louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04441268: Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract
Official title: Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 335
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CC patients underwent surgery of cataratc extraction and primary intraocular lens (IOL) implantation at the Zhongshan Ophthalmic Center between 2010 and 2016 were recruited.

Brief summary: The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Detailed description: Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital cataract. The developmental profile of refraction among patient with congenital catarat is has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC children.After primary IOL implatation, routine examinations including retinoscopy were completed. Data were analysed to to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract and to explore key factors associated with the rate of change.

Eligibility criteria: Inclusion Criteria:

* Children with uncomplicated surgeries
* Children with unilateral/bilateral cataract

Exclusion Criteria:

* Corneal diseases
* Lens luxation
* Glaucoma
* Retinal diseases
* Nystagmus and nanophthalmos

Primary outcomes:
measure: The refraction status (presented as spherical equivalent, SE)
timeFrame: up to three years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: SunYat-sen University
name: Chen Weirong, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02279368: Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment
Official title: Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abuse Neglect Social
Deprivation, Maltreatment Syndrome (Infant or Child)
Lead sponsor: Adwin Life Care
Sponsor class: INDUSTRY
Collaborators: name: Sonal Foundation, India
name: Gyaansanjeevani, Jhunjhunu, Rajasthan, India
name: Khatri education trust, Satnaali, Hariyana, India
First posted: 2014-10-31
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In Northern India, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades. Since families cannot know the sex of the fetus due to Indian government policies, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'.


Eligibility criteria: Inclusion Criteria:

* Families having girl child before
* High risk families with high expectation of having son

Exclusion Criteria:

* Families having son before
* Relocation and moving out of town during study period
* Not ready to consent for intervention

Primary outcomes:
measure: Mother-infant interaction (Parent/Caregiver Involvement Scale)
timeFrame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
Secondary outcomes:
measure: Abuse and neglect outcomes (reported incidences of abuse and maltreatment)
timeFrame: Upto six weeks reported incidences of abuse and maltreatment
Other outcomes:
measure: Child survival rate (reported incidences of injuries and emergencies)
timeFrame: Upto six weeks reported incidences of injuries and emergencies
Locations:
city: Mahesana
country: India
facility: Sonal Foundation
state: Gujarat
city: Satnali
country: India
facility: Khatri educational trust
state: Hariyana
city: Jhunjhunu
country: India
facility: GyanSanjeevani
state: Rajasthan
Study officials:
affiliation: Sonal Foundation, India
name: Alpesh Barot, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Macmillan Research Group
name: Valerie Murray, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00922168: Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
Official title: Pre-operative PSG Assessment of Cardiac Surgery Inpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Central Sleep Apnea
Keywords: Sleep
apnea
obstructive
central
Lead sponsor: Cleveland Medical Devices Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: The Cleveland Clinic
name: Johns Hopkins University
First posted: 2009-06-17
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac surgery patients

Brief summary: The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
* Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

Exclusion Criteria:

* Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
* Subjects undergoing Maze procedure for atrial fibrillation.
* Subjects unable to comply with study procedures.

Primary outcomes:
measure: Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients
timeFrame: September 2009
Secondary outcomes:
measure: Assess Post-Operative Complications of Patients with Sleep Disordered Breathing
timeFrame: September 2009
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Cleveland Medical Devices Inc
name: Hani A Kayyali, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Nancy Foldvary, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Nancy Collop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05182268: Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Official title: Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 186
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients who postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal bone.
2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery.
3. have completely clinical characteristics, follow-up data and/or postoperative audiometric data

Brief summary: Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.

Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.


Eligibility criteria: Inclusion Criteria:

* postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
* the extent of disease was confirmed by preoperative HRCT temporal bone
* undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery

Exclusion Criteria:

* were lacking in clinical characteristics
* had not preoperative audiometric data
* missed the follow-up data
* were lacking in surgical times
* were microscopic combined endoscopic ear surgery

Primary outcomes:
measure: Pure Tone Average(PTA)
timeFrame: at least 1 year
measure: Air-Bone Gap(A-B Gap)
timeFrame: at least 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02613468: Periodontal Condition in Pregnancy and Low Birth Delivery Incidence
Official title: A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Birth Weight
Periodontal Diseases
Keywords: Pregnancy
Low birth weight
Gingivitis
Inflammation
Periodontitis
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 269
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.

Detailed description: This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used.

Eligibility criteria: Inclusion Criteria:

* Age:18-35 years
* Sure of her dates

Exclusion Criteria:

* systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
* Less than two pregnancy

Primary outcomes:
measure: Number of pregnancies
timeFrame: At 9th months
measure: Birth weight
timeFrame: At 9th months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: average of 2nd months, 5th months and 8th months
measure: Clinical attachment level
timeFrame: average of 2nd months, 5th months and 8th months
measure: Gingival index
timeFrame: average of 2nd months, 5th months and 8th months
measure: Plaque index
timeFrame: average of 2nd months, 5th months and 8th months
measure: Bleeding on probing
timeFrame: average of 2nd months, 5th months and 8th months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03416868: Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback
Official title: Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fold Nodules
Muscle Tension Dysphonia
Keywords: Ambulatory
Biofeedback
Voice
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-01-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.

Detailed description: This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Eligibility criteria: Inclusion Criteria:

* Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Exclusion Criteria:

* If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.

Primary outcomes:
measure: Percent Compliance
timeFrame: Week 1, Week 2, Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation
state: Massachusetts
Study officials:
affiliation: Mass General Hospital, Harvard, MGH IHP
name: Robert E Hillman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05716568: Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta
Official title: Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta: A Prospective Study Based on Patient Heart Rate and Body Surface Area Differences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Keywords: CT-angiography
Aortic aneurysm
Aortic dissection
Pre-operative
Contrast dose reduction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.

Detailed description: Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.

For this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.

An in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.

A total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).

Eligibility criteria: Inclusion Criteria:

* Patients requiring CT-angiography of the aorta as requested by clinician
* For aneurysm detection or follow-up
* Or for dissection follow-up
* Thoraco-abdominal aorta or abdominal aorta

Exclusion Criteria:

* Contra-indications for contrast administration (severe renal impairment or adverse reactions)
* Previously endovascular repair of the aorta
* Only thoracic aorta
* No informed consent
* Contrast injection at 4cc/second not possible

Primary outcomes:
measure: Reduction in contrast dose
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Geert Maleux, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06613568: Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Official title: Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Subjects With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Keywords: Renal Disease
Hemodialysis Complication
Kidney Diseases
Dialysis
Renal Dialysis
Hemodialysis, Home
Renal Insufficiency
Kidney Failure, Chronic
Lead sponsor: Diality Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners


Eligibility criteria: Inclusion Criteria:

* Are between 18 and 75 years of age and Care Partner is at least 18 years of age at the time of signing consent
* Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Run-In Period
* In the opinion of the Investigator, have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of the Run-In Period
* In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period

Exclusion Criteria:

* Hgb level of \< 9 g/dL at Screening
* Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:

  1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
  2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
  3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
* Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study

Primary outcomes:
measure: Weekly Standardized Dialysis Adequacy
timeFrame: Up to 16 weeks
measure: Adverse Event Rate
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Goal Ultrafiltration Volume
timeFrame: Up to 22 weeks
measure: Incidence of Pre-Specified Adverse Events
timeFrame: Up to 22 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Diality Inc.
name: Jennifer Joe, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05756946: Guided Tissue Regeneration With a Periodontal Dressing
Official title: Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years.

  * A minimum of 18 teeth, wisdom teeth excluded.
  * Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss \>30%.
  * Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
  * Presence of at least three teeth per quadrant.

Exclusion Criteria:

* Periodontal treatment in the last 3 years.

  * Antibiotic intake 6 months before • the screening visit.
  * Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).

Primary outcomes:
measure: Pain experience
timeFrame: 14 days
Secondary outcomes:
measure: Probing pocket depth
timeFrame: 6 months
measure: Attachment level
timeFrame: 6 months
Other outcomes:
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Mahmoud Abu-Ta'a
Study officials:
affiliation: Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
name: Mahmoud Abu-Ta'a
role: PRINCIPAL_INVESTIGATOR
References: