cyrilzakka/clinical-trials huggingface dataset:
Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation

Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fatmax) has been recognized as potential determinants of endurance performance.

The purpose of this study was to determine the possible interaction between the effects of diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max in endurance-trained men. Specifically, the investigators sought to elucidate whether the stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the morning.

Body weight, height, body composition (DXA), exercise test (MFO and VO2max assessment) will be measured during the 4 evaluations.

Participants were randomized into 4 exercise test conditions:

1. Exercise test in the morning with placebo intake
2. Exercise test in the evening with placebo intake
3. Exercise test in the morning with caffeine intake
4. Execrise test in the evening with caffeine intake

Eligibility Criteria:
Inclusion Criteria:

* Having a body mass index (BMI) ranged from 18.5 to 28 kg/m2
* not suffering any specific disease which can be aggravated by physical exercise
* having previous experience in endurance training (i.e. self-reporting at least 2 years of cycling or running training including more than 3 training sessions/week).
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

Exclusion Criteria:

* Being smoker
* Taking medication or drugs
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.

The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.

Eligibility Criteria:
Inclusion Criteria

* Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years
* Requires peripheral IV as determined by examining physician
* Requires the IV when a study nurse or resident is available
* Able to sign an informed consent

Exclusion Criteria

* Active systemic or cutaneous infection or inflammation;
* Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
* Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
* Currently involved in any other investigational clinical trials;
* Previous vascular grafts or surgery at the target vessel access site;
* Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
* Central line available
* Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)
Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment

The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial.
* All patients should sign the informed consent.

Exclusion Criteria:

* Patients below 18 years.
* Pregnancy.
* Emergency surgery for aortic aneurysm.
* Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.
An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.

This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription.

For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days

Exclusion Criteria:

* Patients who were younger than 18 years of age
* Patients who survived for less than 90 days from the date of dialysis initiation
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients must be willing and able to complete all study-specific procedures and visits
* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria:

* History or presence of chronic bacterial, viral infection, or autoimmune disorder
* Active TB requiring treatment or documented latent TB within the previous 3 years
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy

HIV infection is a major global health problem. Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. However, such therapy has been associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body shape changes; typically thinning and loss of fat from the arms, legs and face, with increased fat appearing in the abdomen and neck. There are also metabolic changes which occur, and subjects can develop increased triglycerides, increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance. This study will take HIV positive subjects who have not yet started antiviral medications (treatment naive)and randomly assign them to one of two treatment arms. These treatment arms will be: Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs. Understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future.


Eligibility Criteria:
Inclusion Criteria:

* CD4 count \> 200 cells/mm
* HIV RNA (viral load) \<= 100,000 copies/ml
* No previous antiviral therapy

Exclusion Criteria:

* AIDS or opportunistic infections
* Active intravenous drug users
* Use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, oxandrolone, megace, dehydroepiandrosterone.
* Subjects with diabetes mellitus
* Subjects who consume \> 2 alcoholic drinks per day
* Pregnant women, premenopausal women unless adequate birth control is in use.
* Acute or chronic liver diseases, liver enzymes elevations \> 2.5 times the upper limit of normal.
* Anemia, an Hct \< 35% for men, or \< 32% for women.
* Abnormal thyroid function tests.
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

Donor criteria:

* deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
* recipients awaiting their first transplant
* recipients ≥ 18 and \>/= 65 years
* recipient's signed informed consent
* waiting list

Exclusion Criteria:

Donor criteria:

* not applicable

Patient criteria:

* recipients participating in another interventional study
* pregnant or lactating patients
* history/demonstration of HIV antibodies or AIDS
* multiorgan transplantation
* transMedics pump
* the explantation team is affiliated another clinic than transplantation team
Vape-Free Text-Messaging: Pilot Study

This is a small pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the e-cigarette cessation text-messaging intervention with young adults in rural areas.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* 18-24 years
* everyday e-cigarette use in the past month
* ownership of a mobile phone or smartphone with texting and internet access abilities
* knowledge of how to use text messages
* plan on quitting e-cigarette use within one month
* home address in a rural county of Wisconsin, Minnesota, North Dakota, and South Dakota

Exclusion Criteria:

* Individuals who reported use of other tobacco products (e.g., cigarettes, smokeless tobacco) than e-cigarettes in the past month
Effect of Exercise in Head and Neck Cancer Patients

Head and neck cancers (HNC) are malignancies originating from the mucosa in the oral cavity, nasopharynx, oropharynx, hypopharynx and larynx. Unfortunately, the majority of patients with HNC have locally advanced disease at diagnosis and should, therefore, be treated with chemoradiotherapy (CRT) or with radical surgery followed by adjuvant (C)RT. Treatment of HNCs with (C)RT frequently results in serious and persistent impairments in physical and psychosocial functioning. In order to prevent worsening of a person's functioning at diagnoses and limit the physical impact of the treatments for HNC, a comprehensive supervised exercise program (CSEP) is needed early during treatment.

There is a need to improve integration of exercise programs into HNC care with aim to help head and neck cancer patients regain physical, mental and social functioning. Currently, no program is available adapted to the specific needs of head and neck cancer patients, in particular during cancer treatment.

The primary scientific objective is to examine the effectiveness of a comprehensive supervised exercise program, in addition to usual care, on health-related quality of life (primary outcome parameters) during treatment of head and neck cancer, compared to usual care only, up to 1 year after diagnosis.

Secondary objectives entail gathering information on the effectiveness of the CSEP, in addition to usual care on secondary outcome parameter such as physical and mental functioning, activity level and participation level; to determine the feasibility of such CSEP (defined as at least 50% of eligible patients enrolling in the study and completing at least 50% of the planned intervention sessions) and possible barriers and facilitators for participating in a CSEP during head and neck cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Diagnosed with primary malignant tumour head and neck region (oral cavity, nasal cavity and paranasal sinuses, pharynx, larynx, salivary glands, thyroid)
* ECOG performance score 0-1
* Planned for curative (chemo)radiotherapy
* Able to complete baseline assessments prior to start of radiotherapy.
* Physically and mentally capable of taking part in an exercise program and motivated to engage in a supervised exercise program.

Exclusion Criteria:

* Patients \< 18 years
* ECOG ≥ 2
* Patient with HNC, treated with palliative intent
* Evidence of distant metastases
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.


Eligibility Criteria:
Inclusion Criteria:

* Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor
* Age 18-75
* One of the following high-risk malignancies
* Chronic Myelogenous Leukemia
* Acute Myelogenous Leukemia
* Myelodysplastic Syndrome
* Myelofibrosis
* Acute Lymphocytic Leukemia
* Acute Lymphoblastic Lymphoma
* Chronic Lymphocytic Leukemia
* Prolymphocytic Leukemia
* Low-grade non-Hodgkin's Lymphoma
* Mantle Cell Lymphoma
* Hodgkin Lymphoma
* Myeloma

Exclusion Criteria:

* Poor cardiac function (EF \<40%)
* Poor pulmonary function (FEV1 and FVC \<50% predicted)
* Poor liver function (bilirubin \>/= 2 mg/dl not due to hemolysis, Gilbert's or primary malignancy)
* Poor renal function (creatinine \>/= 2 mg/dl or creatinine clearance \<40mL/min)
* Karnofsky status \<70%
* HIV positive
Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP). Multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of this study was to investigate the relationship between PSI and presence of MDR pathogens.

Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December 2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.

MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).

The criteria for HCAP is defined as follows: patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; residents of a nursing home or long-term care facility; recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; or patients who attended a hospital or hemodialysis clinic.

Eligibility Criteria:
Inclusion Criteria:

* patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days;
* residents of a nursing home or long-term care facility;
* recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days;
* or patients who attended a hospital or hemodialysis clinic.

Exclusion Criteria:

-
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis

Evaluate the safety and tolerability of VX-659 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers: PARTS A, B, and C

* Males and Females of non-childbearing potential.
* Between the ages of 18 and 60 years inclusive
* Healthy, as defined per protocol.
* Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive
* Body weight \>50 kg

CF Patients: PART D

* Body weight ≥35 kg.
* Males and Females of non-childbearing potential.
* Sweat chloride value ≥ 60 mmol/L at screening.
* Heterozygous for F508del and a minimal function CFTR mutation
* Forced expiratory volume in 1 second (FEV1) ≥40% and ≤90% of predicted at screening

Exclusion Criteria:

Healthy Volunteers: PARTS A, B, and C

* History of any illness or any clinical condition that in the opinion of the investigator might confound the results of the study or pose additional risk to the subject.
* Any condition possibly affecting drug absorption.
* History of febrile illness within 14 days before the first study drug dose.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.

CF Patients: PART D

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
* History of cirrhosis with portal hypertension.
* Risk factors for Torsade de Pointes.
* G6PD deficiency assessed at Screening.
* Abnormal Laboratory Values.
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* History of solid organ or hematological transplantation.
Training Nurses in Basic Hypnoanalgesia Techniques

Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia techniques, and this new tool will translate into a reduction of procedural distress and pain in their patients, thereby opening the way to larger clinical trials in various pediatric settings.


Eligibility Criteria:
Inclusion Criteria:

* children followed in the hematology-oncology outpatient clinic at least 4 times per year
* good understanding in French
* use of topic anesthesia or distraction object allowed, as long as used at all venipuncture measured sessions

Exclusion Criteria:

* prior use of hypnoanalgesia
* patients coming for emergency or non-scheduled appointment
* patients with acute pain on their scheduled appointment to the clinic
* acute psychiatric disease
Krill Oil and Resistance Exercise in Older Adults

The aim of this study is to determine whether krill oil supplementation enhances effects of a pragmatic resistance exercise programme on adaptations in muscle strength, mass, function and neuromuscular function in sedentary older adults. Hypothesis - krill oil supplementation will enhance the beneficial effects of resistance exercise on muscle strength, function, mass and neuromuscular function in sedentary older adults.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 60 years
* scoring a low level of physical activity based on international physical activity questionnaire (not meeting the recommend physical activity which is at least 600 MET-min per week).

Exclusion Criteria:

* Diabetes
* severe cardiovascular disease
* seizure disorders
* uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* cancer or cancer that has been in remission \<5 years
* ambulatory impairments which would limit ability to perform assessments of muscle function
* dementia
* taking medication known to affect muscle (e.g. steroids)
* have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump)
* on anticoagulant therapy
* allergies to seafood
* regular consumption of more than 1 portion of oily fish per week
* already taking fish or krill oil or other n3 PUFA supplements
* femoral neck fracture or other severe of hip or knee operations
* stroke
* Parkinson's disease
* COPD
* kidney disease
* hyperlipidaemia
* obesity
* osteoporosis.
Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.

In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.


Eligibility Criteria:
Inclusion Criteria:

* male
* age \>18
* biopsy-proven non-small cell lung cancer
* surgical intervention planned

Exclusion Criteria:

* current use of 5-alpha reductase inhibitor
* previous diagnosis of prostate cancer
* previous hypersensitivity to 5-alpha reductase inhibitor
STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS

Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.

However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.

In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.

This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children.


Eligibility Criteria:
Inclusion Criteria:

* No objection to participation in the study
* Men and women aged ≥ 70 years
* Patients diagnosed with presbyacusis (age-related bilateral and symmetrical sensorineural hearing loss, all stages combined), with or without the use of a bilateral hearing aid.
* If they use a hearing aid: hearing must have an average free-field fitted tonal threshold of 40 dB max and free-field fitted speech discrimination without lip-reading of 90-100% at 60dB in silence.
* MMSE score ≥ 24/30

Exclusion Criteria:

* Person under legal protection (curatorship, guardianship)
* Person under court order
* Adult unable to provide consent
* Person with a neurocognitive disorder (post-stroke, dyslexia, dyspraxia) or neuro-psychiatric disorder (dementia, autism)
* Severe sensorineural hearing loss with mean free-field threshold \> 40 dB and free-field speech discrimination without lip-reading of \< 90-100% at 60dB in silence
* Asymmetrical sensorineural hearing loss due to an additional cause of hearing loss on one side.

Secondary exclusion criteria:

Person with syntax disorder (discovery of sentence comprehension or production disorders during syntax test)