louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00171392: Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
Official title: Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Acute Rejection After Kidney Transplantation
Keywords: Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
* Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion Criteria:

Subjects expected to discontinue tacrolimus therapy;

* Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
* Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.

Primary outcomes:
measure: Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection
measure: Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
measure: Quality of life related to GI symptoms (GIQLI scale)
measure: Full blood count
measure: Gastrointestinal Adverse Events (check-list)
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT01952392: Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
Official title: Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Effectiveness study
Acute coronary Syndrome
Real-life
France
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-09-30
Enrollment: 4992
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or more, both genders,with an acute coronary syndrome, agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

Brief summary: Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Detailed description: AReMIS (Antiplatelet and Recurrent Myocardial Infarction Study) To compare the relative risk of new myocardial infarction (recurrent myocardial infarction or 'rMI') in patients with a history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate.

Eligibility criteria: Inclusion Criteria:

Patients aged 18 years or more, both genders, with an acute coronary syndrome (ACS), agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

No Exclusion Criteria.

Primary outcomes:
measure: Medical information
timeFrame: At baseline visit
measure: Drug exposure
timeFrame: Current
measure: Drug exposure
timeFrame: Recent
measure: Drug exposure
timeFrame: Past
Secondary outcomes:
measure: Other medical events of interest
timeFrame: During follow-up (up to 12 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Research Site
Study officials:
References:
Clinical trial NCT03433092: Serum Carotenoids and Risk of Gastrointestinal Tract Cancer: Meta-analysis of Ten Studies
Official title: Serum Carotenoids and Risk of Gastrointestinal Tract Cancer: Meta-analysis of Ten Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Tract Cancer
Keywords: Serum carotenoids
Gastrointestinal tract cancer
Meta-analysis
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Provincial Science and Technology Support Project (2016SZ0047)
First posted: 2018-02-14
Enrollment: 40641
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population include people from primary care clinic or community sample.

Brief summary: Previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of GIT cancer.


Eligibility criteria: Inclusion Criteria:

* The study had both case and control groups
* Serum carotenoids levels, relative risk (RR) or OR and corresponding 95% CI were reported
* Patients in case group were diagnosed with GIT cancer

Exclusion Criteria:

·Animal studies

Primary outcomes:
measure: Gastrointestinal Tract Cancer Incident Measure
timeFrame: Through study completion, an average of 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: Huang J, Lu MS, Fang YJ, Xu M, Huang WQ, Pan ZZ, Chen YM, Zhang CX. Serum carotenoids and colorectal cancer risk: A case-control study in Guangdong, China. Mol Nutr Food Res. 2017 Oct;61(10). doi: 10.1002/mnfr.201700267. Epub 2017 Jul 31.
Clinical trial NCT05758792: Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women
Official title: Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Old Age; Debility
Age-Related Sarcopenia
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 168
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age-matched older men and women were included in the study.

Brief summary: The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.

Detailed description: The effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. The aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. The muscle quality Index, fear of fall, and lower extremity functionality were evaluated. The results of older women and men were compared.

Eligibility criteria: Inclusion Criteria:

* Being 65 years old or older
* Having no neurological, orthopedic, communicational,
* Mental disability that affects the evaluations.

Exclusion Criteria:

* Incomplete data and older adults not agreeing to participate in the study.

Primary outcomes:
measure: Muscle Quality Index
timeFrame: 6 months
measure: Lower Extremity Functional Scale
timeFrame: 6 months
measure: International Fall Efficiency Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Pamukkale University
name: Güzin Kara Çakıcı, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
citation: Fragala MS, Fukuda DH, Stout JR, Townsend JR, Emerson NS, Boone CH, Beyer KS, Oliveira LP, Hoffman JR. Muscle quality index improves with resistance exercise training in older adults. Exp Gerontol. 2014 May;53:1-6. doi: 10.1016/j.exger.2014.01.027. Epub 2014 Feb 6.
citation: Gadelha AB, Neri SGR, Nobrega OT, Pereira JC, Bottaro M, Fonseca A, Lima RM. Muscle quality is associated with dynamic balance, fear of falling, and falls in older women. Exp Gerontol. 2018 Apr;104:1-6. doi: 10.1016/j.exger.2018.01.003. Epub 2018 Jan 9. No abstract available.
Clinical trial NCT04392492: Vascular Closure Device in Transcatheter Aortic Valve Replacement
Official title: Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing TAVI at the Karolinska University Hospital

Brief summary: Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing transfemoral TAVI at the Karolinska University Hospital

Exclusion Criteria:

* Patients undergoing TAVI with access other than transfemoral
* Use of closure device other than MANTA

Primary outcomes:
measure: Number of patients with major vascular complications
timeFrame: 6 week follow up
Secondary outcomes:
measure: Number of patients with minor vascular complications
timeFrame: 6 week follow up
measure: Number of patients with vascular closure device failure
timeFrame: 6 week follow up
measure: Number of patients with life-threatening, disabling or major bleeding
timeFrame: 6 week follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Cardiology, Karolinska University Hospital
Study officials:
References:
citation: Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12.
Clinical trial NCT02538692: Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
Official title: Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).

Detailed description: Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.

Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed as IBS according to the Rome III criteria;
* Diarrhea was present for at least 75% of the time;
* With a TCM differentiation as "liver stagnation and spleen defficiency"
* Had a colonoscopy within a year to rule out other bowel diseases.

Exclusion Criteria:

* Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
* Had gastrointestinal surgery within a year;
* Used durgs that affect gastrointestinal motility;
* Had psychological disorder;
* Serious disease in other system, which may bias the outcome measures.

Primary outcomes:
measure: the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
timeFrame: 4 weeks after initiation of treatment
Secondary outcomes:
measure: Stool frequency per week
timeFrame: baseline(week 0), week 4, week 8, week 12
measure: An visual scale rating the degree of IBS-D symptoms
timeFrame: baseline(week 0), week 4, week 8, week 12
measure: Proportion of adverse events
timeFrame: week 4
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of TCM
state: Sichuan
Study officials:
References:
citation: Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.
Clinical trial NCT02576392: FDA: Lowering Orthopedic Opioid Dosing (FLOOD)
Official title: Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2015-10-15
Enrollment: 561
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized trial evaluates an intervention to minimize use of opioids following total hip and total knee replacement. Half the participants will receive an intervention (mailed educational materials, followed by a pharmacist call), and half will receive usual care.

Detailed description: Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute, post-surgical pain. Recent studies have reported that some patients persist in taking opioids for months beyond the surgery. While opioids are commonly used for pain management following surgery, patients and their providers often don't have a planned method to optimize opioid exposure. This can lead to patients entering a cycle of opioid use that is difficult to manage, because, as opioid exposure is continued, pain relief is reduced and side effects increase. The investigators' study is aimed at reducing opioid exposure following total hip and total knee replacement.

Eligibility criteria: Inclusion Criteria:

* total hip replacement or total knee replacement
* 1 year membership with KPNW prior to enrollment

Exclusion Criteria:

* managed by pain clinic, in other pain management trial
* patients at low risk of persistent opioid use

Primary outcomes:
measure: Average morphine equivalents
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente NW
name: David H Smith, RPh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333592: Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Official title: A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
HbA1c
Long-term study
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
* Age in the 20 years or over inclusive
* HbA1c in the range of ≥ 6.5 to \< 9%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Patients with serious diabetic complications and other serious complications

Primary outcomes:
measure: Incidences of Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c at 52 Weeks
timeFrame: at week 0 and week 52
Other outcomes:
Locations:
city: Kanto region, Chugoku region, Kyushu region
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT06905392: AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study
Official title: AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnostic Tests
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

Brief summary: The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.


Eligibility criteria: Inclusion Criteria:

* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
* Subjects must be 18 years of age or older.
* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

Exclusion Criteria:

* Subjects known to be pregnant or breast-feeding.
* Subjects previously enrolled in the study.
* Subject, who has withdrawn consent.

Primary outcomes:
measure: Correlation
timeFrame: 5 month
measure: Stability
timeFrame: 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Múrcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago Compostela
city: Ùbeda
country: Spain
facility: Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz
Study officials:
References:
Clinical trial NCT04926792: Taiwan Registry for Leadless Pacemaker
Official title: Taiwan Registry for Leadless Pacemaker
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sick Sinus Syndrome
Atrioventricular Block
Keywords: Leadless Pacemaker
Taiwan
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taiwan Society of Cardiology
name: Chang Gung Memorial Hospital
First posted: 2021-06-15
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: who attempt or had successfully received a leadless pacemaker implantation

Brief summary: Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

Detailed description: The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.

Eligibility criteria: Inclusion Criteria:

1. The patients who had successfully received leadless pacemaker implantation
2. The patients who attempt to receive leadless pacemaker implantation

Exclusion Criteria:

N/A

Primary outcomes:
measure: Acute complication
timeFrame: On the 1 day of implant procedure
measure: Subacute complication
timeFrame: within 3 month after implant procedure
measure: Leadless Pacemaker performance
timeFrame: aroung 12 months after implant proceure
Secondary outcomes:
measure: Successful implant
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Taiwan Society of Cardiology
name: Chih-Chieh Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: