louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00678444: Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching
Official title: Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Satisfaction
Incomplete bladder emptying
Clean Intermittent Self-catheterization
Prolapse/incontinence surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (CISC) by means of an instructional video and those who do not receive specific preoperative instruction in CISC, other than basic informed consent regarding risks of postoperative urinary retention.


Eligibility criteria: Inclusion Criteria:

* Enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the DIvision of Urogynecology, Department of Obstetrics and Gynecology at Magee Womens Hospital.

Exclusion Criteria:

* Subjects who have performed CISC in the past will be excluded.
* Subjects whose score on the MMSE reflects dementia (\<24) will be excluded.
* Subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded.
* Subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.

Primary outcomes:
measure: State-Trait Anxiety Inventory-State Scores
timeFrame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively
Secondary outcomes:
measure: Patient Satisfaction Scores - Visual Analogue Scores (VAS).
timeFrame: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jerry L Lowder, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04505644: Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section
Official title: Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Cesarean Section? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled study
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.

Detailed description: The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale . There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.

Eligibility criteria: Inclusion Criteria:

* Female
* Primary or secondary cesarean delivery
* Able to consent to research study

Exclusion Criteria:

* 3 or more prior cesarean deliveries
* History of abdominoplasty
* History of abdominal hernia repair with mesh
* Allergy to lidocaine
* Allergy to adhesives in medical tape
* Women who received general anesthesia for their cesarean delivery
* Women with active substance abuse
* Women methadone or suboxone for a history of opiate abuse

Primary outcomes:
measure: Total dose of opioids received in the first 24 hours following Cesarean
timeFrame: 24 hours
measure: Post-operative pain score at 24 hours post-operatively
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of complications of lidocaine use
timeFrame: 72 hours
measure: Return of bowel function
timeFrame: 72 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT03405844: A Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers
Official title: The Effectiveness of a Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers After Competition: A Quasi-experimental Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Injury
Keywords: Shoulder
glenohumeral
stretching
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Swimmers from the winter national trials who competed at state, national or international level, performed at least five swim sessions per week and intended to continue this training level during the following 24 months were eligible to participate in this study.

Brief summary: Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.


Eligibility criteria: Inclusion Criteria:

* elite swimmers

Exclusion Criteria:

* shoulder surgery
* dislocation

Primary outcomes:
measure: Change of glenohumeral rotation degrees
timeFrame: Basline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Jorge Hugo Villafañe
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189144: Testing an Intervention in Irritative Contact Dermatitis
Official title: Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contact Dermatitis
Contact Dermatitis Irritant
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

Detailed description: An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers who gave written informed consent

Exclusion Criteria:

* · skin cancer

  * skin disease
  * skin damage on measurement sites
  * use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  * use of drugs that may cause photosensitivity
  * use of emollients three days prior the inclusion in the trial
  * non-adherence to the trial protocol
  * exposure to artificial and excessive natural ultraviolet (UV) radiation
  * pregnancy and lactation
  * history of vitiligo, melasma and other pigmentation and photosensitivity disorders
  * immunosuppression
  * allergic or irritant reactions to the constituents of the cream

Primary outcomes:
measure: TEWL measurement with Khazaka probe
timeFrame: through study completion, an average of 1 year
measure: hydration measurement with corneometer probe
timeFrame: through study completion, an average of 1 year
measure: erythema measured with mexameter
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: clinical score according to dermatologist scale
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Split
country: Croatia
facility: School of Medicine
Study officials:
affiliation: University of Split, School of Medicine
name: josipa bukic
role: STUDY_CHAIR
References:
Clinical trial NCT04928144: Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Official title: An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: Myopia
Lead sponsor: Sunhawk Vision Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-center, Open-label, first-in-human dose-escalation.
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.


Eligibility criteria: Inclusion Criteria:

* Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes.
* A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator.
* Literate and able to orally communicate.

Exclusion Criteria:

* Non-cycloplegic sphere worse than -4.75 Diopters
* Axial length \> 26 mm
* Hyperopia worse than +1.50 Diopters
* Anisometropia (difference of myopic power \>2.00 D).
* Astigmatism \> 1.5 D.
* Intraocular pressure \> 21 mm Hg or \< 6 mm Hg.

Primary outcomes:
measure: Change from baseline in best corrected visual acuity
timeFrame: 3 days (Part 1) and 28 days (Part 2)
measure: Incidence of Adverse Events
timeFrame: 3 days (Part 1) and 28 days (Part 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Sunhawk Vision Biotech, Inc.
name: Suh-Hang H. Juo, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002344: A Study of Azithromycin in HIV-Infected Patients
Official title: Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
HIV Infections
Keywords: Azithromycin
Bacterial Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients.

The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

Detailed description: The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV seropositivity.
* CD4 count \<= 500 cells/mm3.
* NO active AIDS opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Other active intercurrent illness.
* Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies.
* Signs or symptoms of severe illness that would preclude study participation.
* Known allergies to macrolide antibiotics.

Patients with the following prior condition are excluded:

Clinically important change in baseline status within 4 weeks prior to study entry.

Prior Medication:

Excluded:

* Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.

Known drug or alcohol dependence.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Harris Laboratories Inc
state: Arizona
Study officials:
References:
Clinical trial NCT01206244: Diurnal Variation of Tear Meniscus and Tear Osmolarity
Official title: Diurnal Variation of Tear Meniscus and Tear Osmolarity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: dry eye
tear meniscus
tear osmolarity
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects vs. dry eye patients

Brief summary: This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

Detailed description: This study is to determine the diurnal variation of tear meniscus using OCT and tear osmolarity using Tearlab's osmolarity system in normal subjects and dry eye patients.

Eligibility criteria: Inclusion criteria

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas;
5. Has 20/100 uncorrected visual acuity or better;
6. Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
7. Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
8. Has dry eye according to the study definition of DES (study subjects).

Exclusion criteria

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
3. Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
6. Has worn rigid gas permeable lenses within 1 year;
7. Has had surgery or an eye injury within 6 months.

Primary outcomes:
measure: Variations in tear osmolarity and tear meniscus volume in patients with dry eyes and in healthy control subjects over an 8-hr daytime period.
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Jianhua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01869244: WOODCAST Hand Resting Splint - Study of User Experience
Official title: User Experience From WOODCAST 2mm Hand Resting Splint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Lead sponsor: Onbone Oy
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 18
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 whos treatment involves a hand resting splint. Finnish language skills (written and spoken).

Brief summary: The aim of the study is to collect comments form users of new type of hand resting splint.

Detailed description: An ecologically friendly and biodegradable wood-plastic composite cast (WOODCAST) is used as a hand resting splint in this study.

Eligibility criteria: Inclusion Criteria:

* patient treatment involves hand resting splint; age of patient 18 - 90 years; skills with language Finnish language (written and spoken)

Exclusion Criteria:

* decreased co-operation of the patient; patient with multiple illnesses; malignancy; an illness affecting the general health.

Primary outcomes:
measure: User satisfaction
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Kuntoutus Orton Oy
Study officials:
affiliation: Helsinki University Central Hospital
name: Nina Lindfors, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547844: Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
Official title: Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2015-09-11
Enrollment: 30
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: To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or above
* Patients infected with HIV-1
* Patients treated with Atripla at least the last 6 months.
* Patients with virologic suppression (HIV RNA \<50 copies / ml) for at least the last 6 months.
* Women of childbearing potential must use contraception double barrier.
* Voluntary signature of informed consent

Exclusion Criteria:

* Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic
* Women pregnant or lactating
* Abuse of alcohol or other drugs
* Body Mass Index (BMI)\> 25
* Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...)
* Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
* History or presence of allergy to any of the study drugs or their components

Primary outcomes:
measure: Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References:
Clinical trial NCT02606344: Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV
Official title: Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Domestic Violence
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Sonal Foundation, India
name: Vinita Nursing Home, India
name: Macmillan Research Group UK
First posted: 2015-11-17
Enrollment: 561
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old;
* Must plan to reside in study areas for the next 12 months
* Must visit camp at least 1 time per week
* Must provide contact information of friend or family member

Exclusion Criteria:

* Unwilling to provide local information
* Psychological disturbance, cognitive impairment or threatening behavior

Primary outcomes:
measure: Incidence of New Sexually Transmitted Infections
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence
timeFrame: 12 Months
measure: Proportion of unprotected sexual acts with partner
timeFrame: 12 month
Other outcomes:
Locations:
city: Mahesana
country: India
facility: Sonal Foundation
state: Gujarat
city: Hindaun
country: India
facility: Vinita Nursing Home
state: Rajasthan
city: Deharadun
country: India
facility: NMP Medical Research Institute
state: Uttarakhand
Study officials:
affiliation: NMP Medical Research Institute, India
name: Kalvinder Kour, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Macmillan Research Group UK
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Vinita Nursing Home, India
name: Vinita Makkad, MD
role: PRINCIPAL_INVESTIGATOR
References: