louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05915910: Prospective Collection of Biospecimen in Pediatric Patients and Adult Guardians Diagnosed With Glycogen Storage Disease Type 1B (GSD1b)
Official title: Prospective Collection of Biospecimen in Pediatric Patients and Adult Guardians Diagnosed With Glycogen Storage Disease Type 1B (GSD1b)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glycogen Storage Disease Type IB
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants diagnosed with Glycogen storage disease type 1

Brief summary: The primary objective of this study is to collect whole blood from patients diagnosed with Glycogen storage disease type 1B, which will be used to support the investigation of potential therapies that address the genetic basis of this disease.


Eligibility criteria: Inclusion Criteria:

* Subjects ages 4-85
* Subjects that are diagnosed with Glycogen Storage Disease Type Ib (GSD1b, von Gierke disease)
* Subjects who are G339C Homozygous or L348FS Homozygous or G339C/ L348FS heterozygous or are the biological parent of subjects diagnosed with Glycogen Storage Disease Type Ib (GSD1b, von Gierke disease) and are a biological parent of a subject in Cohort 1 (G339C homozygous) or Cohort 2 (L348FS homozygous)
* Subjects or guardians must be willing and able to provide appropriate photo identification to mobile phlebotomist during at-home visit for verification of identity
* Subjects and/or Guardians must be willing and able to provide appropriate written informed consent and/or assent, as applicable

Exclusion Criteria:

* Subjects will be excluded if they experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the last two months. For subjects in the pediatric population, subjects will be excluded if they experienced excess blood loss, including blood donation defined as 3 mL/kg or up to 50 mL in the last 8-weeks.
* For requests that do not include pregnant subjects, subjects will be excluded if they are pregnant or nursing.
* For requests that do not include subjects with infectious diseases, subjects will be excluded if they have current, active HIV, hepatitis or other infectious diseases (self-reported or medical history reviewed).
* Subjects will be excluded if they have taken an investigational product in the last 30 days.

Primary outcomes:
measure: Bipspecimen collection from subjects that are diagnosed with Glycogen Storage Disease Type Ib (GSD1b, von Gierke disease); Subjects that are the biological parent of subjects diagnosed with Glycogen Storage Disease Type Ib (GSD1b, von Gierke disease)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Sanguine BioSciences, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT01466010: Treatment Outcome After Surgical Treatment of Osteoid Osteoma
Official title: Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoid Osteoma
Keywords: osteoma, osteoid
surgical procedures, operative
bone neoplasms
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with osteoid osteoma at any location.

Brief summary: Purpose of the study:

To retrospectively determine the clinical results in an unselected group of consecutive patients with osteoid osteoma treated by surgery.

Materials and Methods:

In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at any location, the clinical symptoms and imaging findings (radiographs and computed tomography (CT)) were assessed before and after surgery. There were no exclusion criteria for this study. A good response was defined as disappearance of symptoms that were manifested at presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12 months follow-up. After 24 months, a postal questionnaire was used for assessment. Radiographic evaluation (radiographs and thin-slice CT) was performed routinely pre-operatively and one year after surgery.

In case of persisting or recurring symptoms the follow-up protocol was again performed according to the initial protocol.

All patients gave their informed consent both for the surgical intervention as for the use of their patient data in this retrospective study.


Eligibility criteria: Inclusion Criteria:

* patient with osteoid osteoma at any location.

Exclusion Criteria:

* none.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Dept of Radiology
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT05717010: Is There a Risk of Perioperative Stroke Due to the Retraction Used During Anterior Cervical Discectomy?
Official title: Is There a Risk of Perioperative Stroke Due to the Retraction Used During Anterior Cervical Discectomy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Disc Disease
Cervical Stenosis
Cervical Disc Herniation
Keywords: Cerebral blood oxygenation
Near infrared spectroscopy
Cervical disc disease
Cervical microsurgery
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cervical disc surgery

Brief summary: In anterior cervical disc surgery, head and neck extansion position and, surgical retraction used while reaching the anterior surface of the cervical vertebra can be affect the carotid blood flow and constituting a risk for cerebral ischaemia. In this study, we planned to investigate the relationship between head position and retraction, cerebral oxygenation and postoperative cognitive functions in patients undergoing anterior cervical disc surgery.


Eligibility criteria: Inclusion Criteria:

* Aged 18-70 years
* Preoperative Mini-Mental State Examination score of 27-30
* Who were planned to undergo anterior cervical disc surgery under general anesthesia

Exclusion Criteria:

* Patients with hypertension, severe pulmonary disease, anaemia, cardiac disease, ischaemic cerebrovascular disease, renal disease, hepatic disease, pregnancy, uncontrolled diabetes mellitus, stricture or obstruction in the carotid or vertebral arteries or
* Body mass index (BMI) \>30.

Primary outcomes:
measure: Near-infrared spectroscopy (NIRS)
timeFrame: Intraoperative
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: 2 hours postoperative
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Nevin Esra Gumus
Study officials:
affiliation: Samsun University
name: Samsun Üniversitesi
role: STUDY_CHAIR
References:
citation: Smarius BJA, Breugem CC, Boasson MP, Alikhil S, van Norden J, van der Molen ABM, de Graaff JC. Effect of hyperextension of the neck (rose position) on cerebral blood oxygenation in patients who underwent cleft palate reconstructive surgery: prospective cohort study using near-infrared spectroscopy. Clin Oral Investig. 2020 Aug;24(8):2909-2918. doi: 10.1007/s00784-019-03157-8. Epub 2020 Mar 26.
Clinical trial NCT06841510: Efficacy and Safety of GENOSS SES in Patients with Coronary Artery Disease
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients with Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 1116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease treated with GENOSS SES

Brief summary: Efficacy and Safety of GENOSS SES in patients with coronary artery disease

Detailed description: GENOSS SES

Eligibility criteria: Inclusion Criteria:

1. Patients of 19 and over
2. Patients with coronary artery disease treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion Criteria:

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
2. Patients who are pregnant or planning to become pregnant
3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
4. Patients with a life expectancy of less than 1 year
5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
7. Patients participating in randomized controlled trials using other medical devices

Primary outcomes:
measure: Device-oriented composite endpoint
timeFrame: at 12 months after the procedure
Secondary outcomes:
measure: Patient-oriented composite endpoint
timeFrame: at 12 months after the procedure
measure: All-cause deaths
timeFrame: at 12 months after the procedure
measure: Cardiac death
timeFrame: at 12 months after the procedure
measure: Non-cardiac death
timeFrame: at 12 months after the procedure
measure: Any myocardial infarction
timeFrame: at 12 months after the procedure
measure: Target vessel-related myocardial infarction (TV-MI)
timeFrame: at 12 months after the procedure
measure: Any revascularization
timeFrame: at 12 months after the procedure
measure: Clinically indicated target lesion revascularization (TLR)
timeFrame: at 12 months after the procedure
measure: Stent thrombosis
timeFrame: at 12 months after the procedure
measure: Lesion success
timeFrame: during the procedure
measure: Procedure success
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT06758310: Exercise Effects in Native American Adolscents
Official title: Effects of an Individualized Exercise Program on Physical Performance Measures in Southwest Native American Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fitness Testing
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This longitudinal study will investigate effects of exercise participation in Southwest Native American adolescents, ages 11-17, from the Gila River Indian Community. Vital signs, physical activity participation adherence, physical performance measures, and psychological/social measures will be assessed. Participants will attend one educational presentation for the initial session, explaining the benefits of physical exercise and expectations throughout the program. Baseline measurements for strength, flexibility, and cardiovascular fitness will be taken as well as height, weight and blood pressure. Based on individual performance measures, each participant will be provided a personalized exercise program to complete 3-4 times/week for the duration for the duration of the study. Participants will also be provided an exercise journal to track their adherence to their exercise program each week. At the end of the session parents and adolescents separately will be asked to complete a written survey assessing physical, emotional, social, and school function. Physical performance measures will be taken every other week from the initial education and data collection session through 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Active members of the Gila River Indian Community (GRIC) with Native American ancestry
* Ages 11-17

Exclusion Criteria:

* Not active members of the GRIC or no Native American ancestry
* Age \<11 or \>17

Primary outcomes:
measure: Push ups
timeFrame: 6 weeks
measure: Sit ups
timeFrame: 6 weeks
measure: Sit and Reach
timeFrame: 6 weeks
measure: 1 mile run
timeFrame: 6 weeks
measure: Resting Heart Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04029610: Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Official title: Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Goals: 1. To check for frequency and type of arrhythmia in patients undergoing a medical procedure under local anesthesia 2. To examine whether the addition of adrenaline to local anesthesia affects the incidence of arrhythmias

Detailed description: Rationale: Determining the frequency and type of arrhythmia will help determine the need for monitoring and the type of monitoring required during procedures under local anesthesia.

Patients will undergo the prescribed medical procedure using local anesthesia. Patients will be randomized into two groups: Group 1 - Local anesthesia of lidocaine and arterial blockage on the arm; Group 2 - Local anesthesia with lidocaine and adrenalin.

The amount and type of anesthetic used shall be recorded. In addition to the routine monitoring performed today (use of non-invasive blood pressure gauge and oxygen saturation), the patients will be connected to a cardiac holter monitor prior to the start of the surgical procedure and until they are released from the recovery room. Upon completion of the monitoring, the results of the holter test will be transmitted to the electrophysiology unit and analyzed to detect arrhythmias. There will be a registration of side effects reported by patients, which can result from arrhythmias (palpitations, dizziness, fainting, CPR). In patients in whom arrhythmias are detected, the type of arrhythmia and if it was accompanied by clinical symptoms will be recorded.

Eligibility criteria: Inclusion Criteria:

* Adult patients who undergo hand surgery using local anesthesia at Assuta Ashdod Hospital

Exclusion Criteria:

* Patients with a known medical history of cardiac arrhythmia

Primary outcomes:
measure: Arrhythmia
timeFrame: 1 day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Hospital
Study officials:
affiliation: Head, Hand Surgery Unit, Assuta Ashdod Hospital
name: Uri Farkash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06344910: PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC
Official title: PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: electronic health records
electronic nudge
guideline directed medical therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Yale University
First posted: 2024-04-03
Enrollment: 900
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: Patients with heart failure and reduced ejection fraction

Brief summary: This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Treatment for HFrEF at the outpatient clinic cardiology.
* Documented reduced ejection fraction of \<40% based on cardiac ultrasound or cardiac magnetic resonance imaging.

Exclusion Criteria:

* Opt-out for the use of routine clinical data for research purposes

Primary outcomes:
measure: Use of guideline-directed medical therapy (GDMT)
timeFrame: 30 days (primary), 6 months (secondary)
Secondary outcomes:
measure: All-cause mortality
timeFrame: 1 year
measure: Hospitalisation for Heart Failure
timeFrame: 6 months, 1 year
measure: other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
timeFrame: 6 months, 1 year
measure: renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
timeFrame: 30 days, 6 months, 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers, Location AMC
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers, Location VU Medical Center
Study officials:
References:
Clinical trial NCT05185310: Strategies in Patients Undergoing Repeat AF Ablation
Official title: Strategies in Patients Undergoing Repeat AF Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: pulmonary vein ablation
repeat ablation
posterior wall isolation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blinded randomized trial comparing 3 ablation strategies
Primary purpose: TREATMENT

Brief summary: The aim of the proposed research project is to compare the efficacy of three different ablation strategies in patients with atrial fibrillation (AF) who are undergoing their first repeat catheter ablation for recurrent AF.

Detailed description: Reconnection of the pulmonary veins (PV) is generally responsible for AF recurrence in most cases. However, in a growing subset of patients undergoing repeat ablation for recurrent AF, the PVs are chronically isolated and no other non-PV triggers of AF can be identified. The investigators have previously shown that empirically ablating at known common non-PV trigger sites for AF can improve arrhythmia free survival beyond PVI. The left atrial (LA) posterior wall is also increasingly being isolated in AF patients undergoing catheter ablation. However, long term arrhythmia free survival in AF patients undergoing LA posterior wall isolation is not consistently better than PVI alone.

The objective of this study therefore is to assess whether performing empiric ablation of common non-PV trigger sites or achieving LA posterior wall isolation can improve arrhythmia free survival in AF patients who are undergoing repeat AF ablation and in whom the PV remain chronically isolated and/or do not demonstrate AF. The investigators propose to do this as prospective, randomized three arm study.

Eligibility criteria: Inclusion Criteria: All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure).

Exclusion Criteria:

1. Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.
2. Patients who demonstrated non-PV triggers for AF.
3. Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter
4. Failure to obtain informed consent
5. Patients with a mechanical mitral valve

Primary outcomes:
measure: Primary efficacy endpoint
timeFrame: 1 year
Secondary outcomes:
measure: Secondary endpoint
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Sanjay Dixit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01796210: Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)
Official title: Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Analgesia/nociception index
Bispectral index
Propofol
Remifentanil
Suspension laryngoscopy
Endoscopy
Ear-nose-throat
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
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: Adult patients underoing suspension laryngoscopy performed on general anesthesia

Brief summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Detailed description: Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Suspension laryngoscopy for diagnostic or therapeutic purposes
* Total intravenous anesthesia using propofol and remifentanil

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system disorders (epilepsy)

Primary outcomes:
measure: Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes
timeFrame: Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Édouard Herriot, HCL
state: Rhône
Study officials:
affiliation: Hôpital Édouard Herriot, HCL
name: Emmanuel Boselli, MD, PhD
role: STUDY_DIRECTOR
References: