louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05293392: Improving COVID-19 Vaccine Uptake Among Black and Latino Youth
Official title: Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Healthcare disparities
Vaccine hesitancy
Lead sponsor: Nemours Children's Health System
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: University of Delaware
name: ChristianaCare
First posted: 2022-03-24
Enrollment: 5792
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.


Eligibility criteria: Inclusion Criteria:

* Youth 0-21 years of age and their caregiver
* Receiving care at one of four Nemours primary care practices selected for this study

Exclusion Criteria:

* None

Primary outcomes:
measure: COVID-19 Vaccination Rate for Eligible Children
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delaware
state: Delaware
Study officials:
affiliation: Nemours Children's Health
name: Thao-Ly T Phan-Vo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01419392: Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
Official title: Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Recurrent Miscarriage
Keywords: sildenafil citrate
Doppler Ultrasonography
nitric oxide
total antioxidant capacity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 80
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: The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years
* Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses
* Three or more months have elapsed since the last abortion
* Postmenstrual period
* No other therapy allowed during our treatment course

Exclusion Criteria:

* Concomitant use of organic nitrites, or nitrates
* Severe hepatic, renal, or cardiovascular impairment
* History of stroke or myocardial infarction
* Patients with retinitis pigmentosa.

Primary outcomes:
measure: Uterine arteries blood flow
timeFrame: 21 days
Secondary outcomes:
measure: Nitric oxide serum level as a marked of oxidative stress
timeFrame: 21 days
measure: Total antioxidant capacity serum level as a marker of oxidative stress
timeFrame: 21 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
Study officials:
References:
Clinical trial NCT06759792: Physical Activity on Eye Hand Coordination Post Strabismus Surgery
Official title: Effect of Physical Activity on Eye Hand Coordination in Patient With Strabismus Amblyopia Post Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coordination Impairment
Keywords: amblyopia
strabismus
physical therapy
exercises
eye hand coordination
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2025-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of physical activity on eye hand coordination in patient with amblyopia after strabismus surgery.

Detailed description: Eye hand coordination is essential to many of everyday activities. Strabismus not only affect vision but also affect eye hand activities and coordination. Through this study the patients will apply physical therapy sessions to improve eye hand coordination for strabismus amblyopic patient.

Eligibility criteria: Inclusion Criteria:

* Patients are both males and females.
* Their age will range from (10-14) years.
* Patients received strabismus operation.
* Patients are suffering from strabismic amblyopia
* Patients are suffering from eye hand coordination problems
* Patients will begin the training program after 2 months of operation.
* All types of strabismus surgery will be included.

Exclusion Criteria:

* Patient who didn't complete the physiotherapy training program for 3 months.
* Muscular disorders that will impair performance during training.
* Any organic lesion in the eye.
* Neurological disorders.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders.
* Children who can't understand the therapist's instructions and orders
* Amblyopia which is not related to strabismus condition .

Primary outcomes:
measure: Eye Hand Coordination Test
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: lecturer at faculty of physical therapy, Cairo University
name: Amany R M Abdel Wahid, Doctoral degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02893592: Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy
Official title: Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy (Trans-PRK) for Low and Medium Myopia and Astigmatism: Retrospective Study About 118 Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Were included patients with myopia up to -4D (dioptries) and cylinders up to -3D.

Brief summary: The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a lot of interests: facility and speed of procedure as well as suppression of human variable. Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency


Eligibility criteria: Inclusion Criteria:

* patients with stable refractive error (more than 2 years)
* Myopia up to -4.00 diopters and astigmatism up to -3.00 diopters

Exclusion Criteria:

* Phototherapeutic keratectomy (PTK)

Primary outcomes:
measure: visual acuity
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00297492: Gradual vs. Abrupt Cessation Treatment for Smoking
Official title: Gradual vs. Abrupt Cessation Treatment for Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Tobacco
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-02-28
Enrollment: 750
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 study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.

Detailed description: For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the next 30 days to one of three groups: gradual reduction, abrupt cessation, and minimal intervention.

Eligibility criteria: Inclusion Criteria:

* Interested in quitting gradually
* At least 18 years old
* Daily cigarette smoker
* Smoke at least 15 cigarettes per day (CPD)
* No change greater than 20% in CPD in the last month
* Interested in quitting in next 30 days
* Must agree to not use non-cigarette tobacco during study
* No use of smoking cessation medication in last month
* Have phone with voice mail
* Willing to use nicotine lozenge
* No other person in household in study
* Fluent/literate in English

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Currently using medication for depression or asthma
* Heart disease requiring medication
* Heart attack in last month
* Irregular heartbeat
* High blood pressure not controlled by medication
* Stomach ulcers
* Diabetes

Primary outcomes:
measure: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Human Behavioral Pharmacology Lab
state: Vermont
Study officials:
affiliation: University of Vermont
name: John Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007. Epub 2010 May 26.
Clinical trial NCT03204292: Evaluating the Fluid Balance of Mechanically Ventilated Patients by Ultrasonography
Official title: Measurement of the Inferior Vena Cava as a Method of Evaluating the Fluid Balance of Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Overload
Fluid Loss
Keywords: Inferior vena cava
Fluid responsiveness
Central venous pressure
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 57 mechanically ventilated patients examined. 8 patients were excluded from the study because of spontaneous ventilation within 5 days of data collection. Two patients died during the study. Five patients failed to obtain satisfactory results of imaging of vascular structures during subsequent examination. Data from 42 patients were analyzed.

Brief summary: ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao) depends on the daily balance of fluids.

Detailed description: During the routine abdominal ultrasound, the basilar and abdominal aorta were measured using a Sparq Philips ultrasonograph with a convex probe set in abdominal mode. All measurements were performed in one patient by the same operator who were experienced and performed the appropriate course of ultrasonography. The IVC and abdominal aorta were visualized using a paramedian long-axis view via a subcostal approach according to the methodology described by the American Society of Echocardiography. Inferior vena cava width was assessed at an interval of approximately 1 cm distal from connection of the hepatic vein to the inferior vena cava. No significant changes were observed in the width of the inferior vena cava during various respiratory phases, because of the positive pressure ventilation. The widest value was always chosen for the data. The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava. The width of the inferior vena cava and the abdominal aorta was assessed using transthoracic ultrasound for the following five days. Daily differences in the amount of fluid intake and lost was recorded. CVP measurement was performed.

Eligibility criteria: Inclusion Criteria:

* patients who were hospitalized in the Intensive Care Unit
* severe respiratory failure requiring mechanical ventilation

Exclusion Criteria:

* spontaneous breathing,
* severe vascular disease,
* increased intra-abdominal pressure,
* cardiac pacemaker
* cardioverter defibrillator

Primary outcomes:
measure: fluid balance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Cracow
country: Poland
facility: University Hospital
state: Małopolskie
Study officials:
affiliation: Jagiellonian University
name: Tomasz Skladzien, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707092: Use of Preoperative and Postoperative Antimicrobial Treatment
Official title: Use of Preoperative and Postoperative Antimicrobial Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ear Infection Bacterial
Surgical Site Infection
Antibiotic Side Effect
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in two treatment arms
Primary purpose: OTHER

Brief summary: In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.

One group will receive a single treatment with an antibiotic at induction

The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic

Detailed description: 1. Patients will be asked to participate in the study.
2. Randomization
3. Surgery
4. Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation
5. Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study
* Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)

Exclusion Criteria:

* multiple allergies to antibiotic substances
* therapy with an antibiotic substance within the last 6 weeks
* prior radiation to the head and neck patients undergoing revision surgery
* Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection

Primary outcomes:
measure: Adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Infection of surgical site (immediate)
timeFrame: 1 month
measure: Infection of surgical site (long term)
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
Study officials:
References:
Clinical trial NCT02958592: Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study
Official title: Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Tumor
Hepatic Fibrosis
Keywords: shear-wave elastography
hepatic fibrosis
liver tumor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with liver tumor intend to hepatectomy

Brief summary: To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.


Eligibility criteria: Inclusion Criteria:

* (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter.

Exclusion Criteria:

* (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.

Primary outcomes:
measure: Stage of hepatic fibrosis
timeFrame: within the first 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Minshan Chen
role: STUDY_DIRECTOR
References:
citation: Huang Z, Zheng W, Zhang YJ, Xu L, Chen JB, Chen JC, Chen MS, Zhou Z. Assessing Hepatic Fibrosis Using 2-D Shear Wave Elastography in Patients with Liver Tumors: A Prospective Single-Center Study. Ultrasound Med Biol. 2017 Nov;43(11):2522-2529. doi: 10.1016/j.ultrasmedbio.2017.07.003. Epub 2017 Aug 12.
Clinical trial NCT01411592: Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses
Official title: Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Restauration in Situ
Final Loss of Restauration
Debonded Restauration
Keywords: All-Ceramic
Resin-bonded Fixed Dental Protheses
Single Retainer
Randomized Clinical Trial
Resin Bond
Bonding System
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
First posted: 2011-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.

The aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.


Eligibility criteria: Inclusion Criteria:

* sufficient oral hygiene
* one caries free or almost caries free abutment tooth available
* sufficient space for the retainer wing available
* patients willingness to return at regular intervals for at least 5 years for evaluation

Exclusion Criteria:

* clinical symptoms of bruxism
* collision, full or semi-contact sports (Boxing, Karate)
* pregnant women
* untreated advanced periodontitis

Primary outcomes:
measure: Final Loss of the Restauration
timeFrame: 5 years
Secondary outcomes:
measure: Debonding of the RBFDP
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Kiel
name: Matthias Kern, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German.
Clinical trial NCT01961492: Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
Official title: Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed

Exclusion Criteria:

* severe ulcerative colitis (PUCAI \> 65)

Primary outcomes:
measure: Activity of ulcerative colitis
timeFrame: Within 1 year after the intervention
Secondary outcomes:
measure: Colonic inflammation
timeFrame: Within 1 year after the intervention
measure: Colonic inflammation
timeFrame: Within 1 year after the intervention
measure: Adverse events
timeFrame: Within 1 year after the intervention
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Marko Kalliomäki, MD
role: PRINCIPAL_INVESTIGATOR
References: