louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04122248: M6-C Post Approval Study (PAS)
Official title: M6-C Artificial Cervical Disc IDE Post Approval Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Long Term Follow-up
Lead sponsor: Spinal Kinetics
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects eligible for study enrollment will include subjects implanted in the M6-C™ IDE pivotal study

Brief summary: The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

Detailed description: A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.

Eligibility criteria: Inclusion Criteria:

* Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria

Exclusion Criteria:

* Subjects who were withdrawn or withdrew consent to participate in the investigation
* Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
* Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS

Primary outcomes:
measure: Overall subject success
timeFrame: 10 year follow-up
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: annually to 10 years
measure: Neck and arm pain
timeFrame: annually to 10 years
measure: SF-36 Health Survey
timeFrame: annually to 10 years
measure: Patient Satisfaction
timeFrame: annually to 10 years
measure: Odom's Criteria
timeFrame: annually to 10 years
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Spinal Kinetics, LLC
state: California
Study officials:
References:
Clinical trial NCT01908348: Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
Official title: Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Erythritol
Endothelial function
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2013-07-25
Enrollment: 27
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.


Eligibility criteria: Inclusion Criteria:

* Male and Female subjects
* Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose \>125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.

Exclusion Criteria:

* Women with a positive urine pregnancy test
* Body mass index \>35 kg/m2
* Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
* Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
* Treatment with an investigational drug within the last twelve weeks
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
* Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
* Ongoing illicit drug use or alcohol abuse.
* Sensitivity/intolerance to dietary polyols.

Primary outcomes:
measure: Endothelial function
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Naomi M Hamburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06743048: A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique
Official title: Tissue Sparing Laser Assisted Penile Prosthesis Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Erectile Dysfunction Due to Arterial Disease
Erectile Dysfunction Due to Arterial Insufficiency
Erectile Dysfunction Due to Venous Disorder
Erectile Dysfunction Due to Neuropathy
Erectile Dysfunction Following Radical Prostatectomy
Keywords: Cavernosal tissue sparing laser assisted implantation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 7
Sex: MALE
Minimum age (years): 21
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A surgical technique using laser assisted penile prosthesis implantation

Detailed description: A surgical technique using deep-red laser diode for visualization of the implantation track of the penile implant or Holium Laser for clearing the track whenever it is obstructed by fibrotic tissue.

Eligibility criteria: Inclusion Criteria:

* Men with ED not responding to medical treatment

Exclusion Criteria:

* Men with HBA1c more than 10

Primary outcomes:
measure: Successful Penile prosthesis implantation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Nada Hospital
Study officials:
References:
citation: Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.
Clinical trial NCT05901948: Pre-Surgical Grading System of Asherman Syndrome
Official title: Asherman Syndrome: Pre-surgical Grading to Improve Gauge Prognostic Values and Improve Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asherman Syndrome
Keywords: Asherman Syndrome
Hysteroscopy
Intra-Uterine Surgery
Intra-Uterine Adhesions
Classification
Lead sponsor: Ebtesama Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)

Brief summary: Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.

Detailed description: Using the grading system, patients are classified into Mild, Moderate and Severe Asherman Syndrome. With the mild disease having the best prognostic value and a 1 step procedure, Moderate cases having a mediocre prognosis and usually multi-step procedure and Severe cases having a poor prognosis and counseled to other options. This observational study looks at the surgical outcomes following hysteroscopy for cases graded according to the new system to identify the accuracy of the classification in predicting the surgical success and prognostic value.

Eligibility criteria: Inclusion Criteria:

* Asherman Syndrome
* intra-uterine synechiae

Exclusion Criteria:

* patients with a fundectomy or uterine reduction surgery.

Primary outcomes:
measure: Percentage Resumption of normal cavity on hystero-salpingography
timeFrame: 1 month
Secondary outcomes:
measure: Menses
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebtesama Hospital
Study officials:
affiliation: Cairo University
name: Osama Shawki, MD
role: STUDY_CHAIR
References:
citation: Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.
citation: Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.
citation: Di Guardo F, Della Corte L, Vilos GA, Carugno J, Torok P, Giampaolino P, Manchanda R, Vitale SG. Evaluation and treatment of infertile women with Asherman syndrome: an updated review focusing on the role of hysteroscopy. Reprod Biomed Online. 2020 Jul;41(1):55-61. doi: 10.1016/j.rbmo.2020.03.021. Epub 2020 Apr 28.
Clinical trial NCT00367848: Efficacy of Ultrasound in Evaluating Occult Fractures
Official title: The Efficacy of Ultrasound in Evaluating Fractures in the Ankle and Foot in Children When the X-Ray Does Not Demonstrate Fractures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Occult
Keywords: suspected fractures in the ankle and wrist
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-23
Enrollment: 50
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.


Eligibility criteria: Inclusion Criteria:

* boys and girls aged \<=15 years
* suspected fracture of the wrist or ankle (no later than one week after the injury)
* negative or inconclusive x-ray

Exclusion Criteria:

* unwillingness to sign informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Naum Simanovski, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Natalia Simanovski, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01718548: The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Fitness
Executive Function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.


Eligibility criteria: Inclusion Criteria:

* Physical education students

Exclusion Criteria:

* All others

Primary outcomes:
measure: Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
measure: Effect of CS and Lingzhi on Cognitive Functioning
timeFrame: 28 days
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
Clinical trial NCT02785848: Identifying Barriers and Strategies to Support Self-efficacy for Medication Adherence With Text Messaging
Official title: Identifying Patient-centered Barriers and Preferred Strategies to Support Self-efficacy for Medication Adherence With Two-way Text Messaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sickle Cell Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will assess barriers to self-efficacy and medication adherence in the adolescents and adults with sickle cell disease (SCD), asthma, or both, who take daily medications such as hydroxyurea, asthma, or both, have access to mobile phones and/or computers and receive care at the VUMC/Matthew Walker clinic.

Brief summary: The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.


Eligibility criteria: Inclusion Criteria:

1. Receiving care at the VUMC/Matthew Walker clinic
2. Diagnosed with SCD, asthma, or both
3. Currently taking daily medications for SCD, such as hydroxyurea, asthma, or both
4. Having access to a mobile telephone and/or computer
5. Age 12-70 years

Exclusion Criteria:

1. Unable to perform interviews or surveys

Primary outcomes:
measure: Number of patients with barriers to medication adherence
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients that prefer a tailored text messaging technological solution
timeFrame: 1 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Robert Cronin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03192748: A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World
Official title: A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eczema
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2017-06-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim population for observation is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Brief summary: The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Detailed description: In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in clinical real world, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Eligibility criteria: Inclusion Criteria:

Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Exclusion Criteria:

none

Primary outcomes:
measure: Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using runzaozhiyang capsule around two weeks later?
timeFrame: After using runzaozhiyang capsule around two weeks later.
Secondary outcomes:
measure: Is there any abnormality in renal function test index（Bun、Cr） after medication?
timeFrame: After using runzaozhiyang capsule around two weeks later.
measure: Is there any abnormality in ECG after medication?
timeFrame: After using runzaozhiyang capsule around two weeks later.
measure: Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）？
timeFrame: During using runzaozhiyang capsule around two weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773548: Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism
Official title: Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current project involves the application of a VR job training software. We propose to use an interactive VR job interview practice system, Virtual Reality Job Interview Training (VR-JIT), in youths with ASD at the highschool level. This system was developed to bolster job interview practice skills and to help reduce anxiety in adults with ASD. However, it has never before been used in individuals under the age of 18. Our hope is that if this program is utilized in individuals while they are still in highschool, we can target those persons before the window for which risk of unemployment appears to be highest for ASD youths, immediately after high school graduation.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 13 and 18
* Have a diagnosis of ASD or a typically developing child
* Be able to speak and read English fluently

Exclusion Criteria:

* I had a stroke, TBI, or neurologic injury or disease in the past
* I have a history of significant psychiatric illness (like bipolar, schizophrenia, or psychosis)
* I have uncontrolled seizures or other unstable medical complications

Primary outcomes:
measure: Change in mock job interview
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT03054948: SMOFLipid in Patients Who Are Intralipid Intolerant
Official title: Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Home Parenteral Nutrition
Short Bowel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 0
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: Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
* infusion company is able to provide SMOFlipid
* no history of alcohol addiction
* noted to be intolerant to SO based IVFE as defined below.

Exclusion Criteria:

* Pregnant women
* failure to provide consent
* patients who are deemed to be on HPN for less than three months
* patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.

Primary outcomes:
measure: AST
timeFrame: 3-12 months
measure: Glucose
timeFrame: 3-12 months
measure: Triglycerides
timeFrame: 3-12 months
measure: ALT
timeFrame: 3-12 months
measure: Total bilirubin
timeFrame: 3-12 months
measure: CRP
timeFrame: 3-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet S Mundi
role: PRINCIPAL_INVESTIGATOR
References: