louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06178133: Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods
Official title: Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Heart Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 500
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: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the inclusion criteria and those who did not meet the exclusion criteria were admitted to the Department of Cardiovascular Medicine of Peking University Third Hospital from January 1, 2019 to November 31, 2023.

Brief summary: In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

Detailed description: The evaluation of coronary function is becoming more and more important in the guidelines, in which coronary flow reserve (FFR) is the gold standard for diagnosis, but its measurement process requires the application of adenosine, vasodilator, etc. Some patients cannot be measured because of asthma and low blood pressure. A new instantaneous wave-free ratio (iFR), contrastive flow reserve fraction (cFFR) and quantitative flow fraction (QFR) have been developed for the evaluation of coronary function. However, in some patients, the new coronary function evaluation methods were inconsistent with FFR. In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

Eligibility criteria: Inclusion Criteria:

* Age above 18 and below 80 years old, regardless of gender;
* FFR was detected by coronary angiography;
* The coronary angiography images were clear, meeting the requirements of QFR analysis or detecting iFR, cFFR, and resting pd/pa during the operation.

Exclusion Criteria:

* 1) Coronary artery bypass graft (CABG);
* 2) Atrial fibrillation or flutter;
* 3) Left or right coronary opening lesions;
* 4) Pregnancy or breastfeeding.

Primary outcomes:
measure: the discordance between fractional flow reserve and quantitative flow ratio
timeFrame: When the patient has completed coronary angiography and received a diagnosis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Ruitao Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00146133: Weight Loss and Exercise in Physically Limited Obese Elderly Subjects
Official title: Effect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Frailty
Elderly
Keywords: Obesity, Aging, Frailty, exercise, weight loss
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall purpose of this research is to determine the effect of weight loss and physical training on quality of life, physical function, metabolism, bone strength, body fat and muscle mass.

Detailed description: Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty because of decreased strength, joint function, balance and mobility associated with aging. The primary objective of this study is to evaluate the effect of weight loss and physical training on physical function, body composition, metabolism and quality of life in frail, obese elderly men and women. Subjects are randomized to either control or 10% weight loss plus physical training.

Eligibility criteria: Inclusion Criteria:

* Obese (BMI 30 or greater) elderly (age 65 years or older) Frailty

Exclusion Criteria:

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs.

Primary outcomes:
measure: physical function and body composition
Secondary outcomes:
measure: quality of life, metabolic markers
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.
citation: Villareal DT, Banks M, Sinacore DR, Siener C, Klein S. Effect of weight loss and exercise on frailty in obese older adults. Arch Intern Med. 2006 Apr 24;166(8):860-6. doi: 10.1001/archinte.166.8.860.
Clinical trial NCT00627133: Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
Official title: A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Seizure, Alcohol Related
Keywords: Alcohol seizure
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2008-02-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.


Eligibility criteria: Inclusion Criteria:

* No trauma
* Not pregnant
* No other cause for seizure (hypoglycemia, CNS causes, trauma)
* Good family support
* Working telephone contact

Exclusion Criteria:

* Pregnancy
* Renal failure (creatine \> 2mg/dl
* Fever or illness
* Hypotension
* Any trauma

Primary outcomes:
measure: Decreased seizures
timeFrame: 1, 2, 4, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT02742233: Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Official title: A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes
Wound Healing
Dipeptidyl Peptidase 4 Inhibition
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.

Detailed description: Groups:

Diabetic ulcers, saxagliptin + Regular treatment.

Diabetic ulcers, placebo + Regular treatment.

Time Point:

Initial treatment;

Post-treatment ( 1w );

Post-treatment ( 2w );

Post-treatment ( 4w );

Completely healed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
* Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)
* The subject agrees to comply with study protocol requirements and all follow up visit requirements.

Exclusion Criteria:

* Uncontrolled diabetes
* Ulcer infection
* Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions

Primary outcomes:
measure: Completely healing time of the participants'target ulcer during the treatment period.
timeFrame: 16 weeks
Secondary outcomes:
measure: Proportion of participants with complete healing during the treatment period.
timeFrame: 16 weeks
Other outcomes:
measure: Net change from baseline in laboratory test results
timeFrame: Baseline, weeks 1, 2,4,
measure: New ulcers
timeFrame: 16 weeks
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
name: Hongting Zheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05188833: EEG Results of Deep TMS in Patients With OCD
Official title: Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
EEG With Periodic Abnormalities
Keywords: Obsessive compulsive disorder
Deep Transcranial Magnetic Stimulation
Mood
Quality of Life
EEG
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria

Exclusion Criteria:

* Not volunteering to comply with the research program
* Presence of a metal piece on the head
* Having a pacemaker inserted
* Having had a previous epileptic seizure

Primary outcomes:
measure: Electroencephalography
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Beck Depression Scale
timeFrame: 6 weeks after baseline
measure: World Health Organization Quality of Life Scale Short Form
timeFrame: 6 weeks after baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Miray BUDAK, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04242433: HCV RAS Testing in Public Health Programs
Official title: Patterns of Resistance-associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct Acting Antiviral Agents in the Public Health Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Public Health
Direct Acting Antiviral Agents
Resistance Associated Substitutions
Keywords: Resistance associated substitutions
HCV
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The MMPHCRF Cohort patients are treated at 25 sites in Punjab State India with algorithm based DAAs for chronic Hepatitis C.

Brief summary: Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). Pre-existence of resistance associated substitutions (RASs) to direct antiviral agents (DAAs) reduces sustained virologic response (SVR) rates by 3-53% in hepatitis C virus (HCV) genotype 3 infected patients depending on different predictors and the DAA regimen used. This study will prospectively analyze data from the MukhMantri Punjab Hepatitis C Relief Fund (MMPHCRF) to determine the posttreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with daclatasvir-sofosbuvir or sofosbuvir-ledipasvirin patients with chronic HCV.

The study aims to assess the prevalence and effect of RASs on sustained virological response (SVR) rates in patients with treatment failure to a regimen containing sofosbuvir and ledipasvir/daclatasvir.


Eligibility criteria: Inclusion Criteria:

* All viremic chronic hepatitis C

Exclusion Criteria:

* People with disseminated malignancy, advanced cardiovascular, 18 pulmonary, or neurological disease with short life expectancy were not enrolled

Primary outcomes:
measure: Achievement of sustained virological response
timeFrame: 12 weeks after treatment completion
measure: Assessment of RAS
timeFrame: 12 weeks after treatment completion
Secondary outcomes:
measure: Assessment of RAS in treatment failures
timeFrame: 12 weeks after treatment completion
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
References:
Clinical trial NCT01765933: Pharmacokinetic Effects of Oral DMAA
Official title: Pharmacokinetic and Physiological Effects of Oral DMAA Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcomes of Single Oral Dose
Keywords: 1,3-dimethylamylamine
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: University of Tennessee
name: USP Labs, Inc.
First posted: 2013-01-11
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within "party pills," often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.


Eligibility criteria: Inclusion Criteria:

* must be able to swallow pill

Exclusion Criteria:

* self-reported cardiovascular or metabolic problems
* current smokers

Primary outcomes:
measure: pharmacokinetics
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr
Secondary outcomes:
measure: physiological effects on heart rate and blood pressure
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr
Other outcomes:
measure: cutaneous temperature
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr
Locations:
city: Memphis
country: United States
facility: The University of Memphis
state: Tennessee
Study officials:
References:
citation: Schilling BK, Hammond KG, Bloomer RJ, Presley CS, Yates CR. Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men. BMC Pharmacol Toxicol. 2013 Oct 4;14:52. doi: 10.1186/2050-6511-14-52.
Clinical trial NCT02092233: A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Official title: A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes
Keywords: ARIES HSV 1&2
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 1963
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical lesions from pediatic or adult patients suspected of having herpes infection

Brief summary: The ARIES HSV 1\&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA.

The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.

Detailed description: The ARIES HSV 1\&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens.

The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.

Eligibility criteria: Inclusion Criteria:

The specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium

Exclusion Criteria:

The specimen was not properly collected, transported or stored according to instructions provided by Sponsor

Primary outcomes:
measure: Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
timeFrame: Within the first year of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: Tricore
state: New Mexico
city: Burlington
country: United States
facility: Labcorp
state: North Carolina
Study officials:
affiliation: Luminex Corporation
name: David Himsworth
role: STUDY_DIRECTOR
References:
Clinical trial NCT01465633: Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
Official title: Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: bioavailability
levothyroxine
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2011-11-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.


Eligibility criteria: Inclusion Criteria:

* Euthyroid men
* Age: 18 - 50
* Normal values for fT4 und TSH
* Good state of health

Exclusion Criteria:

* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
* History of thyroid function disorders
* Focal or diffuse autonomies of the thyroid gland
* Thyroid nodules \>1 ml according to sonographic examination
* Any acute or chronic illness
* Dermatitis herpetiformis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Research Unit, University of Heidelberg
Study officials:
References: