cyrilzakka/clinical-trials huggingface dataset:
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately 8-10 weeks. For those taking a single OAD, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to Screening. OAD medications that are acceptable to be discontinued include: a sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
* Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs).
* HbA1c \>/=7% and \</=10% if the patient is on diet/exercise therapy only and does not require any OAD discontinuation. HbA1c \>/=6.5% and \</=9% if the patient requires to be washed off an OAD.

Exclusion Criteria:

* Evidence or history of diabetic complications with significant end organ damage.
* History of stroke or transient ischemic attack.
* History of myocardial infarction.
* History of coronary artery bypass graft or stent implantation.
* Clinically significant peripheral vascular disease.
* Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.
* Current history of angina/unstable angina.
* One or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
* A positive urine drug screen.
* Use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
* Blood pressure \>/=160 mm Hg (systolic) or \>/=100 mm Hg (diastolic), following at least 5 minutes of rest.
* Pregnant or nursing females; females of childbearing potential.
Prolonged Overnight Fast, Energy Metabolism and Skeletal Muscle Anabolic Sensitivity

Recent research shows that timing of nutritional intake and daily periods of fasting may have important health effects. In humans, limiting daily food intake to a narrow window (typically \~8 hours) can bring about some beneficial changes in blood concentrations of fats, sugar and the hormone insulin. It is thought that many of these changes are due to the prolonged daily fasting periods and humans will have regularly experienced prolonged fasting periods throughout evolution. In the modern era, food access is widely available and it is not uncommon for the time between breakfast and a late night snack to exceed 14 hours. We have recently shown that extending habitual daily periods of fasting to 16 hours per day also improves the ability of skeletal muscle to take up amino acids, the building blocks of protein. We are interested in studying whether a single episode of prolonged overnight fast (\~16 hours), when compared to a normal overnight fast of 10 hours, is sufficient to stimulate skeletal muscle protein synthesis in response to dietary protein ingestion in healthy humans.

There is a growing interest in the cardiometabolic benefits of various intermittent fasting paradigms (such as alternate day fasting and the 5:2 fast diet), where periods of normal energy intake are punctuated by periods of energy restriction or fasting. A recent alternative to these protocols is time-restricted feeding (TRF), which limits daily food/energy intake to a narrow window (typically 8 to 10h). The major strength of TRF is that it extends the duration of overnight fast without limiting normal calorie intake. Recent evidence from both animal and human studies have shown that habitual daily periods of fasting of as little as 16h can reduce fasting insulin and triglycerides levels, protect against excessive body weight gain in response to high fat and sucrose diets, better maintain fat-free mass, and improve beta-cell responsiveness. We recently completed a 2-week TRF intervention study using the 8h fed (between 8am and 4pm)/16h fast protocol in healthy individuals and found improvements in insulin sensitivity and skeletal muscle uptake of branched chain amino acids. As we did not make measurements of muscle protein synthesis, it is not known whether a single episode of prolonged overnight fast (\~16h) is sufficient to elicit improvements in insulin sensitivity and stimulate skeletal muscle protein synthesis in response to dietary protein ingestion. The aim of the proposed study is to investigate the effect of prolonged overnight fast (16h vs. 10h) on postprandial energy metabolism and skeletal muscle protein synthesis in healthy humans.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-35yrs
* healthy
* non-smoking
* physically active
* no excessive weight loss in past 6 months
* body mass index between 18 and 27 kg.m-2

Exclusion Criteria:

* body mass index under 18 and over 27 kg.m-2
* sedentary
* screening bloods out of range
* excessive weight loss in the past 6 months
* irregular eating patterns
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Key Inclusion Criteria:

* Adults with previously treated recurrent CLL who have measurable lymphadenopathy
* Require therapy for CLL
* Have experienced CLL progression \< 24 months since the completion of the last prior therapy
* Have disease that is not refractory to ofatumumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation

The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.

Specific Aim 1: The investigators will evaluate the total fluids administered in FFP (intervention) and albumin (control) groups. The investigators propose that the FFP group will require less total fluids administered.

Specific Aim 2:The investigators will determine overall complication rates (pulmonary complications, ARDS, ACS, over-resuscitation) in the FFP (intervention) and albumin (control) administration groups. The investigators propose FFP administration will reduce the frequency of these complications.

Specific Aim 3: The investigators will characterize the effects of FFP and albumin administration on endothelial dysfunction in major burns. We will measure glycocalyx degradation products (e.g. syndecan-1, glycosaminoglycans) in the serum. The investigators project FFP will mitigate GDP better than albumin.

Eligibility Criteria:
Inclusion Criteria:

* adult thermal injury patients aged 2:18 years old with burns -\>20% TBSA seen at UCH Burn Center within 8 hours of burn injury

Exclusion Criteria:

* Pregnant patients, prisoners, Jehovah's Witness/inability to receive human blood product/component therapy, electrical injury, chemical injury, friction/shear injury, anticipated death within 48 hours of admission, delayed intervention (\>8 hours post burn), history of renal failure requiring dialysis, Stage IV or V chronic kidney disease, coagulopathy (admission INR \>2.5), cirrhosis (Childs B,C), concomitant life threatening traumatic injuries, receiving blood product transfusion for another reason, inability to obtain consent from patient or legally authorized representative.
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.

OBJECTIVES:

Primary

* To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.

Secondary

* To evaluate overall survival of these patients treated with everolimus.
* To evaluate progression-free survival of these patients.
* To evaluate toxicity of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative studies.

After completion of study treatment, patients are followed up for 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed thyroid cancer

  * Progressive or refractory disease within the past 6 months
  * Locally advanced or metastatic disease
* Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria
* Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy
* No untreated brain metastasis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Creatinine \< 1.5 mg/dL
* Total bilirubin ≤ 1.0 times upper limit of normal (ULN)
* ALT and AST ≤ 3.0 times ULN
* No known hypersensitivity to the study drug
* No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)
* No history of significant neurological or mental disorder, including seizures or dementia
* No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
* No active uncontrolled cardiac disease
* No myocardial infarction within the past 12 months
* Able to take oral medication
* No active peptic ulcer disease
* Must have patient compliance and geographic proximity for adequate follow-up

PRIOR CONCURRENT THERAPY:

* At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy
* At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers
* No prior surgical procedure affecting absorption
* No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group

The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.

Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.

Eligibility Criteria:
Inclusion Criteria:

* people who receive colonoscopy
* people who sign the consent
* having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome

Exclusion Criteria:

* those aged over 75 years
* the disabled
* pregnant women
* chronic renal diseases (CLcr \<50ml/min)
* blood coagulopathy (PT INR \> 1.5, aPTT \> 45 seconds, or platelet count \< 50,000/mm)
* people who refuse to sign the consent
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy

Patients with ischemic cardiomyopathy (left ventricular ejection fraction \<35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is required to examine the effect of LLTS on RA independent of heart rate. Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic cardiomyopathy (LVEF \<35%) and heart failure
2. Implantable device with an atrial lead (dual chamber ICD or CRT-D)
3. Sinus rhythm at the time of the study

Exclusion Criteria:

1. Recent (\<6 months) stroke or myocardial infarction
2. Persistent atrial fibrillation
3. Recurrent vaso-vagal syncopal episodes
4. Unilateral or bilateral vagotomy
5. Pregnancy or breast feeding
6. Uncontrolled diabetes or hypertension
7. Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker)
8. Bifascicular block or prolonged first degree block
9. Hypotension due to autonomic dysfunction
10. Inability or unwillingness to understand and/or sign informed consent
A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study

Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.

Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.

The day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine \[QVM\]) and the Hospital Anxiety and Depression Scale (HADS).

The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance.

Eligibility Criteria:
Inclusion Criteria:

* to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
* to suffer from migraine for more than one year
* to be less than 50 years old at migraine onset
* to have had at least two migraine attacks during the month before recruitment

Exclusion Criteria:

* migraine with aura with motor symptoms (hemiplegic migraine)
* more than 15 migraine attacks per month
* abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months
* prophylactic treatment taken for less than 3 months
Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* The patients signed the written informed consent
* The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
* The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
* The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

* Patients with unresected tumor
* Wild EGFR type
* Allergic to the study drug
* Patients have severe non-cancerous diseases
* Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.

* Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
* Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
* Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
* Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
* Patient records will be reviewed at 5 years to check cardiac status and survival.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years and above
* Willing and able to provide consent
* Able to read
* Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
* Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:

  * LVEF 50-54% by baseline echocardiogram
  * Age ≥ 65
  * BMI ≥ 30 kg/m2
  * Current or prior anti-hypertensive therapy
  * Diagnosis of coronary artery disease (CAD)
  * Diabetes Mellitus
  * Atrial fibrillation/flutter

Exclusion Criteria:

* Children
* Patients who are pregnant
* Only single encounter without follow up
* Cancer diagnosis other than breast or hematological cancer
* Chemotherapy treatment other than anthracycline or trastuzumab
* No prior chemotherapy treatment