louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02784431: Pilot Study of the Contour Neurovascular SystemTM
Official title: Pilot Study of the Contour Neurovascular SystemTM
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Intracranial Aneurysm
Keywords: Brain
Intracranial Aneurysm Treatment
Endovascular Treatment
Brain Aneurysm
Neurovascular diseases
Aneurysms
Cerebrovascular Disorders
Central Nervous System Diseases
Vascular diseases
Lead sponsor: Cerus Endovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

Detailed description: Prospective, single-arm, multi-centre European study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA). Target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral circulation.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years at screening
2. Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
3. IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form

Exclusion Criteria:

1. Ruptured IA
2. Any other IA that requires treatment in the next year
3. IA width \>8.5 or \<2 mm
4. IA neck \>8 or \<2 mm
5. IA minimum height \<4mm
6. IA embolisation would most likely cause stroke
7. Target IA contains other devices/implants (e.g., coils)
8. Inability to access the target IA with the microcatheter
9. Any congenital or iatrogenic coagulopathy
10. Platelet count \<50,000/microliter
11. Known allergy to platinum, nickel or titanium
12. Known allergy to contrast agents
13. Stenosis of the target IA's parent vessel \>50%
14. Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm
15. Taking any anticoagulants (e.g., warfarin)
16. Abnormal clotting parameters
17. Pregnant, breastfeeding or planning pregnancy in the next 2 years
18. Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) or ability to comply with study requirements Participating in another study with investigational devices or drugs

Primary outcomes:
measure: Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Occlusion Status of the Target IA
timeFrame: 6 months (3 patients), 1 year (14 patients), 2 year (2 patients)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01042431: Nutrition Day in Hospitals, Nursing Homes and Community. Israel January 2010
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Status
Keywords: Nutritional status of ward patients and hospitalization outcome
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Orthopedic B' Ward

Brief summary: This study is a one-day international cross-sectional nutritional audit in one ward. The purpose of this study is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, structures and social environment.


Eligibility criteria: Inclusion Criteria:

* A adult patients within the unit from 7H00 to 7H00

Exclusion Criteria:

* Patients younger than 18 years
* Patients admitted and discharged during same calendar day

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05418231: Observation of the Natural Course of Age-related Macular Degeneration
Official title: Observation of the Natural Course of Dry Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dry Age-related Macular Degeneration
Macular Degeneration, Dry
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dry AMD patients in Shanghai General Hospital

Brief summary: This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.


Eligibility criteria: Inclusion Criteria:

* 50-85 yrs male or female AMD patients
* Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.

Exclusion Criteria:

* Any eye with disease that would interfere with the retinal examinations
* Research eye with CNV or high myopia
* Surgeries that may interfere with AMD evaluation
* Long-term uses of medications that are associated with retinal or neural toxicities.
* IOP more than 26 mmHg
* Received cataract surgery in 3 months.
* Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
* Other conditions not suitable for the current study

Primary outcomes:
measure: Visual acuity
timeFrame: 60 months
Secondary outcomes:
measure: Drusen density and shape
timeFrame: 60 months
measure: The rate of 5-year progression
timeFrame: 60 months
measure: GA growth rate
timeFrame: 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaodong Sun, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02367131: Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Official title: Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-02-20
Enrollment: 419
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients start taking JARDIANCE® Tablets within 3 months after launch will be included.

Brief summary: Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion criteria:

Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan

Exclusion criteria:

None

Primary outcomes:
measure: Percentage of Patients With Adverse Drug Reactions (ADRs)
timeFrame: From first drug administration until 7 days after last drug adminstration, up to 52 weeks.
Secondary outcomes:
measure: Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period
timeFrame: Baseline and last observation on treatment, up to week 52.
measure: Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period
timeFrame: Baseline and last observation on treatment, up to week 52.
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: NISND Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00733031: Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer,
Solid Tumors
Advanced Solid Malignancies
Keywords: Phase I,
cancer,
solid tumors,
advanced solid malignancies,
dose escalation,
combination treatment,
TRK inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumors for which standard treatment does not exist or is no longer effective.
* For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
* Relatively good overall health other than cancer.

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Serious heart conditions
* History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition

Primary outcomes:
measure: Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
timeFrame: Weekly for first two treatment cycles, then every 2-4 weeks
Secondary outcomes:
measure: Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy
timeFrame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Nashville
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: AstraZeneca
name: Judith Ochs, MD
role: STUDY_DIRECTOR
affiliation: SCRI Development Innovations, LLC
name: Jeffrey Infante, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Lia Gore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06022731: Artificial Intelligence Evaluation of Fillings
Official title: A Yolo-V5 Approaches to Evaluation of Filling and Overhanging Filling: An Artificial Intelligence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentomaxillofacial Radiology
Keywords: dental filling
dentistry
deep learning,
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 4323
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: These datasets were obtained from the images of the patients who applied to ESOGU Dentistry Faculty, Dentomaxillofacial Radiology clinic for various dental purposes.

Brief summary: The goal of this Non-Interventional Clinical Research is to detect the prevalence and distribution of filling and overhanging filling without the need for additional bitewing radiographs using panoramic images, based on a deep CNN (Convolutional Neural Network) architecture trained through supervised learning.

In this study, retrospectively obtained radiographs were used in the development of artificial intelligence models for relevant situations. These datasets were obtained from the images of the patients who applied to ESOGU (Eskişehir Osmangazi University) Dentistry Faculty, Dentomaxillofacial Radiology clinic for various dental purposes. Eskisehir Osmangazi University Non-Interventional Clinical Research Ethics Board (decision date and decision number: 04.10.2022/22) approved the study protocol. The principles of the Helsinki Declaration were followed in the study.


Eligibility criteria: Inclusion Criteria:

* Images of individuals in the permanent dentition period
* Artifact-free images in the examination region
* Individuals with a history of restorative dental treatment

Exclusion Criteria:

* Images of individuals in mixed dentition
* Radiographic images obtained by incorrect positioning of the patient or containing artifacts

Primary outcomes:
measure: The success of artificial intelligence models for filling and overhanging filling
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
References:
Clinical trial NCT02761031: Perioperative Heart Rate Variability Analysis in Realtime
Official title: Perioperative Heart Rate Variability Analysis in Realtime: Detection of Cardiovascular and Autonomic Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Individuality
Perioperative/Postoperative Complications
Heart Rate and Rhythm Disorders
Surgical Complications From General Anesthesia
Keywords: Heart rate variability
Electrocardiography
Observational study
Non-interventional study
Risk assessment
Perioperative
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Vienna University of Technology
First posted: 2016-05-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients between the ages of 18 and 80 who are undergoing non-cardiac surgery under general anesthesia at Vienna General Hospital may participate.

Brief summary: This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing non-cardiac surgery under general anesthesia
* Patients aged 18-80 years
* Patients who are capable of giving informed consent

Exclusion Criteria:

* Patients \<18 or \>80 years of age
* Patients with an active cardiac pace maker
* Patients with an absent sinus rhythm in ECG
* Patients presenting with a preexisting arrhythmia
* Patients requiring postoperative ICU therapy
* Patients with pheochromocytoma

Primary outcomes:
measure: Heart rate variability
timeFrame: During and immediately subsequent to surgery performed under general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
state: Wien
Study officials:
affiliation: Medical University of Vienna
name: Adam J Bukaty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Ulrich Klein, MD, PD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02627131: Autologous Bone Marrow Stem Cell Therapy for Autism
Official title: Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autistic Disorder
Keywords: Autism
Stem Cells
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Detailed description: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

Eligibility criteria: Inclusion Criteria:

- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders

Primary outcomes:
measure: Change in Total Score of Childhood Autism Rating Scale (CARS)
timeFrame: 3 months and 6 months after transplantation
measure: Number of adverse events
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec International Hospital
Study officials:
affiliation: Vinmec Healthcare System
name: Liem T Nguyen, MD., PhD.
role: STUDY_CHAIR
References:
citation: Sharma A, Gokulchandran N, Sane H, Nagrajan A, Paranjape A, Kulkarni P, Shetty A, Mishra P, Kali M, Biju H, Badhe P. Autologous bone marrow mononuclear cell therapy for autism: an open label proof of concept study. Stem Cells Int. 2013;2013:623875. doi: 10.1155/2013/623875. Epub 2013 Aug 25.
Clinical trial NCT03011931: Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
Official title: Simvastatin Metabolism as a Test for Celiac Disease Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Celiac Disease
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Immunogenics, LLC
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

Detailed description: A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Eligibility criteria: Inclusion Criteria:

1. Gluten-free diet for at least 1 year
2. Clinical endoscopy within the past month
3. Biopsies must show no villous atrophy or villous blunting
4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion Criteria:

1. 1st degree relative with Celiac Disease
2. Positive tTG IgA, already on simvastatin or statin agent
3. Unable to stop non-steroidal or anti-inflammatory drugs
4. Prior history of GI surgery other than appendectomy or cholecystectomy
5. Taking drugs know to inhibit or activate CYP3A4
6. Unable to avoid food known to inhibit CYP3A4
7. History of a reaction to statin drugs in the past
8. Pregnant or nursing women

Primary outcomes:
measure: Compare simvastatin metabolism with intestinal biopsies
timeFrame: Within one month of visit
Secondary outcomes:
measure: Villous height and crypt depth
timeFrame: Within 1 month of visit
measure: Dietary interview
timeFrame: At initial visit
measure: Urinalysis
timeFrame: Prior to administration of simvastatin and at the 3-hour mark
measure: Serologic testing
timeFrame: Prior to administration of simvastatin
measure: DNA sampling
timeFrame: Prior to administration of simvastatin
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph A Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06378931: Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure
Official title: Quality of Life Change in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Secondary Hyperparathyroidism
End Stage Renal Failure
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 80
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 scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure will be invited to participate in this study.

Brief summary: The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.

Detailed description: Study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item Short-Form (SF-36) survey before surgery. Then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their SF-36 score, depression, and anxiety intensity.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years old;
* Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure

Exclusion Criteria:

• Patients refuse to participate

Primary outcomes:
measure: Measure quality of life scores change with respect to time
timeFrame: up to 1 year
Secondary outcomes:
measure: Measure anxiety and depression score change with respect to time
timeFrame: up to 1 year
measure: Measure bone pain scores change with respect to time
timeFrame: up to 1 year
measure: Length of hospital stay
timeFrame: through study completion, an average of 1 week
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Chunling Jiang
role: STUDY_DIRECTOR
References: