louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03869151: Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients
Official title: The Impact of Pretreatment Lymphocyte to Monocyte Ratio on Clinical Outcome for Patient With HCC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular carcinoma patients

Brief summary: To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).

Detailed description: The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma.

Tumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis.

Conversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers.

Monocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development.

Tumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.

Eligibility criteria: Inclusion Criteria:

Patients with child A Hepatocellular carcinoma.

Exclusion Criteria:

* Patients with child C Hepatocellular carcinoma.
* Patients with heart failure

Primary outcomes:
measure: increased over all survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: taha mahran, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: ola abdelfatah, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: aml ebraheem, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: amany amin, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942251: Relapse Predicting Model for First Episode Depression
Official title: The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorders
Keywords: MDD
big data analytics
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

Detailed description: Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

This study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.

Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old;
* Han Chinese;
* Outpatient and inpatient patients;
* Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
* Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;
* Written informed consent was given;
* Junior high school education and above, with enough audio-visual ability to accomplish the visits;
* Normally resident in one country and had a residential address, able to follow-up.

Exclusion Criteria:

* Bipolar disorder rapid cycling or mixed episode;
* Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
* Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
* Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
* Female patients who were pregnant, planning to be pregnant or breast feeding;
* Severe medical or neurological problems.

Primary outcomes:
measure: HAM-D total score
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to relapse
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Mental Health Center
name: Jun Chen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03419351: Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Official title: Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Self-Examination
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons.

The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure.

The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.


Eligibility criteria: Inclusion Criteria:

* existing refractive error
* using glasses or contac lenses

Exclusion Criteria:

* opacities (visus limitating) of cornea, lens or vitreous
* known ocular pathologies except refractive error
* epilepsia
* irregular corneal topography

Primary outcomes:
measure: Refractive Error
timeFrame: 6 month
Secondary outcomes:
measure: Visual acuity
timeFrame: 6 month
measure: Personal evaluation of measuring accuracy (Questionnaire)
timeFrame: 6 month
measure: Time consumption
timeFrame: 6 month
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Eye Hospital
state: BW
Study officials:
References:
Clinical trial NCT02778451: Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography
Official title: Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography Skills
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 17
Sex: ALL
Minimum age (years): 26
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ultrasonography (US) is an operator depended image modality that is difficult to reproduce and interpret by others. Competence of the US operator is crucial for reliable diagnostics but no evidence-based certification of head and neck US skills has been developed. Investigators conducted an experimental study aimed to explore diagnostic accuracy and establish validity evidence for certification standards in surgeon-performed ultrasonography.


Eligibility criteria: 1. Ultrasonography-experienced surgeons

   Inclusion Criteria:
   * Board certified otolaryngologist
   * Daily use of head and neck Ultrasonography
2. Ultrasonography novices:

Inclusion Criteria:

* Medical doctor during internship

Exclusion Criteria:

* experience with head and neck Ultrasonography
* experience with head and neck surgery

Primary outcomes:
measure: Competence score on a generic skills assessment scale (The Objective Structured Assessment of Ultrasound Skills (OSAUS))
timeFrame: up to 24 months
Secondary outcomes:
measure: Diagnostic accuracy assessed by a head and neck surgeon reading the ultrasonography report
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02648451: Acceptability and Tolerance Study of New Oral Nutritional Supplement
Official title: Tolerance and Acceptability of AYMES ROME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
Collaborators: name: Alison Clark Health and Nutrition
First posted: 2016-01-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).

Detailed description: To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES ROME (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with swallowing impairment requiring thickened fluids
* Patients with inflammatory bowel disease or previous bowel resection.

Primary outcomes:
measure: GI side effects when using AYMES Rome
timeFrame: 9 days
Secondary outcomes:
measure: Change to bodyweight of subjects when using AYMES Rome
timeFrame: 9 days
measure: Compliance with prescription of AYMES Rome
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES Rome - frequency
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES Rome - stool consistency
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
affiliation: Alison Clark Health and Nutrition
name: Alison Clarke, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06365151: An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Official title: Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Temporomandibular Disorder
Keywords: temporomandibular joint disorders
fibromyalgia
Osteopathic medicine
chronic pain
musculoskeletal manipulations
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.


Eligibility criteria: Inclusion Criteria:

* be diagnosed as suffering from fibromyalgia,
* present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint,
* be over 18 years old,
* understand Spanish and/or Catalan correctly,
* and read and accept the informed consent form

Exclusion Criteria:

* history of trauma or recent surgery to the head, face or neck;
* systemic, rheumatic or central nervous system diseases;
* diagnosis of malignant tumors or cancer in the orofacial region;
* participate in other studies at the same time.

Primary outcomes:
measure: catastrophizing
timeFrame: week 1, week 4, week 6
measure: functional limitation
timeFrame: week 1, week 4, week 6
measure: functional status, disability and pain
timeFrame: week 1, week 4, week 6
measure: pain and tinnitus
timeFrame: week 1, week 4, week 6
measure: myofascial trigger points
timeFrame: week 1, week 4, week 6
measure: Range of motion
timeFrame: week 1, week 4, week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Cornella de Llobregat
country: Spain
facility: Osteopatia i Fisioteràpia Cornellà
state: Barcelona
Study officials:
affiliation: Departament de infermeria i fisioterapia. universitat de Lleida
name: Llanos de la Iglesia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954651: Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines
Official title: Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received European Union (EU) -Approved COVID-19 Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Vaccine Reaction
Keywords: sars-cov2
vaccine
age
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who voluntarily receive COVID-19 vaccines

Brief summary: Patients who voluntarily visit vaccination centers in Greece against COVID-19 are recruited and their immunization levels against Sars-Cov2 are assesed by measurement of the levels of serum antibodies against Sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9 months post-vaccination).


Eligibility criteria: Inclusion Criteria:

* Subjects who voluntarily receive COVID-19 vaccination

Exclusion Criteria:

* Patients who do not complete their vaccination
* Patients who do not provide info on their health status

Primary outcomes:
measure: Antibody titer against Sars-Cov2
timeFrame: 0-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
Study officials:
affiliation: University of Patras
name: Ioannis Habeos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parthymou A, Habeos EE, Habeos GI, Deligakis A, Livieratos E, Marangos M, Chartoumpekis DV. Factors associated with anti-SARS-CoV-2 antibody titres 3 months post-vaccination with the second dose of BNT162b2 vaccine: a longitudinal observational cohort study in western Greece. BMJ Open. 2022 May 19;12(5):e057084. doi: 10.1136/bmjopen-2021-057084.
Clinical trial NCT00927251: Model 4296 Left Ventricular (LV) Lead Study
Official title: Model 4296 Left Ventricular Lead Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Detailed description: This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.

Eligibility criteria: Inclusion Criteria:

* Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
* On optimal medical treatment according to investigator opinion
* Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
* Patient consent
* Geographically stable

Exclusion Criteria:

* Left Ventricular (LV) lead implant attempt in last 30 days
* Unstable angina or acute myocardial infarction (MI) in past 30 days
* Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
* Contraindicated for transvenous pacing
* Heart transplant
* Contraindicated for less than 1 milligram (mg) dexamethasone acetate
* Enrolled or intends to participate in concurrent drug and/or device study which would confound results
* Life expectancy shorter than duration of the study
* Exclusion criteria required by local law
* Unable to tolerate urgent thoracotomy

Primary outcomes:
measure: Number of Participants With Left Ventricular (LV)Lead Related Complications
timeFrame: Implant to one-month post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
city: Wien
country: Austria
city: Oulu
country: Finland
city: Bad Rothenfelde
country: Germany
city: Essen
country: Germany
city: Heidelberg
country: Germany
city: Luedenscheid
country: Germany
city: Ulm
country: Germany
city: Delhi
country: India
city: Bologna
country: Italy
city: Pesaro
country: Italy
city: Rovigo
country: Italy
city: Breda
country: Netherlands
city: Eindhoven
country: Netherlands
city: Bergen
country: Norway
city: Kosice
country: Slovakia
Study officials:
affiliation: Policlinico S. Orsola-Malpighi in Bologna, Italy
name: M. Biffi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02294851: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tauopathies
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

Detailed description: This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
* Body Mass Index (BMI) of 18.5-30 kg/m\^2, inclusive. BMI=weight (kg)/\[height(m)\]\^2.
* Males and Females, not of child-bearing potential, ages 21 to 65 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential.
* Male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding.
* Any significant acute or chronic medical illness.
* Any history of cancer within 5 years of enrollment.
* Any major surgery within 4 weeks of study drug administration.
* Donation of blood or serum \> 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
* Participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration.
* Inability to be venipunctured and/or tolerate venous access.
* Has smoked or used tobacco products within 6 months prior to study drug administration.
* Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse

Primary outcomes:
measure: Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
city: Dallas
country: United States
facility: Covance Clinical Research Unit Inc.
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: