louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00478478: Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke
Official title: Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy
Merci
Concentric
Embolus
Embolism
Mechanical
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with ischemic stroke treated with a Merci Retriever either alone or in combination with adjunctive therapies such as lytics will be included in the Registry.

Brief summary: Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:

* Post-procedure revascularization success
* 90-day mRS 0-2
* 90-day mortality

Detailed description: The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.

The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

Eligibility criteria: Inclusion Criteria:

* Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. "Treated" is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke
* Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place

Exclusion Criteria:

-There are no exclusion criteria for this protocol

Primary outcomes:
measure: Post-procedure revascularization success
timeFrame: post-procedure
Secondary outcomes:
measure: NIHSS change from baseline to 24-hours
timeFrame: 24-hour
measure: 90-day mRS outcomes
timeFrame: 90-day
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: St. Luke's Brain and Stroke Institute
state: Missouri
Study officials:
affiliation: University of California at San Francisco, SF, CA
name: Wade S Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MABSI St. Luke's, Kansas City, MO
name: Marilyn M Rymer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04608578: Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
Official title: Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Suicide Prevention
Universal Suicide Prevention
Serious Game
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game. The study is a cluster-randomized controlled trial conducted in secondary schools in Flanders.


Eligibility criteria: Inclusion Criteria:

* Dutch speaking
* having access to a smartphone or tablet

Exclusion Criteria:

* not being part of the selected classes in the participating schools

Primary outcomes:
measure: The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)
timeFrame: Baseline and posttest (after 2 weeks)
Secondary outcomes:
measure: Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)
timeFrame: Baseline and posttest (after 2 weeks)
measure: Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)
timeFrame: Baseline and posttest (after 2 weeks)
measure: 2 subscales of the EMO-check kids
timeFrame: Baseline and posttest (after 2 weeks)
measure: Children's Depression Inventory, version 2 (CDI-2)
timeFrame: Baseline and posttest (after 2 weeks)
Other outcomes:
measure: Game Evaluation
timeFrame: Posttest (after 2 weeks)
Locations:
city: Antwerpen
country: Belgium
facility: De!Kunsthumaniora
city: Beveren
country: Belgium
facility: KA Beveren
city: Brugge
country: Belgium
facility: VTI Brugge
city: Denderleeuw
country: Belgium
facility: GO! Atheneum Denderleeuw
city: Gent
country: Belgium
facility: Kunsthumaniora Sint-Lucas
city: Hasselt
country: Belgium
facility: Humaniora Kindsheid Jesu
city: Hasselt
country: Belgium
facility: Middenschool Kindsheid Jesu
city: Heist-op-den-Berg
country: Belgium
facility: GO! Atheneum Heist
city: Kortrijk
country: Belgium
facility: RHIZO Hotelschool
city: Kortrijk
country: Belgium
facility: RHIZO Lyceum OLV Vlaanderen
city: Leuven
country: Belgium
facility: GO! Campus Redingenhof Leuven
city: Ninove
country: Belgium
facility: GO! Atheneum Ninove
city: Roeselare
country: Belgium
facility: De Burgerschool
city: Stabroek
country: Belgium
facility: PITO Stabroek
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018978: Comprehensive Triaged HIV Prevention in Tanzania
Official title: Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV prevention
Behavioral intervention
Community-randomized trial
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2013-12-24
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV testing and counseling, (b) Educational activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime provision of a small amount of food or health products for sex partners of persons testing positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An income generation training program for people testing positive for HIV, (g) Transportation assistance in visiting the HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h) Counseling and transportation support for those on medical treatment for HIV to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. The study will take place within two communities located in Kisarawe district, Tanzania. The intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (STIs) than those in the control community.


Eligibility criteria: Inclusion Criteria:

* Be between 18-55 years of age
* Lives in the household regularly
* Able to provide informed consent
* Plans on living in the study area for the duration of the study (2 years)

Exclusion Criteria:

* Younger than 18 years of age or older than 55 years of age
* Does not reside in the household regularly
* Is not able to provide informed consent
* Does not plan on living in the study area for study duration (2 years)

Primary outcomes:
measure: STI Incidence
timeFrame: 18 months
Secondary outcomes:
measure: Safety and acceptability
timeFrame: 18 months (during intervention)
measure: Sexual risk behavior
timeFrame: 18 months
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Medical University of South Carolina
name: Michael D Sweat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024888: A Study Evaluating the Food Effect on the Pharmacokinetics of SSS17 Capsules in Chinese Healthy Subjects
Official title: Effect of Food on the Pharmacokinetics of SSS17 Capsules: A Study in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects (HS)
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult subjects aged 18 to 45 years
2. Good health status with no clinically significant medical history.
3. Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
4. Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up

Exclusion Criteria:

1. Hypersensitivity to investigational drug/excipients.
2. Dysphagia, GI disorders affecting absorption, or relevant surgery history .
3. Intolerance to venipuncture or needle/blood phobia.
4. Clinically significant disorders affecting drug ADME.
5. Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
6. Family history of malignancy or major surgery within 3 months pre-screening.
7. Participation in other drug/device trials with investigational product use within 3 months.
8. Blood donation/loss within 3 months.
9. Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME.
10. Any medication use within 14 days pre-dosing.
11. Regular alcohol \>14 units/week within 3 months.
12. Smoking \>5 cigarettes/day within 3 months or unwilling to abstain during trial.
13. Caffeine products within 48h pre-dosing.
14. Alcohol consumption within 48h or positive alcohol screen.
15. Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis.
16. Pregnancy/lactation or unprotected sex
17. Positive drug screen, drug abuse history, or drug use within 3 months.
18. Any condition compromising safety/compliance, or investigator's judgment of unsuitability

Primary outcomes:
measure: Cmax
timeFrame: Day1 to Day73
measure: AUC
timeFrame: Day 1 to Day 73
Secondary outcomes:
measure: Tmax
timeFrame: Day1 to Day73
measure: t1/2
timeFrame: Day 1 to Day 73
measure: CL/F
timeFrame: Day 1 to Day 73
measure: AEs
timeFrame: up to Day 73
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affilated Hospital Of QingDao University
Study officials:
References:
Clinical trial NCT03609788: Validation of the Turkish Version of the Pain Sensitivity Questionnaire
Official title: Validation of the Turkish Version of the Pain Sensitivity Questionnaire in Patients With Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: pain sensitivity
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo a low back interventional procedure

Brief summary: The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* adult chronic low back pain patients having pain for greater than 3 months

Exclusion Criteria:

* Failed back surgery syndrome,
* Morbid obesity (body mass index, \>40),
* Being a non-Turkish speaker,
* Substance abuse disorder,
* Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).

Primary outcomes:
measure: Measurement of pain intensity in Turkish people using The Turkish version of the PSQ
timeFrame: 1 day
measure: Pain Catastrophizing Scale
timeFrame: 1 day
measure: Beck Anxiety Inventory
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT00756288: Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses
Official title: A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Actinic Keratoses
Keywords: Actinic Keratoses
Blue light therapy
photosensitizer
Retinoid
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 0
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: Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Detailed description: Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Eligibility criteria: Inclusion Criteria

* Adults aged 18-80 years old
* Subjects with AK lesions who will receive PDT
* Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
* Subjects in good health
* Subjects with willingness and the ability to understand and provide informed consent

Exclusion Criteria

* Subjects who are pregnant or lactating
* Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
* Subjects with use of photosensitizing drugs within 1 week of study start
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects who received previous treatment of target AKs within 4 weeks
* Subjects who are unable to understand the protocol or give informed consent

Primary outcomes:
measure: Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).
timeFrame: 6 weeks
Secondary outcomes:
measure: Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University Department of Dermatology
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785688: Energy Protector Aids for Improving the Lower Back Pain, Sports and Autonomic Nerve
Official title: The Effectiveness of Use an Energy Protector Aids for Improving the Lower Back Pain, Sports and Autonomic Nerve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: the Effect of Infrared Rays Devices on Lower Back Pain
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Cheng-Hsin General Hospital
First posted: 2025-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to explore the impact of Protective gear irradiated by infrared rays intervention on back pain, motor protection and autonomic nerves.

Detailed description: Before and after the experimental control study design, each case, using the Chinese version of the simple pain scale and autonomic nerve measurement and exercise protection knowledge as a research tool, before and after the test (3 months after using the protective gear), collected Lower back pain level: changes in pain intensity and pain effects, and changes in autonomic and motor protection knowledge before and after testing. The research data uses SPSS for Windows 25.0 software package English version for data processing and analysis. The main statistics are Independent t test, Pair samples t test, Chi-square test and Odds ratio etc. It is expected that in the future, patients will be able to provide a safe and effective pain care and improve the quality of life, thereby reducing the recurrence rate of back pain and reducing the social cost of medical treatment

Eligibility criteria: inclusion criteria were: (1) individuals aged 20 to 80 with self-determined lower back pain who scored 3 points or higher on a brief pain scale; and (2) individuals accustomed to using far infrared devices for lower back pain.

excluded criteria were: Unconscious individuals were excluded.

Primary outcomes:
measure: back pain sereve & impact
timeFrame: contineous use back brace for 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei university of nursing and health science
Study officials:
References:
Clinical trial NCT00635388: A Study of the Effects of Probiotics in Children Grades 1-3
Official title: A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 360
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.


Eligibility criteria: Inclusion Criteria:

* Be in good general health as reported by their parent(s)/legal guardian;
* Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
* Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)

Exclusion Criteria:

* Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)

Primary outcomes:
measure: Number of healthy days.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
Study officials:
affiliation: Procter and Gamble
name: Carl J Eastwood, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694278: Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
Official title: Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type II Diabetes
Lead sponsor: Ferzli, George S., M.D. F.A.C.S.
Sponsor class: INDIV
First posted: 2008-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care office

Brief summary: The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term


Eligibility criteria: Inclusion Criteria:

* Adults age 20-65 years
* Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)

  1. A normal or high C-peptide level (to exclude type 1 diabetes) (\>.9ng/ml)
  2. A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
  3. A fasting plasma glucose of 126mg/dl or more on more than one occasion
* BMI 22-34 KG/m2
* Patients on oral hypoglycemic medications or insulin to control T2DM
* Inadequate control of diabetes as defined as HbA1c\>7.5
* No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
* Ability to understand and describe the mechanism of action of ricks and benefits of the operation

Exclusion Criteria:

* Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
* Enrolled in another clinical study which involves and investigational drug
* Diagnosis type 1 diabetes
* Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
* Previous gastric or esophageal surgery
* Immunosuppressive drugs including corticosteroids
* Coagulopathy (INR\>1.5 or platelets\<50,000/ul)
* Anemia (Hgb\<10.0g/dl)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Lutheran Medical Center
state: New York
Study officials:
affiliation: Lutheran Medical Center
name: George Ferzli, MD
role: STUDY_CHAIR
References: