louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03007615: Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
Official title: Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Dry Genital Mucosa
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 33
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy female sex with active sex life;
* Age group: between 45 and 65 years old;
* Menopause for at least six months;
* Whole skin in the region of product analysis;
* No history of reaction to products of the same category
* Understanding, agreement and signature of the Term of Free and Informed Consent.

Exclusion Criteria:

* Gestation or risk of gestation;
* Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
* Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
* Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
* Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
* Any infection in the region of analysis of the product diagnosed at the time of inclusion;
* Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Primary outcomes:
measure: Evaluation of the product's efficiency as a moisturizer through subjective evaluation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00060515: RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease
Official title: An Open-Label Dose-Escalation Phase I Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RG2133 (2',3',5'-Tri-O-Acetyluridine) in the Treatment of Inherited Mitochondrial Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Mitochondrial Diseases
Lead sponsor: Repligen Corporation
Sponsor class: INDUSTRY
First posted: 2003-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.


Eligibility criteria: Mitochondrial Disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01456715: Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.
Official title: Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus
Keywords: Human Papillomavirus Vaccines
Immunogenicity Gardasil Cervarix
Booster dose
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 418
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Two human papillomavirus vaccines are now commercially available.

No clinical data exist regarding:

* The immunogenicity and safety of Gardasil and Twinrix when co-administered.
* The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.

The main objective of the first phase of this clinical trial was:

• To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.

The main objective of the seconde phase of this clinical trial is:

• To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.

Study Design \& Duration:

Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.

Duration of the study:

Participants will be followed for the duration of 10 years post-primary vaccination.

Number of Centres:

One Center.


Eligibility criteria: Inclusion Criteria:

* In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.

Exclusion Criteria:

* Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.

Primary outcomes:
measure: Antibody to HPV
timeFrame: 1 month post booster dose
Secondary outcomes:
measure: Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.
timeFrame: Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University Research Hospital Center
Study officials:
affiliation: INSPQ, CHUQ-CHUL, Laval University
name: Vladimir Gilca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01979315: Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients
Official title: Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with subacute LBP from tertiary rehabilitation clinic

Brief summary: Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown.

This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.


Eligibility criteria: Inclusion Criteria:

* Low back pain for at least 12 weeks
* Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
* No meeting excluding criteria.

Exclusion Criteria:

* No response to initial contact
* Red flag symptoms
* Diabetes mellitus,
* Neurological problems and
* Cancer
* Pregnant patients
* Patients treated chirurgically for the same problem or treated with oral corticosteroids and steroid injections for any reason in the previous month.

Primary outcomes:
measure: Pain hypersensitivity parameters: pain threshold and pressure pain tolerance threshold will be measured by pressure algometer pressure was applied using a probe with an area of 1 cm2 and intensity to a maximum of 1,000 kPa at a rate of 30 kPa/s.
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References:
Clinical trial NCT00637715: Once Daily Given Alfuzosin in the Treatment of BPH
Official title: Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice


Eligibility criteria: Inclusion Criteria:

* Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria:

* Necessity of surgical intervention immediately or within 12 months because of BPH
* The patient has earlier /within 6 months/ obtained treatment because of BPH
* The patient did not improve on earlier alpha-1 blocker treatment
* Known hypersensitivity to alfuzosin
* Orthostatic hypotension in the history
* Concomitant application with another alpha-1 blocker
* Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
* Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
* Intestinal obstruction /because of the castor oil content of the drug/
* Tumorous disease
* Severe, life threatening state

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Laszlo Eros
role: STUDY_DIRECTOR
References:
Clinical trial NCT04848415: Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction
Official title: Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Obstruction
Keywords: Bowel obstruction
Computed tomography
Ultrasound
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ED for abdominal pain and suspicion of bowel obstruction

Brief summary: As reported in previous studies, Point-of-Care Ultrasound (POCUS) has good performance for the diagnosis of bowel obstruction even when compared with CT. This inexpensive, radiation-free tool is available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training period.

The investigators aim to investigate the ability of POCUS performed before CT to exclude the diagnosis of bowel obstruction in patients admitted for abdominal pain.

Detailed description: Bowel obstruction (BO) is frequently suspected in the Emergency Department (ED). Computed Tomography (CT) is commonly used to diagnose this disease. However, CT is not always available in real-time, requires technician times, is associated with increased cost and exposes patients to radiations.

The researchers will investigate the diagnosis performances of POCUS for the diagnosis of BO with comparison with CT which will be considered as the gold standard. The wain objective will be the ability to exclude the diagnosis of BO, the main criteria being the negative predictive value. The secondary objectives will be the diagnosis performances (sensitivity, specificity, positive predictive value), duration and difficulty of POCUS

Eligibility criteria: Inclusion Criteria :

* Adult patients
* Abdominal pain
* Suspected bowel obstruction

Exclusion Criteria :

- Documented end-of-life precluding CT realization

Primary outcomes:
measure: Negative predictive value of POCUS
timeFrame: Through ED stay, up to 24 hours
Secondary outcomes:
measure: Positive predictive value of POCUS for the diagnosis of bowel obstruction
timeFrame: Through ED stay, up to 24 hours
measure: Sensitivity of POCUS for the diagnosis of bowel obstruction
timeFrame: Through ED stay, up to 24 hours
measure: Specificity of POCUS for the diagnosis of bowel obstruction
timeFrame: Through ED stay, up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02045615: Removal Wichita Fusion Nail After Knee Arthrodesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Removal Wichita Fusion Nail After Knee Arthrodesis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had to have their Wichita Fusion Nail extracted

Brief summary: The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.


Eligibility criteria: Inclusion Criteria:

* Extraction of Wichita Fusion Nail

Exclusion Criteria:

* All other kinds of intramedullairy nails used to become a solid knee arhrodesis

Primary outcomes:
measure: Operation technique
timeFrame: first 4 months postop
Secondary outcomes:
measure: Mobility
timeFrame: 1 year postop
measure: Pain measurement following the Visual Analogue Scale
timeFrame: 1 year postop
measure: Major complications after removal
timeFrame: first 2 years postop
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT02958215: Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
Official title: A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia, Obstetrical
Anesthesia, Spinal
Keywords: Orthostatic
Cesarean section
Pregnant
Phenyephrine
Hypotension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 980
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Detailed description: Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Eligibility criteria: Inclusion Criteria:

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion Criteria:

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Primary outcomes:
measure: Incidence of hypotension
timeFrame: within first 24 hours after spinal anesthesia
Secondary outcomes:
measure: Frequency of bradycardia
timeFrame: within first 24 hours after spinal anesthesia
measure: Ephedrine usage
timeFrame: within first 24 hours after spinal anesthesia
measure: intraoperative fluid management
timeFrame: within first 24 hours after spinal anesthesia
measure: Apgar scores
timeFrame: within first 24 hours after spinal anesthesia
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate professor of anesthesia
name: Sayed K Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05017415: Applicability of Uroflowmetry in Children with Cerebral Palsy
Official title: What is the Difference in the Applicability of the Uroflowmetry Between Children with Cerebral Palsy (CP) with Lower Urinary Tract Symptoms (LUTS) and Without Lower Urinary Tract Symptoms (LUTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lower Urinary Tract Symptoms
Keywords: cerebral palsy
lower urinary tract symptoms
incontinence
uroflow measurement
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2021-08-23
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.
Primary purpose: SCREENING

Brief summary: Until now, the use of invasive urodynamics with use of catheters is still the gold standard for lower urinary tract evaluation in subjects with CP. This suggests a psychological and physical impact of invasive urodynamics in subjects with CP and further demonstrates the need to avoid standard use of invasive urodynamics in children and adults with CP.

The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry parameters and different lower urinary tract symptoms will be investigated. Secondly, results of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.

Detailed description: A cross-sectional case-control study comparing children with CP and LUTS and children with CP without LUTS will be conducted with the primary objective to investigate correlation between uroflowmetry parameters and different LUTS.

Children will be evaluated with uroflowmetry and subsequent post void residual measurement and the validated vancouver symptom score for dysfunctional elimination syndrome.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cerebral palsy
* Dutch or French speaking child and parent

Exclusion Criteria:

* History of urological surgery

Primary outcomes:
measure: Amount of pathological uroflow patterns - Qualitative assessment
timeFrame: During cross-sectional testing
measure: Amount of pathological uroflow patterns - Quantitative assessment
timeFrame: During cross-sectional testing
measure: Maximal flow
timeFrame: During cross-sectional testing
Secondary outcomes:
measure: Influencing factors for uroflow measurement
timeFrame: During cross-sectional testing
measure: Voided volume
timeFrame: During cross-sectional testing
measure: Post void residual urine
timeFrame: During cross-sectional testing
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Flanders
Study officials:
affiliation: Ghent University Hospital/Ghent University
name: Bieke Samijn, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536315: Tracheal Mechanics During Bronchoscopy
Official title: Tracheal Mechanics During Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheomalacia
Tracheobronchomalacia
Keywords: COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 145
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.

Brief summary: The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.

Detailed description: This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.

Eligibility criteria: Inclusion Criteria:

* Suspicion of tracheal collapse undergoing bronchoscopy
* Healthy control subject undergoing bronchoscopy for another purpose.

Exclusion Criteria:

* Esophageal pathology
* Tracheostomy
* inability to follow commands

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Stephen H Loring, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24. doi: 10.1378/chest.06-2556.