louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02304952: Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
Official title: Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tennis Elbow
Keywords: Lateral epicondylalgia
Pain
Function
Physiotherapy
Quality of Life
Lead sponsor: Capio Sankt Görans Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.

Detailed description: Of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. In this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. Patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. Home based eccentric exercise program is instructed by a physical therapist and is performed for three months. Women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. Function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. The surgery and eccentric exercise is instructed and followed at the investigators clinic.

Eligibility criteria: Inclusion Criteria:

* over the age of 18 and under the age of 70 year
* lateral epicondylalgia at least two year
* tried conservative treatment

Exclusion Criteria:

* complicated systemic diseases (such as diabetes)
* understand spoken and or/written instructions in Swedish

Primary outcomes:
measure: Function.
timeFrame: 12 month
measure: Pain.
timeFrame: 12 month
Secondary outcomes:
measure: Quality of life.
timeFrame: 12 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio Sankt Göran Hospital
Study officials:
affiliation: Karolinska Institutet
name: Annette Heijne, PT, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05233852: Gender Bias in the Overuse Studies Conducting in Primary Care
Official title: A Framework to Analyze Gender Bias in the Overuse Studies Conducting in Primary Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Severe Adverse Event
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
First posted: 2022-02-10
Enrollment: 1538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults attending primary care consultation from 1 January 2017 to 31 December 2019.

Brief summary: The purpose of this study is to analyze whether the differences between men and women in the frequency of adverse events due to ignoring "Do not do" recommendations in primary care setting are due to biological causes or gender bias.

Detailed description: First, using the Delphi technique, a consensus will be reached on those "Do Not Do" recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the "Do not do" recommendation could cause a serious adverse event. Second, a retrospective cohort study will be carried out in which a random selection of medical records will be reviewed to identify the frequency of adverse events due to ignoring the "Do not do" recommendations previously selected by consensus. Investigators will review a total of 1538 medical records of patients (50% of women) who attended primary care consultation from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia, named ABUCASIS. Adverse events will be identified by using an activation tool used in a previous study (SOBRINA study).

Eligibility criteria: Inclusion Criteria:

* Attending primary care consultation from 1 January 2017 to 31 December 2019.
* Adult

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of severe adverse events
timeFrame: From date of prescription until the date of first documented severe adverse event or date of death from any cause, whichever came first, assessed up to 12 months
measure: Number of female patients who were recommended "do not do"
timeFrame: From 1st January 2022 to 31 December 2022
measure: Number of male patients who were recommended "do not do"
timeFrame: From 1st January 2022 to 31 December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Miguel Hernández University
state: Alicante
Study officials:
References:
Clinical trial NCT01687452: Microparticles, Vector of Genetic Information During HIV Infection
Official title: Microparticles, Vector of Genetic Information During HIV Infection ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV,
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 15
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with HIV, the presence of miRNAs in circulating peripheral blood microparticles (MPs).


Eligibility criteria: Inclusion Criteria:

* Age of 40 +/-10 years
* Seronegativity for the HIV 2
* Patients of the group A: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and having never received from antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml
* Patients of the group B: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and under stable antiretroviral treatment for at least 6 months, with a viral load undetectable plasmatique (\< 40 copies / ml)
* patients of the group C : Matching on the age (+/-3 years) to a patient
* Be considered healthy by the Investigator after a clinical examination Seronegativity for the HIV 1 confirmed in ELISA the day of the taking

Exclusion Criteria:

group A et B

* Age of \< 30 years and \> in 50 years
* Seropositivity for the HIV 2

group C Seropositivity for the HIV 2

- Be under medicinal treatment

Primary outcomes:
measure: NUMBER OF miRNAs
timeFrame: 2 YEARS
Secondary outcomes:
measure: Demonstrate the presence of miRNAs in microparticles
timeFrame: 2 YEARS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
Clinical trial NCT04882800: Evaluation of Extended Wear Technology
Official title: Evaluation of Fitting Modification for Extended Wear Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
Primary purpose: OTHER

Brief summary: Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.

Detailed description: A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.

Eligibility criteria: Inclusion Criteria:

* Mild, Moderate and Moderate Severe Hearing loss
* Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues

Exclusion Criteria:

* Participants who can only wear a size XXS (extra-extra small) extended wear device
* asymmetrical hearing loss
* other diagnosis that may cause hearing fluctuation
* inability to tolerate physical fit of Lyric devices
* inability to be seen for four lab visits

Primary outcomes:
measure: Subjective Questionnaire of Comfort
timeFrame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
measure: Subjective Ratings of Occlusion With Both Devices
timeFrame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Secondary outcomes:
Other outcomes:
Locations:
city: Narberth
country: United States
facility: Main Line Audiology Consultants
state: Pennsylvania
Study officials:
affiliation: Sonova AG
name: Kevin Seitz-Paquette, AuD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261000: Tissue Biomarker for Pegvisomant Action
Official title: Tissue Biomarker for Pegvisomant Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (\>1.3 X ULN), and inadequate GH suppression (\>0.4 ng/mL) following OGTT
* Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
* Normal LFTs before treatment
* Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement

Exclusion Criteria:

* Treatment with a long-acting SRL within 12 weeks before enrollment
* Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
* Clinically significant hepatic abnormalities and/or AST or ALT \>3 X ULN on screening
* Known hypersensitivity to any of the test materials or related compounds
* History of, or known current, problems with alcohol or drug abuse
* Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude

Primary outcomes:
measure: Effect of Pegvisomant on Colon Tissue p53 Expression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Shlomo Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chesnokova V, Zonis S, Zhou C, Recouvreux MV, Ben-Shlomo A, Araki T, Barrett R, Workman M, Wawrowsky K, Ljubimov VA, Uhart M, Melmed S. Growth hormone is permissive for neoplastic colon growth. Proc Natl Acad Sci U S A. 2016 Jun 7;113(23):E3250-9. doi: 10.1073/pnas.1600561113. Epub 2016 May 25.
Clinical trial NCT04815200: Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding
Official title: Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire
Primary purpose: TREATMENT

Brief summary: Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment in comparison to Conventional Nickel Titanium arch wire (NiTi) by Measuring the amount and rate of alignment achieved every 2 weeks for a period of 2 months.

.

Detailed description: Leveling and alignment is the first stage in fixed orthodontic treatment, performed for every patient. Copper nickel titanium (CuNiTi) was modified from conventional nickel titanium (NiTi) to stabilize the super elasticity properties of the initial nickel titanium (NiTi) arch wire against cyclic deformation. The addition of copper to traditional nickel titanium enhances thermal reactive properties and consistency of forces.so the aim of the study is to Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged (18\~33).
2. Moderate crowding (4-8)10.
3. No extractions required.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Missing teeth other than the wisdoms.
3. Patient with dental anomalies.
4. Patient having a deep bite, open bite or cross bite.

Primary outcomes:
measure: Rate of alignment.
timeFrame: 8 weeks
Secondary outcomes:
measure: inter-canine arch perimeter width
timeFrame: 8 weeks
measure: pain assessed by NRS
timeFrame: first 24 hours
measure: inter-molar arch perimeter width.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo University
state: Manial
Study officials:
References:
Clinical trial NCT00956800: Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
Official title: Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Columbus Research Foundation
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.

Detailed description: This will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accuchek 360 software. All will be capable of independent care of their diabetes. All patients will be 19-65 years of age. The end-points will include similar changes in hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care.

There will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* 19-65 years of age
* Type 1 and 2 diabetes
* Computer literate
* Independent care of diabetes
* Insulin pump allowed (Spirit pump only)
* Females on birth control
* Can demonstrate competency in the use of the Accuchek Aviva meter, reliability in doing regular home blood sugar determinations

Exclusion Criteria:

* Creatinine clearance \< 30 cc/min
* Severe loss of vision (diabetic retinopathy)
* Severe diabetic neuropathy
* Known or suspected diabetic gastroparesis
* Patients with heart disease
* Patients with liver disease
* Drug or substantial alcohol use
* Use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure
* Females that are pregnant or are capable of becoming pregnant
* Insulin pump use other than Accucheck Spirit pump

Primary outcomes:
measure: Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Research Foundation
state: Georgia
Study officials:
affiliation: Endocrine Consultants
name: Steven B Leichter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00065052: Modifying the Home Television Watching Environment
Official title: Modifying the Home Television Watching Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Body Weight Changes
Keywords: physical activity
television
child obesity
Reduce TV
Usual control
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if limiting television (TV) and computer time will result in a stabilization or smaller increase in body mass index (BMI), lower energy intake, and increased physical activity in 4-7 year old obese (\>85th BMI percentile) children over two years.

Detailed description: There is a positive correlation between obesity and television watching in adults and children. And, television watching, controlling for current obesity, is a predictor of future obesity. Almost half of all children watch 3 or more hours of television each day. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours each day.

Families will be randomized to one of two conditions. Half the families will be taught to use the TV Allowance to reduce their child's TV and computer use by one-half over a six month period and the other half will use the device to monitor TV watching (control group). This study uses TV Allowance units to monitor home television watching, video game playing, and computer use. The TV Allowance can also be used to limit the amount of TV and computer use by programming it to allow a specific number of hours for each family member. Heights, weights, food intake, and physical activity will be measured at baseline and every six months. The purpose of this study is to determine if limiting television and computer time will result in a stabilization or smaller increase in BMI, lower energy intake, and increased physical activity in 4-7 year old obese (\>85th BMI percentile) children over two years.

Eligibility criteria: * Greater than the 85th BMI percentile
* Minimum of 15 hours of TV watching, computer use, and video game playing per week
* No medical conditions that may affect the child's ability to safely participate in physical activity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: State Universtiy of New York at Buffalo, Department of Pediatrics
name: Leonard H. Epstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein LH, Roemmich JN, Robinson JL, Paluch RA, Winiewicz DD, Fuerch JH, Robinson TN. A randomized trial of the effects of reducing television viewing and computer use on body mass index in young children. Arch Pediatr Adolesc Med. 2008 Mar;162(3):239-45. doi: 10.1001/archpediatrics.2007.45.