louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804323: PASCAL Trabeculoplasty
Official title: Semi-Automated Patterned Laser Trabeculoplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open-Angle Glaucoma
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Argon laser trabeculoplasty (ALT) with 100 ms pulses is an effective therapy for lowering intraocular pressure (IOP). Similar reductions in IOP have been achieved using ns (SLT) and microsecond (MLT) pulses, which produce less thermal damage to trabecular meshwork (TM). Lack of clinically visible changes may make the accurate alignment of subsequent pulses difficult. We describe a novel technique - Patterned Laser Trabeculoplasty (PLT) using the PASCAL Photocoagulator system, and its preliminary evaluation in patients with open angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* 18-year-old patients
* Uncontrolled Open angle (Shaffer IV)
* No previous surgical trabeculoplasty or glaucoma surgery

Exclusion Criteria:

* Patients not willing to participate
* Angle-closure glaucoma
* No clear optical media

Primary outcomes:
measure: Intraocular Pressure
timeFrame: During follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Felix Gil Carrasco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214123: Hypofractionated Radiotherapy for Lung Cancer
Official title: The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to pilot reducing the duration of radiation treatment for lung cancer patients from 6 to 5 weeks using tomotherapy. Specific patient doses will be based on tumor volume being treated. Modeling has shown that increased biologically effective dose (BED) to tumors can be achieved by shortening the radiation delivery schedule and increasing the dose per fraction. This requires decreasing the total dose to hold lung toxicity constant at each dose per fraction level. This is a major paradigm shift in the treatment in this disease and is projected to result in significant improvements in patient outcome as well as a substantial cost savings.


Eligibility criteria: Inclusion Criteria:

* Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria:

* Prior bleomycin or gemcitabine chemotherapy
* Prior thoracic radiotherapy

Primary outcomes:
measure: Grade 3 pneumonitis lasting greater than 2 weeks
timeFrame: 90 days post radiotherapy (XRT)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Anne Traynor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cannon DM, Mehta MP, Adkison JB, Khuntia D, Traynor AM, Tome WA, Chappell RJ, Tolakanahalli R, Mohindra P, Bentzen SM, Cannon GM. Dose-limiting toxicity after hypofractionated dose-escalated radiotherapy in non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4343-8. doi: 10.1200/JCO.2013.51.5353. Epub 2013 Oct 21.
Clinical trial NCT03028623: Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
Official title: A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Method of Tubal Ligation at the Time of Cesarean Section
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 44
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established.

This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.


Eligibility criteria: Inclusion Criteria:

* Subjects must have planned cesarean delivery and desire sterilization
* Subjects must be able to read and provide written informed consent
* Subjects must be English or Spanish speaking

Exclusion Criteria:

* Subjects with known hereditary cancer syndromes
* Subjects with a history of prior tubal surgery
* Subjects with a placenta accreta
* Subjects undergoing trial of labor after cesarean delivery

Primary outcomes:
measure: Time of tubal ligation
timeFrame: at time of procedure
Secondary outcomes:
measure: Total procedure time
timeFrame: at time of procedure
measure: Estimated blood loss
timeFrame: at time of procedure
measure: Rate of aborted procedures
timeFrame: at time of procedure
Other outcomes:
measure: Reoperation rate
timeFrame: within 6 weeks
measure: Length of stay
timeFrame: within 1008 hours
measure: Readmission rate
timeFrame: within 6 weeks
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kate' Pettit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674.
Clinical trial NCT05476523: Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures
Official title: Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eye Movement
Lead sponsor: NeuraLight
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: This is an observational prospective study in a cohort of healthy subjects who are enrolled using convenience and snowballing sampling. The aims of the study is to demonstrate the efficacy of using NeuraLight system to capture oculometric data from healthy participants and to validate the data capture of NeuraLight oculometric measurements as compared with a validated eye-tracker system in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

Detailed description: The purpose of the trial is to demonstrate the efficacy of using NeuraLight system to capture oculometric data from healthy participants, and to validate the data capture of NeuraLight oculometric measurements as compared with a validated eye-tracker system. In addition, we also aim to collect oculometric data from healthy participants in order to optimize a regression model which can be used for future prediction of clinical endpoints in various neurological patients at different stages of disease

Eligibility criteria: Inclusion Criteria:

* Men and women ages between 18 and 90 years old
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form

Exclusion Criteria:

* Inability to sit for 20 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Additional neurological diseases
* Drug or alcohol abuse

Primary outcomes:
measure: Efficacy of data capture
timeFrame: 36 months
measure: Validation of data capture
timeFrame: 36 months
Secondary outcomes:
measure: Optimization of data capture
timeFrame: 36 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: NeuraLight
state: Delaware
Study officials:
affiliation: NeuraLight
name: Eitan Raveh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06489223: Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
Official title: Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
pacifier
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.

This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.

If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation


Eligibility criteria: Inclusion Criteria:

* Infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours,
* Affiliate or beneficiary of a social security scheme,
* With informed consent of the 2 legal representatives.

Exclusion Criteria:

* Known allergy to silicone.

Primary outcomes:
measure: assess the acceptability of the pacifier in the mouth while awake
timeFrame: Day 1 inclusion
Secondary outcomes:
measure: Evaluate the attitude of infants when taking the pacifier in the mouth
timeFrame: Day 1 inclusion
measure: Evaluate whether the pacifier is held in the mouth while awake
timeFrame: Day 1 inclusion
measure: Evaluate how well the pacifier stays in the mouth during sleep
timeFrame: Day 1 inclusion, during the night
measure: Assessment of the safety of the pacifier in infants
timeFrame: Day 1 inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Patricia FRANCO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06562023: Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring
Official title: Botulinum Toxin Versus Mesotherapy on Enhancement of Facial Scarring (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Scars
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.


Eligibility criteria: Inclusion Criteria:

* Patient suffering from vertical or oblique forehead lacerations caused by trauma.
* Recent and fresh wounds.
* Atrophic scar (linear scar).

Exclusion Criteria:

* Infected wound.
* Patient on chemotherapy treatment and history of malignancy.
* Patients suffering from burns on the forehead or complicated lacerations.
* Allergy to drugs used in this study

Primary outcomes:
measure: Change in scar appearance
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in wound width
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02931123: A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cirrhotic Patients Undergoing TIPS Placement
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* consecutive cirrhotic patients undergoing TIPS

Exclusion Criteria:

* age \>75 years; bilirubin levels \>5 mg/dl; creatinine levels \>3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score \>11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score \>18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state \< 26).

Primary outcomes:
measure: incidence of hepatic encephalopathy
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Clinical Medicine
state: RM
Study officials:
References:
Clinical trial NCT00673023: Study the Role of Genetic Variation in the Determining Lipid Profile Response to Dietary Change
Official title: Study the Role of Polymorphism at the CETP Gene Locuse in the Determining Lipid Profile Response to Dietary Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by CETP gene polymorphism.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* History of any cardiovascular diseases
* type 1 diabetes
* type 2 diabetes
* use of lipid-lowering medications
* hypertension
* pregnancy
* Current intake of vitamins and supplements
* History of endocrin disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tabriz University
name: Mohammad Noori, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00138723: Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Official title: A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial.

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.


Eligibility criteria: Inclusion Criteria:

* Overactive bladder syndrome

Exclusion Criteria:

* Less than 8 micturitions in 24 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
citation: Cardozo L, Khullar V, El-Tahtawy A, Guan Z, Malhotra B, Staskin D. Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder. BMC Urol. 2010 Aug 19;10:14. doi: 10.1186/1471-2490-10-14.
citation: Staskin D, Michel MC, Nitti V, Morrow JD, Wang J, Guan Z. Efficacy of fesoterodine over 24 hours in subjects with overactive bladder. Curr Med Res Opin. 2010 Apr;26(4):813-8. doi: 10.1185/03007990903585707.
Clinical trial NCT00947323: Simvastatin for Treating Erectile Dysfunction
Official title: The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Vascular Disease Detected
C Reactive Protein
Keywords: simvastatin
endothelial dysfunction
erectile dysfunction
Lead sponsor: Santa Casa de Porto Alegre
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 41
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.


Eligibility criteria: Inclusion Criteria:

* Erectile dysfunction
* Elevated C reactive protein
* Able to adhere the protocol

Exclusion Criteria:

* Diabetes mellitus
* Cardiac disease
* Cerebral vascular disease
* Hypogonadism
* Any contraindication to simvastatin

Primary outcomes:
measure: Penile erection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04957823: Irisin Expression and Gene Polymorphism in Type II Diabetic Patients With and Without CAD
Official title: Serum Irisin Level & FDNC5 Genetic Polymorphism Can Predict the Presence &Severity of Coronary Artery Disease in Patients With Type II DM?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irisin Gene Polymorphism in Type II Diabetic Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type II diabetic patients with and without coronary artery disease in our center in sohag university hospital.

Brief summary: This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM.


Eligibility criteria: Inclusion Criteria:

* This study will include type II diabetic patients aged between 18 and 45 years old

Exclusion Criteria:

1. Recent acute myocardial infarction.
2. patients with Heart Failure
3. Active infection
4. End stage renal failure (GFR \< 30 ml/min) or on dialysis
5. Liver cell failure
6. Athletes or having heavy muscular exercise in the previous 3 days

Primary outcomes:
measure: Irisin level
timeFrame: 6 months
measure: FNDC5 Genotyping
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag uniersity hosoital
Study officials:
References: