louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01736384: Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery
Official title: Can Genetic Changes Predict Weight Loss and Outcome After Bariatric Surgery and Can it Related to Virus Infection and Function of Liver and Adipose Tissue as Well as Lipid and Protein Profiles.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
name: Ersta Hospital, Sweden
name: Karolinska University Hospital
First posted: 2012-11-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obesity

Brief summary: There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.


Eligibility criteria: Inclusion Criteria:

* laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

* unable to understand swedish

Primary outcomes:
measure: Genetic markers
timeFrame: day of surgery and 1 and 2 years after surgery
Secondary outcomes:
measure: Lipid and protein patterns in plasma and tissues
timeFrame: day of surgery and at 1 and 2 years postoperatively
measure: Previous viral infection
timeFrame: At time of surgery
measure: Genexpression and comorbid disease
timeFrame: At time of bariatric surgery and 1-2 years postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Danderyds Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Erik Näslund, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04332484: Global Coagulation Assessment in Cirrhosis and ACLF
Official title: Clinical Validation of the Use of Global Coagulation Tests Like Thromboelastography and Sonoclot in Liver Disease - A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute-On-Chronic Liver Failure
Cirrhosis, Liver
Keywords: Sonoclot
Thromboelastography
RoTEM
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-04-02
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients of ACLF, Cirrhosis of any etiology and Healthy controls were prospectively enrolled between January 2018 and August 2019.

Brief summary: Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have bleeding complications which can lead to increased mortality. Standard coagulation tests (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient management.

Methods: This prospective observational study compared and validated the point of care (POC) tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy controls respectively.


Eligibility criteria: Inclusion Criteria:

* All patients with Acute on Chronic Liver Failure
* All patients with cirrhosis of Liver

Exclusion Criteria:

* Recent blood or blood component transfusion in last 2 weeks
* HIV infection
* Antiplatelet, anticoagulant or antifibrinolytic therapy
* Patients on Dialysis
* Pregnant females
* Active malignancy in last 5 years
* Chronic heart failure
* Chronic pulmonary disease
* End stage renal disease

Primary outcomes:
measure: Validation of TEG and Sonoclot
timeFrame: Day 3
Secondary outcomes:
measure: Correlation of Point of care test with standard coagulation tests
timeFrame: Day 3
measure: Correlation of Point of care tests with bleeding event
timeFrame: Day 28
measure: Correlation of Point of care tests with mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
citation: Premkumar M, Mehtani R, Divyaveer S, Kajal K, Kulkarni AV, Ahmed S, Kaur H, Kaur H, Dhiman R, Duseja A, De A. Clinical Validation of Global Coagulation Tests to Guide Blood Component Transfusions in Cirrhosis and ACLF. J Clin Transl Hepatol. 2021 Apr 28;9(2):210-219. doi: 10.14218/JCTH.2020.00121. Epub 2021 Feb 18.
Clinical trial NCT02704884: Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetic Patients With Nephropathy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 48
Sex: ALL
Minimum age (years): 32
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.


Eligibility criteria: Inclusion Criteria:

* Adults
* Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose \>126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria \>300 mg/day, and glomerular filtration rate \>90 mL/min)

Exclusion Criteria:

* pregnancy or lactating in women
* allergy or intolerance to soy milk or avoidance of soy milk consumption
* smoking, alcoholism
* recent antibiotic therapy and using of supplements containing vitamins and minerals
* any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.

Primary outcomes:
measure: inflammatory adipokine- Progranulin (PGRN)
timeFrame: 8 week
measure: cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1),
timeFrame: 8 week
measure: serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: 8 week
measure: cystatin C (Cys- C)
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Makan Pourmasoumi
Study officials:
References:
citation: Miraghajani M, Zaghian N, Mirlohi M, Feizi A, Ghiasvand R. The Impact of Probiotic Soy Milk Consumption on Oxidative Stress Among Type 2 Diabetic Kidney Disease Patients: A Randomized Controlled Clinical Trial. J Ren Nutr. 2017 Sep;27(5):317-324. doi: 10.1053/j.jrn.2017.04.004. Epub 2017 May 31.
Clinical trial NCT01477684: Documentation of In-flight Medical Emergencies With Medical Incident Report Forms.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In-flight Medical Emergency
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical incident report forms

Brief summary: The purpose of this study is to perform a descriptive, content-based analysis on the different forms of documentation for in-flight medical emergencies that are currently provided in the emergency medical kits on board commercial airlines.


Eligibility criteria: Inclusion Criteria:

* medical incident report form

Exclusion Criteria:

* no medical incident report form

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
state: NRW
Study officials:
References:
citation: Sand M, Morrosch S, Sand D, Altmeyer P, Bechara FG. Medical emergencies on board commercial airlines: is documentation as expected? Crit Care. 2012 Dec 12;16(2):R42. doi: 10.1186/cc11238.
Clinical trial NCT00613184: Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Official title: Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Syncytial Virus
Human Metapneumovirus
Influenza
Bronchiolitis
Pediatric
Keywords: Respiratory Syncytial virus
Bronchiolitis
Pediatric
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Diagnostic Laboratories, LLC
name: Copan Innovation Murrietta, CA
First posted: 2008-02-12
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Collection of nasal secretions from infants and toddlers for viral testing is usually done using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly designed swab may work better and in this study we compare the new swab with the old style nasal washing.

.

Detailed description: Collection of nasal secretions from infants and toddlers for viral testing is typically performed using the nasal saline aspirate technique described by Hall in 1975.

Nylon flocked swabs (NFS) and universal transport medium for room temperature (UTM-RT) (Copan Medical, Murrieta, CA) storage media have been found to be an effective collection and transport method for bacteria causing sexually transmitted infections.

We adapted these swabs and storage medium to collect respiratory viruses from children less than18 months old and compared detection rates using NFS and traditional nasal aspirates. We will determine the relative roles of the UTM-RT and NFS release and therefore measured viral detection rates of common respiratory pathogens in traditional saline aspirates stored in UTM-RT.

Our primary hypothesis is that nasal secretions collection using NFS stored in UTM-RT will lead to a higher detection rate of the respiratory viruses we arestudying; namely RSV, Influenza and human metapneumovirus from than collection of unpreserved saline nasal aspirates in children less than 18 months of age.

Eligibility criteria: Inclusion Criteria:

* Treating clinican ordered RSV antigen testing

Exclusion Criteria:

* Refusal of consent
* Age \> 18 months

Primary outcomes:
measure: Viral detection rate by PCR
timeFrame: 0 not applicable
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kern Medical Center & David Geffen School of Medicine UCLA
name: Paul Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409184: Whole Blood Collection From Individuals in the Convalescent Phase of SARS-CoV-2 Infection
Official title: Evaluation of Whole Blood Samples From Coronavirus Disease 2019 (COVID-19) Convalescent Patients to Study Immune Response and Severity of Disease Predictors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID
Sars-CoV2
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Versiti
First posted: 2020-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals cared for at Froedtert Hospital, Milwaukee, Wisconsin who meet the inclusion and exclusion criteria as outlined.

Brief summary: The study was not opened.


Eligibility criteria: Inclusion Criteria:

Patients who have previously been diagnosed with COVID-19 but are now asymptomatic \>14 days and a matched number of healthy controls:

1. Consent: Subject able to provide voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
2. SARS-CoV-2 Testing Status:

   1. Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical laboratory OR
   2. Control Population: Subject without testing or negative SARS-CoV-2 testing
3. Complete resolution and current absence of clinical symptoms Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
4. Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary written consent

Exclusion Criteria:

1. Ongoing symptoms of COVID19 due to SARS-CoV-2 infection

   a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
2. Ongoing symptoms not due or not known to be due to SARS-CoV-2 infection

   a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
3. Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment related to COVID-19 due to SARS-CoV-2

Primary outcomes:
measure: Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.
timeFrame: Up to 1 year post infection.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02378584: Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer
Official title: The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: European Hospital
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 236
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

Detailed description: The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.

Eligibility criteria: Inclusion Criteria:

* frozen-thawed healthy blastocyst

Exclusion Criteria:

* post thawed not survival healthy blastocyst

Primary outcomes:
measure: clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity
timeFrame: 12 weeks after embryo transfer
Secondary outcomes:
measure: live-birth rate confirmed by the number of born
timeFrame: term pregnancy delivery
measure: cost-benefit of two endometrial preparation protocol
timeFrame: 30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test
measure: The number of patients with the anxiety and depression increase
timeFrame: Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
state: RM
city: Rome
country: Italy
facility: European Hospital
state: Roma
Study officials:
affiliation: European Hospital
name: ERmanno Greco, MD
role: STUDY_DIRECTOR
References:
citation: Greco E, Litwicka K, Arrivi C, Varricchio MT, Caragia A, Greco A, Minasi MG, Fiorentino F. The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist. J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.
Clinical trial NCT05308784: A Survey of Physician and Molecular Tumor Board Perspectives on the Clinical Utility and Usability of Cellworks Singula™ and Ventura™ Reports in Facilitating Patient Treatment Decisions for Pan-Cancer Patients
Official title: A Survey of Physician and Molecular Tumor Board Perspectives on the Clinical Utility and Usability of Cellworks Singula™ and Ventura™ Reports in Facilitating Patient Treatment Decisions for Pan-Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pan-cancer
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
Collaborators: name: Cellworks Group Inc.
First posted: 2022-04-04
Enrollment: 730
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cancer at any stage

Brief summary: The purpose of this study is to determine the benefit of Cellworks Singula™ and Ventura™ reports on physician and molecular tumor board treatment recommendations across a large set of pan-cancer indications. Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards.


Eligibility criteria: 1. Have any stage of cancer for the indications listed at: https://cellworks.life/mycare101 Patients are eligible at any stage of disease.
2. Expected to be alive 6 months or more
3. Requirements for NGS testing (e.g., panel or whole-exome sequencing): NGS testing has been ordered from or performed by one or more vendors specified at: https://cellworks.life/mycare101 . NGS reports must be ordered or performed within the last 90 days. Cellworks will accept all NGS input formats available, including PDF, VCF, BAM, and FastQ.
4. Requirements for additional laboratory testing If Hematological Indication, Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered If Acute Myeloid Leukemia (AML), FLT3-itd testing has been ordered If Indication is a form of Brain Cancer (e.g., glioblastoma), Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered and MGMT Methylation test has been ordered

Primary outcomes:
measure: Physician satisfaction on Cellworks reports
timeFrame: 2022.1 - 2023.1
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera McKennan
state: South Dakota
Study officials:
References:
Clinical trial NCT01374984: VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Official title: Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Complication of Smallpox Vaccination
Keywords: smallpox
vaccination
complications
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-06-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.

Brief summary: This is a post-marketing study to verify the clinical benefits of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.

Detailed description: This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the first 100 consented patients treated with VIGIV.

Eligibility criteria: Inclusion Criteria:

Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:

* Eczema vaccinatum.
* Progressive vaccinia.
* Severe generalized vaccinia.
* Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions.
* Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
* Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor.

Exclusion Criteria:

None.

Primary outcomes:
measure: Resolution of vaccinia infection complications
timeFrame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
Secondary outcomes:
measure: Vaccinia antibody levels
timeFrame: Day 5 post VIGIV-infusion
Other outcomes:
Locations:
Study officials:
affiliation: Emergent BioSolutions
name: David Cassie, MSc
role: STUDY_CHAIR
References: