louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05096156: Evaluation of Wear Experience With Daily Contact Lenses
Official title: Evaluation of Wear Experience With PRECISION1® Contact Lenses in Biofinity® Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.


Eligibility criteria: Inclusion Criteria:

* Currently wear Biofinity® monthly replacement spherical contact lenses.
* Distance visual acuity of 20/25 or better with current contact lenses.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Ability to give informed consent.
* Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.

Exclusion Criteria:

* No current ocular inflammation or infection.
* Not currently pregnant or lactating.

Primary outcomes:
measure: Subjective Assessment of Precision1® Daily Disposable Contact Lens
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References:
Clinical trial NCT02412956: SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging
Official title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Smoking Cessation
Keywords: mHealth
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 99
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Eligibility criteria: Inclusion Criteria:

1. pregnant,
2. smoke or quit in the past 2 weeks,
3. has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
4. an English speaker.

Exclusion Criteria:

1. not pregnant
2. not currently smoking (or within past 2 weeks)
3. not able to receive text messages
4. not an English speaker

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Hospital
state: District of Columbia
Study officials:
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. J Med Internet Res. 2017 Oct 3;19(10):e333. doi: 10.2196/jmir.8411.
Clinical trial NCT05100615: Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions
Official title: Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions in the Presence of Hydroxyapatite, Nanohydroxyapatite and Combination of Nanohydroxyapatite and Platelet-rich Fibrin. A Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of the Elements
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone


Eligibility criteria: Inclusion Criteria:

* The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.

Exclusion Criteria:

* Any systemic debilitating disease such as:

Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.

Primary outcomes:
measure: healing of periapical lesion
timeFrame: interappointment at 1 month, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amira mohammed fathy Elkholly
Study officials:
References:
Clinical trial NCT00642915: Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
Official title: A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy


Eligibility criteria: Inclusion Criteria:

* All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
* Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.

Primary outcomes:
measure: Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy
timeFrame: Hemoglobin A1c values were measured at Screening and at every visit thereafter.
Secondary outcomes:
measure: Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Tadaaki Karino
role: STUDY_DIRECTOR
References:
citation: Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4.
Clinical trial NCT04316715: Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
Official title: Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adherence, Medication
Keywords: Life-Steps
HIV Prevention
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-03-20
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years or older
2. Male sex at birth or trans man (current gender identity is male) assigned female sex at birth
3. Self-reports as a person who has sex with men
4. PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
5. Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
6. Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence
7. Owns a cell phone that has texting and internet / data capacity

Exclusion Criteria:

1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
2. Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved)
3. Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)

Primary outcomes:
measure: TFV-DP concentrations
timeFrame: 3, 6, 9, 12, 15, and 18 months
measure: Wilson Medication Adherence self-report
timeFrame: up to 18 months
Secondary outcomes:
measure: Retention in PrEP care
timeFrame: 3, 6, 9, 12, 15, and 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Steven A Safren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775515: Laparoscopic Prostatectomy for Chronic Prostatitis
Official title: Laparoscopic Prostatectomy for Chronic Prostatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostatitis
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: chronic
prostatitis
prostate
pain
pelvic
pelvis
inflamation
Lead sponsor: The Krongrad Institute
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 100
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching orgasm, and bleeding.

In many men the symptoms of prostatitis can be chronic. It is estimated that in the United States chronic prostatitis is responsible for as many as two million doctor visits a year. The disease can be ruinous, interfering with work, intimacy, and other things.

The causes of chronic prostatitis are not understood. The treatments commonly used, including antibiotics and prostate massage, work poorly. We now have evidence that laparoscopic prostatectomy can eliminate the misery of chronic prostatitis. This trial aims to quantify and better characterize the effect of laparoscopic prostatectomy on the symptoms of chronic prostatitis.


Eligibility criteria: Inclusion Criteria:

* Age 30 and greater
* NIH-CPSI score of 25 and higher
* Symptom duration of at least one year
* Failed treatment with antibiotics and/or other medications

Exclusion Criteria:

* Inability to tolerate Anesthesia
* Inability to speak any English

Primary outcomes:
measure: NHI CPSI (chronic prostatitis symptom index)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: The Krongrad Institute
state: Florida
Study officials:
affiliation: The Krongrad Institute
name: Arnon Krongrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krongrad A, Lai S: Laparoscopic Prostatectomy for Severely Symptomatic, Treatment-Refractory Chronic Prostatitis: Preliminary Observations from an Ongoing Phase II Clinical Trial. UroToday Int J. 2011 Apr;4(2) http://bit.ly/iLkwht
Clinical trial NCT05126615: Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)
Official title: Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mastectomy
Auriculotherapy
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.

The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.


Eligibility criteria: Inclusion Criteria:

* Women patient over 18 years-old
* Patient scheduled for a mastectomy with immediate reconstruction by latissimus dorsi flap with or without symmetrization on the contralateral breast.
* Patient affiliated or beneficiary of a social security scheme.
* Patient who has given her free and informed consent.
* Preoperative blood test showing no contraindication to the operation.

Exclusion Criteria:

* Refusal of the patient.
* No indication for auriculotherapy:
* Patient having a heavy treatment with neuroleptics,
* Or tricyclic antidepressants which interfere with the action of auriculotherapy.
* Patient undergoing long-term morphine treatment for chronic pain.
* Patient with unweaned opioid addiction.
* Chronic painful patient.
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
* Pregnant, breastfeeding or parturient woman.
* Patient participating in another interventional study.
* Patient who had already participated in this study as part of first breast surgery.
* Patient receiving regular care by auriculotherapy

Primary outcomes:
measure: Presence, or not, of Chronic Post-Surgical Pain (DCPC)
timeFrame: 3 months
measure: Presence, or not, of Chronic Post-Surgical Pain (DCPC)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Champigny-sur-Marne
country: France
facility: Hôpital Privé Paul d'Egine
Study officials:
References:
Clinical trial NCT01671215: Endometrial and Myometrial Changes, With and Without Fibroids
Official title: Endometrial and Myometrial Changes, With and Without Fibroids
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fibroids
Keywords: endometrium
myometrium
fibroids
uterine malformations
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women at the age of 20-45

Brief summary: fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium \& myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.

Detailed description: phase 1-

1. retrospective measurments of uterine dimensions of 100 women with normal uterin
2. measurment of the above during different sycle days in the same woman. 30 women.

phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations

Eligibility criteria: Inclusion Criteria:

* women at IVF unit

Exclusion Criteria:

* inabilty to measure propperly the uterine dimensions

Primary outcomes:
measure: ratio between normal & abnormal(by fibroid) uterine cavity
timeFrame: year
Secondary outcomes:
measure: ratio between endometriom & myometrium area, circumference &n volume
timeFrame: year
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: Tel Aviv University
name: ronni tepper, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02473315: Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Official title: Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylarthritis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition at a temperature of approximately -110 degrees.

A considerable increase in the popularity of WBC has occurred in rheumatologic patients, despite a lack of evidences of its efficiency.

Because of its interesting anti-inflammatory properties, the investigators think that WBC could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis.

This is a proof of concept study.


Eligibility criteria: Inclusion Criteria:

* patients suffering from axial spondyloarthritis diagnosed according to ASAS criteria, with sacroiliitis on X-rays or MRI, with active disease (BASDAI \> 4/10) despite a stable treatment will be included.

Exclusion Criteria:

* contra indication to cooling,
* previous WBC treatment,
* no social security cover

Primary outcomes:
measure: Whole body cryotherpy (WBC) efficacy assesment
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: ANNA DELLYES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405415: Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
Official title: Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Without Diabetes Mellitus
Assessment of Glucose Concentrations
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will perform blood glucose monitoring (BGM) over the course of 14 days and, in parallel, wear continuous glucose monitoring (CGM) systems. Because current CGM systems typically achieve a lower level of analytical accuracy than BGM systems, participants will perform at least 5 blood glucose (BG) measurements per day. In addition, CGM systems are used to obtain minimally-invasive high-frequency glucose measurements to fill the gaps between BG measurements.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Written informed consent
* Subject is legally competent and has the capacity to understand character, meaning and consequences of the study
* Subject is willing to refrain from intake of salicylic acid and ascorbic acid and medication and/or compounds containing these substances

Exclusion Criteria:

* Anamnestically known diabetes mellitus
* Severe acute or chronic disease with potential risk of being adversely affected by the study procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Pregnancy or lactation period
* Known severe skin reactions to adhesives
* Blood donation within the previous two months (according to the subject's statement)
* Language or other barriers potentially compromising an adequate compliance with study procedures

Primary outcomes:
measure: Assessment of glucose concentrations
timeFrame: 14 days per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
state: Baden-Württemberg
Study officials:
affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
name: Guido Freckmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freckmann G, Schauer S, Beltzer A, Waldenmaier D, Buck S, Baumstark A, Jendrike N, Link M, Zschornack E, Haug C, Pleus S. Continuous Glucose Profiles in Healthy People With Fixed Meal Times and Under Everyday Life Conditions. J Diabetes Sci Technol. 2024 Mar;18(2):407-413. doi: 10.1177/19322968221113341. Epub 2022 Jul 25.