louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01574378: Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
Official title: Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Open Surgical Wounds
Keywords: Abdominoplasty
Lead sponsor: Grigoryants Medical Corporation
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 32
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: VLock suture studied in abdominal wound closure. Time and cosmesis was studied


Eligibility criteria: Inclusion Criteria:

* lipoabdominoplasty patients

Exclusion Criteria:

* poor health,
* history of radiation,
* smoking

Primary outcomes:
measure: closure time
timeFrame: 1 day
Secondary outcomes:
measure: Safety- number of complications
timeFrame: 12 months
measure: Cosmesis
timeFrame: 12 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Vladimir Grigoryants, MD
state: California
Study officials:
References:
Clinical trial NCT01547078: Clinical Study of Lyophilized Plasma in Patients With Liver Disease
Official title: A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Liver Disease
Lead sponsor: HemCon Medical Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients at least 18 years of age.
2. Patients with liver disease.
3. Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
4. Patients with an elevated international normalized ratio due to liver disease.
5. Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
6. Patients able and willing to comply with the procedures laid out in the study protocol.

Exclusion Criteria:

1. Patients who are clinically unstable.
2. Patients who have received mediations that could interfere with results of laboratory testing.
3. Patients who have congenital or acquired coagulopathies of non-hepatic origin.
4. Pregnant or nursing women.
5. Active illicit drug use.
6. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
7. Patients previously enrolled in this study.

Primary outcomes:
measure: Assess and compare adverse events
timeFrame: Duration of Study (Less than or equal to 7 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00616278: National Cooperative Growth Study in CKD
Official title: National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End-Stage Renal Disease (ESRD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Keywords: Growth Failure AND
Chronic Renal Insufficiency OR
End Stage Renal Disease
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric clinic

Brief summary: The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.


Eligibility criteria: Inclusion Criteria:

* Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease

Exclusion Criteria:

* Greater than 18 years old
* Not a patient at the UC Davis Medical Center pediatric clinic

Primary outcomes:
measure: The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated.
timeFrame: per the study, the pt will be on GH treatement until the physician instructs them to stop
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Lavjay Butani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06220578: Analysis of Topographic Corneal Parameters
Official title: Analysis of Topographic Corneal Parameters in a Large Cohort of Corneal Refractive Surgery Candidates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornea
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 2694
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients examined in Roaa LASIK center from both sexes between 18-45 years seeking corneal refractive surgery

Brief summary: The Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery

Detailed description: Retrospective non randomized study Analysis of different corneal paremeters obtained by Pentacam for corneal refractive surgery candidates during last 3 years from both sexes between 18 and 45 years K1 - K2 - K max - Pachymetry apex - Pachymetry thinnest - Distance between apex and thinnest - Back elevation - Topography shape - Keratoconus (If present)

Eligibility criteria: Inclusion Criteria:

* Persons from both sexes between 18 and 45 years seeking corneal refractive surgery

Exclusion Criteria:

* Previous intraocular surgery
* Previous corneal surgery
* Corneal opacity

Primary outcomes:
measure: corneal curvature
timeFrame: 7 months
measure: corneal pachymetry
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Minia University
name: Ahmed Abdelghany, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05200078: Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer
Official title: Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Cardiac Event
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-01-20
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with left-sided breast cancer planning for adjuvant radiotherapy

Brief summary: Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.

Detailed description: Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.

Eligibility criteria: Inclusion Criteria:

* Primary left-sided breast cancer post surgery
* Planning for adjuvant breast/chest wall +-RNI

Exclusion Criteria:

* History of cardiovascular disease
* Previous chest radiation
* Bilateral breast cancers

Primary outcomes:
measure: Incidence of clinical or subclinical cardiac injury
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT05553678: The Effect of MDZ on Movement During UIA Clipping
Official title: Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intraoperative Movement
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo elective unruptured intracranial aneurysm clipping surgery
* American Society of Anesthesiologists grade 1,2,3
* age \> 18 year old

Exclusion Criteria:

* Refuse to participate to the study
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* Allergic history of benzodiazepine
* Pregnant

Primary outcomes:
measure: Intraoperative movement
timeFrame: During microscopic surgery
Secondary outcomes:
measure: Motor evoked potential amplitude
timeFrame: immediately postoperative surgery
measure: Motor evoked potential Latency
timeFrame: immediately postoperative surgery
measure: Duration of mechanical ventilation time
timeFrame: End of surgery to extubation time
measure: Duration of ICU stay
timeFrame: From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week
measure: Satisfaction score for intraoperative environment
timeFrame: immediately postoperative surgery
measure: Postoperative delirium
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00067678: Soy Protein in Early Diabetic Nephropathy
Official title: Soy Protein in Early Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathy
Diabetes Mellitus
Keywords: diabetic nephropathy
nephropathy
diabetes
diabetes mellitus
type I diabetes
soy protein
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary protein has been used to slow down renal disease progression, but patients are often unwilling to make these dietary changes. Other research suggests that changing the quality of dietary protein may be as effective as reducing the total amount of ingested protein. This study hopes to show that soy protein, a plant protein relatively high in essential amino acids and with high nutritional value, maye be beneficial to Type I diabetic patients with incipient renal disease.


Eligibility criteria: Inclusion criteria:

* Age 18-40;
* Diabetic nephropathy;
* Type I diabetes mellitus.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Paolo Fanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00842478: Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia
Official title: Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ventilator-Associated Pneumonia
Nosocomial Pneumonia
Pneumonia
Lead sponsor: Hospital Universitari Joan XXIII de Tarragona.
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 400
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: Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.


Eligibility criteria: Inclusion Criteria:

* Adult intubated patients
* Without evidence of pulmonary infection (randomized within 12h of intubation if they were expected to remain ventilated for longer than 48 hours)

Exclusion Criteria:

* Absence of dental pieces
* Current diagnosis of pneumonia or massive bronchoaspiration
* Tracheostomy (or expected within 48 hours)
* Chlorhexidine allergy

Primary outcomes:
measure: Ventilator-Associated Pneumonia (VAP)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: ICU, Hospital Universitari Joan XXIII
Study officials:
affiliation: Hospital Universitari Joan XXIII
name: Jordi Rello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pobo A, Lisboa T, Rodriguez A, Sole R, Magret M, Trefler S, Gomez F, Rello J; RASPALL Study Investigators. A randomized trial of dental brushing for preventing ventilator-associated pneumonia. Chest. 2009 Aug;136(2):433-439. doi: 10.1378/chest.09-0706. Epub 2009 May 29.
Clinical trial NCT03452878: Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients
Official title: Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aggression
Keywords: Amygdala, neurosurgery, aggressive behavior
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 4
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: Refractory aggressive patients.

Brief summary: Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.


Eligibility criteria: Inclusion Criteria:

* Refractory aggression (Adler et al., 2015) defined by extreme levels of aggression after the use of Risperidone or Aripiprazole ou combination of others psychoactive drugs.

Exclusion Criteria:

* Patients with anatomical alterations that may disrupt the surgery, infections or non-controlled diseases, treatment with other experimental drugs, pregnant women or during lactation, psychological or sociological conditions that will not permit the patient to be accompanied by the medical staff.

Primary outcomes:
measure: Change in Aggression Levels
timeFrame: 48 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 48 months
measure: Follow-up hormones
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Sirio-Libanes
name: Luiz Fernando Reis, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04836078: Role of Simvastatin Microsponges in Treatment of Periodontitis
Official title: Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.

Detailed description: Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.

Eligibility criteria: Inclusion Criteria:

* patients with chronic periodontitis with minimum two sites of pocket depth \> 5 mm
* patients with normal lipid profile
* nonsmokers
* patients free from any systemic disorders
* committed patients to complete the treatment with follow-ups.

Exclusion Criteria:

* patients with hyperlipidemia
* patients taking lipid lowering drugs
* smokers
* pregnant
* Lactating women women, patients with mental or psychological illness and medically compromised patients.

Primary outcomes:
measure: Pocket depth
timeFrame: Before the beginning of study
measure: Pocket depth
timeFrame: By the end of study after 6 months of 6 months
measure: Clinical attachment loss
timeFrame: Before beginning of the study
measure: Clinical attachment loss
timeFrame: By the end of study after 6 months of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT02831478: Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Official title: Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 98
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer


Eligibility criteria: Inclusion Criteria:

* Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Type I, II, III or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria:

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
* Subjects must not have significantly tanned skin.

Primary outcomes:
measure: Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
timeFrame: From the beginning of the study until 24 hours after study
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00473278: Analysis of Human Tear Proteins in Children
Official title: Analysis of Human Tear Proteins in Children: A Pilot Study to Describe the Tear Film Proteome of Pediatric Patients Undergoing Ophthalmic Examination.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Disease
Keywords: tear protein
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 2
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children less than 18 years of age

Brief summary: The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film, and any unique aspects of tears in children. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.


Eligibility criteria: Inclusion Criteria:

* Less than 18 years of age
* A parent or legal guardian provide written informed consent to participate
* Able to cooperate with tear sample collection, or a previously planned sedation for other medical purposes

Exclusion Criteria:

* Age greater than or equal to 18 years
* Patients' parents or legal guardians who refuse to sign study consent

Primary outcomes:
measure: Proteome of Human Tears
timeFrame: Single Exam
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Childrens Hospital
state: Colorado
Study officials:
affiliation: Rocky Mountain Lions Eye Institute
name: Malik Y. Kahook, MD
role: PRINCIPAL_INVESTIGATOR
References: