louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06757907: Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis
Official title: Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpetic Keratitis
Keywords: acyclovir
ganciclovir
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Topical ganciclovir 0.15% ophthalmic gel presents a safer alternative for managing herpetic keratitis, offering effective viral suppression with minimal toxicity. This study aims to compare the efficacy and safety of topical ganciclovir versus systemic acyclovir in treating herpetic keratitis, providing valuable insights into optimal management strategies for this condition


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with herpetic keratitis

Exclusion Criteria:

* Patients with known allergies to ganciclovir or acyclovir
* Severe ocular surface disease
* Those who have previously received antiviral therapy for herpetic keratitis within the last month

Primary outcomes:
measure: Corneal healing
timeFrame: At 4 and 6 weeks
Secondary outcomes:
measure: Sie effects
timeFrame: at 4 and 6 weeks
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar university
Study officials:
References:
Clinical trial NCT05529407: Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus
Official title: Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginismus
Keywords: genitopelvic pain disorder, vaginismus
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure

Detailed description: Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Eligibility criteria: Inclusion Criteria:

* non-pregnant/non lactating women aged between 18-50
* diagnosed with primary vaginismus of Lamont level II or higher

Exclusion Criteria:

* hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease.
* Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)

Primary outcomes:
measure: Sucessfull Intercourse-Diary
timeFrame: 30 days
Secondary outcomes:
measure: GRISS: Golombuk Rust Inventory of Sexual Satisfaction
timeFrame: 30 day
measure: FSFI Score
timeFrame: 30 day
measure: Fear of Coitus Subscale
timeFrame: 30 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
citation: Aslan M, Yavuzkir S, Baykara S. Is "Dilator Use" More Effective Than "Finger Use" in Exposure Therapy in Vaginismus Treatment? J Sex Marital Ther. 2020;46(4):354-360. doi: 10.1080/0092623X.2020.1716907. Epub 2020 Feb 13.
Clinical trial NCT03552107: Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic
Official title: Real World Experience With Lorcaserin for Weight Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Weight Loss
Overweight
Keywords: Lorcaserin
Belviq
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2018-06-11
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes 157 patients seen and evaluated in an insurance-based medical weight loss clinic in San Diego, CA. Eligible participants will include patients who are overweight or obese, and who received at least one prescription for Lorcaserin treatment.

Brief summary: This is a retrospective, descriptive study that involves de-identified data consisting of weight changes, pertinent vital signs and laboratory values influenced by body weight, and healthcare utilization of patients prescribed lorcaserin at The Center for Weight Management at the Scripps Clinic in San Diego, CA.

Detailed description: All patients who initiated treatment with Lorcaserin during the review period will undergo chart review. The primary endpoint will be weight change in patients on Lorcaserin and average duration of Lorcaserin treatment over time (up to 1 year). Secondary endpoints will include changes in vital signs, liver function, glucose, and lipids. In addition, time on treatment, reasons for discontinuation of medication, and changes in healthcare utilization (to include inpatient and outpatient utilization) will be examined. This is a retrospective, one-arm observational study that will include chart reviews of 157 patients who have been treated in the clinic.

Eligibility criteria: Inclusion Criteria:

* Received at least one prescription for Lorcaserin treatment
* At least 18 years of age or with guardian/parent able to consent for a minor

Exclusion Criteria:

- Patient under the age of 18 at time of index date

Primary outcomes:
measure: Weight change - in pounds
timeFrame: Up to 1 year of medication use
measure: Duration of Use - in weeks
timeFrame: Up to 1 year of medication use
Secondary outcomes:
measure: Change in heart rate
timeFrame: Up to 1 year of medication use
measure: Change in blood pressure
timeFrame: Up to 1 year of medication use
measure: Change in lipid levels
timeFrame: Up to 1 year of medication use
measure: Change in liver enzymes
timeFrame: Up to 1 year of medication use
measure: Change in glucose values
timeFrame: Up to 1 year of medication use
Other outcomes:
measure: Reasons for Discontinuation
timeFrame: Up to 1 year of medication use
measure: Changes in Healthcare Utilization
timeFrame: Up to 1 year of medication use
Locations:
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Clinic Medical Group
name: Ken Fujioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04200807: Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Official title: Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics, as Valuable Diagnostic and Treatment Efficiency Criterium of Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Term
Neonatal Infection
Keywords: cardiac output; echocardiography; USCOM; neonates
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 163
Sex: ALL
Minimum age (years): 26
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolled both preterm and full-term newborns of any gestational age, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections in control group.

Brief summary: Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function. Continuous-wave Doppler ultrasound monitor USCOM is a relatively new monitor which can perform faster and less complex cardiac function measurement, also it is easier for the operator to get trained. The aim of the study is to assess the level of agreement between cardiac output measured with conventional echocardiography and with USCOM, to present normal ranges for neonates of different gestational age and to look for early signs of hemodynamic changes during sepsis.


Eligibility criteria: Inclusion Criteria:

* newborns of any gestational age
* parental consent acquired

Exclusion Criteria:

* congenital malformations
* hemodynamic instability in control group
* any respiratory support in control group
* infection in control group

Primary outcomes:
measure: Weight measurement
timeFrame: 1 minute
measure: Height measurement
timeFrame: 1 minute
measure: Chest and head circumference
timeFrame: 1 minute
measure: Blood pressure measurement
timeFrame: 1 minute
measure: Pulse rate measurement
timeFrame: 1 minute
measure: Near- Infrared Spectroscopy for regional blood flow
timeFrame: 15-20 minutes
measure: Echocardioscopy for left ventricular outflow tract diameter
timeFrame: 2-3 minutes
measure: Echocardioscopy to measure velocity time integral
timeFrame: 3 minutes
measure: USCOM examination
timeFrame: 3-5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University, Neonatology Centre
Study officials:
affiliation: Vilnius University
name: Vytautas Usonis, MD
role: STUDY_DIRECTOR
References:
citation: Pliauckiene A, Liubsys A, Vankeviciene R, Usonis V. Ultrasonic cardiac output monitor provides effective non-invasive bedside measurements of neonatal cardiac output. J Clin Monit Comput. 2022 Jun;36(3):803-807. doi: 10.1007/s10877-021-00711-2. Epub 2021 Apr 30.
Clinical trial NCT01426607: VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Official title: VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.


Eligibility criteria: Inclusion Criteria:

* AHI \> 30
* Intolerance to CPAP therapy
* Signed informed consent

Exclusion Criteria:

* Epworth sleepiness scale \> 16/24
* Severe cardiac and/or respiratory disease
* BMI\>32 kg/m2
* Dental contraindication to oral appliance

Primary outcomes:
measure: change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
timeFrame: 2 months
Secondary outcomes:
measure: change from baseline to 2-months in markers of OSA severity
timeFrame: 2 months
measure: change from baseline to 2-months in blood pressure
timeFrame: 2 months
measure: change from baseline to 2-months in symptoms of OSA
timeFrame: 2 months
measure: evaluate treatment compliance objectively measured by an embedded micro sensor
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Mans
country: France
facility: CH Le Mans
city: Paris
country: France
facility: Hopital Saint Antoine
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
citation: Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.
citation: Gagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.
Clinical trial NCT00977288: A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
Official title: A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 408
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

Detailed description: This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.

Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.

As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Eligibility criteria: Inclusion Criteria:

* Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion Criteria:

* Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
* Patients has uncontrolled diabetes
* Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Primary outcomes:
measure: The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5.
Clinical trial NCT05329688: Nutrition Education Program for Cancer Patients Receiving Radiotherapy
Official title: The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radiotherapy Side Effect
Nutrition Related Cancer
Keywords: nutrition
radiotherapy
cancer patients
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Asia University
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind (Participant)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

Detailed description: Weight loss is common among cancer patients, and can be attributed to many causes, including mucositis, inability to ingest or absorb adequate calories because of a problem with the alimentary tract, loss of appetite, and metabolic aberrations. Unintentional weight loss may be associated with decreased quality of life (QOL) and a poorer prognosis. Furthermore, for patients who are already in a catabolic state, the increased metabolic demands associated with anticancer treatment (particularly surgery) further worsen the problem. The novel nutrition program might improve the nutrition status and QOL in cancer patients receiving radiotherapy.

Eligibility criteria: Inclusion Criteria:

1. Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.
2. Patients need nutrition support treatment
3. Informed consent

Exclusion Criteria:

1. Critical patients or life expectancy \< 12 weeks
2. Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
3. Unconscious or psychiatric patients
4. Patients with communication problems

Primary outcomes:
measure: risk of malnutrition
timeFrame: Week 0, 12
measure: BMI
timeFrame: Week 0, 12
measure: albumin
timeFrame: Week 0, 12
measure: Quality of Life (QOL)
timeFrame: Week 0, 12
Secondary outcomes:
measure: physical function status
timeFrame: Week 0, 12
measure: Knowledge-Attitude-Practice
timeFrame: Week 0, 12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Szu-Yuan Wu
state: Please Select
Study officials:
affiliation: Asia University, Taiwan
name: Szu-Yuan Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02049788: Effects of a Low Glycemic Index in Obese Children
Official title: Effects of a Low Glycemic Index Diet on Body Composition and Metabolic Syndrome Risks in Obese Thai Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the effectiveness of a low-GI diet program and a standard counseling program in the treatment of obese Thai children.

Detailed description: Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat diet (control group). Both groups were followed-up every month for six months. The primary outcomes were body composition changes during the six-month period, measured by dual X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid profiles.

The adherence to the nutritional education and physical activity recommendation was evaluated by using three-day dietary records (two weekdays and one weekend day) and a physical activity questionnaire at each visit. All participants were examined and counseled about physical activity and life style modification strategies by a pediatrician at every visit.

Eligibility criteria: Inclusion Criteria:

* Children aged between nine to sixteen years old
* BMI higher than the International Obesity Task Force cut-off

Exclusion Criteria:

* psychological problems
* underlying diseases that might affect a weight management program
* used drugs associated with weight increment or reduction
* attended other weight management programs

Primary outcomes:
measure: Change from baseline in body composition measured by BIA and DEXA at month 6
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in metabolic syndrome risks at month 6
timeFrame: 6 months
Other outcomes:
measure: Change from baseline in body weight, BMI z-score and waist circumference at month 6
timeFrame: 6 months
Locations:
city: Patumwan
country: Thailand
facility: Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Sirinuch Chomtho, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965588: Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
Official title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
amyloid beta
vaccine
Lead sponsor: United Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Taiwan University Hospital
First posted: 2009-08-25
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 15-25
* Other inclusion criteria apply

Exclusion Criteria:

* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
* Other exclusion criteria apply

Primary outcomes:
measure: To evaluate safety and tolerability of the vaccine (UB 311).
timeFrame: Screen, treatment & follow-up: 28-30 weeks
Secondary outcomes:
measure: To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).
timeFrame: Screen, treatment & follow-up: 28-30 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Jang Chiu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Pei-Ning Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19.