louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377129: Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques
Official title: Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Residual Rotational Laxity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 46
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: The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 24 months of follow-up
* The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient require a single bundle, "KJ-type" surgical technique
* Contra-indication for MRI scans

Primary outcomes:
measure: Residual rotational laxity during MRI
timeFrame: 7-8 months post-op
Secondary outcomes:
measure: Lysholm score
timeFrame: 7-8 months
measure: International Knee Documentation Committee score
timeFrame: 7-8 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Philippe Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06415929: Etude rétrospective Monocentrique MATRIX
Official title: Single-center Retrospective Study Evaluating the Characteristics, Quality of Life and Satisfaction of Patients Undergoing Nail Resection With Dermal Matrix and Skin Graft Reconstruction at Nice University Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hopital de soins tertiaires- Hopital Pasteur 2-Nice

Brief summary: "Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

"


Eligibility criteria: Inclusion Criteria:

- Adult patients who have undergone complete nail removal for malignancy - Reconstructed with INTEGRA dermal matrix and total skin graft.

Exclusion Criteria:

-Minor patients -Patients who have undergone complete removal of the nail apparatus for malignancy but have been reconstructed in another way (flap, isolated skin graft)

Primary outcomes:
measure: Quality of life evaluation
timeFrame: 3 months too 36 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NiICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Elise Elise
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02314429: Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
Official title: Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vaginosis, Bacterial
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. The primary objective of this phase I study is to assess the safety and the tolerability of this new intravaginal delivery system.

The eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.


Eligibility criteria: Inclusion Criteria:

* Good general physical and mental health
* Presence of normal (lactobacilli-dominated) vaginal microbiota
* Prepared to take oral contraception during the study

Exclusion Criteria:

* Pregnancy
* Lactation
* Systemic disease
* Menopause
* Recent use of antibiotics (\<1 week before entering the study)
* Recent use of intravaginal products or devices (\<1 week before enrolment)
* Presence of vaginal infection

Primary outcomes:
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 1 hour after insertion
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 2 hours after insertion
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 4 hours after insertion
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 8 hours after insertion
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 24 hours after insertion
measure: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
timeFrame: 7 days after insertion
Secondary outcomes:
measure: Assessment of vaginal pH
timeFrame: each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Obstetrics & Gynaecology, Ghent University Hospital P4
Study officials:
affiliation: University & University Hospital Ghent
name: Hans Verstraelen, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verstraelen H, Vervaet C, Remon JP. Rationale and Safety Assessment of a Novel Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release, Intended for Long-Term Protection of the Vaginal Microbiome. PLoS One. 2016 Apr 19;11(4):e0153441. doi: 10.1371/journal.pone.0153441. eCollection 2016.
Clinical trial NCT02982629: Improving Access to Eye Care in Glaucoma Patients
Official title: Improving Access to Eye Care in Glaucoma Patients a Prospective, Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Eye Care
Community Outreach
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2016-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 1. To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma.
2. To evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.

Detailed description: The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. The prospective, randomized, controlled trial entitled "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or "Intervention" group. The primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. This intervention is based on a CDC funded project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.

Eligibility criteria: Inclusion Criteria:

* Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13

Exclusion Criteria:

* Any medical condition that would preclude the subject from providing reliable and valid data.
* Recommended to f/u in less than 1 month time period.

Primary outcomes:
measure: Adherence to Follow-Up
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.
Clinical trial NCT04103229: Urinary Leakage in the Indwelling Urinary Catheterization
Official title: Investigation of Two Different Types of Solution and Volume for Inflating Foley Catheter Balloon in Indwelling Urinary Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urine Leakage in the Indwelling Urinary Catheterization
Keywords: Urine Leakage
Indwelling urethral catheter
silicone catheter
Saline
Balloon
Distilled water
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 128
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem.

In this study, the investigators aimed to investigate the effect of the type and amount of fluid used in inflating the silicone foley catheter balloon on the development of urinary leakage around the catheter. In addition to purpose, the following questions were answered to determine the optimal solution type and volume in inflating the balloon:

* What was the incidence of urinary leakage in IUC?
* Was there a relationship between catheterization time and urine leakage?
* Was there a relationship between the type of fluid used to inflate the foley catheter balloon and urine leakage?
* Was there a relationship between the amount of fluid used to inflate the foley catheter balloon and urine leakage?


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years,
* Patients with indication for IUC (presence of order),
* Patients eligible for the use of a 18 Fr silicone foley catheter,
* Patients who did not have a problem that could affect prostate hypertrophy and/or urinary system miction.

Exclusion Criteria:

* In the study, if urine leakage occurred within 12 hours after catheterization, it was assumed that the leakage was caused by the size of the catheter, and these patients/patients were excluded from the study.

Primary outcomes:
measure: Development of urine leakage around the catheter
timeFrame: through study completion, about three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: İzmir Katip Çelebi University
name: Ayse AKBIYIK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611129: Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
Official title: Use of the 'Patient Journey' Model in the Internet-based Pre-fitting Counseling of a Person With Hearing Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Evaluation
Keywords: Disability Evaluation
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Swansea University
First posted: 2012-06-04
Enrollment: 80
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: The purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.


Eligibility criteria: Inclusion Criteria:

* Ages over 18 years old
* Have symptoms of hearing difficulty
* Access to internet

Exclusion Criteria:

* HHQ results too low (i.e., below 20),
* Participants using hearing aids
* Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program

Primary outcomes:
measure: Hearing Handicap Questionnaire (HHQ)
timeFrame: One week pre-treatment, One week post treatment, Six-moths follow-up
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: One week pre-treatment, One week post treatment, Six moths follow-up
measure: University of Rhode Island Change Assessment Scale (URICA)
timeFrame: One week pre-treatment, One week post treatment, Six months follow-up
measure: Hearing Impairment Acceptance Questionnaire (HIAQ)
timeFrame: One week pre-treatment, One week post treatment, Six months follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: The Swedish Institute for Disability Research, Linköping University
city: Swansea
country: United Kingdom
facility: Department of Vision and Hearing Sciences, Anglia Ruskin University
Study officials:
References:
citation: Manchaiah VK, Stephens D, Andersson G, Ronnberg J, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials. 2013 Jan 24;14:25. doi: 10.1186/1745-6215-14-25.
citation: Manchaiah V, Ronnberg J, Andersson G, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial. BMC Ear Nose Throat Disord. 2014 Apr 7;14(1):3. doi: 10.1186/1472-6815-14-3.
Clinical trial NCT00044629: Combined Behavioral/Pharmacological Therapy for Insomnia
Official title: Combined Behavioral/Pharmacological Therapy for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Sleep Deprivation
Insomnia
Sleep Disorders
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-09-05
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Detailed description: Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.

During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.

Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.

After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.

After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.

Eligibility criteria: Inclusion Criteria:

* be between 21 and 75 years of age
* have a mean total nocturnal wake time of \> 60 min./night
* have a history of insomnia \> 6 months
* have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by \> 2 hrs. from day to day, or routinely lying in bed awake for periods \> 30 min

Exclusion Criteria:

* pregnant women
* the terminally ill
* individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
* individuals with major psychiatric diagnoses
* persons with hypnotic-dependent insomnia
* subjects on antidepressants or anxiolytics
* subjects with evidence of sleep apnea

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sleep Disorders Center
state: North Carolina
Study officials:
References:
Clinical trial NCT01170429: Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
Official title: A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cough Variant Asthma
Keywords: Cough Variant Asthma
Procaterol Hydrochloride
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).

Detailed description: This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.

During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.

Eligibility criteria: Inclusion Criteria:

* male or female patients,18-75 years old;
* cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
* without wheeze and fever;
* without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
* without rales from lung;
* no obvious abnormalities from chest X-ray;
* bronchial provocation test: positive.

Exclusion Criteria:

* patients with chronic pulmonary disease;
* patients who are allergic to ß2 receptor agonist;
* patients taking ß2 receptor agonist for long time;
* severe heart, renal and hepatic disease;
* unable to comply with the protocol;
* pregnant, breast feeding, and childbearing potential women;
* patients improper to the trial according to the investigators' judgment.

Primary outcomes:
measure: Patient cough symptom score
timeFrame: 8 weeks
measure: Therapy duration
timeFrame: 8 weeks
measure: Rates of adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: LCQ Life Quality Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Zhou
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009892: Food Effect Study of Codeine Sulfate
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick Bieberdorf
role: PRINCIPAL_INVESTIGATOR
References: