louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03023475: Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
Official title: Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CABG Graft Integrity
Lead sponsor: Kerckhoff Klinik
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is performed in the standard fashion according to the institutional routine. The patients are randomized preoperatively to one of the devices. The proximal end of the radial artery will be preserved and deep-frozen for histological assessment. Endothelial integrity will be investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.


Eligibility criteria: Inclusion Criteria:

* all adult patients undergoing CABG using the radial artery
* capability to give informed consent

Exclusion Criteria:

* no specific exclusion criteria

Primary outcomes:
measure: Endothelial integrity of the radial artery using histological examination.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Harvesting time
timeFrame: The harvesting time will be measured during the vessel harvesting surgery.
measure: Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.
timeFrame: Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.
measure: Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.
timeFrame: The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
Study officials:
affiliation: Kerckhoff Klinik
name: Arnaud Van Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01719575: Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers
Official title: A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Female and Male
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* no gastrointestinal symptoms
* no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
* written informed consent

Exclusion Criteria:

* pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
* history of abdominal surgery that may influence gastrointestinal motility
* gastrointestinal hemorrhage, mechanical ileus, enterobrosis
* irritable bowel syndrome, inflammatory bowel disease
* severe disturbance of liver, kidney, heart,lung,blood and endocrine
* psychoneurosis, alcoholism, drug dependence
* medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks

Primary outcomes:
measure: gastric fuction of Motilitone
timeFrame: 3 weeks
measure: gastric function of Motilitone
timeFrame: 3 weeks
Secondary outcomes:
measure: adverse events of Motilitone
timeFrame: 3 weeks
measure: small bowel function of Motilitone
timeFrame: 3 weeks
measure: Colon function of Motilitone
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Banpo-dong, Seocho-gu
country: Korea, Republic of
facility: the Catholic university of korea college of Medicine, Seoul St.Mary's hospital
state: Seoul
Study officials:
affiliation: Seul St.Mary's hospital
name: Myung-Gyu Choi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019975: FDG-PET in the Diagnosis of Autoimmune Encephalitis
Official title: FDG-PET in the Diagnosis of Autoimmune Encephalitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Encephalitis
Keywords: Autoimmune Encephalitis
FDG-PET
SPM
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with autoimmune encephalitis admitted to the recruiting centers

Brief summary: The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is:

•is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of autoimmune encephalitis according to clinical criteria
* Brain magnetic resonance imaging performed between clinical presentation and treatment
* Cerebrospinal fluid analysis performed between clinical presentation and treatment
* Brain FDG-PET performed between clinical presentation and treatment
* Autoantibodies testing performed between clinical presentation and treatment

Exclusion Criteria:

* Refusal to give consent for the study

Primary outcomes:
measure: SPM analysis of brain metabolic pattern
timeFrame: up to 6 months
Secondary outcomes:
measure: Sensitivity of basal ganglia hypermetabolism
timeFrame: up to 6 months
measure: Diagnostic delay
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
state: Friuli Venezia Giulia
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: Liguria
city: Pavia
country: Italy
facility: Fondazione IRCCS Mondino
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Monza E Della Brianza
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"
city: Milano
country: Italy
facility: Ospedale San Paolo
Study officials:
affiliation: University of Milano Bicocca
name: Simone Beretta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02272075: SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
Official title: Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: screeening
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

Detailed description: This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared

Eligibility criteria: Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -

Exclusion Criteria: no consent

-

Primary outcomes:
measure: image non-inferiority
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic
state: California
Study officials:
affiliation: Scripps Health
name: Bruce Kahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409275: LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
Official title: STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Fibrosis
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted with pneumonia caused by SARS-CoV-2

Brief summary: Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.

Detailed description: The project consists of a prospective, observational, multicenter study that will evaluate changes in lung function (forced spirometry, measurement of static lung volumes using plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26 and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be confirmed by imaging tests (high resolution chest CT).

Eligibility criteria: Inclusion Criteria:

* Patients admitted for bilateral pneumonia caused by SARS-CoV-2 (confirmed by PCR).
* Age over 18 years.
* Acceptance of informed consent.
* Life expectancy over 1 year.

Exclusion Criteria:

* Patients with a previous diagnosis of interstitial lung disease.
* Inability to attend review visits.

Primary outcomes:
measure: Pulmonary fibrotic changes, short and medium term
timeFrame: 12 months
measure: Degree of lung function impairment
timeFrame: 6 and 12 months
measure: Biological markers
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Pulmonary Department. Hospital Clinico.
Study officials:
References:
citation: Tarraso J, Safont B, Carbonell-Asins JA, Fernandez-Fabrellas E, Sancho-Chust JN, Naval E, Amat B, Herrera S, Ros JA, Soler-Cataluna JJ, Rodriguez-Portal JA, Andreu AL, Marin M, Rodriguez-Hermosa JL, Gonzalez-Villaescusa C, Soriano JB, Signes-Costa J; COVID-FIBROTIC study team. Lung function and radiological findings 1 year after COVID-19: a prospective follow-up. Respir Res. 2022 Sep 12;23(1):242. doi: 10.1186/s12931-022-02166-8.
citation: Safont B, Tarraso J, Rodriguez-Borja E, Fernandez-Fabrellas E, Sancho-Chust JN, Molina V, Lopez-Ramirez C, Lope-Martinez A, Cabanes L, Andreu AL, Herrera S, Lahosa C, Ros JA, Rodriguez-Hermosa JL, Soriano JB, Moret-Tatay I, Carbonell-Asins JA, Mulet A, Signes-Costa J. Lung Function, Radiological Findings and Biomarkers of Fibrogenesis in a Cohort of COVID-19 Patients Six Months After Hospital Discharge. Arch Bronconeumol. 2022 Feb;58(2):142-149. doi: 10.1016/j.arbres.2021.08.014. Epub 2021 Sep 3.
Clinical trial NCT05626075: Correlation Between Corneal Topographic Patterns and Refractive Status Of The Eye in Sohag City,Egypt
Official title: Correlation Between Corneal Topographic Patterns and Refractive Status Of The Eye in Sohag City,Egypt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Change
Keywords: Topographic
visual acuity
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate corneal topographic pattern \& its correlation with refractive status of the eye .

Detailed description: This study will be established in The Future Center for refractive surgery, Sohag, Egypt.

This study will include 100 eyes of patients aged over 15 years. All patients were subjected to topography imaging.

Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

The scheimpflug principle describes the optical imaging condition when the plane of an object is not parallel to the film of the camera and has to cut each other in one line or one point of intersection with the advantage to achieve wide depth of focus.

Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule; this depends mainly on media transparency and pupil size .

Eligibility criteria: Inclusion Criteria:

* Patients aging more than 15 years old
* All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
* There is no restrictions on the range and regularity of keratometry.

Exclusion Criteria:

* Patients with a history of any trauma to the eye.
* Patients with recent contact lens wear.
* history of ocular surgery .
* Patients with distance corrected visual acuity or abnormal retinoscopy examination (e.g., scissoring reflex).

  5. If there was any error in reading the topographic map. 6. Patients with anemotropic refraction.

Primary outcomes:
measure: Thickness
timeFrame: 3 months after begin of study
measure: degree of astigmatism in D
timeFrame: 3 months after begin of study
measure: maximum keratometry
timeFrame: 3 months after begin of study
measure: front and back elevation of the apex (um).
timeFrame: 3 months after begin of study
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Facultyof medicine
Study officials:
affiliation: Sohag Faculty of medicine
name: Mohamed Iqbal, MD.PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03668275: Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization
Official title: A Single-center, Open Randomized Controlled Clinical Trial to Evaluate the Quality and Cost of (Partial) Oncological Home-hospitalization Compared to Standard Ambulatory Hospital Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare.

The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care.

Secondary endpoints that will be evaluated and compared between both randomized groups are: Quality of life related endpoints (i.e. distress, depression \& anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction \& Preferences and Efficiency for the hospital day care unit.


Eligibility criteria: Inclusion Criteria:

* Starting new oncological treatment at the outpatient hospital
* ECOG ≤ 2
* Living within 30 minutes of drive from the hospital

Exclusion Criteria:

* Important comorbidity (ECOG \> 2)
* Life expectancy \< 6 months
* Simultaneous treatment with radiotherapy
* Taking part in clinical trial with any Investigational Medicinal Product
* Language barriers or communication difficulties
* Problematic venous access

Primary outcomes:
measure: Change in Patient-reported Quality of Life - Cancer specific
timeFrame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in Patient-reported Quality of Life - General
timeFrame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
measure: Patient-reported Distress
timeFrame: Inquiry at baseline and 12 weeks
measure: Patient-reported Depression & Anxiety
timeFrame: Inquiry at baseline and 12 weeks
measure: Cost evaluation using study-specific costs questionnaire
timeFrame: 12 weeks
measure: Number of grade 3/4 toxicities according to CTCAE v4.0
timeFrame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
measure: Patient-reported Safety
timeFrame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
measure: Satisfaction using OUT-PATSAT35 CT questionnaire
timeFrame: Inquiry at baseline and 12 weeks
measure: Preference using a self-designed patient-reported questionnaire
timeFrame: Inquiry at baseline and 12 weeks
measure: Wait times for administration of treatment at the oncology day care unit.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: Az Groeninge
Study officials:
References:
Clinical trial NCT05447975: A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease
Official title: A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 394
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators proposed to conduct a cohort study to observe whether Tai Chi intervention could delay the disease progression of Parkinson's disease (PD).

PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from Jan. 2016 to Jan. 2019. Each participant was assessed before participants joined the Tai Chi class. After the recruitment, participants accepted continuous Tai Chi training in the classes till the last follow-up. The investigators performed three times of follow-up in Nov. - Dec. 2019, Oct. - Nov. 2020 and Jun. - July 2021. Using propensity score matching, the investigators matched PD patients who did not receive Tai Chi training as control group in gender, disease duration, age, and Hoehn - Yahr staging. The aim is to observe the effect of Tai Chi on delaying the disease progression of PD.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Parkinson's disease according to 2015 MDS diagnostic criteria and United Kingdom Brain Bank diagnostic criteria in 1992;
2. Hoehn - Yahr staging: 1 - 2.5;
3. The medication was stable at least 3 months before recruiting and not changed during follow-up unless increasing antiparkinsonian drugs or the need of deep brain stimulation (DBS) is required according to the disease severity;

Exclusion Criteria:

1. Secondary causes, such as inflammatory, drug-induced, vascular and toxin-induced parkinsonism.
2. Parkinsonism with other neurodegenerative diseases, such as progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, Wilson's disease.
3. Other neurological diseases, such as stroke.
4. Patients who were receiving any other clinical trials or regular exercise protocols.
5. Patients who had fall incidents in the 6 months before recruiting due to safety considerations.
6. Patients whose Mini-Mental State Examination (MMSE) scores were less than 24.
7. Patients who had medical history that did not fit to exercise, such as orthopedics diseases or cardiopulmonary dysfunction.
8. Patients who received education less than 6 years.
9. Patients who could not walk and live independently.
10. Patients who received brain surgery (e.g. deep brain stimulation);
11. Patients whose exercise length longer than 50 minutes per week.

Primary outcomes:
measure: the annual change of UPDRS total score measured in "ON" state at three follow-ups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00406575: Recombinant Human Relaxin for the Treatment of Decompensated CHF
Official title: A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Congestive Heart Failure (CHF)
Keywords: Congestive heart failure
Relaxin
Hemodynamics
Renal function
Lead sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 11
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: Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Detailed description: Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Eligibility criteria: Inclusion Criteria:

* Hospitalization
* Decompensated chronic CHF (NYHA Class III-IV)
* LVEF \< 35%
* PCWP \> 22 mmHg
* CI \< 2.3 L/min/m2

Exclusion Criteria:

* Acute CHF
* Acute coronary syndrome
* Hypotension or shock
* Recent stroke
* Allergy or sensitivity to test agents
* Significant confounding conditions or medications

Primary outcomes:
measure: Cardiac hemodynamics
timeFrame: Baseline through 27 hours post-infusion or discharge from the hospital.
Secondary outcomes:
measure: Renal function
timeFrame: Baseline through Day 10
measure: Safety and Tolerability assessed by number of patients with adverse events (AEs)
timeFrame: Baseline through Day 30
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Study officials:
affiliation: Charite Hospital, Berlin, Germany
name: Thomas Dschietzig, MD
role: PRINCIPAL_INVESTIGATOR
References: