louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04491188: Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation
Official title: Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Amino Acid Appearace in Blood
Lead sponsor: Lipscomb University
Sponsor class: OTHER
Collaborators: name: Deerland Enzymes
First posted: 2020-07-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.


Eligibility criteria: Inclusion Criteria:

* 18-34 years old Participants must have at least 1 year of resistance training experience.
* Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
* Are free of musculoskeletal injuries
* Are not taking medications that may interfere with study measurements

Exclusion Criteria:

* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care
* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care.

Primary outcomes:
measure: Plasma Amino Acid response
timeFrame: 28-days
Secondary outcomes:
measure: Body Composition
timeFrame: 28-days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Jeremy Townsend
state: Tennessee
Study officials:
References:
Clinical trial NCT05772988: Beta-alanine Supplementation and CrossFit Performance
Official title: Examining the Effects of 3-weeks Beta-Alanine Supplementation on CrossFit® Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-Induced Lactic Acidemia
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2023-03-17
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: This study will randomize CrossFit participants to receive beta-alanine or placebo supplementation for 3 weeks. The study will be double-blind. Performance on the "Fran" test will be completed at baseline and after the 3 week intervention. Respiratory exchange ratio will also be assessed during the performance test at baseline and after 3 weeks.

Detailed description: Beta-alanine is a nutritional supplement often consumed by people involved in high-intensity sports that involve substantial lactic acidosis. If consumed on a regular basis, it improves muscle buffering capacity and exercise performance during high-intensity moderate-duration events. CrossFit involves competitions that are high in intensity and moderate duration and many elite CrossFit athletes have reported taking beta-alanine as a supplement. It has never however been evaluated in a research study for its affect on CrossFit performance. The purpose of the study is therefore to assess the effects of beta-alanine supplementation on CrossFit performance. A maximum of 30 CrossFit participants will participate in this randomized double-blind parallel groups study. Participants will be randomized to receive 6.4 g/d beta-alanine or maltodextrin placebo for 3 weeks. At baseline and after the intervention, participants will complete a "Fran" test, which involves performing sets of repeated dumbbell thrusters alternating with chin-ups. The performance measure is the time to complete the test. During the test, respiratory exchange ratio will be assessed to indirectly assess acidosis.

Eligibility criteria: Inclusion Criteria:

* Minimum of one year of CrossFit experience and doing CrossFit training at least twice a week

Exclusion Criteria:

* Having consumed beta-alanine in the past six months
* Having changed the dose of any other nutritional supplement within the past month
* Having suffered a major physical injury in the past six months

Primary outcomes:
measure: Change from baseline in time to perform a "Fran" CrossFit workout
timeFrame: Baseline, 3 weeks
Secondary outcomes:
measure: Change from baseline in respiratory exchange ratio
timeFrame: Baseline, 3 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT03793088: A Patient-Centric Platform Trial for Precision Oncology
Official title: xCures/CancerCommons Enhanced Learning Treatment Selection and Analysis With Outcomes Research (XCELSIOR) Study: A Patient-Centric Platform Trial for Precision Oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Keywords: Glioblastoma
Glioma
Pancreatic Adenocarcinoma
Lead sponsor: xCures
Sponsor class: INDUSTRY
Collaborators: name: Cancer Commons
name: Musella Foundation for Brain Tumor Research and Information, Inc.
name: Pediatric Oncology Experimental Therapeutics Investigators Consortium
First posted: 2019-01-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will initially include up to 10,000 adult and pediatric patients with recalcitrant or advanced cancers.

Brief summary: XCELSIOR is a non-interventional data registry. Information about treatments, treatment decisions and rationale, and patient outcomes including safety and effectiveness of anti-cancer therapy and associated supportive care will be collected for analysis.

Detailed description: XCELSIOR is patient-centric study for the registration of cancer patients, operations of a virtual tumor board, insight capture in clinical decision making, and collection of longitudinal, observational data in a cancer registry. Patient intake into XCELSIOR will occur through the Cancer Commons Web portal. This includes consent to participate in the data registry, including the collection and review of medical information by a Virtual Tumor Board, generation of patient-specific treatment options with supporting rationale, access to treatment access support services, and inclusion into a registry study that includes safety and efficacy outcomes tracking. Patients will be treated and tracked in their original treatment setting and the data generated will form part of a systematic framework combining expert judgment with artificial intelligence to maximize information gain and improve treatment option set development for individual cancer patients.

Eligibility criteria: Inclusion Criteria:

* Both male and female patients with known or suspected recalcitrant or advanced cancer are eligible to enroll through the Cancer Commons Website
* Patients with any performance status, comorbidity or disease severity are eligible
* Patients or their legally-authorized representative must be willing and able to provide written, informed consent (and assent, if applicable)

Exclusion Criteria:

* Patients must be a resident of or receiving care within the United States or US territories.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 5 Years
measure: Overall Survival (OS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Cancer Commons
state: California
Study officials:
affiliation: xCures / Cancer Commons
name: Mark Shapiro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486888: Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects
Official title: A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (1998 Nmol/ml) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker, defined as no nicotine consumption for at least one year
* Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* Previous participation in this trial or other clinical trials within the last 3 months
* Body weight above 87.5 kg
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
* History of alcohol or drug abuse

Primary outcomes:
measure: Area under the serum insulin concentration-time curve (AUC 0-24 hours)
measure: Maximum serum insulin concentration (Cmax)
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve (AUC 0-6 hours)
measure: Area under the serum insulin concentration-time curve (AUC 6-24 hours)
measure: Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
measure: Time to maximum serum insulin concentration (tmax)
measure: Terminal insulin half life (t½)
measure: Adverse events
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01662388: A Clinical Trial of Proximal Composite Restorations
Official title: A Clinical Trial of Proximal Composite Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Caries in Premolars
Keywords: proximal caries, composite restoration, proximal contact
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring. The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band. Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables

Detailed description: A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two groups. Intervention group teeth received Automatrix band after cavity preparation followed by the separation ring using clamp while the control group received Automatrix band alone.

All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA). Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.

Eligibility criteria: Inclusion Criteria:

* patients who had supra gingival Class II cavities in permanent premolars. Teeth with cavity isthmus less than one-third of intercuspal distance were inducted

Exclusion Criteria:

* Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic bands or brackets or whose adjacent tooth continuous with the cavity side is missing were excluded.

Primary outcomes:
measure: proximal tightness
timeFrame: 1 day (just after dental restoration)
Secondary outcomes:
measure: proximal contours
timeFrame: 1 day (just after restoration placement)
Other outcomes:
measure: Overhang of the restoration
timeFrame: 1 day (just after the restoration placement)
Locations:
city: Karachi
country: Pakistan
facility: Dental Clinics, Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: AKU
name: Farhan R Khan, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06342388: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage
Official title: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage: A Randomized Trial to Identify and Implement Effective Outreach Solutions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: No Medicaid Coverage
Keywords: Medicaid
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Covering Wisconsin
First posted: 2024-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in Wisconsin who lost Medicaid coverage for procedural reasons any time between June 2024 and November 2025

Brief summary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:

1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call?


Eligibility criteria: Inclusion Criteria:

* Eligible for Medicaid
* Lost Medicaid coverage between June 2024 and November 2025

Exclusion Criteria:

* Preferring a language other than English, Spanish, or Hmong
* No working phone number

Primary outcomes:
measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call
timeFrame: 3 months
Secondary outcomes:
measure: Duration of coverage gaps
timeFrame: 6 months
measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call
timeFrame: 6 months
measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Rebecca Myerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018888: Safety and Efficacy Study of Artificial Cornea
Official title: Clinical Assessment of Auro KPro
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Corneal Transplantation
Keywords: Cornea
Transplantation, Cornea
Keratoplasty
Grafting, Corneal
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.

Detailed description: The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology.

Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.

Eligibility criteria: Inclusion Criteria:

* Age more than 20 years
* Willing to participate and review on schedule
* Multiple failed grafts with poor prognosis for regrafting
* Adequate tear film and lid function
* Projection of light in all quadrants
* Bilateral blind

Exclusion Criteria:

* Reasonable chance of success with keratoplasty
* Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
* End stage glaucoma
* Retinal detachment

Primary outcomes:
measure: Visual Acuity
timeFrame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
Secondary outcomes:
measure: Retention of the device
timeFrame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Dr. Jeena Mascarenhas, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00492388: Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: breakthrough
pain
cancer
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

Detailed description: The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain

Exclusion Criteria:

* under 18 years
* non-cancer pain
* allergy to ketamine

Primary outcomes:
measure: pain intensity difference
timeFrame: 60 minutes
Secondary outcomes:
measure: various pain assessments
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Zahid Bajwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03015688: the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Biomarkers
Lead sponsor: Shihezi University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 460
Sex: ALL
Minimum age (years): 38
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 210 patients diagnosed with knee OA in clinics were found in hospital patients .

Healthy controls were recruited from community questionnaires in Shihezi city, Xinjiang province, China.

Brief summary: It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee OA cases were collected from the first affiliated hospital of Shihezi university and healthy controls were recruited from the community. The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .


Eligibility criteria: Inclusion Criteria:

* OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons

Exclusion Criteria:

Participants who met the following criteria were excluded：

* the knee OA concomitant with hip OA,
* suppurative and rheumatoid arthritis,
* gout patients,
* patients who underwent knee arthroscopy surgery within 6 months,
* bilateral or unilateral knee replacements,
* the knee joint trauma patients,
* histories of glucocorticoid and/or sterol hormones.

Primary outcomes:
measure: Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: