louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01949623: Biomarkers In Retinitis Pigmentosa (BIRP)
Official title: Biomarkers In Retinitis Pigmentosa (BIRP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Keywords: RP
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retinitis Pigmentosa patients and Controls

Brief summary: In this study, markers of oxidative stress will be measured in the aqueous humour and plasma of RP patients compared to controls.

Detailed description: People with Retinitis Pigmentosa have loss of night vision followed by loss of central vision due to damage and death of photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers which can be measured. In this study, these biomarkers will be assessed in people with Retinitis Pigmentosa and compared to controls.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age more than or equal to 18 years
* For the study group, patients diagnosed with Retinitis Pigmentosa by the investigators
* For the control group, patients undergoing vitreoretinal surgery for macular hole, epiretinal membrane, vitreomacular traction, retinal detachment, neovascular Age-related Macular Degeneration (AMD) and Diabetic Retinopathy will be eligible

Exclusion Criteria:

* Patients with active or suspected ocular or periocular infection

Primary outcomes:
measure: Aqueous levels of markers of oxidative stress in patients with RP and controls.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00440323: Disturbed Sleep Model Study.
Official title: A Double-blind, Double-dummy, Randomised, Placebo-controlled,Four-way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Noise induced Situational insomnia,
healthy volunteers
SB-649868,
Zolpidem,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.


Eligibility criteria: Inclusion Criteria:

* Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
* Healthy as judged by responsible physician.
* No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
* The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) \<30min., SE (Sleep Efficiency) \>85%, apnea/ hypopnea index \< 10, periodic leg movements (PLM) with arousal index \< 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

* A positive result for the pre-study urine drug/ alcohol breath screen.
* Abuse of alcohol.
* Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.

Primary outcomes:
measure: Total Sleep Time measured overnight across four treatment sessions (4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
measure: The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bettica P, Squassante L, Groeger JA, Gennery B, Winsky-Sommerer R, Dijk DJ. Differential effects of a dual orexin receptor antagonist (SB-649868) and zolpidem on sleep initiation and consolidation, SWS, REM sleep, and EEG power spectra in a model of situational insomnia. Neuropsychopharmacology. 2012 Apr;37(5):1224-33. doi: 10.1038/npp.2011.310. Epub 2012 Jan 11.
Clinical trial NCT00519623: Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Official title: Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Keywords: diabetes
insulin
blood sugar
type 1 diabetes
insulin dependent diabetes
transdermal
Lead sponsor: Altea Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.

Detailed description: The study is looking for patients that meet the following criteria:

* Duration of type diabetes greater than or equal to 10 years
* HbA1C less than or equal to 9.0%
* C-peptide negative
* Ages 18 - 65, male or female
* Body Mass Index (BMI) 18.5 - 32
* Non-smoker
* No advanced diabetes complications
* Not pregnant or breast feeding

Eligibility criteria: Inclusion Criteria:

* Duration of type 1 diabetes greater than or equal to 10 years
* HbA1c less than or equal to 9.0%
* C-peptide negative
* Ages 18 - 65, male or female
* BMI 18.5 - 32
* Non- smoker
* No advance diabetes complications
* Not pregnant or breast feeding

Exclusion Criteria:

* Arm or leg rashes, open wounds, or skin conditions
* Psychiatric disorders
* Participation in a clinical research trial in last 3 months
* Clinically significant acute illness

Primary outcomes:
measure: Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
timeFrame: Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours
measure: Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
timeFrame: Glucose infusion rates were adjusted every 10 minutes as necessary
Secondary outcomes:
measure: Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
timeFrame: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal
Other outcomes:
Locations:
city: 387 Technology Circle, NW, Suite 100, Atlanta
country: United States
facility: Altea Therapeutics Clinical Research Center
state: Georgia
Study officials:
affiliation: Altea Therapeutics
name: Vicky Spratlin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith, A, Zerkel, K, Roerig, P, Mills, S, Humphries, C, Durland, R, Spratlin, V, "Transdermal Delivery of Insulin in Patients with Type 1 Diabetes," American Diabetes Association 68th Scientific Sessions, Abstract 309-OR, Diabetes 57 Supplement 1:A88, 2008.
Clinical trial NCT04483323: Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy
Official title: Erector Spinae Plane Block Versus Intraarticular Injection of Local Anesthetic for Postoperative Analgesia in Patients Undergoing Shoulder Arthroscopy; A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthroscopy
Postoperative Analgesia
Erector Spinae Plane Block
Intraarticular Injection
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To improve the outcome after surgery, effective pain control is needed. The aim of the current study was to compare the efficacy of ultrasound guided erector spinae plane block versus the intra articular injection of local anesthetic for post-operative analgesia in patients undergoing shoulder arthroscopy.

Detailed description: Sample size calculation:

Calculation of sample size was done to detect a 15% difference in the VAS score between two groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of the study. The number will be increased to 30 patients to avoid a 10% dropped out patients.

Statistical analysis Statistical analysis will be done by Statistical Package for the Social Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and standard deviation (SD) and will be compared by unpaired student T test. Categorical variables will be presented as frequency and percentage (%) and will be analysed by the Chi-square test. P value \< 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Posted for elective shoulder arthroscopy

Exclusion Criteria:

* Coagulopathy
* Allergy to local anesthetics
* Chronic use of narcotics
* Necessity for an intra articular drain after surgery
* Patients refusal to participate

Primary outcomes:
measure: The amount of total postoperative rescue analgesic consumption (mg)
timeFrame: First 24 hours postoperative
Secondary outcomes:
measure: Postoperative visual analogue scale
timeFrame: First 24 hours postoperative
Other outcomes:
measure: The time to first request of rescue analgesia (hours)
timeFrame: First 24 hours postoperative
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
affiliation: Lecturer at Tanta University Hospitals
name: Taysser M Abdelraheem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03117023: The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer
Official title: The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: dexmedetomidine
sleep deprivation
gastric cancer
middle-aged and elderly patient
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 55
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 find out the effect of Dexmedetomidine for treatment of sleep deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with Gastric Cancer.

Detailed description: Patients were randomized to receive sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h (DEX group) or sufentanil 0.05ug/kg/h + saline (control group) for 48h. The primary outcome was the total sleep time during the first three days after surgery. The secondary outcomes included pain score, daily sufentanil consumption, time to functional recovery, length of hospital stay and side effects.

Eligibility criteria: Inclusion Criteria:

Elective gastric cancer operation Age ≧ 55 years ASA classification：I to III, BMI: 18-30 kg/m2 without the history of gastrointestinal surgery the normal coagulation function -

Exclusion Criteria:

the history of gastrointestinal surgery Gastrostomy and jejunostomy sleep apnea syndrome or severe osahs Severe liver and heart dysfunction Severe mental illness

-

Primary outcomes:
measure: sleep time
timeFrame: during the first three days after surgery
Secondary outcomes:
measure: pain score
timeFrame: during the first three days after surgery
measure: daily sufentanil consumption
timeFrame: during the first three days after surgery
measure: functional recovery
timeFrame: during the first three days after surgery
measure: length of hospital stay
timeFrame: during the first three days after surgery
measure: side effects
timeFrame: during the first three days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06788223: Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
Official title: Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Hyperparathyroidism Due to Adenoma
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary hyperparathyroidism and parathyroid adenoma, fulfilling the AAES guidelines indications for parathyroidectomy.

Brief summary: The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is:

Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.

Detailed description: Objective: PTeye™ and FLUOBEAM® LX use autofluorescence to confirm visually suspected parathyroid tissue. Real-time intraoperative identification of parathyroid glands can be achieved by the application of both devices. The aim of the present study is to evaluate and compare the efficacy of PTeye™ and FLUOBEAM® LX in identifying parathyroid adenomas.

Methods: Patients undergoing parathyroidectomy due to a parathyroid adenoma will be enrolled prospectively in this study and will be randomly included to Group A (PTeye™) or Group B (FLUOBEAM® LX). After intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0), the efficacy of both devices to confirm the adenomas will be evaluated. Re-evaluation will take place in minutes 1, 3 and 5 during tissue dissection and before adenoma excision.

Eligibility criteria: Inclusion Criteria:

- Patients with Primary parathyroidism with parathyroid adenoma

Exclusion Criteria:

* Parathyroid Hyperplasia,
* Secondary hyperparathyroidism

Primary outcomes:
measure: Identification of the parathyroid adenoma
timeFrame: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
References:
Clinical trial NCT03850223: Clinical Audit On Management Of Congenital Heart Disease In ACUH
Official title: Clinical Audit On Management Of Congenital Heart Disease In Assiut Children University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with congenital heart disease more than one month and less than 18 years

Brief summary: Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.

Detailed description: CHD may be defined as an anatomic malformation of the heart or great vessels which occurs during intrauterine development, irrespective of the age at presentation. The cause of most congenital heart defects is still unknown. Many cases of congenital heart disease are multifactorial and result from a combination of genetic predisposition and an environmental stimulus. A small percentage of congenital heart lesions are related to known chromosomal abnormalities, in particular, trisomy 21, 13, and 18 and Turner syndrome. Of all cases of congenital heart disease, 2-4% are associated with known environmental or adverse maternal conditions and teratogenic influences, including maternal diabetes mellitus, phenylketonuria, systemic lupus erythematosus or congenital rubella syndrome; and maternal ingestion of drugs (lithium, ethanol, warfarin, antimetabolites, vitamin A derivatives, anticonvulsant agents).

Eligibility criteria: Inclusion Criteria:

* children with CHD more than one month

Exclusion Criteria:

* children with CHD less than one month

Primary outcomes:
measure: Clinical audit study to assess management of congenital heart disease in AUCH
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04582123: Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins
Official title: The Comparison of Cross Pin Configurations in the Treatment of Gartland Type III Supracondylar Humerus Fractures: 2 Pins Versus 3 Pins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supracondylar Humerus Fracture
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2020-10-09
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

Detailed description: Fortyfive children with supracondylar humeral fractures were randomly divided into two groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins. The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost to follow up.

Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. All surgeries were performed by the same surgeon.

Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria was children with closed extension Type III of supracondylar fracture of humerus.

Exclusion Criteria:

* Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.

Primary outcomes:
measure: functional outcome of two fixation techniques
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01742923: Tailored Intervention to Improve Medication Adherence in Patients With Hypertension
Official title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
medication adherence
motivational interviewing
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2012-12-06
Enrollment: 532
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: Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.


Eligibility criteria: Inclusion Criteria:

Age: 18 years or older

* Patients receiving ambulatory treatment for hypertension in a hospital setting
* The patient or a carer usually dispenses the patient's medications
* Patient lives in the Southern Region of Denmark
* Written consent

Exclusion Criteria:

* Lives in a care home or institution
* Receive dose dispensed medicine from a pharmacy
* Medicine is dispensed by a nurse in the patient's home
* Correctional mental health patients

Primary outcomes:
measure: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins
timeFrame: One year from inclusion
Secondary outcomes:
measure: Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months
timeFrame: One year from inclusion
measure: Reduction in systolic and diastolic blood pressure
timeFrame: One year from inclusion
measure: Composite endpoint (stroke, myocardial infarction or cardiovascular death)
timeFrame: One year from inclusion
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Hedegaard U, Kjeldsen LJ, Pottegard A, Henriksen JE, Lambrechtsen J, Hangaard J, Hallas J. Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. Am J Med. 2015 Dec;128(12):1351-61. doi: 10.1016/j.amjmed.2015.08.011. Epub 2015 Aug 21.
citation: Hedegaard U, Hallas J, Ravn-Nielsen LV, Kjeldsen LJ. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care. Res Social Adm Pharm. 2016 Mar-Apr;12(2):302-18. doi: 10.1016/j.sapharm.2015.05.006. Epub 2015 May 18.