louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03352505: Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Official title: Associations Between the Cardiovascular Risk Markers and Neuroplasticity in Sedentary or Physically Active Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SCI - Spinal Cord Injury
Cardiovascular Risk Factor
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy participants, wheelchair users

Brief summary: The present study will analyze if exercise is able to elicit the well-known anti-atherogenic effects in patients with SCI. This will be evaluated by measuring vascular parameters such as endothelial and inflammatory blood markers, echocardiography of the heart and peripheral vessels, as well as blood pressure and arterial stiffness, in subjects performing either wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated, whether there is an association between neuroplasticity and cardiovascular health, as measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood levels of the brain-derived neurotrophic factor (BDNF).

We hypothesize that the cardiovascular, physical and psychological benefits of wheelchair dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients


Eligibility criteria: Inclusion Criteria:

wheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.

Exclusion Criteria:

metallic implanters, additional neurologic pathologies, pregnancy

Primary outcomes:
measure: comparison of cardiovascular risk factors between different study groups
timeFrame: October 2017- June 2018
measure: Evaluation of echocardiography results between different study groups
timeFrame: October 2017- June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg
city: Salzburg
country: Austria
facility: Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Study officials:
References:
Clinical trial NCT01549405: Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block, Intercostal Nerve
Keywords: percutanous nephrolitotomy,intercostal nerve block, Ultrasound
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.

Detailed description: Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Patients admitted for the removal of renal stones by percutaneous
* nephrolithotomy (PCNL)
* ASA I-II status

Exclusion Criteria:

* Respiratory or cardiac disfunction
* Neuropathy
* Coagulopathy
* BMI (Body mass index)over 30

Primary outcomes:
measure: Postoperative Analgesic (Tramadol) Consumption
timeFrame: Postoperative 24th hour
measure: Total Consumption of Tramadol Will be Measured for the First 24 Hours
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Postoperative Pain Will be Evaluated.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Derya Özkan
Study officials:
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Derya Özkan, MD
role: STUDY_DIRECTOR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Taylan Akkaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Emine Arık, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Zeynep Koç, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
name: Nihat Karakoyunlu, MD
role: STUDY_CHAIR
affiliation: 1Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Haluk Gümüs, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
name: Hamit Ersoy, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Julide Ergil, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04295005: A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists
Official title: The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 24500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus (T2DM) patients who have been treated with either Empagliflozin, DPP-4i /Sitagliptin or GLP-1-RA (new users only, at least one prescription).

Brief summary: Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis


Eligibility criteria: Inclusion Criteria:

* Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
* At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)

Exclusion Criteria:

* At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)

  * During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).

Primary outcomes:
measure: Direct Healthcare Cost
timeFrame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
measure: Healthcare Resource Utilization
timeFrame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Secondary outcomes:
measure: Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)
timeFrame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Other outcomes:
Locations:
city: Ingelheim am Rhein
country: Germany
facility: Boehringer Ingelheim
Study officials:
References:
Clinical trial NCT02732405: Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis
Official title: A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (Child-Pugh A5 to A6) and No Response to PR or Prior Failure to First Generation Protease Inhibitors (PIs)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C
Compensated Cirrhosis
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: CD Pharma Group S.r.l.
First posted: 2016-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.


Eligibility criteria: Inclusion Criteria:

1. Informed consent form signed,
2. Age \> 18 years,
3. Chronic infection with Hepatitis C virus genotype 1b,
4. HCV RNA \> 100 IU/mL,
5. HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
6. Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) \> 12.5 KPa; or FibroTest or FibroSure \> 0.75 with APRI \>2),
7. Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg (only in selected sites),
8. Albumin level ≥ 3.0 g/dl,
9. Platelet count ≥ 75 x 103/μL.

Exclusion Criteria:

1. Child-Pugh score greater than CP-A6,
2. Patients with HCV genotype 1a, 2, 3, 4, 5, 6,
3. Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance,
4. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive),
5. Decompensated cirrhosis/previous decompensation,
6. Pregnancy,
7. Breast-feeding,
8. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components,
9. Albumin level \< 3.0 g/dl,
10. Platelet count \< 75 x 103/μl,
11. Concomitant participation in any clinical trial.

Primary outcomes:
measure: Sustained virologic response rates 12 weeks after discontinuation of therapy (SVR12). SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
timeFrame: 12 weeks after discontinuation of therapy (SVR12).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01405105: Exacerbating Factors in Inflammatory Bowel Disease
Official title: Exacerbating Factors in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
Collaborators: name: Centocor Ortho Biotech Services, L.L.C.
First posted: 2011-07-29
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Flare of Crohn's disease Flare of ulcerative colitis Quiescent IBD (control)

Brief summary: Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.

Detailed description: Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.

Eligibility criteria: Inclusion Criteria:

* History of verified Crohn's disease or ulcerative colitis

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: Frequency of identifiable trigger for flare
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Dallas VA Medical Center
name: Linda A Feagins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180305: A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
Official title: A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: TSH Biopharm Corporation Limited
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 200
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To investigate the mitochondrial DNA biomarker in a large group of patients suspicious for prostate cancer to evaluate the Mitomic Prostate Test (MPT)'s accuracy in target population.

Brief summary: To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.

Detailed description: To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA \< 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.

Eligibility criteria: Inclusion Criteria:

* Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA \< 10ng/ml within the previous 3 months.
* Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
* Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
* The index biopsy must occur following and within 16 weeks of blood draw.

Exclusion Criteria:

* Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
* Previous diagnosis of prostate cancer;
* Prostate biopsy within the previous 3 months;
* Men with a total PSA\>10ng/ml within the previous 3 months;
* Provides less than the required amount of blood;
* Considered incompetent to provide informed consent;
* Does not understand and read language of informed consent;
* Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
* Males who are not of screening age (\<45);
* Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
* Blood collected after index biopsy.
* Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.

Primary outcomes:
measure: Mitomic Prostate Test (MPT)
timeFrame: 16 weeks
Secondary outcomes:
measure: MPT compared to the current standard of care (SOC).
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00587405: Cyrotherapy vs. APC in GAVE
Official title: Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Watermelon Stomach
Keywords: Watermelon Stomach
Cryotherapy
Argon Plasma Coagulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see if either method of treatment for Watermelon Stomach shows better results

Detailed description: Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. Current endoscopic treatment options, including argon plasma coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat WS by virtue of its mechanism of injury and mode of application.

Eligibility criteria: Inclusion Criteria:

1. Confirmed WS at endoscopy that is associated with significant anemia (Hb \< 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months
2. Able to give informed consent
3. Age \> 18 years

Exclusion Criteria:

1. Endoscopic or histological findings inconsistent with WS
2. Known coagulopathy (INR \> 2), severe thrombocytopenia (platelet count \< 50,000), or bleeding diathesis
3. Endoscopic treatment of WS within the past month
4. Unable or unwilling to give informed consent.

Primary outcomes:
measure: the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
timeFrame: 6 months
Secondary outcomes:
measure: Endoscopic response will constitute the secondary outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo CLinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Louis M Wongkeesong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556005: Efficacy of Trimetazidine in Diabetic Patients
Official title: Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Diabetic Cardiomyopathies
Keywords: Trimetazidine
Diastolic dysfunction
diabetes mellitus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.

Therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.


Eligibility criteria: Inclusion Criteria:

1. Age from 40-75 years
2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%

Exclusion Criteria:

1. Patients with valvular, congenital or ischemic heart disease.
2. Patients with inadequately controlled hypertension (blood pressure\>140/90 mm Hg)
3. Patients with HbA1c% \<10 %
4. Patients with history of intolerance or allergic response to TMZ
5. Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance \< 30 ml/min)
6. Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.
7. Patients with Parkinson's disease or motor disorders
8. Pregnancy and breast feeding

Primary outcomes:
measure: Change from baseline Left ventricular functions at 3 months
timeFrame: at baseline and after three months of intervention
Secondary outcomes:
measure: Change from baseline Tumor necrosis factor alpha at 3 months
timeFrame: at baseline and after three months of intervention
measure: Change from baseline Transforming growth factor beta 1 at 3 months
timeFrame: at baseline and after three months of intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university hospitals
Study officials:
References:
Clinical trial NCT05809505: Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
Official title: Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: telehealth
multiple sclerosis
360-degree Turn Test
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The 360-degree turn test will be applied to patients first in the hospital environment and then by teleconference method, and the results will be recorded.
Primary purpose: DIAGNOSTIC

Brief summary: Walking, balance problems and falls are common in patients with multiple sclerosis. The 360-degree turn test is a test used to evaluate balance. Telerehabilitation is a rehabilitation system that has been increasingly used in recent years. Still, there is a need for studies on whether there is any difference between face-to-face evaluations with patients and telehealth methods. This study aims to investigate the feasibility and safety of the 360-degree turn test delivered via telehealth.

Detailed description: The 360-degree turn test will be performed in the participant's home environment using a standardized protocol from previously published literature. Exercise professionals will administer the test during a single videoconferencing exercise appointment. Prior to the study commencement, clinicians will be given a 30-minute education session and written protocol to facilitate the standardized and safe performance of the test.

The test will be performed in the participant's home environment using videoconferencing. The clinician will explain the 360-degree turn test. Clinicians will record the device used by the participant. Where possible, participants will be instructed to adjust their device or camera to improve clinician visibility. The test will be stopped immediately if the participant reports increased pain, a moderate-significant increase in breathlessness, or is unsteady.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* EDSS score ≤ 5.5

Exclusion Criteria:

* Not giving consent
* History of dislocation or surgery in the lower limbs
* History of fall within six months
* Any other disease, medication or intervention that can cause balance disturbance
* Patients who cannot use devices that is required for teleconference
* Patients that cannot understand English/ Turkish

Primary outcomes:
measure: Number of patients who safely completed the 360-degree turn test and completed the measurement in a way that could be used in clinical trials or follow-up
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam ve Sakura City Hospital
state: Başakşehir
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: