cyrilzakka/clinical-trials huggingface dataset:
Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.

After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* A history of stable documented CAD
* Currently non-smoking males and females ages 30 to 85 years inclusive.

  o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.
* Chronic concomitant medications must be stable for at least 2 months prior to screening
* HDL-C \< 50 mg/dL for men and \< 55 mg/dL for women
* Body Mass Index (BMI) of approximately 18 to 35 kg/m\^2; and a total body weight \>= 50 kg (110 lbs) and \<= 110 kg (approximately 242 lbs)

Exclusion Criteria:

* Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.
* Chronic heart failure (\> New York Heart Association (NYHA) Functional Classification II).
* Ventricular tachyarrhythmias.
* Uncontrolled Type 2 (HbA1c \> 8.5%) or Type 1 diabetes mellitus.
* History of febrile illness within 5 days prior to dosing.
* History of regular alcohol consumption exceeding 10 drinks per week.
* 12-lead ECG demonstrating QTc \> 500 msec at screening.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Cereal-based Products Fortified With Legumes and Effects on Body Weight Management

Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. The effects of dietary intervention on body weight reduction will be examined.

Eligibility Criteria:
Inclusion Criteria:

* normal exercise and dietary habits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* diabetes
* pregnancy
* chronic medical illness
* use of nutritional supplements
* regular intense exercise
* alcohol consumption \> 2 drinks/day
Oxytocin and Social Cognition in Frontotemporal Dementia

Investigations into the components of cognition damaged in frontotemporal dementia (FTD) demonstrate that patients with FTD show deficits in facial and verbal expression recognition, lack insight into what others think or might do (theory of mind skills), and in decision making tasks requiring processing of positive versus negative feedback. These cognitive functions are thought to be critical for appropriate social behavioural regulation (Blair, 2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is an important mediator of social behavior and that oxytocin may facilitate emotion recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008). Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of this study is to determine how administration of intranasal oxytocin to patients with frontotemporal dementia affects behavior and processing of specific types of social and emotional information.The investigators' hypothesis is that oxytocin administration will improve emotional and social cognitive deficits in patients with FTD, resulting in improved decision making and behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable Frontotemporal Dementia or Pick's disease
* Caregiver available to participate in all study visits

Exclusion Criteria:

* Severe language or memory deficits that preclude completion of the cognitive tasks
* Females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause)
* Uncontrolled hypertension
* Bradycardia (rate \<50 bpm) or tachycardia (rate \> 100 bpm)
* Current use of prostaglandins
* Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer
Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study in 96 chronic rhinosinusitis patients who had prior endoscopic sinus surgery and presented with uncontrolled postoperative symptoms. The objective was to evaluate the safety and clinical efficacy of sinus stents relative to systemic glucocorticoids. The steroid-eluting sinus stent consist of a bioabsorbable self-expanding sinus implant coated with 625 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the sinus stent implant provides controlled release of MF to the sinus mucosa over 30 days.

Eligibility Criteria:
Inclusion Criteria:

* The patient underwent pre-functional endoscopic sinus surgery and bilateral ethmoidectomy (for at least 3 months), and was identified by the clinician as having uncontrolled symptoms (Diagnostic criteria of EPOS 2020) with a Snot-22 score of at least 20;
* Edema score of bilateral nasal endoscopy was 2 points both;
* Understands the purpose and procedures of the trial and voluntarily signs the informed consent form;
* The female subjects had no pregnancy or lactation plans during the treatment and follow-up period;
* The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials until the end point of this trial was reached;
* Subjects were 18-65 years old, male or non-pregnant women;

Exclusion Criteria:

* Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extending beyond the middle nasal passage)
* The subject has a known allergic reaction or contraindication to the device material and its degradation products (mamethasone citrate, L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid);
* Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globular sinusitis, systemic vasculitis and granulomatous diseases, tumors, and immune deficiency.
* The patient underwent endoscopic nasal surgery within 3 months.
* Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratory tract infection, or common cold in the 4 weeks prior to screening visit;
* Have a clinically serious metabolic, cardiovascular, immune, neurological, blood, digestive, cerebrovascular, or respiratory disease, or any condition that the investigator believes interferes with the evaluation of the study results or affects the safety of the subjects;
* Symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected to develop symptoms and require nasal spray hormone therapy within 4 weeks of randomization,
Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease

Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality.

The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population.

Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr (HY) stage III or IV
* At least 2 falls in the past 12 months
* Stable antiparkinsonian medication regime
* Ability to ambulate independently for at least 50 m.

Exclusion Criteria:

* Other neurological or orthopedic conditions
* Medically diagnosed hearing loss
* Dementia (Mini Mental Status Exam score \< 24).
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory result for HbA1c \>11% or FPG \>270mg/dL
* Clinical diagnosis of Type II diabetes
* Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria:

* Women who are pregnant
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

* History of evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment
The Impact of Proton Pump Inhibitors on the Fecal Microbiome

The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (CDI).


Eligibility Criteria:
Table 1. Inclusion Criteria for Healthy Volunteers:

1. Healthy individuals without chronic gastrointestinal problems or using antisecretory medications.

Table 2. Inclusion Criteria for Clostridium difficile infection subjects:

1. Newly diagnosed first episode of CDI prior to being treated.

Table 3. Exclusion Criteria for Healthy Subjects:

1. Prior gastrointestinal surgery that has altered the anatomy of the esophagus, stomach, or small/large intestine including appendectomy and cholecystectomy.
2. Chronic daily use of any medications that could alter gastrointestinal secretory or motor function (see Table 2).
3. Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus).
4. Females of childbearing age who are not practicing at least one form of birth control at least one month prior to starting the PPI or are pregnant or lactating (a pregnancy test will be performed on female subjects prior to PPI use).
5. Significant untreated psychiatric disease.

Table 4. Prohibited Medications:

1. Antibiotics within 2 months of the stool sample collection.
2. Probiotics (e.g., Florastor, Align, Flora-Q, VSL#3, lactobacillus, bifidobacterium) within 2 weeks of the stool sample collection.
3. Fiber supplements (e.g., Metamucil, Citrucel, Benefiber), unless maintained on a stable dose for the last 3 months.
4. Chronic use of medications that alter gastric pH: proton pump inhibitors (e.g., omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole) and histamine2 receptor antagonists (e.g., cimetidine, famotidine, ranitidine).
5. Chronic use of medications that affect gastrointestinal motility and/or transit including prokinetic agents (e.g., metoclopramide (Reglan), tegaserod (Zelnorm), domperidone (Motilium), erythromycin), narcotic analgesic agents (e.g., methadone, fentanyl, oxycodone, codeine, morphine, hydromorphone), laxatives including mineral oil, anticholinergic agents (e.g., Bentyl, Levsin), and antidiarrheal agents (e.g., Kaopectate (donnagel), Pepto-Bismol (bismuth subsalicylate), Imodium (loperamide), Lomotil (atropine with diphenoxylate), codeine, tincture of opium).
Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II Studies

The primary goal of this study will be to explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies using conventional and non-conventional MRI sequences.


Eligibility Criteria:
Inclusion Criteria:

* Participating in either the CARE MS I or CARE MS II studies

Exclusion Criteria:

* Not a participant in the CARE MS I or CARE MS II studies
Levetiracetam Treatment of Tardive Dyskinesia

This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.


Eligibility Criteria:
Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

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18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases

This early phase I trial tests the use of a radioactive tracer (a drug that is visible during an imaging test) known as 18F-FMAU, for imaging with positron emission tomography/computed tomography (PET/CT) in patients with brain cancer or cancer that has spread to the brain (brain metastases). A PET/CT scan is an imaging test that uses a small amount of radioactive tracer (given through the vein) to take detailed pictures of areas inside the body where the tracer is taken up. 18F-FMAU may also help find the cancer and how far the disease has spread. Magnetic resonance imaging (MRI) is a type of imaging test used to diagnose brain tumors. 18F-FMAU PET/CT in addition to MRI may make the finding and diagnosing of brain tumor easier.

PRIMARY OBJECTIVES:

I. Assess the correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic 2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (FMAU) PET kinetic analysis parameters.

II. Explore the different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters between patients with presence or absence of recurrent tumor.

OUTLINE:

Patients receive 18F-FMAU intravenously (IV) and undergo a PET/CT scan over 60 minutes. Patients then undergo standard of care mpMRI over approximately 45 minutes.

After completion of study intervention, patients are followed up at 24-96 hours after their 18F-FMAU PET/CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, both men and women
* Documented history of either primary brain tumor (e.g. glioma) or metastatic brain tumor from another primary cancer (e.g. lung, breast, colon, melanoma, kidney)
* Documented radiation therapy regardless of treatments prior to radiation therapy

Exclusion Criteria:

* Unable to give consent
* Inability to remain motionless during imaging studies
* Intractable seizures
* Claustrophobia
* Implantable devices incompatible with magnetic resonance (MR) environment
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine).

Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life).

A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously.

The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.

The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries (laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures) to one of two groups. Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system placed in a subdiaphragmatic (within the abdomen) location. Half of the study group will have bupivicaine, a numbing medicine in the pump while the other half will have sterile saline in their pump. Neither the patient nor the surgeon will be aware of which group any particular patient is in, this is a process known as "blinding" and improves the reliability of the results. All patients will receive the standard locally infiltrated trocar site local anesthetic and either a prescription for Vicodin for ambulatory patients or morphine injected into their vein for patients staying in the hospital.

All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine. Ambulatory patients will be reached by phone for answers to these questions. All patients will have their pain controlled in the usual and standard way at all times. The On-Q pump will be removed at 48hours.

The results will then be statistically reviewed to see if the On-Q pumps were of benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

Exclusion Criteria:

* Patients who refuse consent
* Are converted from laparoscopy to open surgery
* Are allergic to bupivacaine
* Are unable to followup
Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition

One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

The physiopathology and the anatomo-functional correlates of motor, cognitive, and language functions after surgery of PF tumors are still rare and little known. The objective of this study is to analyze them via morphometric MRI analysis and functional and structural connectivity in children away from PF surgery, coupled with clinical data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a low grade glioma of the posterior fossa or a medulloblastoma
* Healthy volunteers without any tumor in the posterior fossa (control case)
* At one year of the last treatment for the retrospective groups, or patient who have an indication to a surgery of a tumor of the posterior fossa
* Eligibility to a functional MRI
* Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Antecedent of neurologic, metabolic or genetic disease
* Brainstem glioma
* Have a contraindication to a MRI
Use of Online Personalized Health Record System to Promote Self-Management of Diabetes

Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
* Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
* Diagnosis of diabetes
* Baseline A1C \>= 7.5%

Exclusion Criteria:

* Initial diagnosis of diabetes within the last 12 months
* Diagnosis of Type 1 diabetes
* Inability to speak and read in English
* Lack of regular access to a computer with Internet and email capabilities
* Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
* Pregnant, planning to become pregnant, or lactating
* Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
* PCP determination that the study is inappropriate or unsafe for the patient
* Investigator discretion for clinical safety or protocol adherence reasons