louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01295164: Measurement of High Order Aberrations in Late Stages Keratoconus
Official title: Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Keratoconus
Keywords: keratoconus, wave-front sensing technology, aberrometer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

Detailed description: The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.

Eligibility criteria: Inclusion Criteria:

* to be able to understand an information and give a consent
* patients over 18
* patients with keratoconus
* affiliated to medical insurance.

Exclusion Criteria:

* non keratoconus patients
* patients under 18
* pregnant women or nursing mothers
* ocular surgery 90 days before inclusion
* ocular infection
* keratitis
* restless patients

Primary outcomes:
measure: The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus
timeFrame: at the 1st day
Secondary outcomes:
measure: To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".
timeFrame: at the 1st day
measure: To describe the measures obtained in advanced stages (3 and 4) of keratoconus.
timeFrame: at the 1st day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hopstial Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Francois Malecaze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182064: Acute Myocardial Infarction by Penetrating Cardiac Trauma
Official title: Relationship of Echocardiographic and Coronary Angiographic Findings in Patients With Acute Myocardial Infarction Secondary to Penetrating Cardiac Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Heart injuries
Posttraumatic myocardial infarction
Echocardiography
Coronary angiography
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2010-08-16
Enrollment: 51
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included patients admitted to the emergency department of the San Vicente de Paul University Hospital with a penetrating stab cardiac injury without previous injuries

Brief summary: Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their damage in the cardiac injury repair. The investigators objectives are to know the PAMI incidence, make an approximation to PAMI pathophysiology, and propose management strategies.


Eligibility criteria: Inclusion Criteria:

* Heart stab Injury

Exclusion Criteria:

* Previous cardiac injuries, coronary artery disease with previous diagnostic, previous coronary angiography (for any indication)

Primary outcomes:
measure: Posttraumatic acute myocardial infarct
timeFrame: 2 days
Secondary outcomes:
measure: Posttraumatic acute myocardial infarct without coronary injury
timeFrame: 10 days
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: San Vicente de Paul Hospital
state: Antioquia
Study officials:
affiliation: Antioquia University
name: Carlos H Morales, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Castano W, Morales CH, Senior JM, Benjumea WY, Sanchez J. Relationship of echocardiographic and coronary angiographic findings in patients with acute myocardial infarction secondary to penetrating cardiac trauma. J Trauma Acute Care Surg. 2012 Jul;73(1):111-6. doi: 10.1097/TA.0b013e318256a0d8.
Clinical trial NCT06287164: Management of Heart Failure in Italian Outpatients Clinics: Observational Study
Official title: Optimization of Therapy in the Italian Management of Heart Failure: OPTIMA-HF Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 4000
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: HF patients in stable clinical conditions

Brief summary: OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.

Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines.


Eligibility criteria: Inclusion Criteria: age \>18 years, post-menopausal, permanent sterile, or childbearing potential on highly effective contraceptive methods women, stable clinical conditions (NYHA class I-III), outpatients setting, capability to understand the study procedures and sign the informed consent form.

Exclusion Criteria: any clinical condition that would have jeopardized patient safety while participating in this study.

Primary outcomes:
measure: HF treatment adherence according to the most recent European Guidelines
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II University of Naples, Department of Advanced Biomedical Sciences
Study officials:
References:
Clinical trial NCT05709964: Comparison of Demographic Data Mentioned by the Patients or Measured by a Physician
Official title: Comparison of Demographic Data Mentioned by the Patients or Measured by a Physician
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included

Brief summary: OSA (Obstructive Sleep Apnea) represents a major risk of postoperative complications. Predictive scores have been developed as the STOP-Bang score and the DES-OSA score. These scores take into account morphological parameters such as weight, height, and neck circumference. These data can be contained from the patients (self-reported) or by the measurements performed by a physician. The aim of this study is to compare the accuracy of both measurements (self-reported by the patient or measured by the physicians).


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for elective surgery on a one-day hospital

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Accuracy of self-reported height measurements
timeFrame: One month
measure: Accuracy of self-reported weight measurements
timeFrame: One month
measure: Accuracy of self-reported neck circumference measurements
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181764: A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
Official title: A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: X-linked Hypophosphatemic Rickets/Osteomalacia
Keywords: XLH
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 15
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: The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Patients with XLH

Exclusion Criteria:

1. Have an active infection or chronic inflammatory disease
2. Have uncontrolled hypertension
3. Have uncontrolled diabetes mellitus
4. History of known immunodeficiency
5. Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
6. Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening
7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

Primary outcomes:
measure: Number and types of adverse events
timeFrame: Up to 7 weeks after dosing
Secondary outcomes:
measure: Profiles of pharmacokinetics
timeFrame: Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose
Other outcomes:
Locations:
city: Tokyo
country: Japan
city: Seoul
country: Korea, Republic of
Study officials:
References:
Clinical trial NCT02454764: 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT
Official title: To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HBV
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT \>/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response


Eligibility criteria: Inclusion Criteria:

1. Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months,
2. HBeAg (+),
3. ALT \< ULN (Upper Limit Normal) on 2 or more occasions in last 6 months \[ULN: 45\]
4. HBV DNA \>2000 IU/mL
5. Age \> 18 years

Exclusion Criteria:

1. Decompensated Cirrhosis
2. Severe HBV flare with reactivation
3. Presentation as ACLF (Acute on Chronic liver Failure)
4. Baseline ALT \> ULN (Upper Limit Normal)
5. Contraindications to PEG-IFN therapy
6. Prior HBV antiviral therapy within 6 months of enrollment
7. Co-infections with HCV/HIV
8. ANA +(autoantibodies suggestive of autoimmune disease) \>1:80
9. Patient not willing for enrollment in the study
10. Pregnancy, lactation
11. Patients who leave the study/ discontinue the therapy before completion

Primary outcomes:
measure: Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart
timeFrame: 65 weeks
Secondary outcomes:
measure: HBsAg loss
timeFrame: 64 weeks
measure: Absence of quantifiable serum HBV DNA
timeFrame: 64 weeks
measure: Development of serious adverse effects, acute hepatitis or hepatic decompensation
timeFrame: 64 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT03847064: Correction of Lower Limb Deformities With Fixator Assisted Nailing
Official title: Correction of Lower Limb Deformities With Fixator Assisted Nailing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deformity; Bone
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: .All those patients who has lower limb deformity irrespective of the cause underwent fixator assisted intramedullary nailing of tibia or femurs for deformity correction were included

Brief summary: It is a retrospective study at a tertiary care hospital. All cases of lower limb deformity whose correction was done with fixator assisted IM nailing from 2010 till 2017 were analyzed.

Detailed description: It is a retrospective study at a tertiary care hospital. All cases of lower limb deformity whose correction was done with fixator assisted IM nailing from 2010 till 2017 were analyzed. Pre Op x-rays and post op x rays will be analyzed for Mechanical Axis Deviation (MAD), anatomical Lateral Distal Femoral Angle (aLDFA), mechanical Lateral Distal Femoral Angle (mLDFA) and Medial Proximal Tibial Angle (MPTA), post-operative activity and functional status of the patients. Data will be analyzed using SPSS

Eligibility criteria: Inclusion Criteria:

- All those patients who underwent fixator assisted intramedullary nailing of tibia or femurs for deformity correction were included

Exclusion Criteria:

* Patients who lost to follow up and those with missing records were excluded from the study.

Primary outcomes:
measure: Correction of lower limb deformities
timeFrame: 2010 till 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01097564: COL4A1 Gene Related Cerebra-retinal Angiopathy
Official title: COL4A1 Gene Related Cerebra-retinal Angiopathy : Clinical Spectrum From Children to Adult, Mutational Spectrum and Application to Routine Management of Affected Patients : a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebra-retinal Angiopathy
Keywords: Genetic
Cerebral angiopathy
Retinal angiopathy
COL4A1 gene
Infantile Cerebral Palsy
Congenital porencephaly
Congenital cataract
Leukoencephalopathy
COL4A1 gene related cerebra-retinal angiopathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-04-01
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * patients children
* patients young adult
* family adult symptomatic
* family adult asymptomatic

Brief summary: This prospective multicenter cohort study aims to define the clinical, radiological and mutational spectrum of the disease related to COL4A1 gene.

Detailed description: 150 index patients (children or young adult) will be prospectively recruited over three years according to eligibility criteria. Relatives will be also recruited.

Clinical, brain MRI-MRA and genetic testing (COL4A1 mutation screening) will be conducted for each included patient or asymptomatic relatives. 13 French investigating centres will be participating to the study.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the index patient :

* Children and young adult (\< 65 years)
* Intracranial hemorrhage of unknown etiology
* leukoencephalopathy
* Any associated signs (including retinal arteriolar tortuosity, intracranial aneurysm, porencephaly, Infantile Cerebral Palsy, juvenile cataract)

Exclusion criteria:

(for the index patient)

* Hypertension
* Diabetes
* Other (than COL4A1) genetic small vessel diseases of the brain

Primary outcomes:
measure: Implication of COL4A1 gene (and other related genes) in intracranial haemorrhages of unknown etiology in children and young adults and in brain diffuse small vessel diseases of unknown etiology in young adults.
timeFrame: at 36 months
Secondary outcomes:
measure: To define the whole clinical, radiological and mutational spectrum of COL4A1 gene.
timeFrame: at 36 months
measure: To define any genotype-phenotype correlation in COL4A1 gene disease.
timeFrame: at 36 months
measure: Application of the results in daily clinical practice
timeFrame: at 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital LARIBOISIERE Neurology Department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hugues CHABRIAT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664664: Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
Official title: A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Keywords: insomnia
sleep maintenance insomnia
sleep quality
non-restorative sleep
multiple awakenings
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 744
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: This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 to 65 years
* Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
* Generally good health

Exclusion Criteria:

* History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
* Any clinically significant medical condition, laboratory finding, or ECG finding
* Pregnant and/or lactating females
* History of substance abuse within 2 years or positive urine drug screen
* Positive Hepatitis B/C results or HIV markers
* History of treatment with an investigational drug within the last month
* Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study

Primary outcomes:
measure: Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
timeFrame: During and after 2 weeks of study drug
Secondary outcomes:
measure: Change from baseline in subjective total sleep time (sTST)
timeFrame: During and after 2 weeks on study drug
measure: Change from baseline in subjective wake time after sleep onset (sWASO)
timeFrame: During and after 2 weeks on study drug
measure: Change in subjective latency to sleep onset (sSLO)
timeFrame: During and after 2 weeks on study drug
measure: Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.
timeFrame: During and after 2 weeks on study drug
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Arena Pharmaceuticals, Inc
state: California
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References:
Clinical trial NCT02375464: Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
Official title: Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Neuroendocrine Tumors
Keywords: neuroendocrine tumor
carcinoid tumor
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-03-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.

Detailed description: Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management.

Gallium-68 has been designated an "orphan drug" due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.

Eligibility criteria: Inclusion Criteria:

* Proven or suspected neuroendocrine tumor Physician referral for imaging

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lenox Hill Hospital
name: STEPHEN C SCHARF, MD
role: PRINCIPAL_INVESTIGATOR
References: