louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04751981: Safety Trial of Patient Specific Guides for Lumbar Fusion
Official title: A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Disorder of Spine
Keywords: Patient Specific Guides
Lumbar Fusion
Spine
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
* Recently has or requires a CT-scan of the spine
* No previous spine surgery on the level being used for patient specific guides
* Sufficient understanding of the English language or interpretation assistance available.

Exclusion Criteria:

* History of alcohol or drug abuse
* History of psychiatric disorders
* Previous spine surgery adjacent or at the level of the surgery
* Unable to read or comprehend the consent form/letter of information

Primary outcomes:
measure: Screw trajectory deviation
timeFrame: Day 1
measure: Screw start point deviation
timeFrame: Day 1
Secondary outcomes:
measure: Pedicle Breach
timeFrame: Day 1
measure: Adverse Event Rate & Serious Adverse Events
timeFrame: Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
measure: Guide Reliability
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06700681: RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation
Official title: Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemodynamic
Remimazolam
Propofol
Cardiac Electrophysiology
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Brief Summary:

The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are:

* Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation?
* Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\].

Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation.

Participants will receive either Remimazolam or Propofol sedation during study period.


Eligibility criteria: Inclusion Criteria:

* Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).

Exclusion Criteria:

* With existing vasopressor or shock status
* Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
* Canceled by cardiologist
* Allergy history to the anesthetics used in this study
* History of abnormal lung function or required oxygen therapy preoperative

Primary outcomes:
measure: Hemodynamic stability--Vasopressor dosage
timeFrame: Introperative
Secondary outcomes:
measure: Respiratory depression require intubation
timeFrame: Introperative
measure: TIVA failure rate
timeFrame: Introperative
measure: LOC time
timeFrame: Introperative
measure: Emergence time
timeFrame: Introperative
measure: Sanctification of cardiologist
timeFrame: Perioperative
measure: QoR-15
timeFrame: Preoperative to post-operative day 1
measure: Mini-Cog
timeFrame: Preoperative to post-operative day 1
measure: Length of hospital stay
timeFrame: Upto 1 month
measure: Adverse outcome
timeFrame: Upto 1 month
measure: Length of CU stay
timeFrame: Upto 1 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Li Yi-Shiuan, Bachelor's
role: STUDY_DIRECTOR
References:
Clinical trial NCT01976481: Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27
Official title: Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Toxicity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 56
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: Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.

The use of a sunbed will be compared to a control group not using a sunbed in the observation period.

* Trial with medical device

Detailed description: We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.

Eligibility criteria: Inclusion criteria: Probands intending to use a commercial sunbed :

1. Age 18 years or older
2. Regular use of commercial sunbeds
3. Oral and written informed consent

Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate

Primary outcomes:
measure: Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Dermatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Dermatology
name: Guenther Hofbauer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05663281: Thrombus Imaging and Treatment Analytics in Neurology
Official title: Thrombus Imaging and Treatment Analytics in Neurology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombus, Brain
Thrombosis
Keywords: Thrombus
Neuroimaging
High-resolution vessel wall imaging
Cerebral ischemia
Cerebral artery
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 100
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: Participants who are confirmed to have extracranial and/or intracranial artery occlusion

Brief summary: In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment.

Detailed description: Cerebral ischemic stroke resulting from thrombosis causes high disability and mortality. There are few biomarkers to evaluate arterial thrombophilia until now. Previous studies have demonstrated that atherosclerotic plaque rupture and erosion are major etiologies initiating thrombosis. Based on previous works targeting the role of plaque and blood flow in cerebrovascular disease, in the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to explore the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. The study's objective was to solve the challenges in the mechanism of thrombus features and the outcome of recanalization therapy, thus helping improve the primary and secondary prevention of cerebrovascular disease.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Extracranial and/or intracranial artery occlusion confirmed by angiography
* Available for magnetic resonance high-resolution vessel wall imaging
* Written informed consent obtained

Exclusion Criteria:

* Extracranial and/or intracranial artery mild to moderate stenosis
* Pregnant women
* Restenosis or occlusion after artery stenting placement

Primary outcomes:
measure: Rate of Successful Recanalization
timeFrame: 1-3 Years
measure: Ischemic Stroke Occurrence
timeFrame: 1-3 Years
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 1-3 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00185081: Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
Official title: Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colonic Neoplasms
Keywords: colon cancer
radioimmunoscintigraphy
colon-specific antigen,
radioimmunotherapy,
radioimmunodetection
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2005-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.

Detailed description: Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease.

Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable.

Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved.

The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody.

We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Histologic or cytologic diagnosis of colorectal cancer
* Karnofsky performance status \>70%

Exclusion Criteria:

* Pregnant or lactating women
* Severe anorexia
* Active second primary malignancy
* Chemotherapy or radiotherapy within four weeks of study entry

Primary outcomes:
measure: Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734
measure: Tumor targeting of In-IMP-205 in patients with colorectal carcinoma
measure: Pharmacokinetics, biodistribution and dosimetry of In-IMP-205
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre Nijmegen
state: Gelderland
Study officials:
affiliation: Radboud University Medical Centre Nijmegen
name: Wim Oyen, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01919281: High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome
Official title: High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: exercise
resistance training
insulin resistance
high intensity interval training
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.


Eligibility criteria: Inclusion Criteria:

* Women
* Age 18-45 years old
* PCOS

Exclusion Criteria:

* Regular high intensity endurance or strength training (two or more times per week of vigorous exercise).
* Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
* On-going pregnancy.

