louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00011661: Social Network Based Intervention to Reduce Lead Exposure Among Native American Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lead Poisoning
Keywords: Lead poisoning
Native Americans
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-28
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine whether adding an inter-generational component to an existing social network-based lay health advisor intervention increases its effectiveness in mobilizing a Native American community to respond to heavy metal contamination from lead and zinc mining.

Detailed description: Ottawa County, Oklahoma, the site of the research, was heavily mined for zinc and lead in the first half of this century. Mine tailings containing heavy metals are stored in large piles up to 200 feet in height. Ottawa County is home to 8 Indian tribes and much of the mine waste is on tribal land. Specifically, the study will: a) integrate existing Native American youth programs with the existing lay health advisor intervention (Society of Clan Mothers and Fathers) to form an inter-generational intervention, b) expand the existing lay health advisor intervention to address cadmium in addition to lead, c) use participatory research methods to involve tribal youth and adults in an air monitoring study, d) assess the extent to which the intervention contributes to belief, attitude and behavior changes that will reduce heavy metal exposure and absorption in Native American children; and e) assess the contribution of the intervention to creating changes in organizational, community, tribal and government (city, county, state, federal) capacity to address heavy metal contamination in Ottawa County, Oklahoma.

Eligibility criteria: Children ages 1-6

Live in Ottawa County, Oklahoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wyandotte
country: United States
facility: Wyandotte Nation
state: Oklahoma
Study officials:
References:
Clinical trial NCT03313661: Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
Official title: Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Detailed description: Type 2 diabetes mellitus (DM) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. Glycemic control is a fundamental part of the management of type 2 DM and difficult to achieve. Different antidiabetic agents can handle diabetic metabolic abnormalities. The development of antidiabetic agentswith novel mechanisms of action is highly desirable. Cabergoline, a long acting D2 agonist, is expected to play a role in the glycemic control.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients.

Exclusion Criteria:

* Other drugs administration

Primary outcomes:
measure: The level of fasting and post prandial BG level
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Faculty of Pharmacy, Tanta University, Egypt
name: Jouliana Atef Morcos, Msc
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, AL-Delta University, Gamasa, Egypt
name: Abla Mohamed Ebeid, Ph D
role: STUDY_CHAIR
affiliation: Tanta University
name: Samy Abdel kader khodeir, Ph D
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Tanta University, Egypt
name: Gamal Abdel khalek Elazab, Ph D
role: STUDY_CHAIR
References:
Clinical trial NCT05721261: Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
Official title: Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nerve Injury
Lead sponsor: Epineuron Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.


Eligibility criteria: Inclusion criteria:

* Peripheral nerve injury

Exclusion criteria:

* Peripheral neuropathy
* Patients with any active implanted device

Primary outcomes:
measure: Sensory recovery
timeFrame: 6 months
measure: Cumulative incidence of adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health Jewett Orthopedic Institute
state: Florida
city: Baltimore
country: United States
facility: The Curtis National Hand Center
state: Maryland
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: Roth | McFarlane Hand & Upper Limb Centre
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Trillium Health Partners
state: Ontario
Study officials:
References:
Clinical trial NCT03452761: Effects of Exogenous Ketones in Healthy Young Adults
Official title: Effects of Exogenous Ketones in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Adults
Keywords: exogenous ketone salts
ketosis
safety
comprehensive metabolic panel
complete blood count
lipid panel
insulin
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Funding source: Pruvit Ventures, Inc
First posted: 2018-03-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, 2-groups (condition and placebo)
Primary purpose: SCREENING

Brief summary: Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.

Detailed description: A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.

Eligibility criteria: Inclusion Criteria:

* Healthy (no known conditions)

Exclusion Criteria:

* Chronic smoker Pregnant

Primary outcomes:
measure: Blood health parameters
timeFrame: 6 weeks on the supplement
measure: Blood health parameter
timeFrame: 6 weeks on the supplement
measure: Blood health parameter
timeFrame: 6 weeks on the supplement
measure: Blood health parameter
timeFrame: 6 weeks on the supplement
measure: Blood ketone levels
timeFrame: Baseline and 6 weeks after chronic consumption
measure: Cardiovascular
timeFrame: 6 weeks on the supplement
measure: Body Composition
timeFrame: 6 weeks on the supplement
measure: Body Composition
timeFrame: 6 weeks on the supplement
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References:
Clinical trial NCT01554761: Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Official title: Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Astigmatism
Cataract
Keywords: astigmatism
pseudophakia
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 30
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: This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.

This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.


Eligibility criteria: Inclusion Criteria:

* cataract candidates
* preoperative corneal regular astigmatism \>0.75D
* Willing and able to complete all required postoperative visits
* Able to comprehend and sign a statement of informed consent

Exclusion Criteria:

* significant intraocular lenses tilt or decentration
* corneal scarring
* Irregular corneal astigmatism
* other ocular diseases
* surgical complication

Primary outcomes:
measure: Pentacam-derived corneal astigmatism
timeFrame: 3month postoperatively
measure: refraction
timeFrame: 3month postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Eye hospital of China Medical Univerisity
state: Liaoning
Study officials:
affiliation: Eye Hospital of China Medical University
name: Jinsong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932161: Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects
Official title: Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: Intrabony defects
Titanium Granules
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).

Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.

Detailed description: Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.

After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.

Eligibility criteria: Inclusion Criteria:

Systemically healthy male and female patients of age \>18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of \>3mm.

Exclusion Criteria:

Medically compromised patients, patients \<18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: from baseline to 6 months
measure: Probing Depth
timeFrame: from baseline to 6 months
measure: Bone Regeneration
timeFrame: at 3 months and 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: from baseline to 6 months
measure: Gingivitis
timeFrame: from baseline to 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Telangana
Study officials:
References:
Clinical trial NCT01760161: Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
Official title: A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Treatment
Robotic Assisted Laparoscopic Surgery
Bilateral Dual Transversus Abdominis Plane Block
Keywords: postoperative pain
opioid consumption
termanalgesia
plasmaropivacain level
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Detailed description: After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for robotic assisted laparoscopis surgery
* acceptance to participate

Exclusion Criteria:

* allergies to local analgetics
* daily use of strong opioids

Primary outcomes:
measure: Pain-score on numerical rating scale
timeFrame: 4 hours after surgery
Secondary outcomes:
measure: Administration of opioids
timeFrame: The first 24 hours after surgery.
measure: Pain-score on numerical rating scale
timeFrame: 8 hours after surgery
measure: Pain-score on numerical rating scale
timeFrame: 24 hours after surgery
Other outcomes:
measure: Thermoanalgesia at dermatome-level th6-th12
timeFrame: 1 hour after bilateral dual transversus abdominis plane block
measure: Plasma-ropivacain level
timeFrame: 15, 30, 60, 120 and 240 mins after the block
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
state: Region Nord
Study officials:
References:
Clinical trial NCT05004961: The Performance of Multi-tracer Multimodality PET in Lymphoma
Official title: The Performance of Multi-tracer Multimodality PET in Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Positron-Emission Tomography
Keywords: Positron-Emission Tomography
Lymphoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients pathologically diagnosed as lymphoma

Brief summary: Investigating the performance of Multi-tracer Multimodality PET in lymphoma

Detailed description: In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by different molecular probe such as FDG, FAPI-04 via multimodality PET (PET/CT and PET/MR). Our Previous studies have shown that uptake of FAPI-04 on PET may be an indicator of lymphoma lesions. The combination of PET with CT/MR allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.

Eligibility criteria: Inclusion Criteria:

* pathologically diagnosed as lymphoma;
* Written informed consent for receiving FAPI-04 PET examinations.
* cancer planned chemotherapy or immunotherapy scheme.
* expected survival ≥ 12 weeks

Exclusion Criteria:

* cannot lie supine for half an hour;
* refuse to join the clinical researcher;
* severe liver or kidney dysfunction
* pregnancy or lactation

Primary outcomes:
measure: SUVmax
timeFrame: 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Yang Zhi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01630161: Smoking Relapse-Prevention Intervention for Cancer Patients
Official title: Smoking Relapse-Prevention Intervention for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: relapse
prevention
smoking
habit
Forever Free
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-28
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.

Detailed description: This study involves participation at four distinct time points over a one-year period.

* Baseline assessment
* 2-month follow-up telephone call
* 6-month follow-up telephone call
* 12-month follow-up telephone call

Eligibility criteria: Inclusion Criteria:

* Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis
* Able to read and write English
* Able to give informed consent
* Have quit smoking after receiving their cancer diagnosis
* Have not quit greater than 3 months prior

Exclusion Criteria:

* Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.

Primary outcomes:
measure: Number of Participants with Relapse at 6 Months
timeFrame: 6 Months
measure: Number of Participants with Relapse at 12 Months
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Vani Simmons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04813861: Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation
Official title: Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Transarterial Chemoembolization
Stereotactic body radiotherapy
Radiofrequency Ablation
Microwave Ablation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been treated for HCC by TACE, followed by additional treatment with RFA, MWA or CK in the following year, between January 2010 and December 2020 by Nancy Regional University Hospital (TACE, RFA, MWA) and Lorraine Institute of Cancer (CK)

Brief summary: Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.

The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.


Eligibility criteria: Inclusion Criteria:

* a HCC treated by TACE followed by RFA, MWA and/or CK
* from 01/2010 to 12/2020
* treated by Nancy Regional University Hospital (TACE, RFA, MWA) and Institut de Cancérologie de Lorraine (CK)

Exclusion Criteria:

* Combined treatment over one year following the last TACE
* No baseline, in between or after combined treatment imaging
* Lesion appeared after TACE treatment

Primary outcomes:
measure: Lesion Response
timeFrame: 4-6 weeks after BWA or RFA or 3-6 months after CK
Secondary outcomes:
measure: Delayed Lesion Response
timeFrame: 1 year after BWA, RFA or CK
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: