louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01861366: Implementation of Nutritional Guidelines and Effects in Nursing Home Residents
Official title: Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implementation Strategies
Nutritional Outcome of Nursing Home Residents
Keywords: Implementation
Guidelines
Nutrition
Nursing home
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.

The hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.


Eligibility criteria: Inclusion Criteria:

* age of 65 or older
* nursing home resident
* persons who manage the examination methods (interviews and blood samples)

Exclusion Criteria:

- persons in terminal stage of life

Primary outcomes:
measure: Nutritional status
timeFrame: 2 years
Secondary outcomes:
measure: Functional status
timeFrame: 2 years
measure: Cognitive status
timeFrame: 2 years
measure: Health-related Quality of Life
timeFrame: 2 years
Other outcomes:
measure: Biochemical markers
timeFrame: 2 years
measure: Morbidity
timeFrame: 2 years
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Tommy Cederholm, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torma J, Winblad U, Saletti A, Cederholm T. Strategies to implement community guidelines on nutrition and their long-term clinical effects in nursing home residents. J Nutr Health Aging. 2015 Jan;19(1):70-6. doi: 10.1007/s12603-014-0522-4.
Clinical trial NCT03999866: Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes
Official title: Awake Airway Assessment With Video Laryngoscopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assessment
Difficult Airway Intubation
Preoperative
Keywords: airtraq
c-mac
d-blade
mcgarth mac x-blade
prediction
difficult airway
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.
Primary purpose: DIAGNOSTIC

Brief summary: preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.

Detailed description: preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.

We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.

Eligibility criteria: Inclusion Criteria:- \> 18 years or \<60 years of age,

* body mass index \< 30
* no difficult airway history or predictor,
* no respiratory tract infections for ten days,

Exclusion Criteria: BMI \> 35, \< 18 or \> 60 years of age, expected difficult airway, pregnant

-

Primary outcomes:
measure: satisfaction of the instructor: visual analogy scale
timeFrame: 2 minutes
Secondary outcomes:
measure: satisfaction of the patient: visual analogy scale
timeFrame: 2 minutes
measure: duration view
timeFrame: 10 seconds
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
affiliation: Associate Professor
name: Zehra I Arslan
role: STUDY_CHAIR
References:
Clinical trial NCT06244966: GUM Remote Testing v4.0
Official title: Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Syphilis Infection
Hepatitis B and Hepatitis C
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparative study of two collection methods for blood samples
Primary purpose: DIAGNOSTIC

Brief summary: Capillary blood sample results are compared to venous blood results

Detailed description: Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample.

This study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow the investigators to assess if results measured in samples taken using the two methods are similar.

The investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.

Eligibility criteria: Inclusion Criteria:

* Adults
* Able and willing to provide informed consent.
* Already having a venous blood sample for clinical care

Exclusion Criteria:

* Failure to consent

Primary outcomes:
measure: Comparative capillary and venous samples screening testing
timeFrame: 1 year
Secondary outcomes:
measure: Comparative capillary and venous samples confirmatory testing
timeFrame: 1 year
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon University Hospital NHS Foundation Trust
state: Devon
Study officials:
References:
Clinical trial NCT02006966: The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer(Primary, Metastatic)
Benign Lung Mass Requiring Operation
Keywords: Systemic lidocaine
postoperative pain
Video-assisted thoracic surgery
VATS
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 65 years
* ASA class 1 and 2
* Patients who are scheduled for video-assisted thoracic surgery

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Pregnancy
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics or chronic pain patients
* Previous history of thoracic surgery (open or video-assisted)
* Patients' refusal

Primary outcomes:
measure: Assessing pain score after operation
timeFrame: 2 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT05721066: Hemostatic Profile of Post COVID-19/Long COVID-19 Patients
Official title: Hemostatic Profile of Post COVID-19/Long COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Post-acute COVID-19 Syndrome
Keywords: COVID-19
Post-acute COVID-19 Syndrome
Coagulopathy
Fibrinolysis
Thrombosis
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 102
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: The list of the patients hospitalized in our Institution due to COVID-19 pneumonia (positive COVID-19 test and radiological pneumonia diagnosis) was retrieved. The patients were recruited through a phone contact, those who were reachable and agreed to participate received an appointment for the in-person study-related procedures at our Hospital. The eligible patient population was represented by subjects hospitalized at out Institution for COVID-19 infection between January 1, 2021, and July 31, 2022. The planned patient population was 100 patients. The final patient population comprised 102 subjects.

Brief summary: The present study aims at assessing long-term hemostatic profile of patients recovered from COVID-19 acute infection that remain asymptomatic (POST-COVID) versus patients with residual symptoms (LONG-COVID) through the employment of a commercially available new generation point-of-care viscoelastic device. The primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from COVID-19.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* recovery from acute COVID-19 infection;
* COVID-19 pneumonia that required hospitalization in our Institution;
* discharge from the hospital minimum 3 months before the day of the visit;
* written consent to participate to the study.

Exclusion Criteria:

* none.

Primary outcomes:
measure: ClotPro EXTEST
timeFrame: Day of the visit
measure: ClotPro INTEST
timeFrame: Day of the visit
measure: ClotPro FIBTEST
timeFrame: Day of the visit
measure: ClotPro TPATEST
timeFrame: Day of the visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Marco Ranucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00886366: Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type II Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
* Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment

Exclusion Criteria:

* Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
* Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
* Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.

Primary outcomes:
measure: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
timeFrame: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions.
measure: Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide)
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions.
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: CPU Sahlgrenska University Hospital
name: Marianne Hartford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891566: Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
Official title: Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: medium to large tear
rotator cuff tear
arthroscopic repair
repair integrity
immobilization
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medium to large size rotator cuff tears

Brief summary: The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.

The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.


Eligibility criteria: Inclusion Criteria:

* Medium to large sized cuff tear (2-4 cm)
* Yes subscapular partial fraying or longitudinal split side to side
* Yes acromioplasty
* Yes AC arthritis with mumford procedure
* Yes biceps tenotomy or tenodesis

Exclusion Criteria:

* No arthritic changes of glenohumeral joint
* No combined infection
* No mini-open procedures
* No complete subscapularis tear
* No incomplete repair
* No small tears or side to side repairs without anchors
* No pregnancy

Primary outcomes:
measure: repair integrity analysis using postoperative MRI
timeFrame: 6 months
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons' score
timeFrame: 2 year postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. doi: 10.1055/s-2006-926476. German.
citation: Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8.
citation: Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. doi: 10.1016/j.arthro.2005.04.109.
citation: Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.
Clinical trial NCT02890966: Multiple Dose Study of SHR4640 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout; Hyperuricemia
Keywords: SHR4640 pharmacokinetics pharmacodynamics
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 55, male;
2. Body weight≥50, BMI:19-25kg/m2;

3.4 mg/dL≤Screening serum urate level≤7 mg/dL;

4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

Exclusion Criteria:

1. Serum creatinine\>upper limits of normal(ULN);
2. Alanine aminotransferase and/or Aspartate aminotransferase\>2×ULN, total bilirubin\>1.5×ULN, glutamyltransferase\>3×ULN;
3. History of hyperuricemia or gout;
4. History or suspicion of kidney stones;
5. Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Primary outcomes:
measure: Adverse events
timeFrame: Clinical significant changes from baseline up to Day 10
Secondary outcomes:
measure: Peak Plasma Concentration(Cmax)(of single dose and at stable status)
timeFrame: Up to Day 10
measure: Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)
timeFrame: Up to Day 10
measure: Half-time(T1/2)(of single dose and at stable status)
timeFrame: Up to Day 10
measure: Time to the peak plasma concentration(Tmax)(of single dose and at stable status)
timeFrame: Up to Day 10
measure: Changes in serum uric acid concentration from baseline
timeFrame: Up to Day 10
measure: Changes in urinary uric acid excretion from baseline
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The South West Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT02014766: Supraclavicular Versus Interscalene Block
Official title: A Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block After Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.

Detailed description: Interscalene block provides effective postoperative analgesia after shoulder surgery. However, it can be associated with significant risk including the phrenic nerve palsy. Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.

Eligibility criteria: Inclusion Criteria:

American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery

Exclusion Criteria:

pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication

Primary outcomes:
measure: pain duration
timeFrame: at 24h after operation
Secondary outcomes:
measure: diaphragmatic movement
timeFrame: preoperative, after block(at 30 min), after operation
measure: motor block
timeFrame: after block(at 30 min), after operation, at 24h
measure: paresthesia
timeFrame: after block(at 30min), after operation, at 24h
measure: complications
timeFrame: after block (at 30 min), after operation, at 24h
measure: supplemental analgesia
timeFrame: after operation, at 24h
measure: pain score
timeFrame: at 24h
measure: patient satisfaction
timeFrame: at 24h
Other outcomes:
Locations:
city: Jeju
country: Korea, Republic of
facility: Cheju Halla General Hopsital
state: Jeju self-governing province
Study officials:
affiliation: Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
name: Chunwoo Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
citation: Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.