louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05027750: Theory-Based Obesity Intervention Program for Women
Official title: Application Of The Theory Of Planned Behavior For Weight Control In Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
women
health behaviors
Theory of Planned Behavior
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of education and counseling given to women according to the Theory of Planned Behavior on weight management. This study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. A total of 78 overweight and obese women included in the study. The participants assigned to either of the groups by the block randomization method. A training program consisting of a total of five sessions applied to the intervention group, and counseling will be provided for 6 months. The data will be analyzed with Statistical Package for Social Sciences (SPSS) 22.0 package program.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being a woman in the age group of 18-49 years
* Having a body mass index (BMI) of 25.0-30.0 kg/m2 (overweight) or \>30.0 kg/m2 (obese)
* Not going through menopause
* Not having diabetes
* Not having thyroid disease
* Not using hormonal contraceptive pills
* Not having polycystic ovarian disease
* Not having a metabolic disease
* Not having Cushing's syndrome
* Not having a disease that prevents physical activity
* Not having hypertension
* Not being pregnant or breastfeeding
* Owning and using a smart phone
* Having a mail account in Google and being able to use it

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Not volunteering to participate in the study
* Women with communication problems
* Women who did not give consent at any stage of the study and who quit the study

Primary outcomes:
measure: Healthy Lifestyle Behaviors-II Scale
timeFrame: 6 months
measure: International Physical Activity Questionnaire Short Form
timeFrame: 6 months
Secondary outcomes:
measure: Change in body mass index
timeFrame: 6 months
measure: Change in waist/hip ratio
timeFrame: 6 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Provincial Directorate of Health
state: Adapazarı
Study officials:
References:
Clinical trial NCT01222650: A Comparative Study of KSO-0400 in BPH Patients With LUTS
Official title: A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign Prostatic Hyperplasia
I-PSS
α1A-AR antagonist
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 400
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.


Eligibility criteria: Inclusion Criteria:

* BPH patients with LUTS

Exclusion Criteria:

* Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia
* Patients with prostate cancer or suspected prostate cancer
* Patients who have any clinically relevant cardiovascular, hepatic or renal disorder

Primary outcomes:
measure: Change in I-PSS Total Score from baseline
timeFrame: Baseline and 12 weeks (LOCF)
Secondary outcomes:
measure: Change in I-PSS Sub-score from baseline
timeFrame: Baseline and 12 weeks (LOCF)
measure: Change in QOL Score from baseline
timeFrame: Baseline and 12 weeks (LOCF)
measure: Change in Qmax (maximum urinary flow rate) from baseline
timeFrame: Baseline and 12 weeks (LOCF)
Other outcomes:
Locations:
city: Kanto region
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
name: Katsumi Hontani
role: STUDY_DIRECTOR
References:
Clinical trial NCT06600750: Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination
Official title: Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Chronic
Arteriovenous Fistula
Artificial Intelligence (AI)
Machine Learning
Keywords: Preoperative Ultrasound Mapping
Radiocephalic Arteriovenous Fistula
Renal Dialysis
Artificial intelligence
Machine Learning
Chronic Kidney Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 494
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022

Brief summary: The goal of this observational study is to assess the efficacy of AI-driven models in analyzing comprehensive ultrasonographic variables across multiple forearm locations to predict successful AVF maturation. The main question it aims to answer is:

Can AI-driven models analyzing comprehensive ultrasonographic variables accurately predict the successful maturation of arteriovenous fistulas (AVFs)?

Participants who underwent radiocephalic arteriovenous fistula (AVF) creation had their preoperative ultrasonographic data analyzed using AI-driven models to predict successful AVF maturation over a four-year retrospective period.


Eligibility criteria: Inclusion Criteria:

* patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022

Exclusion Criteria:

* Patients who did not have follow-up data available

Primary outcomes:
measure: Maturation of the fistula
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Georgiadis GS, Charalampidis DG, Argyriou C, Georgakarakos EI, Lazarides MK. The Necessity for Routine Pre-operative Ultrasound Mapping Before Arteriovenous Fistula Creation: A Meta-analysis. Eur J Vasc Endovasc Surg. 2015 May;49(5):600-5. doi: 10.1016/j.ejvs.2015.01.012. Epub 2015 Feb 27.
citation: Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
citation: Perera GB, Mueller MP, Kubaska SM, Wilson SE, Lawrence PF, Fujitani RM. Superiority of autogenous arteriovenous hemodialysis access: maintenance of function with fewer secondary interventions. Ann Vasc Surg. 2004 Jan;18(1):66-73. doi: 10.1007/s10016-003-0094-y. Epub 2004 Jan 20.
Clinical trial NCT03362255: Measurement of Optic Nerve Sheath Diameter
Official title: Effect of Different Speed of Normal Saline Injection on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Keywords: Optic Nerve Sheath Diameter Injection Speed
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Detailed description: It is known that insufficient intraoperative or postoperative management can lengthen the hospital stay with unwanted complications. Therefore, active and proper management using continuous thoracic epidural catheterization is suggested good option to prevent such potential complication.

According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity.

Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Eligibility criteria: Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain surgery

Primary outcomes:
measure: optic nerve sheath diameter change among 4 time period
timeFrame: Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hee Hong
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong JH, Jung SW, Park JH. The Effect of Speed of Normal Saline Injection on Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia. Pain Physician. 2019 Jul;22(4):E325-E332.
Clinical trial NCT04992455: G8, VES-13 and CARG Scores in Predicting Chemotherapy Toxicity in Geriatric Cancer Patients
Official title: The Predictive Value of G8, VES-13 and CARG Scores in Treatment-related Toxicity in Geriatric Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predicting Chemotherapy Related Toxicity in Elderly Patients
Keywords: g8
ves-13
CARG
chemotherapy-related toxicity
Toxicity tool
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older Patients Receiving Chemotherapy

Brief summary: All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.

Detailed description: All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.

Eligibility criteria: Inclusion Criteria:

* Aged ≥65 years
* Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage)
* Starting a new-line (first-line, second-line or third-line) chemotherapy

Exclusion Criteria:

* Concurrent radiotherapy;
* Simultaneous immunotherapy
* Impaired language
* Cognitive function leading to inability to complete assessments.

Primary outcomes:
measure: G8 (Geriatric 8) screening tool measurement
timeFrame: 15-30 minutes
measure: CARG (Cancer and Aging Research Group) chemotherapy toxicity score measurement
timeFrame: 30-60 minutes
measure: VES-13 (Vulnerable Elders Survey-13) measurement
timeFrame: 30-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdağ Namık Kemal University
Study officials:
affiliation: Namik Kemal University
name: Erdoğan S Şeber, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Namik Kemal University
name: Eyyüp Çavdar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01612143: A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Cross-over Study to Investigate the Relative Bioavailability of Setrobuvir (STV) Tablet Formulation Versus the Reference Setrobuvir Capsule Formulation Following Oral Administration With or Without a High Fat Meal in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults, 18 to 55 years of age inclusive
* Body mass index (BMI) 18.0 - 30.0 kg/m2
* Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination
* Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug
* Non-smokers or use of \< 10 cigarettes (or equivalent nicotine-containing product) per day
* Negative results on following screening laboratory test: urine drug screen, urine alcohol screen
* Willing and able to consume the study-specified meal on day of dosing

Exclusion Criteria:

* Pregnant or lactating women, or males with female partners who are pregnant or lactating
* History of current alcohol abuse and/or other drug addiction \</= 2 years prior to enrollment in the study
* Participation in other clinical studies within 60 days prior to study randomization
* Positive for hepatitis B, hepatitis C or HIV infection

Primary outcomes:
measure: Relative bioavailability: Cmax/area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 168 hours post-dose
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 months
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04810143: Tacrolimus Microsampling
Official title: Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling (VAMS) and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Validate Volumetric Absorptive Microsampling (VAMS) Assay
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.


Eligibility criteria: Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age

   1. Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
   2. Aim 2: outpatient
2. Currently taking tacrolimus

Exclusion Criteria:

1. Non-English-speaking patients
2. Unable to access overnight delivery services (Aim 2 only)

Primary outcomes:
measure: Accuracy of +/-10%
timeFrame: 18-24 months from start of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Thomas C Ryan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00095043: Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
Official title: A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 320
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

Detailed description: The duration of treatment is 1 year.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Insomnia

Primary outcomes:
measure: Safety and tolerability after 12 months of treatment
Secondary outcomes:
measure: Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03442543: Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients By Novel Computed Tomography-Lymphography Guided Technique
Official title: A Novel Technique for Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients by Silver Wire Insertion or Liquid Charcoal Injection Guided by CT Lymphography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Keywords: sentinel lymph node biopsy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.

In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.


Eligibility criteria: Inclusion Criteria:

* node negative early breast cancer

Exclusion Criteria:

* • Unfit patients for general anaesthesia

  * Previous axillary surgery
  * History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
  * Known hypersensitivity to the dye
  * Patients with clinically positive or suspicious axilla
  * Pregnant females

Primary outcomes:
measure: detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Oncology center, Mansoura University
Study officials:
affiliation: Oncology center, Mansoura University
name: Omar Hamdy, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331043: Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
Official title: Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
Collaborators: name: Mahidol University
First posted: 2015-01-05
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.


Eligibility criteria: Inclusion Criteria:

* mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
* fasting serum triglyceride levels below 3.0 mmol/l
* normal liver, kidney and thyroid function
* no lipid lowering medication
* no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion Criteria:

* alcohol abuse (\> 4 portion/per day)
* pregnancy
* use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included

Primary outcomes:
measure: Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls
timeFrame: 4 weeks
Secondary outcomes:
measure: Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Phutthamonthon
country: Thailand
facility: Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Wantanee Kriengsinyos, PhD
role: PRINCIPAL_INVESTIGATOR
References: