louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04234724: Physiological Effects of ANGPTL3 Variants in Humans
Official title: Physiological Effects of ANGPTL3 Variants in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypocholesterolemia
Keywords: Angiopoietin-like protein 3 deficiency
Lipid Metabolism
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the role of ANGPTL3, on lipid metabolism. To explore the role of this protein on glucose metabolism.

Detailed description: Oral fast tolerance test, lipoprotein kinetics and a glucose tolerance test to evaluate the role of ANGPTL3, on lipid metabolism and to explore the role of this protein on glucose metabolism.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 or older meeting at least one of the following criteria

  1. Carrying genetic variants in the gene encoding for ANGPTL3,
  2. Unaffected controls matched for age, race, gender,
  3. Willing to follow study procedures
  4. Able to provide inform consent

     Exclusion Criteria:
* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Taking any medication that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Women that are pregnant or nursing
* History of liver disease or abnormal liver function tests (\>2x upper limit of normal)
* History of kidney disease or chronic renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled diabetes
* Anemia (hemoglobin \<11.0 mg/dL) History of a non-skin malignancy within the previous 5 years Major surgery within the past 3 months
* History of any organ transplant
* History of alcohol or drug abuse
* Participation in clinical trials assessing the efficacy and safety of drugs affecting lipid metabolism within the past 6 weeks (or longer depending on the known half-life of the drug) that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Inability to comply to study procedures

Primary outcomes:
measure: The role of ANGPTL3 on lipid metabolism.
timeFrame: through study completion, an average of 13 weeks
measure: The role of this protein on glucose metabolism.
timeFrame: through study completion, an average of 13 weeks
measure: The role of ANPTL3 on fatty acids
timeFrame: through study completion, an average of 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marina Cuchel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118324: Exergaming Intervention in ALL Patients
Official title: The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
ALL
fitness intervention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. Physical activity at baseline and at the end of study will be assessed using accelerometers. Outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance, and strength.


Eligibility criteria: Inclusion Criteria:

* Eligibility will not be restricted by race or sex
* Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz Children's Hospital or Children's Hospitals and Clinics of Minnesota
* At least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy
* Age 5-17 years at time of study enrollment
* Not smoking
* Currently not involved in a regular (3 times per week) exercise program

Exclusion Criteria:

* Individuals with a physical or mental impairment which would preclude their ability to perform the intervention.
* Bone marrow transplant recipients.
* Any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing
* Due to the intervention being in English, non-English speakers will be excluded

Primary outcomes:
measure: Average minutes of physical activity per day
timeFrame: 6-months
Secondary outcomes:
measure: Average difference of blood pressure
timeFrame: 6 months
measure: Average difference of body composition
timeFrame: 6 months
measure: Average difference in visceral fat
timeFrame: 6 months
measure: Average difference in triglycerides
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Amplatz Children's Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Julia Steinberger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651024: Sano V First In Human Study to Treat ED
Official title: A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction (ED)
Lead sponsor: Sano V Pte Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 10
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System


Eligibility criteria: Inclusion Criteria:

1. Patient understands and has signed the study informed consent form.
2. Documented history of erectile dysfunction
3. Sexually active

Exclusion Criteria:

- 1. Current participation in any clinical study with any investigational drug or device.

2. Patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. Active infection or fever that may be due to infection 4. Life expectancy \< 2 years due to other illnesses

Primary outcomes:
measure: The surgical implant for ED treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03341624: Congenital Cataract With Persistent Fetal Vasculature
Official title: Surgical Treatment and Prognosis of Congenital Cataract With Persistent Fetal Vasculature
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Fetal Vasculature
Congenital Cataract
Keywords: persistent fetal vasculature
congenital cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.

Detailed description: methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.

Eligibility criteria: Inclusion Criteria:

* congenital cataract with Persistent Fetal Vasculature

Exclusion Criteria:

* congenital cataract with no Persistent Fetal Vasculature

Primary outcomes:
measure: visual acuity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT00832624: The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
Official title: Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus Non-insulin-dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.


Eligibility criteria: Inclusion Criteria:

* Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

  * Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
  * Or On A Single AHa

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18
timeFrame: Baseline and Week 18
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04792424: No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation
Official title: No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Citrate Anticoagulation
Ionized Calcium
Continuous Renal Replacement Therapy
Keywords: Regional citrate anticoagulation
Ionized calcium
Continuous Renal Replacement Therapy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial

Detailed description: Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?

Eligibility criteria: Inclusion Criteria:

* Age older than 18 years old and admission in an ICU
* Indication for CRRT
* regional citrate anticoagulation

Exclusion Criteria:

* Acute liver failure defined as AST or ALT \> 5X UNL or TB/DB \> 5X UNL or evidence of cirrhosis
* Severe persistent lactic acidosis (lactate persist \> 8 mg/dL consecutively within 6 hours)
* Receiving heparin anticoagulation
* Severe alkalosis (pH\>7.55) or acidosis (pH\<7.1)
* History of renal allograft
* Known pregnancy
* Patient is moribund with expected death within 24 hr
* Deficiency of ionzed calcium (Cation \< 0.8 mmol/L)

Primary outcomes:
measure: Filter lifetime in hours
timeFrame: 72 hours
Secondary outcomes:
measure: Adverse event
timeFrame: 72 hours
measure: Circuit downtime in hours
timeFrame: 72 hours
measure: Cost per treatment in Baht
timeFrame: 72 hour
measure: Citrate accumulation
timeFrame: 72 hours
measure: Efficacy of CRRT
timeFrame: 72 hours
measure: Citrate dose
timeFrame: 72 hours
Other outcomes:
measure: Change of SOFA scores
timeFrame: 72 hours
measure: Change of APACHE II score
timeFrame: 72 hours
measure: Change of Hct
timeFrame: 72 hours
measure: Change of electrolyte
timeFrame: 72 hours
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn university
Study officials:
References:
Clinical trial NCT02617524: Dedicated Sheath Feasibility Study
Official title: A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Stenosis
Keywords: dedicated sheath
Lead sponsor: Valve Medical
Sponsor class: INDUSTRY
Collaborators: name: Medinol Ltd.
First posted: 2015-12-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).

Detailed description: This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.

During the study, the patient will undergo the following tests:

* Physical examination (includes blood pressure, age, height, weight).
* Echo assessments prior to procedure.
* Hemodynamic study prior and post BAV.
* Full blood count
* Angiography

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Patient understands the implications of participating in the study and provides written informed consent.
* The patient has an indication for balloon aortic valvuloplasty (BAV).

Exclusion Criteria:

* Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
* Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

Primary outcomes:
measure: Device success
timeFrame: Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
measure: Procedure Safety: Adverse Event Assessment for device related and unrelated events
timeFrame: Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT04479124: The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul
Official title: The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Covid19
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 2000
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who admitted to any of the emergency departments of seven study centers during the pandemic will be evaluated.

Brief summary: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Detailed description: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The investigators hypothesize that since the number of hospital applications expected to be decreased due to trauma during the COVID-19 period, the level of hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Eligibility criteria: Inclusion Criteria:

* accepted to participate with an informed consent
* trauma patients who admitted to the study centers

Exclusion Criteria:

* lack of informed consent
* lack of data

Primary outcomes:
measure: trauma admissions
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
References:
Clinical trial NCT00033124: A Behavioral Trial for the Treatment of Methamphetamine Dependence. - 1
Official title: Behavioral Trial for the Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine behavioral treatment for methamphetamine dependence.

Detailed description: To characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a "platform" in future pharmacotherapy trials.

Eligibility criteria: Inclusion Criteria:

Male or Female at least 18 yrs of age; DSM-4 diagnosis of methamphetamine (METH) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for METH dependence.

Exclusion Criteria:

Additional criteria available during screening at the site.

Primary outcomes:
measure: Withdrawal symptoms
measure: New Use algorithm
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: South Bay Treatment Center
state: California
city: Costa Mesa
country: United States
facility: Matrix Institute on Addictions
state: California
city: Honolulu
country: United States
facility: John A. Burns School of Medicine
state: Hawaii
city: Des Moines
country: United States
facility: Powell Chemical Dependency Center
state: Iowa
city: Independence
country: United States
facility: Comprehensive Mental Health Services, Inc
state: Missouri
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Richard Rawson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456624: Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition
Official title: A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Primary outcomes:
measure: Safety (normal results for safety tests)
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: