cyrilzakka/clinical-trials huggingface dataset:
High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT.

Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA

Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.


Eligibility Criteria:
Inclusion Criteria:

* Must exhibit symptomatic knee OA (WOMAC \> 31), radiographic evidence of tibiofemoral OA (2-4 Kellgren-Lawrence scale)
* Age 40-70 years
* Body mass index 20-35 kg/m²
* Cleared by study physician from 12 lead EKG and medical history review

Exclusion Criteria:

* Individuals diagnosed with a cardiovascular condition restricting exercise Individuals currently meeting Department of Health and Human Services Guidelines for Physical Activity (meeting \>150 minutes of exercise per week)
* Individuals currently doing HIIT
* Individuals currently participating in physical therapy for knee OA
* Individuals currently participating in another OA intervention study
* Received a corticosteroid or hyaluronic acid injection involved in the knee in the previous 3 weeks or scheduled for during the intervention
* Diagnosis of gout in the knee
* Diagnosis of Rheumatoid arthritis
* Diagnosis of Fibromyalgia
* Other systemic rheumatic disease
* Severe dementia or other memory loss
* Active diagnosis of psychosis or uncontrolled substance abuse disorder
* Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 6 months
* Diabetics (medications include exogenous insulin)
* Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear in the past 12 months
* On a waiting list for total joint replacement
* Severely impaired hearing or speech
* Pregnant or planning to become pregnant in the next 8 weeks
* Inability to speak English
* Serious or terminal illness as indicated by referral to hospice or palliative care
* Nursing home residence
* Inability to ride a stationary bike
* Any other health problems that would prohibit safe participation in the study.
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).

Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.

This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
* Patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
* Measurable disease defined by RECIST v.1.0
* ECOG performance status of 2 or better
* Adequate organ and bone marrow function defined as

Exclusion Criteria:

* Other tumor type than urothelial carcinoma
* Presence or history of CNS metastasis
* Prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
* Presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
* Peripheral sensory neuropathy grade 2 or worse
* Other serious illness or medical conditions
Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Investigators will collect serum and urine specimens from pregnant patients along the full pregnancy continuum, assay each specimen for selected placental proteins, and examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

Investigators will collect serum and urine specimens from pregnant patients along with ultrasound results and information about factors that may affect the concentrations of proteins or the estimation of gestational age. Investigators will obtain data across the full pregnancy continuum but we will over sample patients within five gestational weeks before and after the 10 week mark.

Investigators will assay each specimen for selected placental proteins (Human placental lactogen (HPL), Schwangerschaftsprotein 1 (SP1), Pregnancy-associated plasma protein A (PAPP-A), A Disintegrin and Metalloproteinase 12 (ADAM12), and Human chorionic gonadotropin (HGC)) and any other proteins of interest identified prior to running assays and will examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

The goal is to identify at least one compound and a concentration threshold for that compound that can be used for differentiating pregnancies of less than 10 weeks in duration from later pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Has an intrauterine pregnancy confirmed by ultrasound
* Not known to have pregnancy-induced hypertension (preeclampsia) or diabetes
* Not known to have a nonviable pregnancy, a multiple pregnancy, a pregnancy with a chromosomal or fetal abnormality, or a pregnancy with growth restriction
* Not currently taking anticoagulants
* Not currently having clinically significant vaginal bleeding, unusual pelvic pain, or other symptom suggestive of a pregnancy complication
* No use of assisted reproductive technology to conceive the current pregnancy
* Not previously enrolled in this study

Exclusion Criteria:

* Does not meet inclusion criteria
Patients Reactions Towards Their Diagnosis as Having COVID-19

Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management.

Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management.

Different factors affecting the response of people toward their diagnosis as COVID-19

Eligibility Criteria:
Inclusion Criteria:

* COVID-19
* Age 18 years of less

Exclusion Criteria:

* Mental diseases making the communication with them difficult
An Open Platform of Serious Games for Cognitive Intervention

Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.

VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.

Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.

The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.


Eligibility Criteria:
Inclusion Criteria:

* Older adults aged 65 years and older.
* Cognitive impairment within a specific range as measured by the Mini-Mental State -Examination (MMSE scores between 7 and 25).
* Ability to interact with the Serious Cognitive Games (SCGs) platform, indicating a necessary level of awareness.
* Functional vision and hearing, with or without aids (glasses/hearing aids), to engage with the SCGs platform.
* Functional upper extremity function to interact with the SCGs.

Exclusion Criteria:

* Presence of influenza, COVID-19, or another virus that could affect performance or pose a risk to others.
* Inability to communicate or comprehend instructions in English
* Moderate to severe limitations in upper extremity control or movement, significant visual or hearing impairments, or attention deficits that could impact the ability to successfully engage with the SCGs. Participants or their care partners who feel these conditions would interfere with study participation are excluded.
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.


Eligibility Criteria:
Key Inclusion:

1. Clinical diagnosis of LGS, which might include the presence of a slow background electroencephalogram (EEG) rhythm, slow spikes-waves pattern (less than 3 Hz), the presence of polyspikes; care should be taken not to include benign myoclonic epilepsy of infancy, atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS).
2. On a fixed and documented dose of one to three concomitant regionally approved antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to randomization with an inadequate response to treatment.
3. Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) during the pre-randomization phase.

Key Exclusion:

1. Familial short QT syndrome
2. Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide
A Study to Implement and Evaluate REFLECT Communication Curriculum for Oncology Based Medical Graduate Students

The purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. The information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.


Eligibility Criteria:
Inclusion Criteria:

* Subjects: Resident or Fellow enrolled in an oncology related training program (Radiation Oncology, Medical Oncology, Palliative Medicine and Hospice Care, Neurooncology).
* Location: Mayo Clinic Arizona.
* Interest: Willingness to participate.

Exclusion Criteria:

* Schedule does not permit to participation.
* Not enrolled in an oncology-based residency or fellowship at Mayo Clinic Arizona.
* Interest: Not willing to participate.
Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

The purpose of this study is to see whether patients controlling their own sedation during colonoscopy are less likely to need help breathing than when an anesthesiologist controls the medicine, and whether we can predict when the need for help will occur. The pump used in the study is approved for clinical use by the FDA, as are the medicines used in the pump.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective, outpatient colonoscopy
2. Age ≥ 18, \<90
3. Meet criteria for conscious sedation (HUP Policy 1-12-11, Appendix F), as determined by the attending gastroenterologist and confirmed by the anesthesiologist by review of history
4. Able to give informed consent

Exclusion Criteria:

1. Have a history of allergy or adverse reaction to propofol or remifentanil
2. Have a condition which would pose an elevated risk for administration of propofol, including primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
3. Female of child-bearing potential (under 50 without surgical sterilization)
4. Unable to understand the use of Patient Contolled Sedation
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

-To compare the single dose bioavailability of Kali and BTG

-To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
* Each subject shall be given a general physical examination within 28days of the initiation study.
* At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
* Each female subject will be given a serum test as part of the pregnancy study screening process.
* Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen

Exclusion Criteria:

* Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
* Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
* Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
* Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
* Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are not able to bear children will not be allowed to participate.
* Female subjects with positive or inconclusive results will be withdrawn from the study.
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent

Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.


Eligibility Criteria:
Inclusion Criteria:

Term newborns with blood cultures taken from them the first 48 hrs

Exclusion Criteria:

* Preterm newborns
* Septic/ill appearing newborns
* Newborns requiring admission to NICU
Gabapentin Alone and in Combination With Carvedilol for the Treatment of Rosacea-Associated Flushing and Erythema:a Randomized Controlled Clinical Trial

The goal of this clinical trial is to learn if Gabapentin works to treat flushing/erythema associated with rosacea. It will also learn about the safety of drug Gabapentin. The main questions it aims to answer are:

* Does drug Gabapentin reduce flushing and erythema associated with rosacea?
* What medical problems do participants have when taking drug Gabapentin? Researchers will compare Gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug Gabapentin works to reduce flushing and erythema associated with rosacea


Eligibility Criteria:
Inclusion Criteria:

* Initial treatment in our hospital; ② Diagnosed by two experienced dermatologists and in accordance with the updated diagnostic criteria of the National Rosacea Society (NRS) Expert Committee \[38\], unconscious disorder and no communication disorder; ③ did not receive any other form of treatment within 4 weeks; ④ Patients who were followed up for 8 weeks or more and had complete clinical data; ⑤ Informed consent was signed before treatment, and the clinical data were agreed to be used for scientific research

Exclusion Criteria:

① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ Patients with contraindication to minocycline, hydroxychloroquine, gabapentin and carvedilol; ④ Unable to complete follow-up and serum specimen collection; ○5 patients were intolerant to minocycline, hydroxychloroquine and carvedilol; ○6 Lactation, pregnancy, liver and kidney dysfunction, psychiatric diseases, cardiovascular and cerebrovascular diseases, systemic lupus erythematosus and other systemic diseases.
The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors

The purpose of this study is to investigate the effects of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) on immune function and cardiovascular disease risk

In a controlled, double-blinded human intervention study the effects of fish oil versus control (olive oil) and of a high versus low consumption of n-6 polyunsaturated fatty acids are investigated. Sixty-seventy healthy men will be randomized to oil capsules and to substitute their dietary fats with one of two types of oil and butter-product that we provide. Outcome variables are ex vivo cytokine production in full blood and isolated immune cells after 24 h of stimulation with bacteria or bacterial components, blood pressure and arterial function, plasma concentrations of cholesterol, triacylglycerol, C-reactive protein and a number of other markers of endothelial function and cardiovascular risk.

The hypotheses are that both increased intake of n-3 polyunsaturated fatty acids (from fish oil) and a low consumption of n-6 polyunsaturated fatty acids increase incorporation of docosahexanoic acid in immune cell membranes and that this decreases the inflammatory response and potential and improve overall cardiovascular disease risk.

The mechanistic aspects of this will be further explored by in vitro studies with monocytes cultured in the presence of varying amounts of polyunsaturated fatty acids.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no chronic diseases and no regular medications)
* BMI \>18.5 and \<27.5 kg/m2
* Daily use of fats and home cooking \>5 d/wk
* Heavy exercise \<7 h/wk
* Not daily smokers (\<5 cigarets/wk)

Exclusion Criteria:
The Rilpivirine Cerebrospinal-fluid (CSF) Study

This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:

* CSF exposure and CSF : plasma ratio of rilpivirine
* Safety and tolerability of switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine
* Changes in cerebral metabolites measured via 1-H MRS after switching antiretroviral therapy to TDF/FTC/rilpivirine
* Seminal fluid exposure of rilpivirine

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected males subjects
* signed informed consent
* willing to switch therapy as per study protocol
* no previous exposure to rilpivirine
* plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
* currently receiving a stable antiretroviral regimen comprising of TDF/FTC with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months
* no clinically-significant resistance documented on any prior HIV-1 genotypic resistance testing
* subjects in good health upon medical history, physical exam, and laboratory testing
* BMI above or equal to 18 and below 32
* Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study.
* Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance
* No contraindications to having a lumbar puncture examination found on MRI of the brain

Exclusion Criteria:

* current alcohol abuse or drug dependence
* positive urine drug of abuse screening
* active opportunistic infection or significant co-morbidities
* current disallowed concomitant medication (as listed in section 4.1.3)
* contraindication to MR examination or lumbar puncture examination
* recent head injury (in last 30 days) or chronic ongoing neurological diseases