louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01391780: Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence
Official title: Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence. A Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence, Stress
Urge Incontinence
Keywords: pelvic floor evaluation,
women,
stress urinary incontinence;
urgency urinary incontinence.
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 20 participants.

Brief summary: Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI).

Methods: 51 women were prospectively divided into two groups, according to the symptoms as SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min Pad Test. Subjective \[urine stream interruption test (UST), visual survey of perineal contraction and transvaginal digital palpation\] and objective (vaginal manometry) evaluations of PFM were performed in all patients.


Eligibility criteria: Inclusion Criteria:

* presence of stress urinary or urgency incontinence

Exclusion Criteria:

* neurological diseases
* previous pelvic surgeries
* diabetes
* cognitive difficulties
* vaginal and urinary infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: São Paulo State University - Medical School of Botucatu
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
name: João L. Amaro, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05447780: Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries
Official title: Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Lumbar Discogenic Pain
Lumbar Spinal Stenosis
Failed Back Surgery Syndrome
Lead sponsor: Anesthesia Research Group UA
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.


Eligibility criteria: Inclusion Criteria:

* back surgery

Exclusion Criteria:

* contraindications to the regional method of analgesia,
* patient refusal,
* patients with diabetes mellitus
* mental illness
* pregnancy

Primary outcomes:
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 2 hours after surgery
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 6 hours after surgery
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 24 hour after surgery
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 48 hour after surgery
Secondary outcomes:
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 1 month after surgery
measure: A Visual Analogue Scale (numerical rating scale (NRS)
timeFrame: 3 month after surgery
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Anesthesia department Medical Network Dobrobut
Study officials:
affiliation: chief of the anesthesia department
name: Yelyzaveta Plechystaya, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05013580: The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane
Official title: The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horizontal Ridge Deficiency
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
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 compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.

Detailed description: Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal.

Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals.

20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.

Eligibility criteria: Inclusion Criteria:

* Be at least 21 years of age
* Be missing 1 to 2 back teeth in the lower jaw for at least three months
* Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
* Have enough bone height at the site

Exclusion Criteria:

* Currently smoke more than 10 cigarettes a day (self-reported)
* Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
* Are pregnant or are lactating (self-reported)
* Have unstable periodontal disease or other dental infection
* Have poor oral hygiene
* Have any clinical conditions that make the subject unsuitable for bone graft surgery

Primary outcomes:
measure: Ridge width changes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Muhammad Saleh, BDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04761380: Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
Official title: Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: dysphagia
Lead sponsor: Kindai University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD subjects were chosen from a group of subjects who had visited the Department of Respiratory Medicine and Allergology at Kindai University Hospital from December 2019 to May 2020.

Brief summary: Background:

Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects.

Methods:

This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stable COPD.
* Age-matched control subjects who did not have any pulmonary disease.

Exclusion Criteria:

* Participants with metallic implants.
* History of stroke disease.
* History of neuromuscular disease.
* Participants who did not have their front teeth.

Primary outcomes:
measure: maximum tongue pressure
timeFrame: 1 day
Secondary outcomes:
measure: handgrip strength
timeFrame: 1 day
measure: fat free mass index (FFMI)
timeFrame: 1 day
measure: skeletal muscle mass (SMI)
timeFrame: 1 day
measure: fat free mass
timeFrame: 1 day
measure: skeletal muscle mass
timeFrame: 1 day
measure: height
timeFrame: 1 day
Other outcomes:
Locations:
city: Ōsaka-sayama
country: Japan
facility: Kindai University Faculty of Medicine
state: Osaka
Study officials:
References:
Clinical trial NCT06058780: Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Official title: Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. In addition, pIOLs have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.


Eligibility criteria: Inclusion Criteria:

* myopia of more than 6 diopter

Exclusion Criteria:

* unstable refraction
* unstable refraction

Primary outcomes:
measure: UCVA
timeFrame: Baseline
measure: UCVA
timeFrame: 3 months postoperative
measure: UCVA
timeFrame: 6 months postoperative
measure: UCVA
timeFrame: 12 months postoperative
measure: BCVA
timeFrame: Baseline
measure: BCVA
timeFrame: 3 months postoperative
measure: BCVA
timeFrame: 6 months postoperative
measure: BCVA
timeFrame: 12 months postoperative
measure: Refraction
timeFrame: Baseline
measure: Refraction
timeFrame: 3 months postoperative
measure: Refraction
timeFrame: 6 months postoperative
measure: Refraction
timeFrame: 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Akram Fekry Elgazzar
Study officials:
References:
Clinical trial NCT02992080: Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
Official title: Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Patient with Cystic Fibrosis
Patient without Cystic fibrosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

Detailed description: The objective of this project is to study the circulating miRNA profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary disease. The identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of CF patients.

Eligibility criteria: Inclusion Criteria:

* Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary disease

Exclusion Criteria:

* Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
* smokers

Primary outcomes:
measure: Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
timeFrame: After blood collection: 2 years
Secondary outcomes:
measure: Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
timeFrame: After blood collection 2 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Montpellier University Hospital (CHU Montpellier) Montpellier University
name: Caroline RAYNAL, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03378180: Measurement of Tracheobronchial Tree Using 3D CT
Official title: Measurement of Tracheobronchial Tree Using Multiplane CT Reconstructions to Guide Selecting Double-lumen Tubes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Double Lumen Tube
Computed Tomography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective measurement of 3D CT scan images obtained from patients admitted for thoracic surgery

Brief summary: Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left main endobronchial lesions.

With recent advances of 3-dimensional spiral CT reconstruction technique, the investigators conducted this retrospective study to measure accurate length of right and left main bronchus and the angle between the center of the right main bronchus and right upper lobe orifice in axial image to help choosing and further manufacturing right-sided double-lumen tubes.

Detailed description: All CT images will be reviewed using the image measurement software with a slice thickness of 1 mm. A level of -450 Hounsfield units and a width of 1000 Hounsfield units were used for bronchial window settings.

The length of right and left main bronchus will be measured from the tracheal bifurcation to the point of their first branches, respectively, in both 2D- and 3D-CT images. The anteroposterior angulation of right upper lobar bronchus will be measured from the axial 2D-images by the angle between the horizontal midline of the right main bronchus and the center of the RUL orifice which indicates the origin of the RUL bronchus in which the right upper lobar bronchus shows maximal diameter.

Eligibility criteria: Inclusion Criteria:

* 3D- thoracic CT scan images obtained between March 1st and October 31th, 2016

Exclusion Criteria:

* younger than 18
* with intraluminal lesions in main bronchus
* with abnormalities of tracheobronchial tree
* with history of tracheobronchial injury or surgery
* diagnosed musculoskeletal deformity.

Primary outcomes:
measure: right upper lobe orifice
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: length of right and left main bronchus
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01130480: Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study
Official title: Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 833
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective study will assess the use and frequency of SMBG and blood glucose control and its influencing factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. The anticipated duration of the study is 6 months.


Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus patients who have received insulin treatment for more than 3 months
* Patients willing to sign written informed consent form
* Patients who meet the criteria for the first cross-sectional investigation and have an HbA1c \< 7% will receive the second cross-sectional investigation

Exclusion Criteria:

* Patients unable or unwilling to comply with the requirements of the protocol

Primary outcomes:
measure: HbA1c change between the baseline and end of study
timeFrame: From baseline to month 6
measure: Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)
timeFrame: From baseline to month 6
Secondary outcomes:
measure: SMBG frequency change between the baseline and the end of the study
timeFrame: From baseline to month 6
measure: Relationship between SMBG frequency change and blood glucose control
timeFrame: From baseline to month 6
measure: To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36
timeFrame: From baseline to month 6
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Tianjin
country: China
city: Wuhan
country: China
city: Xian
country: China
Study officials:
affiliation: Roche Diagnostics (Shanghai) Ltd
name: Bettina Petersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00904280: Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Official title: An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancers, Pain
Lower Back Pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.


Eligibility criteria: Inclusion Criteria:

* The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
* Males or females, age 18 and 75 years, inclusively.
* The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.

Exclusion Criteria:

* The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
* The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
* Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.

Primary outcomes:
measure: Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER
timeFrame: 1 year study
Secondary outcomes:
measure: To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain
timeFrame: 1 year study
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr. Director
role: STUDY_DIRECTOR
References: