louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03338933: Neurobiology of Alcohol and Nicotine Co-Addiction
Official title: Neurobiology of Alcohol and Nicotine Co-Addiction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorder
Nicotine Use Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2017-11-09
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from the Portland VA, Oregon Health \& Science University, community substance abuse treatment programs and by advertisement.

Brief summary: This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users.

Detailed description: This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S. Co-addiction is particularly high in military veterans. Although nationwide estimates peg the rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated for AUD also meet criteria for NUD. The investigators hypothesize that a support vector machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD both or neither and that the algorithm will predict outcome (sobriety or relapse) at three months.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* None

Primary outcomes:
measure: Brain Activation During Functional Magnetic Resonance Imaging (fMRI) in Response to a Stress Modulated Cue Induced Craving Task (DSNBACK)
timeFrame: Baseline
measure: Brain Activation During Resting State MRI.
timeFrame: Baseline
measure: Brain Cortical Thickness Assessed During MRI
timeFrame: Baseline
measure: Brain White Matter Integrity as Assessed by Fractional Anisotropy During MRI
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: William F Hoffman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399333: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
Official title: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Protein Deficiency
Keywords: PDCAAS
Bariatric patient
Lead sponsor: Southeast Bariatrics, PA
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Charlotte
First posted: 2011-07-21
Enrollment: 60
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: SCREENING

Brief summary: The purpose of this research study is to compare the varying qualities of protein supplements utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating the clinical outcome related to protein stores and absorption.

Detailed description: The PDCAAS has been adopted by the Food and Agricultural Organization (FAO) of the World Health Organization (WHO) and is currently recognized as the standard method to evaluate protein quality. This study will also examine patient tolerability, satiety, and satisfaction while using meal replacements versus protein supplements. This research study looks to gain knowledge on the varying qualities of protein and find the most effective protein supplement and/or meal replacement that provides increased patient compliance and promotes a healthy recovery.

Eligibility criteria: Inclusion Criteria:

* Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.
* Not having any medical confounding factors as described in exclusion criteria.
* Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.

Exclusion Criteria:

* Persons who are not undergoing AGB surgery or are unwilling to comply with study methods or are medically not eligible.
* Taking diuretics
* Have been diagnosed with unstable diabetes, unstable neurologic conditions, unstable cardiac conditions or gastro-intestinal disorders, renal dysfunction, wounds, and autoimmune disorders that may increase protein needs.
* Uncontrolled gastrointestinal disease, such as Crohn's disease, diverticulitis, Celiac disease, or ulcerative colitis.
* Active malignancy
* Patients will also be excluded if pre-operative vitamin deficiencies are not corrected by surgery.

Primary outcomes:
measure: Protein Absorption
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient Compliance with Protein Supplement
timeFrame: 4 weeks
measure: Patient tolerability and satisfaction of protein supplement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Southeast Bariatrics
state: North Carolina
Study officials:
affiliation: Southeast Bariatrics
name: David C Voellinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06627933: Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
Official title: Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thromboembolism
Anticoagulant-induced Bleeding
Keywords: joint replacement
prognosis
anticoagulation regimen
thromboembolism
venous thromboembolism
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is planned to include 1,000 patients with cardiovascular diseases who undergo routine endoprosthetics of large joints of the lower extremities. During the follow-up, patients will be divided into subgroups depending on the scheme of perioperative prevention of thromboembolic complications and the presence of risk factors. The comparison will be carried out in the appropriate subgroups.

Brief summary: The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age older than 18 y.o.
* Cardiovascular disease
* Indications for planned lower limb joint replacement surgery

Exclusion Criteria:

* Pregnancy
* Psychiatric disorders
* Decompensated heart failure or acute heart failure
* Known diagnosis of cancer

Primary outcomes:
measure: Bleeding
timeFrame: 1 month
measure: Bleeding
timeFrame: 3 months
measure: Bleeding
timeFrame: 6 months
measure: Thromboembolism
timeFrame: 1 month
measure: Thromboembolism
timeFrame: 3 months
measure: Thromboembolism
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Hospital #1
Study officials:
References:
citation: Okisheva EA, Mironova OI, Berdysheva MV, Pyatigorets ES, Krivova NP, Kurnosova AA, Elizarov MP, Smetanin SM, Lychagin AV, Fomin VV. [Relationship between the pain severity, use of non-steroidal anti-inflammatory drugs and blood pressure in elective large joint arthroplasty of the lower extremities]. Ter Arkh. 2023 Nov 3;95(9):751-756. doi: 10.26442/00403660.2023.09.202373. Russian.
citation: Okisheva EA, Trushina OY, Mamaeva MM, Redyanova EA, Zhazhieva AA, Chasova ID, Panferov AS, Bogdanov MM, Lychagin AV, Fomin VV. [Glucose metabolism disorders and hypoglycemic therapy in patients hospitalized for elective lower limb arthroplasty: a prospective, single-center, real-world study]. Ter Arkh. 2024 Jul 30;96(7):659-665. doi: 10.26442/00403660.2024.07.202780. Russian.
Clinical trial NCT00204633: Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Official title: Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysgerminoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa


Eligibility criteria: Inclusion Criteria:

* Poor prognosis" according IGCCCG-criteria:
* Primary mediastinal tumor
* Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
* Poor marker: AFP \> 10.000 ng/ml or beta-HCG \> 10.000 ng/ml (50.000 IU/l) andd LDH \>10 x upper normal limit
* No previous chemotherapy
* Age \> 18 years
* Performance-Status: WHO =\< 2
* Written informed consent
* Ability to give informed consent

Exclusion Criteria:

* Hemolysis
* Hematological disease with insufficient erythropoiesis
* Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
* Uncontrolled arterial hypertension
* Treatment with rh-Erythropoetin during trial
* Creatinin clearance \< 50 ml/min
* Insufficient bone marrow function (WBC count \< 3.000/ml or platelets \< 100.000/µl)
* Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
* Second malignancy, except of completely resected basal cell carcinoma of the skin

Primary outcomes:
measure: frequency of transfusions (reduction from 90% to 65%)
Secondary outcomes:
measure: proportion of patients with no transfusions
measure: developing of hemoglobin levels
measure: objective remission rate
measure: progression-free- and overall-survival (pfs, os)
measure: quality of life
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Medical Center II, University of Tuebingen
Study officials:
affiliation: South West German Cancer Center, Medical Center II, University of Tuebingen
name: Joerg T. Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05446233: ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Antaitavir Hasophate in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Antaitavir Hasophate.


Eligibility criteria: Inclusion Criteria:

* signing of informed consent
* Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Exclusion Criteria:

* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
* Positive results from urine drug screen test
* Donate blood or lose blood 400 mL or more within 3 month prior to dosing
* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection

Primary outcomes:
measure: Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate
timeFrame: up to 15 days
measure: Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)
timeFrame: up to 15 days
Secondary outcomes:
measure: Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate
timeFrame: up to 15 days
measure: Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
timeFrame: up to 15 days
measure: Number of adverse events (AE) experienced by subjects
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai xuhui central hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00629733: Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
ultra low molecular weight heparin
Lead sponsor: Rovi Pharmaceuticals Laboratories
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers: male subjects aged between 18 and 45 years
2. Body weight: 65-75 Kg
3. Not meaningful abnormalities in physical examination and in clinical history
4. Without evidence of significant organic or psychiatric illness
5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
8. Not give blood in the last 4 weeks.
9. Healthy male volunteers who have not received heparin in the past
10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent

Exclusion Criteria:

1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
2. Important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day
3. Allergy, idiosyncrasy or hypersensitivity to medicines
4. Healthy volunteers who are receiving another medication in the past 15 days
5. Positive serology of hepatitis B, C or HIV
6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
7. Mayor Surgery in the last 6 months
8. Smoking \> 10 cigarettes / day
9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
10. Healthy volunteers with a familiar history evident hemorrhagic episodes

Primary outcomes:
measure: Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers
timeFrame: safety parameters
Secondary outcomes:
measure: Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.
timeFrame: anti-Xa activity
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Dr Manuel Barbanoj
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919633: Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Official title: COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: hepatitis C
HCV
genotype
sustained virological response
rapid virological response
interferon
Lead sponsor: Medtronic Corporate Technologies and New Ventures
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.

Detailed description: The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.

Eligibility criteria: Inclusion Criteria:

* Signed patient consent form
* Genotype 1 chronic HCV with detectable HCV RNA
* No previous treatment for HCV infection
* Hepatitis B and human immunodeficiency virus negative at screening visit
* Able and willing to follow contraception requirements
* Screening laboratory values, test, and physical exam within acceptable ranges
* Weight between 40 kg and 125 kg
* Proficiency in the use of the external pump infusion system

Exclusion Criteria:

* Current or planned enrollment in another investigational device or drug study
* Anticipated inability to complete all clinic visits and comply with study procedures
* History of, or any current medical condition, which could impact the safety of the subject during the study
* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
* Alcoholism or substance abuse with \<6 documented months of sobriety
* Known allergy or sensitivity to interferons or ribavirin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study

Primary outcomes:
measure: Viral Load: Incidence of Sustained Virologic Response (SVR)
timeFrame: 24 weeks after treatment is complete
Secondary outcomes:
measure: Rapid Virologic Response (RVR)
timeFrame: Study Week 4
measure: Early Virologic Response (EVR)
timeFrame: Study week 12
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Andrew Muir, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic Ventures and New Therapies
name: Sarah Mische, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03766633: Accuracy of the LiverVision® Semi-automated Liver Volumetry Software
Official title: Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Liver Cancer
Keywords: LiverVision
Liver
Volumetry
Semi-automated
Living donor liver transplantation
Surgery
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Ankara University
name: University Hospital Tuebingen
name: Imperial College Healthcare NHS Trust
First posted: 2018-12-06
Enrollment: 108
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: Consecutive living liver donors that underwent a CT prior to liver donation. The raters will be 6 surgeons and 6 radiologists, both junior and senior.

Brief summary: The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools.

Detailed description: Liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively.

Liver volumetry is typically performed using CT imaging with specially designed software. Such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years or older)
* Living liver donors.

Exclusion Criteria:

* Recipients

Primary outcomes:
measure: Accuracy of the LiverVision® software volumetric measurements
timeFrame: Baseline (CT performed prior to donation).
Secondary outcomes:
measure: Learning curve of the raters
timeFrame: Baseline (CT performed prior to donation).
measure: Certainty and accuracy of the volumetric measurements.
timeFrame: Baseline (CT performed prior to donation).
measure: Comparison
timeFrame: Baseline (CT performed prior to donation).
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Massimo Malago', MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: