louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00921076: Gait Analysis of Ankle Arthroplasty and Arthrodesis
Official title: Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankle Arthritis
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2009-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint replacement or osteotomies (realignment) of bones. Fusion of arthritic hindfoot joints has been the accepted method of managing hindfoot arthritis for over a century. Recently, total ankle replacement has evolved as a treatment option for patients with end stage ankle arthritis. A comparison of gait for patients before and after hindfoot fusion or total ankle replacement will give further information about the outcome of this treatment. The principal aim of this project is to assess the effect of total ankle replacement or hindfoot fusion on gait. We are also interested in the outcome of the surgery and its effect on your symptoms (eg. pain and mobility). The results of this study will aid researchers in assessing this new treatment modality. Your involvement in this study is critical for the researchers to further analyze this new form of treatment and your time and involvement is appreciated.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic Ankle Arthritis
2. Skeletal maturity
3. Able to give informed consent

Exclusion Criteria:

1. Avascular Necrosis of Talus
2. Obesity (BMI \>30)
3. Prior Ankle fusion or arthroplasty
4. Active or prior infection within 12 months
5. Medical condition precluding major surgery
6. Severe ipsilateral mid or hind foot deformity
7. Severe osteoporotic or osteopenic bone
8. Neuromuscular impairment
9. Age less than 40 years old
10. Cognitive or psychiatric impairment prohibiting accurate follow-up
11. Pregnancy
12. Workers compensation board patients

Primary outcomes:
measure: The primary outcome measure will be micro motion, consisting of component migration and rotation relative to the talus and distal tibia. This will be measured utilizing RSA with bi-planar stereo X-rays taken at several intervals: before weight bearing is
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Timothy R. Daniels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04988776: PECS II Versus ICBN Block Plus SCNB for AV Fistula Creation in CRF Patients
Official title: Comparison Between Ultrasound-guided Pectoral Nerves Block Type II and Intercostobrachial Nerve Block as a Supplement to Supraclavicular Block for Anesthesia of Proximal Arteriovenous Access in End-stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intraoperative Analgesia
Postoperative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Mamdoh Elsayed Lotfy
name: amany aly sultan
name: reem gaber abdel-mageed
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Brachial plexus block (BPB) is often utilized for proximal arm arteriovenous access creation. However, the medial upper arm and axilla are often inadequately anesthetized, as the Intercostobrachial nerve (which provides sensory supply to the axilla, upper medial arm, and a small area at the upper lateral chest) is not a component of the brachial plexus. This requires repeated, an intraoperative local anesthetic (LA) supplementation up to conversion into GA. The intercostobrachial nerve (ICBN) is a purely sensory nerve that arises primarily from the second intercostal nerve (T2) with occasional contribution from T3. Therefore, It is not a component of the brachial plexus and is not anesthetized by brachial plexus blockade. The ICBN can be blocked together with other nerves, such as the pectoral, intercostal, and long thoracic nerves in a recently described technique named pectoral nerves block type II (PECS II ).In this thesis, investigators compared the use of the PECS II block and ICBN block as a supplement to supraclavicular brachial plexus block for providing complete anesthesia of the upper arm for fistula creation surgery.


Eligibility criteria: Inclusion Criteria:

* ESRD patients.
* Proximal Arm Arteriovenous Access Surgery.
* Elective or emergency surgery
* American Society of Anesthesiology (ASA) physical status II to III.

Exclusion Criteria:

* Inability of the patient to provide informed consent, communicate or cooperate
* History of allergy to local anesthetics.
* Preexisting upper limb neurological disease at the side of the surgery.
* Patients on anticoagulant therapy or with history of coagulopathy.
* Previous surgery at or near the site of the study.
* The presence of skin infection at the puncture site.

Primary outcomes:
measure: intraoperative local anesthetic requirement
timeFrame: 1-2 hours after surgery start
Secondary outcomes:
measure: postoperative pain
timeFrame: 24 hours after end of surgery
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ashraf Magdy Eskandr
state: Menoufia
Study officials:
affiliation: resident of anesthesia, menoufia university hospitals
name: reem abdel-mageed, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932876: The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Official title: Assessment of the Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Kidney Disease
Kidney Transplantion
Covid19
Vaccination
Keywords: End Stage Kidney Disease
Kindey Trasplantation
Immune System
Covid19 Vaccination
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End Stage Kidney Disease and Kidney Transplant Recipients

Brief summary: Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Covid 19 vaccination

Exclusion Criteria:

* previous covid infection
* recent infection
* chronic infection
* HBV, HCV, HIV
* Active malignancy

Primary outcomes:
measure: Efficacy of the vaccine
timeFrame: 24 months
Secondary outcomes:
measure: Complications caused by the vaccine
timeFrame: 24 months
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Evangelia Ntounousi
state: Epirus
Study officials:
References:
Clinical trial NCT05623176: Clinical Outcomes and Equality in Healthcare for Emergency General Surgery Patients Undergoing Emergency Laparotomy
Official title: Improvement in Patient Survival and Equality in Care Provision for General Surgery Patients Undergoing Emergency Laparotomy - Can This be Achieved Through the Implementation of Standardised Care Protocols?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdomen, Acute
Keywords: Emergency laparotomy
General surgery
Clinical outcomes
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2022-11-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of adult general surgical patients undergoing an emergency laparotomy during period 2015 and 2029. The cohort of 2015-2022 will be compared to the cohort of 2023-2029 in terms of general outcomes. The cohort of 2023-2029 will specifically be studied for any impact of emergency laparotomy on quality of life.

Brief summary: The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery.

The main questions it aims to answer are:

1. what factors are associated with adverse post-operative events
2. are patients treated differently based on sex or age
3. how does quality of life look like and possibly change over the coarse of a year after surgery

This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.


Eligibility criteria: Inclusion Criteria:

* Undergoing emergency laparotomy due to general surgical indication

Exclusion Criteria:

* Children under 16
* Trauma laparotomy
* Vascular, urological or gynaecological indication for laparotomy

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: In-hospital serious complications
timeFrame: 30 days
measure: Long-term mortality
timeFrame: 1 year
measure: Quality of life questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Rebecka Ahl Hulme, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04948476: Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
Official title: Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2021-07-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to evaluate the feasibility of conducting a randomized controlled trial comparing a standardized dialysis strategy versus usual care (dialysis prescription ordered by each patient's primary nephrologist) in patients with AKI-receiving dialysis.


Eligibility criteria: Inclusion Criteria:

* Received ≥2 sessions of any dialysis modality for presumed AKI
* Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments

Exclusion Criteria:

1. Receipt of dialysis for ≥90 days
2. Known baseline estimated glomerular filtration rate (eGFR) \<15mL/min/1.73m2
3. Strong clinical suspicion of urinary tract obstruction, rapidly progressive glomerulonephritis (RPGN), vasculitis, thrombotic microangiopathy (TMA), myeloma related cast nephropathy, or acute interstitial nephritis (AIN) as the underlying cause of AKI
4. Receipt of any dialysis prior to the current admission within the past 2 months
5. Kidney transplant within the past 12 months
6. Pregnant

Primary outcomes:
measure: Recruitment
timeFrame: 2 years
measure: Fidelity
timeFrame: 2 years
Secondary outcomes:
measure: Dialysis-Free Days
timeFrame: 6-months
measure: Hypotensive Event on Dialysis
timeFrame: 6-months
Other outcomes:
measure: Arrhythmia on Dialysis
timeFrame: 6-months
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Samuel A Silver
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05480176: The China National COPD Screening Program
Official title: The National Chronic Obstructive Pulmonary Disease Screening Program in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Screening
Spirometry
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 800000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are potentially under a high risk of suffering COPD with an age between 35 and 75 years are eligible to be recruited. The participants should be residents who were living in the survey area with more than six months in the past year.

Brief summary: The national COPD screening program is in a cross-sectional manner at the baseline, planning to recruit a total of 800,000 participants from 160 districts or counties (5,000 for each site on average) from 31 provinces, autonomous regions or municipalities directly under the central government of China. The filtered COPD high-risk population and confirmed COPD patients will be managed and followed up according to the standardized clinical guidelines. The major aims of the program are to estimate the prevalences of COPD high-risk population and under- or miss- diagnosed COPD patients, and to manage the development and outcomes of the disease.


Eligibility criteria: Inclusion Criteria:

* adults aged between 35 and 75 years;
* residents living in the survey area with more than 6 months in the past year.

Exclusion Criteria:

* experienced myocardial infarction, stroke or shock in the past 3 months;
* experienced severe cardiac insufficiency, severe arrhythmia or unstable angina pectoris in the past 4 weeks;
* experienced massive hemoptysis in the past 4 weeks;
* received chest, abdominal or ophthalmic surgery in the past 3 months;
* have mental disorders (e.g. auditory hallucinations, visual hallucinations, taking antipsychotics, seizures requiring medication, etc.);
* have cognitive impairment (e.g. dementia, comprehension impairment, etc.);
* have uncontrolled hypertension (i.e. systolic blood pressure \> 200 mmHg, diastolic blood pressure \> 100 mmHg);
* present with heart rate \>120 beats/min;
* have aortic aneurysm;
* have severe hyperthyroidism;
* are pregnant or lactating women;
* experienced respiratory infectious diseases (e.g. tuberculosis, influenza, etc.) in the past month.

Primary outcomes:
measure: Lung function
timeFrame: 2 years
Secondary outcomes:
measure: Respiratory symptoms
timeFrame: 2 years
measure: Exacerbations
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting YANG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846976: Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer
Official title: A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate gland
* Patients with advanced prostate cancer
* Adult male over the age of 18 years old
* Normal liver function (AST \< 2 x Upper Limit Normal)

Exclusion Criteria:

* ECOG performance status of 4.
* Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.

Primary outcomes:
measure: Safety profile of patients treated with a 200 mg daily dose of CASODEX
timeFrame: every three months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
Study officials:
References:
Clinical trial NCT03545776: Critical Care EEG Course
Official title: Teaching the Basics of Electroencephalography to Critical Care Teams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electroencephalogram
Intensive Care Units
Teaching Intervention
Lead sponsor: Ictal Group
Sponsor class: OTHER
Collaborators: name: Versailles Hospital
First posted: 2018-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical care medical and nursing staff

Brief summary: Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.

The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.


Eligibility criteria: Inclusion Criteria:

* Volunteers among medical and nursing ICU staff of the participating ICUs

Exclusion Criteria:

* Experienced or trained ICU staff members to EEG interpretation (pre-test score \> 5/10)

Primary outcomes:
measure: Overall EEG interpretation
timeFrame: at Day 90
Secondary outcomes:
measure: Before/After Comparison
timeFrame: from Day 1 to Day 90 after face-to-face training
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital
city: Clichy
country: France
facility: Department of Anesthesia and Critical Care, Beaujon Hospital
city: Le Chesnay
country: France
facility: Intensive Care Unit - Versailles Hospital
city: Paris
country: France
facility: Medical Intensive Care Unit - Cochin Teaching Hospital
city: Paris
country: France
facility: Medico-Surgical Intensive Care Unit - Saint Joseph Hospital
city: Suresnes
country: France
facility: Intensive Care Unit - Foch Hospital
Study officials:
References:
citation: Legriel S, Jacq G, Lalloz A, Geri G, Mahaux P, Bruel C, Brochon S, Zuber B, Andre C, Dervin K, Holleville M, Cariou A. Teaching Important Basic EEG Patterns of Bedside Electroencephalography to Critical Care Staffs: A Prospective Multicenter Study. Neurocrit Care. 2021 Feb;34(1):144-153. doi: 10.1007/s12028-020-01010-5.
Clinical trial NCT03465176: The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Official title: The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Hypothyroidism
Keywords: aromatherapy
fatigue
hypothyroidism
essential oils
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 42
Sex: FEMALE
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: This study evaluates the effects of an inhaled blend of essential oils on fatigue scores among women who have hypothyroidism. Half of the participants will receive an essential oil blend to inhale daily for two weeks while the other half will serve as controls and inhale a carrier oil.

Detailed description: The inhalation of certain essential oils has been found to increase stamina and reduce fatigue among athletes but have not been evaluated for the purpose of reducing fatigue among women who experience fatigue as a result of a hypothyroid condition.

The essential oils used in this study are inhaled mid-afternoon, the time in which women with hypothyroidism typically experience the lowest levels of energy during the day, otherwise known as the "afternoon slump." The essential oil is administered during this time to evaluate both the immediate effects on fatigue as well as the overall effects, with measurements at the end of both the first and second week of the study.

Fatigue is measured on a multi-dimensional scale, a validated instrument that measures not only physical fatigue but also emotional and mental fatigue.

Eligibility criteria: Inclusion Criteria:

* female
* diagnosed with hypothyroidism
* otherwise healthy

Exclusion Criteria:

• history of thyroid cancer

Primary outcomes:
measure: 83-item Multidimensional Symptoms of Fatigue Inventory
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Institute of Wellness
state: Tennessee
Study officials:
References: