louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01577940: Method Study: Bilateral TAP Block With 24 Hours Infusion
Official title: Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Transversus abdominis plane block
postoperative pain
Postoperative pain management
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 30 years
* written consent
* ASA 1
* BMI between 18 and 25
* males

Exclusion Criteria:

* unable to communicate in Danish
* relevant drug allergy
* alcohol or/and drug abuse
* daily intake of prescription pain medication the last 4 weeks
* pain medication in the last 48 hours
* previously operated abdominal

Primary outcomes:
measure: Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
timeFrame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Secondary outcomes:
measure: Heat pain detection threshold (abdomen)
timeFrame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
measure: Heat pain detection threshold (dominant forearm)
timeFrame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
measure: Long Thermal stimulation (abdomen)
timeFrame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
measure: Lung function
timeFrame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: HOC, anesthesiology, Rigshospitalet
city: Copenhagen
country: Denmark
facility: HovedOrtoCentret, Rigshospitalet
Study officials:
affiliation: HOC, anesthesiology, Rigshospitalet, Copenhagen
name: Pernille L Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.
Clinical trial NCT01198340: Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block
Official title: Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthropathy of Knee Joint
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* patients older than 20 yrs old scheduled for total knee arthroplasty

Exclusion Criteria:

* none

Primary outcomes:
measure: pain scores by use of numerous rating scale (NRS)
timeFrame: 4 days after the surgery
Secondary outcomes:
measure: dose of local anesthetics
timeFrame: 4 days after the surgery
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Anesthesiology and Resuscitology, Okayama University Hospital
Study officials:
affiliation: Okayama University
name: Hideki Taninishi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00462540: A Crossover Study in the Treatment of Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Formoterol
Ipratropium
Crossover
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 40
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 compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
* Meet lung function requirements

Exclusion Criteria:

* Diagnosis of Asthma
* Significant disease other than COPD
* Female pregnant or lactating or planning to become pregnant

Primary outcomes:
measure: Lung function after 2 weeks of treatment
Secondary outcomes:
measure: Lung function at each time point, patient questionnaires, medication compliance,
measure: adverse events, clinical labs, vital signs, ECGs, physical exams
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Research Site
state: Colorado
city: Panama City
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Sunset
country: United States
facility: Research Site
state: Louisiana
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Johnson City
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
Study officials:
References:
citation: Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.
Clinical trial NCT04270240: A NEW SCORING SYSTEM FOR PREDICTION OF PDA
Official title: Can a New Scoring System Predict Hemodynamically Significant PDA Diagnosis and Treatment Requirement for Extremely Preterm Newborns Earlier
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus
Prematurity; Extreme
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 100
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants who born before 28 gestational week and under 1000g of weight will be included.

Brief summary: Patent ductus arteriosus (PDA) is an important morbidity of that the diagnosis and treatment is controversy in premature infants. A number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of PDA. This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

Detailed description: This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* informed consent obtained from parents
* extremely preterm infants
* infants born before 28 gestational week

Exclusion Criteria:

* lack of informed consent
* chromosomal abnormality
* cardiovascular abnormality

Primary outcomes:
measure: Number of Participants with Patent Ductus Arteriosus
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Seda Yilmaz Semerci
Study officials:
References:
Clinical trial NCT00636740: Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Official title: A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone-Refractory Prostate Cancer
Keywords: Prostate cancer, hormone resistant, bisphosphonate
Lead sponsor: Merrion Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.


Eligibility criteria: Inclusion Criteria:

* Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.

Exclusion Criteria:

* Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

Primary outcomes:
measure: Effects on 4 markers of bone metabolism
timeFrame: Weekly
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: Monthly
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology & Oncology Associates, LLC
state: Alabama
city: Lake City
country: United States
facility: Cancer Care of North Florida, P.A.
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Ruston
country: United States
facility: Green Clinic, LLC
state: Louisiana
city: New York
country: United States
facility: New York Urological Associates, PC
state: New York
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Abingdon
country: United States
facility: Cancer Outreach Associates, P.C.
state: Virginia
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonian Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Daugavpils
country: Latvia
facility: O. Hublarovs Private Practice
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital
Study officials:
affiliation: Merrion Pharmaceuticals, LLC
name: Thomas W Leonard, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06061640: The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods
Official title: The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metabolic Dysfunction-associated Fatty Liver Disease
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Chinese Medical University
First posted: 2023-09-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese participants age 18 years or older diagnosed with MAFLD on imaging and healthy volunteers without MAFLD.

Brief summary: This is a case-control study that aims to build a predictive model for MAFLD based on machine learning.

Detailed description: Metabolic dysfunction-associated fatty liver disease (MAFLD) also known as non-alcoholic fatty liver disease (NAFLD), is one of the most prevalent liver diseases worldwide with high prevalence and economic burden, which affects 25% of global adult population. Despite extensive research on understanding the inner pathophysiology of MAFLD, it still keep growing with no approval therapy. Therefore, preventive measures are particularly important in diagnosing MAFLD. So far the liver biopsy is still the gold standard for diagnosis of MAFLD, however considering the invasive process and potential risks, it still has low acceptance for asymptomatic patients, thus non-invasive methods are necessary for this reason.

The purpose of this study is to establish a prediction model to identify MAFLD patients, which can accurately predict whether the participants have MAFLD according to the relevant metabolic indicators of the participants, without the need for invasive examinations such as tissue biopsy.

Eligibility criteria: Inclusion Criteria:

1. aged 18 to 75 years;
2. meeting the diagnostic criteria of MAFLD;
3. no other organic lesions were found in imaging examination;
4. willing and able to sign informed consent.

Exclusion Criteria:

1. significant drinking history (weekly alcohol consumption ≥ 140g for male, or weekly alcohol consumption ≥ 70g for female);
2. presence of evidence for having hepatic steatosis, viral hepatitis, history of hepatic cancer, drug-induced liver injury, liver cirrhosis and other liver and biliary tract diseases;
3. major organ malfunction, severe systemic illnesses, mental health issues, or inability to complete examination;
4. pregnant or pregnancy planning female;
5. missing of important clinical data.

Primary outcomes:
measure: Area under cure
timeFrame: 2022-2024
Secondary outcomes:
measure: Accuracy
timeFrame: 2022-2024
measure: Precision
timeFrame: 2022-2024
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Clinical Medical College of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02448940: The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements
Official title: The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements, Body Composition, Appetite and Serum Lipid Profile in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: probiotics
Lactobacillus
obesity
body composition
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-20
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: TREATMENT

Brief summary: The investigators aimed to study the effect of supplementation with species of Lactobacillus on anthropometric measurements, body composition, appetite and serum lipid profile in overweight and obese adults

Detailed description: The Objective of This Study was Evaluating the Effect of supplementation with Species of Lactobacillus on anthropometric measurements include weight, waist and hip circumference , body composition include body fat and muscle percent, appetite measured by visual analogues scale and serum lipid profile in overweight and obese adults.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* BMI more than 25 Kg/m2

Exclusion Criteria:

* taking drugs that could affect weight change, including anti-diabetic drugs, lipid lowering drugs
* endocrine,cardiovascular, thyroid, or chronic liver disease.
* had received surgery to reduce weight
* taking probiotics or antibiotics within one month
* Pregnancy or lactation or menopause
* A history of cancer
* Heart disease - cardiovascular, pulmonary, renal and diabetes
* A history of autoimmune disease
* Taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers
* weight change over five percent within three months
* change in activity or diet habit

Primary outcomes:
measure: weight change
timeFrame: Change from Baseline in body weight at 12 weeks
Secondary outcomes:
measure: defecation
timeFrame: Baseline,4 weeks, 8 weeks, 12 weeks
measure: blood pressure
timeFrame: Baseline,12 weeks
measure: Anthropometric Measurement BMI
timeFrame: Baseline,4 weeks, 8 weeks, 12 weeks
measure: Anthropometric Measurement WC
timeFrame: Baseline,12 weeks
measure: Anthropometric Measurement HC
timeFrame: Baseline,12 weeks
measure: Appetite
timeFrame: Baseline,4 weeks, 8 weeks, 12 weeks
measure: Anthropometric Measurement WHR
timeFrame: Baseline,12 weeks
measure: mid arm circumference Measurement
timeFrame: Baseline,12 weeks
measure: Serum Lipid Profile
timeFrame: Baseline,12 weeks
measure: skinfold thickness
timeFrame: Baseline,12 weeks
measure: body fat percent
timeFrame: Baseline,12 weeks
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: sardrood Clinic
Study officials:
affiliation: Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
name: Mohammad Alizadeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202240: Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Official title: A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-Drug Interaction
Healthy Volunteers
Tasocitinib (CP-690
550)
Ketoconazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Clinically significant disease
* Recent history of serious infection

Primary outcomes:
measure: AUCinf of tasocitinib (CP-690,550)
timeFrame: 5 days
Secondary outcomes:
measure: AUClast, Cmax, and Tmax of tasocitinib (CP-690,550)
timeFrame: 5 days
measure: Safety: laboratory tests, AE reporting and vital signs
timeFrame: 5 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gupta P, Chow V, Wang R, Kaplan I, Chan G, Alvey C, Ni G, Ndongo MN, LaBadie RR, Krishnaswami S. Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. Clin Pharmacol Drug Dev. 2014 Jan;3(1):72-7. doi: 10.1002/cpdd.71. Epub 2013 Oct 8.
Clinical trial NCT03005340: A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male between 19 and 45
* BW is above 50kg and BMI is between 18.5 and 30.0
* Subject who agreed and signed on informed consent form prior to the study participation

Exclusion Criteria:

* Presence or history of clinically significant disease
* Treatment history of any drug which might affect IP within 10days
* History of other study drugs within 12weeks

Primary outcomes:
measure: Area under the plasma concentration versus time curve(AUCt) of Bazedoxifene
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
measure: Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol
timeFrame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
measure: Peak plasma concentration(Cmax) of Bazedoxifene
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
measure: Peak plasma concentration(Cmax) of Cholecalciferol
timeFrame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dong-A University Hospital
name: Park
role: PRINCIPAL_INVESTIGATOR
References: