louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06146309: Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion
Official title: Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Branch Retinal Vein Occlusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 47
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma \[9\]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for both RVO and glaucoma


Eligibility criteria: Inclusion Criteria:

* patients with unilateral BRVO

Exclusion Criteria:

* History of retinal and/or optic nerve diseases involving glaucomatous optic disc, ischemic optic neuropathy, or optic neuritis.
* History of trauma, intravitreal injections, vitreoretinal surgeries, and retinal or macular lasers.
* A significant media opacity that makes it difficult to capture clear images.
* No history of diabetes and/or hypertension in those recruited as the control group

Primary outcomes:
measure: peri-papillary retinal nerve fiber layer thickness
timeFrame: Base line
measure: peri-papillary retinal nerve fiber layer thickness
timeFrame: 6 months post injection
measure: peri-papillary retinal nerve fiber layer thickness
timeFrame: 12 months post injection
measure: peri-papillary retinal nerve fiber layer thickness
timeFrame: 24 months post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Akram Fekry Elgazzar
Study officials:
References:
Clinical trial NCT02154607: Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients
Official title: Clinical Trial Analyzing the Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Keywords: oral lichen planus
recurrence
Treatment
cancer
Primary disease Management
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. In addition it can have debilitating consequences on the patients' quality of life. The malignant transformation of OLP has been well documented. The aims of this work were to measure the number of patients developing malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by CO2 laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).


Eligibility criteria: Inclusion Criteria:

* Oral lichen planus
* Histological confirmation of diagnosis
* Patient willing for treatment

Exclusion Criteria:

* Patient just does not want to participate as control/study group

Primary outcomes:
measure: stable disease of OLP (clinical observation)
timeFrame: 1 year
Secondary outcomes:
measure: Development of oral cancer (histological report after incisional biopsy)
timeFrame: 3 years
Other outcomes:
measure: Development of reccurrence of OLP (clinical observation)
timeFrame: 3 years
Locations:
Study officials:
References:
Clinical trial NCT01093807: Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension
Official title: Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Keywords: Hypertension
Lercanidipine
Calcium antagonist
Enalapril
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 1039
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.


Eligibility criteria: Inclusion Criteria:

* Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) \< 180 mmHg after a 2 week placebo run-in period
* Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
* Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant

Exclusion Criteria:

* Secondary or severe hypertension
* History of cerebro- or cardiovascular complications
* Type 1 or Type 2 diabetes on drug treatment
* Severe renal or hepatic insufficiency

Primary outcomes:
measure: Change from baseline in sitting diastolic blood pressure (SDBP)
timeFrame: after 10 weeks
Secondary outcomes:
measure: Change from baseline in sitting systolic blood pressure (SSBP)
timeFrame: after 10 weeks
measure: Safety parameters: adverse events, heart rate, laboratory tests physical examination
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié-Salpétrière
Study officials:
affiliation: Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
name: Giuseppe Mancia, Prof
role: STUDY_CHAIR
References:
citation: Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767.
Clinical trial NCT00390507: Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Acceleromyography
TOF-Watch
Posttetanic count
Train of four
Neuromuscular blockade
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-10-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 examine the relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* General anaesthesia \>1 hour
* Surgery in supine position with possibility of monitoring the neuromuscular blockade at the thumb (n.ulnaris stimulation).
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anaesthesia
* Body weight less or exceeding 20% of the ideal body weight
* Pregnancy or breastfeeding

Primary outcomes:
measure: Time to first response to TOF stimulation (T1)
Secondary outcomes:
measure: Time to second response to TOF stimulation (T2)
measure: Time to first post-tetanic count (PTC)
measure: Number of post-tetanic count at first response to TOF
measure: Time to T1=25%
measure: Interval 25-75%
measure: Time to TOF 0.9
measure: Time to TOF 1.0
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Anesthesia, Rigshospitalet
city: Herlev
country: Denmark
facility: Dep. of Anesthesia, Herlev hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Casper C Kjaer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742207: Renal Function Post Cardioversion for Atrial Fibrillation
Official title: Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Renal Insufficiency
Cardioversion
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with new onset atrial fibrillation. Meaning less than three days.

Brief summary: Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema.

In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.


Eligibility criteria: Inclusion Criteria:

* All patients with new onset atrial fibrillation

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Renal dysfunction
timeFrame: Short term - One month
Secondary outcomes:
measure: Mortality
timeFrame: One year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Hellman Y, Cohen MJ, Leibowitz D, Loncar S, Gozal D, Haviv YS, Haber G, Afifi M, Rosenheck S, Lotan C, Pollak A, Gilon D. The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Cardiology. 2013;124(3):184-9. doi: 10.1159/000346618. Epub 2013 Mar 9.
Clinical trial NCT01174407: Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
Official title: Is CD35, CD21 and CD55 Associated With Exudative Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Lead sponsor: Rudolf Foundation Clinic
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with exudative age-related macular degeneration, over 55

Brief summary: The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group.


Eligibility criteria: Inclusion Criteria:

* Man and women over 18 years old
* Filled out informed consent
* Diagnosis of non-exudative/ exudative age related macular degeneneration

Exclusion Criteria:

* Inherited retinal diseases
* Other acquired retinal/ macular
* Missing informed consent

Primary outcomes:
measure: determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration
timeFrame: 1 day
Secondary outcomes:
measure: expression rates of on AMD-patients and a healthy control group
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolf Foundation Clinic
Study officials:
References:
citation: Haas P, Aggermann T, Nagl M, Steindl-Kuscher K, Krugluger W, Binder S. Implication of CD21, CD35, and CD55 in the pathogenesis of age-related macular degeneration. Am J Ophthalmol. 2011 Sep;152(3):396-399.e1. doi: 10.1016/j.ajo.2011.02.017. Epub 2011 Jun 12.
Clinical trial NCT06497907: Environmental Enteropathy Among Infants and Children With Growth Faltering
Official title: Prevalence of Environmental Enteropathy Among Infants and Children With Growth Faltering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Failure
Enteropathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with growth faltering whose weight still below -2 SD for age and sex on the WHO scores after 12 weeks of nutritional rehabilitation with polymeric formula, underwent upper gastrointestinal endoscopy and who were diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula and probiotics
Primary purpose: TREATMENT

Brief summary: The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients whose weight below -2 SD for age and sex on the WHO scores.

Exclusion Criteria:

* Secondary cases of malnutrition or undernutrition.
* Patients with symptoms of GIT problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum.
* Patients who can't commit to a follow up visit every two weeks.

Primary outcomes:
measure: Assessment of the prevalence of environmental enteropathy among children with faltering growth.
timeFrame: 12 weeks of nutritional rehabilitation with polymeric formula.
Secondary outcomes:
measure: Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula.
timeFrame: 8 weeks of nutritional rehabilitation with peptide-based formula.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine-Ain Shams University
state: Abbasia
Study officials:
References:
Clinical trial NCT02090907: Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
Official title: Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Subclinical Hypothyroidism
Keywords: Subclinical hypothyroidism
Atherosclerosis
Cardiovascular disease
Endothelial function
Prevention
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.


Eligibility criteria: Inclusion Criteria:

* age 18 to 65
* confirmed subclinical hypothyroidism

Exclusion Criteria:

* receiving of other treatments for hypothyroidism
* patients with other major medical disorders
* smoking
* hyperlipidemia
* obesity

Primary outcomes:
measure: Change from baseline flow-mediated dilation at 2 months
timeFrame: At baseline and then 2 months after treatment
measure: Change from baseline intima-media thickness at 2 months
timeFrame: At baseline and then 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid endocrinology clinic
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Nasmi Niknam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh JP, Bremner AP, Bulsara MK, O'Leary P, Leedman PJ, Feddema P, Michelangeli V. Subclinical thyroid dysfunction as a risk factor for cardiovascular disease. Arch Intern Med. 2005 Nov 28;165(21):2467-72. doi: 10.1001/archinte.165.21.2467.
citation: Alibaz Oner F, Yurdakul S, Oner E, Kubat Uzum A, Erguney M. Evaluation of the effect of L-thyroxin therapy on endothelial functions in patients with subclinical hypothyroidism. Endocrine. 2011 Oct;40(2):280-4. doi: 10.1007/s12020-011-9465-2. Epub 2011 Apr 20.
Clinical trial NCT06984107: MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)
Official title: Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medication Related Osteonecrosis of the Jaw
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)


Eligibility criteria: Inclusion criteria:

* Patients older than 18 years
* Provided informed consent
* MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
* Need to undergo surgical treatment of MRONJ

Exclusion criteria:

* Patients with history of head and neck radiotherapy
* Neurological and psychiatric conditions
* Pregnancy
* MRONJ stage 3 diagnosis
* Patients who will receive a re-treatment for MRONJ
* Patients with general contraindication for oral surgery
* Patients unable to attend the out-patients visits scheduled by the protocol

Primary outcomes:
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 7 days after surgical treatment
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 14 days after surgical treatment
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 21 days after surgical treatment
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 3 months after surgical treatment
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 6 months after surgical treatment
measure: Clinical wound healing (modified Landry Healing Index)
timeFrame: 12 months after surgical treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Carlo Lajolo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200107: Integrated Treatment Program for Osteoarthritis of the Knee
Official title: Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis Knee
Keywords: Osteoarthritis Knee
Self Care
Treatment Outcome
Patient Education as Topic
Physical Therapy Modalities
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 155
Sex: ALL
Minimum age (years): 50
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 determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program


Eligibility criteria: Inclusion Criteria:

* Active complaint of knee pain
* Diagnosis of knee osteoarthritis according to X-ray
* Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
* Ability to read Hebrew

Exclusion Criteria:

* Previous participation in physiotherapy treatment program
* Gout in knee, rheumatoid arthritis, fibromyalgia
* Complaints that appear in a knee which was operated in the past
* Dementia
* Severe limitations in mobility

Primary outcomes:
measure: Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program
timeFrame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Secondary outcomes:
measure: Change in VAS pain score during participating in the program
timeFrame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
measure: Change in the consumption of drugs during participating in the program
timeFrame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
measure: Changes in Referrals to specialists doctors during participating in the program
timeFrame: after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months
Other outcomes:
measure: Patient satisfaction with treatment
timeFrame: 6 months after enrollment
Locations:
city: Jerusalem
country: Israel
facility: Clalit Health Service
Study officials:
affiliation: Clalit Health Service
name: Ohad Avny, MD
role: STUDY_CHAIR
References: