cyrilzakka/clinical-trials huggingface dataset:
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

Eligibility Criteria:
Inclusion Criteria:

* For extracranial artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was considered for symptomatic stenosis≥70% in invalid patients after intensive medical therapy.
* Successfully had intracranial or extracranial artery stenting

Exclusion Criteria:

* Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months
* Hypersensitivity to contrast agent
* Malignant hypertension
* Difficult to perform the intracranial and extracranial artery stenting
* Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
* Serum creatinine \>1.5 mg/dL
* Hypersensitivity to test drugs
* Difficult to hand follow-up visit
Safety and Efficacy of Empagliflozin in Hemodialysis

A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function
* Thrice-weekly HD
* Willingness and capacity to provide informed consent
* For women of childbearing potential, a negative pregnancy test is required at screening

Exclusion Criteria:

* Does not have capacity to consent
* Anuria (daily urine volume \< 200 mL/day)
* Planned kidney transplant within 3 months
* Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis)
* New York Heart Association (NYHA) Class IV heart failure (HF)
* Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
* History of diabetic ketoacidosis
* Type 1 Diabetes Mellitus
* Hereditary glucose-galactose malabsorption or primary renal glucosuria
* Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease
* Active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative.
* Major surgery within 12 weeks
* Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
* Combination use of angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB)
* Current use of an SGLT2 inhibitor (within 6 weeks prior to randomization)
* Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
* Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
* Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
* Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy.
* Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil

This was a retrospective observational study that relied on data extracted from patient's chart review at the participating centers. Data was entered into an electronic Case Report Form (eCRF) designed to capture all relevant information to achieve the study objectives.

After the ethical approval for each participating site, the respective Investigator and/or designated qualified study staff were responsible for including all eligible patients in a consecutive manner and entering their information into the eCRF. Patients were primarily identified with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO) diagnosis according to the International Classification of Diseases (ICD)-10 code (M45, M07, and L40, respectively). Alternatively, the written diagnosis from applicable departments, such as payment, computing, or data office were also used for patient screening. Potentially eligible patients had their charts reviewed for all selection criteria. Inclusion was performed up to the number of patients determined for each site prior to study initiation or up to completion of sample size. Patient's identification (name, address, and other identifiable data) was not collected and remained confidential.


Eligibility Criteria:
Inclusion criteria:

1. Documented diagnosis with AS, PsA, or PsO, regardless of its severity, by a physician as per patient chart up to secukinumab introduction.
2. Patient treated with secukinumab monotherapy for at least 24 months since 01 January 2016 in Brazil, in accordance with local labelling approval.
3. Biologic-naïve or secondary-naïve patient, who was not using biologic drug for at least 3 months prior to secukinumab introduction.
4. Medical history available from the entire study period i.e., at least 6 months before and 24 months after secukinumab introduction.

Exclusion criteria:

1. No access or availability of patient medical chart.
2. Patient who did not use approved dosing regimens for secukinumab therapy, as per local label.
3. Patient with confirmed clinical history of active tuberculosis or mendelian susceptibility to mycobacterium diseases prior to secukinumab use.
4. Patient treated with systemic corticosteroid doses with immunosuppressant features (prednisone dose higher than 10 milligrams \[mg\] or its equivalent) for at least 2 consecutive weeks or other concomitant immunosuppressant drug during the study period.
Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)

The investigators are hoping to identify early heart failure in patients who do not have symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide (BNP) in doing this.

Measuring Brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP)and can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP/NT-proBNP levels rise when the heart is under pressure as it is in people with heart disease. However, we don't know if this is a useful test to do in people who are at a high risk of developing heart disease but who have no symptoms and have not been diagnosed with any heart problems.

In this study we hope to recruit 3500 participants. This study is being run in conjunction with HBA (recently renamed Bupa) and we estimate that 10,000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 (protocol amended to include people who meet the entry criteria but who are not insured through HBA).

This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests, an ECG and echocardiography as described below.

Participants will undergo a routine blood test which will include measuring NT-proBNP. Only participants in whom NT-proBNP is elevated will undergo additional blood tests (for cardiac markers), an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥60 years
2. Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
3. Subjects at high-risk of subsequent development of heart failure; comprising at least one of:

   * Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
   * Current active ischemic heart disease
   * Prior Cerebrovascular Accident (CVA)
   * Known valvular heart disease without known LV dysfunction
   * Atrial fibrillation
   * Ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
   * Treated hypertension, of at least 2 years duration
   * Treated Diabetes mellitus, of at least 2 years duration
   * Estimated Glomerular Filtration Rate (eGFR) \<50ml/min

Exclusion Criteria:

1. Known systolic or diastolic heart failure
2. Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
3. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
4. Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists. Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS)

The aim of the study is to follow a group of preschool children from early permanent dentition to determine the prevalence and incidence of caries malocclusions and to investigated the related risk factors as age, gender, ethnic origin and non-nutritive sucking habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and dental care.

Once a year a clinical examination were performed. Data were collected with a questionnaire, that was filled out by the parents before the clinical examination, which included questions on child's clinical history, the type of feeding, the use of baby-bottle, the history of non-nutritive sucking habits (dummy-sucking and digit sucking) and the consent to the clinical examination. Two World Health Organization (WHO) calibrated examiners carried out the clinical examinations. They were blinded to the information collected from the parental questionnaires. Dental examinations were performed in a classroom environment under natural light, using gloves and masks in compliance with the infection control protocol, mouth mirrors and disposable paper rulers to measure overjet and overbite (in millimeters). The occlusion was assessed in centric occlusion and was classified according to Foster and Hamilton criteria \[Foster and Hamilton, 1969\] Radiographic examination was not performed.

Eligibility Criteria:
Inclusion Criteria:

* children born in 2008 and 2009 in Chiavari District (Italy)

Exclusion Criteria:

* parents' lack of consent
* absence at the date of the visit; no compliance
* orthodontic treatment; marked occlusal wear or early
* loss of primary teeth
* alterations in the number, size and shape of teeth
* syndromes or systemic problems affecting craniofacial growth
* cleft palate.
Experimental Overfeeding in Humans

The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding.

The homeostatic regulation of body weight implies that biological processes have evolved to protect energy stores from changes to the food environment. Accordingly, many individuals remain remarkably weight stable over years without carefully considering how much they eat or how much energy they expend, which has given rise to the theory that body weight is regulated around an individual biological 'set point'. Notably, overfeeding humans in experimentally controlled conditions, support this phenomenon, but the underlying mechanisms are unknown.

To systematically map out the components of the overfed state, the investigators will execute a 2-week randomized controlled overfeeding trial in lean and overweight individuals. The trial is preceded by a 1-week lead-in period and followed by a 2-wk controlled ad libitum study period. The comparison between lean and overweight subjects, men and women, enables the determination of whether a differential response in overfeeding-induced signals is present in relation to BMI and sex.

Eligibility Criteria:
Inclusion Criteria:

* Male or female otherwise healthy subjects
* 20-40 years of age
* BMI (Body mass index) between 22-30 kg/m2

Exclusion Criteria:

* Present or previous cardiovascular disease, diabetes or thyroid-disease
* smoking
* more than 3 hours of planned physical activity per week
The Early Intervention and Prevention of Diabetes Foot

Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure sensation, superficial pain or temperature. The most commonly used technique for diagnosis of peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC is bothersome and techniques using electric currents to measure NC and needles to study muscle innervations are uncomfortable.

Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can demonstrate neurosensory abnormalities when it is non-invasive test, selective to small fibers despite negative EMG/NCV finding.

The investigators predict QST can be used for the early diagnosis and follow-up of small-fiber neuropathy in diabetes patients. The investigators also predict the early evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to advance stage of DM foot or limb amputation.

Patients will be divide into 4 groups (groups 1 to 4 will be divided by Q-Sense QST (TSA II) . The patient groups will be defined as the followings:

1. Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
2. Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
3. Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), but no foot ulceration
4. Group 4: 100 diabetes patients with neuropathy, PAOD(＋) , and foot ulceration QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
* Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
* Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), without foot ulceration.
* Group 4: 100 diabetes patients with neuropathy, PAOD (＋), and foot ulceration.

Exclusion Criteria:

* Poorly controlled hypertension (SBP≥150 under regular medical treatment)
* Thyroid disease
* Pregnancy
* Have been diagnosed malignancy
* Liver cirrhosis
A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history
* Painful physical symptoms as measured by the Brief Pain Inventory-Short Form

Exclusion Criteria:

* Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia)
* Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
Cigarette and Gastric Contents

The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year

Exclusion Criteria:

* Digestive Diseases, gastroparesis
* Non smokers
* pregnancy
* history of diabetes mellitus
* medication affecting gastric motility
* previous gastrointestinal surgery
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.


Eligibility Criteria:
Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF

The objective of this study was to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume was also assessed.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Diagnosis of primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF
3. Enlarged spleen, measuring 5 cm or greater from the costal margin
4. Must have two or more of the following risk factors:

   1. Over 65 years old
   2. Have the following symptoms often associated with MF: loss of weight, fever, night sweats
   3. Have a low red blood cell count (anemia - hemoglobin \< 10 g/dL)
   4. Have a high white blood cell count (history of white blood cell count \> 25,000/uL)
   5. Have high circulating blasts (\> or = 1%) as measured by blood tests
5. Should have circulating blasts \<10% (as measured by blood tests)
6. Should be capable of self-care
7. Should have adequate bone marrow reserve
8. Should not have the option of stem cell transplantation
9. Should discontinue any prior or ongoing treatment for myelofibrosis prior to entering the study
10. Had no prior treatment with another JAK inhibitor

Exclusion Criteria:

1. Does not have adequate liver or kidney function (as measured by blood tests)
2. Has an active infection (bacterial, viral, etc.)
3. Has active hepatitis A, B, or C or positive for HIV
4. Has another cancer that needs active intervention
5. Had a history of bleeding disorder
6. Had a history of very low platelet counts (as measured by blood tests) not related to treatment of MF
7. Had radiation of the spleen within 1 year of joining the study
8. Does not have adequate heart function
9. Sufficient time has elapsed between stopping previous treatment for MF and joining the study
10. Females who are pregnant or breast-feeding
11. Not able to sign informed consent
12. Has any other active medical conditions that the doctor deems may compromise your safety or ability to join in the study
Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression

Pioglitazone as a Ppar-gamma agonist is an anti diabetic drug. It was also shown that, it has certain anti inflammatory and neuro-protective effects. In recent years it has been proposed that Ppar-gamma agonists may have effects on mood and cognition. In animal studies and in one human case report as well as a pilot study on human subjects these drugs improved symptoms of depression. A randomized controlled and double blind design will provide further evidence for the efficacy of these drugs in major depressive disorder.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major depressive disorder based on DSM-IV TR criteria
* Age 18-50
* Hamilton Depression Rating scale \>=22
* Signing the informed consent form
* Citalopram be the drug of choice for the patient irrespective of other eligibility criteria

Exclusion Criteria:

* Problems in other Axes
* Pregnancy and lactation
* Serious or life threatening disease
* taking other antidepressant in the recent month or Electroconvulsive shock in the recent two months, and taking other psychotropic agents
* Diabetes controlled with drugs or insulin (patients with only lifestyle interventions will be included), Liver disease, Congestive heart failure Class III and IV
* Metabolic syndrome