louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03657719: A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
Official title: Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 : Single group, Part2 : Parallel group
Primary purpose: PREVENTION

Brief summary: Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Detailed description: Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Safety and immunological efficacy will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged over 65 years old
* Informed consent form has been signed and dated

Exclusion Criteria:

* Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Primary outcomes:
measure: Adverse Event
timeFrame: for 7 days from Day0/during study period
Secondary outcomes:
measure: Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
timeFrame: Day 0 and Day 28
measure: Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
timeFrame: Day 0 and Day 28
measure: Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination
timeFrame: Day 0 and Day 28
measure: Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo KIm, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916019: Investigation of the Effects of Exercise on Gene Expression
Official title: Investigation on Gene Expression and Gene Marker Accompanied by a Single Bout of Exercise and Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: gene expression
skeletal muscle
Healthy men
Lead sponsor: Fukuoka University
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus these beneficial effects are likely related to a number of adaptations that occur in skeletal muscle as response to exercise. In the current study, the investigators hypothesised that a single bout of mild exercise performed at LT would be a physiological stimulator of skeletal muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene (i.e., training) for 12 weeks would induce coordinated increases in a large number of metabolic genes, as well as other genes potentially important in the prevention of insulin resistance and metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Men who were all in good health
* All individuals were free from diabetes and none were taking any medications
* All subjects were asked not to change their normal dietary habits, and not to engage in any strenuous physical activity

Exclusion Criteria:

* People who undergone regular exercise for at least 2 years
* Smokers

Primary outcomes:
measure: Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Fukuoka University
Study officials:
affiliation: Fukuoka University
name: Hiroaki Tanaka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05898919: Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
Official title: Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Complications
Postoperative Urinary Retention
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the efficacy of acupuncture in the management of acute postoperative urinary retention.

Clinical question:

Is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy compared with sham acupuncture and neostigmine.

Study design:

The participants who undergo hemorrhoidectomy and report postoperative urinary retention will receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine. The primary outcome was the time to first urination after surgery.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years
* Meets the diagnostic criteria of postoperative urinary retention
* Received milligan-morgan hemorrhoidectomy and general anesthesia

Exclusion Criteria:

* Received Diuretic drugs
* Organic diseases that cause urinary retention
* Severe infection in the urinary tract
* Has a history of adverse reaction to neostigmine
* Cognitive dysfunction that affects outcome assessment
* Being pregnant

Primary outcomes:
measure: The time to first urination after surgery
timeFrame: Immediately after first urination
Secondary outcomes:
measure: The volume of first of urination
timeFrame: Immediately after first urination
measure: Bladder residual urine volume
timeFrame: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
measure: Urination Score
timeFrame: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
measure: Abdominal symptom score
timeFrame: Before treatment, 0.5, 1, and 2 hours after treatment.
measure: Visual analogue score after surgery
timeFrame: 2 hours after treatment.
measure: Adverse effects
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
Study officials:
affiliation: Hospital of Chengdu University of Traditional Chinese Medicine
name: Min Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758219: Validity and Reliability of the Turkish Form of the Knowledge Assessment Scales for Dementia and Urinary Incontinence
Official title: Validity and Reliability of the Turkish Form of the Knowledge Assessment Scales for Dementia and Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence in Old Age
Dementia
Keywords: Urinary Incontinence
Dementia
Validity
Reliability
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 230
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. All patient relatives and hospital staff who meet the inclusion criteria will be included in the study. These participants will be reached through face-to-face communication or online methods (sms, e-mail), and a list of participants will be prepared and evaluations will be made.

Brief summary: The primary aim of the study was to determine the Turkish version of the "Validity and Reliability of the Knowledge Assessment Scales for Dementia and Urinary Incontinence in Community Older People". The secondary aim of the study was to measure the knowledge level of dementia and urinary incontinence in the community-living elderly population.


Eligibility criteria: Inclusion Criteria:

1. Being 55 years of age or older
2. Knowing how to read and write
3. Being willing to participate in the study

Exclusion Criteria:

1. Having any chronic illness that would prevent urinary retention and dementia level

Primary outcomes:
measure: Knowledge Assessment Scales for Dementia and Urinary Incontinence in Community Older People
timeFrame: 20 weeks
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: 20 weeks
measure: Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: 20 weeks
measure: Standardize Mini Mental State (SMMS)
timeFrame: 20 weeks
measure: Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University Physical Therapy and Rehabilitation Center
state: Merkez
Study officials:
References:
Clinical trial NCT06474819: Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Official title: Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complete Heart Block
Second Degree Atrioventricular Block Möbitz Type II
Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
name: Hospital Universitari de Bellvitge
First posted: 2024-06-26
Enrollment: 326
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: Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.

Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.


Eligibility criteria: Inclusion Criteria:

* First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\<45lpm).
* LVEF\>50% at echocardiography performed maximum 7 days before pacemaker implant.
* Informed consent signature.

Exclusion Criteria:

* Life expectancy \<12 months
* Severe cardiac valvular abnormality requiring intervention
* Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
* Inclusion in another trial which may influence the results of this study.

Primary outcomes:
measure: Pacing-induced cardiomyopathy
timeFrame: 12 months
Secondary outcomes:
measure: LVEF during follow-up
timeFrame: 12 months
measure: Mitral and tricuspid regurgitation
timeFrame: 12 months
measure: New York Heart Association (NYHA) class
timeFrame: 12 months
measure: Brain Natriuretic Peptide levels
timeFrame: 12 months
measure: heart failure
timeFrame: 12 months
Other outcomes:
measure: Complications
timeFrame: 12 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Castellón De La Plana
country: Spain
facility: Hospital General Universitario de Castellón
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
Study officials:
affiliation: IDIBELL and Hospital Universitario de Bellvitge
name: Andrea Di Marco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394419: Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
Official title: Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;

  * preoperative serum creatinine \> 1.4 mg/dl
  * Age \> 70 years
  * Diabetes mellitus
  * left ventricular ejection fraction \< 35 % or congestive heart failure (NYHA III or IV)
  * emergency surgery or re-operation

Exclusion Criteria:

* preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein

Primary outcomes:
measure: Incidence of acute kidney injury
timeFrame: within 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Song JW, Shim JK, Soh S, Jang J, Kwak YL. Double-blinded, randomized controlled trial of N-acetylcysteine for prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass. Nephrology (Carlton). 2015 Feb;20(2):96-102. doi: 10.1111/nep.12361.
Clinical trial NCT04501419: Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Official title: Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Obafemi Awolowo University Teaching Hospital
First posted: 2020-08-06
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older female
* Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.

Exclusion Criteria:

* Participants unwilling to sign consent
* Participants under the age of 18.

Primary outcomes:
measure: Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
timeFrame: 12 months
Secondary outcomes:
measure: Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Study officials:
affiliation: Obafemi Awolowo University Teaching Hospitals
name: Adeleye Omisore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05428319: Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers
Official title: Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers: An Immunohistochemical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 70
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Formalin-fixed and paraffin embedded prostatic tissue blocks from 70 patients

Brief summary: Prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. It is a common health problem. Most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. Diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy.

Six transmembrane epithelial antigen of the prostate 1 (STEAP-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. In prostate, the expression of STEAP-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples.

The antibody designated as p40 recognizes exclusively ΔNp63 and not TAp63. In prostate tissues, it has been shown that p40, the ΔNp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. Furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63.

In this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both STEAP-1 and p 40. Also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.


Eligibility criteria: Inclusion Criteria:

* Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy.
* Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma

Exclusion Criteria:

* Patients with recurrence of the primary tumor.
* Patients with a history of preoperative chemotherapy and/or radiotherapy.
* Insufficient or tiny tissue biopsies

Primary outcomes:
measure: Diagnosis of Prostatic Carcinoma
timeFrame: One or two days after staining sections with the markers
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Aliaa Bakr Ahmed
Study officials:
affiliation: Faculty of medicine, Sohag University
name: Aliaa Bakr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771519: Developing an HIV Disclosure Intervention for Men in Uganda
Official title: Development and Assessment of an HIV Disclosure Intervention for Men in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Infections (Not HIV or Hepatitis)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mbarara University of Science and Technology
First posted: 2023-03-16
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care.

Participants assigned to the intervention group will likely participate in the following:

* Sexual health education
* Cognitive behavioral therapy strategies
* Problem-solving skills building
* Motivational interviewing
* Developing a personalized HIV disclosure plan
* Communication skills building
* Role-playing disclosure strategies


Eligibility criteria: For all 3 Aims, "index participants" inclusion criteria will include:

* men living with HIV
* with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions)
* either not accessing antiretroviral therapy (per self-report109 and/or clinic documentation) or accessing antiretroviral therapy without HIV viral suppression
* age ≥18 years,
* with at least one sexual partner in the past three months

Aims 2 and 3 have the additional inclusion criteria:

* men living with HIV without HIV disclosure to at least one partner.

In Aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. These "partner participants" will have the following inclusion criteria:

* age ≥18 years
* partnered with an enrolled man who reports HIV disclosure or plans for HIV disclosure with study support
* referred by the male participant.

Exclusion Criteria:

* an inability to speak the local language (Runyankole) or English
* an inability to provide informed consent

Primary outcomes:
measure: HIV disclosure intervention acceptability
timeFrame: 6 months
measure: HIV disclosure intervention feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Index participant-reported disclosure
timeFrame: 6 months
measure: Partner participant HIV study site/clinic testing and counseling
timeFrame: 6 months
measure: HIV viral suppression
timeFrame: 6 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Brigham and Women's Hospital
name: Pooja Chitneni, MD
role: PRINCIPAL_INVESTIGATOR
References: