louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03417791: Recovery of Serum Creatinine at Discharge Impacts Mortality
Official title: Recovery of Serum Creatinine at Discharge Impacts Mortality, Long-term and Short-term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney; Functional Disturbance
Keywords: recovery
serum creatinine
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the registry and follow up of consecutive patients with increased serum creatinine during hospital in 2007

Brief summary: The aim of our study is to assess the mortality in the in-hospital patients who have elevated serum creatinine. A registry of patients with increased serum creatinine during hospital was conducted at the Guangdong General Hospital from January 1st, 2007 to December 30th, 2013. The primary clinical outcome is all-cause mortality, followed from the date of hospital discharge to Dec 30th 2018. Patients were divided into three groups, according to the serum creatinine recovery ratio (discharge/max serum creatinine). All-cause mortality, including the date of death, was identified from the electronic hospitalization data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record of registration required by law in China. Baseline characteristics, including primary disease diagnosis, blood pressure, major treatment, drug use and et al, were collected. Demographic data were collected from the electronic hospitalization data and electronic hospital discharge records. All co-morbid conditions were identified using International Statistical Classification of Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic hospital discharge records.


Eligibility criteria: Inclusion Criteria:

* In-hospital patients in Guangdong General Hospital in 2007
* Age\>=18y
* Patients with increased serum creatinine during hospital

Exclusion Criteria:

* Death during hospital
* Diagnosed with End-stage renal disease
* given the renal replace therapy during hospital

Primary outcomes:
measure: all-cause mortality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Liming Yao, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02908191: A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
Official title: A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.


Eligibility criteria: Healthy volunteers:

1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
2. Must have chronic hepatitis B with no history of clinical decompensation
3. Seropositive for HIV, HCV, or HDV antibody at Screen
4. Previous treatment with any HBV antiviral treatments within the last 3 months
5. Other known cause of liver disease, including NASH

Primary outcomes:
measure: Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: Up to 57 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
Study officials:
References:
citation: Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9.
Clinical trial NCT00167791: Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant
Official title: Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: transplant
desensitization
kidney transplant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.


Eligibility criteria: Inclusion Criteria:

* Active status on a kidney transplant waiting list with positive cross match against a living donor

Exclusion Criteria:

* Receipt of a live vaccine within 4 weeks prior to randomization
* Previous Treatment with Rituximab

Primary outcomes:
measure: Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.
timeFrame: assess 4 weeks after Rituximab treatment completed
measure: Transplant success or failure following the desensitization protocol.
timeFrame: ongoing assessment for 2 years after transplant
Secondary outcomes:
measure: Decrease in incidence of humoral rejection to less than 50% at 1 year.
timeFrame: assess 1 year after transplant
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Yolanda T Becker, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02093091: Clinical Evaluation of Nanoionomer Filling in Primary Teeth
Official title: Two-year Clinical Performance in Primary Teeth of Nano-filled Versus Conventional Resin Modified Glass Ionomer Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: nano-filled resin modified glass ionomer
clinical performance
class I
primary teeth
dentin bond strength
Filling of class I
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).

Detailed description: First, shear bond strength of each material to primary molars dentin specimens were measured (n=10) using a notched-edge crosshead. Independent sample t-test was used for statistical analysis. Then, a split mouth designed clinical trial was performed in which nano-filled RMGI; Ketac Nano (KN) and conventional RMGI; Vitremer (VR) were used to restore class I cavities of primary molars. Each material group (n=30) was evaluated according to the modified United States Public Health Service (USPHS) regarding marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries, at baseline, after one year and after two years. Wilcoxon signed- rank test and Chi-square test were used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).

Exclusion Criteria:

* Handicapped or uncooperative children and children with extensive or rampant caries.

Primary outcomes:
measure: Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
affiliation: Tanta University, Faculty of Dentistry
name: Sahar E. Abo-Hamar, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875691: Effect of Green Tea on Treatment of Lupus
Official title: The Effect of Green Tea Extract on Some Inflammatory Biomarkers(IL 6, IL1β,TNF α,CRP), Serum Total Antioxidant Capacity(TAC), MDA and Disease Activity in Patients With Systemic Lupus Erythematous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune
Lupus Erythematosus, Systemic
Keywords: disease activity
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 68
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized double blind clinical trial performed on 68 patients (32 in intervention and 36 in control group) diagnosed with SLE. The patients in intervention group were given daily dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and end of the study.

The investigators used SLEDAI (systemic lupus erythematous disease activity index ) questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out at baseline and after 3 month.

Detailed description: noting

Eligibility criteria: Inclusion Criteria:

The patients older than 15 years,diagnosed with systemic lupus erythematous (SLE) according to ACR(American College of Rheumatology) criteria.

Exclusion Criteria:

* Patients with other autoimmune diseases (diabetes, ...)
* Cardiovascular disease
* Patients with infectious or liver disease;
* severe infection
* Pregnancy
* Breastfeeding
* Smoking
* Alcohol consumption
* Use of any dietary supplements
* Changing of medication during the study period

Primary outcomes:
measure: systemic lupus erythematous Disease Activity
timeFrame: Three months after starting of intervention
Secondary outcomes:
measure: measurement of some proinflammatory and anthropometric markers
timeFrame: At baseline and after three months of intervention
measure: Health-Related Quality of Life
timeFrame: At baseline and after three months of intervention
Other outcomes:
measure: Dietary intake
timeFrame: at baseline and after 3 month of intervention
measure: Weight
timeFrame: at baseline and after 3 month of intervention
measure: BMI
timeFrame: at baseline and after 3 month of intervention
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Iran
state: Fars
Study officials:
affiliation: Ahvaz University of Medical Sceinces, Ahvaz, Iran
name: Iran Ahvaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04555291: Analgesic Effect of the QLB-3 for Patients Undergoing a Total Hip Surgery
Official title: Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 60
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: Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.


Eligibility criteria: Inclusion Criteria:

• All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.

* Obligation for all patients to be affiliated with social security
* Patient Informed Consent Signature

Exclusion Criteria:

* chronic opiod consumption
* pregnancy
* mental disorder that prevents the usage of the numeric analog scale
* Contra indications of the realization of QLB

  * Local infection
  * Allergic to the local anesthesia
  * Hemostasis disorder
  * Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection

Primary outcomes:
measure: Opoïd consumption
timeFrame: At 24 Hours
Secondary outcomes:
measure: morphine equivalent dose
timeFrame: At 48 Hours
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de nice - Anesthésie Réanimation
state: Alpes-Maritimes
city: Nice
country: France
facility: Institut Arnaut Tzanck
state: Alpes-Maritimes
Study officials:
affiliation: Anesthésie Réanimation - CHU de Nice
name: Rozier Romain
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04776291: Correlation of Pre- and Post-operative Cancer Imaging Techniques
Official title: PET-PATH: Investigation of New Medical Imaging Techniques for Improving Lung Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2021-03-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Various imaging modalities are used in medical diagnosis such as MRI, CT and PET. The images are sometimes acquired at different times and in different body positions, and thus need to be aligned for precise diagnosis and treatment planning. Different image modalities provide complementary information about the anatomical structure under study. Image registration techniques enable multimodality images to be projected onto a common coordinate system, so that these images can be aligned and spatial correspondences can be established between the images.

This research project aims to investigate the information provided by functional PET and CT images about the tumour environment in lung cancer patients by registering functional PET and CT images with the pathology images acquired from the same patient. On identification of specific region of interest on the functional imaging the investigators will then be able to interrogate the tumour biology. In many cancers, the tumour environment is usually composed of a heterogeneous mass of tissue. The discrimination and classification of the carcinoma substructures is of paramount importance in the radiotherapy planning stage, as a given treatment may be more or less suitable depending on the local characteristics of the tumour. For instance, in hypoxic regions (areas inside the tumour with very low oxygen supply), radiotherapy performs poorly and strategies to intensify treatment to those areas could be investigated.

This project will develop a framework for automatic registration of pathology images, which are taken from a surgically extracted lung tumour, with the corresponding PET/CT scan acquired from the patient before surgery. The registration of these images is essential for the evaluation of the performance of different PET radiotracers.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with primary lung cancer and are due to undergo curative surgical resection of the tumour
* At least one of the tumour's major axes is larger than 30mm.
* The main volume of the tumour is located within the lung tissue.
* Tumour is identified primarily as single mass lesion.

Exclusion Criteria:

* Patient is under 18 years old.

Primary outcomes:
measure: 4D PET-CT images aquired
timeFrame: up to 4 weeks after the PET-CT image is taken.
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: West of Scotland Pet Centre
Study officials:
References:
Clinical trial NCT02576691: Effects of Percutaneous Coronary Intervention in Patients With Cardiac Arrest After Acute Myocardial Infarction: a 2-Year Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: cardiac arrest
percutaneous coronary intervention
cardiogenic shock
outcome
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 2363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 million residents of the South of Zhejiang Province

Brief summary: The purpose of this study is To assess percutaneous coronary intervention 's effect on short- and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest after acute myocardial infarction


Eligibility criteria: Inclusion Criteria:

* underwent successful cardiopulmonary resuscitation from CA after AMI

Exclusion Criteria:

* late tumor;
* underwent Coronary Artery Bypass Grafting after CAG;
* with no attempted resuscitation.

Primary outcomes:
measure: all cause mortality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02307591: Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)
Official title: Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Ebola Virus Disease
Lead sponsor: Emergency NGO Onlus
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.


Eligibility criteria: Inclusion Criteria:

* patient admitted to the Emergency ETC at Goderich with a clinical diagnosis of Ebola virus disease;
* patient who consent to participate in the study.

Exclusion Criteria:

* negative RT-PCR tests for Ebola virus
* age \<2 years
* state of shock upon admission
* onset of fever for more than 6 days
* Glasgow Coma Scale \<12
* known contraindications to administration of amiodarone
* positive for HIV antibodies.

Primary outcomes:
measure: All cause mortality
timeFrame: 10 days
Secondary outcomes:
measure: Adverse events
timeFrame: Day 1-10 , 14
measure: Viral load
timeFrame: Day 2, 5, 10 and 14
measure: Lymphocyte count
timeFrame: Day 2, 5, 10 and 14
measure: IgM anti-Ebola virus antibody titer
timeFrame: Day 2, 5, 10 and 14
measure: IgG anti-Ebola virus antibody titer
timeFrame: Day 2, 5, 10 and 14
measure: Serum concentration of amiodarone
timeFrame: Day 2, 5, 10 and 14
measure: Vital status
timeFrame: Day 14 and 30
Other outcomes:
Locations:
Study officials:
References: