louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00312325: Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Official title: Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Regional Blood Flow
Optic Disk
Keywords: Optic nerve head blood flow
Choroidal blood flow
Prednisolone
Graves´ Ophthalmopathy
optic neuritis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For example, high dose prednisolone treatment has been shown to be an effective therapy for different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis. However, contradictory results exists for the influence of high dose prednisolone therapy per se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of high dose, short time therapy with intravenous prednisolone in patients with optic neuritis and severe Graves´ Ophthalmopathy.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 19 and 65 years, nonsmokers
* Group A: Patients with Graves´ Ophthalmopathy (moderate to severe and active ophthalmopathy; i.e. clinical activity score \>3 or =3) suitable for high-dose treatment with prednisolone as assessed by an independent ophthalmologist
* Group B: Patients with acute onset of optic neuritis suitable for high-dose treatment with prednisolone suitable for high-dose treatment with prednisolone as assessed by the ophthalmologist
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant and not to interfere with prednisolone treatment (normal liver blood parameter and hepatitis serology).
* Ametropy of less than 3 dpt.

Exclusion Criteria:

* Regular use of medication which could interfere with the study objectives, especially treatment with vasoactive drugs
* Active peptic ulcer or insulin dependent diabetes mellitus
* Hepatitis or elevated hepatic blood parameters
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy

Primary outcomes:
measure: Non invasive measurement of optic nerve and choroidal blood flow
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Medical University of Vienna
name: Gabriele Fuchsjaeger-Mayrl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02666625: Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank
Official title: Study of Iatrogenic Effects of Treatment for Childhood Cancer - Constitution of a Biological Samples Bank as Part of a Cohort of Patients (Cohort FCCSS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paediatric Malignancies
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for a paediatric malignancies before the year 2000 having survived two years after treatment of solid tumor diagnosed before 18 years old

Brief summary: The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Patients treated for a first cancer in childhood
* Adult patients
* Signed informed consent
* Patient insured or enjoying a social security scheme

Exclusion Criteria:

* Minor patients
* Under legal protection measure patients
* Refusal of consent

Primary outcomes:
measure: Study of genetic factors who might lead to secondary iatrogenic pathology due to treatment of a childhood cancer
timeFrame: seven years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val de Marne
Study officials:
References:
Clinical trial NCT03974425: One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
Official title: One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 37
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: Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.

Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.


Eligibility criteria: Inclusion Criteria:

* diabetic patients, older than 18years,
* center-involving DME, central macular thickness (CMT) \>300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
* The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.

Exclusion Criteria:

* Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
* uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery \>6 months prior to conversion).
* Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.

Primary outcomes:
measure: central macular thickness after one year
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01956825: The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver
Official title: THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: non alcoholic fatty liver disease
LCARNITINE amino acid
magnesium
fat content
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-10-08
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: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease (NAFLD).

Detailed description: The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease.

the study is an interventional one in which 60 patients who by definition have non alcoholic fatty licer disease (NAFLD) are divided randomly (double blind) into 2 groups: group 1: "study group". receive a product (flavoured water) which contains L-CARNITINE an magnesium. group 2: control. receive placebo. regular water. Length of trial - 12 weeks. The patients will be followed on a weekly base and variuos parameters will be compared (weight, lipid profile, insulin resistance etc.).

"fibrotest" will be used at the beginning of the trial and at the end (week 12) comparing the fat content before and after the treatment.

Eligibility criteria: Inclusion Criteria:

age\>18, \<80 y evidence to non alcoholic fatty liver disease

Exclusion Criteria:

age\<18, \>80 y pregnancy renal failure congestive heart failure active malignancy liver disease - etiology other than non alcoholic fatty liver disease (NAFLD). hypothyroidism/cushing total prenteral nutrition (TPN) in the last 6 month

Primary outcomes:
measure: effect of LCARNITINE and magnesium treatment on the liver fat content
timeFrame: 12 weeks
Secondary outcomes:
measure: effect of L-CARNITINE and magnesium treatment on the metabolic panel
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Hospital
Study officials:
affiliation: Meir Medical Center
name: DAN FELDMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464825: Prevention of Falls in Older Adults by Specific and Progressive Balance Training
Official title: Prevention of Falls in Older Adults by Specific and Progressive Balance Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One intervention group receiving Specific and progressive balance training One control group
Primary purpose: PREVENTION

Brief summary: Three months of balance training with follow-up 6 and 12 months thereafter.


Eligibility criteria: Inclusion Criteria:

* over 60 years with either osteoporosis or Parkinsons disease

Exclusion Criteria:

* under 60 years

Primary outcomes:
measure: Balance performance - one leg stand
timeFrame: up to 24 months
Secondary outcomes:
measure: Fear of falling FES-I
timeFrame: up to 24 months
measure: Health related quality of life - SF-36
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04719325: Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
Official title: Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6 patients and treated using Herbert bone screw, and group B has 6 patients and treated using lag screw.

Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.


Eligibility criteria: Inclusion criteria

* Patients suffering from recent, uninfected anterior mandibular fracture.
* Adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months.
* Fracture that demands open reduction and internal fixation.

Exclusion criteria

* Medically compromised patients contradicting operations.
* Existence of infection at the fracture line.
* Pathological fracture.
* An old fracture.
* Completely edentulous patient

Primary outcomes:
measure: Change in bone density
timeFrame: baseline and 3 months
measure: change in pain scores
timeFrame: 24 hours, 1 week , 4 Weeks and 6 weeks
measure: presence of Intra-fragmentary mobility
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT01010425: Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
Official title: Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ascendis Pharma A/S
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* 20 to 45 years old
* Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
* Others

Exclusion Criteria:

* Known history of hypersensitivity to human growth hormone (hGH)
* Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
* Others

Primary outcomes:
measure: Safety and Tolerability (adverse events, local reactions, immunogenicity)
timeFrame: 0-42 days
measure: Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
timeFrame: 0-28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Ascendis Pharma A/S
name: Ascendis Pharma
role: STUDY_DIRECTOR
References:
citation: Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.
Clinical trial NCT03063125: Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
Official title: Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Low Testosterone Levels
Keywords: radical cystectomy
hypogonadism
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 25
Sex: MALE
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: Participants will be recruited from patients being treated at the University of Kansas Health System.Potiential patients will be recruited from the urology clinic, University of Kansas Cancer Center or during inpatient hospitalization.

Brief summary: The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bladder cancer
* Scheduled to undergo radical cystectomy

Exclusion Criteria:

* Evidence of advanced metastatic disease,
* Undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell
* History of breast or prostate cancer
* Polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months

Primary outcomes:
measure: Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical
timeFrame: 90 days post-RC surgery
Secondary outcomes:
measure: The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy
timeFrame: 30 days post-RC surgery
measure: The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy
timeFrame: Immediately post-operatively RC surgery
measure: The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy
timeFrame: Baseline, prior to RC surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Holzbeierlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542525: Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
Official title: Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Corneal Astigmatism
Keywords: Cataract
Intraocular lens
Astigmatism
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 32
Sex: ALL
Minimum age (years): 20
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 effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Detailed description: Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.

This study will be conducted in Japan.

Eligibility criteria: Key Inclusion Criteria:

* Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
* Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Irregular corneal astigmatism.
* History of anterior segment, posterior segment, or optic nerve pathology.
* History of previous intraocular or corneal (refractive or trauma related) surgery.
* Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
timeFrame: Day 30-60 postoperative
Secondary outcomes:
measure: Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
timeFrame: Day 30-60 postoperative
measure: Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
timeFrame: Day 30-60 postoperative
Other outcomes:
Locations:
city: Chiyoda-Ku
country: Japan
facility: Alcon Investigative Site
state: Tokyo
Study officials:
affiliation: Alcon Japan Limited
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04815525: The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong
Official title: The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasia
Colorectal Cancer
Keywords: colonoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

Brief summary: The primary objective of this study is to analyze the 15-year cumulative incidence of advanced colorectal neoplasia and CRC-related mortality after the index colonoscopy.

Detailed description: This is a territory-wide retrospective observational cohort study using the Clinical Data Analysis and Reporting System (CDARS). We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

Eligibility criteria: Inclusion Criteria:

1. All patients with colonoscopy performed in HA hospitals during the study period would be eligible for screening.

Exclusion Criteria:

1. Patients with documented personal history of colorectal cancers before the study period would be excluded.

Primary outcomes:
measure: Culumative incidence of advanced colorectal neoplasia
timeFrame: 15 years
Secondary outcomes:
measure: CRC-related mortality rate
timeFrame: 15 years
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
References: