louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04317625: Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
Official title: Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 232
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study aims to evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.

Detailed description: The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score \<3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 50
* PSA between 2.5 and 4.0ng/ml
* (Eastern Cooperative Oncology Group)ECOG grade: 0-1
* Normal organic function indexes:
* (absolute neutrophil count)ANC ≧1.5×109/L
* (platelet count)PLT ≧100×109/L
* Hb ≧90 g/L
* (total bilirubin)TBIL ≦1.5×ULN
* (aspartate aminotransferase)ALT≦2.5×ULN
* (alanine aminotransferase)AST ≦2.5×ULN
* (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN

Exclusion Criteria:

* Former serum PSA detection
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system

Primary outcomes:
measure: Incidence of prostate cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
state: Jiangsu
Study officials:
affiliation: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
name: Hongqian Guo
role: STUDY_CHAIR
References:
Clinical trial NCT03850925: Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Official title: Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Scars
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-face comparison study
Primary purpose: TREATMENT

Brief summary: This study compares the application of a picosecond 1064-nm laser with a diffractive lens array with nonablative fractional laser for the treatment of acne scarring.

Detailed description: This trial is a 17-week, prospective, randomized split-face study that compares the results between two facial sides either receiving the picosecond 1064-nm laser or nonablative fractional laser treatment for atrophic acne scar.

Eligibility criteria: Inclusion Criteria:

* Subjects with facial atrophic acne scars
* Subjects who observe the schedules and protocols of the clinical trial
* Subjects who give informed consent to participate in the clinical trial

Exclusion Criteria:

* Subjects who have active acne under treatment
* Subjects who had received any other treatments for acne scarring for 6 months prior to the first treatment
* Subjects who underwent other treatments including chemical, mechanical or laser resurfacing during the study period
* Subjects who have current acute illness
* Subjects who are considered inappropriate for the clinical trial under the judgement of investigators

Primary outcomes:
measure: Changes in the mean of the ECCA grading scale
timeFrame: Week 17
Secondary outcomes:
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Dongtan Sacred Heart Hospital, Hallym University College of Medicine
name: Gyeong-Hun Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811225: Smoking, Sex Hormones, and Pregnancy
Official title: Smoking, Sex Hormones, and Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Contraception
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

Detailed description: The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.

Eligibility criteria: Inclusion Criteria:

* currently taking oral contraceptives
* English fluency
* Ability to provide informed consent

Exclusion Criteria:

* use of progestin only contraceptive
* pregnancy

Primary outcomes:
measure: Change in Smoking Urges
timeFrame: after overnight abstinence on day 8
Secondary outcomes:
measure: Change in Positive and Negative Affect Scale Following Overnight Abstinence
timeFrame: after overnight abstinence on day 8
measure: Change in Cohen Perceived Stress Scale
timeFrame: after overnight abstinence on day 8
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Sharon S. Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen S, Harrison K, Petersen A, Goodson J. Smoking-related symptomatology in pregnant smokers during ad libitum smoking and following overnight smoking abstinence. BMC Res Notes. 2019 Aug 1;12(1):473. doi: 10.1186/s13104-019-4503-x.
Clinical trial NCT01323725: Team-based Financial Incentives for Smoking Cessation
Official title: The Effectiveness of Team-based Financial Incentives for Increasing Long-term Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Team-based financial incentives
Smoking cessation
Lead sponsor: St.Paul's Hospital, Korea
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify the effectiveness of team-base financial incentives for increasing long-term smoking cessation among employees at St. Paul's Hospital, Korea.

Detailed description: About 70% of smokers report that they want to quit, but annually 2 to 3% of smokers succeed. Smoking-cessation programs and pharmacologic therapies have been proven effective in helping smokers quit, but only a few smokers are enrolled in those programs.

Financial incentives may contribute to reinforce smoking cessation among workers through the following pathways: (1) increasing the number of tobacco users who participate in cessation effort; (2) increasing the number of tobacco user who initiate an attempt to quit; and (3) increasing the number of tobacco users who sustain a successful quit effort. Moreover, there is a number of advantages to offering smoking cessation support in the workplace, including the accessibility of the target population, the availability of occupational health support and the potential for peer pressure and peer support. In addition, team-based approach for smoking cessation could likely make use of new or existing cessation support resources offered within the workplace.

This study is a clinical trial of team-based financial incentives for smoking cessation among a sample of 60 smokers, who are health care workers from St. Paul's Hospital in Korea. Smokers will be given a usual care (counseling, education and coverage of prescription drugs) plus a package of financial incentives for self-reported and biochemically validated smoking cessation (urine or saliva cotinine). All incentives will be provided to each team at 6 months post-quit date.

Eligibility criteria: Inclusion Criteria:

* Employees of St. Paul's Hospital at work sites in Korea
* Current smoker who report having smoked at least 5 cigarettes per day for the prior 12 months
* Age 18 or older

Exclusion Criteria:

* Age 17 or younger
* Unwilling to quit smoking
* Smoker who does not want to be enrolled in this trial
* Planning to leave St. Paul's hospital within the next 12 months

Primary outcomes:
measure: Smoking Cessation Rate
timeFrame: 6 months
Secondary outcomes:
measure: Smoking Cessation Rate
timeFrame: 3, 9, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: St.Paul's Hospital
Study officials:
affiliation: St. Paul's Hospital
name: Sang Haak Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265225: Prognostic Value of Stem Cell Related Markers
Official title: Prognostic Value of Stem Cell Related Markers CD24, CD44, CD326 and EPCR, for Predicting Breast Cancer Recurrence in Tumor Stages 0-II
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: breast cancer stages 0-II
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2010-12-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 tumor specimens from women with grade 0-11 ductal breast cancer

Brief summary: The goal of the investigators study is to identify a prognostic marker that will evaluate the probability of recurrence in patients with stage 0-II breast cancer following surgery to remove the tumor.


Eligibility criteria: Inclusion Criteria:

* Ductal Carcinoma in Situ
* DCIS + Microinvasion stages 1 or 11 without positive lymph nodes

Exclusion Criteria:

* tumor specimen with higher than grade II
* BRACA 1 or BRACA 2 mutation
* Neoadjuvant chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poriya
country: Israel
facility: Baruch PMC
state: Lower galilee
Study officials:
References:
Clinical trial NCT04339725: Gut Microbiota Metagenomics for Chronic Liver Disease
Official title: Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Disease Chronic
Keywords: Liver
Fecal
Gut microbiota
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 3240
Sex: ALL
Minimum age (years): 31
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3240 of population stool were collected. All of them are agree to provide it to investigation.

Brief summary: Gut microbiota modulation has effect on chronic liver disease

Detailed description: Chronic liver disease has been known as a disease of the liver which lasts over a period of 6-month. It consists of inflammation, hepatitis, cirrhosis, hepatocellular carcinoma.

Gut microbiota plays an important roles in the chronic liver disease. It can suppress the progression of the liver disease by moulation gut microbiota.

The investigators are still evaluating the effect of gut microbiota on the liver disease.

Eligibility criteria: Inclusion Criteria:

* Age 19+
* Normal : AST or ALT level \< 50IU/L, BMI \< 25
* Liver disease : AST or ATL level ≥ 50IU/L, BMI ≥ 25
* Patients hospitalized with chronic liver disease (viral hepatitis, alcoholic liver disease, non-alcoholic liver disease, cirrhosis, liver cancer)

Exclusion Criteria:

* Normal : AST or ATL level ≥ 50IU/L, BMI ≥ 25
* Liver disease : AST or ALT level \< 50IU/L, BMI \< 25
* If the patient refuses

Primary outcomes:
measure: Fecal DNA
timeFrame: 10 years
measure: Liver enzyme
timeFrame: 10 years
measure: BMI
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Study officials:
References:
Clinical trial NCT03242525: Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis
Official title: Examination of the Time Advantage of Point of Care Testing (POCT) Compared to the Conventional Central Laboratory Analysis in Intraclinical Patient Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood
Point-of-Care Systems
Analysis, Event History
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All bleeding patients assigned to the emergency department and delivery room.

Brief summary: The aim of the present study is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio.

Detailed description: In order to be able to carry out a targeted coagulation therapy for the time-critical treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is necessary.

After taking blood samples for coagulation diagnostics, they are sent to the central laboratory. After the analysis and validation the electronic provision of the results takes place. The loss of time by sample transport, analysis and breadth of the results extends the duration until therapy can be started.

The period of time until these analysis results are determined depends on several factors like daytime, day of week and location of the sample consignor and the availability of the laboratory. Not every clinic is connected to an internal tube mail system so that the samples have to be sent partly with a transport service.

In recent years, Point of Care (POCT) devices have become an increasingly important tool for diagnosing coagulopathic patients.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Missing written consent
* Withdrawal

Primary outcomes:
measure: Time advantage
timeFrame: 2-4 hours
Secondary outcomes:
measure: Correlation between central laboratory and POCT results.
timeFrame: 2-4 hours
measure: Influence of transport type.
timeFrame: 2-4 hours
measure: Influence of daytime and weekday on results availability.
timeFrame: 2-4 hours
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Department of Anesthesia, Intensive Care Medicine and Pain Therapy
name: Kai Zacharowski, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05587725: Human Papillomavirus in Young People Epidemiological Research 3
Official title: A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papillomavirus Infection
HPV
HPV Infection
Anal Cancer
Cancer
Men
HPV 16 Infection
Keywords: Vaccination
Vaccine
Public health
Prevention
Men who have sex with men
Gay and bisexual men
Immunisation
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: The Alfred
name: University of Melbourne
First posted: 2022-10-20
Enrollment: 200
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.

Brief summary: Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program.

The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination.

Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.


Eligibility criteria: Inclusion Criteria:

* Men aged 16 to 20 (i.e. men aged 16-18 years in 2023; men aged 16-19 years in 2024; and men aged 16-20 years in 2025 will be recruited. This is to ensure these men would have been eligible for the 9-valent school-based HPV program)
* Same-sex attracted
* Residing in Australia since 2018

Exclusion Criteria:

* Unable to complete all study requirements in English

Primary outcomes:
measure: Prevalence of quadrivalent vaccine HPV types
timeFrame: Baseline
measure: Prevalence of nonavalent vaccine HPV types
timeFrame: Baseline
measure: Prevalence of type-specific HPV types
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
Study officials:
References:
Clinical trial NCT05391425: The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function
Official title: The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function in Premenopausal vs Postmenopausal Women: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urge Incontinence
Urgency-frequency Syndrome
Keywords: urgency
urge urinary incontinence
solifenacin
sexual function
menopause
anticholinergic
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Arnavutkoy State Hospital
First posted: 2022-05-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that are planned to start treatment with Solifenacin 5 mg (Vesicare 5mg) are enrolled in the study.

Brief summary: This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.

Detailed description: Solifenacin is an anticholinergic drug that is commonly used for lower urinary tract symptoms such as urgency, frequency and urge urinary incontinence. Solifenacin use and sexual function improvement is presented in some research, but the correlation between the improvement in sexual function and LUTS symptoms is yet not investigated. Also the effect on sexual function in premenopausal vs postmenopausal women are unknown.

Eligibility criteria: Inclusion Criteria:

* Women presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that are planned to start treatment with Solifenacin 5 mg (Vesicare 5mg).
* Patients agreed to involve in the study, having discussed other treatment options and possible side effects of the medication.
* Informed consent obtained

Exclusion Criteria:

* urinary tract infection
* stress urinary incontinence
* urinary retention
* grade 2 or above pelvic organ prolapse according to POP-Q scale
* Solifenacin contraindications such as narrow angle glaucoma, allergy of Solifenacin or other components of the drug.

Primary outcomes:
measure: the effect of solifenasin used for lower urinary tract symptoms on sexual function
timeFrame: 6 months
measure: the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women
timeFrame: 6 months
Secondary outcomes:
measure: the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Arnavutkoy State Hospital
state: Arnavutkoy
Study officials:
References: