louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05185154: Natural Course and Prognosis of Hospitalized Patients With Cirrhosis
Official title: Natural Course and Prognosis of Hospitalized Patients With Cirrhosis: a Prospective, Multicenter, and Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 336
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with liver cirrhosis

Brief summary: The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis.

Detailed description: The aim of this prospective study is to collect data on hospitalized patients with liver cirrhosis at four institutions in Korea (Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, Chosun University Hospital, and National Medical Center). If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status \[RFH-NPT\], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. The research database will be updated, every 6 months, to include data on patients' disease outcomes and follow-up care.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with liver cirrhosis
* Admission to the hospital because of cirrhotic complications such as uncontrolled ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, acute kidney injury, bacterial infection, acute liver failure, and etc.

Exclusion Criteria:

* Admission to the hospital without cirrhotic complications
* Patients who refuse the follow-up of outpatient department

Primary outcomes:
measure: All-cause mortality
timeFrame: Up to 2 years
measure: Liver-related mortality
timeFrame: Up to 2 years
Secondary outcomes:
measure: Cause of admission to hospital
timeFrame: At baseline
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Kwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Jae Yoon Jeong
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Won Sohn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519554: Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
Official title: Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biopsy
Keywords: endometrial sampling hysteroscopy
postmenopausal bleeding
endometrial carcinoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.

Detailed description: Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.

A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies

Eligibility criteria: Inclusion Criteria:

* • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.

  * Woman who speak and understand french
  * Woman who give her written informed consent
  * Woman covered by french medical insurance

Exclusion Criteria:

* • Pregnant or breastfeeding patient

  * Patient under guardianship, curators or safeguard of justice.
  * Patient participating in another ongoing study.

Primary outcomes:
measure: To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies
timeFrame: During the pathologist's analysis
Secondary outcomes:
measure: To compare histologic conclusions after 5 and 7Fr biopsies
timeFrame: During the pathologist's analysis
measure: To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma
timeFrame: During the pathologist's analysis
measure: To evaluate the rate of hysteroscopic failure due to cervical stenosis
timeFrame: During the pathologist's analysis
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: APHP
name: Perine CAPMAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803554: Young Donor Plasma Transfusion and Age-Related Biomarkers
Official title: Young Donor Plasma Transfusion and Age-Related Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Ambrosia LLC
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.

Detailed description: Each patient will receive an infusion of plasma derived from a young donor (16-25 years of age). A panel of age-associated biomarkers will be measured before and after treatment.

We have drawn biomarkers from clinical measures of aging and physiology, biomarkers of disease advancement, as well as biomarkers of aging from animal and human studies. These will represent a spectrum of physiologic pathways with evidence-based connections to aging. They include the physiologic processes of inflammation, neurogenesis, stem cell proliferation, blood clotting, immune function, and amyloid plaques. Organ function which will be specifically measured includes the liver, bone marrow, kidneys, pancreas, muscles, cardiovasculature, cerebrovasculature, and the thyroid. Specific disease states connected to these biomarkers include anemia, neutropenia, thrombocytopenia, obesity, diabetes, high cholesterol, elevated risk of cancer, atherosclerosis, dementia, and cataracts.

Visit us at www.ambrosiaplasma.com

Eligibility criteria: Inclusion Criteria:

* 35 years of age or older

Primary outcomes:
measure: Blood biomarkers (1/3)
timeFrame: Change from before treatment to 1 month after treatment
measure: Blood biomarkers (2/3)
timeFrame: Change from before treatment to 1 month after treatment
measure: Blood biomarkers (3/3)
timeFrame: Change from before treatment to 1 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04415554: Aminoglycosides and Duct
Official title: The Effect of Aminoglycosides on Ductus in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm infants hospitalized in NICU

Brief summary: The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms


Eligibility criteria: Inclusion Criteria:

infants born at or above 32 weeks of gestation

-

Exclusion Criteria:

* infants who are unlikely to survive or have congenital heart defects

Primary outcomes:
measure: ductal closure
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01036854: Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)
Official title: Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea
Keywords: Ondansetron, EUR-1025
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.

Detailed description: The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers
* Non- or ex-smokers
* At least 21 years of age but not older than 55 years
* Body mass index targeted to be at least 18.5 and less than 30 kg/m2.
* Acceptable lab tests
* Normal 12 lead ECG
* Negative human chorionic gonadotropin (hCG) for females.

Exclusion Criteria:

* No known hypersensitivity to Ondansetron or any related products
* No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption
* No presence of significant heart disease or disorder discovered on screening ECG
* Not pregnant
* No alcohol or drug abuse history
* No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP)
* No previous Investigational Product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study

Primary outcomes:
measure: Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: Algorithme Pharma INc.
state: Quebec
Study officials:
affiliation: Algorithme Pharma Inc
name: Eric Sicard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02448654: Treatment for Nicotine Addiction in Women
Official title: COMT Inhibition as a Novel Treatment for Nicotine Addiction in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-05-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.

Detailed description: The proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the COMT inhibitor, tolcapone, in nicotine dependent women. This study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. Withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. Smoking urges will be assessed by a self-report scale.

Eligibility criteria: Inclusion Criteria:

* Must be 18yrs to 45yr old woman, read and write in English.
* Must smoke at least 5 or more cigarettes a day
* FTND score at least 4 or higher
* A CO reading of 10 or higher during screening
* Must be in good health as verified by medical history, screening exam, screen laboratory tests.

Exclusion Criteria:

* Excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.

Primary outcomes:
measure: Withdrawal Symptoms (MNWS Score)
timeFrame: Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8)
measure: Smoking Urges (BQSU Factor 1)
timeFrame: Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8)
measure: Smoking Choice Paradigm: Amount Earned ($)
timeFrame: Pill-Day 8 (end of trial)
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Veterans Administration Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Elise DeVito, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830854: Molecular Hydrogen for Cognitive Function and Performance in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognitive Impairments
Aging
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.


Eligibility criteria: Inclusion Criteria:

* Age over 65
* No psychiatric comorbidities

Exclusion Criteria:

* Use of dietary supplements 4 weeks before study commence

Primary outcomes:
measure: ADAS-Cog score for cognitive function
timeFrame: Change from Baseline ADAS-Cog Score at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
References:
citation: Ostojic SM. Molecular hydrogen: An inert gas turns clinically effective. Ann Med. 2015 Jun;47(4):301-4. doi: 10.3109/07853890.2015.1034765. Epub 2015 May 4.
citation: Ostojic SM. Targeting molecular hydrogen to mitochondria: barriers and gateways. Pharmacol Res. 2015 Apr;94:51-3. doi: 10.1016/j.phrs.2015.02.004. Epub 2015 Feb 24.
citation: Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8.
Clinical trial NCT01018654: Validating Interventions for Diverse Adolescents
Official title: Efficacy of Group Treatment for Hispanic Adolescents - RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Keywords: Substance Abuse
Substance Addiction
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-11-25
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.


Eligibility criteria: Inclusion Criteria:

* Adolescent between 13-18 years of age
* Parental consent
* Adolescent speaks English and Spanish
* Adolescent assent to participate in treatment and assessments
* Adolescent meets either DSM-IV diagnostic criteria for substance abuse or dependence
* Adolescent identifies as Hispanic

Exclusion Criteria:

* Adolescent younger than 13 or older than 18 years of age
* Adolescent requires higher level of care than what is provided in study
* Adolescent speaks only English or Spanish
* Parental consent not obtainable
* Adolescent does not assent to study
* Adolescent is overtly psychotic, severely depressed/suicidal, and/or presents with other mental disorder that will limit participation in group treatment
* Adolescent has completed substance abuse treatment elsewhere in the past 90 days
* Adolescent does not identify as Hispanic

Primary outcomes:
measure: Substance Use Levels
timeFrame: Posttreatment, 3, 6, 12-month follow-ups
Secondary outcomes:
measure: Satisfaction with Treatment
timeFrame: Posttreatment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT05659654: The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
Official title: A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: ursodeoxycholic acid
COVID-19
prevention
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers

Detailed description: This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 65 years old.
2. No restriction on gender.
3. Medical-related personnel (working hours \>20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
4. COVID-19 nucleic acid test negative within 48 hours
5. Sign the informed consent form

Exclusion Criteria:

1. Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
2. Previous infection with novel coronavirus within 6 months
3. Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
4. Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
5. Pregnancy and lactation
6. Use of drugs with which ursodeoxycholic acid is contraindicated
7. Other reported health conditions that make participation in the study not in the best interest of the individual

Primary outcomes:
measure: Prevalence of novel coronavirus infection
timeFrame: Receiving 4 weeks of continuous ursodeoxycholic acid
Secondary outcomes:
measure: The proportion of people infected with novel coronavirus who turned severe
timeFrame: 8 weeks
measure: The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus
timeFrame: 8 weeks
measure: The rate of positive serological antibodies in the population of healthy volunteers
timeFrame: 8 weeks
measure: The incidence of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
state: Tianjin
Study officials:
References: