louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01041690: Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease
Official title: Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Proliferative Diabetic Retinopathy
Vitrectomy
Bevacizumab
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2010-01-01
Enrollment: 19
Sex: ALL
Minimum age (years): 9
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of neovascularization in proliferative diabetic retinopathy have demonstrated significant regression in the number of new vessels. Reducing the vascularity of neovascular fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the vitrectomy procedure. The investigators chose to investigate the potential benefit of the use of preoperative bevacizumab in the management of these most complex cases.

Detailed description: PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in the management of severe diabetic eye disease.

SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS: Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05 ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2). Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and post-operative bleedings were recorded.

Eligibility criteria: Inclusion Criteria:

* Tractional Retinal Detachment involving or threatening the macula,
* Tractional+Rhegmatogenous Retinal Detachment, or
* Fibrovascular tissue covering and distorting the macula.

Exclusion Criteria:

* Vitrectomy
* Neovascular glaucoma
* Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)

Primary outcomes:
measure: Intra- and post-operative bleedings were recorded.
timeFrame: 3 months
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department Of Ophthalmology
Study officials:
References:
Clinical trial NCT02175290: Machado-Joseph Disease in Israel
Official title: Machado-Joseph Disease in Israel: Clinical Phenotype and Genotype of a Jew Yemenite Subpopulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinocerebellar Ataxia 3
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 250
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: Spinocerebellar Ataxia 3 Yemenite Jews patients

Brief summary: Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of this study is to describe the clinical phenotype and genotype of the Yemenite Jewish subpopulation with MJD living in Israel


Eligibility criteria: Inclusion Criteria:

* Spinocerebellar Ataxia 3 Yemenite Jews patients

Exclusion Criteria:

* All others

Primary outcomes:
measure: clinical phenotype of SCA3 Yemenite Jews patients
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-saba
country: Israel
facility: Department of Neurology, Meir Medical Center
Study officials:
References:
Clinical trial NCT03219190: A High School Program for Preventing Prescription Drug Abuse
Official title: A High School Program for Preventing Prescription Drug Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prescription Drug Abuse (Not Dependent)
Substance Use
Substance Abuse
Lead sponsor: National Health Promotion Associates, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will develop and evaluate a program to prevent prescription drug abuse in high school students

Detailed description: This Fast-Track SBIR project is designed to address the critical need for an effective primary prevention approach for prescription drug abuse (PDA), an urgent public health crisis in the United States. The project involves developing and testing an innovative new approach to the primary prevention of PDA among high school students utilizing e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the evidence-based substance abuse prevention approach called Life Skills Training (LST). The adapted intervention will address the relationship between PDA and alcohol, tobacco and other drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDA; discourage diversion of prescription medications; enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios.

Eligibility criteria: Inclusion Criteria:

* High school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

Primary outcomes:
measure: Change in any prescription drug use in the past year
timeFrame: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: National Health Promotion Associates
state: New York
Study officials:
affiliation: National Health Promotion Associates
name: Kenneth W Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670590: NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Official title: NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate \< 90 ml/min), cancer, heart failure \> II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

Detailed description: Dietary and physical exercise counseling.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of fatty liver

Exclusion Criteria:

* type I or type II diabetes,
* no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease

Primary outcomes:
measure: Decrease of fatty liver appearance by ultrasound
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04598490: Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site
Official title: Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site- A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance
Keywords: recent
healed
extraction space
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Space closure into old extraction space
Primary purpose: TREATMENT

Brief summary: The aim was to compare the rate of teeth movement into fresh and old extraction sites.

Detailed description: Trial design: Randomized controlled clinical trial with a split mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.

Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper.

The rate of extraction space closure in the lower arch was assessed monthly.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 16 years
* Proclined upper and lower incisors (Ui/max \>115 o, Li/mand \>99o)
* Mild upper and lower arch crowding (\<4mm) or no crowding
* Need for upper and lower first premolars extraction
* Skeletal I malocclusion (1\<ANB \<5)
* Average lower facial height and maxillomandibular plane angle (22 o \<MM\<32 o)
* Class I canine relationship
* Good oral hygiene and healthy periodontium

Exclusion Criteria:

* Poor oral hygiene
* Diseases and medications that were likely to affect bone biology
* Previous orthodontic treatment
* Evidence of bone loss
* Active periodontal disease
* Smoking

Primary outcomes:
measure: Amount of space closure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
Study officials:
affiliation: Jordan University of Science and Technology
name: Elham S A Alhaija, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04827290: Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease
Official title: Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Failure, Chronic
Chronic Kidney Disease stage3
Chronic Kidney Disease Stage 3B
Chronic Kidney Disease Stage 3A (Disorder)
Chronic Kidney Disease, Stage 3 (Moderate)
Diet Habit
Keywords: kidney failure
advanced glycation products
chronic kidney disease
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients


Eligibility criteria: Inclusion Criteria:

* Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and \< 60mL/min)
* Informed consent signed
* Aged 18 to 89 years

Exclusion Criteria:

* Protected adult
* Acute renal failure
* Patient already on a low-AGE diet (\< 1kU AGE/day) following a dietetic consultation
* Current participation in another interventional research

Primary outcomes:
measure: Glomerular Filtration Rate
timeFrame: At 24 months
Secondary outcomes:
measure: Proteinuria
timeFrame: At 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
Study officials:
References:
Clinical trial NCT06803290: Food Effect Study of VHX-896 in Healthy Volunteers
Official title: An Open-Label, Two-Period, Two-Sequence, Two-Treatment Randomized, Single Oral Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetic Profile of VHX-896 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: VHX-896
Food Effect
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 24
Sex: ALL
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: A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations.
* No clinically significant medical, psychiatric or sleep disorders.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse in last 12 months.
* Participants who suffered from significant physical illness in the 4-week period preceding baseline.
* Pregnant or nursing (lactating) women.

Primary outcomes:
measure: Comparative bioavailability of VHX-tablets under fed versus fasted conditions.
timeFrame: 96 Hours
Secondary outcomes:
measure: Assessment of safety and tolerability of single dose of VHX-896 tablets
timeFrame: 17 Days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Vanda Investigational Site
state: Missouri
Study officials:
References:
Clinical trial NCT03827590: Clinical Trials to Assess the Efficacy and Safety of HLIM
Official title: Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Upper Respiratory Tract Infection
Acute Bronchitis
Lead sponsor: SamA Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 487
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of HLIM

Detailed description: A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Eligibility criteria: Inclusion Criteria:

* Age between 2 and 75
* Weight more than 11.5 kg

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension or Diabetes
* Smoking more than 20 pack-years

Primary outcomes:
measure: Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
timeFrame: 5 days
measure: Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
References:
Clinical trial NCT03828890: Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Official title: A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The long-term goal for this study is to improve compliance of screening for diabetic retinopathy among subjects with diabetes. Researchers are also doing this research to determine the ability of appropriately trained family physicians to screen for and identify Diabetic Retinopathy using a retinal camera in addition to determining an overall patient perspective of the convenience and cost-effectiveness of retinal imaging within a primary care setting.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age
* Diabetes Mellitus Type I or II
* Patient is willing and able to provide informed written consent

Exclusion Criteria:

• Known Diabetic Retinopathy

Primary outcomes:
measure: Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist
timeFrame: 6 months.
Secondary outcomes:
measure: Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.
timeFrame: 6 months
Other outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan Farford, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061190: Beta Blockers In Acute Ischemic Stroke
Official title: Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2010-02-03
Enrollment: 20
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: The objective of this trial is to assess the safety and efficacy of neuro- and cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.

Detailed description: The main objective of this trial is to assess the efficacy and safety of propranolol in middle cerebral artery stroke patients. The primary hypothesis is as follows: Early administration of propranolol reduces the frequency of cardiovascular and/or neurological complications including vascular death in the first 30 days after acute ischemic stroke. Secondary hypotheses are as follows: Early administration of propranolol improves neurological and functional outcome of patients with acute ischemic stroke. Early administration of propranolol reduces post-stroke immunodepression and therefore lowers the rate of pneumonia after acute ischemic stroke, without increasing the frequency of auto-aggressive, CNS antigen-specific T cells. Early administration of propranolol influences alterations in cardiologic, electrophysiologic phenomenons as a reaction to autonomic dysregulation after acute ischemic stroke. Early administration of Propranolol reduces growth of infarct as determined by MRI examinations in the first 6 days.

Eligibility criteria: Inclusion Criteria:

* Symptom onset within 18 hours
* Acute ischemic MCA-territory stroke
* Patients with suspected stroke in MCA-territory and a) NIHSS \> 3 or b) imaging evidence of MCA-infarction

Exclusion Criteria:

* Patients already receiving beta-blockers
* Anti-arrhythmic, antiinfectious, antiinflammatory or immunosuppressive therapy
* Patients with a major heart disease, hypotension, bradycardia or any contraindication to the use of Propranolol

Primary outcomes:
measure: composite incidence of cardiovascular and/or neurological complications including vascular death
timeFrame: 90 days
Secondary outcomes:
measure: mRS and lethality
timeFrame: 90 days
measure: number of SAEs and treatment withdrawals
timeFrame: 90 days
measure: immunological & cardiological parameters
timeFrame: 90 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, University Berlin, Center for Stroke Research Berlin
Study officials:
affiliation: Charité, University Berlin, Center for Stroke Research Berlin
name: Wilhelm Haverkamp, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083290: Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets
Official title: Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets in Healthy Subjects Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: spironolactone
linearity of pharmacokinetics
Healthy volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets


Eligibility criteria: Inclusion Criteria:

* Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG

Exclusion Criteria:

* Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.

Primary outcomes:
measure: Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma
timeFrame: up to 72 h after the study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Accutest Research Laboratories (I) Pvt. Ltd.
Study officials:
affiliation: Accutest Research Laboratories (I) Pvt. Ltd.
name: Suhas Khandave, MD
role: PRINCIPAL_INVESTIGATOR
References: