louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03224013: Hyperopic LASIK With Crosslinking Versus Standard LASIK
Official title: Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.

Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.
Primary purpose: OTHER

Brief summary: Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).

Detailed description: Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.

Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

Exclusion Criteria:

* Patients with previous intraocular or corneal surgery, active corneal disease

Primary outcomes:
measure: assessment of changes in refractive spherical equivalent
timeFrame: preoperative and 3 months and 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MD, Phd, FEBO
name: Jorge L Alio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00182013: Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Spectrum Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 106
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.


Eligibility criteria: Inclusion Criteria:

* Males and females age 6 to 18 years of age
* Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
* Patients must have an initial score on the Y-MRS total score of at least 15.
* Patient must be able to participate in mandatory blood draws.
* Patient must be able to swallow pills.

Exclusion Criteria:

* Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study

Primary outcomes:
measure: Young Mania Rating Scale
timeFrame: baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joshi G, Petty C, Wozniak J, Faraone SV, Doyle R, Georgiopoulos A, Hammerness P, Walls S, Glaeser B, Brethel K, Yorks D, Biederman J. A prospective open-label trial of quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder. J Affect Disord. 2012 Feb;136(3):1143-53. doi: 10.1016/j.jad.2011.09.042. Epub 2011 Oct 28.
Clinical trial NCT02550613: Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma
Official title: Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: MR/PET, hepatocellular carcinoma, HCC
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 100 HCC patients who are admitted for curative or non-curative treatments, including operation, radiofrequency ablation, TACE, target therapy, chemotherapy, or radiotherapy.

Brief summary: The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients.

Detailed description: This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Eligibility criteria: Inclusion Criteria:

1. Prior Informed Consent Form
2. At least one measurable tumor, according to RECIST version 1.1.
3. Age \> 20 years.
4. ECOG performance status 0 or 1.
5. Life expectancy \> 3 months.
6. Confirmed Diagnosis of HCC
7. Adequate renal function (Serum creatinine ≦ 1.5 x upper limit of normal).

Exclusion Criteria:

1. Age \<20 years old
2. Pregnancy
3. Contraindication for MRI: claustrophobia or MR non-compatible devices
4. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
5. History of other malignancy

Primary outcomes:
measure: The recurrence rate at 3 months after treatment
timeFrame: 3 months
Secondary outcomes:
measure: The overall survival after treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Medical Imaging, National Taiwan University Hospital
name: Bang-Bin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00751413: Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)
Official title: A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 6 to Less Than 12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.


Eligibility criteria: Inclusion Criteria:

* Patient has mild to moderate asthma
* Patient is able to swallow pills
* Patient is able to have have blood draws

Exclusion Criteria:

* Patient has required a visit to the hospital or emergency room due to an asthmatic event in the last 3 months
* Patient has an upper respiratory tract infection (URI)
* Patient has a history of stroke
* Patient consumes more than 4 caffeinated beverages per day

Primary outcomes:
measure: To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
timeFrame: Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study.
Secondary outcomes:
measure: To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients
timeFrame: Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910013: Femoral Block With or Without Ropivacaine for Analgesia After Total Knee Replacement (TKR)
Official title: A Randomized Trial Comparing the Efficacy on Post-operative Analgesia of Intra-articular Ropivacaine Added to a Femoral Block After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Total Knee Replacement
Keywords: TKR
Femoral block
Ropivacaïne
intra-articular ropivacaïne
post-operative analgesia
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 80
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: Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks.

The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.


Eligibility criteria: Inclusion Criteria:

* Primary total knee replacement
* Age \> 18 years old
* Accept the study

Exclusion Criteria:

* Revision surgery
* Use of anticoagulants drugs
* Neurologic disorder
* Unable to sign consent form

Primary outcomes:
measure: Narcotic consumption per 24 hours after surgery (mg/kg)
timeFrame: 48 hours
Secondary outcomes:
measure: VAS score at 24 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
affiliation: Hôpital Enfant-Jésus
name: Dr Stéphane Pelet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625713: Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center
Official title: Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ano-Rectal Infection Bacterial Nos
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 600
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: The study population corresponds to patients seen in hospital, in emergency consultation or programmed for a suspicion of infectious ano-rectitis and for whom a sampling for diagnostic purposes will be carried out and addressed in microbiology.

Brief summary: Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.


Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18
* Patient consulting or hospitalized in the proctology center
* Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis

Exclusion Criteria:

* Patient's opposition to participate
* Patient deprived of liberty
* Patient under guardianship

Primary outcomes:
measure: Evaluate the clinical presentation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Vincent De Parades, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140213: A STUDY BEFORE/AFTER THE IMPLEMENTATION OF AN ANTI-INFECTIOUS PRESCRIPTION AID
Official title: EVALUATION OF 30-DAY MORTALITY AFTER A VISIT TO THE LAPEYRONIE ADULT EMERGENCY DEPARTMENT OF THE CHU MONTPELLIER FOR SEPSIS OR SEPTIC SHOCK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Keywords: Adult patients
Probabilistic antibiotic therapy to be initiated
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients with severe sepsis in the Montpellier emergency department

Brief summary: Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.


Eligibility criteria: Inclusion criteria:

* Major patients
* Sepsis or septic shock
* Oral consent

Exclusion criteria:

* minor patients
* death before antibiotherapy
* care limitations
* pre-hospital antibiotherapy

Primary outcomes:
measure: Numbers of patient 30-day mortality
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
measure: Numbers of patient 90-day mortality
timeFrame: 90 days
measure: Numbers of patient 6 months mortality
timeFrame: 6 months
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Hamza GHOMRANI, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03216213: Evaluating Attitudes Towards Organ Donation in Singapore
Official title: Evaluating Attitudes Towards Organ Donation in Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Control
Behavior
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: One survey is conducted. Exploring the effect of different messages on family members' decision making on organ donation.

Detailed description: The investigators intend to examine the impact of nudging interventions in the form of a vignette designed to emulate the standard procedure of informing family members of a loved one's unfavourable prognosis. The investigators intend to examine the effect of the interventions on the eventual decision-making process of the family member.

Eligibility criteria: Inclusion Criteria:

* Above age 21
* Singapore Citizens and Permanent Residents

Exclusion Criteria:

* Below age 21
* Non-citizens
* Not able to make decisions for self

Primary outcomes:
measure: Binary survey item - Preferred option for mother's situation
timeFrame: 3 minutes
measure: 10cm line scale survey item - Willingness for participant's mother's organs to be donated under brain death
timeFrame: 3 minutes
Secondary outcomes:
measure: 10cm line scale survey item - Willingness for participant's mother's organs to be donated under cardiac death
timeFrame: 3 minutes
measure: 10cm line scale survey item - Willingness for participant's own organs to be donated under brain death
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
Clinical trial NCT02239913: Topiramate-Phentermine Combinations for Cocaine Dependence
Official title: Topiramate-Phentermine Combinations for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Use Disorder
Keywords: Cocaine
Pharmacotherapy
Phentermine
Topiramate
Self-Administration
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-09-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use by the intranasal or intravenous route

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, topiramate or phentermine

Primary outcomes:
measure: Reinforcing Effects
timeFrame: Nine times over approximately five weeks inpatient admission.
Secondary outcomes:
measure: Subjective effects
timeFrame: Nine times over approximately five weeks inpatient admission.
measure: Physiological Effects
timeFrame: Daily over approximately five week inpatient admissions
measure: Side effects
timeFrame: Daily over approximately five weeks of inpatient admission
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Craig R Rush, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03070613: Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Official title: Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Polyp
Keywords: Colonoscopy
Fluorescence guided surgery
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above
* Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
* In the investigator's opinion, is able and willing to comply with all study requirements

Exclusion Criteria

* Participant who is unable to unwilling to give informed consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study
* Participants with known egg allergies, ovalbumin allergy and soya allergies

Primary outcomes:
measure: Signal to background ratios of identified colonic lesions under white light and under fluorescence
timeFrame: During procedure
measure: Number of dysplastic and cancerous lesions identified under white light and under fluorescence
timeFrame: During procedure
Secondary outcomes:
measure: Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups
timeFrame: 12 months
measure: Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.
timeFrame: 12 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Thomas Barnes
state: Oxfordshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
References: