louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03367065: Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mesenteric Ischemia
Permeability CT Technics
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This feasibility study has therefore several aims:

1. construct a dedicated CT perfusion protocol for GIT wall perfusion;
2. used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model;
3. from the image acquired, evaluate current parameters of perfusion including the permeability ones


Eligibility criteria: Inclusion Criteria:

* all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution

Exclusion Criteria:

* contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
* inability to provide informed consent

Primary outcomes:
measure: number of computerised tomography with interpretable data
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
state: Aquitaine
Study officials:
affiliation: CHU Poitiers
name: Guillaume HERPE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594865: The Glycaemic Effects of Glucerna® in Critically Ill Patients.
Official title: Glucerna in Critically Ill Patients (GluCip Trial): Investigating the Glycaemic Effects of a Reduced-carbohydrate, Modified-fat, Fiber-containing Enteral Formula (Glucerna®) in Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Glucose Regulation
Keywords: Enteral Nutrition
Continuous Glucose Monitoring
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2015-11-03
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: To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Patients with an anticipated stay of at least 48 hours of admission to the intensive care
* Expected to receive enteral feeding for at least 48 hrs
* Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
* Patient or surrogate understands and signs informed consent document.

Exclusion Criteria:

* Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system
* Patients previously randomised into the GluCip trial
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.

Primary outcomes:
measure: Glucose variability
timeFrame: 72 hours
Secondary outcomes:
measure: Amount of insulin use
timeFrame: 72 hours
measure: Time in target range
timeFrame: 72 hours
measure: Mean glucose and standarddeviation
timeFrame: 72 hours
measure: Number of severe hypoglycemic events
timeFrame: 72 hours
measure: Duration of severe hypoglycemic events
timeFrame: 72 hours
measure: Number of severe hyperglycemic events
timeFrame: 72 hours
measure: Duration of severe hyperglycemic events
timeFrame: 72 hours
measure: Daily calorie administration
timeFrame: 72 hours
measure: Daily nutrient administration
timeFrame: 72 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord-Holland
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis
name: Peter HJ van der Voort, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06526065: Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)
Official title: Molecular Mechanisms in Malignant Lymphoma- Predict
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Wuerzburg University Hospital
name: University Hospital Ulm
name: University of Leipzig
name: University Hospital Regensburg
name: University Hospital Freiburg
name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: University of Kiel
name: University Hospital, Essen
First posted: 2024-07-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime

Brief summary: The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.

Detailed description: Observational study of 500 recruited and 300 evaluable patients with de novo large cell B Cell lymphoma, age 18-80. Standard guideline recommended treatment by treating physicians discretion. Collection of clinical data, PET-CT data, liquid biopsy, WGSequencing to determine optimal prognostic factors to surpass prediction offered by current IPI.

Eligibility criteria: Inclusion Criteria:

1. Histological diagnosis of DLBCL\&LBCL
2. Planned treatment with guideline-based first-line therapy
3. Patient's consent
4. All genders, Patient age ≥ 18 years
5. Ability to consent

Exclusion Criteria:

1. Treatment with R-CHOP/-like regimens already started
2. Relationship of dependence/ direct employment with the investigator
3. Active HIV-infection
4. Presence history of other active cancers (with the exception of basal cell carcinoma of the skin)

Primary outcomes:
measure: Progression-free Survival (PFS-2) with 95% confidence intervals
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Event-free survival (EFS)
timeFrame: 5 years
measure: Response rates
timeFrame: 2 years
measure: Safety and toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Lower Saxony
Study officials:
affiliation: PI of the study
name: Lorenz Trümper
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02791165: Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient
Official title: Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with an acute STEMI

Brief summary: There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute reperfused STEMI in order to identify the optimal day for performing the CMR scan.

Detailed description: This will be a prospective observational study with serial CMR imaging only.

CMR scan Each patient will receive one CMR scan performed on Day 1, Day 3, Day 5, Day 10 following the PPCI procedure on a 3T Philips scanner (see study flow below). All CMR scans will be analysed at a central CMR corelab.

For Day 1, 3, 5, 7 and 10 CMRs, parameters will be collected as follows:

* Left ventricle (LV) ejection fraction and indexed LV end systolic and diastolic volumes and mass using short-axis SSFP cine imaging and myocardial tagging sequences).
* The AAR by T1 and T2 mapping18 as a percentage of the LV over time.
* Signal intensity of T1 and T2 mapping in the MI zone, MI core and remote myocardium over time.
* The incidence of intramyocardial haemorrhage (IMH)(hypo-enhancement on T2\* mapping sequence)26.
* The volume of microvascular obstruction (MVO) defined as signal intensity 2 standard deviated below the mean signal intensity of the remote myocardium on the T2\* maps.

Additional sequence for Day 3 and 7 CMR scans:

• All the above plus MI size (measured in mass of LGE and expressed as a percentage of the LV mass).

Eligibility criteria: Inclusion Criteria:

1. Confirmed STEMI as per PPCI procedure reports/ clinical notes
2. Proximal to mid coronary artery occlusion.
3. Ability to provide informed consent

Exclusion Criteria:

1. Previous myocardial infarction or coronary artery bypass graft surgery
2. Contraindication for CMR (e.g. ferromagnetic implants, claustrophobia, estimated glomerular filtration rate \<30mL/min)

Primary outcomes:
measure: All cause mortality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Heart Centre Singapore
name: National Heart Centre Singapore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092365: A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)
Official title: A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 413
Sex: ALL
Minimum age (years): 40
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 compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Detailed description: The duration of treatment is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion Criteria:

* Any known allergy to the study drugs

Primary outcomes:
measure: Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.
Secondary outcomes:
measure: OA of the knee as measured by PGART over 6 wks of treatment.
measure: WOMAC Question #1 over 6 wks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Birbara C, Ruoff G, Sheldon E, Valenzuela C, Rodgers A, Petruschke RA, Chang DJ, Tershakovec AM. Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies. Curr Med Res Opin. 2006 Jan;22(1):199-210. doi: 10.1185/030079906X80242.
Clinical trial NCT03901365: The Effect of Neuroscience Pain Education on Quality of Life in Patients with Chronic Low Back Pain
Official title: The Effect of Neuroplastic Pain Education on Quality of Life in Patients with Chronic Low Back Pain Who Treated Via Manual Therapy: a Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Quality of Life
Pain
Keywords: Manual Therapy
Neuroscience pain education
Quality of life
Chronic low back pain
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Manual therapy are among the therapeutic approaches frequently used in chronic low back pain (CLBP). Although most clinicians conduct patient education according biomedical model of pain, a relatively new approach which is referred to as neuroscience pain education (NPE) is promising in patients with CLBP. Therefore the aim of this study was to investigate whether NPE in patients with CLBP who treated via manual therapy technique will produce different outcomes in terms of pain severity and QoL compared to traditional patient education.


Eligibility criteria: Inclusion Criteria:

* Volunteered to participate in the study.
* Patients with 18-65 years
* Had low back pain for at least 6 months,
* Reported pain severity of 5 or greater according to the numeric pain rating scale

Exclusion Criteria:

* Previous spine or lower extremity surgery
* Severe osteoporosis
* Spondyloarthropathy
* Spondylolisthesis
* Lumbar stenosis
* Lumbar fractures
* Malign tumor

Primary outcomes:
measure: Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire
timeFrame: Change from Baseline SF-36 at 4th weeks.
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Change from Baseline NPRS at 4th weeks.
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Yoncali Physical Therapy and Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT04343365: Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board
Official title: Feasibility of Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board in Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Incurable Disease
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are patients at Moffitt Cancer Center

Brief summary: This study will evaluate the ability of a multidisciplinary group, the Evolutionary Tumor Board (ETB), to develop therapeutic strategies in patients without curative options.


Eligibility criteria: Inclusion Criteria:

* Participant must be considered likely incurable given a standard of care. This is inclusive of participants in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but not curative options for care.
* Participant must have a life expectancy greater than 3 months
* Participant must have an ECOG performance status 0-2
* Participant and primary Oncologist are willing to consider the therapeutic strategies recommended by the ETB
* Willingness to be followed over time and allowing collection of clinical data including scans and serial blood sampling.

Exclusion Criteria:

* None

Primary outcomes:
measure: ETB developing therapeutic strategies
timeFrame: Baseline to up to 60 months from end of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jingsong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079048: PEEK Retentive Elements Versus Conventional
Official title: Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Mandible
Keywords: Ball attachment
overdenture
patient satisfaction
PEEK
retention measurement.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings

Detailed description: Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures.

Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings.

Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.

Eligibility criteria: Inclusion Criteria:

* edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders

Exclusion Criteria:

* exposed to radiotherapy

Primary outcomes:
measure: retention
timeFrame: 3 months to six months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 3 months to six months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Mohamed Sharaf
Study officials:
References:
citation: Sharaf MY, Eskander A, Afify MA. Novel PEEK Retentive Elements versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial. Int J Dent. 2022 Feb 28;2022:6947756. doi: 10.1155/2022/6947756. eCollection 2022.
Clinical trial NCT02325648: The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Surface Malignancies
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergoing HIPEC cytoreductive surgery

Brief summary: The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.


Eligibility criteria: Inclusion Criteria:

* Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

Exclusion Criteria:

* Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.

Primary outcomes:
measure: Vital sign
timeFrame: from 30 minutes to 90 minutes after HIPEC
measure: Body temperature
timeFrame: from 30 minutes to 90 minutes after HIPEC
measure: serum glucose
timeFrame: from 30 minutes to 90 minutes after HIPEC
measure: pulmonary vascular permeability index
timeFrame: from 30 minutes to 90 minutes after HIPEC
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: South Korea
Study officials:
References:
citation: Kim MH, Yoo YC, Bai SJ, Lee KY, Kim N, Lee KY. Physiologic and hemodynamic changes in patients undergoing open abdominal cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. J Int Med Res. 2021 Jan;49(1):300060520983263. doi: 10.1177/0300060520983263.
Clinical trial NCT03013348: Automated Identification of Psychogenic Nonepileptic Seizures
Official title: Automated Identification of Psychogenic Nonepileptic Seizures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Convulsion, Non-Epileptic
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 104
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES recorded during that admission.

Brief summary: A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures

Detailed description: This is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (sEMG) artifact previously recorded during routine video-electroencephalographic (vEEG) monitoring

Eligibility criteria: Inclusion Criteria:

A subject will be eligible for inclusion in this study if the following criteria apply.

* Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission.
* Male or female between the ages of 2-99
* Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments

Exclusion Criteria:

* No exclusion criteria have been established for this study.

Primary outcomes:
measure: > 70% sensitivity of a post processing method for classification of psychogenic nonepileptic seizures in sEMG artifact captured during vEEG recordings as compared to vEEG interpretation by a panel of three independent Neurologists.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Jonathan Halford, MD
role: PRINCIPAL_INVESTIGATOR
References: