louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00575133: Prospective Cohort Study in Patients With NAFLD
Official title: Multicentric, Prospective, Non-interventional, Long-term Cohort Study in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 150
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: Patients with non-alcoholic fatty liver disease

Brief summary: To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.

Detailed description: Patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with NAFLD (see exclusion criteria). Of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained. In addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. In case of high clinical, laboratory and radiological suspicion for NAFLD, a diagnostic liver biopsy will be performed. A part of the liver tissue is used for histological confirmation of NAFLD and subsequent grading and staging according established criteria. Parts of the remaining liver tissue will be stored for later molecular and histological analysis. In addition, several serum samples are collected of patients and stored for future analysis. All patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis. Liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.

Eligibility criteria: Inclusion criteria:

* Patients with histologically confirmed fatty liver disease

Exclusion criteria:

* History of significant alcohol consumption
* Viral hepatitis
* Autoimmune hepatitis
* Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
* Hepatotoxic medication (e.g. amiodarone).

Primary outcomes:
measure: Disease regression/progression
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Endocrinology and Diabetology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Endocrinology and Diabetology
name: Giatgen Spinas, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065233: Pangenomic Study During Alcoholic Cirrhosis
Official title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Cirrhosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 1325
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2 groups with 2 subgroups:

* patient with HCC
* HCC with Child A
* HCC with Child B/C
* patient without HCC
* Child A without HCC
* Child B/C without HCC

Brief summary: Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.


Eligibility criteria: Inclusion Criteria:

* 35 to 70 years old
* Compensated cirrhosis or not
* Caucasian origin of the parents
* Patient with cirrhosis (histological proof or obvious)

Exclusion Criteria:

* HIV, HBV, HCV positive
* Known Homozygotia (C282Y+/+)
* Important hepatocytary iron overload for patient with resection
* HCC non histologically prooved

Primary outcomes:
measure: Existence of HCC and Pangenomic analysis of DNA polymorphism
Secondary outcomes:
measure: cirrhosis severity (compensated or not)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
city: Paris
country: France
facility: Jean Verdier UH
city: Paris
country: France
facility: Paul Brousse UH
city: Rennes
country: France
facility: Rennes UH
Study officials:
References:
citation: Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Feray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.
Clinical trial NCT02838433: Study of Anti-telomerase T CD4 Immunity in Melanoma
Official title: Study of Anti-telomerase T CD4 Immunity in Melanoma: Predictive Biomarker and Implications for Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor T cell immunity.

Recent progresses on the field of tumor immunology underline the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as UCP: Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this study in melanoma before and after treatment.


Eligibility criteria: Inclusion Criteria:

* patient with melanoma, any stade, without history of anti-cancer treatment (surgery, chemotherapy, targeted therapy, immunotherapy...) except for patients with stade IV melanoma for which immunotherapy or targeted therapy is considered. In this case, a first-line chemotherapy treatment is allowed
* written informed consent

Exclusion Criteria:

* patient with immunosuppressive treatment
* active autoimmune diseases, HIV, hepatitis C or B virus
* patients under guardianship, curatorship or under the protection of justice, pregnant women

Primary outcomes:
measure: Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
Study officials:
References:
Clinical trial NCT05183633: A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
Official title: A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients Susceptible to Falls
Lead sponsor: Curbell Medical Products, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have been previously scheduled for a urodynamic study

Brief summary: A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

Detailed description: The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.

Eligibility criteria: Inclusion Criteria:

* Patients that have been previously scheduled for a Urodynamic Study

Exclusion Criteria:

-

Primary outcomes:
measure: Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.
timeFrame: Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.
Secondary outcomes:
Other outcomes:
Locations:
city: Cheektowaga
country: United States
facility: Western New York Urology Associates
state: New York
Study officials:
References:
Clinical trial NCT02652533: Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
Official title: Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Atresia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2016-01-12
Enrollment: 41
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dL age \<3 months

Brief summary: The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.

Detailed description: The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.

Eligibility criteria: Inclusion Criteria:

* neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dL age \<3 months

Exclusion Criteria:

* inability to obtain parent/guardian consent.
* inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2).
* no other exclusion criteria.

Primary outcomes:
measure: Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1)
timeFrame: 2 years
Secondary outcomes:
measure: Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2)
timeFrame: 6 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital/Stanford University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jonathan Dillman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449433: A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Official title: A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.


Eligibility criteria: Inclusion Criteria:

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
* Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
* Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%)
* Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
timeFrame: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose
Secondary outcomes:
measure: Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
timeFrame: Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03627533: The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
Official title: The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
in Vitro Fertilization
BCL2 Gene mRNA Overexpression
Oocyte Maturation
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
First posted: 2018-08-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: electroacupuncture versus sham electroacupuncture
Primary purpose: TREATMENT

Brief summary: Interventional studies compared electroacupuncture group versus sham electroacupuncture group to granulosa cell apoptosis index, oocyte maturation, GDF9 and BMP15 levels, and fertilization rate in in vitro fertilization program

Detailed description: The study was conducted at the Dr.Cipto Mangunkusumo National General Hospital, Indonesia in September - November 2018.The inclusion criteria are patients who underwent controlled ovarian stimulation with antagonist protocol, age 30-39 years, BMI \<29kg / m2. Exclusion criteria were not having a skin infection at acupuncture point and not using a pacemaker. Then patients were randomly divided into two groups: electroacupuncture and sham electroacupuncture. Electroacupuncture therapy was done 6 times at: 2 times before and 4 times during controlled ovarian stimulation.Apoptotic index of granulosa cells were examined by quantitative real time PCR techniques for BAX/BCL-2 expression.Oocyte maturation and fertilization rate output parameters are examined by competent embryologists after ovum pick up while GDF9 and BMP15 levels were examined by quantitative real time PCR techniques for GDF9 and BMP15 mRNA expression

Eligibility criteria: Inclusion Criteria:

* women underwent controlled ovarian stimulation with antagonist protocol
* BMI \< 29 kg/m2
* willing and sign the inform consent
* follow the research until completed

Exclusion Criteria:

* having skin infection at acupoint location
* use a pacemaker

Primary outcomes:
measure: Index apoptotic (Ratio Bax/Bcl-2) of granulosa cells, GDF9 and BMP15
timeFrame: "up to 1 months"
Secondary outcomes:
measure: oocyte maturation index
timeFrame: "up to 1 months"
measure: Fertilization rate
timeFrame: "up to 1 months"
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Indonesian University
state: DKI Jakarta
Study officials:
affiliation: Medical Acupuncture of Indonesian University
name: Christina Simadibrata, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00549133: Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Official title: Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Diabetes Mellitus Type 2
Keywords: Microalbuminaria in hypertensive patients with type II diabetes mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients


Eligibility criteria: Inclusion Criteria:

* non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
* mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion Criteria:

* congestive heart failure
* azotemia
* insulin dependent diabetes
* liver insufficiency
* pregnancy
* cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)
Secondary outcomes:
measure: Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04809233: Expanded Access to Tipifarnib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)
Keywords: Lymphoma
T-Cell
Peripheral
Non-Hodgkin
HRAS
Peripheral T-cell
Lead sponsor: Kura Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).

To request access, use Responsible Party contact information provided in this record.

Expanded access for tipifarnib is only available in the United States.


Eligibility criteria: Inclusion/Exclusion Criteria:

Diagnosed with HRAS-mutant carcinomas or peripheral T Cell Lymphoma (PTCL).

Adult, ages 18+.

Have exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.

Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.

Meets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: