cyrilzakka/clinical-trials huggingface dataset:
Pilot Trial of Adaptive Radiotherapy Boost for HNSCC

The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* ECOG performance status of 0, 1
* Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
* Patients with measurable disease, either at primary site or neck per RECIST 1.1.
* For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
* International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
* Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.

Exclusion Criteria:

* Pregnancy or lactation
* Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
* Patients who had undergone definitive surgery for the index cancer.
* Patients with distant metastatic disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery

Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in prone position surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Eligibility Criteria:
Inclusion Criteria: meet both of

1. Patients receiving scheduled prone position spine surgery
2. BMI 18.5\~30 kg.m-2

Exclusion Criteria:

1. age younger then 20 yrs or elder than 80 yrs
2. pregnant women
3. patients in intensive care units
4. patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
5. patients with ongoing infection
6. patients allergic to voluven
A Multiple Dose Study Of PF-06678552 In Healthy Subjects

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential.
* Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg
* Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Intraventricular Catheter System for IVH

The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.

Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and is associated with higher rates of morbidity and mortality than all stroke subtypes.

Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after ICH.

There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital sequence in patient management, there are reported risks including infection and limitations related to erroneous readings associated with current ICP monitors. Physicians lack the appropriate tools to employ active intermittent aspiration and drainage with continuous ICP monitoring.

The current clinical study is being initiated to evaluate the hypothesis that active irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood from intraventricular space.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years of age
* Intraventricular hemorrhage documented on head CT or MRI scan
* Need of cerebrospinal fluid drainage
* Indication for active treatment evaluated by the treating physicians
* Signed informed consent obtained by patient or Legal Authorized Representative
* Treatment possible within 72 hours of ictus

Exclusion Criteria:

* Patient has fixed and dilated pupils
* Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.

Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven ampullary adenoma or adenocarcinoma with intraductal biliary extension ≥1cm who were deemed medically unfit for surgery or declined surgery

Exclusion Criteria:

* pancreatic invasion, lymph node invasion, distant metastasis, or coagulopathy.
Follow-up of Patients With Multivessel Coronary Artery Disease After CABG

The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. The primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.

Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually associated with impairment in quality of life, and with a high risk for cardiovascular events including myocardial infarction and cardiovascular death. Because of the anatomical and/or functional extension of the disease, combined with high-risk clinical features (left ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG surgeries are performed annually.

Although the benefits of CABG for those high-risk patients have been well established in the long-term, the best follow-up strategy after surgery is still controversial. Current guidelines generally recommend that the follow-up of patients after CABG should be based on the same strategies proposed for patients with stable angina. The investigators hypothesized that the early identification of myocardial ischemia or progression of coronary atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone for the prevention of cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Documented obstructive coronary artery disease
* Isolated, recent CABG (\< 30 days from inclusion)

Exclusion Criteria:

* Concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc
* Glomerular filtration rate \< 30mL/min/1.73m2
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability

Visual perceptual defects in children can negatively affect their activities of daily living.The aims of this study were to develop and evaluate an interactive digital game system for correcting visual perceptual defects and to evaluate the effectiveness of the proposed system.


Eligibility Criteria:
Inclusion Criteria:

* Record of developmental disability diagnosis
* Ability to understand instructions
* TVPS-3 score lower than 25% of the norm reference and diagnosis of visual perceptual defect
* Test of Nonverbal Intelligence-3rd Edition score higher than 70

Exclusion Criteria:

* Did not follow or understand the instructions for participating in the study
* Had severe defects in vision, hearing, etc.
Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test

Human Papilloma virus is the most common sexual infection in women, which can leads to cervical lesion and cervical cancer. Pap test is recommanded in women of 25 years old until 65 years old in order to screen subclinic lesions and improve prognosis. Yet, scientific knowledge about chronic disease showed negative consequences on quality of life.

However, no study until now has striven to evaluate the consequences of an abnormal pap test on sexuality in adult women. The aim of this study is to evaluate if an abnormal pap test have an impact on the sexual functions in women because of the anxiety and psychological consequences of the diagnosis


Eligibility Criteria:
Inclusion Criteria:

* Adult women with an abnormal pap test.
* Diagnosis known 4 to 12 weeks before the appointment for colposcopy

Exclusion Criteria:

* Cervical cancer
* Pregnancy
Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia

This study evaluates the relationship between myelodysplastic syndromes (MDS) and cardiovascular disease. MDS patients will be evaluated for the presence of mutations and whether they are associated with an increased risk of heart disease (CVD) and inflammation compared to healthy adults. Patients without symptoms of CVD will receive CT scans to assess for hidden disease and if that is related to their mutations.

Myelodysplastic syndromes (MDS) are a type of blood cancer that can cause infection or bleeding because they prevent the formation of blood components and may lead to leukemia and death. MDS can arise from changes (or mutations) to a patient's DNA. MDS patients have increased risk of heart disease compared to healthy adults. The investigators will look for links between mutations in MDS patients and increased risk of heart disease. They will also use "CT imaging" to see if MDS patients have asymptomatic artery disease but may lead to heart disease in the future and if that is related to their mutations. The researcher will try to link mutations in MDS patients to markers of inflammation and to the amount of artery disease on CT imaging to look for patterns. The goal is to find certain mutations that are associated with inflammation and heart disease. This may ultimately allow hematologists to test MDS patients with these mutations for heart disease and/or treat them early so they have a better and longer life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of: myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), Chronic myelomonocytic leukemia leukemia (CMML), or low-blast acute myeloid leukemia (AML, blasts 20-29%) less than 24 months ago
* Alive and registered in the MDS-Canada (MDS-CAN) database
* Known comorbidity history and known history of cardiovascular disease
* Able to provide peripheral blood sample for cytokine analysis
* Able top provide samples for next generation sequencing (NGS) - if diagnosis 0-6 months ago: peripheral blood; if diagnosis 6-24 months ago: diagnostic bone marrow aspirate slides or peripheral blood

Exclusion Criteria:

* MDS/MPN patients other than CMML due to higher prevalence of Janus Kinase 2 (JAK2) mutation (a known risk factor for CVD)
* Disease progression without available diagnostic bone marrow slides for NGS
The Effect of Music on Anxiety in the Appointment Period

The goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. The main questions it aims to answer are:

Can music reduce the psychological symptoms of anxiety at the end of the appointment? Can music reduce heart rate and blood pressure at the end of the appointment?

Researchers will compare if the presence of zen music during the appointment influences anxiety levels.

Participants in the intervention group will listen to music during the appointment. Those in the control group will not have music in the office during the appointment.


Eligibility Criteria:
Inclusion Criteria:

* scheduled appointment;
* agree to participate in the clinical trial.

Exclusion Criteria:

* 17 years or younger;
* deaf;
* illiterate.
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or previously untreated acromegalic patients
* Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\])
* Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
* No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
* Symptomatic cholelithiasis
Renal Sympathetic Modification in Patients With Chronic Renal Failure

The purpose of this study is to observe the incident of uremia and dialysis requirement after renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal failure, and evaluate safety and efficacy of the intervention.

Chronic renal failure is serial clinical manifestations because of kidney damage. Previous studies found sympathetic nerves over activity in chronic renal failure patients. Traditional therapies included medications and dialysis replacement therapy need to spend much money. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of chronic renal failure. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary medications besides expectant intervention, and patients in control group will receive appropriate medications only. We aim to observe the effect of serum creatinine, creatinine clearance rate, glomerular filtration rate, urine microalbumin, urine microalbumin/creatinine, and composite cardio cerebrovascular events after renal sympathetic modification using THERMOCOOL® catheter, and evaluate safety and efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old, and ≤ 75 years old of age
* at least three months history of definite kidney damage
* renal function of serum creatinine of \< 354umol/L, and/or creatinine clearance rate of ≥ 30ml/min, and/or estimated glomerular filtration rate of ≥ 45ml/min for recent 2-3 times evaluation. Besides, the value of creatinine clearance rate fluctuated no more than 30% in recent three months, and 15% in the following two weeks.
* urine microalbumin, and/or urine microalbumin/creatinine is abnormal, and/or quantity of 24 hrs urine protein suggests kidney damage.
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* congenital renal diseases cause to chronic renal damage
* estimated glomerular filtration rate (eGFR) of \< 45mL/min
* taking medicine of glucocorticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), or cytotoxic drugs at present
* value of 24 hrs urine protein is of \> 10g at least once in recent three months, or serum albumin of \< 25g/L
* has the history of renal restenosis or renal stents implantation
* has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
* carcinoma patients
* patients with sick sinus syndrome
* pregnant women
* mental disorders
* patients that have allergy to contrast agent
* patients that do not go with follow-up
* others such as researcher considers it is not appropriate to be included into the study
TPS After Upper Blepharoplasty

Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.

This is a prospective, randomized, comparative, case series study of 100 eyelids (50 consecutive women patients) treated with cosmetic upper blepharoplasty by a single surgeon. Patients were randomized to receive traditional upper blepharoplasty with a single running suture skin closure versus orbicularis oculi muscle fixation to periosteum (brassiere sutures) prior to skin closure. Patient age, follow-up length, complications and treatment were analyzed. The mean of TPS, BFS and TPS/BFS ratio was measured before and after surgery at 3 anatomic landmarks.

56 eyelids (28 patients) were treated with traditional single suture blepharoplasty and 44 eyelids (22 patients) had brassiere sutures. After surgery, the mean change in TPS was 2.10 mm with brassiere sutures compared to 2.04 mm without (p \<.001). The mean change in BFS was 3.33 mm with brassiere sutures compared to 3.19 mm without (p \<.001), The mean change in TPS:BFS ratio at all 3 anatomic landmarks was statistically significant in both groups but the change was statistically greater with the use of brassiere sutures (p \<.001).

Brassiere sutures during upper blepharoplasty were associated with a postoperative increase in TPS decrease in BFS, and increase in TPS/BFS.

Eligibility Criteria:
Inclusion Criteria:

* Female underwent cosmetic upper blepharoplasty and brassiere suture with blepharoplasty

Exclusion Criteria:

* History of thyroid eye disease, levator dehiscence ptosis, blepharospasm, facial nerve paresis, a history of previous upper facial surgery or trauma, and postoperative follow-up for less than 6 months.
Treatment for First-Episode Schizophrenia

This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.

The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.

Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.

First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00320671

Eligibility Criteria:
Inclusion Criteria:

* First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria:

* Prior treatment with antipsychotic medications.