louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01198808: Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker
Official title: Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: Bladder cancer
chemotherapy
T cells
Immunotherapy
Tumor-specific immunity in bladder cancer
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients with muscle-invasive bladder cancer, who are referred to the university hospital: Krankenhaus rechts der Isar der Technischen Universität München

Brief summary: Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy.

It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed muscle-invasive urothelial carcinoma
* Age \> 18 years
* Hemoglobin \> 10g/dl
* Signed Informed Consent
* Karnofsky index \< 70%

Exclusion Criteria:

* Clinically relevant second malignancy
* Severe comorbidities (e.g. NYHA III, end-stage renal disease)
* Chronic infectious disease (HIV, Tuberculosis)
* Immunosupression
* Severe psychiatric diseases
* Blood donation in the last 4 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Urologische Klinik der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Department of Urology, Technische Universität München
name: Thomas Horn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01556308: Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara
Official title: Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidermolysis Bullosa Simplex Dowling Meara
Keywords: Dowling Meara
Epidermolysis bullosa
inflammation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis characterized by spontaneous or post traumatic large cutaneous blisters. No curative treatment is actually available. Some data suggest a role of inflammation in the occurrence of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in DM-EBS.

Material and methods: A first retrospective immunohistochemical study will be led on remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In case of flare of the disease, the liquid and the top of the blisters will be took. Samples will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic analysis in association with a quantitative PCR will be made on the top of the blisters. If unknown, genotypic study will be made.

Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer new therapeutic ways.


Eligibility criteria: Inclusion Criteria:

* male or female
* older than 1 year-old
* severe Dowling Meara epidermolysis bullosa (more than 2 blisters per day)
* systematic written informed consent
* child consent
* affiliated to french social security

Exclusion Criteria:

* younger than one year-old
* no consent
* non affiliated to french social security
* participation to another clinical trial within 3 months ago
* intercurrent disease justifying the withdrawal of the study
* own patient decision to stop the study, withdrawal of informed consent

Primary outcomes:
measure: Markers of inflammation in epidermis in patients with severe DM-BS
timeFrame: Baseline
Secondary outcomes:
measure: clinical characterization of DM-EBS Genotype-phenoty
timeFrame: Baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Archet 2
Study officials:
References:
Clinical trial NCT04265508: Assessment of Hemostatic Profile in Liver Cirrhosis
Official title: Assessment of Hemostatic Profile in Patients With Mild to Advanced Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 67
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: All patients attending the in- and outpatient care of the department of hepatology between 12/2017 and 05/2018 meeting the inclusion criteria were offered to participate in the present study. Inclusion criteria were liver cirrhosis and age of ≥ 18 years. Furthermore, a platelet count of at least 70 x103/µL was mandatory to ensure adequate measurement of MEA using the Multiplate analyzer. Patients were excluded when given a platelet concentrate three weeks prior to inclusion or in case of pregnancy.

Brief summary: Our study included both in- and outpatients suffering from liver cirrhosis attending the out- and inpatient care of the department of hepatology. Demographic and biochemical data as well as medical history including cause of liver cirrhosis, end stage kidney failure and medication with anticoagulants were recorded. To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM).


Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* age of ≥ 18 years
* platelet count of at least 70 / nl

Exclusion Criteria:

* transfusion of platelet concentrate three weeks prior to inclusion
* pregnancy
* age \< 18 years
* missing informed consent

Primary outcomes:
measure: Aggregation of platelets
timeFrame: Venous blood was collected via a cannula inserted into a cubital vein. Platelet function was measured by MEA using the Multiplate analyzer 15min after blood draw and after activation with commercially available standard reagents
Secondary outcomes:
measure: Viscoelastic measurements
timeFrame: Venous blood was collected via a cannula inserted into a cubital vein. Thrombelastometric assays were performed 15min after blood draw.
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Universital Hospital Frankfurt / Main
state: Deutschland
Study officials:
References:
Clinical trial NCT00361608: Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Official title: Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type I Diabetes
Keywords: diabetes
hypoglycemia
monitor
children with Type I Diabetes
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Schneider Children's Medical Center, Israel
First posted: 2006-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes I

Brief summary: This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.

Detailed description: The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days.

During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:

1. glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
2. glucose levels tested by SBGM -Self Blood Glucose Measurement.

These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Age between 12-18 years
* Diagnosis of type I diabetes for at least a year
* Home close to participating center
* Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.

Exclusion Criteria:

* Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
* Any other pre-existing medical pathology unrelated to diabetes.
* Inability of the patient or his guardian to use the Guardian RT.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Liat de Vries, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02272608: Evaluation of Sleep Apnea Related Inflammation With CRP, ESR and Neutrophil toLymphocyte Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from sleep apnea and were referred to perform polysomnoraphy constituted the study groups. There were grouped into 4 according to apnea- hypopnea scores: control, mild apnea, moderate apnea and severe apnea.

Brief summary: There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Detection of altered inflammatory markers in OSAS patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge, NLR has not been studied in OSAS. We conducted the present study to evaluate the association between OSAS and inflammatory markers CRP, ESR and NLR.


Eligibility criteria: Inclusion Criteria: Subjects who were referred for polysomnography (PSG) testing and performed the test were included Exclusion Criteria: Patients with malignancy, diabetes mellitus, dyslipidemia, cardiovascular disease or hypertension, chronic inflammatory processes, thyroid dysfunction, chronic hepatic disease, renal failure, any acute- subacute infectious disease within past 2 months, if data are incomplete such as blood sample testing results, if they were unable to perform complete PSG testing.

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Primary outcomes:
measure: Evaluation of systemic inflammatory markers C-Reactive Protein, Erythrocyte Sedimentation Ratio and neutrophil to lymphocyte ratio in sleep apnea patients
timeFrame: After withdrawal of serum samples, patients were taken to sleep lab at the same day and polysomnography reports were evaluated 24 hours later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06250608: Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.
Official title: Evaluation of Cerebral Oxygen Saturation(rSO2) Measurements Between Frontal Lesion Area and Normal Area of Brain by Pulse Oximetry(NIRSITX) Using Near-infrared Spectroscopy in Acute Ischemic Stroke Patients, Prospective, Single-center, Non-randomized, Open-label, Exploratory Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke Patients
Lead sponsor: OBELAB, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Helptrial Inc.
First posted: 2024-02-09
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain. The purpose of the clinical trial is to compare differences in cerebral oxygen saturation values, and the efficacy and safety are evaluated through additional exploratory clinical trials.


Eligibility criteria: Inclusion Criteria:

* Adults over age 19
* Patients diagnosed with acute ischemic stroke within 7 days of symptom onset
* Patient's condition confirmed to have an acute ischemic stroke and also brain blood vessels condition confirmed through brain imaging such as Brain CT/CTA/CT perfusion and Brain MRI/MRA
* Patients voluntarily agree to participate and scheduled to participate in this clinical trial
* Patients willing to comply with the clinical trial protocol

Exclusion Criteria:

* Patients without brain imaging result
* Patients diagnosed with jaundice (hyperbilirubinemia) with abnormal skin color - Patients who find it difficult to wear medical devices for clinical trial on their foreheads
* Patients who has skull fractures of external shape not maintained normal
* Patients who does not agree to participate in this clinical trial
* Patients who are currently participating in another clinical trial or have participated in another clinical trial within 30 days of the screening date
* Patients who is determined from investigator that participating is inappropriate because it may affect the results of the clinical trial or ethically

Primary outcomes:
measure: Comparison of rSO2 values obtained from NIRSITX, a medical device for clinical trials, between the frontal lobe on the side with brain lesions and the frontal lobe on the contralateral side.
timeFrame: Baseline and follow-up (24 hours later)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05469308: Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation
Official title: Predictivity and Evaluation of the Adherence of Ambulatory Patients Treated With a Direct Oral Anticoagulant for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Anticoagulant
Adherence
Keywords: Direct oral anticoagulant
Adherence
Proportion of days covered
adherence questionary
Girerd adherence questionary
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The rhythm disorders of Atrial Fibrillation (AF) require continuous treatment with anticoagulants to prevent stroke. The introduction of direct oral anticoagulants (DOACs) quickly supplanted the administration of anti-vitamin K (AVK) which presented an elevated risk of hemorrhage.

However, the adherence of the treatments by the OAD is very poor, several studies show that 30 to 50% of the patients fail to adhere to their treatment very soon after starting it. In a recent study, in the United States, using data collected between 2010 and 2014 in more than 60,000 patients with AF, Yao et al show that less than 50% of patients can be considered "adherent".

They conclude in this study that adherence to anticoagulation is low in practice, although it may be slightly improved with DOACs. More recently a meta-analysis shows that 66% of patient treated by DOACs were considered adherent (PDC \> 80 %). In addition, therapeutic adherence seems to be essential in patients with a CHA2DS2-VASc score ≥2. Indeed improving adherence reduces the risk of stroke occurrence. The investigators propose to evaluate during an interview in the pharmacy, the adherence of ambulatory patients (at the time of their renewal of treatment at the pharmacy) by the "Proportion of Days Covered" (PDC) of the treatment by AOD, and by a simplified questionnaire and to define a profile of patients treated for AF at risk of nonadherence to AOD (PDC adherence prediction score). The investigators perform an observational, prospective multicenter study , in which patients adherence will be quantified in a standardized method.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Consultation in the community pharmacy
* long-term treatment for at least six months with an DOACs.
* Patients able and agreeing to participate in the evaluation of their adherence

Exclusion Criteria:

* Treatment by DOACs limited in the duration
* Contra-indications of DOACs

Primary outcomes:
measure: Number of AOD specific PDC
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01261208: The Study of the Prevalence of Helicobacter Pylori Infection Among HIV/AIDS Cohort
Official title: The Study of the Prevalence of Helicobacter Pylori Infection Among HIV/AIDS Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV, AIDS, Helicobacter pylori
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 200
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: HIV/AIDS group

Brief summary: The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in Kaohsiung Medical University Hospital and collect the cases who were suspicious of Helicobacter Pylori infection.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of HIV
* the person who have stomach pain, vomiting or nausea

Primary outcomes:
measure: all cause stomach pain
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Tropical medicine center
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Jih-Jin Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817608: Weaning From Mechanical Ventilation in the ICU
Official title: Weaning From Mechanical Ventilation in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: sf-36
Katz
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients receiving mechanical ventilation

Brief summary: The investigators objective is to assess quality of life and functional outcome in patients requiring short-term mechanical ventilation. Additionally, the investigators plan to measure the recovery of peripheral muscle strength and respiratory muscle strength during recovery.


Eligibility criteria: Inclusion Criteria:

* ICU patients who require mechanical ventilation for at least 2 days
* the ability to speak English
* willing to participate

Exclusion Criteria:

* patients who require mechanical ventilation at home before hospitalization
* patients previously requiring mechanical ventilation at an LTAC facility

Primary outcomes:
measure: quality of life scores
timeFrame: up to one year after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago Health Sciences Division
state: Illinois
Study officials:
affiliation: Loyola Univ Chicago Health Sciences Division
name: Amal Jubran, MD
role: PRINCIPAL_INVESTIGATOR
References: