cyrilzakka/clinical-trials huggingface dataset:
The Effects of Consuming Palm Oil With Different Macronutrient Intakes on Blood Lipids

The purpose of this study is to determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health.

The purpose of this study is to determine the effects of palm oil on blood lipids, cardiovascular health and inflammation. Potential subjects will be screened until 24 qualifying healthy participants are enrolled. After enrollment participants will undergo a baseline battery of tests including blood draws, body composition, measures of height and weight, blood lipid profile (cholesterol, lipoprotein particle size, quantity and fatty acid composition), insulin sensitivity using a static index, inflammation, antioxidant status and measurement of energy expenditure and substrate oxidation by indirect calorimetry. Participants will be randomly divided into one of two arms/tracks, either a low carbohydrate diet arm or a high carbohydrate diet arm. Each diet arm consists of 3 phases a low saturated fat control diet where the primary cooking oil is canola oil and two saturated fat diet phases where the primary cooking oil is either palm oil or butter.

Participants will begin with the low saturated fat diet phase first which consists of 50% of fat calories derived from canola oil for 3 weeks. At the end of this control diet phase the battery of tests completed at baseline will be repeated. After a 2-week washout period participants will then proceed in random order into either the palm oil or butter diet phases of their diet arm/track. The palm oil and butter diet phases are also 3 weeks in duration and separated by a 2 week washout period. The palm oil and butter diet phases will derive 50% of the fat calories from either palm oil or butter. Both oils are high in saturated fat but differ in the quality of saturated fat. At the end of each diet phase the testing battery completed at baseline will be repeated. The subjects will never be exposed to more than minimal risk and in return will receive 9 weeks of food, individualized reports of their study results and a monetary stipend. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health. This knowledge can be used to aid dietary recommendations for cardiovascular health and control of blood lipids.

Eligibility Criteria:
Inclusion Criteria:

* normocholesterolemic

Exclusion Criteria:

* hypercholesterolemia
* diabetes
* liver disease
* kidney disease
* other metabolic or endocrine dysfunction
* diagnosis of cancer within the previous 5 years
* hypertension
* current use of cholesterol reducing medications
* current use of diabetic medications
Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine

The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.

The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 65 years old with nausea associated migraines at least twice per month

Exclusion Criteria:

* Patients \<18 or \>65 years old
* Patients without a diagnosis of acute migraine
A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Inadequate blood sugar control
* No current treatment with other medications to lower blood sugar

Exclusion Criteria:

* Major heart, liver or kidney problems
* Pregnant or breast feeding
Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

The first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome.

The second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.

To evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree Celsius rise in ipsilateral arm temperature after a stellate ganglion block.

Blocks will both be performed with 10 mL of xylocaine/bupivacaine. Secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years
* Patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of Budapest) at the upper extremity

Exclusion Criteria:

* Refusal of a patient
* Coagulopathy
* Systemic infection or local infection at the needle injection site
* Major deformation at the level of the neck (radiotherapy, surgery, etc. )
* Concomitant chronic pain syndrome
* Post-pneumonectomy on the controlateral side
* Severe hepatic impairment or severe renal impairment (Clcr under 30 ml/min)
* Known allergy to local anesthetics of amide type
* Inability to understand a numeric pain scale
Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.

This study evaluates the effectiveness of warm packs, perineal massage and hands off, during labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal tears, need of suture, perineal edema, perineal pain, use of drugs for perineal pain, and satisfaction with the technique used.

This study is a randomised controled trial.

Eligibility Criteria:
Inclusion Criteria:

* parturient in active phase of labour
* single fetus at term (37-42 weeks)
* bent cephalic fetal presentation
* parity less than four children

Exclusion Criteria:

* use any perineal preparation techniques during pregnancy
* clinical indication for caesarean section
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Eligibility Criteria:
Inclusion Criteria:

In- and outpatients who:

* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
* had had ≥6 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

* had a severe psychiatric disorder or an antisocial personality disorder
* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
* had a history of delirium tremens or alcohol withdrawal seizures
* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
* was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.
The Effects of Chronic Otitis Surgery on SVV

Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.

All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Otitis Media
* Who had surgical treatment

Exclusion Criteria:

* A patient who had the vestibular disease before
* Neurologic disease
* Patients who had ear, brain and musculoskeletal surgery before
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential

Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Female subjects who are 40 years of age or older
* Subject has no history of symptoms and/or physical signs of breast cancer on the side of the targeted breast
* Subject underwent routine Full-Field Digital Mammography (FFDM) which showed one or more abnormalities, including calcifications, and was referred for diagnostic work-up within 4 weeks
* Subject is surgically sterile (must have documentation of bilateral oophorectomy and/or documented hysterectomy), post-menopausal (must have documentation of cessation of menses for greater than one year) or, if of childbearing potential, a documented negative urine pregnancy test within 4 weeks is required.
* Subject breast size is compatible with the dimensions of 24x31 cm of the image detector
* Subject must be in sufficient good health to be able to undergo an examination on mammography equipment as determined by the Investigator

Exclusion Criteria:

* Subject or a legally authorized representative is unable to provide written informed consent
* Clinical assessment and DBT cannot be performed within 4 weeks of screening FFDM examination
* Subject is breast-feeding
* Subject has breast implants or reconstructed breasts
* Subject is undergoing radiotherapy or chemotherapy
* Subject has a history of prior radiotherapy treatment on the side of the targeted breast
* Subject has been previously enrolled in this study
* Subject is participating or has participated in another trial of an investigational product
Comparisons of Two Airway Clearance Techniques

The goal of this clinical trial is to compare the effectiveness of two airway clearance techniques for patients with ventilator associated pneumonia. The main questions it aim to answer are:

* effect of the therapies on volume changes
* outcome on sputum clearance Participants will receive airway clearance techniques of
* chest physiotherapy
* high frequency chest wall oscillation.

Sputum can be accumulated in the airways of intubated patients, resulting in recurrent pneumonia. The airway clearance therapy is often utilized with chest physiotherapy or high frequency chest wall oscillation which has become popular for its easy of use and less time consuming to the healthcare workers. The main questions it aim to answer are on effectiveness of the therapies on lung volume changes and sputum clearance by two airway clearance techniques. With the oscillation of entire chest wall, the investigators hypothesize that the high frequency chest wall oscillation is more effectively clear sputum in the distal airways.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic pulmonary disease
* Diagnosed with ventilator associated pneumonia
* Receive airway clearance therapy

Exclusion Criteria:

* Head injury, spinal injury
* Instable hemodynamics
* Intercranial pressure \> 20 cmH2O
* Active hemoptysis
* Empyema
* Eye surgery
* Abdominal distension
* Chest tube insertion
* Active tuberculosis
Comparison of Different Oral Rehydration Solutions

Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients. The investigators believe that taste of the standard ORS is the biggest reason why these patients are not complaint. The new ORS in the market has been prepared with this in mind. The investigators want to study if this new ORS will improve the compliance in this patient cohort.


Eligibility Criteria:
Inclusion Criteria

* All patients with short bowel syndrome treated by the HPN program.

Exclusion Criteria

* Participants who have do not provide written consent.
* Participants who lack the ability to provide informed consent
* Participants who are not anticipated to be on HPN for at least 6 months (determined by PrincipaI Investigator).
* Pregnant women
* Participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the PrincipaI Investigator)
Non-invasive Measurement of Glucose with Advanced Spectroscopy Techniques and Machine Learning Models

Primary aim of this pilot study is to provide evidence for a non-invasive, continuous, and transcutaneous measurement method to determine blood glucose levels robustly and accurately.

The study is divided into 3 sub-studies focusing on

* Interchangeability of Lab demo 1.0
* Evaluation of advanced spectroscopy methods and their miniaturisation potential
* Robustness of machine learning model to changes over time

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated written informed consent by study participant prior to any mandatory study-specific procedures, sample collection, or analysis
* Apparently healthy Male or Female adult aged between 18 and 75
* Willingness to follow the study procedures

Exclusion Criteria:

* In Female subjects: pregnancy or breastfeeding period
* A diagnosis of diabetes mellitus (any type) with ongoing insulin therapy (basal or basal plus bolus) or sulfonylurea therapy
* Prior severe hypoglycemia event (stage 3 or above; e.g., seizure, loss of consciousness, emergency hospitalisation)
* Prior event of severe hyperglycemia resulting in diabetic ketoacidosis or hyperosmolar hyperglycemic state, or emergency hospitalisation
* Documented medical history of bleeding disorder
* Being under anticoagulant medication
* Insufficient knowledge of project languages (English/German)
* Known sensitivity to medical-grade adhesives or other skin-related complications, which might influence the outcome
Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise

The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables treatment of the tendinopathies and the broken muscle fibrilare. It is base on the application of galvanic current through a acupuncture needle. To analyze the effectiveness of therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric exercises or dry needling with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols.
* Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus.

Exclusion Criteria:

* Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder.
* Individuals have received the proposed treatment in one month´s period previously.
* Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
* Pregnant women can not receive this treatment intervention.
Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)

The overall aim of this study is to develop a test that predicts the prognosis of IPF (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments for IPF are likely to work.

The overall objectives of this study are

* Discover and validate novel biomarkers and gene expression profiles for use in subsequent intervention studies in patients with IPF
* To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
* Investigate genetic associations and epigenetic modifications which affect disease severity and progression
* Prospectively evaluate longitudinal disease behaviour in patients with IPF and NSIP with a view to developing composite clinical end-points for subsequent use in intervention studies in patients with IPF

Biomarkers that can be used for the following purposes will be identified:

* Identify patients (Diagnostic)(e.g. discriminate between health and disease)
* Correlate with disease severity (extent of disease, staging of disease)
* Predict clinical progression (Prognostic)(stable vs progressive disease)
* Track response to therapy (Therapeutic response)- Predict response to known efficacious treatments \& Correlates with changes in clinical endpoints/mortality/quality of life
* Predict risk of exacerbations (could be used to prevent exacerbations or reduce their severity)
* Correlate with complications and/or comorbidities (e.g. biomarkers of Pulmonary Arterial Hypertension, Gastro Oesophageal Reflux in IPF, etc)

Eligibility Criteria:
Inclusion Criteria:

A diagnosis of IPF using the consensus criteria (32)and Non Specific Interstitial Pneumonia.

* Between the age group 18-85 years.
* Sub classified into Mild (TLCO\>60), Moderate (TLCO 40-60), Severe (TLCO\<40).
* People who volunteer to undergo a bronchoscopy for research

Exclusion Criteria:

* People who do not have IPF/NSIP (i.e. Hypersensitivity Pneumonitis, Sarcoidosis)
* People who cannot give informed consent.
* People who are being considered for bronchoscopy, any contra-indication to undergoing this procedure as set out in the British Thoracic Society guidelines (Thorax 2001; 56: suppl I: i1-i21). These will be part of the study but not undergo the Broncho Alveolar Lavage.