Primary outcomes:
measure: insulin resistance
timeFrame: 10 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 10 weeks
measure: Maximum oxygen uptake
timeFrame: 10 weeks
measure: Endothelial function
timeFrame: 10 weeks
Other outcomes:
measure: Menstruation diary
timeFrame: up to 6 months
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging , NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almenning I, Rieber-Mohn A, Lundgren KM, Shetelig Lovvik T, Garnaes KK, Moholdt T. Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Polycystic Ovary Syndrome: A Pilot Study. PLoS One. 2015 Sep 25;10(9):e0138793. doi: 10.1371/journal.pone.0138793. eCollection 2015.
Clinical trial NCT05385081: PREcision Medicine in Cancer in Odense, Denmark
Official title: PREcision Medicine in Cancer in Odense, Denmark (PRECODE) Feasibility of Genomic Profiling and Frequency of Genomic Matched Treatment in Solid Tumors With no Treatment Options
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Solid Tumor
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single-center cohorte study
Primary purpose: DIAGNOSTIC

Brief summary: The traditional approach to cancer treatment has changes from using drugs approved for the specific cancer diagnosis to a tumor agnostic approach when treating solid tumors. How often will tumor biopsy and genomic profiling in patients with advanced solid tumors with no further evidence based treatment options result in biomarker-driven targeted treatment ? Feasibility of the investigation of patients and median turnaround time from biopsy to available genomic profile is evaluated.

Detailed description: Genomic profiling in patients with advanced solid tumors and no further evidence based treatment options is a newer approach. The frequency of genomic alterations varies between individual tumor types and the actionability of somatic variants are different but evolves in line with the development of new targeted drugs. In accordance with expected short survival short assessment time is important to minimize the risk of patient detoriation during the investigation. A fresh biopsy from lesions in progression is preferred for analysis. To minimize the duration of the genomic profiling a genpanel analysis covering the most frequent oncogene targets is preferred.

The primary objective is to evaluate the feasibility of the investigational procedures. The secondary objective is to investigate how often genomic changes in tumor tissue gives rise to a targeted treatment offer and to evaluate the clinical benefit using the Growth Modulation Index.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥ 18 years
* Diagnosis of advanced solid tumors
* Evidence based treatment options are exhausted
* Performance Status 0-2
* Adequate organ function
* Life expectancy of at least 3 months

Exclusion Criteria:

• inclusions criteria not met

Primary outcomes:
measure: Turn around time genomic profiling
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Frequenc of matched treatment offer
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense Universitets Hospital dept of oncology
Study officials:
affiliation: Departement of Oncology Odense University Hospital
name: Karin H Hansen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021981: Improving Health Outcomes: Blood Pressure
Official title: Improving Health Outcomes: Blood Pressure Program in Practice Sites Located in the Chicago Metropolitan Area and in Maryland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Quality Improvement
Primary Care
Blood Pressure, High
Feedback
Knowledge
Lead sponsor: American Medical Association
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2013-12-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This quality improvement project will be conducted in 10 ambulatory practice sites that are distinguished by their medical specialty and practice size. There are 9 diverse sites that specialize in family medicine and internal medicine. One site is a cardiology practice. Practices range in size from a mid-size medical group to a single-physician practice. The total number of physicians participating in this project is between 40 and 50. The sites are located in various neighborhoods in the Chicago and Baltimore metropolitan areas and in rural Maryland. The patient populations of the sites are representative of the United States population.

Brief summary: This quality improvement project is focused on improving hypertension care delivery processes in ambulatory clinical practices, 5 in Illinois and 5 in Maryland for a total of 10 practice sites.The primary aim of this quality improvement project is to improve blood pressure control among patients receiving routine care for hypertension in a diverse group of ambulatory clinical practices. A secondary aim is for American Medical Association (AMA) and Johns Hopkins Medicine (JHM) quality improvement staff to figure out the best way to help clinical practices in achieving improved blood pressure control, including working to increase the use of home blood pressure monitoring.


Eligibility criteria: The Practice Sites must

* Self-identify as either primary care internal medicine, family practice, or cardiology
* Have an electronic health record
* Serve patient populations that are diverse and representative of the U.S. adult population
* Have a significant number of male and female patients, age 18 or older, voluntarily receiving care for hypertension
* Have the resources, staff, and commitment to complete this quality improvement project

Primary outcomes:
measure: Improve blood pressure control
timeFrame: One year
Secondary outcomes:
measure: The best way to help clinical practices improve blood pressure control
timeFrame: One year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: American Medical Association
state: Illinois
Study officials:
affiliation: American Medical Association
name: Omar Hasan, MBBS MPH FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06098781: Gynaecological Gender-affirming Surgeries
Official title: Patient Reported Outcomes After Gynaecological Gender Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Dysphoria
Keywords: hysterectomy
colpectomy
vaginectomy
tubectomy
patient-reported outcome measure
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trans-masculine or non-binary individuals (assigned female at birth) with wish to undergo gynaecological gender-affirming surgeries

Brief summary: The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth).

The main question it aims to answer are:

• What is the experienced effect of gynaecological gender-affirming surgeries

Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.


Eligibility criteria: Inclusion Criteria:

* assigned female at birth
* scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)

Exclusion Criteria:

* age below 18 y/o
* surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)

Primary outcomes:
measure: Experienced effect on gender dysphoria
timeFrame: 3& 9 months
measure: Experienced effect on gender dysphoria measured by GCLS
timeFrame: 9 & 18 months
Secondary outcomes:
measure: Experienced effect on psychological well being
timeFrame: 3 & 9 months
measure: Experienced effect on confidence
timeFrame: 3& 9 months
measure: Experienced effect on sexual experience
timeFrame: 3& 9 months
measure: Surgical satisfaction
timeFrame: 3& 9 months
measure: Impact of health on satisfaction of life
timeFrame: 3 & 9 months
measure: Physical complaints post-operatively
timeFrame: 3 & 9 months
measure: Recovery time postoperatively
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Location VU Medical Center
Study officials:
References: