cyrilzakka/clinical-trials huggingface dataset:
Physiologic Effect of Spices Ingestion

Human studies have shown that capsaicin, a compound extracted from chilly peppers, can stimulate certain physiologic functions (for example, energy expenditure, thermogenesis, lipid oxidation, heart rate, etc.).

The purpose of this study is to measure the impact of ingesting various spicy molecules on a set of physiologic parameters compared to a placebo. The molecules were selected for their different sensory properties.

The results of this study will allow us to implement an effective method for measuring the impact of ingesting spices on certain body functions (for example, metabolism and autonomic nervous system activity). This study will also allow us to identify the beneficial properties of eating certain spices.

Primary objective and outcome:

The main objective of this study is to establish a methodology to evaluate the acute impact of spice ingestion on metabolism and autonomic nervous system activity.

Primary outcomes:

Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).

Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive minutes (measured by indirect calorimetry).

As secondary outcomes blood pressure changes and facial temperature changes on specific area (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry data for energy expenditure measure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI: 19-25 kg/m2, ≥ 60 kg body weight
* Moderate spicy food eaters
* Having signed the informed consent.

Exclusion Criteria:

* Any gastrointestinal disorder
* Subject sensitive or not used to eat spicy food
* Smokers
* Subject with beard or mustache
* Abnormal thyroid function
* Intake of medication that could affect body weight and/or energy expenditure
* Weight loss \> 5% in the last 3 months
* Under antibiotics or regular treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure, lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
* History of allergy
* Physical activity level \> 300 min of moderate or intense exercise per week
* Have a alcohol consumption higher than than 1 drink/day
* Consumption of illicit drugs
* Subject who cannot be expected to comply with the study procedures, including consuming the test products
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial

Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency is common in HF patients. Previous small studies have shown that thiamine supplementation can improve left ventricular systolic function in HF, but larger clinical studies are lacking. Given the ease of supplementation and the potential benefits in HF, we aim to conduct a pilot randomized controlled trial (RCT) using high dose thiamine supplementation in HF patients. The main goal of this pilot study is to determine the feasibility of recruitment for an RCT of thiamine supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60
* NYHA class II-IV symptoms
* Recent HF-related admission in past 12 months OR NT-proBNP \>600ng/L within 60 days of screening
* LVEF ≤45% on 2D/3D echocardiography or radionuclide angiography (RNA) in the past 12 months (on optimal therapy)
* Medically optimized prior to enrolment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker (± neprilysin inhibitor), β-blocker, and/or aldosterone antagonist at target or maximally tolerated doses.
* Patients must be stable on medications without hospitalization in the past month.

Exclusion Criteria:

* Taking \>2.5mg/d of thiamine supplement. Allows standard multivitamin. B complex vitamin not allowed due to high thiamine content.
* Unable to swallow study medication. A placebo swallowing test will take place at screening.
* Clinical indication for thiamine supplementation including symptomatic thiamine deficiency (Wernicke's encephalopathy, severe malnutrition, refeeding syndrome) and heavy alcohol use, \>15 standard drinks per week in men and \>10 standard drinks per week in women.
* End-stage renal disease on dialysis
* Severe mitral valve disease because this impacts the accuracy of speckle tracking analysis on echocardiography.
* Non-English speaking (unable to complete questionnaires).
* Unable to provide written consent.
* Cognitive impairment without a caregiver administering medications.
* Expected survival \<1 year due to non-cardiac disease.
* Expected heart transplantation in \<6 months (± left ventricular assistive device).
* Allergies to the ingredients of the study medication or placebo
Urotensin II in Chronic Kidney Diseases and Kidney Transplants

The investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls.

The investigators will determine the urotensin II levels in Chronic kidney disease patients, kidney transplants, and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18

Exclusion Criteria:

* Inability to give a written consent
Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress

Physical inactivity and sedentary time are highly prevalent worldwide and are associated with many adverse health outcomes. Workers adults spend two-thirds of their workday sitting, so they are particularly at risk. Exercise is considered a preventive and treatment tool for diseases, however, the effects of Concurrent Training (that is, aerobic plus resistance training) are not well established in healthy adults.

This research project aims to analyze the effects of a concurrent training program on metabolic profile, lung function, stress and quality of life, as well as body composition and physical fitness in sedentary adults.

This is a single-blinded two-arm RCT with parallel groups. After completion of baseline assessments, eligible participants will be randomized in a 1:1 ratio to participate in concurrent training group or control group. Repeat assessments will be taken immediately post 8 weeks and post 16 weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with ages between 40 to 64 years old
* Physically inactive adults
* Full-time workers in a sedentary job
* BMI between 18 and 35 kg/m2
* Maintain the current diet and undergo all testing procedures

Exclusion Criteria:

* Chronic disease (e.g., diabetes, cardiovascular disease, pulmonary disease)
* Cognitive impairments and/or psychiatric conditions that could interfere with the study outcomes
* Take any medication that could interfere with the study outcomes
* Limitations that prevent them from practicing exercise
* History of heart failure/myocardial infarction
* Uncontrolled or abnormal blood pressure
* Smokers
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients

Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
* ATP Auto-switch function is programmed ON

Exclusion Criteria:

* Presence of a contra-indication to the ICD therapy
* Life expectancy less than 12 months
A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have measurable disease
* Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
* ECOG PS: 0-1

Exclusion Criteria:

* Subjects with centrally located squamous cell carcinoma of the lung
Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use

The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder.

Central venous catheterisation is one of the invasive procedures commonly used in the treatment and care of patients in internal and surgical clinics and generally in intensive care units and in the follow-up of patients to be operated. Central venous catheters (CVC) are indispensable diagnostic and therapeutic applications in modern medicine. It is a practical method used in cases where venous vessels cannot be used.

Central venous catheterisation is a cannula inserted into the subclavian, jugular or femoral vein. Nurses are responsible for the care and daily control of central venous catheters inserted by physicians. Central venous catheterisation is widely used by nurses in clinical wards, intensive care units and during surgical procedures for many indications such as monitoring, drug administration and parenteral nutrition. Subclavian vein and jugular vein are most commonly used for this purpose. Many complications such as haemothorax, pneumothorax, malposition, air embolism and infection may develop during CVC applications. The role of the nurse is very important in the determination of CVC complications.

In terms of the individual with a central vein catheter, it constitutes a situation where the individual is worried about a catheter placed in his/her body and needs to be sensitive to the area where it is placed. They should be careful while performing daily life activities with the catheter. The presence of the central jugular vein catheter in the neck area affects the head position, and the sagging of the catheter lumens on the dressing causes skin sensitivity.

Individuals with central jugular vein catheters experience some problems such as discomfort due to sagging of the catheter lumens, inability to move comfortably in head and neck movements and sagging of the catheter lumens. The aim of this study was to develop an innovative design of central jugular vein catheter lumen holder to ensure the position, fixation and comfort efficiency of the central jugular vein catheter and to evaluate its ergonomic use.

Eligibility Criteria:
Inclusion Criteria:

* Being a healthy individual over the age of 18
* Not having had a central jugular vein catheter inserted before for any reason (no experience)
* Being literate
* Voluntarily agreeing to participate in the research
* Being able to carry out daily life activities individually

Exclusion Criteria:

* Leaving work voluntarily
* Limitation in the head and neck area
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.

Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Provide a signed written informed consent prior to any study-specific procedures
3. Meet the clinical criteria for either cUTI or AP
4. Requires hospitalization to manage the cUTI or AP
5. Agrees to use effective methods of contraception

Exclusion Criteria:

1. Known or suspected disease that may confound the assessment of efficacy.
2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
3. Rapidly progressive illness such that the subject is unlikely to survive the study period.
4. Pregnant or breastfeeding women
5. History of a seizure disorder requiring current treatment
6. Creatinine clearance \< 15 mL/min or on renal dialysis
7. Neutropenia or elevated liver enzymes
8. Hypersensitivity to beta-lactam antibiotics
9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* M/F 18-64 yo
* newly diagnosed pulmonary TB
* sputum positive
* adequate contraception

Exclusion Criteria:

* poor health
* rifampicin resistance
* treatment with other anti TB agents in last 3 mos.
* extrapulmonary TB
* COPD
* neuropathy
* ECG wih QRS prolongation ove 120 msec
* CV disorder
* diabetes requiring insulin
* Metabolic disease
* drug/alcohol abuse
* pregnancy
* use of substances that are strong inhibitors/inducers of CYP450
* use of ARV
Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neutropenia
* Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
* Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)

Exclusion Criteria:

* Other sources of chronic pain
* Previously tried loratadine for 7 consecutive days or more for bone pain
* Allergy to loratadine
* Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication
International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial

The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.

Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.

In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.

Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.

Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at 24 0/7-28 6/7 gestation weeks'
* PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life

Exclusion Criteria:

* Infants died before 72 hours of life
* Infants detected PDA but treated before 72 hours of life
Home-Based High Intensity Interval Training Intervention for Low Active Adults

The purpose of this study is to examine the effect of a home-based high intensity interval training intervention on exercise among low active adults (defined as engaging in exercise 90 minutes or less per week). Participants will be randomly assigned to a HIIT-based intervention or a wait-list control each lasting 12 weeks (participants in the wait-list control condition will have the option of receiving the HIIT intervention following the 12 weeks).

The intervention will be a 12-week high intensity interval training workout that will consist of home-based exercise sessions prescribed by the exercise counselor. The exercise sessions will be based on exercises the participant can confidentially engage in (regular push-ups vs. knee push-ups vs. wall push-ups). The goal will be to engage in three exercise sessions per week. The participants will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. The exercise counselor will also engage in dialogue that will motivate the participant to exercise.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Exercising for 90 minutes or less each week
* Access to the Internet

Exclusion Criteria:

* A history of coronary heart disease (history of myocardial infarction, symptoms of angina)
* Orthopedic problems that would limit physical activity participation
* Diabetes
* Stroke
* Osteoarthritis
* Any other medical condition that may make physical activity unsafe or unwise.
* Current or planned pregnancy
* Psychosis or current suicidal ideation
* Psychiatric hospitalization within the last six months
Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population

Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously increasing with population aging progressing. Mineral and bone disorder (MBD) is a common complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in hemodialysis patients, as well as mortality.

Joint effects of Kidney failure and aging on elderly hemodialysis patients make the contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients. Since not much studies had been done for this specific subject, thus, research on elderly patients who is taking Maintenance hemodialysis is very necessary. This study is a retrospective research to identify optimized target value of Calcium and Phosphorus for elderly patients taking maintenance hemodialysis and hence provide guidance for clinical practices. The data for this study will be provided by Beijing Blood Purification Quality Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices will be collected amongst elderly patients who were elder than 65 years and was taking maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for hemodialysis treatment


Eligibility Criteria:
Inclusion Criteria:

* The data shall include the information of elderly hemodialysis patients who were 65 years or elder between Jan 1st, 2012 and Dec 31st, 2016

Exclusion Criteria:

* The patients who only has less than 6 months history of hemodialysis since selected in the research patient group The patients who passed away within 3 months since selected in the research patient group The patients who took less than 3 hemodialysis in a week The patients who took kidney transplant during the research time period The patients who do not have blood biochemical results in the records
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery

The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.

The aim of the study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on reducing total blood product use during complex spine surgery.

The primary outcome will include estimated blood losses and blood product utilization during and after surgery (48 hours).

Secondary outcomes also include hospital length of stay, and cost analysis of the 2 methodologies.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \< 80 years old.
2. Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
3. Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
4. Preoperative hemoglobin Level \>10 g/dl.
5. OR time \> 4 hours.
6. No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).

Exclusion Criteria:

1. Age \< 18 or age \> 80 years old.
2. Anterior spine surgeries or posterior spine surgeries involving \<5 levels.
3. Minimally invasive spine surgeries.
4. Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
5. Patients with Hemoglobin level of \<10 g/dl on preoperative baseline laboratory values.
6. Trauma and Emergency spine surgeries.
7. Patients with spine malignancy diagnosis, either primary or metastatic.
8. OR time \< 4 hours.
9. Patients who refuse to use allogenic blood products.
10. Patients with contraindications for the use of anti-fibrinolytic therapy.