louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03324256: Energy Drinks and Vascular Function
Official title: Acute Effect of Energy Drinks on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Function
Keywords: Energy drink consumption
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

Detailed description: The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Being Male
* 18-30 years of age
* No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
* BMI ≤ 30 kg/m\^2 and blood pressure ≤ 140/90 mmHg
* Consumption of \<400mg of caffeine/day
* Prior history of consumption of energy drinks

Exclusion criteria:

* Being female
* Age \<18 or \>30 years
* BMI\> 30 kg/m\^2 and blood pressure \> 140/90 mmHg
* Use of medication that may affect vascular measures
* Use of tobacco products including smoking
* Vegan or vegetarian diet
* Being energy drink or caffeine naïve or consumption of \>400 mg of caffeine/day
* Consumption of \>1 energy drinks per month
* Being a shift worker

Primary outcomes:
measure: Change in endothelial function
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
Secondary outcomes:
measure: Change in arterial stiffness
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
measure: Change in wave reflection
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
measure: Change in peripheral and central blood pressures
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
measure: Change in thrombosis and platelet function
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
measure: Change in circulating factors related to vascular function
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
measure: Change in heart rhythm
timeFrame: Before and 1 and 2 hrs following consumption of drink and gum
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799656: Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
Official title: Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Diabetic neuropathy
painful pain
postoperative
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.

The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.

Detailed description: This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.

Exclusion Criteria:

* Presence or history of cancer within the past five years
* Patients with a history of HIV infection
* Patients with active hepatitis B or C
* Patients with any pain other than the neuropathic pain of greater or equal severity
* Patients with a diabetes mellitus for less than 6 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in average daily pain intensity
timeFrame: after 28-days treatment
Secondary outcomes:
measure: Responder rate
timeFrame: after 28-days treatment
measure: Rescue medication intake
timeFrame: during 28-days treatment
measure: Change in Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: after 28-days treatment
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
name: Hans-Goerg Kress, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290856: Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Official title: Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer
Pancreas Adenocarcinoma
Cholangiocarcinoma
Keywords: circulating tumor DNA
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced malignancy

Brief summary: Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making.

Detailed description: Advanced pancreatic cancer (PDAC) and cholangiocarcinoma (CCA): -Could the Idylla ctKRAS test select the \~10% of PDAC patients with KRASwt eligible for more extensive diagnostics? In PDAC and CCA, is it possible to detect patient samples with KRAS G12C or BRAF mutation for study inclusion? Could the ΔCq-value of the tests be used as a semi-quantitative tumor marker? What is the clinical value compared to the current tumor marker CA19-9?

•

Metastatic Colorectal Cancer: Are the ctDNA assays useful in detecting primary resistance and/or monitoring for secondary/acquired resistance to EGFR antibody treatment? How does the sensitivity, specificity and turnaround time of the ctDNA assays compare to tissue-based analysis? Could the Idylla ctDNA assays accelerate detection of KRAS G12C or BRAF mutations, and hence facilitate study inclusion in the first line setting? Could the ctDNA assays guide rechallenge with EGFR treatment?

Can the information of liver metastases or prognostic markers (s-CEA, s-CRP) guide timing of ctDNA sampling?

Eligibility criteria: Inclusion Criteria:

Newly referred patients with advanced pancreatic cancer (\~20/year), Cholangiocarcinoma (\~20/year), metastatic colorectal cancer (mCRC) (\~50/year) and anti-EGFR-treated mCRC patients (\~10/year) to Oslo University Hospital are eligible for inclusion.

Primary outcomes:
measure: Clinical validity of ctDNA tests
timeFrame: 1 week
Secondary outcomes:
measure: Resources needed for ctDNA assays in routine diagnostics
timeFrame: 1 week
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university Hospital
Study officials:
affiliation: Oslo University Hospital
name: Ragnhild Nome, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294956: A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* NaFl Corneal staining sum score ≥ 3 in either eye
* Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion Criteria:

* No contact lenses wear throughout the study period
* Must not have had punctal plugs inserted within 30 days preceding enrollment

Primary outcomes:
measure: Corneal Staining
timeFrame: Day 42
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.
Clinical trial NCT04446156: Liver Diseases in PLWH
Official title: Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Liver Diseases
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PLWH crowd in Zhejiang Province

Brief summary: In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of liver function damage in people living with HIV (PLWH). There are a large number of PLWH in China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus, hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis, and treatment of liver function damage in PLWH complicated in China.

The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH in eastern China.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Non-hospitalized patients diagnosed with HIV infection;
* Sign the informed consent voluntarily.

Exclusion Criteria:

* Severe active infection requiring parenteral antibiotics or antifungal treatment within 30 days before the assessment;
* Other major chronic diseases that may affect health-related quality of life, such as extrahepatic malignant tumors;
* Psychotic patients, patients with severe cognitive or neurological deficits;
* Women during pregnancy and lactation;
* Those who refuse to sign informed consent.

Primary outcomes:
measure: Prevalence of liver disease in PLWH
timeFrame: 2020-12-31
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the first affiliated hospital of Zhejiang university school of medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01596556: The Effect of Smoking on Thermoregulation
Official title: The Effect of Smoking on Thermoregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: smoking
exercise
heat tolerance
heat stroke
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: International Diabetes Federation
First posted: 2012-05-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To the best of our knowledge, a possible relation between smoking and heat injuries or heat intolerance was never scientifically examined, although such a relation is logical according to the observations that smoking has a thermogenic effect, decreases physical fitness and affects the body's heat dissipation.16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will perform VO2 test and heat tolerance test (HTT) in different conditions.

Detailed description: 16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or five times. During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency. During their second visit all subjects will go through the same test after exposure to nicotine. During the smokers' third visit they will go through the same test, after exposure to cigarette smoking. During the non-smokers third visit and the smokers fourth visit - they will go through an exercise heat tolerance test without prior smoking. During the fifth visit the smokers will go through an exercise heat tolerance test after exposure to cigarette smoking. During the smokers' sixth visit and the non-smokers fourth visit they will go through an HTT after exposure to nicotine.

Eligibility criteria: Inclusion Criteria:

* age 18-30
* healthy
* after medical checkup
* after signing concent form
* for the smokers: smoking 0.5-1.5 packs of cigarettes a day at least 2 years.

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* diabetes
* anhydrosis
* skin disease
* acute illness
* detoxification from nicotine
* allergy to nicotine
* smoking other then specified in the inclusion criteria

Primary outcomes:
measure: Heat tolerance
timeFrame: 2-3 days
measure: VO2max
timeFrame: 2-3 days
Secondary outcomes:
measure: Rectal temperature
timeFrame: experimental days 4,5,6
measure: Heart rate
timeFrame: experimental days 4,5,6
Other outcomes:
Locations:
city: Tel-Hashomer Ramat-Gan
country: Israel
facility: The Institute of Military Physiology Heller Institute of Medical Research
Study officials:
affiliation: Sheba Medical Center
name: Amit Druyan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05742256: Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer
Official title: Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Oxycodone
Keywords: Oxycodone
Postoperative analgesia
lung cancer
thoracic paravertebral nerve block
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 159
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age \> 60 years
2. Patients undergoing thoracoscopic lobectomy
3. ASA (American Academy of Anesthesiologists) Grades I-III
4. There were no obvious abnormalities in heart, liver, and kidney function
5. Sign the informed consent form for this clinical study

Exclusion Criteria:

1. History of oxycodone or sufentanil allergy
2. Renal or hepatic dysfunction
3. History of drug or alcohol abuse
4. Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
5. Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
6. People with head trauma or other brain diseases -

Primary outcomes:
measure: The main indicators were NRS scores at rest and cough at 24 h postoperatively.
timeFrame: at 24h after surgery
Secondary outcomes:
measure: Time to double-lumen tracheal extraction
timeFrame: Within two hours after surgery
measure: NRS score at rest and cough
timeFrame: at 2h , 4h, 12h, 48h after surgery
measure: sedation score (Ramsay sedation score)
timeFrame: at 2 h , 4 h , 12 h ,24 h,48 h postoperatively
measure: sufentanil consumption
timeFrame: Within 48 hours after surgery
measure: oxycodone consumption
timeFrame: Within 48 hours after surgery
measure: analgesic pump compressions
timeFrame: Within 48 hours after surgery
measure: additional analgesic doses
timeFrame: Within 48 hours after surgery
measure: incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
timeFrame: Within 48 hours after surgery
measure: gastrointestinal recovery (exhaust time)
timeFrame: Within 48 hours after surgery
measure: laboratory results of C-reactive protein 1 day before and after surgery
timeFrame: Within 48 hours after surgery
measure: laboratory results of interleukin-6 laboratory test 1 day before and after surgery
timeFrame: Within 48 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00188409: Pneumothorax Post CT Lung Biopsy
Official title: Pneumothorax Following CT-Guided Lung Biopsy: Is There a Role for the Post Biopsy CT in Patient Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Nodules
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A CT scan is performed after a lung biopsy in order to detect a Pneumothorax. We postulate that CT is more useful than chest radiography


Eligibility criteria: Inclusion Criteria:

* all patients having a lung biopsy

Exclusion Criteria:

* none

Primary outcomes:
measure: detection of pneumothorax
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: narinder paul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04937556: Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: ProbiSearch SL
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.

The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.


Eligibility criteria: Inclusion Criteria:

* Adult (18-65 years).
* Mild infection by SARS-CoV-2 detected by PCR or Antigen.
* Onset of COVID-19 symptoms up to 5 days before the day of inclusion
* Without hospitalization or oxygen supplementation on the day of inclusion.
* Signed written informed consent

Exclusion Criteria:

* Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
* Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
* Congenital or acquired immunodeficiency
* Body Mass Index (BMI)\> 30
* Coagulation disorders
* Short bowel syndrome or any surgery on the gastrointestinal tract.
* Metabolic disorders (diabetes, etc.).
* Heart failure and cardiac medical history
* Pregnant women.
* HIV positive.
* Immunocompromised
* History of significant gastrointestinal diseases
* Use of other probiotics during the last month.
* Uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.

Primary outcomes:
measure: Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
timeFrame: 1 month
Secondary outcomes:
measure: Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.
timeFrame: 1 month
measure: Duration of the symptoms produced by the SARS-CoV-2 infection
timeFrame: 1 month
measure: Severity of symptoms produced during SARS-CoV-2 infection
timeFrame: 1 month
measure: Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2
timeFrame: 1 month
measure: Percentage of participants with worsening of lower respiratory tract infections
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
References: