louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02376608: Bioavailability of Omega-3 Food Supplement in Healthy Subjects
Official title: Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biological Availability
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* males or females
* any ethnic origin
* BMI 18.5 - 30.0 kg/m2
* generally in good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* prescribed systemic or topical medication within 14 days and slow release medication considered to be active within 14 days.
* omega-3 fatty acids or fish oil within 2 weeks of dosing.
* any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
* any medication incl. St.John's Worth known to chronically alter drug absorption/elimination within 30 days
* Subjects still present in clinical study or in the past 3 months
* recent blood donation
* drug allergy or significant allergic disease
* allergic or hypersensitivity to omega-3 acids, fish, soya, oleic acid, sesame oil or other constituents in pharma preparation
* high consumption of alcohol
* high consumption of tobacco
* hepatitis or HIV
* vegetarians
* earlier participated in or withdrawn from the study
* not willing to follow dietary restrictions
* frequent occurence of migraine attacks
* subjects that should not participate according to investigator

Primary outcomes:
measure: Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.
timeFrame: Pharmacikinetics up to 36 hours post-dose
measure: Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.
timeFrame: Pharmacikinetics up to 36 hours post-dose
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: During entire study period, an expected average of 7 weeks from screening to last visit.
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Study officials:
affiliation: Covance Clinical Research Unit (CRU) Ltd.
name: Adam Strong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04637308: Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
Official title: A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fluid Retention
Keywords: Fluid Retention
Chemotherapy
Succinylated gelatin
Breast cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breast cancer patients who received docetaxel chemotherapy were randomly divided into two groups; experimental group: the patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day; control group: observation. Primary endpoint: total incidence of fluid retention. Secondary endpoints: severity and duration of fluid retention, change in quality of life score.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age ≥18 years
* Diagnosed with breast cancer
* ECOG 0-2
* Received chemotherapy with docetaxel

Exclusion Criteria:

* Existed peripheral edema, ascites and pleural or pericardial effusion
* Serum creatinine exceeds 1.5 times of the upper normal limit
* Total serum bilirubin exceeds 1.25 times of the upper normal limit, or ASAT exceeds 2 times of the upper normal limit

Primary outcomes:
measure: Total incidence of fluid retention
timeFrame: 6 months
Secondary outcomes:
measure: severity of fluid retention
timeFrame: 6 months
measure: change in Functional Assessment of Cancer Therapy-Breast subscale score
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366308: Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population
Official title: Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population: Temporal Trend, Targeted and Repeat Biopsies, and Pathological Characterization: Comparative Study - Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Pathology
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 10000
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study analyzed data from 10,038 patients suspected of PCa who underwent transperineal PBx at our medical center, from 2011 to 2022.

Brief summary: Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.

Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of PCa who underwent transperineal PBx at our medical center, from 2011 to 2022

Exclusion Criteria:

* Patients with other cancers

Primary outcomes:
measure: Positive rate of prostate biopsy
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06300008: Cetylated Fatty Acid for Reducing Pain After TKA
Official title: Efficacy of Cetylated Fatty Acid for Alleviating Postoperative Pain After Total Knee Arthroplasty: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Postoperative Inflammation
Keywords: Cetylated fatty acid
TKA
Postoperative pain
Inflammation
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.


Eligibility criteria: Inclusion Criteria:

* Age 50-80 years
* Osteoarthritic knee patients underwent unilateral primary TKA
* Participants understand and consent to the protocol of the trial

Exclusion Criteria:

* Inflammatory knee arthritis
* Previous knee surgery or trauma
* Previous knee infection
* Skin problem around the knee such as eczema, psoriasis, wound infection
* Allergy to studied drug

Primary outcomes:
measure: Visual analog scale
timeFrame: post-op Day2
measure: Visual analog scale
timeFrame: post-op week2
measure: Visual analog scale
timeFrame: post-op week6
measure: Visual analog scale
timeFrame: post-op week12
measure: inflammatory marker
timeFrame: post-op day2
measure: inflammatory marker
timeFrame: post-op week2
measure: inflammatory marker
timeFrame: post-op week6
measure: inflammatory marker
timeFrame: post-op week12
measure: Knee skin temperature
timeFrame: post-op Day2
measure: Knee skin temperature
timeFrame: post-op week2
measure: Knee skin temperature
timeFrame: post-op week6
measure: Knee skin temperature
timeFrame: post-op week12
Secondary outcomes:
measure: Knee circumference (cm)
timeFrame: post-op Day2
measure: Knee circumference (cm)
timeFrame: post-op week2
measure: Knee circumference (cm)
timeFrame: post-op week6
measure: Knee circumference (cm)
timeFrame: post-op week12
measure: Knee Range of Motion
timeFrame: post-op Day2
measure: Knee Range of Motion
timeFrame: post-op week2
measure: Knee Range of Motion
timeFrame: post-op week6
measure: Knee Range of Motion
timeFrame: post-op week12
measure: Modified WOMAC
timeFrame: post-op week2
measure: Modified WOMAC
timeFrame: post-op week6
measure: Modified WOMAC
timeFrame: post-op week12
measure: Thai forgotten joint score
timeFrame: post-op week2
measure: Thai forgotten joint score
timeFrame: post-op week6
measure: Thai forgotten joint score
timeFrame: post-op week12
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
affiliation: Thammasat University Hospital
name: Supakit Kanitnate, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01461408: Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons
Official title: Promoting HPV Vaccination Through African American Beauty Salons: a Pilot Test of a Culturally-Competent Education and Empowerment Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: HPV Vaccination
Beauty Salons
Health Education
Sexual Health
Lead sponsor: MEE Productions, Inc.
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2011-10-28
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about HPV vaccination. The educational messages will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators believe that it is only after women who are opinion leaders among their peers begin positively supporting HPV prevention that it will gain wider acceptance.

The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis.

* The investigators hypothesize the ability to successfully recruit eight (8) beauty salons for participation
* The investigators hypothesize the ability to successfully train multiple stylists per site to talk to their clients about HPV and its impact on women of color
* The investigators hypothesize that knowledge and awareness of HPV, as well as intentions to vaccinate will significantly improve among women who attend a salon-based health education session


Eligibility criteria: Inclusion Criteria:

* Mother of an 9-18 year old female
* Female who is 18-26 years old

Exclusion Criteria:

* Not a mother of an 9-18 year old female
* Not a female who is 18-26 years old

Primary outcomes:
measure: Recruitment of 8 beauty salons
timeFrame: 6 months
Secondary outcomes:
measure: Intentions to Vaccinate Against HPV
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pre-selected beauty salons
state: Pennsylvania
Study officials:
affiliation: MEE Productions, Inc.
name: Ivan Juzang, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Amy Leader, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543608: Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia
Official title: Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed to be Due to Gram-Positive Pathogens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hospital-Acquired Pneumonia
Ventilator-Associated Pneumonia
Health-Care-Associated Pneumonia
Keywords: pneumonia
nosocomial pneumonia
Lead sponsor: Arpida AG
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 135
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 compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours \[q12h\]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.


Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:

  * hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or
  * ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or
  * health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:

    1. hospitalization for at least two days within 90 days of the current infection,
    2. residence in a nursing home or long-term care facility,
    3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection

Exclusion Criteria:

* Acute Physiology and Chronic Health Enquiry (APACHE) II score \< 8 or ≥ 25.
* Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.
* Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.

Primary outcomes:
measure: Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
timeFrame: at test of cure (TOC) visit
measure: Efficacy: Iclaprim clinical cure rates
timeFrame: at TOC and end of therapy (EOT)
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sharp HealthCare
name: David Willms, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651508: Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Official title: Open Label, Multi-center, Phase 2 Study of KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Previously Treated With First-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV.
* Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC.
* Good performance status.

Exclusion Criteria:

* Prior treatment with an epothilone.
* Known central nervous system (CNS) metastases.
* Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.

Primary outcomes:
measure: Objective response rate of KOS-1584
timeFrame: up to one year
Secondary outcomes:
measure: Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Consultants In Blood Disorders & Cancer
state: Kentucky
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00659308: Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy
Official title: Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bullous Keratopathy
Keywords: pain
bullous keratopathy
amniotic membrane
anterior stromal puncture
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-04-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

Detailed description: Patients with symptomatic bullous keratopathy were randomized in 2 groups and submitted to amniotic membrane transplantation or anterior stromal puncture. The follow up was made with 1, 3, 6 and 12 months. Evaluation included complete ophthalmologic exam, esthesiometry, pachymetry, impression cytology and evaluation of pain.

Eligibility criteria: Inclusion Criteria:

* bullous keratopathy

Exclusion Criteria:

* age under 18 years old
* asymptomatic bullous keratopathy
* corneal infection
* ocular hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Fabiana Paris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pires RT, Tseng SC, Prabhasawat P, Puangsricharern V, Maskin SL, Kim JC, Tan DT. Amniotic membrane transplantation for symptomatic bullous keratopathy. Arch Ophthalmol. 1999 Oct;117(10):1291-7. doi: 10.1001/archopht.117.10.1291.
citation: Gomes JA, Haraguchi DK, Zambrano DU, Izquierdo Junior L, Cunha MC, de Freitas D. Anterior stromal puncture in the treatment of bullous keratopathy: six-month follow-up. Cornea. 2001 Aug;20(6):570-2. doi: 10.1097/00003226-200108000-00003.
Clinical trial NCT01436708: The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms/Sexual Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
urinary symptoms
sexual function
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all women with pelvic organ prolapse , especially with cystocele, in our outpatient department or the room of urodynamic studies.

Brief summary: Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations.


Eligibility criteria: Inclusion Criteria:

* all cases with with pelvic organ prolapse

Exclusion Criteria:

* nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References: