louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01914432: Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
Official title: A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Hypertension
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 210
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: To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 19 years of age
* Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
* Other exclusions applied

Primary outcomes:
measure: Change in Diastolic Blood Pressure, Change in LDL Cholesterol
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Yuhan Corporation
name: Su Youn Nam, MD
role: STUDY_DIRECTOR
References:
citation: Oh GC, Han JK, Han KH, Hyon MS, Doh JH, Kim MH, Jeong JO, Bae JH, Kim SH, Yoo BS, Baek SH, Rhee MY, Ihm SH, Sung JH, Choi YJ, Kim SJ, Hong KS, Lee BK, Cho J, Shin ES, Rhew JY, Kim H, Kim HS. Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clin Ther. 2018 May;40(5):676-691.e1. doi: 10.1016/j.clinthera.2018.03.010. Epub 2018 Apr 17.
Clinical trial NCT03708432: 500mg Fulvestrant in HR+ MBC
Official title: An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: To study the real world use of 500mg Fulvestrant in HR+ MBC.

Detailed description: An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with ER/PR+，HER2- advanced breast cancer
2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.

3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.

4.Available medical history

Exclusion Criteria:

1. Incomplete medical history
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao Y, Li Y, Gong C, Xie Y, Zhang J, Wang L, Cao J, Tao Z, Wang B, Hu X. Optimal duration of prior endocrine therapy predicts the efficacy of Fulvestrant in a real-world study for patients with hormone receptor-positive and HER2-negative advanced breast cancer. Cancer Med. 2020 Dec;9(23):8821-8831. doi: 10.1002/cam4.3491. Epub 2020 Oct 6.
Clinical trial NCT05226832: Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome
Official title: Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Intradetrusor triamcinolone injections are already the standard of care for IC patients with Hunner's lesions, but its role in management of IC without Hunner's lesions has yet to be determined. Triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. We will recruit 27 females 18 years of age or older that have been diagnosed with IC/BPS. Patients will undergo a one-time cystoscopy along with the triamcinolone injections for IC management as a part of the research study. Validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. Follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. Scores at follow-up visits will be compared to baseline.


Eligibility criteria: Inclusion Criteria:

* Patients must meet an appropriate diagnosis of IC from NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)
* Patients must be female
* 18 years or older
* Have an official diagnosis of Interstitial Cystitis/Bladder Pain Syndrome

Exclusion Criteria:

* Patients who do not meet NIDDK inclusion criteria for Interstitial Cystitis as described above will not me enrolled in the study
* The presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared)
* Pregnant women
* Patients who have the inability to consent on their own behalf
* Prisoners

Primary outcomes:
measure: O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00455637: Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
Official title: A Phase II, Randomised, Double-blind, Dose-ranging Study in Children and Young People to Determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spasticity Due to Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cerebral Palsy
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.


Eligibility criteria: Inclusion Criteria:

* Male or female aged between 4 and 16 years (inclusive).
* Diagnosis of cerebral palsy.
* Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents.
* Paediatric Pain Profile score of 25 or greater.

Exclusion Criteria:

* Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
* Planned or anticipated requirement for surgery during the study period.
* History of hypersensitivity to the investigational drug or any of its excipients.
* Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.

Primary outcomes:
measure: To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
timeFrame: From baseline to the end of study (week 20)
measure: The primary endpoint will be the change in score in the Paediatric Pain Profile.
timeFrame: From baseline to the week 4 assessment
Secondary outcomes:
measure: To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points.
timeFrame: Weeks 12, 16 and 20
measure: To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points.
timeFrame: Weeks 4, 12, 16 and 20
measure: To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.
timeFrame: Weeks 4, 12, 16 and 20
Other outcomes:
Locations:
city: Chailey
country: United Kingdom
facility: Chailey Heritage Clinical Services
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06516237: Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
Official title: Relationships Between Intestinal Ultrasound Parameters and Elastography Measurements With Histopathologic Findings in a Prospective Cohort of Patients With Ulcerative Colitis: Development of Novel Imaging and Molecular Biomarkers of Fibrosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 50 Consecutive adult (18 years of age and older) patients with an established diagnosis (\> 3 months) of ulcerative colitis irrespective to state of disease and treatment, undergoing routine investigations by colonoscopy or sigmoidoscopy(according to the current standard of care indications and ECCO guidelines), will be enrolled and undergone routine biopsies in the distal colon and intestinal ultrasound with Shear wave elastography measurements. In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers. Any medication will be kept stable in the interval between the two procedures.
Primary purpose: OTHER

Brief summary: Prospective multicenter interventional non-randomized cross-sectional study. Ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings.

This study aims to develop novel imaging and molecular biomarkers of fibrosis, through the use of intestinal ultrasound and shear wave elastography, using histologic specimens obtained by endoscopic biopsies as reference standard.


Eligibility criteria: Inclusion Criteria:

* Adult, 18 years of age and older,
* Established diagnosis (\> three months) of ulcerative colitis,
* Performing colonoscopy, according to current standards of care and ECCO guidelines,
* Ability to understand and comply with the study procedure and sign an informed consent form

Exclusion Criteria:

* Pregnancy,
* presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare),
* inability to undergo intestinal ultrasound within the time set by the study,
* poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen.
* subjects who needs to change therapy

Primary outcomes:
measure: To correlate ultrasound findings with histopathological elements of lesions
timeFrame: 1 day
Secondary outcomes:
measure: To correlate shear wave elastography measurements with histopathological elements of lesions
timeFrame: 1 day
Other outcomes:
measure: To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution
timeFrame: 1 day
Locations:
Study officials:
References:
Clinical trial NCT00363337: A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: Adults
Bipolar Depression
Bipolar Disorder
Bipolar I
Bipolar II
Depression
Lead sponsor: Lindner Center of HOPE
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2006-08-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.


Eligibility criteria: Inclusion Criteria:

* subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.

Exclusion Criteria:

* subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: per protocol
Secondary outcomes:
measure: Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP)
timeFrame: per protocol
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Susan L McElroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McElroy SL, Suppes T, Frye MA, Altshuler LL, Stanford K, Martens B, Leverich GS, Post RM, Keck PE Jr. Open-label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial. J Affect Disord. 2007 Aug;101(1-3):275-81. doi: 10.1016/j.jad.2006.11.025. Epub 2007 Jan 16.
Clinical trial NCT04862637: Detecting the Changes of Swallowing Function in Oral Cancer Patients
Official title: Using High Resolution Impedance Manometry (HRIM) Combined With Videofluoroscopic Swallow Study (VFSS) to Investigate the Changes of Swallowing Function in Oral Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Swallowing Function
Keywords: dysphagia
swallowing
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with the diagnosis of oral cancer

Brief summary: The evidence of swallowing changes in tongue cancer patients is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).

Detailed description: Objective: to investigated the swallowing changes in tongue cancer patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).

Methods: 1. patients are fulfilled tongue cancer diagnosis; 2.they will undergo VFSS and HRIM examinations before or after surgery if they experience discomfort while swallowing.

Eligibility criteria: Inclusion Criteria:

* patients elective received oral cancer surgery and suitable to receive mandibular-lip split or pull-through resection surgeries

Exclusion Criteria:

* 1. patients had major underlying disease, ex: heart, brain, lung, liver disease
* 2. coagulopathy
* 3.pregnancy
* 4. the patients could not have good compliance

Primary outcomes:
measure: pharyngeal pressure
timeFrame: 15 minutes during the examination postoperative 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01816737: Fetal Blood Flow Response to Partial Occlusion by External Compression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Age
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.


Eligibility criteria: Inclusion Criteria:

singleton

Exclusion Criteria:

multiple gestation

Primary outcomes:
measure: pulsatility index in fetal vessels
timeFrame: at the time of pressure aplication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01472237: Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure
Official title: Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Malnutrition
Nutritional Intervention
Mortality
Lead sponsor: Hospital San Juan de la Cruz
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 120
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: The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients admitted for heart failure
* \> 18 years old
* Malnutrition determined by MNA test (\< 17 points)

Exclusion Criteria:

* If is not possible to perform a nutritional assessment
* Planned PCI or CABG to correct heart failure etiology

Primary outcomes:
measure: Mortality and heart failure hospitalizations
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Úbeda
country: Spain
facility: Hospital San Juan de la Cruz
state: Jaen
Study officials:
References:
citation: Bonilla-Palomas JL, Gamez-Lopez AL, Anguita-Sanchez MP, Castillo-Dominguez JC, Garcia-Fuertes D, Crespin-Crespin M, Lopez-Granados A, Suarez de Lezo J. [Impact of malnutrition on long-term mortality in hospitalized patients with heart failure]. Rev Esp Cardiol. 2011 Sep;64(9):752-8. doi: 10.1016/j.recesp.2011.03.009. Epub 2011 Jun 8. Spanish.
citation: Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5.
citation: Bonilla-Palomas JL, Gamez-Lopez AL, Castillo-Dominguez JC, Moreno-Conde M, Lopez Ibanez MC, Alhambra Exposito R, Ramiro Ortega E, Anguita-Sanchez MP, Villar-Raez A. Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure. Arch Med Res. 2016 Oct;47(7):535-540. doi: 10.1016/j.arcmed.2016.11.005.