louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02788617: Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
Official title: A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 100
Sex: FEMALE
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: Female outpatients involved in an assisted reproduction procedure.

Brief summary: This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent before initiation of any study procedures
* Be a female outpatient, ≥ 18 years of age at the time of informed consent
* Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
* Eligible to allow embryos to develop through day 5 before implantation or freezing

Exclusion Criteria:

* Presence of ovarian endometriotic cyst
* Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
* Need for pre-implantation genetic diagnosis/screening of embryos
* Use of time-lapse embryo imaging
* Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center

Primary outcomes:
measure: Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Huntington Reproductive Center
state: California
city: Clearwater
country: United States
facility: Women's Medical Research Group
state: Florida
city: Hoffman Estates
country: United States
facility: InVia Fertility Specialists
state: Illinois
city: Cincinnati
country: United States
facility: Institute for Reproductive Health
state: Ohio
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas - Fort Worth Fertility Associates
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Pleasant Grove
country: United States
facility: Utah Fertiity Center
state: Utah
city: Sandy City
country: United States
facility: Reproductive Care Center
state: Utah
Study officials:
affiliation: Allergan
name: Fabian Somers, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06322641: A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists
Official title: FLAME-ASCVD-Nephro A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
Systemic Inflammation
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nephrologist with ASCVD and CKD patients

Brief summary: The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD)


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Is a Nephrologist.
* Has been in practice greater than or equal to 3 years.
* Sees at least 20 patients with ASCVD and CKD per month.
* Treats patients for more than only dialysis

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Does not meet inclusion criteria requirements

Primary outcomes:
measure: Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD
timeFrame: At the time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: KJT Group, Inc.
state: New York
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
Clinical trial NCT03549741: Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility
Official title: Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Infertility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse


Eligibility criteria: Inclusion Criteria:

* unexplained infertility, Primary or secondary.
* Absence of galactorrhoea.
* Normal serum prolactin.
* Normal hysterosalpingography.
* Normal spermogram.

Exclusion Criteria:

* Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
* Known hypersensitivity for cabergoline or clomiphene citrate.
* Other factors of infertility as tubal factor, uterine factor or male factor.

Primary outcomes:
measure: The number of mature follicles
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01330641: Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
Official title: Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendonitis
Keywords: Tendonitis
Rotator Cuff
Shoulder
Injection
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 75
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: This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.

Detailed description: Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.

Eligibility criteria: Inclusion Criteria:

* rotator cuff tendinitis

Exclusion Criteria:

* diabetes
* allergy to contrast dye
* renal disease
* pregnancy
* frozen shoulder

Primary outcomes:
measure: Radiographic e Radiographic Evidence of Successful Subacromial Injection
timeFrame: One-hour post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Department of Orthopaedic Surgery
state: California
Study officials:
affiliation: University of California, Davis
name: Richard A Marder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733641: Test-Retest Reliability in DETECT
Official title: Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Reliability Properties of a Concussion Screening Tool
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteer athletes without concussion

Brief summary: Healthy volunteers without concussion, currently participating in non-or-limited contact sports teams at Emory University will undergo Display Enhanced Testing for Concussion and mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and day 90. Prior to enrollment participants will be allocated to the test-retest arm or the exercise arm.


Eligibility criteria: Inclusion Criteria:

* age \> or = 16
* eligible for active participation during the National Collegiate Athletic Association (NCAA) season or member of the 2011 - 2012 or 2012-2013 club team
* Participation in a non or minimal contact sport

Exclusion Criteria:

* \< age 16
* history of concussion in the previous 6 months
* any of the following: learning disabilities, attention deficient disorder, attention deficit hyperactivity disorder, depression or other psychiatric disorder, sleep apnea, seizure disorder, migraine headaches, previous central nervous system (CNS) surgery
* chronic drug or alcohol use; or drug or alcohol use with the previous 24 hours
* inability to complete the study protocol (90 days)

Primary outcomes:
measure: Primary Objective is to assess the reliability of the DETECT cognitive assessment tool, as measured by changes in DETECT scores from baseline in non-injured athletes.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT00012441: Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis
Official title: Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: Renal Dialysis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-03-08
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. Several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. Whether this form of treatment can be expanded to the 220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If the pilot study is effective, then participation in a larger, multicenter trial is expected. The endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys, and improvement in physical function as measured by maximal oxygen uptake.


Eligibility criteria: Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT01526941: Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
Official title: A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 27
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: This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
* BMI (Body Mass Index) maximum 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg/day
* Currently being treated with insulin aspart products
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* Cardiac problems
* Severe, uncontrolled hypertension

Primary outcomes:
measure: Steady state area under the glucose infusion rate profile, 6-12 hours
Secondary outcomes:
measure: GIRmax, the maximal glucose infusion rate value
measure: tmax, time to maximum glucose infusion rate value
measure: area under the glucose infusion rate profile
measure: Time to 50% of area under the glucose infusion rate profile, 0-12 hours
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: Area under the curve
measure: t½, terminal half-life
measure: Adverse events
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852.
Clinical trial NCT03205241: Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
Official title: Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance or Oxidative and Inflammatory Parameters in Healthy Male Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Inflammation
Keywords: Exercise
Fish Oil
Cycling
Inflammation
Oxidative stress
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University of Worcester
First posted: 2017-07-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, placebo-controlled, double blind, crossover design study
Primary purpose: BASIC_SCIENCE

Brief summary: Research Plan

Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout between supplementation periods. During the performance trials blood, expired air and heart rate were collected. The blood samples have been used to investigate the production of inflammation resulting from the cycling performance test. Inflammation has been assessed using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work done from the cycling performance will be analysed to investigate whether there is a relationship with power and inflammation and whether this is modulated by fish oil supplementation.

Specific Aims

1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.
2. Is a modulation of the inflammatory response connected to cycling performance.

Hypotheses

1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response
2. A reduction in inflammation will improve cycling performance

Anticipated Outcomes

A high level of cycling performance, indicated by a high average power, will be associated with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of inflammation and consequently cycling performance will be improved.


Eligibility criteria: Inclusion Criteria:

* recreationally trained male cyclists

Exclusion Criteria:

* History of coagulation/bleeding disorder
* History of metabolic disease
* Serious allergy
* History of heart disease
* Regular use of anti-inflammatory drugs
* Vitamin or fish oil supplementation over the past 6 months
* Known to have blood-borne virus
* Females

Primary outcomes:
measure: Work Done
timeFrame: 15 minutes during time trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loughborough University
name: Lynsey S Wilson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01215617: The Effect of Aerobic Interval Training on Obstructive Sleep Apnea
Official title: The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Randomized controlled study
Exercise training
Lung function
Heart function
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.

Detailed description: Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients. Sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. Lack of exercise is associated with OSAS severity, independent of body mass. Participation and motivation to exercise is low in OSAS patients, with less that one third of the patients reporting regular exercise routines. We aim to investigate if aerobic interval training improves OSAS in obese subjects.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 kg/M2
* Apne - hypopnea index (AHI) \> 10
* No significant comorbidities
* Abel to exercise

Exclusion Criteria:

* Inability to exercise due to musculoskeletal conditions
* Known ischemic cardiovascular disease
* Drug abuse
* Mental illnesses

Primary outcomes:
measure: Apnea-hypopnea index change
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Sleep quality
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Karlsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
Clinical trial NCT00543517: Study A - MK0767 Monotherapy Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
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 test if MK0767 lowers blood glucose after 20 weeks compared to placebo.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes
* Non-pregnant females and patients who agree not to become pregnant during the study

Exclusion Criteria:

* Patients with Type 1 Diabetes
* Patients who have been treated with insulin or other antihyperglycemic agents
* Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: