louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00627003: A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Official title: A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 43
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.


Eligibility criteria: Inclusion Criteria:

* Idiopathic RLS
* Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
* In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

* Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS

Primary outcomes:
measure: Sleep efficiency
timeFrame: Week 5
measure: PLMS-arousal index (PLMS-AI)
timeFrame: Week 5
Secondary outcomes:
measure: Sleep Questionnaire Form A
timeFrame: Weeks 2 and 5
measure: Quality of Life for RLS questionnaire
timeFrame: Weeks 2 and 5
measure: Clinical Global Impressions
timeFrame: Weeks 2 and 5
measure: Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography
timeFrame: Weeks 2 and 5
measure: Total score of the severity rating scale of the International RLS (IRLS) Study Group
timeFrame: Weeks 2 and 5
measure: RLS-6 severity scales
timeFrame: Weeks 2 and 5
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04082403: The Impact of Suction- Assisted Laryngoscopy and Airway Decontamination on Intubation Times
Official title: The Impact of Suction- Assisted Laryngoscopy and Airway Decontamination on Intubation Times
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contaminated Airway
Lead sponsor: Mater Misericordiae University Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study was formulated to test the hypothesis that comprehensive training in Suction- Assisted Laryngoscopy and Airway Decontamination techniques reduces mannequin intubation times for Anaesthesia trainees.

Detailed description: To assess the clinical impact of in Suction- Assisted Laryngoscopy and Airway Decontamination (SALAD) training among 37 anaesthesia trainees. Intubation mannequin will be used to assess intubation times for contaminated airways pre and post SALAD training.

Eligibility criteria: Inclusion Criteria:

All Anaesthesia trainees employment in Mater Misericordiae University hospital during the month of August 2019 - October 2019 were invited to partake in the study.

Exclusion Criteria:

All intensive care trainees with no training in intubation were excluded from the study.

Primary outcomes:
measure: Time to intubation as preformed on a mannequin .
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00554203: Sulfasalazine and Endothelial Function
Official title: Effect of Sulfasalazine on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and atherosclerosis. This study will examine the effects of the anti-inflammatory drug sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period, subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated dilation of the brachial artery will be studied before and after each drug. We hypothesize that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* History of coronary artery disease

Exclusion Criteria:

* G6PD deficiency defined by red blood cell G6PD activity assay
* Sulfa allergy
* Aspirin allergy
* Allergy to furosemide (lasix), hydrochlorthiazide, sulfonylureas, acetazolamide (Diamox) or other carbonic anhydrase inhibitors
* SGOT, SGPT, alkaline phosphatase, total bilirubin greater than 2 times the upper limit of normal
* WBC less than 4.0 or greater than 11.0 K/UL
* Platelet count less than 150 K or greater than 450K
* Hematocrit less than 30% 7
* Serum creatinine greater than 1.5 mg/dl
* Unstable angina or acute MI within 2 weeks
* Warfarin treatment
* Immunosuppressive treatment (methotrexate, cyclosporine, etc.)
* Digoxin treatment
* Phenytoin (Dilantin) treatment
* Methenamine (Mandelamine, Urex) treatment
* Probenecid or sulfinpyrazone (Anturane, Aprazone) treatment
* Porphyria
* Symptomatic GI obstruction
* GU obstruction (not including clinical evidence of benign prostatic hypertrophy)
* Pregnancy

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 6 weeks
Secondary outcomes:
measure: serum markers of inflammation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabit CE, Holbrook M, Shenouda SM, Dohadwala MM, Widlansky ME, Frame AA, Kim BH, Duess MA, Kluge MA, Levit A, Keaney JF Jr, Vita JA, Hamburg NM. Effect of sulfasalazine on inflammation and endothelial function in patients with established coronary artery disease. Vasc Med. 2012 Apr;17(2):101-7. doi: 10.1177/1358863X12440117.
Clinical trial NCT01239303: Effects of Citrulline on Gut Functioning During Excercise
Official title: Effects of Citrulline on Gut Functioning During Excercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal
Hypoperfusion
Gut Damage
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2010-11-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy individuals. Improving the availability of NO might result increase splanchnic perfusion and prevent organ damage during exercise.

Detailed description: The gastrointestinal (GI) tract plays an important role in the human body. The wall of the GI system regulates digestion and absorption of nutrients and it also has a very important function as a barrier between internal and external environment. The penetration of harmful substances and microbiota of the GI lumen (external environment) to the systemic circulation (internal environment) depends on this barrier. Previous studies have shown that exercise in healthy subjects provides hypoperfusion of the splanchnic area, resulting in intestinal damage, increased small intestinal permeability and liver damage. Similar splanchnic hypoperfusion occurs in patients with compromised circulation.

During episodes of splanchnic hypoperfusion, the de novo synthesis of nitric oxide (nitric oxide, NO) from arginine is compromised. This impaired NO synthesis may play a role in the development of organ dysfunction during exercise. L-citrulline administration, a precursor of arginine and NO, may result in improved NO availability and organ perfusion, thereby preventing organ damage.

Eligibility criteria: Inclusion Criteria:

* male
* age 18-35 years

Exclusion Criteria:

* not healthy
* use of medication or related products
* alcohol misuse
* smoking

Primary outcomes:
measure: GI perfusion
timeFrame: 2 hours
measure: gut damage
timeFrame: 5 hours
measure: microcirculation
timeFrame: 5 hours
Secondary outcomes:
measure: liver damage
timeFrame: 5 hours
measure: kidney damage
timeFrame: 5 hours
measure: amino acid analysis
timeFrame: 5 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
Clinical trial NCT06467903: Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device
Official title: A Prospective, Comparative Multicenter Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using the SW as Medical Device and the SW as MD Comparator, When Evaluating the Patient's Retinal Image
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Bonmedix Holding a.s.
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: specific screening exhamination
Primary purpose: SCREENING

Brief summary: A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device

Detailed description: A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using the SWaMD medical device and the SWaMD comparator, when evaluating the patients retinal image

Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 40 years
* Signed informed consent
* Confirmed type 1 or 2 diabetes mellitus

Exclusion Criteria:

* Ocular findings that do not allow retinal photography (significant nystagmus, corneal leukoma, dense cataract, hemophthalmus, etc.)
* Patient has a condition or is in a situation that, in the opinion of the investigator, may bias the results of the study, may significantly interfere with the patient's participation in the investigation, or may result in unproducible photographs of a dilated ocular fundus
* Patients with restrictions on personal freedom by administrative or legal order

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Příbram
country: Czechia
facility: Jakub Sedivy
state: Or
Study officials:
affiliation: GP
name: Petr Šonka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06339203: Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)
Official title: Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Cesarean Section; Infection
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2024-04-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Singleton pregnancy
* Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital
* Planned post-operative follow up with Loma Linda OBGYN
* Speak English or Spanish
* At least one of the following medical complications: Obesity BMI\>= 30kg/m2, Diabetes, Spontaneous rupture of membranes, Intraamniotic infection

Exclusion Criteria:

* Emergency cesarean delivery

Primary outcomes:
measure: Composite wound evaluation scale after caesarean delivery
timeFrame: Up to 8 weeks postop
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Ruofan Yao, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01379443: Rehabilitation of Children With Multiple Disabilities
Official title: The Comparative Effect and Expense of More and Less Integration of Services That Provide Treatment and Rehabilitation for Children With Multiple Disabilities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy
Autism
Down's Syndrome
Brain Injury
Keywords: Children
Rehabilitation
Family Functioning
Mental Health
Costs
Integration
Lead sponsor: Children's Treatment Network
Sponsor class: NETWORK
Collaborators: name: McMaster University
First posted: 2011-06-23
Enrollment: 445
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the study is to compare the usual care and treatment of children and youth (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe York with a co-ordinated, navigated approach to care using the Children's Treatment Network (CTN) services.

Detailed description: The Children's Treatment Network (CTN)links existing children's services rather than creating a new Centre. The purpose of the evaluation is to compare the effectiveness and efficiency of this service with the usual care that people receive. 500 Children will be randomized to receive either usual care (250) or the co-ordinated, navigated care from CTN (250). The primary question to be addressed is whether the more integrated CTN model of service improves family-centered services, parent mental health, parenting, family function and the quality of the child's life and the families resource needs as well as reduce expenditures for the families' use of all other health and social services compared to the outcomes of usual care alone. What children and families with what characteristics and circumstances most benefit from which approach to the treatment of childhood disability in Simcoe-York? At what cost?

Agencies providing services to children will be evaluated as to how effective their integration of teams are functioning, their partnership with each other and capacity building in the community.

Eligibility criteria: Inclusion Criteria:

* Children and youth up to 19 years of age
* living in Simcoe-York.
* English speaking
* multi-need family
* children on agency service wait lists
* children under the care of Children's Aid Societies
* Families with more than 1 disabled child

Exclusion Criteria:

-youth over 19 years.

Primary outcomes:
measure: Parental reports in the Quality of Life of Children and Youth
timeFrame: 12 and 24 month
Secondary outcomes:
measure: Integration of teams amongst service providers. Integration was measured at two levels using the Integration of Human Services Measure.
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: Children's Treatment Network
name: Sandy Thurston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262443: Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip
Official title: Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Keywords: Atrial flutter
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
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 efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Detailed description: No more available data

Eligibility criteria: Inclusion Criteria:

* Both sexes; age\>18 yrs
* ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
* No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
* Patients willing to accept the tests and to follow standard procedures
* Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment

Exclusion Criteria:

* Atrial fibrillation
* Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
* Intra atrial thrombosis
* NYHA class IV
* Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
* Untreated Wolf Parkinson White syndrome
* Contraindications to oral anticoagulation
* Life expectancy \< 12 month
* Major surgery or interventional procedure already planned in the 6 month following ablation
* Pregnancy or breast-feeding
* Participation in another study

Primary outcomes:
measure: Percentual success of the procedure during the hospitalization
timeFrame: Up to 4 days
measure: Percentual success of the procedure at 3 months from procedure
timeFrame: 3 months
measure: Percentual success of the procedure at 6 months from procedure
timeFrame: 6 months
Secondary outcomes:
measure: •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.
timeFrame: Up to 4 days; 3-6 month
measure: Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given
timeFrame: Up to 4 days
measure: Safety of the procedure
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: RA
city: Torino
country: Italy
facility: Maria Pia Hospital
state: TO
Study officials:
affiliation: Maria Cecilia Hospital
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001243: Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
Official title: Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Presbyopia
Lead sponsor: Optall Vision
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

Detailed description: To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Presbyopic
* 40 - 59 years

Exclusion Criteria:

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism

Primary outcomes:
measure: Number of eyes improving 3 lines or more near visual acuity
timeFrame: 1 hour
measure: Eyes improving 3 lines or more near visual acuity
timeFrame: 1 hour
measure: Eyes improving 3 lines or more near VA
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optall Vision
Study officials:
affiliation: Optall Vision
name: Cesar Alejandro S Galeana, MD
role: PRINCIPAL_INVESTIGATOR
References: