louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01303120: Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
Official title: Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-24
Enrollment: 107
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.

Detailed description: Bupivacaine will be used for all the nerve blocks.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Undergoing two TKA
* Understanding PCA protocol

Exclusion Criteria:

* Skin infection near injection site
* Allergy to local analgesics
* Peripheral neuropathy
* Coagulopathy
* Dementia
* Proven opioid dependency

Primary outcomes:
measure: Efficacy of single short femoral nerve block
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
citation: Stav A, Reytman L, Sevi R, Stav MY, Powell D, Dor Y, Dudkiewicz M, Bayadse F, Sternberg A, Soudry M. Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Rambam Maimonides Med J. 2017 Jan 30;8(1):e0006. doi: 10.5041/RMMJ.10281.
Clinical trial NCT05095220: Integration of NAVOY® Sepsis in an Electronic Health Record System
Official title: Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
ICU
prediction
decision support
machine learning
intensive care
Lead sponsor: AlgoDx
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 1000
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: Adult ICU patients admitted to the ICU during the enrolment period.

Brief summary: The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.


Eligibility criteria: Inclusion Criteria:

* The subject is admitted to the ICU during the enrolment period.
* The subject is 18 years of age or older at the time of admission to the ICU.

Exclusion Criteria:

* None.

Primary outcomes:
measure: NAVOY® Sepsis prediction performance
timeFrame: 6 months
Secondary outcomes:
measure: Integration validation
timeFrame: 6 months
measure: NAVOY® Sepsis prediction results
timeFrame: 6 months
measure: Fulfilment of Sepsis-3 criteria
timeFrame: 6 months
measure: Sepsis specific management
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Southern General Hospital
Study officials:
affiliation: Southern General Hospital
name: Martin Arlbrandt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03611920: Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth
Official title: Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Permanent Teeth: A Long-term Follow-up After 9-16 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Trauma
Avulsion
Periodontal Regeneration
Pulpal Regeneration
Topical Dexamethasone
Topical Tetracycline
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with avulsed permanent teeth who were treated between 2000-2008 at the Department of Oral Surgery, zmk Bern

Brief summary: To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.

Detailed description: Two different medications were applied prior to replantation. A) Topical tetracycline, B) topical dexamethasone. Teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. Endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. All patients received systemic tetracycline for 10 days after accident and were subsequently re-examined.

Follow-up examinations included periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow, periapical radiograph and intraoral photographs. Additionally a OHIP-14 questionnaire was carried out to determine the oral health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Avulsion of a permanent tooth
* Written informed consent

Exclusion Criteria:

* Extended dry period of more than 60 minutes

Primary outcomes:
measure: Number of teeth with periodontal regeneration
timeFrame: After a mean observation period of 12.9±2.4 years (one visit only)
measure: Number of teeth with pulpal regeneration
timeFrame: After a mean observation period of 12.9±2.4 years (one visit only)
Secondary outcomes:
measure: Number of teeth that survived
timeFrame: After a mean observation period of 12.9±2.4 years (one visit only)
measure: Number of teeth with open versus closed apex at accident
timeFrame: At baseline
measure: Patients satisfaction
timeFrame: After a mean observation period of 12.9±2.4 years (one visit only)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: zmk Bern
Study officials:
affiliation: Department of Oral Surgery and Stomatology, zmk Bern, University Bern
name: Vivianne Chappuis, PD Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00432120: Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?
Official title: Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiography (Just Before Intervention): the PRAGUE-8 Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2007-02-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. However, the vast majority of patients in the current interventional cardiology practice do not undergo planned PCI, but rather "ad-hoc" PCI performed immediately after coronary angiography . Whether clopidogrel should be administered as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic levels at the time of possible ad-hoc PCI is not known.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome)
3. Signed written informed consent

Exclusion Criteria:

1. Thienopyridine treatment in previous two weeks
2. Contraindication for clopidogrel
3. CAG scheduled less than 6 hours after potential randomization
4. Clinically significant bleeding (i.e. with hemoglobin fall by \> 50 g/l and/or requiring transfusions or surgery) in previous 3 months.

Primary outcomes:
measure: Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention
timeFrame: within 7 days
Secondary outcomes:
measure: Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow after PCI, bleeding complications and each individual component of the combined primary endpoint
timeFrame: within 7 day
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Charles University
Study officials:
affiliation: Charles University, Prague, Czech Republic
name: Petr Widimsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University, Prague, Czech Republic
name: Zuzana Motovska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712382: Promoting Maintenance of Change Following Brief Intervention for Alcohol Use
Official title: Promoting Maintenance of Change Following Brief Intervention for Alcohol Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking in College
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: All students who enroll in the study will receive an efficacious counselor-delivered brief motivational intervention. The intervention is based in principles of motivational interviewing. Students complete a baseline assessment on their alcohol use and alcohol-related consequences. During the hour-long session, the counselor uses information from the baseline assessment to compare the student's level of alcohol consumption to that of peers at the same university, discuss choices that may lead to experiencing negative consequences, and provide opportunities for the student to set goals for risk reduction.

This study will develop and pilot a maintenance enhancement intervention. The intervention is expected to consist of four components, for example: (1) Student participants may learn to use techniques based in mindfulness to cope with negative emotions. (2) Student participants may identify barriers to reducing their alcohol use and identify protective strategies for navigating those barriers. (3) Student participants may be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students may also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode. (4) Parents may also receive a handbook encouraging communication with their student about alcohol use.


Eligibility criteria: Inclusion Criteria:

Student participants must meet the following eligibility criteria:

* Currently enrolled student at the University of Massachusetts Amherst
* First time violator of the university alcohol policy
* Mandated to complete the Brief Alcohol Screening and Intervention of College Students (BASICS) intervention
* Minimum age 18

Parent participants must meet the following eligibility criteria:

• The parent or guardian of students who meet all of the student participant criteria

Exclusion Criteria:

• None.

Primary outcomes:
measure: Drinking Intentions
timeFrame: Immediate post-test
measure: Coping motives
timeFrame: Immediate post-test
measure: Parent-student communication
timeFrame: Immediate post-test
measure: Maintenance self-efficacy
timeFrame: Immediate post-test
measure: Recovery self-efficacy
timeFrame: Immediate post-test
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00553982: Patellar Resurfacing in Total Knee Arthroplasty
Official title: Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Pain
Keywords: Replacement
Knee
Patella
Arthroplasty
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 130
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.

Purpose:

The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.


Eligibility criteria: Inclusion Criteria:

* Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.

Exclusion Criteria:

* Patients who are not able to cooperate
* Serious deformity (not suitable for a standard CR prosthesis)
* Patellar thickness less than 18 mm
* Prior operation involving the extensor mechanism
* Rheumatoid arthritis
* Severe medical disability limiting the ability to walk
* Revision surgery
* Knees with predominantly patellofemoral arthrosis

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 3 years follow up
Secondary outcomes:
measure: Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)
timeFrame: 3 years follow up
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet HF, Lillehammer
Study officials:
affiliation: Sykehuset Innlandet, Lillehammer
name: Eirik Aunan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06481982: Value of Advanced MRI Techniques in the Assessment of Endometriosis
Official title: Value of Advanced MRI Techniques in the Assessment of Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 300
Sex: FEMALE
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: Women undergoing routine MRI for endometriosis staging.

Brief summary: Endometriosis is a common gynaecological disease, mostly in women of reproductive age, with a prevalence of about 10 %, which is defined by the presence of endometrial-type tissue outside the uterine cavity. Endometriosis is usually limited to the abdominal and especially the pelvic cavity, extra-abdominal lesions are rare. Within the pelvis it shows a wide variety of locations predominantly affecting the ovaries and the uterus or the peritoneum, uterine ligaments and other pelvic structures. Traditionally, there are three major phenotypes of endometriosis: Ovarian endometrioma (OMA), superficial peritoneal endometriosis (SPE), and deep infiltrating endometriosis (DIE). A lesion is considered a DIE, if it shows infiltration deeper than 5 mm into the peritoneum. The ectopic endometrial implants may induce inflammatory processes, causing scar tissue formation, adhesions, and consequently pelvic anatomy distortion.

The prospective study aims to investigate the value of advanced MRI techniques to improve the assessment of pelvic endometriosis.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo clinically indicated MR imaging for endometriosis evaluation.

Exclusion Criteria:

* Non-MRI compatible devices/implants

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
References:
Clinical trial NCT01005082: Low Salt Diet in Idiopathic Hypercalciuria
Official title: Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypercalciuria
Keywords: Low salt diet, idiopathic hypercalciuria, calcium stone formers
Calcium stone formers with idiopathic hypercalciuria
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Università Vita-Salute San Raffaele
name: University of Milan
name: Catholic University of the Sacred Heart
First posted: 2009-10-30
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone in patients affected by idiopathic calcium nephrolithiasis.

Treatment duration: three months Primary end-point: correction of hypercalciuria Main inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and \>200 mg/day in females); 18-65 years.

Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis, sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D, acetazolamide, anti-epileptic drugs


Eligibility criteria: Main inclusion criteria:

* idiopathic calcium stone formers, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and 20 mg/day in females);
* 18-65 years.

Main exclusion criteria:

* primary hyperparathyroidism,
* primary hyperoxaluria,
* enteric hyperoxaluria,
* bowel resection,
* inflammatory bowel disease,
* renal tubular acidosis,
* sarcoidosis, sponge kidney,
* hyperthyroidism,
* use of hypercalciuric drugs such as Vitamin D,
* acetazolamide,
* anti-epileptic drugs

Primary outcomes:
measure: Normalization of urinary calcium levels
Secondary outcomes:
measure: Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University Hospital
Study officials:
References:
citation: Borghi L, Schianchi T, Meschi T, Guerra A, Allegri F, Maggiore U, Novarini A. Comparison of two diets for the prevention of recurrent stones in idiopathic hypercalciuria. N Engl J Med. 2002 Jan 10;346(2):77-84. doi: 10.1056/NEJMoa010369.
citation: Nouvenne A, Meschi T, Prati B, Guerra A, Allegri F, Vezzoli G, Soldati L, Gambaro G, Maggiore U, Borghi L. Effects of a low-salt diet on idiopathic hypercalciuria in calcium-oxalate stone formers: a 3-mo randomized controlled trial. Am J Clin Nutr. 2010 Mar;91(3):565-70. doi: 10.3945/ajcn.2009.28614. Epub 2009 Dec 30.
Clinical trial NCT03569982: Integrative Care and Acupuncture in MOHS Surgery
Official title: Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Anxiety and Pain in Patients Undergoing MOHS Surgery for Dermatological Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Integrative medicine
Peri-operative anxiety
Pain
MOHS surgery
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's image and anxiety about the need for repeated surgeries. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery.

Detailed description: MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area, with immediate microscopic examination in a frozen slice of the full margin. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's appearance and image and anxiety about the need for repeated surgeries performed on the same day to remove the tumor. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery. The study was designed on the basis of interdisciplinary collaboration of researchers from plastic, integrative and gynecological medicine.

Eligibility criteria: Inclusion Criteria:

\* Patients referred to MOHS surgery

Exclusion Criteria:

* Pregnancy
* Hypertension treated with alpha and beta-blockers
* Chronic atrial fibrillation
* insulin dependent diabetes type 1
* Thyroid disease (hyperthyroidism)

Primary outcomes:
measure: Anxiety as assessed by State-Trait Anxiety Inventory
timeFrame: 8 hours
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 30 minutes
measure: Pain as assessed by visual analogue scale
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lin Medical Center
Study officials:
References: