louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03221803: Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment
Official title: Patient Satisfaction and Bone Changes in Bilateral Distal Extension Case Using OT Cap Versus OT Vertical Attachment "Randomized Clinical Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Bone Changes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?


Eligibility criteria: Inclusion Criteria:

* patients age ranged between 35-45years old.
* All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.
* The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.
* Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.
* Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment
* The opposing dentition is intact arch with no noticeable over eruption or tilting or restored with acceptable fixed restoration.
* All patients are free from neurological, muscular disorders and tempro-mandibular joint disorders.
* Only patients who can be easily motivated to achieve and maintain good oral

Exclusion Criteria:

* Patient with limited skills
* Un co-operative patients.
* patient with bad oral hygiene

Primary outcomes:
measure: patient satisfaction assessed using questionnaire
timeFrame: 9 months
Secondary outcomes:
measure: bone height
timeFrame: 9 months
measure: bone density
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04191603: TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
Official title: THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Fibroid
Ovary Cyst
Endometrial Hyperplasia
Cervical Dysplasia
Lead sponsor: Alkü Alanya Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
Primary purpose: DIAGNOSTIC

Brief summary: WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

Detailed description: COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

Eligibility criteria: Inclusion Criteria:

* APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria:

* MALIGNANCY

Primary outcomes:
measure: VAGINAL DEHISSENS
timeFrame: 0 DAY-365 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alku Alanya Education and Research Hospital
Study officials:
affiliation: ALKU EDUCATİON AND RESEARCH HOSPITAL
name: MERAL TUĞBA ÇİMŞİR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03318003: Auto-PAP Therapy For Improved Fetal Growth
Official title: Auto-PAP Therapy For Improved Fetal Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Pregnancy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: ResMed Foundation
First posted: 2017-10-23
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old;
* no more than 20 weeks pregnant;
* pregnant with one baby;
* found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study.

Exclusion Criteria:

* more than 20 weeks pregnant;
* pregnant with twins, triplets, or more babies;
* a current smoker, drink alcohol, or use recreational drugs;
* currently using positive-airway pressure therapy for treatment of obstructive sleep apnea;
* diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.

Primary outcomes:
measure: Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
timeFrame: 3rd trimester
Secondary outcomes:
measure: Presence or Absence of Placental Hypoxia
timeFrame: At delivery the placenta will be collected and processed.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Heath System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise M O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03411603: Validation of a Nutrient Profiling System for Reformulation
Official title: Food and Diet Based Validations of a Nutrient Profiling System for Reformulation in Two Nationally Representative Surveys
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Poor
Keywords: nutrient profiling
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-01-26
Enrollment: 6991
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Representative samples of the US and French adult populations

Brief summary: The objectives of the study are to assess the validity of Nestlé reformulation criteria in two national dietary surveys: the US NHANES 2011, and the French INCA2 2006-07.

Detailed description: Background: The Nestlé Nutritional Profiling System (NNPS) has been developed to guide food and beverage reformulation. It is not known whether products passing the NNPS standards have a higher overall nutritional density, and whether the higher consumption of NNPS Pass products is associated with a higher dietary quality.

Objective: The objectives were (i) to compare the classifications derived from the NNPS and the validated UK Ofcom nutrient profiling system; and (ii) to assess the NNPS construct validity against healthy and unhealthy diets in French (Individual and National Survey on food Consumption 2006-2007) and the US (National Health and Nutrition Examination Surveys 2011-2012) nationally representative dietary surveys.

Design: NNPS outcomes (PASS, FAIL, Out-of-scope) of foods were compared to UK Ofcom outcomes. Contributions of NNPS outcomes to energy intakes were compared between diets nutritional quality classes defined by two methods: based on a food-based quality indicator (PNNS-GS in France, HEI-2010 in the US), or on a combination of three nutrient-based indicators (MAR, MER, energy density).

Eligibility criteria: Inclusion Criteria:

* All participants of INCA2 and NHANES 2011-12 surveys

Exclusion Criteria:

* Missing dietary intake data

Primary outcomes:
measure: Healthy Eating Index 2010
timeFrame: 2011-12
measure: PNNS-GS diet score
timeFrame: 2006-07
Secondary outcomes:
measure: Mean Adequacy Ratio
timeFrame: 2006-07 and 2011-12
measure: Mean Excess Ratio
timeFrame: 2006-07 and 2011-12
measure: Energy density
timeFrame: 2006-07 and 2011-12
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Kathryn Porter
role: STUDY_DIRECTOR
References:
Clinical trial NCT00832403: Gore Tex Implants in the Treatment of Atrophic Rhinitis
Official title: Gore Tex Implants in the Treatment of Atrophic Rhinitis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Atrophic Rhinitis
Keywords: atrophic rhinitis
implants
Polytetrafluoroethylene
Lead sponsor: Hospital Felicio Rocho
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.

Brief summary: This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa.

The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment.

All patients have improved after the procedure.

Detailed description: Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.

Eligibility criteria: Inclusion Criteria:

* Symptoms of atrophic rhinitis, with previous clinical treatment without good results

Exclusion Criteria:

* Patients with mental illness

Primary outcomes:
measure: improvement of fetid crusts and atrophy of the mucous bone covering
timeFrame: after surgery recovery
Secondary outcomes:
measure: lack of side effects such as infection
timeFrame: after the treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00611403: Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Official title: Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: LASIK
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 137
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled for bilateral LASIK surgery
* Patient is in good general health
* Eye glasses prescription of -1 to -8

Exclusion Criteria:

* Significant Dry Eye
* Presence of eye disease
* Uncontrolled systemic disease

Primary outcomes:
measure: Percentage of Patients With Clinical Success at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Goblet Cell Density of the Eyes at Month 6
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05301803: An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Official title: A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: electrophysiology
atrial fibrillation
cardiac ablation
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
Collaborators: name: Medicept Inc.
First posted: 2022-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients indicated for EP study or cardiac ablation.

Brief summary: The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

Detailed description: A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.

Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Eligibility criteria: Inclusion Criteria:

* Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
* At least 18 years of age.
* Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Exclusion Criteria:

* Patient inability to understand or refusal to sign informed consent.
* Patient is a prisoner or under incarceration
* Patients who in the opinion of the physician are not candidates for this study.

Primary outcomes:
measure: Baseline Noise Comparison
timeFrame: EP and ablation procedures can take up to six hours
measure: Freedom From Major Adverse Events, Evaluated at Hospital Discharge
timeFrame: From EP procedure to discharge is usually one day.
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: The University of vermont
state: Vermont
Study officials:
affiliation: The University of Vermont Medical Center
name: Nathaniel C Thompson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05955703: Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Guality Life Style
Official title: Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Adherence to Treatment and Healthy Lifestyle Behaviors of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patient
Keywords: Adherence to treatment
healthy lifestyle behavior
hemodialysis
nursing
precede-proceed model
quality of life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.

Detailed description: The Precede proceed model includes structured training phases to bring positive behavior change. The model, which consists of training phases, provides the researcher with the opportunity to identify the problem and the deficiencies that cause the problem, evaluate the quality of life with these deficiencies and develop a health program for its solution. In order to apply the nine-phase model, the individual-patient's voluntary cooperation, determination and active participation in health practices are required.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* Hemodialysis treatment for at least 6 months,
* A total score of 1 or more from the Dialysis Diet and Fluid Restriction Non-Compliance Scale,
* A score between 1 and 7 on the scale of compliance with medical treatment,
* Place, time, person orientation,
* Does not have a psychiatric illness or a problem that prevents written or verbal communication,

Exclusion Criteria:

* Diagnosed with psychiatric illness Individuals with a diagnosis of malignancy wanting to leave research
* Those who do not attend all of the trainings / do not want to continue
* Individuals whose general condition is deteriorated

Primary outcomes:
measure: Evaluation of the Effect of the Training Program based on the Precede-Proceed Model on quality of life style of Hemodialysis Patients
timeFrame: six month
Secondary outcomes:
measure: 2. Evaluation of the Effects of the Continuation Test (follow-up test results 3 months after the post-test) and the Education Program Based on the Pre-Continuation Model on the Quality of Life of Hemodialysis Patients
timeFrame: three month
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References:
Clinical trial NCT06146803: the "Level of Resilience" Influencing Self-care in Heart Failure Patients
Official title: How Much the "Level of Resilience" Influences Self-care in a Group of Subjects Suffering From Heart Failure: Observational, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congestive Heart Failure
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included

Brief summary: Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

Detailed description: Primary objective

-Evaluate levels of resilience in subjects suffering from heart failure.

Secondary objectives

* Evaluate the levels of self-care in subjects suffering from heart failure.
* Evaluate the correlation between the level of resilience and the level of self-care;
* Evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure.

Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included

Eligibility criteria: Inclusion Criteria:

* Subjects suffering from heart failure;
* Subject aged between \>18 years and \<90 years;
* Ability to understand the Italian language;
* Clinical conditions that allow the questionnaire to be completed;
* Ability to provide written informed consent.

Exclusion Criteria:

* Subjects suffering from other forms of diabetes;
* Subjects suffering from serious psychiatric disorders;
* Serious clinical conditions that do not allow the questionnaire to be completed;
* Inability to provide written informed consent.

Primary outcomes:
measure: Evaluate levels of resilience in subjects suffering from heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate levels of self-care in subjects suffering from heart failure
timeFrame: 12 months
measure: Evaluate the correlation between the level of resilience and the level of self-care
timeFrame: 12 months
measure: Evaluate which characteristics positively influence the level of resilience and the degree of self-care of patients with heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCSS
state: RM
Study officials:
References: