louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02712073: Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire
Official title: Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-03-17
Enrollment: 1260
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: Patients seen in precolonoscopy consultation

Brief summary: In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.


Eligibility criteria: Inclusion Criteria:

* Men or woman \> 18 years old
* Patient agreeing to participate in the study
* Prescription of a bowel preparation respecting the marketing authorization.

Exclusion Criteria:

* Major patient under guardianship, or protected person,
* Pregnant woman,
* Patient who doesn't understand French or can't read
* People not affiliated with a social security scheme or of such a scheme

Primary outcomes:
measure: Score performance
timeFrame: within 6 month
Secondary outcomes:
measure: acceptability of questionnaire
timeFrame: end of study
measure: Adenoma detection
timeFrame: within 6 month
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers UH
city: Cholet
country: France
facility: Cholet hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon hospital
city: Nantes
country: France
facility: Nantes UH
Study officials:
References:
Clinical trial NCT03367273: Thymic Stromal Lymphopoietin (TSLP) in Vitiligo
Official title: Study of the Cutaneous Expression of Thymic Stromal Lymphopoietin (TSLP) in a Sample of Vitiligo Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: study \& verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.


Eligibility criteria: Inclusion Criteria:

* • Patients with generalized non-segmental vitiligo.

  * Both sexes.
  * Age \< 18 years old age.
  * New cases or cases not receiving any medication for at least 3 months ago.

Exclusion Criteria:

* • Age: Patients \< 18 years.

  * Segmental or universal vitiligo.
  * Pregnant and lactating females. Autoimmune diseases

Primary outcomes:
measure: Expression levels of TSLP in patients of Vitiligo.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04377373: Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum
Official title: Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genu Valgum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female with bilateral genu valgum with age range 18-25 and BMI≥ 30 (kg/m2)

Brief summary: Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.

Detailed description: Sixty four female participants were under the following procedures:

* Screening for genu valgum via postural assessment from frontal view, then measuring the Q angle bilaterally.
* Patients with Q-angle \>20 degress were under the following procedures:

A. Full-Length AP standing X-ray,then the investigators measured the hip-knee angle (the angle between the mechanical axis of the femur and the tibia). It will be obtained by connecting the center of the femoral head to the midpoint of the tibial eminential spine in a line tangential to the femoral condyles, and another line from here to the centre of the trochlea tali.

B-Lumbo-sacral X-ray lateral view was done at the time and the sacral angle was the measured by Ferguson´s technique in degrees using a protractor and this was the sacral angle.

C- During the same session, trunk range of motion was measured by Modified schober test D- Collected data were taken for statistical analysis.

Eligibility criteria: Inclusion Criteria:

1. Female with bilateral genu valgum (Q angle\> 20 degrees.
2. Age ranges from 18-25 years old.
3. BMI ≥ 30 (kg/m2)

Exclusion Criteria:

1. Previous lumbar surgery
2. lumbar spine fracture
3. Spondylolisthesis
4. Foraminal or extra foraminal lumbar disc herniation
5. spinal tumors, and bone metabolic diseases 6 - Knee surgeries

Primary outcomes:
measure: Sacral angle
timeFrame: 30 minutes
measure: Lumbar range of motion measured by Modified Shobber test
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
affiliation: Lecturer,Cairo University
name: Nasr A. Abdelkader, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03590873: The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients
Official title: The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Surgery
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
First posted: 2018-07-18
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.

Detailed description: This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.

Eligibility criteria: Inclusion criteria:

* age ≥ 18 years old
* burn patients undergoing surgery (TBSA \> 20%)

Exclusion criteria:

* age \< 18 years old
* history of renal disorder
* history of cardiac disorder

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: At the end of the surgery, approximately 3 hrs
Secondary outcomes:
measure: Intraoperative red blood cell transfusion
timeFrame: At the end of the surgery, approximately 3 hrs
measure: Postoperative pulmonary complication
timeFrame: Within 7 postoperative days
measure: Postoperative cardiovascular complication
timeFrame: Within 7 postoperative days
measure: Postoperative renal complication
timeFrame: Within 7 postoperative days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02849873: Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream
Official title: Randomized Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison With Tazorac Cream in Subjects With Moderate to Severe Acne Vulgaris Under Maximal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 48
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.

Detailed description: Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

Eligibility criteria: Key Inclusion Criteria:

* Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).
* Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit).
* Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit.
* Subjects with facial acne inflammatory lesion count no less than 20 but no more than 40.
* Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100.

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema.
* Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Subjects with a facial beard or mustache that could interfere with the study assessments.
* Subjects with more than 2 facial nodules.

Primary outcomes:
measure: Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne.
timeFrame: 15 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Valeant Site 01
state: Alabama
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
Clinical trial NCT00677573: Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders
Official title: Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: ART
poor responder
GnRH antagonist
Gonadotropins
Lead sponsor: German Hospital, Istanbul
Sponsor class: OTHER
Collaborators: name: Bahceci Women Health Care Center
First posted: 2008-05-14
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.


Eligibility criteria: Inclusion Criteria:

* At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.

Exclusion Criteria:

* High responder patients

Primary outcomes:
measure: pregnancy rate per embryo transfer
timeFrame: 6 months
Secondary outcomes:
measure: number of oocytes retrieved
timeFrame: per patient
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Alman Hastanesi
Study officials:
References:
Clinical trial NCT00764673: The 3DKnee™ System: A Post-Market Study
Official title: The 3DKnee™ System: A Post-Market Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Varus Deformity
Avascular Necrosis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.


Eligibility criteria: Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Have knee joint disease related to one or more of the following

  * degenerative joint disease, including osteoarthritis or traumatic arthritis
  * Avascular necrosis of the femoral condyles
  * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  * Moderate valgus, varus, or flexion deformities
  * Rheumatoid arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* Patient must be over 18 years of age

Exclusion Criteria:

* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
* Is younger than 18 years of age

Primary outcomes:
measure: Knee Society Score Evaluation
timeFrame: 2 year
measure: Knee Society Function Score
timeFrame: 2-year
measure: Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
timeFrame: 2-year
measure: Safety Assessment
timeFrame: 2-year
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: 2-year
Other outcomes:
Locations:
city: St. Peters
country: United States
facility: St. Peter's Bone & Joint Surgery
state: Missouri
Study officials:
affiliation: St. Peter's Bone and Joint Surgery
name: John McAllister, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695773: Laparoscopic Vs. Open Prostatectomy Outcomes
Official title: Laparoscopic Vs. Open Prostatectomy Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer Surgery
Keywords: Prostate Cancer Surgery
Laparoscopic surgery for Prostate Cancer
Prostatectomy
Urologic Surgical Procedures
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 158
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A Lahey Clinic IRB approved database and current clinic population of patients having a laparascopic or open prostatectomy

Brief summary: This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.

Detailed description: This study is a post surgical, data collection effort in order to gather definitive, Quality of Life(continence, impotence) information regarding the outcomes of patients who have undergone either Laparoscopic vs. Prostatectomy surgeries for Prostate Cancer. As part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted. The information collected may benefit patients who undergo a prostatectomy

Eligibility criteria: Inclusion Criteria:

* Subjects who have undergone a prostatectomy

Exclusion Criteria:

* none

Primary outcomes:
measure: The post-surgical questionnaire information collected will be used to determine any benefits to future patients who are to undergo a prostatectomy
timeFrame: Post Surgical
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: John A. Libertino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931827: Acceptability of Long-term Progestin-only Contraception in Europe
Official title: Acceptability of Long-term Progestin-only Contraception in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 436
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 20-35 years switching from short-acting hormonal contraception

Brief summary: The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.


Eligibility criteria: Inclusion Criteria:

* Women aged 20-35 in good general health requesting contraception
* Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
* Women who have given a written informed consent to participate in the study (if applicable)

Exclusion Criteria:

* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study
* Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern

Primary outcomes:
measure: Continuation rate
timeFrame: At 24 months
Secondary outcomes:
measure: Continuation rate
timeFrame: At 12 months
measure: Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)
timeFrame: Initial and after 3, 6, 12 and 24 months
measure: Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons
timeFrame: At 24 months
measure: Incidence of Adverse Events, Serious Adverse Events
timeFrame: During 24 months
measure: The return to fertility of women discontinuing the method for wish for pregnancy
timeFrame: 12 months after discontinuation
Other outcomes:
Locations:
city: Many Locations
country: France
city: Many Locations
country: Ireland
city: Many Locations
country: Slovakia
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01672827: Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
Official title: A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Alzheimer's Disease
Mild Cognitive Impairment
Positron Emission Tomography (PET)
PET Images
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.


Eligibility criteria: Inclusion Criteria:

* Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
* The subject was classified as one of the following:

  1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
  2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
  3. Elderly healthy volunteer (age ≥55).
  4. Young healthy volunteer (age ≤40).
  5. Subject with probable Alzheimer Disease (pAD).
  6. Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.
timeFrame: Post flutemetamol administration
measure: Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.
timeFrame: Post flutemetamol administration
Secondary outcomes:
measure: Inter-Reader Agreement of PET Images Without Anatomic Images
timeFrame: Post Flutemetamol Injection
Other outcomes:
Locations:
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, MD
role: STUDY_CHAIR
References: