cyrilzakka/clinical-trials huggingface dataset:
The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; previously provisionally named 2019 novel coronavirus or 2019-nCoV) disease (COVID-19) emerged at December 2019 in Wuhan, Hubei Province, China. This infectious disease soon caused a large global outbreak and became a major public health issue. As of 19:00, 12 March 2020, the total number of confirmed cases of SARS-CoV-2 in China has reached 80982 with 3173 death, and 110 other countries have officially reported 45164 cases of SARS-CoV-2 infection with 1520 death.

In this particular time, only patients with SARS-CoV-2 or other diseases with an emergency condition were receipted by most of the hospitals in Hubei Province, even in many other regions of China. The delayed treatment for many chronic diseases, such as malignant tumors, is an increasing serious problem. One major concern was that patients with malignant tumors were generally older in age with low immunity. Preliminary study has shown that cancer patients are most susceptible to infect SARS-CoV-2 and more likely to develop a severe pneumonia. But many other researches suspected that conclusion. Moreover, many of the patients with malignant tumors are facing short term death from tumors rather than the risk of infection. Nevertheless, there is not sufficient evidence to insure the safety of chemotherapy in high-risk region of COVID-19, and there is also not sufficient information to judge which patients' tumor therapy can be appropriately delayed. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 to 80 years old female.
* Patient must have histologically confirmed either type of gynecological malignancies.
* Chemotherapy must be essential for the patient.

Exclusion Criteria:

* Diagnosed or suspected patients with covid-19 pneumonia, according to the symptom, nucleic acid tests, antibody tests for SARS-CoV-2, or CT scan of the lungs.
* Patient has a prior SARS-CoV-2 infection without clinical cure for 28 days.
* Patient has close contact with diagnosed or suspected SARS-CoV-2 infected person within 14 days.
* Patient has inadequate general condition, severe complication or organ dysfunction not fit for chemotherapy (based on the judgment of researchers).
* Patient or the family refuses to sign the informed consent.
* Patient does not cooperate in following up.
Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform real time electrochemical detection during deep brain stimulation surgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation?

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are undergoing DBS neurosurgery. This will be an acute study. Patients with medically identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for implantation of DBS will be selected for this study. These patients will then be consented preoperatively to undergo extracellular electrophysiology which is typical in these cases to determine the target site for implantation of the DBS electrodes. Following this electrophysiologic procedure, the patient will have electrochemical electrode implanted to (1) determine whether there is adenosine release at the site of stimulation during ventral intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and (3) determine whether there is dopamine and adenosine release at the site of stimulation during Globus Pallidus DBS.

Eligibility Criteria:
Inclusion Criteria:

* adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

Exclusion Criteria:

* pregnant patients,
* prisoners,
* children (age less than 18), and
* any patients identified as unsuitable for these protocol by the Mayo DBS committee.
Observational Study of the Structural-functional Connectome in Patients With Epilepsy

Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of focal or generalized epilepsy confirmed by specialist evaluation;
* at least one MRI scan of the brain that includes T1w
* at least one recording with resting state EEG
* age between 6 and 65 years at the time of the evaluation of the present study;
* ability to take part in a neuropsychological assessment.

Exclusion Criteria:

* vascular causes or non-low grade tumors as causes of epilepsy
* age different from the range 6-65 years
* neuroradiologic examination not complete
* absence of resting state recording
* inability to take part in a neuropsychological evaluation.
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.

The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>49years with a clinical diagnosis of AD
* Mini Mental Status Examination (MMSE) score 10-29/30
* on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
* able to speak English
* patient or designate able to sign informed consent
* stable chronic medical conditions (Heart disease, thyroid disease)
* reliable caregiver

Exclusion Criteria:

* age \<50 years
* medically unstable
* unable to swallow liquids
* diagnosis of diabetes mellitus
* residence in a nursing/long term care home
* allergy to coconut
* allergy to olive oil
Detection of Ultrasound Contrast Signals in the Cerebral Circulation

To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography.

The purpose of this study is to determine whether the intravenous microbubbles used to improve border delineation during dobutamine stress echocardiographies (DSE) can be detected within the cerebral circulation.

Eligibility Criteria:
Inclusion Criteria:

* male or female age \>19 years of age
* scheduled for a stress echocardiogram
* negative urine pregnancy test within two hours of ultrasound contrast administration required for females of childbearing age unless post-menopausal or with evidence of surgical sterilization
* be conscious and coherent, and able to communicate effectively with trial personnel

Exclusion Criteria:

* pregnant or lactation
* life expectancy of less than 2 months or terminally ill
* Known or suspected hypersensitivity to ultrasound contrast agent used for the study
* complicated hemodynamic instability
* Known left main disease
In-Home Adjustment of New Spinal Cord Injury Caregivers

To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for informal caregivers of individuals with SCI during the transition from hospital to home. The TAP was previously developed for stroke caregivers and has been found to decrease caregiver strain and depression. In the proposed study, the TAP will be modified for SCI and implemented at a state-of-the-art SCI rehabilitation facility with a very high volume of SCI treatment and with telehealth technology already in place through which to test the intervention.

SCI Caregivers will be randomly assigned to either the TAP group or to a control receiving the standard care provided by the rehabilitation facility. The TAP begins before discharge and extends across six weeks. It includes three components to improve caregiver mental health and informal care: (1) skill development, (2) education, and (3) supportive problem solving. TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician. Data will be collected from caregivers and individuals with SCI at baseline immediately before discharge and at 2 and 4 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

SCI Patient Inclusion Criteria:

* have a telephone in the home or cellular phone and are able to talk on the phone in English
* are able to provide informed consent
* demonstrate a clinician-rated loss in motor/sensory function on the ASIA scale (i.e., have a spinal cord injury)

Caregiver Inclusion Criteria:

* have a telephone in the home or cellular phone and are able to talk on the phone in English
* are able to provide informed consent
* are a primary caregiver of the individual with SCI
* Caregivers with scores below 10 on the literacy screen will identify a family member or friend to review the guidebook with the caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver and function in that additional capacity

Exclusion Criteria:

* individual with SCI receives his/her primary care from a professional caregiver or other individual outside of the household besides the primary caregiver
* individuals with SCI or caregivers with known current uncontrolled substance dependence, aphasia, anosognosia (deficit in self-awareness), or treatment due to known self-inflicted injury
* individuals living alone
* prisoners
* SCI patient without decision making capacity to consent
Prevalence of Glucose Intolerance and Risk Factors in Ethiopian Immigrants in Israel; Follow-up Study.

High risk population: Screening for impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the year 2000 study
* Signature of Informed Consent Form

Exclusion Criteria:

Pregnancy

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MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial

In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform.

This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Blood culture positive, of ANY of the following bottle types:
* BD Bactec Standard Aerobic and Anaerobic,
* BD Bactec Plus Aerobic and Anaerobic,
* bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
* bioMerieux BacT/Alert FAN Aerobic and Anaerobic.

Exclusion Criteria:

* BD Bactec Lytic, Pediatric, or other bottle types not listed above.
* bioMerieux Pediatric FAN or other bottle types listed above.
* Trek bottles.
* Specimens from patients under 18 years of age.
Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease

The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping (PC), the current gold standard of flow volume measurements.

Many conditions of the heart or the lungs lead to differences in how the blood is pumped to the lungs. Specifically, some areas of the lung may receive less blood supply than others. We would like to do a research study in children and adolescents who have a heart condition or a chronic or stable lung condition. We are doing this study to see if measuring the circulation of blood in the lungs in children is possible using magnetic resonance imaging (MRI) with a special dye (contrast medium) injection called Magnevist®.

Eligibility Criteria:
Inclusion Criteria:

Cardiac Patients:

1. Patients \> 6 years of age
2. Patients with suspected or confirmed congenital or acquired heart disease
3. Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
4. And receive gadolinium (= MRI contrast medium) as part of their clinical investigation

Pulmonary Patients:

1. Patients \> 6 years of age
2. Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.

Exclusion Criteria:

1. Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
2. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
3. Patients with a known allergy to gadolinium.
4. Patients with a history of allergic disposition or have anaphylactic reactions
5. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min)
6. Have Sickle Cell anemia
7. Known pregnancy, or breast feeding
8. Patient is uncooperative during a MRI without sedation or anesthesia
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)

To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.

To investigate the dose response of DE-127.


Eligibility Criteria:
Inclusion Criteria:

* Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
* Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
* Distance vision correctable to logMAR 0.2 or better in both eyes
* Normal intraocular pressure of not greater than 21 mmHg in both eyes
* No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria:

* Amblyopia or manifest strabismus including intermittent tropia
* Ocular disorders that potentially affect myopia or refractive power
* Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
* Systemic disorders that potentially affect myopia or refractive power
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity


Eligibility Criteria:
Inclusion Criteria:

* Abnormal pulmonary function test results;
* focal, upper limb spasticity, upper motor neuron syndrome

Exclusion Criteria:

* Previous exposure to botulinum toxin of any serotype
Computerized Intervention for Loneliness

This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.

This study hopes to assess whether a month long interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Participants will be randomized into an active treatment condition or a control treatment that involves a healthy living and relaxation protocol. The investigators hypothesize that participants in the IBM condition will have lower levels of negative interpretation bias and loneliness than those in the healthy habits condition at post treatment and follow up. The investigators further hypothesize that the effects of IBM on loneliness will be accounted for by changes in interpretation bias.

Eligibility Criteria:
Inclusion Criteria:

* Score of \>48 on the UCLA Loneliness Scale

Exclusion Criteria:

* Concurrent psychotherapy for social anxiety or depression
* Unstable psychotropic medication status (i.e. a change within the last month)
* History of psychotic or (hypo)manic symptoms
* Alcohol or other substance abuse or dependence within the last three months
* Previous participation in a similar IBM study
Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting

The goal of the study was to test whether a sonographic examination instead of an X-ray allows the position of a tube in the stomach to be checked.

Participants were patients admitted at an intensive care unit who required a nasogastric tube for several reasons (for example nutrition). After obtaining an informed consent from the patient or the family, the researchers checked the position of the tube with ultrasound and compared it with the gold standard, which is radiography. Data analysis allowed the concordance between the two tests to be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* an already inserted nasogastric tube or required nasogastric tube insertion
* no contraindication for chest or abdominal X-ray
* no contraindication for neck and upper abdominal ultrasonography

Exclusion Criteria:

* pregnancy
* basal skull fractures
* facial fractures
* previous or recent surgery of the neck, esophagus or stomach
"Bliib Fit - Mach Mit!" in Residential Care Facilities

The goal of this clinical trial is to learn, if the video-based exercise program "Bliib fit - mach mit!" can be used to improve physical fitness in older adults living in residential care facilities. The main questions it aims to answer are:

Does the video-based exercise program improve participants' physical fitness? Does the video-based exercise program improve participants' quality of life, perceived fall risk, self-efficacy and daily physical activity levels?

Researchers will compare this exercise program to an optimized standard care activation program (caregiver-led) to see if the video-based program can affect physical fitness in older adults living in residential care facilities.

Participants will participate in the exercise or activation program for 12 weeks, four times a week, with each session lasting 20 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Low to moderate risk of falling
* Physically and cognitively able to independently carry out exercise instructions (based on referral of clinical staff on site)
* Mini Mental State Examination (MMSE) test score ≥ 20

Exclusion Criteria:

* Inability to speak or understand German
* High risk of falling
* Unstable cardiovascular condition or other health condition, which does not support a safe participation in exercise program (based on referral of clinical staff on site, patient file)
* Scheduled transfer to another institution within the next 3 months
Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients

This study is conducted to determine if using a mouthwash containing propolis, clove oil and chlorhexidine will improve the caries risk of high risk patients in comparison to using a mouthwash containing chlorhexidine only.

A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 years of age.
* Patients should be with high caries risk assessment.

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease.
* Patients with a diseased salivary gland
* History of allergies or other adverse reactions to chlorhexidine, propolis, bee stings, or clove
* Patients on any antibiotics during the past month