louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04287920: Acamprosate Safe to Use in Individuals With Liver Disease.
Official title: A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol-related Liver Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Is acamprosate safe to use in individuals with liver disease.

Detailed description: Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.

Eligibility criteria: Inclusion criteria:

* Aged 21 or over
* Diagnosis of alcohol-related liver disease and AUD.

  * The diagnosis of alcohol-related liver disease will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging and laboratory findings and typical histology on liver biopsy, if performed. Underlying liver disease may include alcoholic hepatitis, advanced (F3-F4) fibrosis, and/or portal hypertension.
  * The diagnosis of AUD will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with DSM-5 diagnostic criteria for AUD (all categories of mild, moderate and severe considered eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).
* Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
* At study enrollment, initial MELD-Na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. The second phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or more at enrollment.
* Have capacity to provide consent themselves

Exclusion criteria:

* Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min
* Congestive heart failure (NYHA class II or higher)
* Hypotension, requiring the use of vasoconstrictors (i.e. midodrine)
* Pregnancy, lactation or refusal to use a reliable method of birth control if a sexually active female of childbearing potential. Although no human trial data is available, animal studies suggest possible teratogenic effects of acamprosate (Merck, 2005).

Primary outcomes:
measure: Adverse Event
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Alcohol Craving
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Douglas A Simonetto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02785874: Statin With Palliative Therapy for HCC
Official title: Statin With Palliative Therapy for HCC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HCC
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.

Detailed description: Most liver cancer patients did not accept the cure as the main objective of the treatment after diagnosis because they choose alternative therapies palliative based, such as hepatic arterial chemoembolization, chemotherapy and radiation therapy.

Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer, yet the clinical effect for Statin is still unknown.

In a previous study of 20,220 liver cancer patients in health care database, the investigators discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.

This study is a continuation of previous health insurance database studies for clinical trials to verify whether Statin could prolong disease-free survival role for palliative treatment of liver cancer.

Eligibility criteria: Inclusion Criteria:

1. \>20 years old.
2. BCLC stage B , stage C and stage D

Exclusion Criteria:

1. Cancer diagnosis before HCC was conﬁrmed and incurable.
2. \<20 years old, \> 90years old.
3. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Primary outcomes:
measure: Overall Survival
timeFrame: Up to two year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: WanFangHospital
Study officials:
affiliation: WanFangHospital
name: Ming Shun Wu, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01349374: Skin Samples of Diabetic Patients and Healthy Volunteers Collection
Official title: Study Aiming to Collect Skin Samples of Diabetic Patients and Healthy Volunteers for Cellular Reprogramming, Within the Framework of New Therapeutic Strategies in Diabetes Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients diagnosed for type 2 diabetes, with a BMI between 20 and 25, without familial history and known genetic cause of diabetes.
* Diabetic patients diagnosed for MODY diabetes (1, 2, 3, 4, 5 or 6), with a BMI between 20 and 25.
* Healthy volunteers, siblings of MODY patients (1, 2, 3, 4, 5 or 6).
* Healthy volunteers without familial history of diabetes.
* Patients over 18 years old.
* Patients with social insurance coverage
* Patients who signed a consent form

Exclusion Criteria:

* Type 1 diabetic patients.
* Pregnant women or women who might get pregnant

Primary outcomes:
measure: Nothing will be measured, the aim of the study is the obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines.
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
Clinical trial NCT00282074: Evaluating Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Fertile Males
Official title: Prospective Trial to Evaluate Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Males in the Fertility Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hernia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.


Eligibility criteria: Inclusion Criteria:

* Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery.

Exclusion Criteria:

* History of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Joseph Kuriansky, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02473874: Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy
Official title: Spectral Comparison Between Spatially Modulated Quantitative Spectroscopy and Polarization-Sensitive Hyperspectral Multimode Dermoscopy for the Purpose of Skin Compositional Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanocytic Nevus
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2015-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.

Brief summary: The purpose of this study is to obtain skin spectroscopic data from two imaging systems.

Comparison groups:

* Skin Spect dermoscope
* Spatially modulated quantitative spectrometer

Detailed description: The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.

Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.

This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.

Eligibility criteria: Inclusion Criteria:

* Skin lesion a mole located on flat surface of the body

Exclusion Criteria:

* Mole located on complex surface
* Pregnant women

Primary outcomes:
measure: Changes in human skin structure
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Kristen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03571074: Hyperoxia Before and After Cardiac Arrest and Myocardial Damage
Official title: Hyperoxia Before and After Cardiac Arrest and Myocardial Damage, a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with in hospital cardiac arrest, who had return of spontaneus circulaiton and was then admitted to ICU in a hospital in the Capital Region of Denmark.

Brief summary: Several studies show how patients with hyperoxia after cardiac arrest has increased mortality, but the association of hyperoxia before cardiac arrest and myocardial damage has never been investigated. Neither has the association between hyperoxia after cardiac arrest and myocardial injury.

Our research hypothesis is that hyperoxia before cardiac arrest aggravates myocardial damage, secondly we wish to analyze the association between hyperoxia after cardiac arrest and myocardial injury.

The exposure variables is oxygenation within 48 hours before and 48 hours after cardiac arrest, our primary outcome is myocardial damage and will be measured as peak troponin within 30 days after cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* With a record of ICD-10 diagnosis of cardiac arrest in 2014, admitted to a hospital in the Capital Region of Denmark.
* First recorded cardiac arrest in 2014
* Admitted to ICU
* Serum troponin measured within 7 days after cardiac arrest

Exclusion Criteria:

* Out of hospital cardiac arrest, OHCA
* In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.

Primary outcomes:
measure: Peak troponin within 30 days after cardiac arrest
timeFrame: 30 days
Secondary outcomes:
measure: 30-day and 1-year mortality
timeFrame: Up to 1 year.
measure: Troponin area under the curve within 3 days after cardiac arrest
timeFrame: 3 days
measure: Length of ICU stay after cardiac arrest
timeFrame: through study completion,on average of 4-8 weeks.
measure: Length of hospital stay after cardiac arrest
timeFrame: through study completion,on average of 4-8 weeks.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT06289374: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery
Official title: The LABS Study: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery (BIORESOURCE 2: Longitudinal)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oesophageal Adenocarcinoma
Gastric Adenocarcinoma
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2024-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in a hospital (secondary or tertiary level care) setting

Brief summary: Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis.


Eligibility criteria: Inclusion Criteria:

* Aged 18-90 years at the time of initial recruitment
* Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1

Exclusion Criteria:

* Oesophageal squamous cell carcinoma
* Previous oesophageal and gastric resection
* History of another cancer within five years. If a new other cancer type is diagnosed within the sampling time frame, no further samples will be taken.
* Participants with co-morbidities preventing breath collection
* Unable or unwilling to provide informed written consent
* Pregnant women

Primary outcomes:
measure: Salivary microbial biomarkers to predict treatment response and long-term prognosis
timeFrame: 48 months
Secondary outcomes:
measure: Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment
timeFrame: 48 months
measure: Quality of life measure up to 2 years following cancer surgery using validated questionnaires
timeFrame: 48 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
Clinical trial NCT04782674: Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
Official title: A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EBV Infection
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 3
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 suffer EBV infection related disease

Brief summary: This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases


Eligibility criteria: Inclusion Criteria:

1. According to the HLH-04 diagnostic criteria, it meets the HLH diagnostic criteria. EBV infection occurs in cells with EBV-DNA copy number significantly increased in peripheral blood or tissue, or where EBV coding small RNA(EBER) is detected in tissue or peripheral blood. Or Straus' 1988 diagnostic criteria for CAEBV.
2. Informed consent

Exclusion Criteria:

1. Patients who cannot cooperate with saliva collection
2. Patients who are unwilling to cooperate with the project research according to the project research plan.

Primary outcomes:
measure: Diagnosis
timeFrame: baseline
measure: Monitoring
timeFrame: 2 to 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03309774: Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Official title: Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I
Keywords: Children
Complex Regional Pain Syndrome
Relaxation
Bergès relaxation
Pain
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Complex regional pain syndrome (CRPS) is a disease provoking chronic pain in the limbs, following a trauma. Patient care is complicated by the variable clinical picture and response to treatment. The stress level of the organization, for chronic pain impacts the regulation of the autonomic balance. The study of time and frequency domain analysis of Heart Rate Variability (HRV) allows non-invasive and reproducible assessment of the autonomic balance.

Detailed description: The hypothesis in this study is that the sympathovagal balance could be altered in children with CRPS. But the impact of relaxation on pain and balance has been proven. This study aims to assess the impact of the assumption by the relaxation therapy in children suffering from CRPS, on sympathovagal balance.

It is an experimental prospective single-center study to highlight after a standardized relaxation program, changes in the time and frequency indices variability in heart rate, parameters of pain and quality of life with the CRPS children 6 to 16 years.

Eligibility criteria: Inclusion Criteria:

* Parents affiliates or entitled to a social security scheme
* Children from 6 to 16 years with Complex Regional Pain Syndrome (CRPS) type 1
* Diagnosis according to the Budapest criteria.

Exclusion Criteria:

* Child with pathologies reaching the central nervous system or the brain stem.
* Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
* Children requiring emergency surgery or trauma or septic or inflammatory context.
* Children with some psychiatric diseases
* Children who no understand french enough

Primary outcomes:
measure: high frequency index
timeFrame: at 3 months
Secondary outcomes:
measure: blood pressure
timeFrame: at 3 months
measure: life quality of children
timeFrame: at 3 months
measure: evaluation of pain
timeFrame: at 3 months
measure: evaluation of pain
timeFrame: at 3 months
measure: evaluation of pain
timeFrame: at 3 months
measure: intensity of pain
timeFrame: at 3 months
measure: location of pain
timeFrame: at 3 months
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent Gautheron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432874: Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration
Official title: A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2007-02-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Visually significant cataract requiring surgery

Exclusion Criteria:

* Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
* Any intraoperative complications
* Cataract incision length \< 1 mm
* Pregnancy

Primary outcomes:
measure: Proportion of eyes with wound leakage at the end of surgery
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: John Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Mark D Mifflin, MD
role: PRINCIPAL_INVESTIGATOR
References: