louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00735761: Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
Official title: A Randomized, Double-Blind, Active-Controlled, Subject Initiated Study Comparing ME-609 to Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 201
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: The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

Detailed description: The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older.

This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.

Eligibility criteria: Inclusion Criteria:

* History of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study.
* Stable HIV infection
* CD4+ T-cell count 100 to 500/mm3

Exclusion Criteria:

* Systemic treatment with other antiviral agent or corticosteroids within two weeks prior to and during the treatment period, except for antiretroviral treatment in HIV subjects
* Topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration
* Significant skin condition that occur in the area typically affected by herpes recurrences
* Nursing or pregnancy
* Concurrent cancer therapy

Primary outcomes:
measure: The primary variable was episode duration, measured from the start of treatment until loss of hard crust for an ulcerative recurrence and from the start of treatment to time of no signs or symptoms for a non-ulcerative recurrence (Investigator-assessed).
timeFrame: from start of treatment until loss of hard crust
Secondary outcomes:
measure: The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.
timeFrame: Start of recurrence until start of next recurrence
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden
name: Anders Sönnerborg, MD PhD Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216928: A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
Official title: Pilot Study Investigating a New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Reverse Signaling
Anti-TNF
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Blood test in Rheumatoid Arthritis (RA) patients with good response to anti-Tumor Necrosis Factor (anti-TNF) and in patients with moderate or non-response will be done in the month following the evaluation of clinical response to therapy. Isolation of mononuclear cells and purification of monocyte by negative selection. Cell culture of monocyte in presence or not of anti-TNF for 24 hours and analyze of CD36 (cluster of differentiation antigen 36) expression (principal outcome). For secondary outcomes analyze monocyte phenotype, NRF2 nuclear translocation, and clinical data of patients.


Eligibility criteria: Inclusion Criteria:

* RA defined according to the American College of Rheumatology (ACR) 2010 criteria,
* treated by anti-TNF + methotrexate, good responders in in one arm, and moderate or non-responders in the other arm according to EULAR (European Ligue Against Rheumatism) response criteria after three months of treatment

Exclusion Criteria:

* contra-indication to anti-TNF
* corticosteroid more than 10mg by a day equivalent prednisone,
* modification of DMARD (disease-modifying antirheumatic drugs) in the last three months
* comprehension trouble
* Factors modifying CD36 -cluster of differentiation antigen 36- expression as diabetes mellitus, kidney disease, HIV

Primary outcomes:
measure: CD36 expression
timeFrame: Day 0
Secondary outcomes:
measure: Monocytes
timeFrame: Day 0
measure: Nuclear translocation of NRF2
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Jean-Frédéric Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002728: Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Lead sponsor: Ortek Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 6 - 9 years.

Brief summary: The purpose of this study is to evaluate a methodology for detecting early forming cavities in children that is more accurate and reliable than the gold standard used by dentists around the world. The new method uses an electrical current device to detect early enamel mineral loss before it can develop into a cavity. The manual gold standard is for a dentist to probe the surfaces of the teeth with a fine pick, searching for areas of defect.


Eligibility criteria: Inclusion Criteria:

Children whose parents authorize participation by signing a consent form. Children who attend public school only. Children in good health. Children between 6 and 9 years of age. Children with all first permanent molars erupted. All permanent first molars must not have any signs of cavitation but only one molar can have some mineral loss(e.g. white spots).

Children must show some caries in the primary molars as a sign of caries susceptibility.

-

Exclusion Criteria:

Children of parents or a guardian who do not agree to participate in the study. Children registered in private schools. Children not in good health. Children undergoing antimicrobial or antibiotic treatment. Children outside the range of age selected for the study. Children with one or more first permanent molars unerupted. Children with any cavitation in the occlusal surface of any first permanent molar.

Children who do not have a sign of dental caries in the primary molars as a sign of caries susceptibility.

Children who do not allow themselves to be examined.

-

Primary outcomes:
measure: To compare the detection of occlusal caries lesions in the first permanent molars of Venezuelan children by electrical conductance and visual-tactile means.
timeFrame: 14 months from baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Universidad Central de Venezuela
Study officials:
References:
Clinical trial NCT02053428: Comparison of Percutaneous Image-guided Gastrostomies
Official title: Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Head and neck cancer
Percutaneous image-guided gastrostomy
Pain
Quality of life
Complication
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 60
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: Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at Interventional Radiology for PIG at our institution. To date, there is no guideline for PIG and no direct comparison of two PIG techniques. The proposed pilot study is to compare the two different types of PIG techniques in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two PIG techniques.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years;
2. Life expectancy \> 6 months;
3. Diagnosed with head and neck cancer; and
4. Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite.

Exclusion Criteria:

1. Pregnancy; or
2. Established pharyngeal obstruction and/or presence of an enteral feeding device.

Primary outcomes:
measure: Pain experience
timeFrame: pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure
Secondary outcomes:
measure: Technical success
timeFrame: Day 0 post procedure
measure: Catheter malfunction rate
timeFrame: Up to six months post procedure
measure: Tube site complications
timeFrame: Up to six months post procedure
measure: Quality of life
timeFrame: Up to six weeks post procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kong Teng Tan, MB BCH BAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894928: A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants
Official title: A Phase 1 Study to Investigate the Effect of Cholestyramine on the Pharmacokinetics of LOXO-783 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cholestyramine
LOXO-783
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-06-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.


Eligibility criteria: Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
timeFrame: Predose on Day 1 upto 96 hours postdose of each treatment period
measure: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783
timeFrame: Predose on Day 1 upto 96 hours postdose of each treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Clinical Research Unit
state: Texas
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin, MD; PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03088228: Maternal Periodontal Status and Cytokines in Preeclampsia
Official title: Maternal Periodontal Status and Gingival Crevicular Fluid Levels of Interleukin-6, Interleukin-35, and Interleukin-37 in Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Periodontal Diseases
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 23 severe preeclamptic patient, 30 mild preeclamptic patient and 29 healthy pregnant women were recruited to this study.

Brief summary: Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia.

Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 45 years
* 25 and 40 weeks of gestation.
* Healthy pregnants, mild and severe preeclampsia

Exclusion Criteria:

* Patients with accompanying diseases
* multiple gestations
* congenital abnormalities were excluded from the study.

Primary outcomes:
measure: maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05640128: Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism
Official title: Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperaldosteronism; Primary
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: collaborative work within 2 hospitals at the CHU of Caen, at the CHRU of Lille, concerning the evaluation of the biological markers of primary hyperaldosteronism (PAH) with the dosage of aldosterone in LC -MS/MS, which is performed in both centers, with two different techniques. The main objective is to define the range of Aldosterone concentrations in LC MS/MS, of renin in an automated method, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism. , in order to establish a threshold for the screening of PAH by the RAR, and for the confirmation of PAH by a dynamic test with an Aldosterone threshold post salt load test.


Eligibility criteria: Inclusion Criteria:

* Patients (18-75 years old) with moderate to severe hypertension, which justifies carrying out an etiological assessment in a hospital environment.
* Assessment carried out in compliance with the standardized measurement conditions of the RAR defined by the SFE consensus,
* Signature of a written consent by the patient

Exclusion Criteria:

* Patient on antihypertensive treatment other than alpha-blockers, calcium channel blockers or centrally acting antihypertensive
* Etiology of secondary hypertension other than PAH

Primary outcomes:
measure: Aldosterone values in LC-MS/MS (and renin) and RAR calculation and calculation of an RAR threshold for PAH screening which differentiates between essential hypertension and PAH.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References:
Clinical trial NCT00678028: Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection
Official title: Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Urinary Tract Infections
Keywords: MBL, UTI
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young women with recurrent UTI - study group and young women witout recurrent UTI - a control group

Brief summary: Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity and there are proofs of relation between patients with recurrent infections and lack of MBL, we decided to explore a possible relation between low levels of MBL and different genotypes of MBL in young women and the risk to develop recurrent UTI.


Eligibility criteria: Inclusion Criteria:

* women above 18 years old.
* premenopausal
* recurrent UTI

Exclusion Criteria:

* pregnancy
* immunocompromised
* active malignancy
* HIV carrier

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
References:
Clinical trial NCT01135628: Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy
Official title: Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Cirrhosis
Minimal Hepatic Encephalopathy
Keywords: Hepatic cirrhosis
Minimal hepatic encephalopathy
Hyperproteic and fiber-rich diet
Lactobacillus reuteri
Psychometric Hepatic Encephalopathy Score (PHES)
Critical Flicker Frequency (CFF)
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* Hepatic Cirrhosis
* Minimal hepatic Encephalopathy

Exclusion Criteria:

* Personal history of surgery in the last 4 weeks
* Use of neuropsychiatric drugs
* Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
* Thyroid disorders without replacement therapy
* Hepatic or renal transplant
* Alcoholism with active ingest of alcohol in the last 6 months
* Pregnancy
* Labour turn-overs
* Spontaneous bacterial Peritonitis
* Personal history of hepatocellular carcinoma
* Placement of transjugular intrahepatic portosystemic shunt
* Use of a probiotic in the last 6 months

Primary outcomes:
measure: Reverse minimal hepatic encephalopathy
timeFrame: 3 months
measure: Reverse minimal hepatic encephalopathy
timeFrame: 6 months
Secondary outcomes:
measure: Prevention of progression
timeFrame: 3 months
measure: Prevention of progression
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas de Nutricion
name: Aldo Torre-Delgadillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211128: The Evolving Use of Robotic Surgery
Official title: The Evolving Use of Robotic Surgery: A Population-based Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Robotic surgery
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Unity Health Toronto
name: Western University
name: McMaster University
name: University of Ottawa
name: Saskatchewan Cancer Agency
First posted: 2022-01-27
Enrollment: 123074
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: Ontario adults that received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018.

Brief summary: A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018.

Detailed description: A retrospective, population-based analysis examining the rates of robotic surgery in Ontario between the years of 2009 - 2018. The purposes of the study were (i) to describe temporal trends and (ii) patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Minimum 18 years old
* Received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018

Exclusion Criteria:

* Non-Ontario residents
* Non-elective procedure
* Patients without OHIP eligibility
* Patients who had an identical procedure in the previous two years

Primary outcomes:
measure: Temporal trends
timeFrame: 2009 - 2018
Secondary outcomes:
Other outcomes:
measure: Determinants of surgery type
timeFrame: 2009 - 2018
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: