louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03339947: French Travelers' Knowledge of Risk of Acquiring ESBL-PE
Official title: Poor Knowledge Among French Travelers of the Risk of Acquiring Multidrug-resistant Bacteria During Travel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Travel Medicine
Keywords: Multidrug-resistant Enterobacteriaceae acquisition
travellers' diarrhoea
international travel
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital between January 2016 and May 2016 and who completed the questionnaire were included in the study.

Brief summary: Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the risk of acquiring MRE.

Detailed description: Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, The investigators aimed to assess, among persons attending a consultation for travel medicine and international vaccines, patients level of knowledge regarding the risk of acquiring MRE, preventive behaviours and the need to inform health professionals that they had recently travelled if the patients require medical care after their return. A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who attended this consultation between January 2016 and May 2016 and who completed the questionnaire were included in the study. The questionnaire was completed before the planned travel. The travellers answered the questionnaires before seeing the physician.

Eligibility criteria: Inclusion Criteria:

* Adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital
* Adult who completed the questionnaire

Primary outcomes:
measure: Level of knowledge regarding multidrug resistant Enterobacteriaceae
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Migault C, Kanagaratnam L, Nguyen Y, Lebrun D, Giltat A, Hentzien M, Bajolet O, Drame M, Bani-Sadr F. Poor knowledge among French travellers of the risk of acquiring multidrug-resistant bacteria during travel. J Travel Med. 2016 Oct 30;24(1):taw073. doi: 10.1093/jtm/taw073. Print 2016 Jul. No abstract available.
Clinical trial NCT04955847: Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
Official title: Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Induction of Labor
Vaginal Delivery
Cesarean Section
Keywords: Induction of Labor
PGE1
PGE2
vaginal delivery
cesarean section
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six)

Brief summary: Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction.

Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term.

The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.


Eligibility criteria: Inclusion Criteria:

* age of patient\> 18 years
* patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).

Exclusion Criteria:

* intrauterine fetal death,
* preterm pregnancy,
* scarred uterus
* contraindications to vaginal delivery.

Primary outcomes:
measure: Variation of vaginal deliveries within 24hours patient number in both groups
timeFrame: 24 hours
Secondary outcomes:
measure: Variation of Cesarean section patient number in both groups
timeFrame: 24 hours
measure: Variation of indications for cesarean section in both groups
timeFrame: 24 hours
measure: Variation of uterine contractility abnormalities in both groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT02264847: Human Chorionic Gonadotrophin & Trigger
Official title: Trigger or Not to Trigger? : An Answer for an Old Question
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovulation Disorder
Keywords: Clomiphene Citrate
Ovulation trigger
Human chorionic gonadotrophin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In women being treated with medicines to help eggs to grow (called ovulation induction), The investigators wish to know whether adding medicines (called ovulation triggers) that help to release the egg (ovulation) would lead to more women having babies without causing harm compared with not giving them ovulation triggers.

Detailed description: Women will be treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the investigators tried to determine the benefits and harms of administering an ovulation trigger to anovulatory women receiving treatment with ovulation-inducing agents in comparison with spontaneous ovulation following ovulation induction. so we will have comparison between 2 groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.

Eligibility criteria: Inclusion Criteria:

1. Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )
2. Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months)
3. Age 18-40 years
4. Duration of primary infertility more than2 years
5. No history of ovulation induction treatment
6. No history of thyroid disease
7. Normal results on hysterosalpingogram
8. Husband with normal semen analysis

   -

Exclusion Criteria:

1. Ovarian cyst
2. Endometrioma
3. Liver disease

Primary outcomes:
measure: Ovulation rate
timeFrame: 1 year
Secondary outcomes:
measure: chemical pregnancy
timeFrame: 1 year
measure: Clinical pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine , Cairo University
Study officials:
affiliation: Cairo University
name: Waleed El-khyatat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.
Clinical trial NCT03701347: A Comparison of Three Simulators for Colposcopy LEEP Training
Official title: A Comparison of Three Simulators for Colposcopy LEEP Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colposcopy
Keywords: Colposcopy
Simulator
Comparison Study
Learning effectiveness
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 60
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: This randomized controlled trial evaluates the learning effectiveness of three different types of Colposcopy simulators objectively with Objective Structured Assessment of Technical Skill (OSATS) and subjectively with self-reported confidence survey. A total of 60 participants, randomly assigned into 3 groups, will learn from Hefler's, Reeve's or authors' simulators. The investigators hypothesize that the proposed simulator affords better learning objectively and subjectively with improved functional fidelity.

Detailed description: Colposcopy and colposcopic treatment is a unique skill that is acquired only following careful training. A colposcopist plays an important role to correctly diagnose, take appropriate biopsies and perform appropriate safe and effective treatment of women with preinvasive cervical disease. However, no surgical treatment comes without risk and colposcopy treatment is no different. Risks from a colposcopy treatment can include intraoperative complication such as bleeding, injury to surrounding organs by the instrument used i.e. laser burns, diathermy burns and damage to bladder, rectum, vulva or vagina. Other complication may include insufficient tissue excised or ablated during treatment leading to failure of cure and risk of recurrent treatment. Recurrent treatment especially excisional treatment has been shown to increase the risk of preterm labour for future pregnancies. In view of this, training in colposcopy and colposcopy treatment is a crucial part of effective cervical cancer prevention.

In this study, the investigators aim to determine if Hefler's, Reeve's or authors' simulators are more effective at supporting the colposcopy training. The significance of the result lies in the effectiveness of training simulator for colposcopy training and the confidence of doctors when they perform their first colposcopy.

Eligibility criteria: Inclusion Criteria:

* Year 4 and Year 5 Medical students who have completed their Obstetrics and gynaecology attachment
* Practicing medical doctors who have and have not performed Colposcopy LEEP

Exclusion Criteria:

* Students who have not completed their Obstetrics and gynaecology attachment

Primary outcomes:
measure: OSATS Score
timeFrame: 10 minutes
measure: Self-reported confidence score
timeFrame: 1 minute
Secondary outcomes:
measure: Quality of specimen
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Department of Obstetrics & Gyanecology
Study officials:
References:
Clinical trial NCT03104647: VRP-Clinic Software Evaluation - in Support of Rehabilitation (VRP02)
Official title: Evaluation of the Performance of VRP-Clinic in Healthy Subjects in the Support of Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Lead sponsor: VRHealth Group Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shaare Zedek Medical Center
First posted: 2017-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The current study is designed to evaluate neck movements performed according to the VRP-Clinic software, and to verify that they promote physical activities that correspond with physical rehabilitation.

Detailed description: The study will take place at Shaare Zedek Medical Center (SZMC). The study will include a single visit.

Each subject will put on the VR headset and perform a series of neck movements guided by graphic instructions appearing in the VR environment. The session will be recorded with a video camera which will subsequently be viewed and evaluated by clinicians. The clinicians will identify each movement seen on the video from a predefined list and determine if such a movement is recommended as part of a rehabilitation training program.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female
2. Age 18-65

Exclusion Criteria:

1. History of neck related disorders (Whiplash, disc degeneration disease or other acute cervical spine conditions)
2. Current neck pain
3. Under medical treatment or observation for any health-related issue during the study
4. Recent trauma
5. Oncology background
6. Acute disease/illness
7. Pregnancy.
8. Using drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotics or antidepressants)
9. Vision problems that require glasses (not all frame types can fit into the headset)

Primary outcomes:
measure: Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements
timeFrame: Up to 2 weeks after the session
Secondary outcomes:
measure: Number of Participants With Any Adverse Event Occurring During the Study
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Yair Barzilay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University of Jerusalem
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00482547: Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)
Official title: Study of a Urethral Catheter Coated With Eluting Silver Salts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Catheterization
Keywords: urinary tract infection
urinary catheter
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 1188
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: Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.

Detailed description: This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).

Eligibility criteria: Inclusion Criteria:

* male or female at least 18 years of age
* life expectancy of 3 months or more
* expected to require a urinary catheter for at least 48 hours

Exclusion Criteria:

* recent urinary tract surgery or instrumentation
* presence of a urinary tract device
* concurrent genitourinary tract infection
* recent indwelling urinary catheter
* requires use of a non-study urinary catheter

Primary outcomes:
measure: Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
timeFrame: >=48 hours to 10 days
Secondary outcomes:
measure: Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
timeFrame: >=48 hours to 10 days
measure: Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
timeFrame: >= 48 hours to 10 days
measure: Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
timeFrame: >= 24 hours to 10 days
measure: Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
timeFrame: >= 24 hours to 10 days
measure: Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
timeFrame: 10 days
Other outcomes:
measure: Number of Subjects With a bUTI Catheterized for >=48 Hours.
timeFrame: From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.
measure: Number of Subjects With a sUTI Catheterized for >=48 Hours.
timeFrame: From time of catheterization until 10 days or 48 hours after catheter was removed
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: University of Nebraska
name: Mark Rupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03939247: Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
Official title: Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tendinopathy
Keywords: elbow
tendinopathy
physiotherapy
exercise
electrotherapy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled Trial
Primary purpose: TREATMENT

Brief summary: This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises, stretching);
* "CPT + Tecare" (idem CPT group + tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive Tecare device) The treatment will include 18 30-minute sessions

Detailed description: This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises by means of an isokinetic dynamometer, stretching);
* "CPT + Tecare" (idem CPT group + Tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive "Tecare" device) The treatment will include 18 30-minute sessions.

The "Tecaretherapy" consists in using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process.

Outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.

Eligibility criteria: Inclusion Criteria:

* Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography

Exclusion Criteria:

Patients:

* with contra-indications for a Tecaretherapy (Pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis)
* reporting injections and/or shockwaves in the past (for the tendinopathy)
* with an associated neurogenic dysfunction

Primary outcomes:
measure: change in the "Patient-Rated Tennis Elbow Evaluation" score
timeFrame: up to 6 months
Secondary outcomes:
measure: change in pain Intensity
timeFrame: up to 6 months
measure: change in pain Pressure thresholds
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liege
Study officials:
affiliation: University of Liege
name: Marc Vanderthommen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Bénédicte Forthomme, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331447: Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
Official title: A Pilot Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions


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 exemestane or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: BioKinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis N Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References: