louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01476865: Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients
Official title: Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Synovium, Multiple Sites
Disorders of Subchondral Bone, Multiple Sites
Disorders of Cartilage, Hand Joints
Arthritis, Rheumatoid
Healthy People
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-11-22
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)

Brief summary: The purpose of this study is to establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis.

Detailed description: Rheumatoid arthritis (RA) is a chronic inflammatory, systemic and auto-imune disorder affecting primarily the joints. In RA, inflammatory synovium causes destruction of cartilage, erosion of the adjacent bone and ultimately loss of function of the affected joint. Newer imaging techniques, such as ultrasound (US), have shown promise in evaluation of RA. Many US scoring system have been used to classify and quantify the synovium, effusion, erosion and cartilage for assessing and monitoring AR. However, its use is considered problematical because there are very few data on normal joints and, at this point, there is no clear definition of excess amount of synovium in normal people.

Eligibility criteria: Inclusion Criteria:

* no articular disease (healthy group)
* establish rheumatoid arthritis (RA group)

Exclusion Criteria:

* diabetes
* hypothyroidism- hemophilia
* pregnancy
* previous septic arthritis
* previous articular surgery
* symptomatic osteoarthritis
* no superimposed collagenoses (RA group)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, professor
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Rita NV Furtado, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Flávia S Machado, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04163965: Data Collection for Pacemaker Recognition Through Capacitive ECG
Official title: Data Collection for Pacemaker Recognition Through Capacitive ECG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker DDD
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the signal quality of capacitive ECG (cECG) on pacemaker patients and whether paced rhythms of the pacemaker can be distinguished from the normal beats using cECG signals.

Detailed description: In contrast to classical gold-standard ECG, cECG electrodes can sense the electrical activity of the heart even over the clothing of the subject, which allows several applications in out-of-hospital monitoring. The proposed scenarios for cECG revolve around the unobtrusiveness of the measurement with an inferior signal quality to gold standard ECG. The electrical spikes, that come into existence due to the paced rhythms given by a pacemaker, are only visible in ECG signals recorded by adequate medical instrumentation. Whether cECG can deliver enough signal quality to identify the electrical spikes of the paced rhythms needs to be investigated by recording simultaneous normal and capacitive ECG signals.

Eligibility criteria: Inclusion Criteria:

* Subject has an implanted pacemaker
* Subject is under ambulatory or stationary treatment in Uniklinik RWTH Aachen
* Subject gives his/her written consent
* Subject is legally and mentally competent to follow the instructions

Exclusion Criteria:

* Subject has other electrically active implants
* Cardiopulmonary or hemodynamically unstable subjects
* Subject is placed in a judicial institution
* Subject is in a dependency or employment relationship with the examiner
* Subject is legally or mentally unable to give consent for the participation

Primary outcomes:
measure: Sensitivity and Specificity of Paced Rhythm Identification
timeFrame: up to 10 weeks after the data collection is completed for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
Study officials:
References:
Clinical trial NCT00470665: Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients
Official title: An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Allograft Recipients
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-08
Enrollment: 460
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.


Eligibility criteria: Inclusion criteria:

* Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
* Age \>= 13 years, weight \>= 40 kg
* Women must have a negative pregnancy test at study entry

Exclusion criteria

* Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
* Active systemic infection, or localized major infection or known HIV
* Patients with residual kidney function \>20 mL/min

Primary outcomes:
measure: First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.
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: Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF; Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation. 2008 Nov 15;86(9):1187-95. doi: 10.1097/TP.0b013e318187bab0.
Clinical trial NCT01721265: 3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
Official title: 3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Keywords: HCV
Hepatitis C
IDX184
IDX719
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include subjects who participated in studies of Idenix anti-HCV DAAs.

Brief summary: All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.

In this study, researchers will try to find answers to these questions:

* How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
* Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?

Detailed description: The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.

Eligibility criteria: Inclusion Criteria:

* Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
* Have participated in an Idenix-sponsored study of an Idenix DAA
* Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
* Agreed to comply with the visit schedule and laboratory tests

Exclusion Criteria:

* Treatment with placebo only, in an Idenix sponsored study
* Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA

Primary outcomes:
measure: Durability of Sustained viral response [SVR]
timeFrame: every 3 months
Secondary outcomes:
measure: Kinetics of resistant variants
timeFrame: every 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04141865: Effect of Xen Implantation on the Aqueous Humor Proteome
Official title: Effect of Xen Implantation on the Aqueous Humor Proteome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
First posted: 2019-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with open angle glaucoma treated with a glaucoma drainage device.

Brief summary: The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.

Detailed description: The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Male or female of any racial or ethnic origin, 18 years or older
* Able to provide written informed consent.
* Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt

Exclusion Criteria:

* History of conjunctivitis or any ocular infection within the past 3 weeks.
* Any active inflammation of the cornea or the anterior chamber (uveitis)

Primary outcomes:
measure: Aqueous humor proteome
timeFrame: Change from baseline at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis Price, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04960865: Kinesio Taping and Calf Muscle Fatigue
Official title: Effects of Kinesio Taping on Calf Muscle Fatigue in Collegiate Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Calf Muscle
Kinesio tape
Muscle fatigue
Heel raises
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm parallel group
Primary purpose: PREVENTION

Brief summary: Muscle fatigue results in decreased ability in muscles to generate force. Kinesio Tape may reverse the adverse effects of fatigue. Thus this study will examine the acute effects of Kinesio tape on muscle fatigue.

Detailed description: The participants will be divided into three groups; 1. Experimental group: Kinesio tape with 50% tension will be applied; 2. Sham group: Kinesio tape without any tension will be applied; 3. Placebo group: Rigid tape without any tension will be applied.

Eligibility criteria: Inclusion Criteria:

* Healthy cooperative individuals.
* Female athletes who were engaged in training at least 3 times a week.
* The subject should perform a minimum of 23 hell raises.

Exclusion Criteria:

* Musculoskeletal injuries, cardio-pulmonary vestibular and neurological complication and systemic disorder.
* Consumption of any pre-workout supplement in the last 6 months.
* Involvement in any other training program.

Primary outcomes:
measure: Number of heel raises
timeFrame: 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rana A, Tyagi D, Alghadir AH, Khan M. Effects of Kinesio taping on calf muscle fatigue in college female athletes: A randomized controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31004. doi: 10.1097/MD.0000000000031004.
Clinical trial NCT05968365: Evaluate the Safety and Effectiveness of Electronic Vision-aid Device
Official title: Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Blind
Lead sponsor: Wicab Technologies (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The clinical trial was a prospective, single-group, uncontrolled design using the target value method

Three centers participated

A total of 36 patients were enrolled. It was developed and produced by Weikan Technology in subjects who agreed to be enrolled

The "Vision Pro" is trained, and after no less than 3 hours of training, the subject is good at it

Evaluate the safety and effectiveness of obstacle perception and recognition in the process of walking, and evaluate the test product in auxiliary sight

Safety and effectiveness of obstacle perception and recognition for disabled walkers.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 (including 18 and 65 years old)；
2. Visually impaired people；
3. Primary blind and visually impaired people
4. visual acuity is no light \~ \< 0.02；
5. visual field radius less than 5°);

Exclusion Criteria:

1. . Allergic to nickel or stainless steel;
2. epileptic seizures;
3. pregnant women； 4.、implanted with electronic medical devices ；

5、 intellectual disability ； 6、 mental illness; 7、 Oral diseases； 8、oral ulcers, herpes, herpes simplex, oral thrush and map tongue； 9、 speech dysfunction, 10、limited mobility and hearing impairment;

Primary outcomes:
measure: obstacle identification
timeFrame: 40 minutes
Secondary outcomes:
measure: obstacle avoidance test
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tongren Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00587665: Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
Official title: A Prospective Study of Low Dose Ketamine as an Adjunct to Fentanyl in Pediatric Patients Following Outpatient Tonsillectomy and Adenoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 122
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy


Eligibility criteria: Inclusion Criteria:between 3 and 12 years of age

* ASA 1 or 2

Exclusion Criteria:

* did not consent

Primary outcomes:
measure: amount of post op narcotic use
timeFrame: 5 days
Secondary outcomes:
measure: degree of nausea and vomiting
timeFrame: 5 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Gregory Schears, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01318265: Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
Official title: A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: drug interactions
ketoconazole
pharmacokinetics
human volunteers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between 18 and 45 years of age, inclusive
* BMI between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

* Subjects with evidence of disease, conditions affecting drug absorption or metabolism
* Treatment with other investigational drug within 30 days
* History of regular alcohol or recreational drug consumption
* Use of prescription drugs within 14 days
* Use of nonprescription drugs and dietary supplement within 7 days
* Blood donation within 30 days

Primary outcomes:
measure: Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.
timeFrame: 1 month
measure: Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
timeFrame: 1 month
Secondary outcomes:
measure: Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
timeFrame: 1 month
measure: Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
timeFrame: 1 month
measure: Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.
timeFrame: 1 month
Other outcomes:
Locations:
city: Brighton
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00585065: CRT Pilot Study for Children With Heart Failure
Official title: Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pediatric Heart Failure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.


Eligibility criteria: Inclusion Criteria:

1. Chronic and severe heart failure, NYHA class III or IV
2. Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
3. Chronic systemic ventricular dysfunction as defined in the protocol.
4. Intra ventricular conduction delay defined by spontaneous QRS duration \> ULN for age.
5. All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
6. Signed and dated informed consent.
7. Able to receive pectoral or abdominal implant.

Exclusion criteria:

1. Suspected acute myocarditis.
2. Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
3. Acute coronary syndrome.
4. Adolescents who are pregnant.
5. Patient with BVP device implanted previously.
6. Patient has had prior/past heart transplantation.

Primary outcomes:
measure: Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
timeFrame: Within 30 days of CRT implant to 12 months post implant
measure: Collection of survival information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
timeFrame: Within 30 days of CRT implant to 12 months post implant
Secondary outcomes:
measure: Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines
timeFrame: Within 30 days of CRT implant to 12 months post implant
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Elizabeth Saarel, MD
role: PRINCIPAL_INVESTIGATOR
References: