louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04099823: MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
Official title: MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics and Association of Intracranial CSF Flow with Brain Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hydrocephalus
Alzheimer Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Researchers are trying to test a MR imaging method for detection of Cerebral Spinal Fluid (CSF) flow in the brain to help diagnosis and better understand diseases that affect brain function.

Detailed description: The purpose of this research is to figure out if MR imaging can detect movement of CSF (fluid around the brain) to help better diagnosis and understand the cause of diseases that affect brain function. We are doing this research study to find out if movement of CSF is different between healthy adults and those with a disease that affects brain function.

Eligibility criteria: Inclusion Criteria:

* A healthy control will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.
* Patients who have a suspected diagnosis of altered CSF dynamics including but not limited to normal pressure hydrocephalus will be referred to Dr. Cogswell by their care team to be included in the study. Conditions of altered CSF dynamics include obstructive and non-obstructive hydrocephalus and may be associated with headaches and/or decreased cognitive function.
* Similarly, patients with impaired cognitive function including but not limited to Alzheimer's disease will be referred to Dr. Cogswell by their care team to be included in the study.

Exclusion Criteria:

* Subjects with non-MRI compatible devices
* required sedation
* women who may be pregnant will be excluded.
* The first 10 subjects with normal pressure hydrocephalus will not have previously been shunted.

Primary outcomes:
measure: CSF flow measurement
timeFrame: At the time of MR exam, approximately one hour
Secondary outcomes:
measure: Volume of CSF spaces
timeFrame: At the time of MR exam, approximately one hour
measure: White matter disease
timeFrame: At the time of MR exam, approximately one hour
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Petrice Cogswell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03286023: Stereotactic Radiotherapy for Brain Metastases
Official title: Stereotactic Radiotherapy for Patients With Brain Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastasis Brain
Keywords: brain metastases
stereotactic radiation
cyberknife
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 110
Sex: ALL
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: Patients with brain metastases

Brief summary: Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.


Eligibility criteria: Inclusion Criteria:

* Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
* Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
* Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
* Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
* Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
* Signed informed consent

Exclusion Criteria:

* Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
* Metastases greater than 3 cm at the start

Primary outcomes:
measure: Evaluation of tumoral response
timeFrame: 4 weeks after treatment
measure: Evaluation of tumoral response
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Evaluation of toxicity
timeFrame: 1, 3, 6, 9, 12, 15 months after treatment
Other outcomes:
Locations:
city: Esch-sur-Alzette
country: Luxembourg
facility: Centre Francois Baclesse
state: SUD
Study officials:
References:
Clinical trial NCT03724123: Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery
Official title: Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Surgery--Complications
Keywords: random forests
heart valve surgery
support vector machines
artificial neural networks
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
Collaborators: name: Institute of Bioinformatics, JKU Linz
First posted: 2018-10-30
Enrollment: 2229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent heart valve surgery of any kind between 2008-01-01 and 2014-12-31 were included.

Brief summary: Machine learning methods potentially provide a highly accurate and detailed assessment of expected individual patient risk before elective cardiac surgery. Correct anticipation of this risk allows for improved counseling of patients and avoidance of possible complications. The investigators therefore investigate the benefit of modern machine learning methods in personalized risk prediction in patients undergoing elective heart valve surgery.

Detailed description: The investigators performe a monocentric retrospective study in patients who underwent elective heart valve surgery between January 1, 2008, and December 31, 2014 at our center. The investigators use random forests, artificial neural networks, and support vector machines to predict the 30-days mortality from a subset of demographic and preoperative parameters. Exclusion criteria were re-operation of the same patient, patients that needed anterograde cerebral perfusion due to aortic arch surgery, and patients with grown up congenital heart disease.

Eligibility criteria: Inclusion Criteria:

\* Patients who underwent heart valve surgery of any kind between 2008-01-01 and 2014-12-31 were included.

Exclusion Criteria:

* re-operation of the same patient
* patients that needed anterograde cerebral perfusion due to aortic arch surgery
* patients with grown-up congenital heart disease

Primary outcomes:
measure: Area under the curve for different prediction models
timeFrame: Patients will included from 01.01.2008 - 31.12.2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bodenhofer U, Haslinger-Eisterer B, Minichmayer A, Hermanutz G, Meier J. Machine learning-based risk profile classification of patients undergoing elective heart valve surgery. Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1378-1385. doi: 10.1093/ejcts/ezab219.
Clinical trial NCT01228123: Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients
Official title: Prospective Randomised Clinical Trial of the Effect of Continuous Versus Intermittent Renal Replacement Therapy on the Mortality and Outcome of Acute Renal Failure in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Renal Failure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.

Detailed description: please see above

Eligibility criteria: Inclusion Criteria:

* all ICU patients requiring renal replacement therapy

Exclusion Criteria:

* patient denies informed consent
* patient not requiring intensive care therapy
* kidney transplanted patients
* chronic renal failure (serum creatinine \> 3mg/dl)

Primary outcomes:
measure: Survival at 2 weeks after RRT
timeFrame: 2 weeks after RRT in follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
affiliation: Charite University Medicine
name: Achim Joerres, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
citation: Schefold JC, von Haehling S, Pschowski R, Bender T, Berkmann C, Briegel S, Hasper D, Jorres A. The effect of continuous versus intermittent renal replacement therapy on the outcome of critically ill patients with acute renal failure (CONVINT): a prospective randomized controlled trial. Crit Care. 2014 Jan 10;18(1):R11. doi: 10.1186/cc13188.
Clinical trial NCT02195323: Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Official title: Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Keywords: autologous bone marrow mesenchymal stem cells chronic kidney disease
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

Detailed description: We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* CKD symptoms
* CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
* Patient's age between 25 - 60 years
* Ability to understand and willingness to sign consent from

Exclusion Criteria:

* Pregnant or lactating
* Basis disease such as diabetes, malignancy and autoimmune
* Unable to follow post-operative exercise regimen or return for evaluations

Primary outcomes:
measure: mass formation
timeFrame: 6months
measure: Creatinin
timeFrame: 1 month
Secondary outcomes:
measure: GFR
timeFrame: 6months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of regenerative medicine department &cell therapy center of Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Mazandaran University of Medical Sciences, Mazandaran, Iran
name: Atieh Makhloogh, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
name: Reza Moghadasali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03336723: Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial
Official title: Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osseointegration Failure of Dental Implant Due to Infection
Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values\<0.05 were considered statistically significant


Eligibility criteria: Inclusion Criteria:

Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.

Exclusion Criteria:

1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity

-

Primary outcomes:
measure: Osseointegration
timeFrame: from T0 to T2 - 2 month
measure: Marginal bone loss
timeFrame: 4 month after T0
measure: IL1b concentration
timeFrame: 4 month
measure: IL6 concentration
timeFrame: 4 month
measure: Microbiologic samples
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02461823: The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
Official title: The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.

Detailed description: Porcelain fused to metal (PFM) has been used in dentistry for the last five decades.

Zirconia (zirconium oxide, ZrO2) is the white crystalline powder oxide of the naturally occurring metal zirconium. Research of the medical utilization of zirconia dates back to the late 1960s. However, its utilization in dentistry did not start until the 1990s, when zirconia began to be used as a form of endodontic posts and implant abutments. The current literature contains studies that investigated the influence of zirconia implants and abutments on periodontal tissue, but to the investigators' knowledge, no work has been yet published which compares the influences of crown types on hard and soft tissues.

This prospective study will be conducted in the Department of Periodontology and in the Department of Maxillofacial Rehabilitation at Rambam Health Care Campus.

Eligibility criteria: inclusion criteria:

1. Patient age 18 - 85 years old
2. In need for one or more fixed partial prosthetic crown or bridge

exclusion criteria:

1. Smokers
2. Active periodontal disease
3. history of compromising systemic disease
4. Allergy to materials used in the study
5. current drug abuse
6. Pregnant or intend to become pregnant
7. severe salivary gland dysfunction
8. Severe medical complications ( organ transplants, cancer, immunocompromised, or undergoing long-term antibiotic or steroid therapy )

Primary outcomes:
measure: PgE2 ( Prostaglandin E2)
timeFrame: 4 months
Secondary outcomes:
measure: PIaque index
timeFrame: 4 months
measure: GIingival index
timeFrame: 4 months
measure: Pocket depth
timeFrame: 4 months
measure: Clinical attachment level
timeFrame: 4 months
measure: bone level
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096
name: Dr Ilan Hirsh, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542423: Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
Official title: Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. The ENDOLUNG Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Postoperative Complications
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.

Detailed description: Endocan is an endothelium derived soluble dermatan sulfate proteoglycan. Literature data shows that alterate levels of its blood concentration correlate with the onset of pulmonary failure in patients with major trauma and septic shock.

In cardiac surgery respiratory failure and infections are threatening complications leading to mortality rates up to 80%. A rapid diagnosis and treatment of this pathology is crucial to improve the clinical outcome.

Unfortunately specific data for the efficacy of Endocan predictive value in cardiac surgery patients are not available.

The investigators aim to determinate if Endocan can be a helpful tool to identify patients developing acute respiratory failure after cardiac surgery and anticipate specific treatment in order to improve survival.

Eligibility criteria: Inclusion Criteria:

* Able to give written consent
* Elective cardiac surgery
* More than 18 years old

Exclusion Criteria:

* Less than 18 years old
* urgency / emergency cardiac surgery
* pregnancy
* refusal
* unable to give written consent
* oncologic patients
* concomitant inflammatory or infective pulmonary disease

Primary outcomes:
measure: Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure
timeFrame: from day -1 of the intervention to day 3, one blood sample per day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06931223: Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia
Official title: Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functioanl Dyspepsia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 200
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 use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.


Eligibility criteria: Inclusion Criteria:

1. adult patients with primary FD who meet the diagnostic criteria for Roman IV;
2. able to complete the questionnaire, trial evaluation and sign the written informed consent.

Exclusion Criteria:

1. organic gastrointestinal diseases by gastroenteroscopy within 6 months;
2. severe insufficiency of heart, liver, kidney, lung and other important organs and with congenital diseases;
3. allergic to the drugs used in this study
4. being pregnant, lactating or planning to become pregnant;
5. are taking or have taken monoamine oxidase inhibitors within the past 5 weeks;
6. have a known risk of narrow angle glaucoma.

Primary outcomes:
measure: Leuven Postprandial Distress Scale (LPDS) score
timeFrame: Until the end of the study, up to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: