louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00282763: A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005)
Official title: Proprietary Information - Exploratory (Non-confirmatory) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know as PHN or Post Shingles Pain).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of postherpetic neuralgia with pain having lasted at least 6 months
* Able to complete study questionnaires, patient diary, and comply with daily study medication
* Patient is not satisfied with current treatment for pain control

Exclusion Criteria:

* Pregnant or nursing female
* History of evidence of a condition that in the opinion of the investigator, may interfere with the study results (e.g., diabetic neuropathy of fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease)

Primary outcomes:
measure: proprietary information - exploratory (non-confirmatory) trial
Secondary outcomes:
measure: proprietary information - exploratory (non-confirmatory) trial
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00404963: A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
Official title: A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study With Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: GSK376501,
First Time in Human,
Single Dose,
Dose Escalation,
Healthy Overweight/Obese Volunteer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 72
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: DIAGNOSTIC

Brief summary: This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.

Detailed description: A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)

Eligibility criteria: Inclusion:

* Healthy
* Non-smoking
* Overweight or obese subjects with a BMI between 27 and 35.

Exclusion:

* Women who are pregnant, lactating, or are of child-bearing potential

Primary outcomes:
measure: Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes.
timeFrame: throughout the study
Secondary outcomes:
measure: Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers
timeFrame: throughout the study
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT00286663: Autoimmune Hepatitis Study
Official title: Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis, Autoimmune
Keywords: AIH, Autoimmune Hepatitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to determine the role special antibodies play in possibly identifying Autoimmune Hepatitis through the following:

Identify the response of specific T cells to antibodies and Monitor the response of the cells that regulate the immune system

Detailed description: The object of this protocol is to characterize and monitor auto antigen-specific T cell responses in blood and liver biopsies of patients with anti-SLA/LP or anti-LKM-positive autoimmune hepatitis. The results will provide insight into the pathogenesis of autoimmune hepatitis and the monitoring of auto antigen-specific T cell reactivity in correlation to disease exacerbation and therapy.

Eligibility criteria: Inclusion Criteria:

Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis

Exclusion Criteria:

Subjects with a hematocrit of \<25

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Parvez S Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05615363: A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Edema (CHF)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists


Eligibility criteria: Inclusion Criteria:

* Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
* Subjects undergoing any of the following diuretic therapies

  * Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
  * Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
  * Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
* Subjects who were currently hospitalized or who are able to be hospitalized

Exclusion Criteria:

* Subjects with acute heart failure
* Subjects with an assisted circulation device
* Subjects who cannot sense thirst or who have difficulty in ingesting water

Primary outcomes:
measure: Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8
timeFrame: From baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Harasanshin Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takeshi Tsunoda
role: STUDY_DIRECTOR
References:
Clinical trial NCT02625363: Water Intake and Glycemic Response : Preliminary Study
Official title: Water Intake and Glycemic Response : Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Glycemic Index
Water Intake
Glycemic Response
Lead sponsor: Nutrifood Research Center, Jakarta, Indonesia
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Glycemic index concept is widely used to determine impact of a food to blood glucose. Several studies showed that water content and intake after meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. Currently these studies found conflicting results. Therefore, this study aims to determine whether water intake, specifically after meal, may influence the glycemic response and glycemic index value of the meal.

Detailed description: Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.

Eligibility criteria: Inclusion Criteria:

* Age between 20-40 years
* fasting blood glucose 70-99 mg/dL
* Indonesians

Exclusion Criteria:

* having diabetes
* smoking
* if women, pregnant or lactating
* being allergic to food used in this study
* having gastrointestinal disturbance
* in regular medication
* refusal to sign the consent form

Primary outcomes:
measure: 2 h postprandial blood glucose level (Glycemic Response)
timeFrame: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
measure: Glycemic index value of meal (white bread)
timeFrame: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Nutrifood Indonesia
state: DKI Jakarta
Study officials:
affiliation: Nutrifood Research Center
name: Vanessa Yolanda, SSi
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrifood Research Center
name: Astri Kurniati, MAppSc
role: STUDY_CHAIR
affiliation: Nutrifood Research Center
name: Lina Antono, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
citation: Young KWH, Wolever TMS. Effect of volume and type of beverage consumed with a standard test meal on postprandial blood glucose responses. Nutrition Research 18(11): 1857-1863, 1998
citation: Torsdottir I, Andersson H. Effect on the postprandial glycaemic level of the addition of water to a meal ingested by healthy subjects and type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1989 Apr;32(4):231-5. doi: 10.1007/BF00285289.
citation: Gregersen S, Rasmussen O, Winther E, Hermansen K. Water volume and consumption time: influence on the glycemic and insulinemic responses in non-insulin-dependent diabetic subjects. Am J Clin Nutr. 1990 Sep;52(3):515-8. doi: 10.1093/ajcn/52.3.515.
Clinical trial NCT05422963: Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai
Official title: Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 1000
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: severe and critical COVID-19 patients admitted to specific medical systems in Shanghai.

Brief summary: This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients.

Detailed description: 1. To Describe the clinical characteristics of severe and critical COVID-19.
2. To analyze the relationship between the clinical characteristics and their clinical prognosis;
3. To analyze the relationship between clinical intervention and their clinical prognosis.

Eligibility criteria: Inclusion Criteria:

* severe and critical covid-19 patients who met the "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)"
* admission time more than 24 hours

Exclusion Criteria:

* admission time less than 24 hours

Primary outcomes:
measure: 28-day mortality
timeFrame: one year
Secondary outcomes:
measure: 60-day mortality
timeFrame: one year
measure: ICU length of stay
timeFrame: one year
measure: the percentage of organ failure
timeFrame: one year
measure: time for virus to turn negative
timeFrame: one year
measure: The overall description
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Erzhen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02967263: Etiology, Epidemiology and Prognostics of AKI
Official title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Proteinosis
Epidemiology
Risk factors
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients aged \>18 years, with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China.

Brief summary: * To investigate the etiology and epidemiology of acute kidney injury (AKI).
* To find out risk factors associated with the occurence of AKI.
* To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.
* To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Detailed description: 1. To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.
2. To evaluate the association of serum nutritional variables and prognosis of AKI.
3. Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (\<7 days) and late death (\>7 days, \<28 days) patients.
4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.
5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.
6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."

Eligibility criteria: Inclusion Criteria:

* age \>=18 years and \<= 88 years
* clinically diagnosed with acute kidney injury, according KDIGO criteria.

Exclusion Criteria:

* preexisting chronic kidney failure (defined as an eGFR \<60 ml/min per 1.73 m2)
* post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI
* known acute renal dysfunction
* hospital stays \<24 hours
* malignancy

Primary outcomes:
measure: all-cause mortality
timeFrame: 90 days
Secondary outcomes:
measure: renal function survival rate
timeFrame: 90 days
measure: days in hospital
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
name: Feng Ding, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04545463: Hypocholesterolemic Effect of Fibracep
Official title: Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Fiber
Cholesterol
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 90
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: FIBRACEP is an onion based fiber that has demonstrated in vitro and in animal models the capacity to increase HDL cholesterol levels as well to improve other lipid profile species. This intervention aims to demonstrate FIBRACEP's blood lipid profile improvement effect. For that purpose, hypercholesterolemic subjects will be recruited and given a daily dose of 7 g of FIBRACEP for two months. Changes in blood lipid profile will be the end-point of the study.


Eligibility criteria: Inclusion Criteria:

* Total cholesterol levels above 200 mg/dL, observed in at least 3 different days
* Body mass index between 25 and 35 (Overweight and obesity type 1 diagnosis)

Exclusion Criteria:

* Type 1 and Type 2 Diabetes
* Allergy to any compound described in FIBRACEP

Primary outcomes:
measure: Blood HDL-cholesterol
timeFrame: 2 months
Secondary outcomes:
measure: Blood lipid profile
timeFrame: 2 months
measure: Blood lipoprotein number
timeFrame: 2 months
measure: Blood lipoprotein size
timeFrame: 2 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: José Serrano Casasola
Study officials:
References:
Clinical trial NCT01902563: Osteopathic Approach Into Neonatology Ward: the NE-O Model
Official title: Osteopathic Approach Into Neonatology Ward: the NE-O Model
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.
Keywords: osteopathic manipulative treatment
newborns
preterm infants
procedures
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-07-18
Sex: ALL
Minimum age (years): 29
Maximum age (years): 40
Standard ages: CHILD

Brief summary: Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU).

The aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, NICU environment, medical and paramedical assistance.


Eligibility criteria: Inclusion Criteria:

* newborn admitted to neonatal intensive care unit
* informed consent signed from parent or legal guardian

Exclusion Criteria:

* post surgery patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05387863: Decision Aid (DA) for Renal Patients
Official title: Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Tumor
Renal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. The study team will develop a decision aid (DA) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.


Eligibility criteria: Inclusion Criteria:

* Male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter.
* Patients scheduled for standard-of-care clinical exams with the NYU Urology Department

Exclusion Criteria:

* Stage IV cancer of any type
* Inability to provide informed consent
* Vulnerable subjects will not be recruited

Primary outcomes:
measure: Knowledge Score
timeFrame: Pre-Counsel, 1 day Visit
measure: Decision Satisfaction Score
timeFrame: Post-Counsel, 1 day Visit
measure: Shared Decision Making
timeFrame: Post-Counsel, 1 day Visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stella Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogarty J, Siriruchatanon M, Makarov D, Langford A, Kang S. An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 2;11(9):e41451. doi: 10.2196/41451.