louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05882409: Education Given on Their Attitudes Towards Violence Against Women and Their Conflict
Official title: Effects of Education Given to University Students on Their Attitudes Towards Violence Against Women and Their Conflict and Awareness Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: University Students
Attitudes
Conflict
Education
Women
Violence
Awareness
Keywords: Awareness
Conflic
Education
Student
Violence against women
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Violence against women is the violation of human rights faced by women of all ages, cultures and education levels everywhere. It can be experienced in many different ways, either individually or socially.

Aim: The study was conducted to investigate the effects of education given to university students on their attitudes towards violence against women, and their conflict and awareness levels.

Detailed description: Methods: The sample of this randomized controlled experimental study comprised 87 (experimental group=45; control group=42) university students studying in health-related fields. The students in the experimental group received in one session education on violence against women and conflict, whereas the students in the control group did not receive any education. The study data were collected with the Personal Information Form, Attitudes towards Violence Scale among University Students, and Conflict and Violent Awareness Scale.

Eligibility criteria: Inclusion Criteria:

* Women who lived in the city center,
* University students
* Studying in health-related fields
* Women who volunteered to participate in the study

Exclusion Criteria:

* Being a man
* Training other than health-related fields
* Those who do not live in the city center
* Involuntary

Primary outcomes:
measure: Attitudes towards Violence Scale among University Students
timeFrame: 5 months
measure: Conflict and Violent Awareness Scale
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sukran Ertekin Pinar
Study officials:
affiliation: Cumhuriyet University
name: Sukran E Ertekin Pinar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03559309: Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia
Official title: A Pilot Study Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia in Clinical Routine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atherosclerosis
Hypercholesterolemia
Post Prandial Lipemia
Cardiovascular Diseases
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: numares AG
name: Sanofi
First posted: 2018-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, open-label, pilot study with 24 cardiovascular high risk patients (N=24) having insufficient Low density lipoprotein cholesterin (LDL-C) reduction despite standard of care lipid-modifying therapies (LMTs), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-PCSK9 antibody Alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz.


Eligibility criteria: Inclusion Criteria:

1. Patient scheduled for treatment with Alirocumab in clinical routine (after approval of cost coverage by insurance company)
2. No previous treatment with PCSK9 antibodies
3. Signed informed consent form

Exclusion Criteria:

1. Age of \< 18 years
2. Pregnancy (pregnancy test at screening visit)
3. Breast-feeding
4. Impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)

Primary outcomes:
measure: Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab
timeFrame: From baseline to 10 weeks of treatment
Secondary outcomes:
measure: Change of FDD (flow-dependent dilation) in response to Alirocumab
timeFrame: From baseline to 10 weeks of treatment
measure: Change of intima media thickness in response to Alirocumab
timeFrame: From baseline to 10 weeks of treatment
measure: Change of post-prandial lipaemia in response to Alirocumab
timeFrame: From baseline to 10 weeks of treatment
measure: Change of the lipoprotein subfractions in response to Alirocumab
timeFrame: From baseline to 10 weeks of treatment
measure: Changes of inflammatory parameters in response to Alirocumab
timeFrame: From baseline to 10 weeks of treatment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Günther Silbernagel, MD. Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03616509: GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition
Official title: Treatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prader-Willi Syndrome
Keywords: Growth Hormone
Functional Magnetic Resonance
Strength
Body composition
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Parc de Salut Mar
First posted: 2018-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First phase: 2m with placebo Second phase: 12 m with growth hormone
Primary purpose: TREATMENT

Brief summary: Prader-Willi syndrome (PWS) is a genetic disorder associated with growth hormone (GH) deficiency, central hypotonia and hyperphagia that leads to life-threatening obesity. Treatment with GH in adult patients is not well stablished in guidelines of Health National System (HNS). The investigators has experience in the study of brain connectivity in these patients in relation to satiety. To date, there is no evidence about the effect of GH on central hypotonia (brain areas related with muscle tone maintenance). So, the main objective is to examine these anatomical areas before and one year after GH treatment.

Methodology: Structural and functional magnetic resonance imaging to 30 PWS patients before and after GH treatment and we will compare them to a control group.

Expected results: PWS group will show abnormal functional and structural connectivity in circuitry of muscle tone maintenance that will improve after GH treatment. These favorable changes and the absence of secondary effects will help to justify the use of this treatment and its inclusion in practical clinical guidelines of HNS for the management of this syndrome in the adulthood.


Eligibility criteria: Inclusion Criteria:

* PWS \>=18 years with growth hormone deficit
* Signed informed consent by the patients or their legal guardian

Exclusion Criteria:

* Severe obesity
* No controled diabetes mellitus
* No treated obstructive sleep apnea or severe obstructive sleep apnea
* Active cancer
* Active psychosis

Primary outcomes:
measure: Examine brain connectivity areas related with muscle tone maintenance
timeFrame: 24 months
Secondary outcomes:
measure: Evaluation of strength
timeFrame: 24 months
measure: Evaluation of body composition
timeFrame: 24 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
Study officials:
affiliation: Corporacio Sanitària Parc Taulí
name: Olga Gimenez-Palop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05773209: Choroidal and Retinal Changes After RLRL Therapy in Diabetes and Diabetic Retinopathy
Official title: Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetic Retinopathy
Keywords: Repeated low-level red-light (RLRL) therapy
Choroidal thickness
Lead sponsor: The Second People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 58
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.

Detailed description: The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up

Eligibility criteria: Inclusion Criteria:

1. Aged 35-55 years
2. Diagnosis of type 2 diabetes mellitus
3. No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography

Exclusion Criteria:

1. Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
2. Patients with complications such as DME and retinal detachment
3. History of ocular surgical operations
4. Severe systemic diseases
5. Those who could not cooperate with the examination for any reason
6. Cognitive impairment or mental illness
7. Patients with other ocular diseases

Primary outcomes:
measure: Changes in subfoveal choroidal thickness
timeFrame: 1 month
Secondary outcomes:
measure: Changes in choroidal vascularity index
timeFrame: 1 month
measure: Changes in OCTA-derived parameters of the choroid and retina
timeFrame: 1 month
measure: Changes in DR grading
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: The Second People's Hospital of Foshan, Guangdong Province,China
name: Xiangbin Kong, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00005709: Lipoprotein Metabolism in Hypertensive African-Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hyperinsulinism
Hypertension
Insulin Resistance
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease.

Detailed description: BACKGROUND:

The study was part of the initiative "Collaborative Projects (R01s) on Minority Health". The concept for the initiative was developed by the NHLBI staff after the 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The initiative was approved at the September 1992 National Heart, Lung, and Blood Advisory Council and released in October 1992.

Julian Marsh was one of three investigators in a collaborative program with Bonita Falkner as Program Coordinator.

DESIGN NARRATIVE:

In a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins B and A-I, the dominant lipoproteins of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL). They used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. They hypothesized that in hypertensive African Americans with hyperinsulinemia, more of the smaller Very Low Density (VLDL) particles are secreted and converted to LDL.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sumner AE, Kushner H, Tulenko TN, Falkner B, Marsh JB. The relationship in African-Americans of sex differences in insulin-mediated suppression of nonesterified fatty acids to sex differences in fasting triglyceride levels. Metabolism. 1997 Apr;46(4):400-5. doi: 10.1016/s0026-0495(97)90055-x.
citation: Sumner AE, Kushner H, Lakota CA, Falkner B, Marsh JB. Gender differences in insulin-induced free fatty acid suppression: studies in an African American population. Lipids. 1996 Mar;31 Suppl:S275-8. doi: 10.1007/BF02637090.
citation: Sumner AE, Falkner B, Diffenderfer MR, Barrett PH, Marsh JB. A study of the metabolism of apolipoprotein B100 in relation to insulin resistance in African American males. Proc Soc Exp Biol Med. 1999 Sep;221(4):352-60. doi: 10.1046/j.1525-1373.1999.d01-92.x.
Clinical trial NCT05020509: Intravascular Injection Rates During Lumbar Medial Branch Block
Official title: Comparison of Intravascular Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravascular Injection
Keywords: intravascular injection
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block.

Detailed description: In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, the investigators postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, the investigators used the real time fluoroscopy after injection of contrast medium.

The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block

Eligibility criteria: Inclusion Criteria:

* facet joint arthropathy

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality

Primary outcomes:
measure: incidence of intravascular injection
timeFrame: 1 minute after finishing lumbar medial branch block
Secondary outcomes:
measure: time required to complete lumbar medial branch block
timeFrame: Baseline, 1 second after the completion of lumbar medial branch block
measure: radiation amout to complete lumbar medial branch block
timeFrame: Baseline, 1 second after the completion of lumbar medial branch block
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
References:
Clinical trial NCT00985309: Clinical Parameters Predicting Unsatisfactory Cervicovaginal Cytology in Conventional Smears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unsatisfactory Pap Smear
Keywords: unsatisfactory
Pap smear
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2009-09-28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital

Brief summary: According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be categorized into specimen rejected, or specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000 well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory smear deserves careful follow-up and studies. Although the Bethesda system allows criteria modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no studies investigated the clinical factors related to the incidence of unsatisfactory smear. Thus, the investigators designed this trial to study the clinical factors relating to unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear between March 2006 and August 2006 in our hospital will be obtained from the Pathological Department first. Then the investigators will review the medical records from HIS system and pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis. Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause, location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization, hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients who missed any of above data will be excluded for analysis. The investigators will use univariate and multivariate analysis for data processing and statistic analysis to find out the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.


Eligibility criteria: Inclusion Criteria:

* A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital

Exclusion Criteria:

* nil

Primary outcomes:
measure: unsatisfactory Pap smear rates in various clinical conditions
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of OB/GYN, Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT04250909: Retrospective Follow-up of BIOLUX P-I/-II
Official title: Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overall Mortality
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 132
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from previous studies.

Brief summary: The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.


Eligibility criteria: Inclusion Criteria:

1. Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II
2. Subject was treated either with Passeo-18 PTA or Passeo-18 LUX
3. Written informed consent by subject or subject's legal representative or impartial witness/waiver

Exclusion Criteria:

1. Subject did neither participate in BIOLUX P-I nor BIOLUX P-II
2. Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA
3. Subject is not willing to sign an informed consent /data release form

Primary outcomes:
measure: Overall survival
timeFrame: 60 months
Secondary outcomes:
measure: Overall survival, defined as the time in days after index procedure to date of death from any cause.
timeFrame: 60 months
measure: Major amputations of target extremities
timeFrame: 60 months
measure: Clinically-driven target lesion revascularization
timeFrame: 60 months
measure: Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.
timeFrame: 60 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
city: Bonheiden
country: Belgium
facility: Vascular Research Center Bornheiden, Imelda Hospital
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
city: Bad Krozingen
country: Germany
facility: Clinic of Cardiology and Angiology II Bad Krozingen
city: Berlin
country: Germany
facility: Gefäßzentrum am KEH
city: Leipzig
country: Germany
facility: University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)
city: Rosenheim
country: Germany
facility: Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum
Study officials:
affiliation: Clinic of Cardiology and Angiology II Bad Krozingen
name: Thomas Zeller, Prof Dr
role: STUDY_CHAIR
References: