louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03538496: Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery
Official title: Erector Spinae Plane Block Versus Thoracic Paravertebral Block on Postoperative Pain for Video Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The paravertebral block has been successfully used in various surgical patient groups for purposes of anesthesia or postoperative pain management such as thoracotomy, breast surgery and abdominal surgery. The aim of this study is to compare the analgesic effects of erector spinae plane block and paravertebral block in patients undergoing video assisted thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Undergoing video assisted thoracoscopic surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: First 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative 0-24 hours
measure: Block performing time
timeFrame: First hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT03126396: Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers
Official title: Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcers, Leg
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of efficacy \& tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

Detailed description: Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.

Eligibility criteria: Inclusion Criteria:

1. Male or female over 18 years old who has provided his/her written informed consent
2. Patient who can be monitored by the same investigation team throughout the whole duration of the study
3. Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing
4. Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
5. Ulcer area between 3 and 20 cm2
6. Ulcer duration between 3 and 18 months,
7. Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
8. Moderately or heavily exudative ulcers.

Exclusion Criteria:

A. Clinical infection on the wound bed.

Primary outcomes:
measure: Efficacy - % of Wound Area Regression (WAR
timeFrame: at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Chenôve
country: France
facility: URGO
Study officials:
References:
Clinical trial NCT01567696: Clinical, Radiographic and Laboratory Analysis of Failures of Joint Replacements
Official title: Defining the Inflammatory Cytokines in Patients With Adverse Reactions to Metal-on-Metal Hip Replacements
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Joint
Keywords: Revision,
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥18 years of age, that present with a failed joint replacement.

Brief summary: The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Analysis of joint replacement failure will include a through analysis of laboratory, radiographic, implant, surgical and demographic data.

Detailed description: To examine all clinical data in patients with failed total hip and total knee replacements including patient demographics (age, sex, comorbidities, etc.), patient clinical data (history and physical exam and lab findings) and including implant specifications and radiographic findings (for implant type, implant size, implant bearing surface type, position, stability, etc.).

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* failed hip or knee replacement
* willing to sign informed consent

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
Study officials:
affiliation: UCSD
name: Scott Ball, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05893758: Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
Official title: A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
PFO
Keywords: Lifetech
Cera PFO
Occluder
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.

Brief summary: The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.


Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);
2. Associated with TIA or cryptogenic stroke;
3. Patients was implanted with the investigational device as per IFU instructions;
4. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion Criteria:

1. Any contraindication mentioned in the corresponding IFU;
2. Patients did not conduct any follow up visit after hospital discharge.

Primary outcomes:
measure: Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications
timeFrame: from attempted procedure to 24 months post-implantation.
Secondary outcomes:
measure: Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt
timeFrame: at procedure, 6 months and 12 months post-implantation
measure: Incidence of device or procedure related Adverse Events (AEs)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of device or procedure related Serious Adverse Events (SAEs)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of Device Deficiencies (DD)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of death
timeFrame: from attempted procedure to 24 months post-implantation
Other outcomes:
Locations:
city: Myszków
country: Poland
facility: Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint
city: Oświęcim
country: Poland
facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim
city: Tychy
country: Poland
facility: Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland
city: Ustroń
country: Poland
facility: Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP
city: Zakopane
country: Poland
facility: Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem
Study officials:
References:
Clinical trial NCT02711358: Indomethacin Use in Pain Relief During Intrauterine Device Insertion
Official title: Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Family Planning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.


Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to intrauterine device placement

Primary outcomes:
measure: Mean pain score during IUD insertion
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02464358: An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women
Official title: The Impact of an Information-Motivation-Behavioral Skills (IMB) Based Educational Intervention to Improve Gardasil Use in a Population of Undergraduate Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: HPV
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.

Detailed description: HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.

Methods: Participants were randomly assigned to a single-session intervention or attention-control arm and were assessed at pre-intervention, post-intervention, and at 1-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Enrollment in a psychology course at the University of Connecticut

Exclusion Criteria:

* Completion of the HPV vaccination series

Primary outcomes:
measure: HPV, Cervical Cancer, and HPV Vaccine Knowledge Questionnaire
timeFrame: One month
measure: Vaccination Motivation Questionnaire
timeFrame: One month
measure: Behavioral Skills Questionnaire
timeFrame: One Month
Secondary outcomes:
measure: Behavioral uptake of the HPV vaccine Questionnaire
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut
name: Dean G Cruess, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Giselle K Perez, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06135558: Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
Official title: Presence and Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Colon Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage II colon cancer patients

Brief summary: Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer.


Eligibility criteria: Inclusion Criteria:

* (1) colon cancer patients with the preoperative staging of stage I-III who lacked distant metastasis; (2) patients who underwent radical resection, with postoperative pathology confirmed as pT3-4N0M0; and (3) complete follow-up information

Exclusion Criteria:

* (1) patients who received neo-adjuvant therapy; (2) patients with multiple primary colorectal cancer; and (3) patients with a history of malignant tumors

Primary outcomes:
measure: DFS
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05494658: Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
Official title: A Multicenter Randomized Controlled Study of Preoperative Oral Administration of Branched-chain Amino Acids in Reducing Postoperative Insulin Resistance in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Colorectal Cancer
Keywords: postoperative insulin resistance
branched chain amino acids
colorectal cancer
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2022-08-10
Enrollment: 224
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative insulin resistance refers to the phenomenon that the body's glucose uptake stimulated by insulin is reduced due to stress effects such as trauma or the inhibitory effect of insulin on liver glucose output is weakened after surgery.

There is a clear link between postoperative insulin resistance and poor perioperative prognosis. Therefore, exploring interventions to reduce postoperative stress insulin resistance, stabilize postoperative blood glucose, and reduce postoperative complications are clinical problems that need to be solved urgently. In recent years, research on branched-chain amino acids and metabolic diseases has become a hot spot. Studies have found that in the rat model, preoperatively given a high branched-chain amino acid diet can inhibit postoperative insulin resistance and stabilize blood glucose levels. This research plan is to try to add branched-chain amino acids before surgery to observe the occurrence of postoperative insulin resistance in patients.


Eligibility criteria: Inclusion Criteria:

1. Age 50-80 years old ;
2. Clinical diagnosis of colorectal cancer;
3. Planned elective laparoscopic radical resection of colorectal cancer;
4. Preoperative American Society of Anesthesiologists（ASA）score grade I-III ;
5. Informed consent was obtained from patients.

Exclusion Criteria:

1. Clinical diagnosis of Diabetes mellitus;
2. Preoperative insulin resistance ;
3. Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above);
4. Eating disorders caused by gastrointestinal obstruction;
5. Pregnant or lactating women;
6. Patients with severe mental illness.

Primary outcomes:
measure: The proportion of postoperative blood glucose>8mmol/L
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative blood glucose
timeFrame: 1 day
measure: Homeostasis model assessment - insulin resistance （HOMA-IR）
timeFrame: 1 day
measure: Postoperative complications
timeFrame: 1 month
measure: Postoperative hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
Study officials:
References:
Clinical trial NCT04940858: Evaluation of Dentists Burnout in Turkey
Official title: Evaluation of Dentists Burnout in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Psychological
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 497
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dentist who is still working as a dentist in a health institute.

Brief summary: The aim of this study is to determine the level of burnout in Turkish dentists. The Copenhagen Burnout Inventory of 19 questions will be used to assess burnout; and 4 more about; gender, occupational age, institution and title. All surveys will be conducted online and we plan to reach approximately 400 participants. After the burnout levels are determined, it will be statistically investigated whether there is a difference between the groups according to gender, occupational age, institution and title.


Eligibility criteria: Inclusion Criteria:

* Being a dentist who is still working
* Accepted electronically to participate in our study
* Completed and submitted our electronic questionnaires successfully

Exclusion Criteria:

* Did not answer all questions of survey

Primary outcomes:
measure: Participants' burnout levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Selcuk University, Dentistry Faculty
state: Konya
Study officials:
References:
Clinical trial NCT02399358: Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
Official title: Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyponatremia
Keywords: Drug induced Hyponatremia
Cyclophosphamide
Hyponatremia
Cyclophosphamide induced Hyponatremia
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (Over 18 years) admitted for high-dose cyclophosphamide.

Brief summary: Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.

Detailed description: Primary objectives

1. To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
2. Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
3. To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.

Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.

Exclusion Criteria:

* Refusal to participate or to the process of informed consent.

Primary outcomes:
measure: Hyponatremia
timeFrame: Between 6 and 8 hours after the infusion of cyclophosphamide is performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Peron 4190
state: Capital Federal
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Fernando Warley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Belen Bonella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Victoria Otero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Bruno L Ferreyro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05823558: Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients
Official title: Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 301
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 50-90 years old osteoporotic, osteopenic and healthy people

Brief summary: In osteoporosis, sarcopenia is a common condition. Sarcopenic measurements can be made by evaluating muscle thickness in different regions. We aim to evaluate lumbar muscle losses in patients with osteoporosis in the lumbar region and to examine whether these muscle losses are correlated with the level of osteoporosis. The patients will be divided into 3 groups as healthy, osteopenic and osteoporotic according to DEXA measurements. Demographic values, comorbidities, osteoporosis drugs used, fracture histories, L1-4, L2-4, femoral neck and total BMD and t values of the patients, psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging. Lumbar MR muscle measurements will be made by 1 physician blind to the DEXA values of the patients.


Eligibility criteria: Inclusion Criteria:

* 50-90 years old
* 2. Recent MRI of the lumbar region with DEXA evaluation

Exclusion Criteria:

* Have had previous lumbar surgery
* Any previous lumbar injection
* Stage 3-4 Lumbar Listesis
* Presence of Lumbar Discopathy accompanied by neurological deficit

Primary outcomes:
measure: Lomber Muscle Measurement
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Etfal Training and Research Hospital
Study officials:
References: