louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02359656: Recent and Non United Odontoid Fractures
Official title: Recent and Non United Odontoid Fractures: Clinical and Biomechanical Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Odontoid Process
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life.


Eligibility criteria: Inclusion Criteria:

Patients aged 65 years or older who had undergone surgical or non - operative management of odontoid non-unions were sorted and their dataset of follow - up monitoring was examined for completeness and accuracy. According to our inclusion criteria, patients with complete sets of collected data and a follow-up examination of at least five years after treatment of the non - union were finally enrolled in this study. Collected data included variables, such as age, gender, mechanism of injury, fracture type, associated injuries, presence and severity of primary neurological deficits, primary treatment, clinical and neurological outcome after primary treatment, methods of treatment, clinical and radiographic outcome after treatment of the non-union, as well as morbidity and mortality of the patients.

Exclusion Criteria:

Exclusion criteria for this study contain patients with previous or subsequent surgery at the cervical spine level, patients with incomplete data sets, as well as patients with penetrating mechanism of injury or congenital cervical spine anomalies. Incomplete data set was determined, if pertinent clinical or radiographic data of follow - up monitoring (e.g. documents of clinical findings or functional results, radiographs, CT-scanning, e.g.) were missing.

Primary outcomes:
measure: Functional outcome (range of motion) and radiographic (bony fusion) long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions.
timeFrame: follow up of at least 5 years
Secondary outcomes:
measure: Composite outcome measure consisting of multiple measures as late bony fusion, cervical spin, neurological sequalea
timeFrame: follow up of at least 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06657456: Impact of Phytosterol-Rich Extract on Lipid Profile
Official title: Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cholesterol, Elevated
Hypercholesterolaemia
Lipid Metabolism Disorders
Dyslipidemias
Keywords: Cholesterol
Cholesterol, Elevated
Hypercholesterolaemia
Lipid Metabolism Disorders
Dyslipidemias
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2024-10-24
Enrollment: 42
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: The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.

Detailed description: The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Eligibility criteria: Inclusion Criteria:

* Adults (age \> 18 YO)
* Total cholesterol levels at screening ≥ 200 mg/dL

Exclusion Criteria:

* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Use of prescribed medication which may interfere with study measurements.
* Unwillingness or inability to comply with clinical trial procedures.
* Subjects whose condition makes them ineligible for the study at the investigator's discretion.
* Pregnant or having the wish to become pregnant, or lactating.
* Recent participation in another nutritional or medical trial

Primary outcomes:
measure: Blood lipid profile
timeFrame: Day 1, at 28 and 56 days
Secondary outcomes:
measure: Anthropometric parameters
timeFrame: Day 1, at 28 and 56 days
measure: Body composition measures
timeFrame: Day 1, at 28 and 56 days
measure: Oxidation markers
timeFrame: Day 1, at 28 and 56 days
measure: Dietary Intake
timeFrame: Day 1, at 28 and 56 days
measure: Adherence to the Mediterranean diet
timeFrame: Day 1, at 28, and 56 days
measure: Blood pressure
timeFrame: Day 1, at 28 and 56 days
measure: Physical Activity
timeFrame: Day 1, at 28 and 56 days
measure: Liver safety variables
timeFrame: Day 1, at 28 and 56 days
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM San Antonio Catholic University of Murcia
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Desirée Victoria Montesinos
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio de Murcia
name: Ana Mª García Muñoz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03224156: Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy
Official title: Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathy, Dilated
Sudden Cardiac Death
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.

Brief summary: PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Detailed description: Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF\>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).

CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.

PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Acquired candidate predictors are among others:

* Global and regional T1/T2
* T1/T2 inhomogeneity
* Extracellular volume fraction
* Microvascular dysfunction
* LA function and filling fraction
* Global and regional circumferential, radial or longitudinal myocardial strain
* Biomarkers

Eligibility criteria: Inclusion Criteria:

* Dilated Cardiomyopathy
* ICD Indication
* age ≥ 18 years
* signed informed consent

Exclusion Criteria:

* severe claustrophobia
* rest dyspnea
* tachycardia or severe arrhythmia
* intolerance to gadolinium-based contrast agent

Primary outcomes:
measure: Primary Combined Endpoint
timeFrame: 18 months
Secondary outcomes:
measure: Mortality
timeFrame: 18 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg, Krehl Klinik, Department of Cardiology
state: Baden-Württemberg
city: Weinheim
country: Germany
facility: GRN Hospital Weinheim
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT05488756: Comparison of the Different Exercises on Chronic Neck Pain
Official title: Comparison of Three Different Exercise Training in Patients With Chronic Neck Pain: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Pain, Neck
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.

Detailed description: The aim of this study is to compare the conventional therapy, cervical stabilization exercise approach, and core stabilization exercise in addiction to cervical stabilization in patients with chronic neck pain.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain more than 3 months
* Medically stable

Exclusion Criteria:

* Patients with benign or tumors in the cervical region
* Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
* Patients with history of spinal fractures
* Patients with congenital anomaly
* Patients with neck surgery and spinal instability

Primary outcomes:
measure: Pain Intensity Assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Demografic Characteristic of Participants
timeFrame: 1 week before the first treatment session
measure: Posture Evaluation
timeFrame: 4 weeks
measure: Evaluation of Cervical Range of Motion
timeFrame: 4 weeks
measure: Disability Evaluation
timeFrame: 4 weeks
measure: Assessment of Quality of Life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Eylül Pınar Kısa
Study officials:
References:
Clinical trial NCT01057056: The Role of Mind Body Therapy in Geriatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Elderly
Treatment
Keywords: patients in a sub-acute geriatric rehabilitation department
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity.

Objective: To assess the effect of mind-body intervention as an adjunct to medical and physical rehabilitation in geriatric patients.

Design: Prospective study Setting: University affiliated large city general hospital


Eligibility criteria: Inclusion Criteria:

* suitable candidates had to be aged 18 years or older
* treated in the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) and
* were willing and able to complete the study protocol.

Exclusion Criteria:

* severe unstable chronic illness (e.g., congestive heart failure, chronic renal failure, cancer).

Primary outcomes:
measure: Well-being: Short Form-36 (SF-36), Geriatric Depression Scale (GDS)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01964456: "Self-consciousness and the Inter-subjective Body"
Official title: "Narcisse & Echo : Self-consciousness and the Inter-subjective Body"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Bodily self-consciousness
intersubjective body
Anorexia Nervosa
Joint perception task
Interoceptive awareness
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: The Volkswagen Foundation
First posted: 2013-10-17
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa.

Detailed description: Anorexia nervosa is a severe psychiatric disorder, with high level of mortality. Anorexic patients often experience a serious disturbance in body and their own shape perception.

We hypothesize that bodily self-consciousness is co-constituted by four subjective dimensions which are all inter-subjectively open: in encountering others, one's body is experienced as

1. objectified,
2. the bearer of inter-subjective feelings,
3. an inter-subjective agent and
4. the anchor of an inter-subjectively negotiated perspective.

Across several experiments, we sought to determine which dimension of bodily self-consciousness is altered in Anorexia Nervosa compared to healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Women
* From 18 to 35 years old
* Understanding and being fluent in French
* Hospitalized or followed in consultation for Anorexia nervosa (Restrictive Anorexia or Purge according to the MINI)
* Informed consent signed by the patient
* Diagnosis of Anorexia according to her psychiatrist (and confirmed by the DSM IV) with a BMI between 11 and 18.

Exclusion Criteria:

* Somatic Pathology (cancer, cardiac, renal or respiratory insufficiency, central neurological affection), evolutionary, or risking to be life-threatening within less than year
* Neurological Histories (neurological pathology susceptible to alter attentionnal capacities or field of vision and vision of colors (Encephalitis, Degenerative Brain tumour (méningiome, gliome, astrocytome), Congenital Neurodegenerative Pathology, Multiple sclerosis, Amyotrophic side Hardening, Epilepsy)
* Neuroleptic or psychotropic Treatment in doses inferring a slumber, a disorder of the concentration
* Dyschromatopsie
* No insurance
* Comorbidity of psychiatric type

Primary outcomes:
measure: Joint perception task
timeFrame: 1 week
Secondary outcomes:
measure: Body Shape Questionnaire
timeFrame: 1 week
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
Study officials:
affiliation: CHSA
name: Mathias GOROG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384656: Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
Official title: Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group. The trial is double-blind and conducted at a single center.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing isolated OPCAB.
* Age: 20\~75.

Exclusion Criteria:

* Emergency operation.
* Patients with MR ≥ 2.
* Patients with IDDM.
* Patients with random sugar ≥ 250 mg/dL.
* Patients with serum creatinine ≥ 2.0 mg/dL.
* Patients with acute myocardial infarction within 1 week of surgery

Primary outcomes:
measure: CK-MB(creatinine kinase-MB) mass
timeFrame: 12 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Shim JK, Yang SY, Yoo YC, Yoo KJ, Kwak YL. Myocardial protection by glucose-insulin-potassium in acute coronary syndrome patients undergoing urgent multivessel off-pump coronary artery bypass surgery. Br J Anaesth. 2013 Jan;110(1):47-53. doi: 10.1093/bja/aes324. Epub 2012 Sep 17.
Clinical trial NCT00110656: Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
Official title: A Retrospective Follow Up Study to Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Kidney transplant
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.

Brief summary: The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.


Eligibility criteria: Inclusion Criteria:

- Patients who withdrew from one of the qualifying studies (i.e. patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism \[HPT\]; in particular parathyroid hormone \[PTH\], calcium and phosphorus levels in blood associated with kidney failure) due to kidney transplantation.

Exclusion Criteria:

- Patient has any kind of disorder that compromises the ability of the subject to give written informed consent

Primary outcomes:
measure: PTH Values
timeFrame: 12 months post kidney translplant
Secondary outcomes:
measure: Calcium and Phosphorus
timeFrame: 12 months post kidney transplant
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05668156: Finding Consensus in Fasting Terminology
Official title: Defining Fasting: Finding Common Ground Using the Delphi Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consensus Development
Keywords: consensus
fasting
fasting terminology
therapeutic fasting
Delphi
Delphi method
decision-making
intermittent fasting
periodic fasting
prolonged fasting
religious fasting
intermittent dry fasting
caloric restriction
diet
nutrition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinicians or scientists

Brief summary: A consensus-based decision making process on fasting terminology will be conducted using the Delphi technique. To this aim, experts around the world are invited.

Detailed description: The consensus-based decision making process on fasting terminology will include a maximum of five rounds of questionnaires that experts are invited to complete online using a pseudonym. Prof. Dr. med. Michalsen's department has prepared rough definitions of key terms for the questionnaire to be evaluated by the experts. These terms should serve as a starting point for the discussion. After each questionnaire round the experts' comments are reviewed by the project team and a new questionnaire with the suggested modifications from the previous round will be sent to the experts.

If consensus can't be reached by round three, a live-online-discussion will be held to facilitate the further proceedings.

The results are to be published in a peer-reviewed journal; individual statements will not be shared in the publication.

Eligibility criteria: Inclusion Criteria:

* clinicians or scientists with at least 5 peer-reviewed publications on fasting or
* at least one peer-reviewed publication and 5 years of clinical experience with fasting

Exclusion Criteria:

- not more than 2 experts from one institution are allowed to participate

Primary outcomes:
measure: Definitions of fasting regimens
timeFrame: repetition of the survey until consensus is reached, max. 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: