louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02371486: Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Official title: Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Complications; Cesarean Section
Keywords: cesarean section defect
implantation
ivf
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cesarean scar defects (CSDs), i.e. deficient uterine scars following a cesarean section, involve discontinuity at the site of a previous Cesarean section scar. These anatomical defects have been reported to be associated with postmenstrual spotting, chronic pelvic pain and infertility. Few case series have suggested improved fertility (most probably by improving implantation of embryos) The aim of this study is to prospectively record embryonal implantation rate during IVF in patients with CSDs, and to evaluate the effect of hysteroscopic repair of CSDs on fetal implantation during IVF.

Detailed description: 150 patients undergoing IVF after cesarean section will be recruited. demographic, clinical and treatment data will be collected. ultrasound and hysteroscopic evaluation of the CSD will be performed. IVF treatment will be provided. In case of failure of IVF treatment, patients will be randomized to hysteroscopic repair of CSD versus second IVF treatment

Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF after cesarean section

Exclusion Criteria:

* Patients who underwent CSD repair
* Patients with low ovarian reserve
* Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps

Primary outcomes:
measure: Embryo implantation rate
timeFrame: completion of two IVF cycles after randomization - approx. 2 months
Secondary outcomes:
measure: Fluid in Uterus
timeFrame: completion of two IVF cycles after randomization - approx. 2 months
measure: Correlation between size and type of the defect fluid accumulation
timeFrame: completion of two IVF cycles after randomization - approx. 2 months
measure: Correlation between the size and type of the defect and implantation rate during IVF treatment
timeFrame: completion of two IVF cycles after randomization - approx. 2 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The chaim sheba medical center,Tel Hashomer
Study officials:
References:
Clinical trial NCT05020886: Turning Performance in Stroke
Official title: Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke

Brief summary: Turning is a challenging task for stroke patient. Previous studies showed that turning is one of the activities which resulting in falling frequently in stroke. However, the assessment tool of turning performance is still lack of reliability and validity. Furthermore, the main factors which affected turning ability in stroke are not approved yet.


Eligibility criteria: Inclusion Criteria:

* 6 months after first stroke.
* Able to independently walk 7 meter at least without any device
* MMSE score ≧ 24

Exclusion Criteria:

* Unstable medical conditions (such as deep vein thrombosis)
* Any disease which has known affecting walk(heart failure, diabetes)

Primary outcomes:
measure: Turning angle
timeFrame: 10 minutes
measure: Turning time
timeFrame: 10 minutes
measure: Turning step
timeFrame: 10 minutes
measure: Single leg supported time during turning
timeFrame: 10 minutes
measure: Swing time during turning
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06823986: Extraction Space Consumption and Overjet Reduction After Maxillary Anterior Enmasse Retraction in Orthodontics
Official title: The Relation Between Extraction Space Consumption and Overjet Reduction During Maxillary Anterior En-Masse Retraction by Two Levels of Force Application
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Extraction Space Consumption and Overjet Reduction
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Extraction space consumption and overjet reduction after maxillary anterior enmasse retraction in orthodontics

Detailed description: The Relation between Extraction Space Consumption and Overjet Reduction during Maxillary Anterior En-Masse Retraction by Two Levels of Force Application

Eligibility criteria: Inclusion Criteria:

* 1. Young adult male and female patients (Age range from 18 to 25 years) with maxillary dental protrusion.

  2. Patients with Angle class I or class II division I malocclusion with maxillary anterior teeth protrusion and proclination. 3. Skeletal class I. 4. Healthy compliant and motivated patient. 5. No missing of any tooth except wisdom teeth. 6. Good oral hygiene.

Exclusion Criteria:

* 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Smoking history. 5. Presence of periodontal diseases. 6. Previous maxillary anterior surgery. 7. Gingival overgrowth.

Primary outcomes:
measure: extraction space consumption and amount of overjet reduction in millimeters.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Omnia Megahed Hussein Hemeid
state: Helwan
Study officials:
affiliation: Professor of orthodontics
name: Samir Abdo Ibrahem, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06128486: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens
Official title: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Yung Sheng Optical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.


Eligibility criteria: Inclusion Criteria:

1. The subject must sign the informed consent form.
2. The subject must be at least 20 years of age as of the date of evaluation for the study.
3. The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
4. The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
5. The subject must have normal eyes, except ametropia.
6. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
7. The subject must appear able and willing to fill the daily card.

Exclusion Criteria:

1. The subjects who need to use ophthalmic medicine for therapy.
2. The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
3. The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
4. The subjects who have clinically significant tear secretion abnormal.
5. The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.

Primary outcomes:
measure: The effectiveness of corrected visual acuity
timeFrame: 3 Months
Secondary outcomes:
measure: Lens fitting (Lens position)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
measure: Lens fitting (Lens movement)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
measure: Lens fitting (Lens edge)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Other outcomes:
measure: Safety evaluation
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Mackay Memorial Hospital
name: Huey-Chuan Cheng, MD / MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri-Service General Hospital
name: Ming-Cheng TAI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388163: Gentian Violet Treatment for Hidradenitis Suppurativa
Official title: Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: HS
Gentian Violet
nonsurgical treatment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a survey study being conducted to describe how subjects with Hidradenitis suppurativa (HS) respond to treatment with gentian violet. The study will rely primarily on qualitative survey responses and quantitative changes in skin appearance.

Detailed description: Hidradenitis suppurativa (HS) is a chronic disease of the folliculopilosebaceous unit, often found in intertriginous areas of the body. The pain and impairment of HS leads patients to report a decreased quality of life, even in comparison to other debilitating cutaneous disease states. Pharmalogic management of HS can vary from topical antibiotics or intralesional corticosteroids for mild cases to immunosuppressants and biologic agents in refractory cases. Gentian violet is a topical antiseptic used to treat many cutaneous yeast infections. It also has a role in improving wound healing in sites of active ulceration. It is our hypothesis that gentian violet will help minimize skin trauma in sites of active HS to promote improved wound healing and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.

Exclusion Criteria:

* Exclusion criteria include children, absent HS lesions at the time of clinic, and cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.

Primary outcomes:
measure: Skin's Redness
timeFrame: baseline pre-treatment
measure: Skin's Redness
timeFrame: 1 month post-treatment
measure: Skin's Drainage
timeFrame: baseline pre-treatment
measure: Skin's Drainage
timeFrame: 1 month post-treatment
measure: Skin's Pain
timeFrame: baseline pre-treatment
measure: Skin's Pain
timeFrame: 1 month post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rita Pichardo-Geisinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774263: The Acceptability of a Real-time Localization for Patients and Caregivers
Official title: The Acceptability of a Real-time Localization of Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease
Keywords: Acceptability study
new technologies
health sector
real time location system
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Gerontopole Auvergne Rhone-Alpes (AURA)
name: Saint Etienne School of Mine
First posted: 2021-03-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population who have been hospitalized at least once and caregivers who works in emergency service

Brief summary: Technological innovations are taking over our daily lives, particularly in the health sector. Real-time location systems for healthcare professionals and patients are developing in hospitals. Today few studies have focused on the acceptability of this new technology. The present research, which aims to study the acceptability of a real-time localization systems, reveals a definite utility and acceptability from the patient's point of view, subject to conditions. Indeed, the guarantee of data security and the concrete interest for the patient must be explained. For healthcare professionals working in emergency departments, the usefulness of new technologies in their work is now well established. Nevertheless, the acceptability of a real-time location systems received lukewarm reviews. It depends mainly on reticence linked to the fear of a possible deviation in the use of the data collected.

Detailed description: study the acceptability of a real-time localization of patients and caregivers

Eligibility criteria: Inclusion Criteria:

* For general population : people have been hospitalized at least once
* For caregivers : works in emergency service

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship

Primary outcomes:
measure: opinion and representations about a real time localization system
timeFrame: Days:30
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Gérontopole AURA
Study officials:
affiliation: augusto@emse.fr
name: Vincent Augusto
role: STUDY_DIRECTOR
References:
Clinical trial NCT03123263: Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer
Official title: Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early stage HER 2 + breast cancer

Brief summary: This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Detailed description: Transtuzumab based chemo-immunotherapy is commonly administered to patients diagnosed with early stage HER-2 expressing breast cancer, because it decreases the risk of relapse.

Transtuzumab affects cardiac function and potential benefits in decreasing cancer recurrence have to be balanced against short and long term toxicity.

We have previously identified a high prevalence of metabolic syndrome and type II diabetes mellitus in our patients with breast cancer. These patients may be particularly susceptible to cardiotoxic effects of transtuzumab based therapy.

Aim of this study is to assess the changes in the cardiac function of women who are undergoing transtuzumab based therapy for early stage breast cancer.

Eligibility criteria: Inclusion Criteria:

* Stage 1,2,3 breast cancer
* Her2+

Exclusion Criteria:

* Stage 4 cancer

Primary outcomes:
measure: LVEF
timeFrame: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)
Secondary outcomes:
measure: Number of Participants Hospitalized for Cardiac Issues.
timeFrame: 1 year
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Ttuhsc
state: Texas
Study officials:
affiliation: TTUHSC El Paso
name: Sumit Gaur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214863: AcrySof Toric Clinical Results
Official title: Clinical Results With the AcrySof Toric Intraocular Lens (IOL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataracts
Astigmatism
Keywords: Toric Intraocular Lens (IOL)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)

Brief summary: This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator

Exclusion Criteria:

* Ocular comorbidities affecting visual outcome data,
* Prior refractive surgery,
* Irregular astigmatism

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 day to 6 months
Secondary outcomes:
measure: Postoperative refractive cylinder
timeFrame: 1day to 6 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
citation: Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.
Clinical trial NCT03543163: Treatment of Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft
Official title: The Evaluation of Recession Depth After Treating Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: buccal fat pad graft
sub-epithelial connective tissue graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 24
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: This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II gingival recession


Eligibility criteria: Inclusion Criteria:

1. Patients are systemically healthy based on questionnaire dental modification of Cornell index.
2. Patients are periodontally healthy with no contraindication for periodontal surgery.
3. All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
4. O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
5. Buccal recession defects are classified as Miller Class I or II.
6. Presence of identifiable CEJ.
7. The papilla fill the interdental spaces as far as the contact area
8. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

1. Miller Class III or IV recession defects
2. Pregnant female.
3. Smokers as smoking is contraindicated for any plastic periodontal surgery
4. Patients with special needs or with any mental problems.
5. Patients undergoing radiotherapy
6. Teeth with carious or non-carious lesion or cervical restorations
7. Rotated teeth and tooth extrusion with or without occlusal abrasion
8. Patient undergone any prior periodontal surgery in the relevant region.

Primary outcomes:
measure: Recession Depth
timeFrame: 6 months
Secondary outcomes:
measure: Thickness of keratinized tissue
timeFrame: 6 months
measure: Post-operative pain
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06408363: Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
Official title: Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Barotrauma;Ear
Tympanum; Perforation
Keywords: Barotrauma
Tympanic Membrane Perforation
Eustachian Tube
Hyperbaric Oxygenation
Lead sponsor: Hospital Felicio Rocho
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. Several pressurization protocols have been proposed to reduce the incidence of this trauma, but barotrauma is still the main cause of poor adherence to hyperbaric therapy. Therefore, this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing the first hyperbaric session.
* Understanding and properly carrying out equalization maneuvers

Exclusion Criteria:

* Patients who did not understand the equalization maneuvers
* Patients with specific contraindications to hyperbaric therapy
* Patients with acute middle ear or tympanic membrane disease

Primary outcomes:
measure: Incidence Reduction of Barotrauma
timeFrame: Until completion of the study, on average 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
state: Minas Gerais
Study officials:
References:
Clinical trial NCT01649063: Comparing the Shape and Frequency of Uterine Contractions
Official title: Principle Investigator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Contractions
Delivery
Keywords: Uterine contraction;
Shape; Frequency;
First stage labor;
Fall
Rise ratio.
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primiparous women

Brief summary: Dystocia is the most common indication for primary cesarean section. The most common cause of dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more attention is usually paid on fetus and pelvic rather than on the role of uterine contraction in delivery. So we decided to determine the relationship between dystocia and uterine contraction patterns.


Eligibility criteria: Inclusion Criteria:

* age 18-35 years
* singleton pregnancy with cephalic term presentation
* tendency to do vaginal delivery
* having no medical or mental diseases
* having no pregnancy complications
* Intact membranes
* BMI\<26

Exclusion Criteria:

* using oxytocin before and during the monitoring of contractions
* performing cesarean section for any reason except arrested delivery or pelvic constriction
* the birth weight\< 2500 or \>4000
* using the analgesia such as epidural anesthesia morphine and pethidine during the study

Primary outcomes:
measure: the shape and frequency of uterine contractions
timeFrame: up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: