cyrilzakka/clinical-trials huggingface dataset:
Adults Regulating Their Weight Everyday With Mobile Internet Support

Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised controlled trial evaluating the effectiveness of a mobile app based weight loss intervention designed to increase self-regulation in adults living with obesity.

Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised, controlled trial examining the effectiveness of the self-regulation intervention to promote weight loss, when delivered through a mobile application, with no in-person contact, among a sample of \~ 1,294 adults living with obesity in the United Kingdom. Further, the investigators will assess the safety of the intervention regarding any a potential unintended consequence, which is the development of disordered eating. The intervention comprises daily self-weighing and daily reflection on the day's task of controlling weight through implementation of actions, and selection of new actions for the next day. It encourages users to build up a repertoire of actions for life that suit them in controlling weight.

Eligibility Criteria:
Participation is open to those who meet the following eligibility criteria:

* aged ≥ 18 years;
* living with obesity (BMI ≥ 30 if of white ethnicity; ≥ 27.5 for all other ethnic groups);
* full- time residents in the UK, without the intention to move outside the UK within the next 12 months;
* able to access the internet with a smartphone;
* able to access and use a digital weighing scale;
* can understand English;
* not presently signed up with an intention to attend, or have in the previous three months attended, a weight management programme;
* not currently participating in another weight management study;
* not lost \> 5 kg (10 pounds) body weight in the previous six months;
* not undergone bariatric surgery, or presently scheduled to have bariatric surgery;
* not pregnant, or planning a pregnancy in the next 12 months;
* not previously been diagnosed with an eating disorder;
* not recently been diagnosed with a disease, or expected to undergo treatment for a disease, associated with substantial weight loss e.g., cancer treatment.
Characterizing the Senior High Cost User (HCU) in Ontario

High cost users (HCUs) are a small group of patients who use a disproportionate amount of health care resources. This study is a retrospective population-based matched cohort analysis of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years or older in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013). The study objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on their demographics, co-morbidities, medication use, health service utilization, healthcare expenditures, medication costs and clinical outcomes, and to determine the relative contribution of medications to senior HCUs expenditures

Senior high cost users (HCUs) with annual healthcare expenditures within the top 5% of Ontarians will be identified using established ICES costing algorithms. This cohort will be matched to a cohort of non-HCUs using a 3:1 matching ratio (non-HCU to HCU) based on age at cohort entry (+/- 1 month), sex and geographic location of residence (based on LHIN) for comparative analysis. Descriptive statistics will be used to describe the study populations and outcomes. Regression analyses will be used to adjust for potential confounders when analyzing healthcare resource utilization and costs as a function of HCU status (e.g. income, type of residence, co-morbidities, rural/urban) and/or when analyzing sub-populations \[e.g. chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF)\]. Logistic regression will be performed using the patient level data to predict the impact of individual factors on the likelihood of becoming a senior HCU.

Eligibility Criteria:
Inclusion Criteria:

* Ontario residents registered in RPDB between April 1, 2013 - March 31, 2014
* Annual total health care expenditures in FY2013 equal to or greater than financial threshold for the top 5% of all Ontarians

Exclusion Criteria:

* Death on OR prior to index date
* Age \> 105
* Annual total health care expenditures in FY2012 fiscal year greater than financial threshold of 5% of all Ontarians in FY2013
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus
* Has moderate or severe renal insufficiency

Exclusion Criteria:

* Has type 1 diabetes mellitus or a history of ketoacidosis
* Is on a new weight loss program
* Has active liver disease
* Is on dialysis or is likely to need dialysis during the study
Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors

The purpose of this study is to test whether perifosine- a drug that inhibits the protein AKT, and has had some success in the treatment of adult cancers- is safe and effective in treating cancer. The investigators want to find out what effects, good and/or bad, it has on the patient and the cancer. The investigators are testing different dose schedules of perifosine and the patient will be asked to partake in one of the dose schedules.


Eligibility Criteria:
Inclusion Criteria:

* Any solid tumor that failed standard therapy.
* Patient must have evidence for tumor by CT, MRI, PET scan, MIBG scan, serum markers, or tissue sampling.
* Age ≤ 21 years.
* Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age\> 16 years and Lansky score for age ≤ 16 years)
* ANC≥ 1000 at least 24 hours off GCSF
* Platelets ≥ 75k at least one week off platelet transfusions
* Hg≥ 8g/dL at least one week off PRBC transfusion
* AST ≤ 3 x the upper limit of normal
* ALT ≤ 3 x the upper limit of normal
* Total bilirubin ≤ 2.0 mg/dl
* serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
* ≥ 3 weeks since last non-nitrosourea chemotherapy
* ≥ 6 weeks since last nitrosoureas
* ≥ 4 weeks since last RT
* Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to drug initiation. Females must not be breast feeding.
* Patients must be able to swallow tablets whole

Exclusion Criteria:

* Pregnancy
* Patients must not have active infection or serious intercurrent medical illness.
* HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.
* Patients must not be taking EIAEDs. If patients were previously EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients

To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.

Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate \< 50% and MAADP \> 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;
2. Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;
3. Coronary angiography reveals stenosis lesions;
4. Discovery of ADP induced platelet inhibition rate \< 50% and MAADP \>47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation);
5. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography);
3. Pregnant or lactating women;
4. severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl;
5. Impaired liver function before surgery: Serum GPT \> 120U/L;
6. Bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or cavum subarachnoidale bleeding, patients with antiplatelet agent and anticoagulant treatment contraindications and hence are unable to undergo anticoagulant therapy;
7. Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
8. Leucocyte \< 3.5 x 109; and/or platelet \< 100,000/mm3 or \> 750,000/mm3;
9. Patient's life expectancy is less than 12 months;
10. Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
11. Those waiting for heart transplant;
12. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
Preoxygenation Optimisation in Obese Patients

Oro-tracheal intubation in operating room in obese patients with BMI \> 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

This study will be designed as followed : Patients will be randomized in 2 groups :

* Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
* Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.

Eligibility Criteria:
Inclusion Criteria:

* Obese patient with BMI \> 35kg/m2
* Age between 18 and 80 years
* Requiring a crash induction sequence for oro-tracheal intubation.

Exclusion Criteria:

* Pulse oxymetry \< 90% in ambient air
* Haemodynamic instability
* Burned patient
* Indication of intubation vigil in spontaneous ventilation
* Patients with a documented Cormack IV exposition before inclusion
* Protected adult
* Pregnancy
* Lack of consent
* Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.
* Lack of French social protection
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* Hepatic dysfuction, or AST: \>=100 IU/L or ALT: \>=100 IU/L at the pre-examination
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins

To determine the effect and safety of Varisolve® 0.125% \[0.2%\]

In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% \[0.2%\] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein

Eligibility Criteria:
Inclusion Criteria:

1. Male or female; age of consent to 75 years
2. Baseline VEINES-Sym Questionnaire score less than 75 points
3. Superficial venous disease manifested by both symptoms and visible varicosities
4. Varicose vein clinical classification CEAP 2 through 5
5. Incompetence of SFJ (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
6. Ability to comprehend and sign an informed consent document and complete study questionnaires in English

Exclusion Criteria:

1. Incompetence of the small saphenous vein (SSV)
2. Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
3. Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
4. Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
5. Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
6. Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel.
7. History of pulmonary embolism or stroke.
8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
9. Current anticoagulation therapy (within 7 days of enrollment).
10. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
11. Previous treatment in this study or in a previous Varisolve® study.
12. Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) or clinically significant laboratory abnormalities.
13. Known allergic response to polidocanol, or severe and multiple allergic reactions.
14. Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit.
15. Pregnant or lactating women.
16. Current alcohol or drug abuse.
Median Effective Dose of Remifentanil for the Prevention of Pain Caused by the Injection of Rocuronium

As a medium-and long-term non-depolarizing muscle relaxant, rocuronium has the advantages of quick effect, no histamine release and accumulation and no obvious cardiovascular adverse reactions, so it has been widely used in clinical anesthesia induction. However, when given intravenously, rocuronium can cause adverse reactions such as injection pain and limb retraction, which can lead to needle prolapse, extravasation of injection drugs, swelling of injection site, serious induction delay, and cardiovascular adverse events in severe cases. Remifentanil is a synthetic opioid drug hydrolyzed by esterase. Compared with other opioid drugs, remifentanil has the advantages of quick effect, short half-life and short time of hemodynamic changes, so it is an ideal analgesic in clinical anesthesia. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of Remifentanil to suppress pain in rocuronium injection.


Eligibility Criteria:
Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA # or # level.

Exclusion Criteria:

* Allergy or contraindication to remifentanil or rocuronium; required for Central venipuncture catheterization;
* Abnormal liver or kidney function;
* Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
* Hearing and language impairment;
* Peripheral vascular disease;
* Severe cardiovascular disease or neurological disorders;
* Failure of one-time peripheral venipuncture;
* Infection of hand or wrist skin.
A Study Of BOTOX For The Treatment Of Glabellar Lines

This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.


Eligibility Criteria:
Inclusion criteria:

* Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.

Exclusion criteria:

* Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
* Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Effects of Walking Analysis on Surgical Outcomes

The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.

Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.

Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Able to walk
* Under evaluation for orthopedic surgery to correct walking problem(s)

Exclusion Criteria:

* Orthopaedic surgery in past 1 year
* Injection of botulinum toxin in past 6 months
Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children

The aim of the present study is:

To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:

• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent


Eligibility Criteria:
Inclusion Criteria:

1. Patients with end stage liver disease that need dental extraction before liver transplant
2. Patients aged between 4 and 9 years old
3. Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)

Exclusion Criteria:

1. Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
2. Patients having genetic bleeding disorders
3. Patients with renal diseases
Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer

The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed squamous cell cancer of the head and neck
* Eligible sites: oral cavity, oropharynx, hypopharynx, larynx.
* Patients requiring postoperative IMRT.
* KPS \> 70%.
* Patient has signed specific protocol consent prior to registration.
* Calcium test within normal limits.
* No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years.
* Labs completed with 30 days of registration (CBC \& platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation.
* Liver CT if alk phos, SGOT, or bili elevated.
* Bone scan if elevated alk phos

Exclusion Criteria:

* Metastatic disease.
* Patient using Salagen or concurrent chemotherapy.
* Previous XRT for head and neck tumors.
* Active untreated infection.
ALPHA Sitagliptin Add on to Metformin (0431-103)

Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin


Eligibility Criteria:
Inclusion Criteria:

Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry
Increasing Patient Engagement in the Annual Well Visits Program

NYU Langone Health calls patients to remind them to schedule their annual well-health appointments (including annual well visit, mammograms, etc.). The proposed study will test different iterations of the call script with the goal of increasing call completion rate and the number of scheduled appointments within an appropriate timeframe.


Eligibility Criteria:
Inclusion Criteria:

* Members attributed to NYU Langone Health under a shared savings arrangement who are due for preventive services and/or screenings and are eligible to be receiving a reminder call.

Exclusion Criteria:

* N/A