louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06519409: Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation
Official title: Comparative Treatment Evaluation of Human Mandibular Class II Furcation Defects Using Bone Grafts and Antimicrobial Photodynamic Therapy-A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Furcation Defects
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.

Detailed description: To test the efficacy of photodynamic therapy (Indocyanine green) along with placement of xenograft (Cerabone®-Natural bovine bone grafting material, Botiss biomaterials) to treat a class II furcation defects. The topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. In the control group, the defects were filled with xenograft (Cerabone®) whereas the test group received photodynamic therapy (Indocyanine green) in addition to grafting. Radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.

Eligibility criteria: Inclusion Criteria:

Systemically healthy subjects Age group of 25-60 years Presence of class II furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation.

Vertical probing depth (VPD) ≥4mm Horizontal probing depth (HPD) ≥4 mm Gingival margin (GM) coronal to or at the level of the roof of the furcation

Exclusion Criteria:

Current and former smokers Administration of antibiotics in the last 6 months History of any periodontal therapy in the past 6 months Known allergic responses to bovine derived graft materials and photosensitizers.

Pregnant and lactating women.

Primary outcomes:
measure: percentage of bone fill
timeFrame: 9 months
Secondary outcomes:
measure: Clinical efficacy
timeFrame: 9 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Dr. Prabhuji MLV
state: Karnataka
Study officials:
References:
Clinical trial NCT04101409: Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
Official title: Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuroma, Acoustic
Keywords: decision aids
shared decision making
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with acoustic neuroma had several treatment options. One of standard treatment is to receive the Gamma knife stereotactic radiosurgery, other options included suboccipital craniotomy and conservative treatment. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits their needs.

The investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on acoustic neuroma patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and post-treatment depression. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility criteria: Inclusion Criteria:

1. Patients with acoustic neuroma.
2. Tumor diameter ≤ 3.5cm.
3. The tumor type is Schwannoma.

Exclusion Criteria:

1. Patients with acoustic neuroma less than 20 years old
2. Pregnant woman
3. Patients can not cooperate with Gamma Knife treatment
4. Patients with acoustic neuroma who do not have their own abilities
5. Tumor diameter \> 3.5cm.

Primary outcomes:
measure: Decisional conflict
timeFrame: 4 weeks after discussion of treatment choice
measure: Knowledge
timeFrame: 4 weeks after discussion of treatment choice
Secondary outcomes:
measure: Decision regret
timeFrame: 4 weeks after treatment
measure: Post-treatment depression
timeFrame: 4 weeks after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03339609: Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
Official title: Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Urologic Diseases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2017-11-13
Enrollment: 83
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: continent children with normal development: community sample

Brief summary: Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. In regard to this, the International Continence Society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. Despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population.

The initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. In addition, the influence of several factors on uroflow parameters was analysed to complement current literature.


Eligibility criteria: Inclusion Criteria:

• Normal development

Exclusion Criteria:

* (Recurrent) urinary tract infections
* LUTS which interfered with daily life
* Fecal incontinence
* History of genitourinary or renal surgery
* Medication for incontinence during the last 3 months
* Pelvic reeducation during the last 6 months
* Neurologic problems influencing continence

Primary outcomes:
measure: Uroflow curve pattern - Clinical assessment
timeFrame: 2017
measure: Uroflow curve pattern - Mathematical assessment
timeFrame: 2017
Secondary outcomes:
measure: Maximal flow
timeFrame: 2017
measure: post-void residual urine
timeFrame: 2017
measure: voiding time
timeFrame: 2017
measure: voided volume
timeFrame: 2017
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
References:
Clinical trial NCT01803009: Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Official title: Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.


Eligibility criteria: Inclusion Criteria:

* Age 50-75 years old
* No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year.
* Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.

Exclusion Criteria:

* Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
* Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
* Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
* Inability to speak and read English

Primary outcomes:
measure: Satisfaction with NCI CRC RAT
timeFrame: 1 day
measure: Perceived risk of developing CRC
timeFrame: 1 day
measure: Intent to be screened within six months
timeFrame: 6 months
measure: Stage of readiness to screen
timeFrame: 1 day
measure: Preferred CRC screening test
timeFrame: 1 day
Secondary outcomes:
measure: Uptake of CRC screening
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
Study officials:
affiliation: IU School of Medicine
name: Peter H. Schwartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918632: Food Effect Study Of AG-013736 In Healthy Volunteers
Official title: A Phase I Open-Label Study In Healthy Volunteers To Compare The Plasma Pharmacokinetics of Polymorph Form XLI AG-013736 In The Fasted And Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: food-effect pharmacokinetics AG-013736 food fasting
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study is designed to evaluate the effect of food on typical blood levels obtained after oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a high-fat, high-calorie meal.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence of history of clinically significant blood, kidney, endocrine, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Active smokers or users of other tobacco products as well as users of certain drugs.
* Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone (FSH) test results at Screening.

Primary outcomes:
measure: To assess the effect of a high-fat, high-calorie meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers.
timeFrame: 2 months
Secondary outcomes:
measure: To assess the effect of a moderate-fat, standardized meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers.
timeFrame: 2 months
measure: To assess the safety and tolerability of single-dose polymorph Form XLI AG-013736 when administered with a high-fat, high-calorie meal, a moderate-fat, standard-calorie meal and overnight fasting in healthy volunteers.
timeFrame: 2 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06883032: Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
Official title: Validation of the QuickSee Plus Device
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Refractive Errors
Keywords: refractive errors
eyeglasses
Lead sponsor: PlenOptika, Inc.
Sponsor class: INDUSTRY
Collaborators: name: New England College of Optometry
name: National Eye Institute (NEI)
First posted: 2025-03-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.


Eligibility criteria: Inclusion Criteria:

* who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale
* who are aged between 18 years and 65 years

Exclusion Criteria:

* whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C)
* who are unable to provide consent
* who have undergone any eye surgery
* who have a history of ocular disease
* who are taking systemic drugs
* who wear more than one pair of single vision eyeglasses for distance
* who more than occasionally wear soft contact lenses
* who are unable and unwilling to wear the eyeglasses provided by the study for the required duration

Primary outcomes:
measure: Patient Preference
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England College of Optometry (NECO) Center for Eye Care of Commonwealth
state: Massachusetts
Study officials:
References:
citation: Joseph S, Varadaraj V, Dave SR, Lage E, Lim D, Aziz K, Dudgeon S, Ravilla TD, Friedman DS. Investigation of the Accuracy of a Low-Cost, Portable Autorefractor to Provide Well-Tolerated Eyeglass Prescriptions: A Randomized Crossover Trial. Ophthalmology. 2021 Dec;128(12):1672-1680. doi: 10.1016/j.ophtha.2021.05.030. Epub 2021 Jun 7.
Clinical trial NCT02236832: Study of the Neural Basis of Analogical Reasoning
Official title: Organisation du Cortex préfrontal ventrolatéral Pour l'Analogie: Approche Bimodale Chez le Sujet Sain et Chez le Patient Ayant un Syndrome Frontal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frontotemporal Dementia
Progressive Supranuclear Palsy
Healthy Subjects
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Fondation pour la Recherche Médicale
First posted: 2014-09-11
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Frontal patients are impaired in categorisation and analogical reasoning tasks, and different functional imaging studies from our group have shown the involvement of the prefrontal cortex in categorisation and analogy tasks. The aim of this project is to test our hypotheses about the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.


Eligibility criteria: Inclusion Criteria:

Healthy subjects:

* subject affiliated to national health insurance
* informed consent signed
* normal neurological examination
* subject aged at least 20

Patients:

* FTD or PSP diagnostic criteria filled
* patient affiliated to national health insurance
* informed consent signed

Exclusion Criteria:

* Severe psychiatric symptomatology and psychotropic drug use
* unability to understand or perform the cognitive tasks.

Primary outcomes:
measure: Performance in the implicat task
timeFrame: day of inclusion (one day)
measure: Performance in the Similitude task
timeFrame: from inclusion to 4 months after inclusion
Secondary outcomes:
measure: recording of EEG
timeFrame: day of inclusion (one day)
measure: Analysis of MRI
timeFrame: day of inclusion (one day)
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM (Institut du cerveau et de la Moelle épinière)
Study officials:
affiliation: Institut du Cerveau et de la Moelle épinière, Paris
name: Richard Levy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04012632: Kisspeptin/GPR54 Pathway and Early Puberty
Official title: Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Puberty, Precocious
Keywords: SNP
kisspeptin
GPR54
Lead sponsor: Shenzhen Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2019-07-09
Enrollment: 628
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen

Brief summary: There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset varies greatly among individuals, and much of this variation is modulated by genetic factors. This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway genes and the risk of early puberty in Chinese Han girls.


Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of central precocious puberty or early and fast puberty.

Exclusion Criteria:

* The participants who were not the first visit to the hospital and had been treated before.
* The participants who were with endocrine disorders.

Primary outcomes:
measure: the polymorphism in the KISS1/GPR54 pathway genes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Li D, Wu Y, Cheng J, Liu L, Li X, Chen D, Huang S, Wen Y, Ke Y, Yao Y, Su Z, Zhou L. Association of Polymorphisms in the Kisspeptin/GPR54 Pathway Genes With Risk of Early Puberty in Chinese Girls. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz229. doi: 10.1210/clinem/dgz229.
Clinical trial NCT03347032: Remote Ischemic Preconditioning for Renal Protection in TAVI
Official title: Remote Ischemic Preconditioning for Renal Protection in Patients Undergoing Transcatheter Aortic Valve Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Renal Insufficiency
Contrast-induced Nephropathy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 46
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: Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.


Eligibility criteria: Inclusion Criteria:

- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention

Exclusion Criteria:

* Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
* Systemic hypotension (systolic blood pressure \< 90mmHg)
* Patients currently on hemodialysis
* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
* Patients enrolled in other active cardiovascular investigational studies
* Severe comorbidities with a life expectancy of less than 6 months
* Pregnant or lactating women
* Patients unable to provide consent
* Patients taking the medication glibenclamide for treatment of diabetes

Primary outcomes:
measure: Renal function as a measured by serum creatinine
timeFrame: 48-72 hours
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 6 months
measure: Clinical Outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: William O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References: