louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002329: A Study of MDL 28,574A in HIV-Infected Patients
Official title: A Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Oral Dose-Tolerance Study of Oral MDL 28,574A Solution in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: MDL 28574
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To characterize the safety profile of MDL 28574A following both acute and subchronic dosing in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this drug when administered as oral solution. To determine the pharmacokinetic profile of MDL 28574A and castanospermine (from which MDL 28574A is derived) following both acute and subchronic dosing.

Detailed description: In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7. In Part B, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \>= 500 cells/mm3.
* No evidence of AIDS.
* No antiretroviral therapy within 30 days prior to study entry.

NOTE:

* Presence of lymphadenopathy in two or more extrainguinal sites, at least 1 cm in diameter for 3 or more months, is permitted.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant abnormalities on routine hematology (other than CD4 count and Western blot), serum chemistry, and urinalysis.
* Abnormal EKG.
* Positive stool guaiac.
* Abnormal medical history or physical exam including temperature, heart rate, and blood pressure.
* Clinically significant organ abnormality or disease.
* Positive urine drug screen for illicit drugs.
* Inability to comply with study procedures.

Concurrent Medication:

Excluded:

* Routine treatment with nonprescription medications.
* Treatment with other medications except with approval of the investigator.

Patients with the following prior conditions are excluded:

* Prior participation in this trial.
* Serious physical or mental illness within 1 year prior to study entry that would confound interpretation of data.

Prior Medication:

Excluded:

* Antiretroviral therapy within 30 days prior to study entry.
* Known medications that alter renal, hepatic, or hematologic/immunologic function (such as barbiturates, phenothiazines, cimetidine, and immunomodulators) within 14 days prior to study entry.
* Routine treatment with nonprescription medications within 3 days prior to study entry.

History of alcohol or drug abuse within the past year.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
Study officials:
References:
Clinical trial NCT06449729: Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism
Official title: Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism on Conventional Treatment: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hypoparathyroidism being treated with calcitriol or alfacalcidiol.

Brief summary: Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* diagnosis of chronic (≥ 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient PTH concentration in relation to the presence of hypocalcemia
* patients being treated with calcitriol or alfacalcidiol
* patients able to sign the written informed consent

Exclusion Criteria:

* pregnancy
* severe renal failure requiring dialysis treatment
* macroproteinuria
* use of antihypertensive drugs such as thiazides, ACE inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs
* pazients affected by diabetes mellitus- insulin-treated

Primary outcomes:
measure: The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Andrea Giustina
Study officials:
References:
Clinical trial NCT00949429: Quality of Postoperative Pain Management in Cardiac Surgical Patients
Official title: Quality of Postoperative Pain Management in Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: postoperative pain
cardiac surgery
risk factors
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for cardiac surgery in Siriraj Hospital

Brief summary: The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

Detailed description: Objectives

1. To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively.
2. To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients.
3. To compare the preoperative pain expectation and postoperative pain experience in the same patient.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for cardiac surgery in Siriraj Hospital
* age \> 18

Exclusion Criteria:

* unable to communicate with the patient

Primary outcomes:
measure: Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively
timeFrame: 48 hours
Secondary outcomes:
measure: Risk factors of postoperative pain in cardiac surgical patients
timeFrame: 48 hours
measure: Patient's preoperative pain expectation and postoperative pain experience
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Kasana Raksamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05063929: Impacts of Fruit on the Gut Health and Human Health
Official title: An Investigation of the Impact of Fruit on the Gut Microbiota and Its Metabolites: Connections to Human Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Health
Healthy Aging
Cognition
Keywords: Metabolome
Microbiome
Cognition
Fruit intake
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.

Detailed description: The Investigators findings will provide data critical to the understanding of the effects of fruit intake on the gut microbiome and the capacity of the microbiota to biotransform nutrients contained within fruits as well as the subsequent impact on circulating status of those metabolites. Concurrently, health outcomes that may be linked to these changes including cognition, motor control, vascular function and cardiometabolic health risk markers will be assessed in healthy adults.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women 30 to 70 years old

Exclusion Criteria:

* History of:

  * stroke or myocardial infarction
  * gastrointestinal disorders
  * neurological disorders (epilepsy, multiple sclerosis, Parkinson's disease, stroke, etc)
  * known metabolic disorders (liver, renal or clinically diagnosed diabetes)
  * drug treatment for lipid reduction or hypertension,
  * psychiatric medication use

Primary outcomes:
measure: Change from baseline in composition of bacterial fecal microbiome at 8 weeks
timeFrame: At baseline, at 8 weeks
Secondary outcomes:
measure: Change from baseline in processing speed (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
measure: Change from baseline in Vascular health at 8 weeks
timeFrame: At baseline, at 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Shirin Hooshmand
state: California
Study officials:
References:
Clinical trial NCT00339729: Johnston County ADHD Study: Environmental, Reporductive, and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)
Official title: Johnston County ADHD Study: Environmental, Reproductive and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit Hyperactivity Disorder
Keywords: Children
Behavior
Epidemiology
Lead
Learning Disorder
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 8000
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

Detailed description: We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

Eligibility criteria: * INCLUSION CRITERIA:

During the first phase of the study, all children will be screened by the homeroom teacher, EXCEPT for those students in certain self-contained classrooms. Self-contained classrooms for students with an IQ less than 70 or autism will be omitted from the screening. In the second phase of the study, children designated as "LEP", or Low English Proficiency, will be excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: NIEHS, Research Triangle Park
state: North Carolina
Study officials:
References:
Clinical trial NCT01370629: Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
Official title: A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
cardioversion
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 2015
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care

Brief summary: This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.


Eligibility criteria: Inclusion Criteria:

* To be treated with intravenous vernakalant, independently of this study
* Participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations

Exclusion Criteria:

- Enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. Participation in another non-interventional drug or device study or registry is permitted.

Primary outcomes:
measure: Number of Participants Experiencing Significant Hypotension
timeFrame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
measure: Number of Participants Experiencing Significant Ventricular Arrhythmia
timeFrame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
measure: Number of Participants Experiencing Significant Atrial Flutter
timeFrame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
measure: Number of Participants Experiencing Significant Bradycardia
timeFrame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Secondary outcomes:
measure: Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute
timeFrame: Up to 90 minutes after the start (baseline) of first infusion of vernakalant
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Aalborg
country: Denmark
city: Kuopio
country: Finland
facility: Kuopio Hospital
city: Paderborn
country: Germany
facility: St-Vincenz Krankenhaus
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Malmo
country: Sweden
facility: Skanes Universistetssjukhus
Study officials:
References:
Clinical trial NCT02500329: Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients
Official title: Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients (GetUp Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endothelial Function
Type 2 Diabetes
Gemigliptin
Acarbose
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 4, single center, randomized, open-labeled study. The primary objective of the study is to compare effect of gemigliptin and acarbose on endothelial function.

Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* age: 20-80yrs
* patients with type 2 diabetes (duration of diabetes \>=3 months)
* HbA1c :\>7.0 and \<=9.0% on metformin monotherapy
* no changes on medications during recent 3 months.

Exclusion Criteria:

* patients with type 1 diabetes
* history of medications including α-glucosidase inhibitor, glinide, GLP-1 analogue, other DPP-4 Inhibitors, or insulin during recent 3 months.
* history of acute diabetic complication, acute coronary events, or coronary bypass surgery/interventions during recent 6 months.
* patients with congestive heart failure (NYHA II\~IV) or clinically significant ventricular arrhythmia
* serum ALT or AST\> 2.5 x upper normal range
* serum direct bilirubin \> 1.3 x upper normal range
* serum creatinine \> (men) 1.5 mg/dL, (women)\>1.4 mg/dL
* smoker
* pregnant women, or breast-feeding women
* medication with acetylsalicylic acid or vitamin K antagonist

Primary outcomes:
measure: endothelial function (reactive hyperemic index)
timeFrame: 4 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 4 weeks
measure: Postprandial 2hour glucose
timeFrame: 4 weeks
measure: Glycated albumin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Boramae medical center
Study officials:
affiliation: Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
name: Min Kyong Moon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583829: Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder
Official title: Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
neurofeedback
biofeedback
computer attention training
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of two computer-based attention training systems, one with and one without neurofeedback. The training systems intend to help children learn to focus and attend more effectively.

Detailed description: The current study is examining a neurofeedback (NF) computer attention training system that teaches children to alter their brainwave activity with a Cognitive Training attention training system (CT). The investigators hypothesize that both treatments will show improvement in ADHD symptoms and academic outcomes compared to a control condition.

104 children with ADHD in grades 2 and 4 are randomly assigned to receive the NF, CT, or a Waitlist-Control (WLC) condition that receives NF or CT the following academic year. Children receive forty 45-minute sessions three times a week at school for 4 months. A comprehensive assessment, consists of data completed by teachers, parents, participants, and double-blind classroom observations.

Eligibility criteria: Inclusion Criteria:

* diagnosis of ADHD (any subtype, per report of the child's physician or school psychologist) entering 2nd or 4th grade at the beginning of September 2009 and 2010.
* combined IQ (Intelligence Quotient) at or above 80,
* ability to read English sufficiently to complete assessments and intervention protocols

Exclusion Criteria:

* mental retardation,
* coexisting diagnosis of conduct disorder,
* pervasive developmental disorder, or
* other serious mental illness (eg., bipolar disorder, psychosis, autism)

Primary outcomes:
measure: Behavioral Observations of Students in School (BOSS)
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Naomi J Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05245929: En Masse Distaliaztion Via Skeletal Anchorage
Official title: Evaluation of Two Bone Anchored Appliances for en Masse Distalization of Maxillary Buccal Segment in Class II Patients: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication, Angle Class II Patients, Distalization
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.


Eligibility criteria: Inclusion Criteria:

* Full set of permanent teeth present, except for third molar
* Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
* No systemic conditions interfering with treatment, as reported by patient
* No previous Orthodontic treatment
* Good Oral Hygiene
* No use of any for of anti-inflammatory drugs

Exclusion Criteria:

* Patient who required surgery to correct skeletal discrepancies
* Patient with congenital dentoskeletal disorders
* Missed or Mutilated teeth in Maxillary arch
* Patients with poor oral hygiene

Primary outcomes:
measure: Amount of distalization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University, faculty of dental medicine orthodontic clinic
state: Nasr City
Study officials:
References:
Clinical trial NCT00766129: Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts
Official title: Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stenosis in Saphenous Vein Graft, Drug Eluting Stent
Keywords: saphenous vein graft, TAXUS stent, Chopin stent
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.


Eligibility criteria: Inclusion Criteria:

1. Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
2. Stable coronary artery disease or non ST segment elevation acute coronary syndrome
3. Reference segment diameter in range of 2.5-4.5mm

Exclusion Criteria:

1. Cardiogenic shock
2. Contraindications to prolonged dual antiplatelet therapy
3. Female of child birth potential unless on effective contraception
4. Other medical condition that may limit survival

Primary outcomes:
measure: Neointima hyperplasia volume by Intravascular Ultrasound
timeFrame: 9 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 5 years
measure: Cardiovascular mortality
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Target lesion revascularization
timeFrame: 5 years
measure: Angiographic late loss
timeFrame: 9 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Adam R Witkowski, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: