louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04195919: The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
Official title: A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemodialysis Patients
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients


Eligibility criteria: Inclusion Criteria:

1. Subjects who aged 20 to 80 at the time of screening
2. Subjects with 50.0kg≤Body Weight≤90.0kg and 18.0kg/m2≤BMI≤27.0kg/m2
3. Subjects who meet the following kidney functions

   * group1(hemodialysis patients): MDRD-eGFR ≤ 15 mL/min/1.73m2
   * group2(helthy control): MDRD-eGFR ≥ 90 mL/min/1.73m2

Exclusion Criteria:

1. Subjects who have a uncontrolled or unstable disease such as liver, nervous system, immune system, respiratory system, endocrine system or blood / tumor disease, cardiovascular disease, mental disorders (mood disorder, obsessive compulsive disorder, etc.) or history
2. Subjects who have a gastrointestinal disease (such as Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or history of gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the test drug.
3. Subjects with a history of significant hypersensitivity reaction such as anaphylaxis or angioedema to DPP-IV inhibitors
4. Subjects who have AST (SGOT) and ALT (SGPT) greater than 1.5 times the upper limit of normal range, at the time of screening test including additional tests.

Primary outcomes:
measure: AUClast
timeFrame: 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose
measure: Cmax
timeFrame: 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05470218: Leucine, MTOR and Athero
Official title: Protein, Platelet, and Monocyte
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2022-07-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-group crossover
Primary purpose: BASIC_SCIENCE

Brief summary: High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. Recent work in mice has implicated monocytes/macrophages and mTOR signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. We aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mTOR activator) contents on circulating human monocytes and platelets. Study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. Activation of amino acid-dependent signaling pathways (particularly mTOR) and downstream sequelae will be evaluated in the isolated monocytes and platelets.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* able to drink milk-based liquid mixed meal

Exclusion Criteria:

* Current Pregnancy
* Allergies to meal ingredients
* History of Diabetes
* History of Heart Disease
* History of High blood pressure
* History of Stroke
* History of Cancer
* History of Organ transplant
* Taking Rapamycin/Sirolimus
* Taking Torisel/Temsirolimus
* Taking Afinitor/Everolimus
* Taking any statin medication

Primary outcomes:
measure: p-mTOR in monocytes
timeFrame: change from before meal at 1 hour and 3 hours, compared to before
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06672718: A Study of SPY002-091 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-091 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Spyre Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Altasciences Company Inc.
First posted: 2024-11-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Up to 40 weeks
Secondary outcomes:
measure: Cmax
timeFrame: Up to 40 weeks
measure: Tmax
timeFrame: Up to 40 weeks
measure: AUC
timeFrame: Up to 40 weeks
measure: t1/2
timeFrame: Up to 40 weeks
measure: ADA
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Spyre Site 1
state: California
Study officials:
affiliation: Spyre Therapeutics
name: Joshua Friedman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01050218: Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Official title: A 9-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic Peripheral Neuropathy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Outpatients who have completed double-blind treatment in study 322 (NCT01050218) for DPN. Subjects must have completed all scheduled evaluations, with no major protocol violations and no events that, in the opinion of the investigator, would preclude the subject's entry into the long-term open-label study.
* Women of childbearing potential must have a negative serum pregnancy test on day 91 of the short-term study. A woman of childbearing potential is one who is biologically capable of becoming pregnant. "Biologically capable" includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study who are biologically capable of becoming pregnant must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. Medically acceptable forms of contraception include oral contraceptives, transdermal, injectable, or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm.

Exclusion Criteria:

* Presence of any new and/or clinically important medical condition that might compromise subject safety (including, but not limited to, significant changes in glycemic control).
* Pregnancy, lactation, or plans to become pregnant during the study.
* Use of prohibited treatments.
* Meets any of the exclusion criteria listed for study 322 (NCT01050218).

Primary outcomes:
measure: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).
timeFrame: Baseline and 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Allen R, Sharma U, Barlas S. Clinical experience with desvenlafaxine in treatment of pain associated with diabetic peripheral neuropathy. J Pain Res. 2014 Jun 23;7:339-51. doi: 10.2147/JPR.S55682. eCollection 2014.
Clinical trial NCT00917618: The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
Official title: The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee
exercise
cycling
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: PNC Band arthritis research fund
name: Mad Dogg Athletics
First posted: 2009-06-10
Enrollment: 37
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis

Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.


Eligibility criteria: Inclusion Criteria:

* symptomatic and radiographic knee OA

Exclusion Criteria:

* severe patella femoral knee pain that would make cycling difficult
* medical condition which would prohibit an exercise program

Primary outcomes:
measure: Preferred gait speed
timeFrame: 12 weeks
Secondary outcomes:
measure: WOMAC
timeFrame: 12 weeks
measure: KOS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Mercy Hospital of Pittsbugh
state: Pennsylvania
Study officials:
affiliation: Mercy Hospital of Pittsburgh
name: Kelly Krohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salacinski AJ, Krohn K, Lewis SF, Holland ML, Ireland K, Marchetti G. The effects of group cycling on gait and pain-related disability in individuals with mild-to-moderate knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Dec;42(12):985-95. doi: 10.2519/jospt.2012.3813. Epub 2012 Aug 2.
Clinical trial NCT04994418: The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Official title: The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Inflammation
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to determine the impact of dietary sodium and fructose on blood pressure and inflammation in young healthy adults.

Detailed description: Excess dietary salt is associated with an increased risk of cardiovascular diseases. Some healthy adults have been determined to be more sensitive to dietary salt than others, which can result in a 10% or more increase of blood pressure. The mechanisms underlying salt sensitivity of blood pressure are not fully understood. Previous research has suggested excess intake of added sugars, especially fructose, can increase salt sensitivity of blood pressure. Chronic elevated consumption of salt and fructose independently have been shown to have damaging effects on the body, however, the combination of both salt and fructose has not been fully studied in humans. The purpose of this research study is to determine if increased dietary fructose consumption will stimulate salt-sensitive hypertension and induce proinflammatory cytokines through activation of the immune system. Understanding how the body regulates blood pressure during times of elevated salt and fructose is important for determining cardiovascular risk in a population with normal blood pressure.

Eligibility criteria: Inclusion Criteria:

* normal blood pressure
* males, females, minorities

Exclusion Criteria:

* high blood pressure
* body mass index (BMI) of \> 30 kg/m2
* smokers or nicotine users
* pregnancy

Primary outcomes:
measure: 24-hour Blood Pressure
timeFrame: Day 7 of diet intervention
measure: Inflammatory cytokines
timeFrame: Day 7 of diet intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Ronald K McMillan, M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: William B Farquhar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239018: Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
Official title: A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: De Novo Kidney Transplantation
Keywords: Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS


Eligibility criteria: Inclusion / Exclusion Criteria

- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

Primary outcomes:
measure: To assess glomerular filtration rate at month 3 post transplantation
Secondary outcomes:
measure: Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.
measure: Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.
measure: Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months
measure: Incidence of graft and patient survival within 6 and 12 months
measure: Safety and tolerability based on adverse event (AE) reporting.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04187118: Quality of Life in Lymphoma Patients One Year Post-chemotherapy
Official title: Quality of Life in Lymphoma Patients and Cancer Care Pathway One Year Post-chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Keywords: Lymphoma
Quality Of Life
Cancer Care Pathway
Post-Chemotherapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Force Hémato
name: Hospitalidee
First posted: 2019-12-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lymphoma

Brief summary: Malignant lymphomas are considered as among the most chemo-sensitive cancers. ML are cured in more than 85% of patient, the majority with complete response. After this active phase of treatment, patients are in "after cancer period". Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient. Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life. The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.

Detailed description: Quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy. Care cancer pathway will be also evaluated. Self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.

Eligibility criteria: Inclusion Criteria:

* Patients being in complete response after a first therapy for lymphoma
* Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation
* Patients informed of the study and not opposed to the research

Exclusion Criteria:

* Patients under legal guardian .
* Patients unavailable to formulate non-opposition to the study

Primary outcomes:
measure: Quality of life change: Quality of Life-C30 French version
timeFrame: Change from baseline quality of life at 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Loïc YSEBAERT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02651818: Changes in Quality of Life Following Surgical Treatment of Benign Non-toxic Goiter
Official title: The Impact of Surgical Treatment of Benign Non-toxic Goiter on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Goiter
Keywords: Goiter
Thyroid disease
Struma
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 104
Sex: ALL
Minimum age (years): 20
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: All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter

Brief summary: The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery.

All investigations follow already scheduled treatments.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
* The patients must be able to understand, read and write Danish

Exclusion Criteria:

* Previous surgery to the neck
* Diabetes or any neuromuscular disorders
* Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof

Primary outcomes:
measure: Change in quality of life following thyroidectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Christian Godballe, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06469918: The Co-Op @ HeartWorks
Official title: The Co-Op @ HeartWorks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Keywords: HLHS
congenital heart defect
CHD
Hypoplastic left heart syndrome
Lead sponsor: HeartWorks, Inc.
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human subjects with congenital heart disease

Brief summary: This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.


Eligibility criteria: Inclusion Criteria:

* Adult with a congenital heart defects/disease
* Caregiver of a minor with a congenital heart defect/disease
* Authorized family member of a now deceased person with congenital heart defect/disease

Exclusion Criteria:

- Not having a congenital heart defect/disease

Primary outcomes:
measure: Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: HeartWorks, Inc.
state: Minnesota
Study officials:
References: