cyrilzakka/clinical-trials huggingface dataset:
The Glycaemic Index of Manuka Honey

Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different geographical locales around the North Island of New Zealand and tested for glycaemic index (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed honey containing 25g of available carbohydrate in 200 ml water and the blood glucose responses measured (area under the curve; AUC) and compared to that of 25 g of available carbohydrate from glucose.


Eligibility Criteria:
Inclusion Criteria:

* healthy (Body mass index (BMI) 20-25)
* non-smoking
* aged between 18-45 years
* absence of diabetes or chronic illness
* not taking any medications.

Exclusion Criteria:

* currently dieting
* suffering from illness or chronic disease
* currently taking medication
* smokers (including recreational)
* outside healthy BMI range
Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan

Development and internal validation of an easy-to-use tool for clinical pain assessment. The tool has to be applicable in any clinical practice and without the need for expensive and complicated hospital tools to identify the source of persistent pain after the treatment of cancer.

An adequate selection of physiotherapy treatment for persistent pain after the treatment of cancer, depends highly on the mechanism of the pain.

Pain can arise from a damaged nerve or tissue (skin, lymphatic system...). But when pain becomes chronic, alterations to the central nervous system can occur, as regulations of the facilitating and inhibiting mechanisms. These alterations may cause central sensitization pain. The body is now sensitized and cannot distinct harmful from harmless stimuli.

Each type of pain requires a specific treatment, therefore identification of the pain mechanism is crucial. Up till now, expensive and complex tests were performed in a hospital setting to determine if a patient suffers from neuropathic, nociceptive or central sensitization pain. This study aims for developping an assessment tool that does not require expensive devices but can be easily performed by any physiotherapist, within the timeframe of a standard consultation.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated for primary cancer: breast, prostate, lung/bronchus, colon/rectum, gynecologic (uterus or ovary)
* Complete remission
* Curative treatment finished
* Ongoing hormonal and targeted treatment permitted
* Patient experiences pain (NRS minimum 3/10 during the past week)

Exclusion Criteria:

* Active metastasis
* Palliative status
* Other type of cancer than mentioned in inclusion criteria
* Pregnancy
Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

Our hypothesis is that with comparison of effectiveness of two most common techniques of treatment for myofascial pain syndrome (injection of local anesthesia and ischemic compression) we could choice the most adequate to treat this disease. This way we could decrease the expenses with medicines, examinations, consultations and the time that women remains without a diagnosis and treatment.

After evaluation and diagnostic confirmation, the patients will be randomized and submitted to the treatment with lidocaine injection or ischemic compression. Each treatment will be placed once a week, for four weeks. Women randomized for treatment with Ischemic compression, will be first subjected to transcutaneal electrostimulation(TENS), in order to receive analgesia on trigger point. The analgesia will be used to inhibit the painful stimulation. The device used for this will be the Dualpex 961, with 100 Hertz of frequency and pulse of 250ms. The intensity will be vary according the painful threshold of each patient. The electrostimulation will be made for 30 minutes. The electrodes will be applied around the trigger point. After analgesia, the ischemic compression will be applied. This therapy consists in a continuous pressure on trigger point. For this we will use one algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. This therapy will be applied three times with duration of 60 seconds each with a 30 seconds of rest between the applications. Injection of anesthesia: this therapy will be applied directly in trigger points with two mL of lidocaine 0.5% with needle of 22 gauges directly and perpendicularly in trigger point. The Evaluations for each treatment will be carried immediately before the randomization; In one month: immediately after the four weeks of treatment; - Three months: three months after the treatment; - Six months: six months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Women with chronic diagnosis of pelvic pain;
2. Women in menacme;
3. Presence of the diagnostic criteria for abdominal myofascial syndrome;
4. Agreement with the Term of Free and Clarified Assent.

Exclusion Criteria:

1. Endometriosis, interstitial cystitis, syndrome of the irritable intestine or another illness that it justifies or it contributes for chronic pelvic pain;
2. Endometrioma or hernia evidenced to the ultrasound of the abdominal wall.
Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 40 years of age or older
* Diagnosis of COPD at hospital discharge
* Hospitalization for a COPD exacerbation

Exclusion Criteria:

* Patients hospitalized for the first time at the participating site without a documented history of COPD
* Patients currently participating of having ever participated in a COPD-related clinical trial
* Patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, AIDS)
Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces

Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of limb muscles and ground reaction forces are different in patients with sacroiliac joint pain, as compared to healthy controls.

Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the electromuscular activation of the limb muscles or ground reaction forces.

Hypothesis III: The effects proposed in hypothesis II are different in patients with sacroiliac joint pain, as compared to healthy controls.

The sacroiliac joint is among the most frequently involved anatomical structure in low back pain. Pelvic belt anatomy makes the sacroiliac joint more vulnerable to be involved in chronic painful conditions. However, the anatomical and functional correlate of sacroiliac joint pain is yet undetermined. According to the guidelines of International Association for the Study of Pain (IASP), painful conditions should primarily be managed conservatively.

However, existing studies fail providing sound evidence on the effects of conservative devices to therapy sacroiliac joint pain. In the study, a total of 17 patients suffering from sacroiliac joint pain and 17 controls were investigated by means of magnetic resonance imaging, EMG, health surveys and ground reaction force measurements.

A pelvic compression belt was administered in two levels of compression and the corresponding magnetic resonance imaging, EMG and ground reaction force data were measured.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnostically confirmed sacroiliac joint pain
* controls without any history of musculoskeletal disorders

Exclusion Criteria:

* endoprostheses, metallic implants
* somatoform disorders, claustrophobia, pregnancy
* surgical interventions on the spine, degenerative joint diseases elsewhere
Real-World Study of Vivity Intraocular Lenses (IOLs)

The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.

In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 13 months. This study will be conducted in China.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an approved informed consent;
* Willing and able to attend all scheduled study visits as required per protocol;
* Diagnosed with cataracts in both eyes;
* Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
* Planned bilateral cataract removal by phacoemulsification.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
* Clinically significant corneal diseases;
* Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
* Previous intraocular surgery history;
* Pregnancy or lactation during study or planning to be pregnant/lactating;
* Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
* Other planned ocular surgical procedures;
* Patients who can only undergo cataract surgery in one eye.
* Other protocol-specified exclusion criteria may apply.
The Short- and Long Term Outcomes of Early Routine PCI With the Standard Treatment in Low-intermediate Risk ST-elevation Myocardial Infarction Patients Who Successfully Fibrinolysis.

1. Objective: To evaluate short- and long-term in the STEMI patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients.
2. Educational/ application advantages: To evaluate the time of early and delay PCI after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate GRACE risk score patients. No available of randomized controlled study in these group of the patients.

1.Research design: Intervention trial 1.1 Study domain: STEMI patients who will receive the fibrinolysis for reperfusion therapy 1.2 Target population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.

1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital

Inclusion criteria:

1. The patients who received the percutaneous coronary intervention after fibrinolysis
2. Adult patients with age more than 18 years old
3. GRACE risk score less than 155 (low-intermediate risk)

Exclusion criteria:

1. The patients who received primary PCI or rescue PCI
2. The patients who had the previous history of coronary-artery bypass surgery
3. The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)

1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay \| confounders)

1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.

1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).

1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. The patients who received the percutaneous coronary intervention after fibrinolysis
2. Adult patients with age more than 18 years old
3. GRACE risk score less than 155 (low-intermediate risk)

Exclusion Criteria:

1. The patients who received primary PCI or rescue PCI
2. The patients who had the previous history of coronary-artery bypass surgery
3. The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
Promoting Adolescent Investment In Diabetes Care

Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (\>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).

Eligibility Criteria:
Inclusion Criteria:

* \>12 and ≤18 years old
* Diagnosed with type 1 diabetes ≥12 months
* Speaks English fluently
* Cognitively able to participate in incentive program and complete surveys.
* Have access to a mobile phone to receive goal-obtainment and incentive updates
* Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
* Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics

Exclusion Criteria:

* Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
* Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
* Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
* Cognitively or physically unable to participate
* Patient is unable to speak in the English language
* Patient is unable to read in the English language
* Patient is a ward of the state
* Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Pharmacokinetics (PK) study

To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion Criteria:

* Chronic or acute renal disease
* Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk
Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction.

This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.

Subarachnoid hemorrhage (SAH) or bleeding in the brain is a form of stroke. SAH mostly results from ruptured aneurysms. This severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. One frequent complication after SAH is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. The pathophysiologic processes which drive vasospasm remain unclear. This study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. Additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm.

Eligibility Criteria:
Inclusion Criteria:

* Admission to neurosurgical ICU Klinikum der Universität München
* SAH
* External CSF drainage

Exclusion Criteria:

- AGE \< 18
Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented heart failure (NYHA class II-IV)

Exclusion Criteria:

* Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

The aim of this prospective observational study is to evaluate the performance of Amigo RCS in ablation procedures for most common arrhythmias as compared to a conventional manual approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation

Exclusion Criteria:

* NA
Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow

The specific aim of this proposed project is to implement a standard process for integrating MedlinePlus health information prescriptions into the clinic workflow.

Hypothesis 1: Individuals in the intervention group who receive tailored email health information with provider selected MedlinePlus links and added commentary for patient specific conditions will be more likely to seek information / use MedlinePlus compared with individuals in the control group.

Hypothesis 2: Individuals in the intervention group who receive tailored email health information with provider selected MedlinePlus links and added commentary for patient specific conditions will be more satisfied with the information received compared with individuals in the control group.

Providing patient education in an outpatient practice can be challenging in part due to the variety of patient medical conditions and the quantity of materials needed. Increasingly, electronic resources such as those found on the internet have the potential to provide easily accessible needed information. However, clinicians do not have the time to assemble a list of websites for their patients and even if they did, the quality of information varies greatly and would require close screening. MedlinePlus is a free National Library of Medicine sponsored website that features health information on hundreds of conditions with all information carefully screened for quality standards by expert librarians. We will conduct a pilot study to seamlessly integrate provider-customized MedlinePlus health education prescriptions for specific conditions into the normal clinic workflow to motivate patients to access and expand their use of MedlinePlus to benefit their health. As HIV prevention/education is very important, we will include the HIV clinic as well as a general internal medicine clinic.

Eligibility Criteria:
Inclusion Criteria:

* To be included in the study population, patients must also be seen by their physician for one of the 21 target health conditions (Allergic Rhinitis, Asthma, Back Pain, Benign Prostatic Hypertrophy, Bursitis, Depression/Anxiety, Diabetes Mellitus, Esophageal Reflux, HIV, Hyperlipidemia, Hypertension, Insomnia, Irritable Bowel Syndrome, Obesity, Osteoporosis (senile), Shoulder Pain, Sinusitis, Symptomatic Menopause, Urinary Incontinence, Urinary Tract Infection, Vaginitis) and be willing to provide an email address.
* Patients will be included only once.
* All patients in the intervention and the control group will receive the survey.
* All physicians and staff at the Fairview Clinic and HIV Clinic will be invited to complete the physician or staff survey.

Exclusion Criteria:

* No email address
Implementation of Transdx Group for POTS

The proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction. The investigators hypothesize that their intervention will result in improvements in the transdiagnostic mechanisms specifically targeted by components of their intervention including sleep, information processing, and youth/parent experiential avoidance.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent participants must be

  1. between the ages of 13-18 years old,
  2. english speaking, and
  3. have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or POTS.
* Participants must also:

  1. endorse symptoms of autonomic dysfunction on the COMPASS 31 (measures are described below), and show
  2. moderate functional impairment, and/or
  3. some psychiatric symptoms in the domains of anxiety and/or depression.
* FDI scores must be greater than 12 (see Kashikar-Zuck et al., 2011 for an empirical rationale).
* Must have attended at least one day of school per week during the past month.
* On the measures of anxiety (SCARED) and depression (CDI), the adolescent's scale score must be above the "average" range based on T scores (CDI) or within the "clinical" range (SCARED).
* Each participant must have at least one English-speaking parent/legal guardian who can provide informed consent for the adolescent, as well as participate in the study.
* Each adolescent and their parent/legal guardian(s) must be English-speaking.

Exclusion Criteria:

* Adolescent participants;

  1. wards of the state,
  2. endorse active homicidal or suicidal ideation,
  3. have an intellectual disability, a pervasive developmental disability or significant developmental delay,
  4. endorse an active substance use disorder, and
  5. are currently participating in individual or group psychotherapy.
  6. do not have in-network health insurance that covers Health and Behavior interventions, or
  7. are unable to self-pay.
* Parent/legal guardian(s) are

  1. unwilling to participate in the study,
  2. are non-English speaking, or
  3. have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or
  4. do not have legal custody of the adolescent participant.