louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01594034: Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation
Official title: Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoperitoneum
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in the ICU on a ventilator

Brief summary: Our objective is to determine whether or not the presence of hemoperitoneum in trauma patients is associated with increased Carbon Monoxide (CO) formation, and to determine if elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired platelet aggregation, and/or multiple organ failure.


Eligibility criteria: Inclusion Criteria:

1. Hospitalized males 18 years of age or older,
2. Diagnosis of isolated blunt OR blunt and penetrating trauma,
3. Admitted or expecting to be admitted to the Intensive Care Unit,
4. On mechanical ventilation, and
5. Written informed consent obtained

Exclusion Criteria:

1. Female gender, (Females will be excluded from this study as the menstrual cycle and other estrogen variations are known to be associated with cyclic changes in CO production adding a potential confounder to the interpretations of our findings.)
2. Diagnosis of isolated penetrating trauma,
3. Acute hemothorax or pneumothorax,
4. Treatment with antiaggregants (ASA, clopidogrel, aggrenox or ticlopidine),
5. Enrollment in another research study,
6. Prisoners,
7. Inability to perform CO measurement within 96 hours after hospital admission.

Primary outcomes:
measure: •Establish a method for reliably measuring CO excretion in patients.
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: University of Texas
name: Robert Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05949034: Effects of E-Cigarettes in Menthol Smokers
Official title: Effects of E-Cigarettes in Menthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-cigarette Use
Smoking Behaviors
Keywords: menthol
cigarette
smoking
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.


Eligibility criteria: Inclusion Criteria:

* Daily cigarette smoking for at least the past 2 years
* Interest in trying e-cigarettes
* Report smoking mentholated cigarettes

Exclusion Criteria:

-- Pregnancy and/or breastfeeding

Primary outcomes:
measure: Preference Ratings
timeFrame: 1 hour
measure: Mood - Positive Affect Negative Affect Schedule
timeFrame: 4 hours
measure: Mood - Profile of Mood States
timeFrame: 4 hours
measure: Cigarette Craving
timeFrame: 4 hours
measure: Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale
timeFrame: 4 hours
measure: Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale
timeFrame: 4 hours
measure: Smoking Motivation
timeFrame: 2 hours after experimental session outset
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Adam Leventhal, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04971434: Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping
Official title: Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.

Detailed description: In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed Fatty liver patients by ultrasonography
* Class I obese patients

Exclusion Criteria:

* Cardiovascular and respiratory disorders/diseases.
* Autoimmune disorders/diseases.
* Pregnancy
* Other liver disorders/diseases.

Primary outcomes:
measure: high-density lipoprotein
timeFrame: It will be measured after 4 weeks of treatment
measure: low-density lipoprotein
timeFrame: It will be measured after 4 weeks of treatment
measure: cholesterol
timeFrame: It will be measured after 4 weeks of treatment
measure: triglyceride
timeFrame: It will be measured after 4 weeks of treatment
Secondary outcomes:
measure: c reactive protein
timeFrame: It will be measured after 4 weeks of treatment
measure: blood glucose
timeFrame: It will be measured after 4 weeks of treatment
measure: blood pressure
timeFrame: It will be measured after 4 weeks of treatment
measure: rate of pulse
timeFrame: It will be measured after 4 weeks of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292734: STILDEP: Zolpidem in Depressive and Dysthimic Patients
Official title: Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Initiation and Maintenance Disorders
Depression
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.


Eligibility criteria: Inclusion Criteria:

* Depressive and dysthimic patients in acute phase of mild to moderate severity
* Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)

Exclusion Criteria:

* Regularly use of sleeping pills in the last 2-3 month
* Use of any sleeping pils in the last week
* Insufficient hepatic
* Myasthenia gravis
* Proven hypersensivity to Zolpidem
* Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
* History of evidence of alcohol or drug abuse
* Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
* Abnormal snore
* Work an alternating shift
* Suffering from periodic leg movement disorder and sleep apnea

Primary outcomes:
measure: To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Sanofi-Aventis
Study officials:
affiliation: sanofi-aventis Hungary
name: László Erős, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170534: Intervention for Male STDs in India
Official title: An Intervention for Male STD Patients in India
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sexually Transmitted Infection
Keywords: India, male, sexually transmitted infection, STI, STD
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-09-15
Enrollment: 1892
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.

Detailed description: India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C\&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.

Eligibility criteria: Inclusion Criteria:

1. Males, over 16 years of age
2. Hindu or Marathi speakers
3. Have no plan to move permanently out of Mumbia in the following 12 months
4. have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
5. Patients will be required to provide an address that can be located by a tracer.

Exclusion Criteria:

1. HIV positive subjects.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital
Study officials:
References:
Clinical trial NCT06522334: Interstitial Lung Disease Registry Study: Prospective and Retrospective Observational Study in Austria
Official title: Interstitial Lung Disease Registry Study: Prospective and Retrospective Observational Study in Austria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Ludwig Boltzmann Institute for Lung Health
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Everybody with a diagnosis of interstitial lung disease, over 18 years old will be asked to participate.

Brief summary: The goal of this registry is to systematically record epidemiological and clinical data throughout the whole interstitial lung disease course - starting with the diagnosis, therapy, follow up of lung function, symptom control, adverse events, medication, survival and death.

There are no additional interventions regarding this registry.


Eligibility criteria: Inclusion Criteria:

* diagnosis of interstitial lung disease
* written informed consent

Exclusion Criteria:

* to not comprehend and rightfully judge participation

Primary outcomes:
measure: Mortality
timeFrame: 10 years
measure: Loss of lung function
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence
timeFrame: 10 years
measure: Response to drugs
timeFrame: 10 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Klinik Hietzing
city: Wien
country: Austria
facility: Klinik Penzing
city: Wien
country: Austria
facility: Ludwig Boltzmann Institut for Lung Health
city: Wien
country: Austria
facility: Klinik Ottakring
city: Wien
country: Austria
facility: Klinik Floridsdorf
Study officials:
References:
Clinical trial NCT02819934: A Phase I Study to Investigate the ADME of KD101
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Detailed description: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Eligibility criteria: Inclusion Criteria:

* Are able to provide written informed consent
* The subject is a healthy Korean aged 20 to 55 years, inclusive.
* The subject weighs at least 55 and has a body mass index (BMI)over 27

Exclusion Criteria:

* Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
* Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
* Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
* Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
* Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
* Subject who have history of allergy.
* Subject who can not continue proper contraception method during study period.
* Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
* Subjects who are unable to abstain from smoking during the PK/PD testing period
* Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product
* Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Primary outcomes:
measure: Total radioactivity at feces,urine,blood to measure total recovery rate
timeFrame: 13day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00795834: Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease
Official title: Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Keywords: polyphenolics
flavonols
lipids
endothelial function
vascular risk factors
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.

Detailed description: This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.

Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 55 years
* BMI \> 25

Exclusion Criteria:

* Present smoker or smoked within the last 2 years
* HBA1C \> 6.0%
* eGFR\<60
* LFT \>/= 3 times upper limit of normal
* Hypertension: systolic blood pressure \> 160mmHg; diastolic blood pressure \> 90mmHg, or on medication for hypertension.
* Chronic disease, likely to be clinically relevant (eg:

cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)

* Vitamin supplements within the previous 14 days
* Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).

Primary outcomes:
measure: Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
timeFrame: Baseline and post intervention
Secondary outcomes:
measure: Established and novel blood markers for vascular disease
timeFrame: baseline and post intervention
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: British Heart Foundation Glasgow Cardiovascular Research Centre
Study officials:
affiliation: University of Glasgow
name: Naveed Sattar, MBChB PhD FRCPath FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.
Clinical trial NCT01769534: Registry and Fluid Banking of Pancreatic Cystic Lesions
Official title: Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Cysts
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).

Brief summary: The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.

Detailed description: The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).

Eligibility criteria: Inclusion Criteria:

* consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts.

Exclusion Criteria:

* Patient unable to give informed consent
* age\<18 or \>85, patients with clinically suspected pseudocysts.

Primary outcomes:
measure: To validate the Sendai criteria prospectively in patients with pancreatic cysts.
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Endoscopy Centrer at OU Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: John T Maple, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01334034: Safety of NNC 0123-0000-0338 in Healthy Subjects
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male subject
* Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
* Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician

Primary outcomes:
measure: Number of adverse events
timeFrame: from trial product administration and until completion of the dosing visit (Day 0 to Day 6)
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve
timeFrame: from 0 to 120 hours after a single dose
measure: Area under the glucose infusion rate-time curve
timeFrame: from 0 to 24 hours after a single dose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: