louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04464317: Dysphagia and Vocal Cord Injury Following Cardiac Surgery
Official title: Vocal Cord Impairment and Dysphagia in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dysphagia
Cardiovascular Diseases
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

Brief summary: Aiming to determine the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients and evaluate the impact of VFMI on health-related outcomes.

Detailed description: This is a retrospective study to determine:

1. the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients
2. evaluate the impact of VFMI on health-related outcomes.

Eligibility criteria: Inclusion Criteria:

* All cardiac surgery patients January 2010-April 2020 at Shands Hospital
* Patients aged between 18 and 90 years
* Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

Exclusion Criteria:

* Under 18 years old or over 90 years old

Primary outcomes:
measure: Incidence of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients
timeFrame: January 2010-June 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Eric Jeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385317: Mindfulness to Mitigate the Effect of Anxiety-depression-fear in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Mindfulness to Mitigate the Effect of Anxiety-depression-fear in COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety.

Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.


Eligibility criteria: Inclusion criteria:

* Lung disease diagnosis
* Demonstrated competence in proposed technology
* Current or past smoking status
* Patient Health Questionnaire-2 (PHQ-2) or Generalized Anxiety Disorder scale (GAD-2) score \>2 points or answering yes to a validated question of fear of being breathless ("Do you experience fear, or panic when you have difficulty getting your breath a good bit of the time?")

Exclusion criteria:

* High likelihood of non-compliance or low confidence using the technology
* Patients currently in pulmonary rehabilitation
* Inability to walk
* Prescribed antidepressant or antianxiety medication within last month
* Documented substance abuse
* Cognitive impairment as defined by the Mini-Mental test score \< 24.

Primary outcomes:
measure: Change in Quality of Life as measured by the Chronic Respiratory Questionnaire
timeFrame: baseline, 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03848117: Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
Official title: Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Patient Rated Tennis Elbow Evaluation (PRTEE)
Mobilization with movement
Deep Transverse friction massage
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned into two groups: Cyriax Approach group and Mulligan approach group. A coin was flipped at start of data collection for the first patient to be assigned odd number and included in cyriax group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from lateral epicondylitis patients visiting the DHQ Hospital Bahawalnagar.
Primary purpose: TREATMENT

Brief summary: Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.

Detailed description: A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.

Eligibility criteria: Inclusion Criteria:

* Age group 20-50 years of both gender.
* Vas \< 7
* Positive mills test and cozens test.
* Local tenderness on palpation over lateral epicondyle of the humerus.
* From sub-acute to chronic more than 2 weeks.

Exclusion Criteria:

* Any previous pathology of bone around elbow.
* Corticosteroid injection in the preceeding 3 months.
* Absence of clinical signs of tennis elbow.
* Any other systemic illness like metabolic, metastatic, infective disorders.
* Any other neurological abnormalities.
* Allergies to Mulligan tape.

Primary outcomes:
measure: Patient related tennis elbow evaluation pain scale
timeFrame: Upto 4 weeks
measure: Patient related tennis elbow evaluation functional disability scale
timeFrame: Upto 4 weeks
Secondary outcomes:
measure: Hand grip strength chart index
timeFrame: Upto 4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Sammar Abbas
state: Punjab
Study officials:
References:
Clinical trial NCT00873717: Improvement of Nutritional Status in Elderly Residents of Long-term Facilities
Official title: Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders
Keywords: elderly
long-term facilities
nutritional status
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 114
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.

The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

Detailed description: Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.

The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.

The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.

Eligibility criteria: Inclusion Criteria:

* Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: comparison of GNRI mean-score between arms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Centre gérontologie Les Abondances
state: Ile de France
city: Clichy
country: France
facility: Institut ROGUET
state: Ile de France
city: Colombes
country: France
facility: AP-HP, Louis Mourier Hospital
state: Ile de France
city: Paris
country: France
facility: Hôpital Bretonneau
state: Ile de France
city: Puteaux
country: France
facility: Hôpital de Puteaux
state: Ile de France
city: Sevran
country: France
facility: AP-HP, Hôpital René Muret-Bigottini
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe CHARRU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marysette FOLLIGUET, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT01609517: The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
Official title: The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Success or Failure of Spinal Anesthesia
Keywords: Spinal anesthesia
determinant
duration
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 209
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period

Brief summary: In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.

Detailed description: Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.

Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
* American Society of Anesthesiologist Physical Status classification I \~ III

Exclusion Criteria:

* Bupivacaine allergy
* medical history of spinal surgery
* Diabetic neuropathy
* active infection at the lumbosacral area
* other contraindication of spinal anesthesia

Primary outcomes:
measure: spinal anesthetic success/ failure
timeFrame: at 2 hour after the anesthetic induction
Secondary outcomes:
measure: Peak level of sensory block at anesthesia induction
timeFrame: during 20 min after anesthetic induction
measure: Spinal anesthesia sensory/motor block level at the end of surgery
timeFrame: 2 hours after induction (at the end of surgery)
measure: the incidence of tourniquet pain
timeFrame: at 90 min afer anesthetic induction
measure: Incidence of hypotension, bradycardia
timeFrame: during 2 hours after anesthesia induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sangmin M. Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Ji Sun Hahm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635617: SFDI in High Energy Lower Extremity Fracture
Official title: Spatial Frequency Domain Imaging-based Perfusion Imaging to Assess Soft Tissue Injury in High Energy Lower Extremity Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Keywords: Trauma
Orthopaedic
Lower Extremity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2022-12-02
Enrollment: 56
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: Patients 18 years of age or older who present to DHMC (Lebanon) with high energy lower leg trauma.

Brief summary: This is a non-randomized prospective study of 20 patients with high energy lower extremity fractures evaluating feasibility and acceptability of SFDI, a real-time optical imaging technology.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* High energy lower extremity fracture
* Provision of informed consent

Exclusion Criteria:

* Upper extremity fracture
* Metatarsal fractures

Primary outcomes:
measure: Feasibility and acceptability of the SFDI Imaging
timeFrame: 4 minutes or less
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081817: Accuracy Comparison of Two CGMs in Hospitalized Patients
Official title: Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2021-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients requiring an insulin drip.

Brief summary: The purpose of the study is to determine the accuracy of two different continuous blood sugar monitoring systems in hospitalized patients by comparing them standard laboratory blood sugar testing in the hospital.


Eligibility criteria: Inclusion Criteria:

1. All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of ≥24 hours
2. Age ≥18 years at the time of consent
3. Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion ≥12 hours
4. Willingness to provide informed consent and follow all study procedures

Exclusion Criteria:

1. Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment
2. Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.)
3. Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment
4. Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome

Primary outcomes:
measure: Difference in glucose measurement
timeFrame: 5 Days
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Medical Center
state: California
Study officials:
References:
Clinical trial NCT04957017: Effect of Hand-Washing Training in Covid-19
Official title: Effect of Training on Given to Women With Chronic Disease on Hand-Washing Behaviours, Attitudes and Nutrition During the Covid-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Covid-19 Pandemic
Keywords: COVID-19
hand hygiene
chronic disease
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted in order to inform, the women with chronic disease in rural areas, about hand-washing and nutrition, and to evaluate the efficiency of the training program. A randomized-controlled trial was performed based on CONSORT checklist. 90 women in total were included in the study, 45 for each group. The women in the intervention group were given, by the researcher, the training on the importance of hand-washing and appropriate food choices. The training given to the women in rural areas created significant benefit for them to have the appropriate food choices and hand-washing behaviours.


Eligibility criteria: Inclusion Criteria:

* Be women, agreeing to participate.

Exclusion Criteria:

* Be man, unable to communicate.

Primary outcomes:
measure: The Nutritional Knowledge Level Scale for Adults (NKLSA)
timeFrame: Three months
measure: Social Hand-Washing Knowledge Form
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy university
Study officials:
References:
citation: Geleta TA, Deriba BS, Beyane RS, Mohammed A, Birhanu T, Jemal K. COVID-19 Pandemic Preparedness and Response of Chronic Disease Patients in Public Health Facilities. Int J Gen Med. 2020 Nov 5;13:1011-1023. doi: 10.2147/IJGM.S279705. eCollection 2020.
citation: Cintoni M, Rinninella E, Annetta MG, Mele MC. Nutritional management in hospital setting during SARS-CoV-2 pandemic: a real-life experience. Eur J Clin Nutr. 2020 May;74(5):846-847. doi: 10.1038/s41430-020-0625-4. Epub 2020 Apr 6. No abstract available.
Clinical trial NCT01161017: Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Official title: Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mechanism-based choice of therapy for pain:

Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?


Eligibility criteria: Inclusion Criteria:

* female and male migraine patients with a number of month attacks ≥ 4,
* age 18-75,
* without any other chronic pain.

Exclusion Criteria:

* any migraine preventive treatment for last 6 month \& psychiatric,
* language or cognitive dysfunction precluding use of psychophysics.

Primary outcomes:
measure: Therapeutic response to the analgesic drugs
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT01159717: CT Versus CEUS Findings of Complex Cystic Renal Lesions
Official title: Complex Cystic Renal Lesions: Evaluation of Computed Tomography Findings With Contrast Enhanced Ultrasound in Terms of the Bosniak Classification System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Neoplasms
Computed Tomography
Ultrasonography
Contrast Media
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing a CT procedure.

Brief summary: Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).

Detailed description: All subjects receive an contrast enhanced CT due to different clinical indications. When a complex cystic renal lesion is found an evaluation with CEUS is performed. The CEUS protocol included a native baseline examination of both kidneys. After a bolus injection of 1.5 ml SonoVue (Bracco, Milano, Italy) an examination of the affected kidneys is performed over a time period of at least three minutes. An optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. When both examinations are done the lesions were classified using the Bosniak classification system and a comparison of both methods will be done.

Eligibility criteria: Inclusion Criteria:

* Finding of a complex cystic renal lesion

Exclusion Criteria:

* age \< 18 y, gravity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Radiology, University Hospital Basel, University of Basel
Study officials:
affiliation: Department of Radiology, University Hospital Basel, University of Basel
name: Joachim Hohmann, MD
role: PRINCIPAL_INVESTIGATOR
References: