louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03924271: Prevalence Study of Iron Deficiency in Patients With Cancer
Official title: Prevalence Study of Iron Deficiency in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 1200
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: Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. In inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (French Health High Authority 2011)


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over the age of 18
* Patient in an oncology department (any type of tumor, any type of treatment, initiated or not)
* Patient affiliated or beneficiary of a social security system
* Patient with written consent

Exclusion Criteria:

* Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent

Primary outcomes:
measure: Blood iron status
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Luporsi E, Turpin A, Massard V, Morin S, Chauffert B, Carnot A, Cacoub P; Behalf of the CARENFER Study Group. Iron deficiency in patients with cancer: a prospective cross-sectional study. BMJ Support Palliat Care. 2024 May 17;14(2):215-221. doi: 10.1136/bmjspcare-2021-002913.
Clinical trial NCT01417871: ABC Program in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Reduction in Patients With Metabolic Syndrome
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with metabolic syndrome

Brief summary: Aims: We evaluate the efficacy of the "Active Body Control (ABC) Program" for weight reduction in patients with metabolic syndrome.

Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized, clinical trial 60 patients will be treated according to the ABC program and 60 control patients will receive standard therapy.


Eligibility criteria: Inclusion Criteria:

* metabolic syndrome

Exclusion Criteria:

* tumor cachexia

Primary outcomes:
measure: weight reduction
timeFrame: 12 month
Secondary outcomes:
measure: incidence of metabolic syndrome
timeFrame: 12 month
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University Magdeburg
Study officials:
References:
Clinical trial NCT01410071: Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction
Official title: Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sphincter of Oddi Dysfunction
Abdominal Pain
Keywords: Sphincter of Oddi Dysfunction
Lead sponsor: Wisconsin Center for Advanced Research
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2011-08-04
Enrollment: 153
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: physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction

Brief summary: The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

Detailed description: Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures \>40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

Eligibility criteria: Inclusion Criteria:

* over age 18
* suspected history and clinical features suggestive of sphincter of oddi dysfunction

Exclusion Criteria:

* prior history of endoscopic therapy for sphincter of oddi dysfunction
* no proven sphincter of oddi dysfunction on manometry

Primary outcomes:
measure: symptom improvement
timeFrame: one year
Secondary outcomes:
measure: improved quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: GI Associates
name: Nalini M Guda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237471: Impact of Tight Glycaemic Control in Acute Myocardial Infarction
Official title: Impact of Tight Glycaemic Control With Insulin on Novel Vascular Disease Risk Factors and Myocardial Function and Perfusion in Acute Myocardial Infarction Patients With Hyperglycaemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Infarct
Hyperglycemia
Keywords: Acute Myocardial Infarction
Hyperglycaemia
Insulin Infusion
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Bristol-Myers Squibb
First posted: 2005-10-12
Enrollment: 40
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 determine whether tight glycaemic control with insulin improves myocardial function and myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular risk factors in patients with acute myocardial infarction and hyperglycaemia.

Detailed description: We will randomise patients with acute myocardial infarction and blood glucose levels (BGLs) \>=10mmol/L within 24 hours of pain onset, to either tight glucose control (aiming BGLs 4.5 - 7mmol/L) with an insulin infusion (for 24 hours) followed by subcutaneous insulin or standard control (BGL 6 - 12mmol/L) without the use of an insulin infusion. Serial myocardial contrast echocardiography will measure changes in myocardial perfusion and function from baseline to 3 months between each group. We will also measure changes in inflammatory and endothelial markers over this time to see whether tight glucose control improves these surrogate endpoints.

Eligibility criteria: Inclusion Criteria:

* Age \>=18years
* Acute Myocardial Infarction
* Blood Glucose Level \>=10mmol/L
* Wall motion abnormality on baseline echocardiogram

Exclusion Criteria:

* Active infection/inflammation
* Cardiac shunt
* Cognitive Impairment
* Insulin allergy

Primary outcomes:
measure: Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.
Secondary outcomes:
measure: Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Leo Rando, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05178771: Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels
Official title: The Efficacy of Application of Platelet-rich Fibrin on Periodontal Clinical Parameters and Gingival Crevicular Fluid Platelet-derived Growth Factor-BB and Periostin Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: PRF
PDGF-BB
Periostin
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A split-mouth procedure will be formed. Two quadrants in each participant will be selected; the sites will be divided into two groups: control site( will treat by ScRp only) and test sites( will treat by ScRp and PRF)
Primary purpose: TREATMENT

Brief summary: Determine the efficacy of the non-invasive application of PRF on periodontal clinical parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival crevicular fluid.

Detailed description: The adjunctive use of PRF with conventional ScRp may improve clinical healing, decrease tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment time. Since PRF can be utilized as a safe, natural method to repair tissues at a low cost. Our aim is to evaluate the effectiveness of the non-invasive application of PRF as an adjunct to ScRp in patients with stage III grade B periodontitis through measurements of gingival crevicular fluid levels of PDGF-BB and Periostin before and after treatment and compare it with ScRp alone. A split-mouth procedure will be performed to reduce confounders as possible.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients.
* Patients with periodontitis.

Exclusion Criteria:

1. Medical history of systemic disease: diabetes, pregnancy, or lactation.
2. Previous periodontal treatment for the last 6 months
3. Grade II mobility
4. Smoker or alcoholic patient.
5. Teeth with untreated caries, endodontic lesions
6. Symptoms of recent acute illness e.g., COVID-19 will be excluded as well

Primary outcomes:
measure: clinical parameters
timeFrame: 4 weeks and 3 months
Secondary outcomes:
measure: PDGF-BB and periostin level in GCF
timeFrame: 4 weeks and 3 months
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Babylon University
state: Babel
Study officials:
References:
Clinical trial NCT05421871: Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along With Laser Therapy
Official title: Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along With Laser Therapy in Non-Specific Low Back Ache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Ache
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along with Laser Therapy in Non-Specific Low Back Ache

Detailed description: Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along with Laser Therapy for finding the better method for the treatment of Non-Specific Low Back Ache

Eligibility criteria: Inclusion Criteria:

* Both male and female within the age range of 18-60 years.
* Visual analogue scale that scores 3 and higher.
* Non radiating low back pain

Exclusion Criteria:

* Patients with a history of spinal diseases and injury
* Spinal stenosis
* Degenerative changes
* Neuropathy
* Intervertebral disc collapse.
* Spinal discectomy
* Spinal laminectomy

Primary outcomes:
measure: Spinal Stabilization Exercises in Non-Specific Low Back Ache
timeFrame: 6 Months
Secondary outcomes:
measure: Maitland Mobilization Along with Laser Therapy in Non-Specific Low Back Ache
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Al-Zahra Medical complex Johar town, Laser spine center Model town, Laser spine center Johar town.
Study officials:
References:
Clinical trial NCT05846971: Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Official title: Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barrett Esophagus
Esophageal Cancer
Lead sponsor: Capsulomics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 100
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: Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different clinical and prognostic assay information.

Detailed description: Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions for virtual patient cases when presented with different clinical and prognostic assay information. The data from this study will be published in a peer-review scientific journal.

Eligibility criteria: Inclusion Criteria:

1. Be currently practicing board-certified gastroenterologist practicing in the United States
2. Have practiced (as a board-certified gastroenterologist) for greater than 2
3. Be English-speaking
4. Have ≥ 50 Barrett's esophagus patients under care annually
5. Have Internet access
6. Have no prior experience with the methylation assay test
7. Provide voluntary informed consent to participate in the study.

Exclusion Criteria:

1. Non-practicing gastroenterologists
2. Less than two years of gastroenterology practice
3. Non-English speaking
4. Does not have access to the internet
5. Does not consent to participate in study

Primary outcomes:
measure: Clinical performance change in physician behavior.
timeFrame: 1 year
measure: The impact of methylation assay on physician confidence in clinical care decision-making.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Capsulomics, Inc.
state: Maryland
Study officials:
References:
Clinical trial NCT02764671: Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
Official title: The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Keywords: recombinant hepatitis B vaccine
safety
immunogenicity
Lead sponsor: Shenzhen Kangtai Biological Products Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Guangdong Provincial Institute of Biological Products And Materia Medica
First posted: 2016-05-06
Enrollment: 5000
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.


Eligibility criteria: Inclusion Criteria:

* Subjects who are healthy full-term infants after birth, Apgar score ≥8;
* Subjects with a birth weight ≥ 2500g;
* Subjects' guardians are able to understand and sign informed consent;
* Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

* Family history of eclampsia, epilepsy and encephalopathy;
* Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
* Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
* Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
* Subjects had serious acute and chronic diseases;
* with temperature ≧37.1℃;
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Within 30 days after hepatitis B vaccination
Secondary outcomes:
measure: Geometric mean titer of anti-hepatitis B virus surface antigen antibody
timeFrame: The 30th day after whole course of hepatitis B vaccination
measure: Geometric mean titer of anti-hepatitis B virus surface antigen antibody
timeFrame: The 1th year after whole course of hepatitis B vaccination
measure: Geometric mean titer of anti-hepatitis B virus surface antigen antibody
timeFrame: The 2th year after whole course of hepatitis B vaccination
measure: Geometric mean titer of anti-hepatitis B virus surface antigen antibody
timeFrame: The 3th year after whole course of hepatitis B vaccination
Other outcomes:
Locations:
city: Maoming
country: China
facility: Gaozhou District Center for Disease Control and Prevention
state: Guangdong
city: Yunfu
country: China
facility: Xinxing District Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Zheng Huizhen, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01953471: Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)
Official title: Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis Due to Grass Pollen
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 959
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with allergic rhinitis due to grass pollen

Brief summary: Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 6 and 65 years.
* Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
* Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
* Patients presented for symptomatic management of allergic rhinitis.
* Patients having Symptoms score ≥ 6.

Exclusion Criteria:

* Patients involved in any other clinical/observational study.
* patients unable to fill in the study questionnaires.
* Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
* Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
* Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.

Primary outcomes:
measure: Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.
timeFrame: 6 months per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
Study officials:
affiliation: Hôpital Foch
name: Philippe DEVILLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06876571: Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
Official title: Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: T-Cell Lymphoproliferative Disorder
Lead sponsor: Invivoscribe, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 250
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: Samples from subjects with diagnosed T-Cell Lymphoproliferative disorders or suspected of T-Cell Lymphoproliferative disorders with negative T-Cell Clonality Testing results

Brief summary: This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.


Eligibility criteria: Inclusion Criteria:

1. De-identified, residual FFPE specimens with a minimum of 8 curls
2. Subject Age ≥ 18
3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:

   1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis
   2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
   3. Mycosis fungoides or Sézary syndrome sample are acceptable
4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease

Exclusion Criteria:

1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)

Primary outcomes:
measure: % Agreement
timeFrame: Through Study Completion at one year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Invivoscribe, Inc.
state: California
city: Hallbergmoos
country: Germany
facility: LabPMM GmbH
city: Kawasaki-shi
country: Japan
facility: LabPMM GK
state: Kanagawa
Study officials:
References: