louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03735732: Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior
Official title: Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Magnetic Resonance Imaging
Habits
Eating Behavior
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy lean and obese volunteers

Brief summary: The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Detailed description: Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Eligibility criteria: Inclusion Criteria:

* experimental: participants with obesity
* control: participants with normal-weight

Exclusion Criteria:

* currently dieting
* intolerance to provided food
* cognitive impairment
* contraindications for fMRI measurements

Primary outcomes:
measure: Change in neuronal correlates
timeFrame: before and 5 minutes after visually presented food items
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
References:
Clinical trial NCT01712152: Myocardial Involvement in Carriers of Duchenne Muscular Dystrophy: An MRI-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carrier of Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy
carrier
cardiac MRI
myocardial fibrosis
female
Lead sponsor: Hospital Rudolfstiftung
Sponsor class: OTHER
Collaborators: name: Oesterreichische Muskelforschung
First posted: 2012-10-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: data base of carriers of Duchenne muscular dystrophy

Brief summary: Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet muscles, but they may develop a poor heart function due to the involvement of the heart muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only after the heart has already become weaker. Cardiac magnetic resonance tomography can detect myocardial fibrosis already at preserved heart function and may facilitate early therapy. In our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests, EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to assess the extent of cardiac affection and its association with the clinical development.


Eligibility criteria: Inclusion Criteria:

genetic and/or histological identification as a carrier of DMD age above 18 years able and willing to conform to the requirements of the study provided written informed consent exclusion of pregnancy in women of childbearing potential

Exclusion Criteria:

Claustrophobia Excessive obesity to an extent where CMR cannot be performed Chronic renal failure with a GFR \<30 ml/min/1,73m² Implanted pacemakers/defibrillators Severe arrhythmia Inability to cooperate during the CMR Known intolerance to gadolinium Positive pregnancy test Unable or unwilling to conform to the study protocol

Primary outcomes:
measure: T1 mapping
timeFrame: 1 year
Secondary outcomes:
measure: left ventricular function
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: 2nd Medical Dept., Rudolfstiftung
Study officials:
affiliation: Hospital Rudolfstiftung
name: Paul Wexberg, MD
role: STUDY_DIRECTOR
References:
citation: Wexberg P, Avanzini M, Mascherbauer J, Pfaffenberger S, Freudenthaler B, Bittner R, Bernert G, Weidinger F. Myocardial late gadolinium enhancement is associated with clinical presentation in Duchenne muscular dystrophy carriers. J Cardiovasc Magn Reson. 2016 Sep 22;18(1):61. doi: 10.1186/s12968-016-0281-y.
Clinical trial NCT05082532: Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Official title: Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Femoropopliteal Occlusive Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 60
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: Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.

Detailed description: Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.

Eligibility criteria: Inclusion criteria:

* Patients with critical limb ischemia(grade 4,5\&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
* Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
* Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
* If the lesion extends to popliteal artey against knee flexion.

Exclusion criteria:

* Pediatric patients.
* Patients with isolated infra-popliteal occlusion.
* Patients with popliteal blind segment with bad runoff.
* Patients with acute thrombotic occlusions.
* Patients with previous bypass surgery in affected limb.
* Patients with aneurysmal lesion in the affected limb.

Primary outcomes:
measure: peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II63-81. doi: 10.1583/08-2658.1.
Clinical trial NCT03067532: Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons
Official title: Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical School Student
Healthy Population
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was applied to the various surgery area . And the complete understanding and practice of the robotic system is very important condition for successful robotic surgery.

Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And investigator want to study about the ability of home made robotic surgery simulator versus existing robotic simulation system.


Eligibility criteria: Inclusion Criteria:

1. medical student of Yonsei University College of Medicine
2. first time of robotic surgery system
3. voluntary participation of this study

Exclusion Criteria:

1. minors \& foreigner
2. involuntary participation of this study
3. refuse to sign a consent form

Primary outcomes:
measure: comparing the understanding and competence level of robotic surgery system
timeFrame: examination day of study participation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02326532: Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Official title: Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Veterans
Lead sponsor: North Florida Foundation for Research and Education
Sponsor class: OTHER
Collaborators: name: Pfizer
name: US Department of Veterans Affairs
First posted: 2014-12-29
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of this proposal is to address barriers to the use of patient reported outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.

Detailed description: This is a randomized, controlled, single-blinded study that compares outcome data in patients for whom PRO data either is or is not made available to the treating physician. The question addressed by this proposal is whether patient reported outcome (PRO) data change patient's outcomes. The hypothesis is that the availability of these data in the form of the patient-completed Multidimensional Health Assessment Questionnaire/routine assessment of patient index data (MDHAQ/RAPID3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.

Eligibility criteria: Inclusion Criteria:

* US veteran
* Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network

Exclusion Criteria:

* Outside of service network
* Non-veteran

Primary outcomes:
measure: physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
timeFrame: 1 year
Secondary outcomes:
measure: patient satisfaction
timeFrame: 1 year
measure: medication compliance
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VAMC
state: Florida
Study officials:
affiliation: Veterans Health Administration, University of Florida
name: Michael R Bubb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243432: Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer
Official title: Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Breast Carcinoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HR+/HER2- advanced breast cancer patients

Brief summary: CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 yo
* Histological diagnosis of HR+/HER2- advanced breast cancer
* Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
* Immunohistochemical expression levels of estrogen and progesterone receptors
* First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
* Signing of informed consent approved by local Ethic Committee

Exclusion Criteria:

* Absence of clinical and pathological data that would compromise the definition of the study endpoints
* HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
* Previous chemotherapy for treatment of metastatic disease

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Through study completion, an average of 1 year".
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 1 year".
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 1 year".
measure: Incidence of Adverse Events (AEs)
timeFrame: Through study completion, an average of 1 year".
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico A. Gemelli - IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Alessandra Fabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05867732: A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）
Official title: A Multicenter Observational Cohort of Degenerative Spine Diseases in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Spine Diseases
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 10000
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: Patients with degenerative spine disease (lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, scoliosis deformity, etc.) seen and treated in participating units between January 2015 and January 2022, excluding patients with neoplastic disease

Brief summary: Study type: The objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted decision-making system

The main questions it aims to answer are:

* \[question 1\] to construct a database of patients with degenerative spinal diseases and to study their associated prognosis, complications, and other risks
* \[Question 2\] Use big data to build a risk early warning model and assisted decision making system The study will not intervene with patients


Eligibility criteria: Inclusion criteria:

* patients with degenerative spine disease admitted to the units participating in the study from January 2015 to mid-January 2022;
* complete patient data with no more than 5% missing;

Exclusion Criteria:

* Patients with oncology;

Primary outcomes:
measure: Collect demographics (Hospital Information System)
timeFrame: 2022.03
Secondary outcomes:
Other outcomes:
Locations:
city: Xianmen
country: China
facility: Wenle Li
Study officials:
affiliation: Xiamen University
name: Wenle Wenle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532632: Taste and Smell Impairment in Critically Ill COVID-19 Patients
Official title: Taste and Smell Impairment in Critically Ill COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smell Disorder
Taste Disorders
Coronavirus Infection
Keywords: Coronavirus disease-19
anosmia
hyposmia
dysgeusia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-80, who were treated in the intensive care unit with the diagnosis of Coronavirus disease-19 and were discharged

Brief summary: Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

Detailed description: Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.

Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18-80
* Agree to participate in the study
* Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19

Exclusion Criteria:

* Pre-existing smell and taste impairment
* The patients have no enough cooperation to answer the questionnaire
* Having additional diseases such as dementia and Alzheimer

Primary outcomes:
measure: taste and smell impairment
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and Training Hospital
Study officials:
References:
citation: Hopkins C, Surda P, Whitehead E, Kumar BN. Early recovery following new onset anosmia during the COVID-19 pandemic - an observational cohort study. J Otolaryngol Head Neck Surg. 2020 May 4;49(1):26. doi: 10.1186/s40463-020-00423-8.
citation: Sayin I, Yasar KK, Yazici ZM. Taste and Smell Impairment in COVID-19: An AAO-HNS Anosmia Reporting Tool-Based Comparative Study. Otolaryngol Head Neck Surg. 2020 Sep;163(3):473-479. doi: 10.1177/0194599820931820. Epub 2020 Jun 9.
Clinical trial NCT00999232: Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Keywords: erythromycin
prokinetics
nasojejunal tubes
Bengmark feeding tube
post-pyloric feeding
pancreatitis
Non-critically ill patients having pancreatitis who require jejunal enteral nutrition
Lead sponsor: Canisius-Wilhelmina Hospital
Sponsor class: OTHER
First posted: 2009-10-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.


Eligibility criteria: Inclusion Criteria:

* Aged 18-80 years
* Having pancreatitis
* Require jejunal enteral nutrition

Exclusion Criteria:

* Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)
* Pregnancy
* Hypersensibility to erythromycin
* Cardiac arrhythmias with a prolonged QT-time
* Simultaneous usage of drugs impairing peristalsis

Primary outcomes:
measure: The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.
Secondary outcomes:
measure: The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
measure: Adverse events using this self-propelled tube
Other outcomes:
Locations:
Study officials:
References:
citation: van den Bosch S, Witteman E, Kho Y, Tan AC. Erythromycin to promote bedside placement of a self-propelled nasojejunal feeding tube in non-critically ill patients having pancreatitis: a randomized, double-blind, placebo-controlled study. Nutr Clin Pract. 2011 Apr;26(2):181-5. doi: 10.1177/0884533611399924.
Clinical trial NCT03210532: Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 129
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Adults both male and female who are ≥19,\<80 years old
* at screening, 140mmHg≤ SBP\<180mmHg \& 90mmHg≤ DBP\<110mmHg \& LDL-C≤250mg/dL \& triglyceride\<400mg/dL

Exclusion Criteria:

* at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
* secondary hypertension or secondary dyslipidemia
* patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
* women who are pregnant or lactating

Primary outcomes:
measure: Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
timeFrame: 8-week
measure: Change of LDL-C(Low Density Lipid Cholesterol) from baseline
timeFrame: 8-week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance Hospital
Study officials:
References: