louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00805155: Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions
Official title: Bioequivalence of Three Mometasone Furoate 0.1% Topical Lotions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioequivalence
Mometasone Furoate
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
timeFrame: Over the course of two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01013155: Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 48
Sex: ALL
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: The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablet under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Perindopril or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 20 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
References:
Clinical trial NCT05191355: Screening for Hypercholesterolemia in Children Using Dried Blood Spot
Official title: Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia, Familial
Pediatrics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults with heterozygous familial hypercholesterolemia and healthy subjects

Brief summary: Purpose:

Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.

Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.

The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement

Hypothesis

* to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
* to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* patients/kindreds in family with a documented history of hypercholesterolemia
* healthy subjects for controls

Exclusion Criteria:

* refusal to participate in the study
* For control patients: to have a known dyslipidemia

Primary outcomes:
measure: Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon, Dept of Endocrinology
city: Bron
country: France
facility: Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique
Study officials:
affiliation: Hospices Civils de Lyon
name: Noël PERETTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652755: Plasma Cystatin C and Acute Kidney Injury
Official title: Use of Cystatin C in Predicting AKI in Patients Undergone Cardiopulmonary Bypass Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Keywords: cystatin C,acute kidney injury,
Lead sponsor: Jinhua Central Hospital
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergone cardiopulmonary bypass surgery

Brief summary: To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.

Detailed description: This is a prospective AKI observational study in patients undergone cardiopulmonary bypass surgery. pCysC and plasma creatine will be measured at entry to ICU.AKI was defined as 50% increase in plasma creatine above baseline.The predictive and diagnostic performance of pCysC will be assessed from area under receiver operator characteristic curve(AUC) and odds ratio(OR).

Eligibility criteria: Inclusion Criteria:

* patients with CPB and admitted to ICU

Exclusion Criteria:

* patients with the age \>80 or \<18 years
* with preexisting renal dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua central hospital
state: Zhejiang
Study officials:
affiliation: Jinhua Municipal Central Hospital
name: Hongying Ni, MM
role: STUDY_CHAIR
References:
Clinical trial NCT00121355: Novofine Autocover Safety Needle Versus BD Safety Glide
Official title: An Open-Label, Multi-Center, Prospective Cross-Over Study of Preference and Safety of NovoFine® Autocover(TM) Needles Compared to BD Safety Glide (TM) Syringes in the Hospital Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Healthcare Professionals
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-07-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the NovoFine® Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.


Eligibility criteria: Inclusion Criteria:

* Hospital nurses with prior injection training without an infectious blood borne disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06349655: The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19
Official title: Real-World Effectiveness and Safety of Oral Azvudine in Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Azvudine
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Henan Provincial Chest Hospital
name: The Affiliated Infectious Disease Hospital of Zhengzhou University
name: The Fifth People's Hospital of Anyang
name: Shangqiu Municipal Hospital
name: Nanyang Central Hospital
name: Luoyang Central Hospital
name: Guangshan County People's Hospital
name: Fengqiu County People's Hospital
First posted: 2024-04-05
Enrollment: 32864
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: People who have COVID-19 and have an indication for Azvudine or Paxlovid.

Brief summary: To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

1. Age above 18 years old (including the cut-off value), regardless of gender;
2. Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China;
3. Informed consent has been signed.

Exclusion Criteria:

1. Known or suspected allergic to the components of Azivudine tablets;
2. Patients with severe liver, kidney, heart and other organ damage;
3. Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
4. Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;

Primary outcomes:
measure: All-cause death
timeFrame: Up to 30 days (form the date of confirmed COVID-19)
Secondary outcomes:
measure: Composite disease progression
timeFrame: Up to 30 days (form the date of confirmed COVID-19)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zujiang Yu, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06012955: Study on the Effect of Target-controlled Infusion for General Anesthesia in Cardiac Surgery
Official title: Study on the Effect of Target-controlled Infusion of Propofol and Remifentanil for Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Mechanical Ventilation Time
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or olderundergoing cardiac surgery under general anesthesia

Brief summary: The purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years and older who underwent cardiac surgery

Exclusion Criteria:

* Mechanical ventilation support before surgery;
* Combined with any type of non-cardiac surgeries;
* Second exploratory thoracotomy after surgery;
* Died or discharged within 48 h after surgery;
* Missing clinical data

Primary outcomes:
measure: Duration of postoperative mechanical ventilation
timeFrame: 4 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00486655: NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Official title: Assisted Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cholelithiasis
Cholecystitis
Keywords: Cholecystectomy
NOTES
Transgastric
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed description: A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Eligibility criteria: Inclusion Criteria:

* Ability to undergo general anesthesia
* Age \>= 18 yrs. of age and \<= 85 yrs. of age
* Ability to give informed consent

Exclusion Criteria:

* Acute cholecystitis
* BMI \>= 40
* Contraindicated for EGD
* Presence of common duct stones
* Presence of esophageal stricture
* Altered gastric anatomy

Primary outcomes:
measure: Quality of Life
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of complications
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Clinic
state: Oregon
Study officials:
affiliation: Oregon Clinic
name: Lee Swanstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312455: Effects of Fatty Acid Supplementation on Substance Dependent Individuals
Official title: Cholesterol and Fatty Acids in Cocaine Addiction Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-related Disorders
Keywords: Substance abuse
Depression
Aggression
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-04-10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many substance dependent individuals continue to abuse a variety of substances during treatment for their disorder. Often, substance dependent individuals are co-diagnosed with depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may play a role in treating individuals with such substance abuse problems. The purpose of this study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance dependent individuals.

Detailed description: Past research suggests that low levels of some PUFAs play a role in the pathophysiology of depressive and aggressive disorders. In addition, there is also evidence that PUFAs play a role in treating substance dependent individuals. The purpose of this study is to determine the efficacy of EFA and DPA in treating substance dependent individuals.

Participants will be randomly assigned to receive either 3 grams of n-3 PUFAs or placebo. Treatment will last 3 months, followed by an observation period of 3 months. Study visits will occur monthly and will last approximately one hour. Study visits will include blood tests and a physical exam. Throughout the study, participants will continue to receive standard substance abuse treatment and will complete urine tests at regular intervals.

Eligibility criteria: Inclusion Criteria:

* Current or history of drug or alcohol dependence
* Used substances of abuse during the 3 months prior to study entry
* Enrolled in one of the VA New York Harbor Healthcare System Brooklyn campus substance abuse clinics

Exclusion Criteria:

* Current or history of hallucinations, delusions, or memory problems
* Major physical illness (e.g., cardiovascular, pulmonary, gastrointestinal, renal, neuromuscular, or endocrine disorder)
* Liver function test greater than one standard deviation above upper normal limit
* Allergic to fish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VA New York Harbor Healthcare System
name: Laure Buydens-Branchey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569814: A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 100
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.


Eligibility criteria: Inclusion Criteria:

* a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant hypersensitivity to study drug, any other drug
* Hypotension or hypertension
* Active liver disease
* History of gastrointestinal disease
* History of excessive alcohol abuse
* Participation in any other study within 3 months

Primary outcomes:
measure: Cmax of Fimasartan, Amlodipine and Rosuvastatin
timeFrame: 0~144 hour after medication
measure: AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
timeFrame: 0~144 hour after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
References:
Clinical trial NCT04748614: Analysis Before and After COVID 19
Official title: Comparative ICU Cost, Hospital Stay and Mortality Analysis Before and After COVID 19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cost of ICU
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 500
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: All patients hospitalized in intensive care in the last 3 months of 2019 and all SARS-Cov2 patients hospitalized in intensive care in the last 3 months of 2020.

Brief summary: In our study, we aimed to compare the average length of stay, death rates and costs of intensive care patients in October-November-December 2019 (before COVID 19) and October-November-December 2020 (during COVID 19).


Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* All patients in intensive care unit in last three months of 2019
* All SARS-Cov2 patients in intensive care unit in last three months of 2020

Exclusion Criteria:

* Under 18 years old

Primary outcomes:
measure: Cost of ICU
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Khan AA, AlRuthia Y, Balkhi B, Alghadeer SM, Temsah MH, Althunayyan SM, Alsofayan YM. Erratum: Khan, A.A., et al. Survival and Estimation of Direct Medical Costs of Hospitalized COVID-19 Patients in the Kingdom of Saudi Arabia (Short Title: COVID-19 Survival and Cost in Saudi Arabia). Int. J. Environ. Res. Public Health 2020, 17, 7458. Int J Environ Res Public Health. 2020 Dec 17;17(24):9458. doi: 10.3390/ijerph17249458.