louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03435432: Plasma Lipid Response to Glucose Drink
Official title: Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines blood lipid responses to a glucose drink. Participants drink a fatty formula and 5 hours later drink either a glucose solution or water (as control), in one of two randomized study visits. Blood lipid levels are monitored throughout the study period.

Detailed description: Participants are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 hours later, they drink 50 grams of glucose in 50 ml of water in one visit and 50 ml of water in another. The 2 visits are randomized. Blood samples are taken before and after they drink the high fat liquid formula, and continued until 3 hours after they drink glucose or water. Lipid levels in the blood samples are measured in the lab.

Eligibility criteria: Inclusion Criteria:

* Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman.
* Body mass index 20 to 27 kg/m2

Exclusion Criteria:

* Patients with active inflammatory bowel disease
* Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
* Patients with active bowel malignancy
* Patients with diabetes mellitus or known/ suspected motility disorders of the gut
* Patients with decompensated liver disease
* Patients on ezetemibe or bile acid sequestrants
* Unstable cardiac or respiratory disease
* Any changes to medication in the preceding month.

Primary outcomes:
measure: Blood lipid responses to glucose drink
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Tornto General Hospital, UHN
state: Ontario
Study officials:
References:
Clinical trial NCT02355652: Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study
Official title: Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: Total knee arthroplasty
IKS Score
cemented, uncemented
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).

Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.

The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.

The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.


Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis
* Need for a total knee arthroplasty

Exclusion Criteria:

* Age \< 50 or \> 80
* Need for a different procedure than a TKA
* Preoperative knee flexion \< 90°
* Need for a TKA associated with a combined femoral or tibial osteotomy
* Knee already operated except for arthroscopy
* Mediocre bone quality

Primary outcomes:
measure: IKS 2011 Score measuring the clinical results of TKA
timeFrame: One year postoperative
Secondary outcomes:
measure: Number of patients in each arm with radiological loosening signs of the TKA components
timeFrame: One year postoperative
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe NEYRET, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792852: Improving the Health and Social Participation of People With Disabilities From Underrepresented Groups Post COVID
Official title: Feasibility of ENGAGE to Address Social Isolation Related to the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disabilities Multiple
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-03-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm community-based feasibility study examining recruitment, retention, adherence, and satisfaction with ENGAGE, a community-based intervention designed to address pandemic-related social isolation among people with disabilities. We will also examine preliminary, within-group effects on social participation. The findings of this study will inform a larger trial to examine intervention efficacy.

Detailed description: Social isolation has been shown to negatively affect physical and mental health, particularly among people with disabilities. Social isolation among people with disabilities has been exacerbated by the COVID-19 pandemic. Even now, people with disabilities remain hesitant to return to social and community activities due to ongoing risk of severe cases and death. Yet, we do not have strong models of intervention designed to address this problem.

ENGAGE is an intervention that may address this gap. ENGAGE was designed to address social and community participation among people with stroke. We have since conducted qualitative research to inform adaptation of ENGAGE to meet the needs of a broader range of people with disabilities related to participation in the context of the ongoing COVID-19 pandemic. This study is the next step in testing and refining the adapted intervention protocol. At the end of this study, we will have a finalized adapted intervention protocol ready for large-scale efficacy testing.

Eligibility criteria: Inclusion Criteria:

* Self-identify as disabled
* Report problems with social participation
* Speak English
* Live in a community setting

Exclusion Criteria:

* Severe communication impairment limiting ability to verbally indicate interest in participation

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 8 weeks
measure: Intervention Satisfaction
timeFrame: 8 weeks
Secondary outcomes:
measure: Social Participation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Joy Hammel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202552: Two-site Intradermal Influenza Vaccination in Elderly
Official title: Two-site Intradermal Influenza Vaccination in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza
aged
intradermal injection
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

Detailed description: The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody

Eligibility criteria: Inclusion Criteria:

* healthy male or female volunteer aged at least 60 years old
* willing to participate in this study

Exclusion Criteria:

* previous influenza vaccination within 6 months
* systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
* history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
* ongoing acute febrile illness (oral temperature, ≥37.5 c )
* congenital or acquired immunodeficiency
* treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
* long-term treatment with systemic corticosteroids
* receipt of blood or blood-derived products in the previous 3 months
* history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.

Primary outcomes:
measure: immunogenicity
timeFrame: 4 months
Secondary outcomes:
measure: comparison of the immunogenicity
timeFrame: 4 months
measure: safety
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01318252: AL-54478 Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma (OAG)
Ocular Hypertension (OHT)
Keywords: Elevated IOP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 64
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: The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with either OAG or OHT.
* Patients who are able to comply with the scheduled visits.
* Patients who have had a physical exam within 6 months of the Screening Visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
* Patients with extreme narrow angle with complete or partial closure.
* Patients with a cup to disc ratio more than 0.8.
* Patients with a severe central visual field loss in either eye.
* Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
* Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
* Patients with best-correct visual acuity less than 20/80.
* Patients who have had ocular infection or inflammation within the past 3 months.
* Patients who have clinically relevant progressive retinal disease.
* Patients who have severe illness or conditions.
* Patients who have hypersensitivity to a prostaglandin analogu.e
* Patients who are unable to safely discontinue all IOP-lowering medications during washout.
* Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Ravaughn Williams
role: STUDY_DIRECTOR
References:
Clinical trial NCT03355352: Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump (PCA=Patient Controlled Analgesia)) After Urogenital Intervention at the Clinical Daily Routine
Official title: Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump) After Urogenital Intervention at the Clinical Daily Routine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Analgesic Quality
Mobility
Keywords: Zalviso
sufentanyl
PCA
Dipidolor
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at the teaching hospital of university tuebingen which get an surgical urological intervention and which correspond with the inclusion criteria.

Brief summary: The observational study will check if there is a difference in the postoperative care of patients with urogenital intervention while using the standard PCA-syringe pump or using the Zalviso sufentanyl sublingual analgetic system.

The study will exactly examine, using questionaire for the patient, the medical stuff (nurses and anesthesiologist) the difference in the analgetic quality, the difference of the patients' mobility while being treated with one of the analgetic system and if there is a difference in the cost-efficiency.

We want to examine 50 Patients in each group. The studies should be finished in about one year.


Eligibility criteria: Inclusion Criteria:

* Patients after urological interventions with no indication of an periduralanästesia
* Patients compliant for a PCA system, and complied with the analysis of their data

Exclusion Criteria:

* F03 dementia
* F10.2 dependence syndrome alcohol
* F11.2 dependence syndrome opioids
* F12.2 dependence syndrome cannabinoids
* F13.2 dependence syndrome sedatives and hypnotics
* F14.2 dependence syndrome cocaine
* F15.2 dependence syndrome coffin
* F.16.2 dependence syndrome hallucinogens
* F22 schizophrenia
* F41.1 generalized anxiety disorder

Primary outcomes:
measure: analgesic quality
timeFrame: 1 year
measure: mobility
timeFrame: 1 year
Secondary outcomes:
measure: medical cost efficiency
timeFrame: 1 year
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Tuebingen, clinic of anästhesiology and intensiv care
Study officials:
References:
Clinical trial NCT03281252: A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
Official title: A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Failure, Acute on Chronic
Hemostatic Disorder
Keywords: liver failure
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre-acute-on-chronic liver failure and acute-on-chronic liver failure

Brief summary: Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.


Eligibility criteria: Inclusion Criteria:

* patient with previously or undiagnosed chronic liver disease/cirrhosis;
* serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT\>10ULN（male 300 U/L; female 200 U/L)

Exclusion Criteria:

* those who had or been diagnosed hepatocellular carcinoma or other types of malignancies;
* pregnancy;
* obstructive biliary diseases or other disease lead to bilirubin evaluation;
* using steroid or immunosuppressant in 4 weeks;
* prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver transplantation.
* combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2\<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS\<8)

Primary outcomes:
measure: 28-day progression
timeFrame: 28-day
Secondary outcomes:
measure: major bleeding event
timeFrame: 90-day
measure: 28-day mortality
timeFrame: 28-day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00962052: Biomarker Discovery and Application in Bladder Cancer
Official title: Biomarker Discovery and Application in Bladder Cancer: Identification and Detection of Gene Methylation, Tumor Specific Antigenes Markers of BCG Treatment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medical Diagnostic Laboratories, LLC
First posted: 2009-08-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Those currently diagnosed and undergoing treatment for bladder cancer (100).
2. Those currently diagnosed with other urogenital cancers including prostate cancer and kidney cancer (50).
3. Those currently diagnosed with non-malignant urogenital conditions including urinary tract infection, interstitial cystitis, and kidney stones for specificity analysis (50).
4. Healthy control patients (50).

Brief summary: The investigators' long-term objective is to research and develop innovative new tests which diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine samples. The investigators plan to detect methylated DNA targets and control targets by methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples from bladder cancer positive and negative patients to determine its sensitivity and specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder tumor specific protein is identified, the investigators will assess its presence in the urine of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent assay (ELISA). The investigators plan to use both in vitro models and patient clinical samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and identify biomarkers of treatment effectiveness. Once a biomarker is identified, the investigators will assess its presence in the urine of bladder cancer and absence in healthy patients.

Once the investigators determine the feasibility of these tests, the investigators will further perform an extensive clinical study, comparing the tests to existing diagnostic methods. This study will provide the foundation for FDA approval, which is required for tests to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The investigators' tests will improve early detection of bladder cancer, thereby improving patient health and decrease cancer deaths, a key mission of the National Institutes of Health.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
Clinical trial NCT05129852: The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
Official title: The Effect Of Reiki And Massage With Sage Oil On Pain In Young Girls With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: midwifery, nurse, alternative therapies
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with alternative therapy is a randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study was a randomized controlled trial. It included young girls with primary dysmenorrhea in a district located in the south of Turkey and was conducted between March 01, 2021 and June 30, 2021. The sample size of this research was decided by performing a power analysis in the power statistical program. Considering the parameters of the groups, the effect size was calculated to be 0.5003604. Since α was found to be 0.05 and power (1 - β) was 0.95, a total number of 66 participants were distributed into three equal groups (sage oil massage: 22, Reiki: 22, control: 22). Considering the possibility of case losses, 30 participants were included in each group; finally, a total of 90 people were included in the study. For data collection, a questionnaire regarding sociodemographic characteristics and the visual analog scale (VAS) were used. Reiki and massage with sage oil were applied for 30 minutes, and no application was performed on the control group.


Eligibility criteria: Inclusion Criteria:

Being female Not married

Exclusion Criteria:

Psychiatric problem Communication barrier Those who refuse to work

Primary outcomes:
measure: Individual Introductory Information Form
timeFrame: 2 months
measure: VAS pain scores
timeFrame: 2 months
measure: Body Mass Index
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Nazife Bakir
state: Bucak
Study officials:
References: