louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00527592: A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Comfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
* Best corrected visual acuity of 20/200 Snellen or better in each eye.
* Intraocular pressure within protocol-specified range.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any abnormality preventing reliable applanation tonometry in the study eye(s).
* Any eye conditions or procedures as specified in protocol.
* Progressive retinal or optic nerve disease from any cause.
* Use of contact lenses in the study eye(s).
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Comfort Immediately After Dosing
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05762692: High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients
Official title: Clinical Feasibility and Efficacy of High-flow Nasal Oxygenation During Intravenous Deep Sedation in Pediatric Dental Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Sedation
Dental Treatment
Pediatric Patients
Keywords: high-flow nasal oxygenation
dental treatment
children
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: It is important to choose an appropriate oxygenation technique during intravenous deep sedation in pediatric dental treatment. The study is to evaluate the efficacy and safety of high-flow nasal oxygenation in intravenous deep sedation in pediatric dental patients.


Eligibility criteria: Inclusion Criteria:

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time over 60 mins.

Exclusion Criteria:

1. Conditions which the attending considers to be unfit for elective surgery or tubeless anesthesia.
2. Any contraindications of high flow nasal oxygenation.
3. Any contraindications or allergic history of propofol.

Primary outcomes:
measure: Hypoxemia
timeFrame: Intra-operative
Secondary outcomes:
measure: Severe Hypoxemia
timeFrame: Intra-operative
measure: Desaturation
timeFrame: Intra-operative
measure: Intra-operative airway assistance
timeFrame: Intra-operative
measure: Operation interruption
timeFrame: Intra-operative
measure: Intra-operative end-tidal carbon dioxide level
timeFrame: Intra-operative
measure: Intra-operative transcutaneous carbon dioxide level
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University of Stomatology
Study officials:
References:
Clinical trial NCT00553592: Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: XTL Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 336
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: To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years or older
* Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
* Chronic bilateral pain due to diabetic neuropathy
* Pain for at least six months
* Primary pain is located in the feet
* Others-contact site for information

Exclusion Criteria:

* Symptoms of other painful conditions
* Presence of amputations other than toes
* Clinically significant psychiatric or other neurological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years
* Others-contact site for information

Primary outcomes:
measure: Pain and Safety
timeFrame: 14 weeks
Secondary outcomes:
measure: Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
Study officials:
affiliation: XTL Bio
name: Mark Roffman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01485692: Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Official title: Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychomotor Agitation
Keywords: Violence
Aggression
Psychiatric emergencies
Psychomotor agitation
Violent patient
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.


Eligibility criteria: Inclusion Criteria:

* patients featuring psychomotor agitation, with clinical need for intramuscular injection

Exclusion Criteria:

* delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options

Primary outcomes:
measure: Reduction in the agitation score
timeFrame: 90 minutes
Secondary outcomes:
measure: Adverse effects
timeFrame: 12,24 hours after baseline
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Celia Mantovani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mantovani C, Labate CM, Sponholz A Jr, de Azevedo Marques JM, Guapo VG, de Simone Brito dos Santos ME, Pazin-Filho A, Del-Ben CM. Are low doses of antipsychotics effective in the management of psychomotor agitation? A randomized, rated-blind trial of 4 intramuscular interventions. J Clin Psychopharmacol. 2013 Jun;33(3):306-12. doi: 10.1097/JCP.0b013e3182900fd6.
Clinical trial NCT06169592: Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation
Official title: Verification of Prognostic Risk Factors of Thrombohemorrhagic Complications in Early Follow-up Period in Recipients After Living Related Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Liver Transplant; Complications
Lead sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end stage liver cirrhosis who underwent living related liver transplantation.

Brief summary: The aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years and up to 70 years;
* Signed informed consent for inclusion to the study;
* End stage liver cirrhosis.

Exclusion Criteria:

* Pregnancy;
* Extrahepatic factors influencing systemic hemostasis;
* Concomitant hematological diseases affecting the hemostatic system;
* Severe concomitant disorders.

Primary outcomes:
measure: Thrombosis of vascular anastomosis
timeFrame: 1 month
Secondary outcomes:
measure: Hemorrhagic complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
Study officials:
References:
Clinical trial NCT03538392: Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Official title: Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Peripheral Arterial Disease
Arterio-venous Fistula
Arteriovenous Graft
Lead sponsor: Cagent Vascular LLC
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.

Brief summary: The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

Detailed description: Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.

Eligibility criteria: * Subject requires angioplasty
* Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use

Primary outcomes:
measure: Performance
timeFrame: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Secondary outcomes:
measure: Collection of device related Major Adverse Events (MAE) until discharge
timeFrame: Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01251692: Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions
Official title: Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Corneal Erosions
Keywords: Corneal erosions
PTK
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.

Detailed description: A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).

Eligibility criteria: Inclusion Criteria:

Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed

Exclusion Criteria:

* Diabetes
* Autoimmune diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Olhos de Goiânia
name: Belquiz A Nassaralla
role: STUDY_CHAIR
References:
Clinical trial NCT00446992: Diabetes in Neuropsychiatric Disorders
Official title: Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Schizoaffective
psychosis
olanzapine
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.

We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Detailed description: Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Eligibility criteria: * Age 18-64
* Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
* No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
* Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
* No history of cocaine use in the previous 30 days, and
* No laboratory evidence of diabetes at baseline (fasting glucose \<126 mg/dL or 2-hour glucose \<200 mg/dL on a glucose tolerance test)

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline and 4 week intervals
measure: Fasting Glucose
timeFrame: Baseline and 4 week intervals
measure: Fasting Insulin
timeFrame: Baseline and 4 week intervals
measure: Hemoglobin A1c
timeFrame: Baseline and 4 week intervals
measure: IL-6
timeFrame: Baseline and 4 week intervals
measure: Triglycerides
timeFrame: Baseline and 4 week intervals
measure: Cholesterol Total
timeFrame: Baseline and 4 week intervals
measure: HDL
timeFrame: Baseline and 4 week intervals
measure: LDL
timeFrame: Baseline and 4 week intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
Study officials:
affiliation: Vice Chair of Psychiatry MCG
name: Brian Kirkpatrick, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Egea E, Miller B, Garcia-Rizo C, Bernardo M, Kirkpatrick B. Metabolic effects of olanzapine in patients with newly diagnosed psychosis. J Clin Psychopharmacol. 2011 Apr;31(2):154-9. doi: 10.1097/JCP.0b013e31820fcea3.
Clinical trial NCT01091792: Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)
Official title: DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Glioblastoma Multiforme
Keywords: GBM
Grade IV
glioma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-03-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.

Detailed description: Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for 12 months. Blood samples will be obtained from these patients at 3 different time points during this study.

Eligibility criteria: Inclusion Criteria:

* Histologically proven GBM
* Karnofsky status equal to or greater than 60%

Exclusion Criteria:

* Inadequately controlled hypertension
* Prior history of hypertension crisis or hypertensive encephalopathy
* History of stroke or transient ischemic attach within 12 months

Primary outcomes:
measure: Changes in the peripheral blood T-reg profile between pretreatment and 4 weeks after completion of treatment with the addition of bevacizumab to RT and TMZ in patients with glioblastoma
timeFrame: 1 year
Secondary outcomes:
measure: Immunologic shift in the phenotypic T cell, B cell, NK cell and DC repertoire induced by RT-TMZ-BEV comparing pretreatment and 4 weeks after completion of treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hithcock Medcial Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Camilo E Fadul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05155592: Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients
Official title: Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Uveitis
Adalimumab
Keywords: Uveitis
Adalimumab
TNF-α inhibitor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Detailed description: TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of non-infectious uveitis
* nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
* Family members and patients who are willing to stop should agree and accept relevant examinations
* The informed consent is read and signed by the patient or a legally authorized represent

Exclusion Criteria:

* Unwilling to sign informed consent
* There is systemic autoimmune disease uncontrolled situation
* Patients who may require surgery in the near future
* Vision meets the standards of low vision and blindness
* Silicone oil or gas filling after vitreous surgery

Primary outcomes:
measure: relapse rate of inflammation
timeFrame: 24 months
Secondary outcomes:
measure: Best corrected visual Acuity
timeFrame: 24 months
measure: macular structure
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang, PhD
role: PRINCIPAL_INVESTIGATOR
References: