louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01872533: Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Official title: Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Insulin Resistance
Keywords: obesity
hypoxia
insulin sensitivity
altitude
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 9
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to moderate hypoxia (\~ 15% O2, similar to conditions at an altitude of \~7500 feet) will improve glucose metabolism.


Eligibility criteria: Inclusion Criteria:

* Aged 20-45 years
* Male
* Obese category (BMI \> 30 kg/m2)
* Healthy as assessed by a self-reported health questionnaire
* Non-smokers
* Weight stable over the past 3 months (\<2kg fluctuation)

Exclusion Criteria:

* Female
* Diabetes
* Sleep apnea
* Hypertension
* History of altitude sickness
* Individuals taking any chronic medications
* Individuals taking any stimulants
* Individuals taking beta-blockers
* Individuals with chronic alcohol consumption (\>3 drinks per day) or drug abuse.
* Individuals unable to abstain from caffeinated beverage or alcohol the days of study testing
* Individuals with history disease or history of stroke

Primary outcomes:
measure: Change in Insulin sensitivity
timeFrame: Change from baseline to 10 nights of hypoxia exposure
Secondary outcomes:
measure: Change in oxygen tension in adipose tissue
timeFrame: Before and after 10 nights of hypoxia exposure
measure: Glucose uptake in myotubes
timeFrame: Before 10 nights of hypoxia exposure
measure: Change in gene and protein expression
timeFrame: Before and after 10 nights of hypoxia exposure
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Lecoultre V, Peterson CM, Covington JD, Ebenezer PJ, Frost EA, Schwarz JM, Ravussin E. Ten nights of moderate hypoxia improves insulin sensitivity in obese humans. Diabetes Care. 2013 Dec;36(12):e197-8. doi: 10.2337/dc13-1350. No abstract available.
Clinical trial NCT00946933: Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses
Official title: Effects of Chronic Acid-Base Changes on the Ventilatory and Perceptual Response to Hypercapnia, Hypoxia and Exercise in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: acid-base balance
ventilatory control
dyspnea
exercise
modified rebreathing procedure
Normal
older
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. The main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. Some possible contributing factors include abnormalities in the control and/or mechanics of breathing. To evaluate these possible contributory factors, the investigators will compare ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental conditions where the investigators increase or decrease breathing requirements by altering dietary salt intake in healthy 40-80 year old men and women.

Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day treatment period. Breathlessness intensity will be measured and compared at a standardized work rate, ventilation or end-tidal PCO2 during these tests.


Eligibility criteria: Inclusion Criteria:

* healthy, regularly active adults
* non-smoking
* BMI 18-30 kg/m2

Exclusion Criteria:

* history of lung and/or heart disease (including cardiac arrhythmias) or other comorbidity which could interfere with proper conduct of the intervention or tests
* hypotension or hypertension
* hypercholesterolemia
* sleep disordered breathing
* inability to perform cycle exercise or comply with other testing procedures

Primary outcomes:
measure: Breathlessness intensity (10-point Borg scale)
timeFrame: Measured at the end of each 3 day treatment period
Secondary outcomes:
measure: Exercise capacity (peak VO2)
timeFrame: Measured at the end of each 3 day treatment period
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Respiratory Investigation Unit at Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University and Kingston General Hospital
name: Denis E O'Donnell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827033: Effects of Meditation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Meditation Training
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to learn about the effects of doing meditation (sitting quietly and concentrating) on people's ability to pay attention and be relaxed.


Eligibility criteria: Inclusion Criteria:

* aged 18-55
* currently enrolled in methadone maintenance program

Exclusion Criteria:

* history of: a severe medical or psychiatric condition (except substance abuse; e.g., schizophrenia); brain trauma affecting cognitive functioning
* prior experience with meditation

Primary outcomes:
measure: computerized attention task
timeFrame: within 1 week after training
Secondary outcomes:
measure: stress questionnaires
timeFrame: within 1 week after training
measure: mindfulness questionnaire
timeFrame: within 1 week after training
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: BPRU, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Miriam Z Mintzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174133: Impact of LVAD Implantation on Micro- and Macrovascular Function
Official title: Impact of LVAD Implantation on Micro- and Macrovascular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Heart Failure
Keywords: left ventricular assist device
endothelial function
microvascular perfusion
microparticles
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end stage heart failure

Brief summary: End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.


Eligibility criteria: Inclusion Criteria:

* patients after HTX
* patients after LVAD implantation
* patients with stable coronary heart disease and normal systolic left ventricular function
* healthy volunteers
* written informed consent

Exclusion Criteria:

* acute inflammation
* cardiac arrhythmia
* renal failure
* malignant disease

Primary outcomes:
measure: Macrovascular function measured by flow-mediated vasodilation (FMD)
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Microvascular function assessed by non-invasive laser Doppler imaging
timeFrame: 3 months after implantation
measure: microparticles determined by Flow Cytometry
timeFrame: 3 months after implantation
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02513433: Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia
Official title: Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Insensitivity, Congenital
Keywords: Lumbar epidural anaesthesia
Lead sponsor: Government Medical College, Haldwani
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.

Detailed description: Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.

Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.

The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.

Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.

Eligibility criteria: Inclusion Criteria:

* ASA Grade I and II patients of either sex
* Age 18-60 years
* Undergoing various hip surgeries under lumbar epidural anesthesia

Exclusion Criteria:

* Refusal for epidural
* ASA-III\&IV
* Head injury
* Psychiatric disease
* Known allergic to test drugs
* Major systemic disease
* Any analgesia with in past 24 hours

Primary outcomes:
measure: Onset of sensory block
timeFrame: 30 minutes
Secondary outcomes:
measure: Time for 2 segment regression of sensory block
timeFrame: 90 minutes
measure: Time to achieve maximum motor block
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Haldwani
country: India
facility: Government Medical College
state: Uttarakhand
Study officials:
affiliation: Professor and Head of the department
name: Geeta Bhandari, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241487: A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Official title: An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypertension
Keywords: Hypertension, Valsartan/Amlodipine,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.


Eligibility criteria: Inclusion Criteria:

* Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.\>/= 140/90 mmHg in non diabetics or \>/= 130/80 mmHg in diabetics

Exclusion Criteria:

* Patient having B.P.\>= 180/110 mmHg in non diabetics or \>= 160/100 mmHg in diabetics
* Type 1 Diabetes or uncontrolled type 2 Diabetes.
* PCI in last 12 months.
* Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)
timeFrame: 4 weeks
Secondary outcomes:
measure: Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.
timeFrame: 8 weeks
measure: Safety and Tolerability of the Trial Medication
timeFrame: 8 weeks
measure: The incidence of Edema
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dr Ahmed Anwar Clinic,
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01483287: The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in Irritable Bowel Syndrome (IBS)
Official title: The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: Gastrointestinal Symptoms
Bloating
Distention
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is characterized by recurrent pain and/or discomfort, altered stool form, and abdominal distension. It has been established that food items such as beans, peas, lentils, peppers, and onions can increase gas production. What these have in common is that they all contain large amounts of complex carbohydrates. The enzymes in the small intestine are not able to fully digest these large molecules, which in turn are fermented by the colonic microflora. This fermentation is conducted through the production of short chain fatty acids and gases such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break down these indigestible carbohydrates to galactose and sucrose in the small intestine and to facilitate the absorption and minimize the gas production from bacteria in the colon.

The aim of this study is to assess if the gastrointestinal symptoms, above all problems from gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin capsules) is ingested with food.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Irritable Bowel Syndrome(IBS), (in accordance with ROME III criteria), and
* With the specific symptoms of bloating and/or abdominal distension.

Exclusion Criteria:

* The patients should not have any other gastrointestinal diseases such as IBD or celiac disease.

Primary outcomes:
measure: Change in symptoms
timeFrame: 24 hours
Secondary outcomes:
measure: Changes in expiration air
timeFrame: 24 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT06068387: A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
Official title: A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are:

* Is the para-aortic lymph node metastasis prediction model accurate and feasible?
* Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
* It was treated initially without surgical and chemotherapy.
* Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
* Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
* ECOG score:0 \~ 1.
* The expected survival time\>6 months;
* There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.

Exclusion Criteria:

* History of immune disease who need to take immunosuppressive drugs.
* History of serious mental illness and brain functional disorder.
* Other malignancies were diagnosed within five years or needed treatments.
* Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
* Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
* Patients who cannot understand the research regimen and refuse to sign the informed consent form.
* Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Primary outcomes:
measure: The accuracy of the prediction model
timeFrame: 2 years
Secondary outcomes:
measure: PFS
timeFrame: 3 years
measure: LRR
timeFrame: 1 year
measure: LRR
timeFrame: 2 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03959787: Surgical Patient Knowledge and Safe Use of Opioids
Official title: Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2019-05-22
Enrollment: 100
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: Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to provide standardized written materials to surgical patients about the risks of opioids and how to safely use opioids after surgery. Investigator has developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids.

The objective of this study is to determine whether the pamphlet increases surgical patients' knowledge about the safe use, proper storage and disposal of opioids.

Detailed description: Participants presenting to the preoperative clinic will be recruited for this trial. After informed consent is obtained, patients will be randomized to one of 2 groups: 1) educational pamphlet and standard care, or 2) control group - standard care (no pamphlet) All patients will complete the opioid knowledge questionnaire to test baseline knowledge on opioids. If patient is randomized to the educational pamphlet and standard care, patient will receive the educational pamphlet and standard care. After the patient reviews the pamphlet, the patient will complete the questionnaire again. If the patient is randomized to the control group, the patient will receive the usual standard of care.

All patients will be contacted by telephone 15 days and 30 days after surgery to conduct the follow-up.

Eligibility criteria: Inclusion Criteria:

* All English speaking
* Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic

Exclusion Criteria:

* Patients who are on opioids for chronic pain
* Patients have taken opioids in the past 30 days
* Patients who are unable to read and understand English

Primary outcomes:
measure: Change in knowledge
timeFrame: day 1
Secondary outcomes:
measure: Knowledge retention
timeFrame: 15 and 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: