louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05737446: Oxygen Partial Pressure After Breast Cancer Surgery
Official title: Oxygen Partial Pressure After Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Surgery-Complications
Hypoxia
Keywords: Breast cancer surgery
postoperative hypoxia
Lung function
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 60
Sex: FEMALE
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: Women with breast cancer scheduled for surgery.

Brief summary: Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after breast cancer surgery.

Inclusion: 60 women undergoing breast cancer surgery. Exclusion: Dementia or cognitive impairment that makes it impossible to participate in the study.

Arterial blood gas and lung function are undertaken before surgery and the day after surgery

Detailed description: Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease. The cause of postoperative hypoxia and reduced lung function is unknown. Previous studies report that arterial partial pressure (PaO2) decreased by an average of 2 kilopascal after abdominal surgery, while carbon dioxide partial pressure (PaCO2) was unchanged and vital capacity decreased by 35%. The effect of breast cancer surgery on oxygen and carbon dioxide partial pressure and lung function has to the best of the investigators knowledge not been investigated. This study aims to investigate possible changes in oxygen partial pressure, carbon-dioxide partial pressure and vital capacity after breast cancer surgery.

Design: Prospective cohort study participate in studies. Method: Blood gas measurements and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery and at follow-up.

Power analysis: There is a need to investigate 27 patients if the mean (SD) difference is 0.5 (1) kilopascal. Due to drop-outs the investigators calculate a need to include up to 60 patients.

Eligibility criteria: Inclusion Criteria:

• Women scheduled for surgery because of breast cancer.

Exclusion Criteria:

• Dementia or cognitive impairment that makes it impossible to participate in the study.

Primary outcomes:
measure: Oxygen partial pressure
timeFrame: 1 day
Secondary outcomes:
measure: Carbon dioxide partial pressure
timeFrame: 1 day
measure: Vital capacity
timeFrame: 1 day
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 1 day
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Surgery, University hospital
state: Vasterbotten
Study officials:
affiliation: Dept Surgery, University hospital, Umea, Sweden
name: Karl A Franklin, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315846: Acetylcholinesterase in Postoperative Delirium
Official title: Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients in the head clinic of the University of Heidelberg, Germany with surgery, that requires them to stay in Hospital for at least 3 days postoperatively

Brief summary: The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Elective surgery

Exclusion Criteria:

* Preexisting psychiatric or neurological disease
* No surgery
* Reduced level of consciousness

Primary outcomes:
measure: change of acetylcholinesterase (U/l)
timeFrame: one day before surgery, 1-24h after surgery, 25-72h after surgery
Secondary outcomes:
measure: change of NuDESC
timeFrame: one day before surgery, 1-24h after surgery, 25-72h after surgery
measure: change of medication
timeFrame: one day before surgery, 1-24h after surgery, 25-72h after surgery
measure: ICD-codes of main disease
timeFrame: 25-72h after surgery
measure: ICD-codes of coexisting diseases
timeFrame: 25-72h after surgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Konstanze Plaschke, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03381846: Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
Official title: Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatofibrosarcoma Protuberans
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to explore the challenges that providers face which may prevent them performing this potentially superior treatment. This study will provide a comparison of outcomes and recurrence rates in pediatric patients treated by MOHS versus traditional excision.


Eligibility criteria: Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.

Primary outcomes:
measure: Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year.
timeFrame: Recurrence will be assessed at 1 year.
Secondary outcomes:
measure: All cause mortality
timeFrame: All cause mortality will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.
measure: Mortality related to dermatofibrosarcoma protuberans
timeFrame: Mortality related to dermatofibrosarcoma protuberans will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.
measure: Morbidity secondary to surgical procedure
timeFrame: Morbidity secondary to surgical procedure will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.
measure: Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at two years.
timeFrame: Recurrence will be assessed at 2 years. (Not all patients will have a full two years of follow up)
measure: Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at five years.
timeFrame: Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Randall K Roenigk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06572969: Effect of 8-week Incremental Elastic-Resistance Kick Training in Taekwondo Athlete's
Official title: Effect of 8-week Incremental Elastic-Resistance Kick Training in Taekwondo Athlete's: Roundhouse Kick Quality and Physical Performance Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength
Performance
Keywords: Youth
Performance
Strength
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 37
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to assess the effects of an 8-week incremental elastic-resistance kick training program on the roundhouse kick quality and physical performance, in comparison to conventional training methods of youth Taekwondo athletes. A two-group parallel, randomized, quasi-experimental design was used, dividing Participants into experimental (n=11, age: 15.5 ± 1.5 years, stature: 169.5 ± 15.5 cm, body mass: 63.2 ± 26.2 kg; training experience: 7.0 ± 3.0 y) and control group (n=10, age: 14.8 ± 1.2 years, stature: 162.0 ± 14.0 cm, body mass: 53.15 ± 21.4 kg; training experience: 5.5 ± 1.5 y), undergoing tailored Elastic Resistance training alongside their regular Taekwondo regimen. The study measured various performance metrics including Roundhouse Kick velocity, impact scoring, isometric muscle strength, counter movement jump performance, and simple reaction times.


Eligibility criteria: Inclusion Criteria:

* Being part of a unified youth development program;
* Minimum of four weekly training sessions, each session lasting 90 minutes.

Exclusion Criteria:

* Musculoskeletal, neurological, or orthopedic injury that may impair their participation.

Primary outcomes:
measure: kick velocity
timeFrame: 8 weeks
Secondary outcomes:
measure: Simple Eye-Hand Reaction Time Test
timeFrame: 8 weeks
Other outcomes:
measure: Eye-Foot Reaction Time Test
timeFrame: 8 weeks
measure: Back-Leg-Chest Muscle Strength Dynamometry
timeFrame: 8 weeks
measure: Margaria-Kalamen Anaerobic Alactic Power Test
timeFrame: 8 weeks
measure: 10 m Sprint test
timeFrame: 8 weeks
measure: Jump Performance Test
timeFrame: 8 weeks
Locations:
city: Kaunas
country: Lithuania
facility: Bruno Figueira
Study officials:
References:
Clinical trial NCT01882569: Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery
Official title: Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Trauma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy patients undergoing back surgery

Brief summary: Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.


Eligibility criteria: Inclusion Criteria:

1. Ages 18 - 90
2. Men and women
3. Undergo back surgery

Exclusion Criteria:

1. Any systemic disease that might compromise the immune system (e.g. lupus)
2. Current diagnosis of cancer
3. Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.
4. Unwilling to sign informed consent

Primary outcomes:
measure: Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells
timeFrame: Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University SOM
name: Martin S Angst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04526769: Detecting SARS-CoV-2 in Tears
Official title: Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
COVID-19
Corona Virus Infection
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
Tear
Nasopharyngeal Swab
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients meeting inclusion criteria who are willing to participate will be included until the total number of 30 participants is reached.

Brief summary: Purpose:

* To determine the presence of SARS-CoV-2 in tears
* To determine SARS-CoV-2 receptors in tear production system

Detailed description: This is a prospective case series. NP swab and tear samples will be collected simultaneously from the confirmed or suspected COVID-19 patients. The samples will be transferred to the lab for SARS-CoV-2 testing. The presence of absence of SARS-CoV-2 will be compared in tears versus NP swabs.

The second part of the study is a histopathology examination series. Normal lacrimal gland and ocular surface tissue samples already stored at the UMN ocular pathology lab and Lion's Gift of Sight Eye Bank will be used for IHC staining for ACE2 and similar targets.

Eligibility criteria: Inclusion Criteria:

- Patients presenting at study sites with confirmed or suspected COVID-19

Exclusion Criteria:

* Pregnancy or nursing
* non-English speakers
* Those unable to read
* Those in other vulnerable study populations

Primary outcomes:
measure: COVID-19 Virus Detection in Tears
timeFrame: At day 1 of study participation
measure: COVID-19 Virus Detection in Nasopharyngeal Swabs
timeFrame: At day 1 of study participation
Secondary outcomes:
measure: Expression of ACE2 in Lacrimal Gland Samples
timeFrame: At day 1 of study participation
measure: Expression of ACE2 in Ocular Surface Samples
timeFrame: At day 1 of study participation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hossein Nazari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03243669: High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
Official title: High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Adenoma
Keywords: Colonoscopy
High-definition endoscopy
Virtual chromoendoscopy
Adenoma detection rate (ADR)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 2146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.


Eligibility criteria: Inclusion Criteria:

* referred for colonoscopy
* signed informed consent

Exclusion Criteria:

* subtotal colectomy
* known colorectal tumor or polyp prior to colonoscopy
* genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
* inflammatory bowel disease
* primary sclerosering cholangitis

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: 7-10 days
Secondary outcomes:
measure: Number of adenomas
timeFrame: 7-10 days
measure: Type of adenomas
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Raf Bisschops, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.
citation: Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.
Clinical trial NCT00663169: Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Gouty
Keywords: Arthritis Gouty
ACZ885
IL1B protein
Pain
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 6
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: This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.


Eligibility criteria: Inclusion Criteria:

* score over 50 on the 0-100 VAS pain scale
* acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria:

* Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
* Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
* Pregnant or breastfeeding women
* Major surgery with high infection risk
* History of severe allergy to food or drugs
* History or risk of tuberculosis
* Active infection

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
timeFrame: 72 hours
Secondary outcomes:
measure: Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
timeFrame: 72 hours
measure: Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
timeFrame: 4 months
measure: Time to Walk Independently (if Applicable) During Treatment Period
timeFrame: 4 months
measure: Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
timeFrame: 4 months
measure: Change in C-reactive Protein (CRP) From Baseline at Month 4
timeFrame: Baseline, Month 4
measure: Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
timeFrame: Baseline, Month 4
measure: ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
timeFrame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
measure: Change From Baseline in Pain Using a Visual Analog Scale at Month 4
timeFrame: Baseline, Month 4
measure: Number of Patients Who Took Rescue Medication
timeFrame: 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigator Site
state: Alabama
city: New Brunswick
country: United States
facility: Novartis Investigator Site
state: New Jersey
city: Lausanne
country: Switzerland
facility: Novartis Investigator Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06518369: Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting
Official title: Analysis of a Preoperative Prehabilitation Program Among Rural Geriatric Patients Compared to Standard of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Frailty
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over age 60 who require elective major abdominal surgery

Brief summary: The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.

Detailed description: The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.

The prehabilitation program will take place for 4-6 weeks before your surgery and will include:

* Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)
* Review of lab results including complete blood count, creatinine, albumin, and prealbumin
* Review of chronic conditions
* An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
* Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.
* Educational information and video instruction
* Weekly phone calls to motivate, ensure adherence, and assess progress.
* Measurements of hand grip strength and body weight

Eligibility criteria: Inclusion Criteria:

* Subjects over age 60 who require elective major abdominal surgery

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Postoperative hospital length of stay
timeFrame: From date of hospitalization until date of hospital discharge, up to 30 days
measure: Discharge disposition
timeFrame: From date of hospitalization until date of hospital discharge, up to 30 days
Secondary outcomes:
measure: Adverse outcomes after surgery
timeFrame: 30 days after surgery
measure: Hospital readmission rates
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: Robert Packer Hospital Sayre PA
name: Nancy Georgetson, AGNP-C
role: PRINCIPAL_INVESTIGATOR
References: