louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05461066: Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy
Official title: Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pharmacist-Patient Relations
Lead sponsor: Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed.


Eligibility criteria: Inclusion Criteria:

* smoker over 18 years old
* consent to participate
* presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.

Exclusion Criteria:

* cognitive impairment
* drug uses
* pregnancy or lactation.

Primary outcomes:
measure: Smoking cessation
timeFrame: Before/after the intervention (1 year)
measure: Quality of Life (EuroQOL-5D)
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
measure: Cost-utility
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05761366: Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
Official title: Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Malignancy
Keywords: Malignancy
Prostate Specific Membrane Antigen Positive Tumor
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 400
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: In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Detailed description: Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Eligibility criteria: Inclusion Criteria:

1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
2. Age is 18 or older; No gender limitation.
3. Signed the informed consent.
4. Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
2. Claustrophobia.
3. Pregnant or lactation women.
4. Received experimental drug or device within 1 month.

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Chaoyang
Study officials:
affiliation: National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC
name: Rong Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618266: Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 375
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: Patients with Macular Oedema due to Retinal Vein Occlusion

Brief summary: Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Macular oedema due to retinal vein occlusion

Exclusion Criteria:

* Not living in metropolitan France

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments
timeFrame: Baseline, Month 6
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 6, Month 4, Month 12, Month 18, Month 24
measure: Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
timeFrame: Baseline, Month 24
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2307-2318. doi: 10.1007/s00417-016-3394-y. Epub 2016 Jun 11.
Clinical trial NCT02393066: Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery
Official title: A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorder; Mental, Sedative
Pain, Postoperative
Surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 \~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 \~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment \[0h\], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.


Eligibility criteria: Inclusion Criteria:

* non-emergent major abdominal tumor surgery with ICU admission
* the need of sedation during ICU stay

Exclusion Criteria:

* age older than 99 years
* age younger than 20 years
* refractory arrhythmias
* refractory shock status after resuscitation
* new onset of myocardial infarction
* severe heart failure or NYHA 4
* APACHE score \> 30 when recruiting
* severe liver cirrhosis or CHILD B or C
* organ transplantation within one year
* pregnancy
* allergic to propofol or dexmedetomidine

Primary outcomes:
measure: cardiac index
timeFrame: six hours after recruitment
Secondary outcomes:
measure: mean arterial pressure
timeFrame: six hours after recruitment
measure: heart rate
timeFrame: six hours after recruitment
measure: stroke volume
timeFrame: six hours after recruitment
measure: urine output
timeFrame: six hours after recruitment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00240266: Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Official title: A Randomised, Double-blind, Placebo-controlled, Crossover Pilot Study to Define the High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Dyslipidemia
Keywords: Metabolic Syndrome
Dyslipaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 15
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* males aged 45-65
* insulin resistance
* central obesity
* LDL-C \<6 mmol/L
* plasma triglycerides \>=1.7 and ≤5.5 mmol/L
* HDL-C ≤1.2 mmol/L.

Exclusion Criteria:

* total cholesterol \>7mmol/L
* pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Primary outcomes:
measure: Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.
Secondary outcomes:
measure: Determine the effect of treatment with rosuvastatin on:
measure: - cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
measure: - plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT.
measure: - plasma concentration of preβ1-HDL.
measure: - plasma concentration of LDL cholesterol, HDL-C and apoA-1.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
Study officials:
affiliation: Baker Heart Research Institute
name: Paul J Nestel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342066: Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form
Official title: Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form on Clinician Decision: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of both sex ,age from 18-40 with different oral hygiene and different dental condition but with good periodontal condition and no multiple extraction

Brief summary: Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study

Detailed description: A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride.

Thus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not

Eligibility criteria: Inclusion Criteria:

* Patients should be in range of 18-40 years old. Patient should have good periodontal health

Exclusion Criteria:

* Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction

Primary outcomes:
measure: Reproducability "degree of matching between cariogram and cambra
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Univeristy
state: Manial
Study officials:
affiliation: Professor, Conservative Dentistry Department, Faculty of dentistry, Cairo University, Egypt.
name: Mohamed farid, prof.Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03412266: RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT
Official title: Reduced Intensity Conditioning Regimen for Low- and Intermediate-risk Myelodysplastic Syndrome Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: RIC regimen; MDS; haplo-HSCT; survival
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 1
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: This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in low- and intermediate-risk myelodysplastic syndrome (MDS) patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for MDS patients who did not have identical sibling donor (ISD) or unrelated donor (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes for transplant failure in MDS patients, and the risk of TRM for haplo-HSCT recipients was higher than that of ISD recipients. RIC regimen can decrease the risk of TRM for haplo-HSCT recipients; however, the risk for relapse may increase in these patients. Thus, RIC regimen may be more appropriate for low- and intermediate-risk MDS patients receiving haplo-HSCT. The study hypothesis: Using RIC haplo-HSCT regimen in patients with low- and risk MDS can reduce TRM and improve survival.

Detailed description: RIC regimen was given for low and intermediate MDS patients who would receive haplo-HSCT. The primary end point was transplant-related mortality. The secondary end points were overall survival, disease-free survival, relapse, , graft-versus-host disease (GVHD), and infections. Following time is 1 years.

Eligibility criteria: Inclusion Criteria:

* Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

* Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure

Primary outcomes:
measure: Transplant-related mortality
timeFrame: Participants will be followed for an expected average of 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology,Beijing
state: Beijing
Study officials:
affiliation: Peking University Institute of Hematology
name: Xiao-Jun Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202266: A Multiple Dose Study Of PF-05161704 In Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Multiple Ascending Dose
Phase 1
Safety and Tolerability
PK
Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight \>50 kg (110 lbs.)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.

Primary outcomes:
measure: Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring
timeFrame: 2 weeks
measure: Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
timeFrame: 2 weeks
Secondary outcomes:
measure: Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL
timeFrame: 2 weeks
measure: Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01719666: Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
Official title: Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Episodic Patellar Dislocation
Keywords: MPFL
patella
dislocation
release
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.


Eligibility criteria: Inclusion Criteria:

* age between 18yo and 45yo
* indication for MPFL reconstruction
* unilateral or bilateral indication

Exclusion Criteria:

* indication for bony procedures
* previous surgery for PF disorders
* patient refusal

Primary outcomes:
measure: Patellar tilt measurement
timeFrame: 2 years of follow up
Secondary outcomes:
measure: rate of complications
timeFrame: 2 years of follow up
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References: