louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05677503: Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients
Official title: Determination of the Relationship Between Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: _All patients included in the study will be subjected to:

1. Full history:

   1. Personal history: e.g. age, sex and smoking.
   2. Family history of cardiac diseases
   3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
2. Detailed clinical examination
3. Electrocardiogram
4. Laboratory investigation:

   1. Routine investigation in the form of CBC including RDW
   2. Specific investigation which include NT-proBNP and cTnT

Brief summary: the study is to investigate the relationship of several parameters of complete blood count (CBC) including RDW with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac troponin T (cTnT) in a cohort of acute myocardial infarction (AMI) patients.

Detailed description: Patients and methods:

* Type of study: Observational prospective study
* Place of study: Sohag cardiology and gastroenterology center, department of cardiology and cardiac care unit.
* Ethical considerations: This research will be revised by the Scientific Ethical Committee of Sohag University Hospital. Consents will be taken from all patients.
* Study Methods:

  * A prospective study on 30 patients diagnosed as acute myocardial infarction on which measurement of CBC, serum NT-proBNP, and cTnT levels will be performed at the time of admission and by the time of discharge.

    1. Full history:

       1. Personal history: e.g. age, sex and smoking.
       2. Family history of cardiac diseases
       3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
    2. Detailed clinical examination
    3. Electrocardiogram
    4. Laboratory investigation:

       1. Routine investigation in the form of CBC including RDW
       2. Specific investigation which include NT-proBNP and cTnT

Eligibility criteria: Inclusion Criteria:

* patients diagnosed as acute myocardial infarction

Exclusion Criteria:

Patient with

* Decompensated heart failure
* Pulmonary hypertention
* Acute pulmonary embolism
* Septic shock

Primary outcomes:
measure: complete blood count (CBC)
timeFrame: 7 months
measure: Level of (NT-proBNP)
timeFrame: 7 months
measure: Level of (cTnT)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03602703: Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Official title: Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-Induced Liver Injury
Keywords: Direct acting antiviral drugs immune responses
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cases recruited divided into three groups .Each group either treated or not with DAAs

Brief summary: Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC

Detailed description: Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.

Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.

Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.

Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.

B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.

Cell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with HCC on top of HCV related liver cirrhosis either received treatment or not
* Patients without HCC either received treatment or not .
* Patients with chronic HCV as a control group either received treatment or not.

Exclusion Criteria:

* Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc
* Patients with recurrent HCC after curative treatment.

Primary outcomes:
measure: Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Lecturer
name: Haidi Ramadan, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580203: Collection Of Tissue, Blood, and Other Specimens From Patients With Head and Neck Tumors To Study the Causes, Diagnosis, Prevention and Treatment of Cancers
Official title: Collection of Tissue, Blood, and Other Specimens From Patients With Head and Neck Diseases to Study the Causes, Diagnosis, Prevention and Treatment of Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancers
Keywords: HEENT cancers
larynx
thyroid
sarcoma
specimen analysis
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2007-12-24
Enrollment: 1468
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: Patients with head and neck diseases who have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.

Brief summary: This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.

Detailed description: This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.

Eligibility criteria: Inclusion Criteria:

* Patients with head and neck diseases are eligible if they have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
* Patients will be entered onto this protocol without preference for any racial or ethnic group.
* Patients may have received prior chemotherapy, radiation, surgical therapy, immunotherapy, or differentiation therapy.
* The specimen collected must be large enough to allow conventional testing necessary for patient care, with the portion of the specimen reserved for research laboratory analysis excised from residual tissue that would otherwise have been discarded.

Exclusion Criteria:

* Patients not giving informed consent will be excluded.

Primary outcomes:
measure: Collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Specimens will be used to investigate growth, development, and transformation of normal and abnormal cells in the future.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Bhuvanesh Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04854603: Dairy Products With Reduced Sugar and Blood Glucose
Official title: The Effect of Dairy Products With Reduced Added Sugar Content on Blood Glucose, Satiety and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose, High
Metabolic Disease
Overweight and Obesity
Keywords: Sugar intake
Sweeteners
Diabetes
Obesity
Sweetened food products
Chocolate milk
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as yogurt have added sugar. Our recent studies have shown that the partial reduction of added sugar in chocolate milk and yogurt is not associated with any inferior sensory characteristics such as taste and pleasantness compared to their full-sugar counterparts. The current project will investigate whether the liquid dairy products with reduced sugar content (value-added products) have any benefits on blood glucose control in humans.


Eligibility criteria: Inclusion Criteria:

* 19-35 y males and females, non-smokers

Exclusion Criteria:

* having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.

Primary outcomes:
measure: Blood glucose
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Satiety
timeFrame: 0-120 minutes
measure: Food intake
timeFrame: 120 minutes
measure: Thirst
timeFrame: 0-120 minutes
measure: Physical comfort
timeFrame: 0-120 minutes
measure: Food pleasantness
timeFrame: at 0 and 120 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: Mount Saint Vincent University
name: Bohdan Luhovyy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931003: Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Official title: Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Carotid Stenosis
Symptomatic Carotid Artery Stenosis
Keywords: Hypertension
Carotid Stenosis
Symptomatic Carotid Artery Stenosis
Glomus ectomy
Carotid endarterectomy
Carotid Stenting
Lead sponsor: Samara State Medical University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 90
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: Carotid endarterectomy (CEA) is a well-established procedure for preventing ischemic brain damage. Stenosis of the precerebral vessels are often combined with arterial hypertension. In recent decades, many works have appeared that indicate that the course of arterial hypertension (AH) changes after CEA. However, it remains unknown how this is related to the choice of surgical tactics.

Detailed description: Purpose of the study: to substantiate the choice of the method of surgical treatment in patients with a combination of hemodynamically significant stenosis of the carotid bifurcation and arterial hypertension of 2-3 degrees.

Tasks:

1. To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.
2. To study the course of hypertension in patients after stenting of the internal carotid artery.
3. To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.
4. To substantiate the choice of a surgical treatment strategy in patients with significant stenosis of the carotid bifurcation and 2-3 degree of hypertension.

Methods for examining patients: collection of complaints and anamnesis, objective examination, questioning of patients, instrumental examination (ultrasound of BCS, daily monitoring of blood pressure, CT of the brain, cerebral angiography).

As a result of the study, the optimal tactics of surgical treatment in patients with carotid artery stenosis and the presence of hypertension will be determined.

Eligibility criteria: Inclusion Criteria:

* Presence of symptomatic ICA stenosis 70-90%
* Arterial hypertension of 2 or 3 degrees
* CEA operation with carotid glomus removal or ICA stenting operation

Exclusion Criteria:

* severe diabetes
* traumatic brain injury in history
* IHD, stable angina pectoris 3-4 FC.
* presence of clinical signs of vertebrobasilar insufficiency
* the presence of significant stenosis of the renal arteries
* CKD stages 3b-5

Primary outcomes:
measure: Change the degree of arterial hypertension
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Samara State Medical University
Study officials:
References:
Clinical trial NCT06077903: GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Official title: A Single Center, Single Arm Phase I Clinical Study of GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single center, single arm phase I clinical trial. This study proposes to enroll 20 subjects, with a trial protocol including chemotherapy pretreatment, reinfusion of autologous tumor infiltrating lymphocyte injection, and interleukin-2 injection.


Eligibility criteria: Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass Volume ≥1cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
* 2.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 3. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
* 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 5.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);

Primary outcomes:
measure: Incidience and severity of adversed events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT01774643: A Study of Pancreatic Cancer in Xenografts From Liver Metastases
Official title: A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Liver Metastases
Tumor Tissue Biopsy
Blood Samples
Keywords: Pancreatic cancer
Liver metastases
Tumor tissue biopsy
Blood samples
Xenografts
Murine
Genomic profiling
Circulating biomarkers
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 31
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: Pancreatic cancer patients with liver metastases

Brief summary: This is a feasibility study to perform image-guided liver biopsies in 25 patients who have pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the liver). This will contribute with samples for the bio-bank (bank of tumors) and develop xenografts (human tumors growing in mice) for further analysis of genes.

Detailed description: This study might bring a better understanding of the metastatic pancreatic cancer and evaluate the differences between the metastatic and the primary pancreatic cancer (the type that does not have metastasis).

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years old
* Pancreatic cancer with liver metastasis
* No contraindication to image-guided biopsy of liver metastasis, including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.
* Provide written informed consent
* ECOG 0,1 or 2

Exclusion Criteria:

* Inability to lie supine for more than 30 minutes
* ECOG 3 or more
* Serious medical risk factors involving any of the major organ systems or including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.

Primary outcomes:
measure: Number of patients with adverse events due to biopsies
timeFrame: up to 2 years
measure: Number of successful xenografts
timeFrame: up to 2 years
measure: Number of similarities and differences between original patient tumor sample with xenograft sample
timeFrame: up to 2 years
measure: Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival)
timeFrame: up to date of death from any cause
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Neesha Dhani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03095690: Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease
Official title: Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Keywords: Osteoporosis
Parkinson
HR-pQCT
bone microstructure
fracture risk
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease according to the criteria of the UKPDBB.
* Parkinson's disease of moderate severity (Index HOEHN and Yahr \<5)
* Patient can respond to questionnaires, with or without help

Exclusion Criteria:

* Patients with active psychiatric illness preventing the realization of examinations
* Severe Parkinson's disease (Index HOEHN and Yahr ≥5 )
* Heavy-morbidity including heart failure NYHA\> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed
* Pregnancy

Primary outcomes:
measure: Measurement of volumetric bone mineral density at the tibia and radius
timeFrame: 0 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Orleans
country: France
facility: CHR d'ORLEANS
Study officials:
affiliation: CHR d'ORLEANS
name: Eric LESPESSAILLES, Ph
role: PRINCIPAL_INVESTIGATOR
References: