louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03209791: Ethanol Induces Skeletal Muscle Autophagy
Official title: Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcoholic Liver Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically characterized patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using protocols already established by the PI.

Brief summary: In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.

Detailed description: Hypothesis: Ethanol mediated modification of skeletal muscle proteins to form MAA adducts that in turn induce skeletal muscle autophagy.

Patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using anthropometry, bioelectrical impedance analysis, CT image analysis and DEXA if available.

Control Subjects. Controls will be recruited by advertisement. All control subjects will have a normal clinical history, physical examination, and screening chemistries. They will not have any significant medical conditions requiring the use of medications. Their nutritional status within 20% of normal as defined by ideal body weight.

Eligibility criteria: Inclusion Criteria:

Alcoholic liver disease:

* clinical, biochemical, imaging criteria and liver biopsy where available
* Age 18 - 65 years old

Controls:

* Serum liver transaminases (i.e. ALT and AST) 40 IU/L
* Normal liver ultrasound
* Age 18 - 65 years old

Exclusion Criteria:

For both groups - alcoholic liver disease and controls:

* Poorly controlled diabetes mellitus (HbA1C\>9.5 g/dl)
* Untreated Hyper- / hypo- thyroidism
* Patients on dialysis, renal disease with serum creatinine 1.5 mg/dL
* Active intravenous drug use
* History of bowel surgery or gastric bypass surgery
* Medications known to alter muscle protein metabolism (i.e. corticosteroids, tamoxifen, high-dose estrogen, testosterone or anabolic steroids)
* Metastatic disease, Advanced cardiac or pulmonary disease
* Pregnancy
* Coagulopathy- INR \>1.4 and platelet count \<80,000/ml.

Primary outcomes:
measure: Skeletal Muscle Autophagy
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Srinivasan Dasarathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760591: Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)
Official title: Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Failure
Keywords: Acute kidney failure
Colonoscopy
Neutrophil gelatinase-associated lipocalin
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 30
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: 18-65 year old volunteers who want to get colonoscopy

Brief summary: Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. There are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. Several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. Its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. We would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation of classical markers for kidney damage such as serum creatinine. The investigators will investigate the change of NGAL following sodium phosphate bowel preparation.


Eligibility criteria: Exclusion Criteria:

* Who takes ACE-inhibitor, ARB
* Has a renal or heart disease
* Has a serum electrolyte disturbance

Primary outcomes:
measure: NGAL
timeFrame: Baseline, colonoscopy day, post 1day, post 2 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
Study officials:
References:
Clinical trial NCT02197091: Communication Effectiveness in Cancer Treatment
Official title: A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults receiving cancer treatment

Brief summary: This pilot research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy.

SECONDARY OBJECTIVES:

I. To explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care.

II. To gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care.

OUTLINE:

Patients complete questionnaires, including the Functional Assessment of Cancer Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.

After completion of study, patients are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of cancer
* Patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document

Primary outcomes:
measure: Patient perceptions about the nature of their therapy and diagnosis
timeFrame: Baseline
measure: Feasibility, as assessed by accrual rate
timeFrame: Up to 5 years
measure: Feasibility, as assessed by participation rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Incidence of discrepancies between patient perceptions and the clinical record
timeFrame: Baseline
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katharine Duckworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266691: Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer
Official title: Molecular Metastasis in Lymph Nodes is Associated With Survival of Patients With Stage I NSCLC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Regional Lymph nodes
Molecular metastasis
Driver gene mutation
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 237
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: Histologically or cytologically proven diagnosis of early stage NSCLC

Brief summary: Analysis of driver gene variation in early stage non-small cell lung cancer

Detailed description: Fluorescence quantitative polymerase chain reaction (PCR) was used to detect the variation of driver gene in regional lymph nodes of early stage non-small cell lung cancer (NSCLC), and to analyze the relationship between the variation and disease recurrence and survival prognosis. evaluate the effect of the variation of driving gene in lymph nodes of early stage NSCLC on prognosis, identify the high-risk factors that promote the recurrence and metastasis of early stage tumor. so as to improve the diagnosis and treatment path of lung cancer, provide important pathological basis for the clinical diagnosis and treatment of early stage non-small cell lung cancer, enable patients to receive more accurate treatment, and improve their survival prognosis.

Eligibility criteria: Inclusion Criteria:

1. Female or male, 18 years of age or older
2. Histologically or cytologically proven diagnosis of early stage NSCLC
3. The lesion was completely resected by radical surgery
4. Able to get tumor tissue sample
5. Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up

Exclusion Criteria:

1. Combine with other tumor type
2. The investigator judges the situation that may affect the clinical search process and results

Primary outcomes:
measure: Driver gene mutation frequency of early stage NSCLC
timeFrame: 2019
measure: Correlation of Clinicopathological characteristics and driver gene mutation in regional lymph nodes of early stage NSCLC
timeFrame: 2019
measure: Correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
timeFrame: 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tian Y, Lai Q, Zheng Y, Ying L, Wang C, Jin J, Huang M, Wu Y, Li H, Zhang J, Su D. Oncogenic Alterations in Histologically Negative Lymph Nodes Are Associated with Prognosis of Patients with Stage I Lung Adenocarcinoma. Cancers (Basel). 2022 Feb 6;14(3):824. doi: 10.3390/cancers14030824.
Clinical trial NCT04590391: Visual and Auditory Breathing-swallowing Coordinated Training
Official title: Validation of Visual and Auditory Breathing-swallowing Coordinated Training Equipment in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing-Swallowing Coordination
Dysphagia Rehabilitation
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Dysphagia is caused by multiple factors, and respiratory-swallowing discoordination is considered to be one of the factors. The investigators recently developed a visual and auditory breathing-swallowing coordinated training device. In this study, investigators examined the validity of a this device for healthy subjects. The investigators will examine which respiratory phase the swallowing occurs when the swallowing is started in accordance with the signal lighting and voice of this device.


Eligibility criteria: Inclusion Criteria:

* Subjects with written informed consent to participate in the study

Exclusion Criteria:

* Subjects with an apparent swallowing disorder
* Subjects with clinically evident cerebrovascular diseases

Primary outcomes:
measure: Time from signal lighting and sounding to start swallowing
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References:
Clinical trial NCT05870891: Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
Official title: Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Lead sponsor: General Mills
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2023-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL) value of portions of white bread containing 5 g available carbohydrate measured in this study is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods will be measured to determine their glycemic impact.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-75 inclusive
* Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days
* Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
* Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria at screening
* Pregnant or lactating individuals
* Personal history of diabetes
* Major trauma or surgical event within 3 months of screening
* The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator
* Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines
* Known intolerance, sensitivity, or allergy to any ingredients in the study test meals. All allergens should be assumed to be a result of manufacturing practices.
* Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification

Primary outcomes:
measure: Equivalent glycemic load
timeFrame: -5 minutes to 120 minutes
Secondary outcomes:
measure: Insulin iAUC over 120 minutes
timeFrame: -5 minutes to 120 minutes
measure: Glucose iAUC over 120 minutes
timeFrame: -5 minutes to 120 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research, Ltd.
state: Ontario
Study officials:
References:
Clinical trial NCT06420791: The Dual Impact of Cirrhosis on Transplantation for Hepatocellular Carcinoma：a Two-center Retrospective Cohort Study in China
Official title: The Dual Impact of Cirrhosis on Transplantation for Hepatocellular Carcinoma：a Two-center Retrospective Cohort Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Cirrhosis
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously registered liver transplant recipients

Brief summary: Background: This study aims to investigate the correlation between cirrhosis and hepatocellular carcinoma (HCC) recurrence after Liver Transplantation.

Methods: The study retrospectively collected data enrolled from 519 HCC patients who underwent liver transplantation from two center(the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital, January 2015 to December 2020), Based on important variables, 1:3 propensity score matching (PSM) were performed respectively.


Eligibility criteria: Inclusion Criteria:

The patients undergoing liver transplantation for HCC from January 2015 to December 2020.

Exclusion Criteria:

Re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 90 days.

Primary outcomes:
measure: The overall survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 2-5 years
Secondary outcomes:
measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University school of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01531491: Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
Official title: Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Intravenous
Anesthesia Recovery Period
Keywords: Emergence
Hypercapnia
Hypocapnia
Propofol
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the rate of propofol elimination from the brain and the blood will be increased and the patient will awake more quickly. There has been no study about the effects of hypercapnia. The investigators will evaluate hypercapnia's effects on the recovery time from propofol anesthesia.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA PS) I-II
* Age 20 - 60 years male and female
* Elective schedule with minor surgery under general anesthesia

Exclusion Criteria:

* Body mass index (BMI) \>= 30 (kg/m2)
* Patient with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
* Patient with medication affecting on this study
* Patient with general anesthesia history within one month

Primary outcomes:
measure: Time to open eyes under investigator's command
timeFrame: From cessation of propofol infusion to patient's eye opening (seconds)
Secondary outcomes:
measure: Time to breath spontaneously
timeFrame: From cessation of propofol infusion to patient's spontaneous breathing (sec)
measure: Change of bispectral index (BIS)
timeFrame: From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.
measure: Time to open mouth under investigator's command
timeFrame: From cessation of propofol infusion to patient's mouth opening (seconds)
measure: Time to extubation
timeFrame: From cessation of propofol infusion to extubation (sec)
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
state: Kyunggido
Study officials:
affiliation: Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
name: Junyong In, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01160991: Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism
Official title: Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Diabetes
Insulin Resistance
Keywords: schizophrenia
olanzapine
atypical antipsychotic drugs
amisulpride
diabetes
insulin resistance
insulin secretion
glucose
euglycemic hyperinsulinemic clamp
hyperglycemic clamp
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-07-13
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.

Detailed description: 10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo). Subsequently, measurements of insulin sensitivity and insulin secretion are performed by euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.

Eligibility criteria: Inclusion Criteria:

* healthy male volunteers
* written informed consent

Exclusion Criteria:

* BMI \> 30 kg/m²
* Diabetes mellitus
* Hypertension
* Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
* History of seizures

Primary outcomes:
measure: insulin sensitivity
timeFrame: 90 thru 120 min after application of study drug
Secondary outcomes:
measure: pancratic c-peptide secretion
timeFrame: 120 thru 180 minutes after administration of study drug
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Central Institute of Mental Health, Mannheim
name: Daniel Kopf, M.D.
role: PRINCIPAL_INVESTIGATOR
References: