louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001879: Collections of Blood and Stool Samples in Patients With Acute Hepatitis
Official title: Collection of Blood and Stool Samples in Patients With Acute Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Keywords: Liver Disease
Novel Agents
Serum
Viruses
non-A,G Hepatitis
Seronegative Acute Hepatitis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. Researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. Researchers call conditions like this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection.

Seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia.

Researchers have attempted to identify the cause of these conditions but have been unsuccessful. Therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible.

Detailed description: While several viruses have been identified as agents of liver inflammation, some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses A, B, C, or E. Seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences, especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Efforts in the Hematology Branch to identify an infectious agent in these latter two syndromes have been unsuccessful, probably because they are immune-mediated and also accompanied by massive tissue destruction. We now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research. Samples will be collected from patients in United States Army clinics; patient identifiers will be employed.

Eligibility criteria: Collection of blood samples.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Atillasoy E, Berk PD. Fulminant hepatic failure: pathophysiology, treatment, and survival. Annu Rev Med. 1995;46:181-91. doi: 10.1146/annurev.med.46.1.181.
citation: Williams R. Classification, etiology, and considerations of outcome in acute liver failure. Semin Liver Dis. 1996 Nov;16(4):343-8. doi: 10.1055/s-2007-1007247.
Clinical trial NCT04818879: Abdominal Electromyographic Control in Vojta Therapy
Official title: Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Muscles
Keywords: Electromyography
Abdominal Muscles
Muscle Contraction
Outcome and Process Assessment
Health Care
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Colegio Profesional de Fisioterapeutas de Castilla y León
First posted: 2021-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Vaccinated in the 10 days prior to the intervention
* Fever

Primary outcomes:
measure: Electromyographic activity in abdominal muscles
timeFrame: Change from Baseline electromyographic activity at 7 minutes.
Secondary outcomes:
measure: Date of birth
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: International Physical Activity Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
affiliation: University of Salamanca
name: Fátima Pérez-Robledo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289379: The Effect of High Frequency Jet Ventilation (HFJV)During Laparoscopic Operations
Official title: The Effect of High Frequency Jet Ventilation (HFJV)on Pneumoperitoneum Induced Cardiovascular Changes, During Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: pneumoperitoneum
laparoscopy
HFJV
cardiovascular
Symptomatic
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-02-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis.

Exclusion Criteria:

* ASA 3 and 4

Primary outcomes:
measure: Cardiac functionality (Cardiac output,VOLUME)
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
Clinical trial NCT02757079: Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
Official title: Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Disorders
Neurodevelopmental Disorder
Keywords: Melatonin
NPC-15
Sleep disorders
Neurodevelopmental disorder
Sleep latency
DSM-5
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

Detailed description: This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Eligibility criteria: Inclusion Criteria:

* Female or male patients aged 6 to 15 years.
* Patients with "neurodevelopmental disorder" diagnosed by using DSM-5.
* Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months
* Patients who are out-patient, not hospitalized patient.
* Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.

Exclusion Criteria:

* Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than " the most severe" by using DSM-5.
* Patients who took melatonin (including supplement) in history.
* Patients who had taken Ramelteon within 4 weeks before clinical study starts.

Primary outcomes:
measure: Sleep latency with electronic sleep diary at week 10.
timeFrame: 10 weeks
Secondary outcomes:
measure: Sleep latency with electronic sleep diary at week 26.
timeFrame: 26 weeks
measure: Abnormal behavior checklist Japanese version
timeFrame: Week 10, 26
measure: Adverse events
timeFrame: 28 weeks
measure: Laboratory findings, vital sign
timeFrame: 28 weeks
measure: Electro cardiogram
timeFrame: 28 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Department of Pediatrics and Child Health Kurume University School of Medicine
name: Yushiro Yamashita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753779: A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Official title: Efficacy of WelChol® as an Add-on to Simvastatin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Males or females
* \> or = to 18 years of age
* On a stable dose of simvastatin for 4 or more weeks
* LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
* TG \< 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception

Exclusion Criteria:

* BMI \> 40
* Allergic to colesevelam HCl
* History of swallowing disorder
* History of gastrointestinal motility disorder
* Any disorder that might interfere with the study
* History of drug or alcohol abuse

Primary outcomes:
measure: The percent change in LDL-C from baseline to endpoint
timeFrame: 6 weeks
Secondary outcomes:
measure: The absolute change in LDL-C from baseline to endpoint
timeFrame: 6 weeks
measure: The absolute and % change of total cholesterol
timeFrame: 6 Weeks
measure: The absolute and % change in triglycerides
timeFrame: 6 Weeks
measure: The absolute and % change in HDL-C
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Castle Rock
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Bartlett
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT00081679: SES, Health Behaviors and CVD Among Vietnam-Era Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2004-04-21
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs.

Detailed description: BACKGROUND:

Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson \& Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health.

DESIGN NARRATIVE:

The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Miriam Hospital
name: Jeanne McCaffery
References:
Clinical trial NCT00725179: Treatment of Acetaminophen Toxicity With N-acetylcysteine
Official title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetaminophen Toxicity
Keywords: acetaminophen toxicity
n-acetylcysteine
liver toxicity
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adolescent patients with acetaminophen toxicity

Brief summary: Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.


Eligibility criteria: Inclusion Criteria:

* Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
* Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained \> 4 hours post ingestion
* Between the ages of 0-21 years

Exclusion Criteria:

* Serum APAP concentrations are not actually documented
* Patient did not receive oral or IV NAC treatment
* Patient has a preexisting liver disease such as cirrhosis or hepatitis C
* Patient \> 21 years of age

Primary outcomes:
measure: Duration of oral vs IV NAC treatment in hours
timeFrame: From admission to discharge
Secondary outcomes:
measure: Overall healthcare costs associated with IV vs Oral NAC treatment
timeFrame: From admission to discharge
Other outcomes:
Locations:
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
Study officials:
affiliation: CHMCA
name: Martha Blackford, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278.
citation: Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev. 2005;24(2):131-43. doi: 10.2165/00139709-200524020-00007.
citation: Kanter MZ. Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning. Am J Health Syst Pharm. 2006 Oct 1;63(19):1821-7. doi: 10.2146/ajhp060050.
citation: Blackford MG, Felter T, Gothard MD, Reed MD. Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review. Clin Ther. 2011 Sep;33(9):1322-30. doi: 10.1016/j.clinthera.2011.08.005. Epub 2011 Sep 3.
Clinical trial NCT04941079: Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study
Official title: Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Myopathy
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health controls who are willing to receive two dose of SARS-CoV-2 inactivated vaccine.

Brief summary: This study is a prospective observational study. We aim to investigate the safety and efficacy of inactivated SARS-CoV-2 vaccine between immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health controls. The main study factors include adverse events following immunization (AEFI), serum specific antibody (Acetylcholine receptor (AChR) antibody, Anti-MuSK (muscle-specific kinase) antibody, myositis antibody) and virus neutralizing antibody titers.


Eligibility criteria: Inclusion Criteria:

1. Complete behavioral ability
2. Voluntary willingness to vaccinate
3. Clinically confirmed immune-related myopathy (myasthenia gravis and inflammatory myopathy) and immune-related myopathy (myasthenia gravis and inflammatory myopathy)was stable
4. Informed consent to the research

Exclusion Criteria:

1. No independent behavior ability
2. Vaccination is contraindicated
3. Other diseases that significantly affect the immune function
4. Other diseases that may significantly affect immune function are being treated
5. Vaccination contraindication was found during the study observation period
6. Other diseases that may significantly affect immune function were diagnosed during the study observation period
7. Treatments for other diseases that may significantly affect immune function were initiated during the study observation period
8. Refused regular follow-up

Primary outcomes:
measure: Adverse events following immunization (AEFI)
timeFrame: 6 months
measure: Serum specific antibody
timeFrame: 6 months
measure: Virus neutralizing antibody titer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00710879: Evaluation of a Multi-Purpose Solution
Official title: A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solutions
Keywords: Efficacy
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
* Must be able and willing to comply with all treatment and follow-up study procedures.
* Must have a clear central cornea.
* VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

* Systemic disease affecting ocular health.
* Using systemic or topical medications.
* Wear monovision, multifocal or toric contact lenses.
* Any grade 2 or greater slit lamp findings.
* Pregnancy

Primary outcomes:
measure: Antimicrobial Efficacy
timeFrame: 2 weeks, 3 months
Secondary outcomes:
measure: Solution Related AE's and Lens Changes
timeFrame: 3 months, 6 months
measure: Solution Utlility
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Dr. Nicholas Marsico
state: California
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Bev Barna
role: STUDY_DIRECTOR
References: