety
timeFrame: 4 weeks
measure: Hedonic visual analogue scale
timeFrame: 4 weeks
measure: Gastrointestinal side-effects
timeFrame: Once weekly, over 4 weeks
measure: Fingerprick blood c-peptide
timeFrame: 4 weeks
measure: Fingerprick blood triglyceride concentration
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Benjamin T Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00357383: Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Official title: Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Infections, Bacterial
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Detailed description: The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Eligibility criteria: Inclusion Criteria:

* Male or female aged from 18 to 45 years old;
* Written informed consent;
* Healthy volunteers without any subjective ocular symptom;
* Normal ocular examination in both eyes (corrected visual acuity \>= 6/10, normal slit lamp examination, tear prism height \> 0.1mm, tear break-up time (BUT) \>= 10 seconds, lissamine green test score \< 4);
* Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
* number of corneal stained punctuations \>= 5;
* blepharitis, conjunctivitis, uveitis;
* contact lenses;
* topical ocular treatment within the last month;
* ocular laser within the last 3 months;
* ocular surgery, including LASIK and PRK, within the last 12 months;
* systemic macrolide within the last month;
* medication during the study (except: paracetamol and contraceptives).

Primary outcomes:
measure: Ocular pharmacokinetic in tears
Secondary outcomes:
measure: Tolerance
Other outcomes:
Locations:
Study officials:
affiliation: ASTER, Paris, France
name: Didier CHASSARD, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888783: Two Measures of Tactile Acuity in CRPS Type I Patients
Official title: Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CRPS Type I of the Upper Extremity
Neuropathy of the Median Nerve
Healthy Controls
Keywords: CRPS Type I
tactile acuity
2-point-discrimination
Grating Orientation Task
sensory signs
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
* Patients diagnosed with a neuropathy of the median nerve
* Healthy Controls,matched in age and gender to both patient cohorts

Exclusion Criteria:

* intolerable hyperalgesia
* lesions at the fingertips
* high grade digit contracture
* central neurologic disorders
* psychiatric disorders

Primary outcomes:
measure: tactile acuity as measured by 2-point-discrimination
timeFrame: unique measurement of maximal one hour duration
measure: tactile acuity as measured by the Grating Orientation Task (GOT)
timeFrame: unique measurement of maximal half an hour duration
Secondary outcomes:
Other outcomes:
measure: Touch threshold for light touch
timeFrame: unique measurement, duration approx. 5 minutes
Locations:
city: Bochum
country: Germany
facility: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Study officials:
affiliation: Ruhr University Bochum
name: Christoph Maier, Prof. Dr.
role: STUDY_CHAIR
References: