louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06933654: Iris Suture Fixation vs Iris Claw for Correction of Aphakia
Official title: Iris Suture Fixation vs Iris Claw for Aphakic Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakic Eye
Keywords: Iris suture fixation , iris claw, aphakia
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2025-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs

Detailed description: The eyes were randomly divided into two groups, A and B. Group A included 25 eyes in which an iris claw lens was used; specifically, the Artisan aphakia intraocular lens (Ophtec BV, Groningen, The Netherlands), a PMMA IOL with an 8.5 mm length, 1.04 mm maximum height, and a 5.4 mm optical zone width. Group B also included 25 eyes, in which iris fixation of posterior chamber foldable IOLs was performed using a single-piece PMMA IOL. This IOL had a 6 mm optic, a total diameter of 12.75 mm, and featured one eyelet for suture fixation in each haptic. The A-constant used was 118.2.

Eligibility criteria: Inclusion Criteria:

* Surgical aphakia with no capsular support, with CDVA 4/60 or better on Snellen chart including: Aphakic eyes after complicated cataract surgery, crystalline lens subluxation (Marfan syndrome, pseudoexofoliation syndrome or trauma), 2nd intervention in traumatized eyes, cases with sublaxated or dislocated IOLs.

Exclusion Criteria:

* Surgical aphakia with decompensated corneas, aphakic patients with posterior segment pathologies like cystoid macular edema, choroidal neovascular membrane, aphakic patients with insufficient iris tissue, and rubeosis iridis, aphakic patients with intractable glaucoma.

Primary outcomes:
measure: Best-corrected visual acuity (BCVA)
timeFrame: at 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebsar Eye Center
Study officials:
affiliation: Benha University, Ebsar Eye Center
name: Ehab Saad, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317054: Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France
Official title: Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior and Behavior Mechanisms
Keywords: Gambing
occupational health services
psychosocial risks
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 410
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: employees coming in consultation in occupational medicine, between the 2016-11-01 and the 2017-04-30

Brief summary: Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work.

Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).


Eligibility criteria: Inclusion Criteria:

* all employees coming in consultation in occupational medicine, between the 2016-11-01 and the 2017-04-30, with the investigator, having given their consent and replied to the questionnaires were included.

Exclusion Criteria:

* Employees who did not speak the French language and those who refused to participate in the study were excluded. The number of refusals to participate and their reason were identified by the investigator. In addition, for employees who came to consult several times during the collection period, we only included the data from the first visit, in order to avoid overrepresentation.

Primary outcomes:
measure: Gambling prevalence
timeFrame: 6 month
Secondary outcomes:
measure: link between workand gambling
timeFrame: 6 month
measure: type of game
timeFrame: 6 month
Other outcomes:
Locations:
city: Quimperlé
country: France
facility: Santé au travail en cornouaille
state: Bretagne
Study officials:
References:
Clinical trial NCT01346254: Glucose Control in Pre-Diabetic Renal Transplant Patients
Official title: Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Kidney Transplantation
Keywords: after
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system.

It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes.

This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months.

The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Time since renal transplantation \> 6 months
* Stable graft function
* Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl)
* Informed consent of the patient

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Patients with NODAT (2h glucose level at OGTT \>200 mg/dl)
* allergy against vildagliptin or pioglitazone
* pregnancy
* GFR\<15ml/min/1.73 with need for dialysis
* hepatic impairment

Primary outcomes:
measure: Oral glucose tolerance test (OGTT)
timeFrame: three months
Secondary outcomes:
measure: glycated hemoglobin
timeFrame: 3 months
measure: Renal function
timeFrame: 3 months
measure: Liver function
timeFrame: 3 months
measure: Lipid profiles
timeFrame: 3 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken
Study officials:
affiliation: Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
name: Marcus Säemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Clinical trial NCT01013454: A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin
Official title: A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.


Eligibility criteria: Inclusion Criteria:

* Healthy, Caucasian, male, adult light to regular smokers

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

Primary outcomes:
measure: Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit
timeFrame: 8 days
Secondary outcomes:
measure: Evaluation of adverse events (including skin irritation)
timeFrame: 8 days
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 NCT00204854: Telephone and Mail Intervention for Alcohol Use Disorders
Official title: Telephone and Mail Intervention for Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Use Disorders
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-09-20
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomized controlled trial and benefit-cost study of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol abuse or dependence


Eligibility criteria: Inclusion Criteria:

* primary care patients with DSM-IV alcohol abuse or dependence

Exclusion Criteria:

* pregnancy
* suicidality
* alcohol treatment in prior 3 months

Primary outcomes:
measure: Self-reported alcohol consumption in the prior 28 days
measure: Number of risky drinking days in the prior 28 days
Secondary outcomes:
measure: Health care utilization
measure: car crashes
measure: criminal justice system involvement
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Richard L Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313454: Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
Official title: A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: dry eye syndrome
keratoconjunctivitis
ophthalmic
eye disease
corneal disease
keratitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-12-10
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.


Eligibility criteria: Inclusion Criteria:

* Bilateral dry eyes
* Capable of providing written informed consent

Exclusion Criteria:

* Chronic or recurring epistaxis (nosebleeds)
* Uncontrolled systemic disease
* Blood coagulation disorder
* Females who are pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
timeFrame: Pre-application to Post-application on Day 0
Secondary outcomes:
measure: Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)
timeFrame: Pre-application to Post-application on Day 0
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Allergan
name: Michelle Senchyna
role: STUDY_CHAIR
References:
Clinical trial NCT01883154: The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
Official title: The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Pregnancies
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from pregnancies complicated with IUGR, Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We intend to assess these factors in placental tissue, in cord blood and maternal blood.

Brief summary: Genetic and environmental factors are believed to play a major role in intrauterine growth and intrauterine programming. We intend to study genetic factors such as Telomere homeostasis, senescence, genomic instability and the presence of Genomic copy number variations in placental tissue from pregnancies complicated with Intrauterine growth restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We also intend to assess these factors in cord blood and maternal blood.

Detailed description: Based on the previous data from our group as well as other laboratories, we postulate that there is a correlation between impaired telomere homeostasis, senescence genomic instability and intra-uterine programming in placentas and in fetuses exposed to suboptimal intrauterine conditions such as hypoxia or hyperglycemia. Improved understanding of the mechanisms that produce the genomic changes in IUGR placentas and their influence on later risks of developing the metabolic syndrome should provide basis for future research that might lead into improved outcome of IUGR fetuses.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Intrauterine growth restriction
* A diagnosis of Gestational diabetes
* A diagnosis of pre gestational Diabetes
* IVF pregnancy

Exclusion Criteria:

* chorioamnionitis
* meconium stained amniotic fluid
* A request of the patient for Cord blood retrieval for preservation

Primary outcomes:
measure: Rate of Copy Number Variations
timeFrame: 10 yeras
Secondary outcomes:
measure: Telomere length
timeFrame: 10 years
measure: Number of copies of mitochondrial DNA
timeFrame: 10 years
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
References:
Clinical trial NCT05974254: Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation
Official title: Auricular Acupuncture As Part Of A Multimodal Regimen For Reduction Of Opioid Analgesic Use After Distal Radius Open Reduction and Internal Fixation- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radius Fracture Distal
Pain, Postoperative
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will test the hypothesis that patients receiving an intraoperative auricular acupuncture protocol will require less postoperative opioid analgesic use compared to those who do not receive acupuncture in the setting of a multimodal analgesic protocol for patients receiving surgery to repair distal radius fractures at a Level 1 trauma center under brachial plexus anesthesia with sedation.


Eligibility criteria: Inclusion Criteria:

* Patient ages 18-64
* American Society of Anesthesiologists Physical Status 1, 2, or 3
* Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block

Exclusion Criteria:

* Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential for altered metabolism of anesthetic and perioperative medications
* Allergy to any of the standard anesthetic agents
* Patient inability to properly communicate with investigators
* Patient or surgeon refusal

Primary outcomes:
measure: Total opioid analgesic use for 14 days after surgery
timeFrame: 14 days
Secondary outcomes:
measure: Pain scores
timeFrame: 14 days
measure: Incidence of side effects associated with opioid use
timeFrame: 14 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Jaime Ortiz, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01829854: To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery
Official title: Unrecognised Obstructive Sleep Apnoea In Cardiac Surgery Patient In The Asian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnoea
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing open heart surgery and is more than 45 years old . These patient are also required to stay in hospital for more than 5 days .

Brief summary: This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open heart surgery .


Eligibility criteria: Inclusion Criteria:

* adults male and female , aged 45 years old and above
* undergoing open heart surgery that requires hospital stays of more than 5 days

Exclusion Criteria:

* previous diagnosis and treatment of OSA or any sleep related breathing disorder.
* unwilling or physically unavailable for polysomnography before surgery.
* Patient undergoing MAZE procedure .
* Patient with severe COPD

Primary outcomes:
measure: Incidence of Obstructive Sleep Apnoea
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Sivakumar Krishnasamy, MD, MMed(Surgery)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914654: Concentrations of Formoterol in Blood and Urine
Official title: Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Doping
Formoterol
Urinary concentrations
Beta-agonists
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
First posted: 2009-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.

Detailed description: The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose.

Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18-45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to study day.
* Subjects with other chronic diseases than asthma and allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 10 days prior to study day.

Primary outcomes:
measure: Serum and urine concentrations of formoterol
timeFrame: baseline, 4, 8, and 12 hours after medicine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital, Respiratory Research Unit
Study officials:
affiliation: Bispebjerg Hospital, Respiratory Research Unit
name: Jimmi Elers, MD
role: PRINCIPAL_INVESTIGATOR
References: