cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive.
* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ 1.5 mg/dL
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 5 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1.
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 5 weeks after the follow-up visit at the end of the study

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes).
* The subject has a history of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject.
* The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test at Screening or is known to be positive for human immunodeficiency virus (HIV).
* The subject has a known or suspected allergy to any of the components of the trial products including mycophenolate mofetil (MMF) or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions.
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening.
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day.
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
Brain Imaging and Retreatment Study of Persistent Lyme Disease

The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.

Some people with a history of Lyme disease continue to have problems despite having received "textbook duration" antibiotic therapy. When memory, attention, or thinking problems persist, the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical scientific questions about the treatment and cause of PLD symptoms.

This 24-week treatment study will evaluate each patient's response to treatment using neuropsychological testing and state-of-the-art brain imaging. The brain tests include neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian Medical Center, the remaining treatments will be done in the patient's home. Patients will be screened over the phone and in person to confirm study eligibility.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants must:

* Be 18-65 years old
* Have persistent problems with memory, verbal fluency, or attention after having contracted Lyme disease.
* Be able to travel to New York for 4-5 evaluations over the course of one year. Travel costs for participants in need may be partially or fully reimbursable.
* Have had a history of well-documented Lyme disease using the CDC's clinical criteria and a current positive IgG Western blot or PCR.
* Have received, at some point in the past at least 3 weeks of IV antibiotic therapy for Lyme disease.

Exclusion Criteria:

Ineligible from participation are people with the following:

* Other major medical or neurologic problems
* Smoke more than 10 cigarettes a day
* Uncontrolled high blood pressure
* Allergy to ceftriaxone (Rocephin)
* History of marked cocaine abuse

Twenty healthy subjects are also being sought for the study.
Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients

Primary objective: to characterize hypertensive patients treated for at least 1 month with Telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment).

Secondary objectives:

* to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation.
* to compare the characteristics of the beneficiary population to those of the initial target population defined in the SPC (summary of product characteristics) for Telmisartan


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients treated with Telmisartan for at least one month, consulting a medical practitioner (for whatever reason)

Exclusion Criteria:
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting

For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.


Eligibility Criteria:
Inclusion Criteria:

* Radiological evidence of a tibial plateau fracture requiring grafting
* Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).

Exclusion Criteria:

* Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
* Active or past history of malignant tumor.
* Evidence of systemic or localized infection at time of surgery.
* Pregnant or lactating females.
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston

To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 13-84, and
2. Patients diagnosed with type 2 diabetes, and
3. Patients have a BMI equal to or \>25 (23, if Asians), and
4. Hemoglobin A1c value equal to or \>7%

Exclusion Criteria:

1. Ages \<13 or \>84
2. Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
3. Previous diagnosis of type 1 diabetes
4. Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
5. Other medical condition or medication administration deemed exclusionary by the study investigators
6. Prisoners
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer

The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.

PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology)
* BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm
* Patients who pass standard clinical MRI screening procedures
* Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN
* Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN

Exclusion Criteria:

* Allergy to FDG or gadolinium
* Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging
* Known kidney disease or poor renal function
* Pregnant
Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

This study evaluated the efficacy of rapid molar intruder (RMI) in treating anterior open bite in the mixed dentition. The study sample consisted of 40 patients who had a skeletal anterior open bite. The sample was allocated randomly into two groups: the RMI group and the control group. The skeletal, dentoalveolar and soft tissue changes occurring after treatment were assessed by using lateral cephalometric images.

Many appliances have been used to treat skeletal anterior open bite (AOB) malocclusion, such as removable appliances, extra-oral appliances (vertical chin cup and vertical head gear), fixed appliances, Orthognathic surgery and functional appliances. Treatment with these appliances produces soft and hard dentofacial tissue changes. Many studies have been carried out in order to study these changes.

In this study, the investigators treated AOB using RMI. Patients were divided into two groups to evaluate the efficacy of RMI.

RMI group: Rapid molar intruder was applied. Control group: Untreated control group. In order to evaluate the changes occurring, lateral cephalometric images were taken in both groups at the beginning of the treatment (T1) and after 9 months of the first cephalograms (T2).

Eligibility Criteria:
Inclusion Criteria:

1. Patients in the mixed dentition
2. Chronological age between 8 and 12 years
3. skeletal class I or II malocclusion
4. Skeletal anterior open bite was assessed clinically and then confirmed radiographically: SN/GoMe was greater than 33°, MM was greater than 27
5. No general problems
6. Good oral health

Exclusion Criteria:

1. Presence of periodontal diseases
2. Presence of general diseases, syndromes or cleft lip and palate
3. Patients with previous orthodontic treatment
SHARE Model Communication Course and Do-not-resuscitate Signing

This study aimed to investigate the effect of attending a SHARE model communication course by emergency physicians on patient notification and signing of do-not-resuscitate (DNR) orders for critical patients in the emergency room.

An observation form designed based on the SHARE model was completed by two observers who noted the communication process between physicians and patients and family members during patient notification and signing a DNR order. To assess the influence of physicians attending a SHARE model course on the signing of DNR orders, a propensity score-matched population was created to reduce the potential selection bias of patients and family members.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a "Do not resuscitate" order.
* Patients who was not register with "Do- not- resuscitate" on their health insurance card.

Exclusion Criteria:

* Trauma patients.
* Suicide patients.
* Patients of age less than 20.
Circulating circRNA in Acute Ischemic Stroke

CRAST is to analyze the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

Circular RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke. Distinctive expression patterns of circRNA will be identified by individual quantitative real time polymerase chain reaction (qRT-PCR). A diagnostic or predictive model will be established using logistic regression. The panel of these altered circRNAs may be associated with acute IS and could serve as a novel diagnostic or predictive method.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan
* Within 72 hours of symptom onset
* Good performance status
* Signed an approved informed consents

Exclusion Criteria:

* a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases
Study of Surgery in Patients With Idiopathic Macular Hole

The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Eligibility Criteria:
Inclusion Criteria:

* patients with IMH
* patients signed the ICF
* patients with course of IMH less than 3 years

Exclusion Criteria:

* patients with hyper myopia
* patients with traumatic macular hole
* accompanied or secondary of other fundus disease
* open or reopen after receiving MH surgery
* patients with retinal detachment
* received vitrectomy due to other diseases
* glaucoma cannot be controled by medication
* patients with other retinal or choroidal disease that may affect VA
* poor patients compliance
* poor condition that cannot undertake the surgery
* dioptric media opacities which make it difficult to exam fundus or measure on OCT
Vestibular Therapy in Alzheimer's Disease

Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).
* Age ≥ 60 years.
* Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).
* Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.
* Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.
* Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Exclusion Criteria:

* Diagnosis of severe AD (CDR≥3).
* Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
* Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
* Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
* Lack of availability to participate in 8 weeks of VT or active control.
Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

Little innovation in the material used for middle ear packing has occurred over the past decade, despite the fact that animal models have shown increased acute inflammation and increased fibrosis in the long term histologically. Although Chitosan Succinamide has shown improved wound healing and hemostasis in the nasal cavity mucosa, it has yet to be used as a support material, hemostatic agent, and healing agent in the middle ear. This study will utilize Chitosan Succinamide as an alternative to purified gelatin foam as a support material in primary tympanoplasty surgery.

A prospective cohort study will be performed. Healthy adults (age \> 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Single tympanic membrane perforation

Exclusion Criteria:

* Chronic recurrent infection or otorrhea
* Previous ear surgery for the study ear
* Shellfish allergy
* Cerebral Spinal Fluid (CSF) leak concern
PSV on Ventilation Inhomogeneity and Lung Function in Patients Under SB Across LMA

General anesthesia has been demonstrated to have a negative impact on lung function. Both surgery and patient position influence the perioperative lung function. Laryngeal mask airway (LMA) has been proved to be safe and efficient to maintain the airways patent during general anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in clinical practice. The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients in the lithotomy position and spontaneously breathing through LMA with and without PSV.

This study is a randomized controlled trial. Participants for this study will be recruited from the Gynecological department of the University Hospitals of Geneva, scheduled for gynecological procedures in the lithotomy position under general anesthesia. A total of 40 patients will be enrolled and randomly assigned into 2 groups: Group SB (spontaneously breathing without PSV) and Group PSV (spontaneously breathing with PSV). Measurements of end-expiratory lung volume (EELV) and ventilation inhomogeneity will be performed in all patients with a nitrogen multiple breath washout method, before and 1 hour after surgery. Similarly, airway resistance (Rrs) and reactance (Xrs) will be measured at the same time by using the Forced Oscillation Technique.

The primary endpoint: Perioperative changes in ventilation inhomogeneity (LCI) and respiratory mechanics (Rrs and Xrs) of patients, positioned in lithotomy and undergoing general anesthesia while breathing spontaneously through LMA with or without PSV.

The secondary endpoints: Presence of respiratory complications, oxygen need in the recovery room, length of stay in the recovery room and in the hospital. Correlation between duration of positioning and surgery with lung function and volume measurements.

Relevance: There are no studies that addressed the value of pressure support ventilation to overcome the potential changes in lung function following spontaneous ventilation across a LMA in the lithotomy position.

Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologists physical status (ASA) Ⅰ and Ⅱ grade, adult female patients, aged between 18 and 50 years scheduled for elective gynecological surgery in the lithotomy position.

Exclusion Criteria:

1. Age\<18 years and \>50 years old
2. ASA score of III-V
3. Patients with a potentially difficult airway (cervical spine disease, Mallampati classification III or IV or mouth opening of \<2.5 cm)
4. Risk of regurgitation/aspiration(previous upper gastrointestinal tract surgery, known or symptomatic hiatus hernia, oesophageal reflux, peptic ulceration or not fasted)
5. Respiratory diseases(bronchial asthma requiring therapy)
6. Patient refusal
7. Malignant hyperthermia history
8. Sore throat within 10 days
9. Body mass index (BMI) \>30 kg/m2
10. Cardiac disease associated with dyspnea more than New York Heart Association II
11. Severe psychiatric disorder.