cyrilzakka/clinical-trials huggingface dataset:
The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste

The purpose of this trial is to determine if the colour of sweets (candy) effects taste.

The purpose of this trial is to increase children's awareness of randomised controlled trials and gain insights into the best way to conduct a fair comparison. Everyday children are faced with health claims, some reliable and some not so reliable. The purpose of the SMARTY trial is to help children critically assess and develop a critical eye when it comes to information they encounter every day, in particular when it comes to their health. The SMARTY trial is a pragmatic, two group, parallel, randomised trial.

Eligibility Criteria:
Inclusion Criteria:

* parental/guardian consent obtained

Exclusion Criteria:

* unable or unwilling to ingest intervention.
* medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)
Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients

The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles in post stroke patients. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound.

Sub-acute stroke patients during the rehabilitation period in the rehabilitation hospital will be examined. Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as a biofeedback.

The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.

Eligibility Criteria:
Inclusion Criteria:

* one to 6 months post first stroke
* understand the language and simple instruction
* willing to participate in the study
* mini mental assessment \>21

Exclusion Criteria:

* Aphasia
* side neglect
* active urinary tract infection
* has been treated before for pelvic floor rehabilitation
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
* HCV RNA ≥ 10\^4 IU/mL at screening
* Classification as treatment naive or treatment experienced
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

* Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
* Screening electrocardiogram (ECG) with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation

Patients under sedation not uncommonly develop upper airway obstruction or other respiratory complications and no airway device is available to provide reliable maintenance of the airway at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway in most sedated patients and improve O2 delivery to the airway. In addition it may also greatly facilitate the monitoring of expired CO2, which is widely recognised as the most important monitor of adequacy of breathing, yet frequently impossible to perform satisfactorily in sedated patients at the moment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient, age \>18 and \<80
2. Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures

Exclusion Criteria:

1. Expected procedure require access to or involve the nostrils.
2. Obesity (BMI \>=30)
3. Chronic lung diseases (e.g. COPD) associated with chronic hypoxia
4. Pregnant or lactating women.
5. Known chronic liver or renal disease.
6. Mentally incapable of providing informed consent
Rapid Renal Sympathetic Denervation for Resistant Hypertension

The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.

Eligibility Criteria:
Inclusion Criteria:

1. Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
2. Age 18-85 years.
3. Able to provide informed consent and comply with follow-up visits.

Exclusion Criteria:

1. Diameter of left or right renal artery less than 4 mm or greater than 7mm.
2. Length of target segment of left or right renal artery less than 20mm.
3. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
4. End-stage renal disease requiring dialysis or renal transplant.
5. estimated Glomerular Filtration Rate \< 45 mL/min per 1.73 m2.
6. Type 1 diabetes mellitus.
7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
9. Bleeding disorder or refusing blood transfusions.
10. Pregnancy or breast feeding.
11. Peripheral vascular disease precluding catheter insertion.
12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
13. Current enrollment in another investigational drug or device Study.
Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System

STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Confirmed diagnosis of metastatic NSCLC
* Pemetrexed Starts 1st line (either induction or maintenance) in any of the following periods:
* January 1, 2010 to March 31, 2010
* October 1, 2011 to December 31, 2011

Exclusion Criteria:

* Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.
Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients

This study evaluates the effect of the use of nasal CPAP in the cardiac function, measured by strain and TEI index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and obesity. In order to do so, 76 patients will be studied, half will use sham CPAP and half will use therapeutic CPAP for three months, with echocardiogram, laboratory studies, ambulatory monitoring of arterial tension and sleep study before and after CPAP use.

The obstructive sleep apnea syndrome (OSAS) is a disease characterized by repeated episodes of partial of total obstruction of the upper airway during sleep. It affects 3.2% of adults in Mexico City. These patients have a higher risk of suffering traffic accidents, cardiovascular diseases, a lower quality of life and premature death. The association between OSAS and heart failure is complex, but it is known that they have a higher risk of myocardial dysfunction with OR 2.4 (IC 95% 1.2 - 4.6), with higher mortality against controls. Type 2 diabetes mellitus (DM2) is a chronic metabolic disease that leads to macro and micro vascular damage, and is the first cause of mortality in Mexico (13.8% of all deaths in people older than 20 years). Its general prevalence in adults is of 7%. There is a strong association between OSAS, insulin resistance and DM2, with studies with 86% of patients with DM2 having some degree of sleep apnea reported, with 22.6% having severe OSAS. The presence of DM2 doubles the risk of cardiovascular disease in men and triples it in women, with coronary cardiac disease being the main cause of death. Patients with OSAS have altered myocardial function even in asymptomatic state, also patients with DM2 have been shown to have abnormalities in myocardial function, myocardial performance and myocardial elongation in comparison with a control group. There is no current information about the effect of treatment with CPAP on myocardial performance of patients with OSAS, DM2 and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical data of obstructive sleep apnea: snoring, witnessed apneas, excessive daytime somnolence.
* Previous diagnosis of type 2 diabetes mellitus, with medical treatment according to the ADA 2012 guidelines, but only with one of the next drugs: biguanides, sulphonylurea, meglitinide, thiazolidinedione, alpha-glucosidase inhibitors.
* Obesity, defined by a body mass index higher than 29 kilogram per square meter.

Exclusion Criteria:

* Type 1 diabetes mellitus.
* Insulin dependent type 2 diabetes mellitus
* Fasting plasma glucose higher than 212 mg/dL .
* Antecedent of myocardial infarction, heart failure or arrhythmia.
* Obstructive sleep apnea in treatment.
* Urgent need of CPAP treatment (public transport drivers, heavy machine operators).
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials

The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.

Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Number of groups/cohorts: 1 (All subjects were observed in the same manner).

Eligibility Criteria:
Inclusion Criteria:

* All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Home And Locally Observed - Tracking (HALO-Trak)

The goal of this observational study is to collect biometric, HRQoL, immune response and genomic data continuously and intermittently during and after chemo or immunotherapy for the generation of a complex dataset using a platform which can aggregate different types of data collected over a time period and, to test the potential for analysis within and across data sets with linkage to clinical outcomes. The framework will have capabilities to integrate data from electronic medical records (EMRs) such as Epic, as well as digital streams including sensor, genomic, imaging and pathology. Such a platform can realise the potential for machine learning (ML) methodologies to address important cancer outcomes.

The Investigators overarching aim is to determine the relationship between measures of physical performance status including heart rate and steps, health related quality of life (HRQoL) and genomic and immunogenomic phenotype on cancer outcomes in patients receiving chemotherapy or immunotherapy for haematological or metastatic cancer including renal (papillary, and RCC), breast, prostate, and other solid tumours. The primary objective is to test the feasibility of integrating diverse data streams (genomic, HR QoL and biometric) on a novel platform, capable of integrating data streams thus generating complex datasets for analyses using machine learning methodologies.

Secondary objectives will be to conduct exploratory analysis assessing the relationship between individual and combined data types and cancer outcomes.

Analysis using existing and novel computational models will be applied to the data to events in the acute and chronic setting that are common in patients diagnosed with cancer undergoing systemic therapy such as chemotherapy and immunotherapy. The outputs from this study will help inform future studies and trials designed to inform patients about their health status during cancer therapy

Eligibility Criteria:
Inclusion Criteria:

* ● A diagnosis of a metastatic or haematological cancer undergoing systemic therapy

  * Undergoing at least 1 planned cycle of chemotherapy or immunotherapy, according to standard of care practices.
  * Ability to understand and the willingness to sign a written informed consent.
  * Able to ambulate without assistance or walking aid.
  * Have an Android or iOS phone and willing to download the Ethera app

Exclusion Criteria:

* ● Physical disabilities that preclude daily walking

  * Inability to provide informed consent.
  * Unable to use and operate the Ethera Health Monitoring Smartphone App. (Apple or Android)
  * Medical or psychiatric condition which in the investigator's opinion would affect the successful completion of the study.
Nursing Management of Irritable Bowel Syndrome (IBS) 2008

The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
* In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
* Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
* Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.

Exclusion Criteria:

* Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
* Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
* Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
* Recent travel to regions with endemic parasitic diseases
* Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
* Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
* Women who are pregnant, breast feeding, or planning to get pregnant in the next year
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions

* Lesion characteristics including histology
* Procedural outcomes
* Safety Outcomes
* Efficacy outcomes

Eligibility Criteria:
Inclusion Criteria:

* UGI neoplastic lesions \> 10mm

  * Lesions for ESD limited to the mucosal and/or submucosal layer OR
  * Lesions for EFTR limited to the muscularis propria layer OR
  * Lesions for STER limited to the submucosal and/or muscularis propria layer
* Aged 18 years or older

Exclusion Criteria:

* Age less than 18
* Unable to give informed consent
* Pregnant or lactating patients
* Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally
Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection

In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.

Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.


Eligibility Criteria:
Inclusion Criteria:

1. patients with periprosthetic joint infection
2. indicated for debridement surgery
3. high risk for wound complication, including one of the followings: diabetes mellitus, use anticoagulants other than aspirin, current smoker, on immunomodulators or steroids, malnutrition, liver disease, renal failure, BMI \> 35 kg/m2

Exclusion Criteria:

1. previous flap surgery on the indexed joint
2. younger than 18 years of age
3. silver allergy
Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive

Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the disease. That is why research is looking to the development of preventive treatments like nutraceuticals. This project aims to determine the anti-inflammatory properties of sera of patients who received supplementation of their diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be collected during visits for hyaluronic acid injections in OA patients. These sera will be tested in vitro in a model of inflamed chondrocytes.


Eligibility Criteria:
Inclusion Criteria:

* 50 years old and over
* Patients with knee osteoarthritis (ACR criteria)
* Patients requiring injection of hyaluronic acid (no corticosteroid associated)
* Radiological stage of knee osteoarthritis 1, 2 or 3 (Kellgren-Lawrence)
* Informed consent form signed

Exclusion Criteria:

* younger than 50 years
* protected adult
* Pregnant woman
* Radiological Stage 4 osteoarthritis (Kellgren-Lawrence)
* knee osteoarthritis secondary to arthritis
* Taking a long term treatment of osteoarthritis (Piasclédine®, Diacéréine®, glucosamine, chondroitin)
* inflammatory pathology other than osteoarthritis
* Taking anti-inflammatory medications
* Refusal to participate in the study
* Use of food supplements with anti-inflammatory properties
* Arthroscopy less than 6 months
* corticosteroid injection \<3 months
* INR\> 4 or TCA\> 2 (anticoagulants)
* Being allergic to lactose
Monitoring Hypertensive Patients's Cerebral Oxygen Saturation

The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.


Eligibility Criteria:
Inclusion Criteria:

* patients have hypertension more than 3 year,whether well-controlled or uncontrolled,
* scheduled for major abdominal surgery for at least 2 h
* under general anesthesia
* American Society of Anesthesiologists（ASA）physical status : II \~ III
* Age \> 30

Exclusion Criteria:

* pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;
* ASA physical status \>IV
* hepatic failure
* renal failure
* preoperative Mini-Mental State Examination (MMSE) score less than 24
* a history of cardiovascular surgery or craniotomy
* cardiac failure
* respiratory failure
Comparison of Short-term Effects of Extracorporeal Shock Wave Therapy, Low-level Laser Therapy and Pulsed Electromagnetic Field Therapy in Knee Osteoarthritis

120 patients with Kellgren-Lawrence grade 2-3 knee osteoarthritis will be randomized into four groups: Control group, Extracorporeal shock wave therapy (ESWT) (once a week for 3 sessions), Low-level laser therapy (LLLT) (twice a week for 8 sessions), and Pulsed electromagnetic field therapy (PEMF) (twice a week for 8 sessions), with 30 patients in each group. All participants will be instructed in a daily exercise program, including knee joint range of motion, stretching, and strengthening exercises (3×10 repetitions). Outcome measures, including the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form-36 (SF-36), and Timed Up \& Go (TUG) test, will be assessed at baseline after treatment and at 3rd month.


Eligibility Criteria:
Inclusion Criteria:

* experiencing knee pain persisting for more than 6 months, radiological assessment confirming grade 2 and grade 3 knee osteoarthritis based on the Kellgren-Lawrence system
* no history of physical therapy or regular use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last 6 months,
* absence of any pathology other than osteoarthritis that could cause knee pain,
* no lumbar spine or hip pathology that could refer pain to the knee,
* free from any conditions that would prevent participation in exercise or physical therapy
* willing to regularly participate the treatment programs were included in the study.

Exclusion Criteria:

* presence of a condition that impairs ambulation,
* a documented history of spinal stenosis,
* evidence of a neurological disorder based on medical history or physical examination,
* the existence of an inflammatory or metabolic disorder that could lead to secondary osteoarthritis,
* administration of intra-articular knee injections within the past year,
* use of NSAIDs, paracetamol or topical agents within the preceding week,
* a prior history of surgical intervention involving the knee joint.