louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06643819: Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
Official title: A Randomized, Double-blind, Active-controlled, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 324
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A(Sacubitril∙Valsartan)


Eligibility criteria: Inclusion Criteria:

* Participants who are 19 years old or older.
* Participants who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

* Participants with a history of secondary hypertension or suspected secondary hypertension.
* Participants with a orthostatic hypotension.
* Participants who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period.
* Participants with type 1 diabetes or poorly controlled diabetes.
* Participants who treated other clinical trial drugs within 4 weeks of screening visit.
* Participants with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
* Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
* Participants who are unable to participate in this clinical trial at the discretion of the investigator.

Primary outcomes:
measure: change from baseline in MASBP(Mean Ambulatory Systolic Blood Pressure)
timeFrame: 10 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References:
Clinical trial NCT02455219: DatScan With Prototype Collimator
Official title: Investigating the Use of Siemens Prototype UHRSZ Collimator for Imaging DatScan SPECT/CT Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to Nuclear Medicine for a clinically indicated DatScan for the diagnosis of Parkinson's disease

Brief summary: A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or filter that enhances or improves photos. The prototype collimators are able to magnify target organs about four times compared to the current collimators. In this study we are validating a new collimator design, which will allow for quantitative measurement of dopamine receptors within the brain, not previously performed using a single photon gamma camera.

Detailed description: Previously PET/CT has been used for this measurement but the L-DOPA is not FDA approved and thus of limited availability. DatScan (I123 ioflupane) is an FDA approved and clinically indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters (DAT) in the brains of mammals, in particular the striatal region of the brain. A feature of Parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. By introducing an agent that binds to the dopamine transporters a quantitative measure and spatial distribution of the transporters can be obtained. The use of SPECT/CT (with the new validated collimators) and the FDA approved DATScan biomarker would allow for readily available diagnosis of Parkinson's disease

Eligibility criteria: Inclusion Criteria:

* all patients referred

Exclusion Criteria:

* anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.

Primary outcomes:
measure: comparing images with prototype collimator to clinical images
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03129919: Arch Dimension and Inclination of the Upper and Lower Incisors Changes
Official title: Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion, Angle Class I
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis


Eligibility criteria: Inclusion Criteria:

* Complete permanent dentition, except third molars.
* Class I malocclusion, determined by Angle ANB 2 plus or minus 2
* Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient.
* Little index with minimum Irregularity 4-6 mm.
* Patients with x-rays of initial profile and at the end of alignment and leveling in good condition.

Exclusion Criteria:

* Models in poor condition that do not allow measurements.
* Patients who do not wish to participate in the study
* Patients with cleft lip and palate
* Patients with craniofacial anomalies
* Patients with previous orthodontic treatment

Primary outcomes:
measure: Incisomaxillary angle
timeFrame: At the end of the alignment and leveling phase, an average of 8 months
Secondary outcomes:
measure: Transverse development of the upper and lower jaws
timeFrame: Each time wire is changed in the sequence suggested by the author, an average of 3 months
measure: Inclination of the lower incisor
timeFrame: At the end of the alignment and leveling phase, an average of 8 months
Other outcomes:
Locations:
Study officials:
name: Claudia Forero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764019: Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Official title: Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Motility Disorder
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.

High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.

The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.


Eligibility criteria: Inclusion Criteria:

* Patients: digestive symptoms
* Healthy subjects: asymptomatic

Exclusion Criteria:

* Patients: organic disorders
* Healthy subjects: organic disorders

Primary outcomes:
measure: Contractile activity
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Malagelada C, Karunaratne TB, Accarino A, Cogliandro RF, Landolfi S, Gori A, Boschetti E, Malagelada JR, Stanghellini V, Azpiroz F, De Giorgio R. Comparison between small bowel manometric patterns and full-thickness biopsy histopathology in severe intestinal dysmotility. Neurogastroenterol Motil. 2018 Mar;30(3). doi: 10.1111/nmo.13219. Epub 2017 Sep 22.
Clinical trial NCT02778919: Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: Change of average Numerical Rating Scale (NRS) score of pelvic pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidences of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
Clinical trial NCT01195519: The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis
Official title: The Study Will Investigate the Quality of Life in PD or HD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Dialysis
Hemodialysis
Keywords: peritoneal dialysis
hemodialysis patients
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: peritoneal dialysis and hemodialysis patients

Brief summary: Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. This study will investigate the predictive model of quality of life in terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the further evidence to the government to develop the effective interventions for dialysis patients. The optimal goal is to promote the quality care.


Eligibility criteria: Inclusion Criteria:

* above 20 years old PD or HD patients
* conscious clear and no psychosis
* literate and can communicate
* willing to participate and sign informed consent

Exclusion Criteria:

* Not volunteer
* subject felt weak or uncomfortable and patients decision to withdraw from the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
state: NO.111, Section 3, Hsing-Long Rd, Taipei
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Tso-Hsiao Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00566319: Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes
Official title: A Randomised Controlled Trial to Investigate the Effect of a Structured Educational Programme on Physical Activity Levels and Glucose Tolerance in People With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Exercise
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Diabetes UK
First posted: 2007-12-03
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.


Eligibility criteria: Inclusion Criteria:

* 2-h blood glucose ≥ 7.8 mmol/l and \< 11.1 mmol/l
* Fasting plasma glucose \< 7 mmol/l
* BMI ≥ 25 kg/m2 (or 23 kg/m2 for those from a South Asian ethnic origin)
* Aged 18 or over

Exclusion Criteria:

* Taking medication known to significantly interfere with glucose tolerance
* Participating in regular vigorous physical activity
* Unable to participate in moderate intensity physical activity
* Pregnant

Primary outcomes:
measure: 2-hour glucose
timeFrame: 2 hours
Secondary outcomes:
measure: Pedometer counts, Fasting glucose, total cholesterol, HDL-cholesterol, LDL- cholesterol, TNFα, IL-6, CRP, systolic and diastolic blood pressure, body mass, waist circumference, BMI, physical activity, psychological determinants
timeFrame: Pedometer counts, 7 days ; everything else, 2 hours
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: University of Leicester
name: Melanie Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yates T, Davies MJ, Sehmi S, Gorely T, Khunti K. The Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: are improvements in glucose regulation sustained at 2 years? Diabet Med. 2011 Oct;28(10):1268-71. doi: 10.1111/j.1464-5491.2011.03357.x.
Clinical trial NCT03738319: Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
Official title: Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Grade Serous Carcinoma
Ovarian Cancer
Exosomes
Prognosis
Early Diagnosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 20 patients of high grade serous ovarian cancer (HGSOC) and 20 patients with benign gynecologic diseases, whose data will be applied for construction of diagnostic model of miRNA/lncRNA from exosome. There will be 120 patients suspected of HGSOC, whose data will be applied for validation of such diagnosis model.

Brief summary: This study aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.


Eligibility criteria: Inclusion Criteria:

* Confirmed primary high grade serous ovarian cancer
* Willing to accepted debulking surgeries and adjuvant chemotherapy
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Differential expression of miRNA/lncRNA
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900819: Evaluation of Dexterity in Prevalent Peritoneal Dialysis Patients
Official title: Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All prevalent PD patients from our center will be included

Brief summary: The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

Detailed description: All peritoneal dialysis patients from Peritoneal Dialysis unit will, after information and consent, have to realise four tests, one time each, to quantify their manual dexterity. The tests are already used to measure dexterity: Purdue Pegboard, Jebsen test, JAMAR, Pinch test. These tests will be performed during an in-hospital visit.

Eligibility criteria: Inclusion Criteria:

* patients treated by peritoneal dialysis in Caen University Hospital

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: success of dexterity measurement in peritoneal dialysis patients evaluated by the Purdue Pegboard
timeFrame: baseline
measure: success of dexterity measurement in peritoneal dialysis patients evaluated by the Jebsen test
timeFrame: baseline
measure: success of dexterity measurement in peritoneal dialysis patients evaluated by the JAMAR
timeFrame: baseline
measure: success of dexterity measurement in peritoneal dialysis patients evaluated by the Pinch test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT01939119: Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion
Official title: Examination of the Body-fluid Balance in Patients With Retinal Vascular Occlusion Before and During Hemodilution and the Influence of Drinking Habits on the Degree of Body Hydration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dehydration
Retinal Vascular Occlusion
Keywords: retinal vascular occlusion
drinking habits
body hydration
body-fluid balance
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with retinal vascular occlusion

Brief summary: The purpose of this study is to examine the body-fluid balance in patients with retinal vascular occlusion and the influence of drinking habits and hemodilution on the degree of body hydration.

Detailed description: Patients with retinal vascular occlusion who are hospitalized for hemodilution and cardiovascular risk assessment are asked to report their drinking habits. Hydration status before and during hemodilution is assessed with a body-fluid analyzing scale.

Eligibility criteria: Inclusion Criteria:

* informed consent
* age over 18 years

Exclusion Criteria:

* age under 18 years
* hypertensive urgency
* myocardial infarction \< 4 weeks ago, chest pain
* heart rhythm disorders, high degree valvular defects
* pacemaker, defibrillator
* peripheral arterial occlusive disease
* end stage renal disease
* acute hepatitis, chronic inflammatory intestinal disease
* pregnancy

Primary outcomes:
measure: changes in body-fluid balance
timeFrame: 1 week
Secondary outcomes:
measure: number of participants with dehydration
timeFrame: 1 week
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic
state: Germany/ Saxony
Study officials:
affiliation: University Eye Clinic Dresden
name: Lutz E Pillunat, MD
role: STUDY_DIRECTOR
References: