cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
* Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive)
* Subjects with severe renal impairment (or End-Stage Renal Disease who are not on dialysis) and with an eGFR \<30 mL/min, estimated using the Cockcroft-Gault equation at screening and Day -1
* Subjects with normal renal function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
* Subjects with normal renal function are matched by gender, age (±10 years) and BMI (± 20%) to at least one renally impaired subject.

Exclusion Criteria:

* Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
* Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
* Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
* Subjects with a history of or any concomitant active malignancy.
* Subjects with a history of drug or alcohol abuse.
* Subjects with, or with a history of, any clinically significant neurological, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
* Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
* Renally impaired subjects with kidney transplantation, or on dialysis
Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation

This study is a retrospective research in order to compare and analysis the risk factor, clinical manifestation and efficacy of albicans candidemia by pulling medical records. We hope that this retrospective research will let us understand the method of treatment and prevention of albicans candidemia in order to improve the quality of healthcare.


Eligibility Criteria:
Inclusion Criteria:

* above 20 years old
* hospital patients
* albicans candidemia patients

Exclusion Criteria:

* pregnant patients or patients under 16 years old
* liver cirrhosis and Child C
Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilling criteria for SCID-1-verified bipolar I or II disorder
* Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
* Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).

Exclusion Criteria:

* Being or having been in a defined affective episode the last month before inclusion
* Hospitalization in the last two months before inclusion
* Working night shifts
* Sleep apnea
* Medical conditions incompatible with participation.
* Inability to cooperate in the 3-week initial phase before randomization.
The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients

Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. The study is aimed to evaluate an intervention to improve patients with Stroke.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or older
* able to give informed consent

Exclusion Criteria:

* recurrent stroke
* a diagnosis of subarachnoid haemorrhage
* significant impairments precluding participation - inability to give informed consent
* another condition likely to impact their participation in the trial (e.g. life-threatening condition other than cardiovascular disease)
* expected discharge to hospital/nursing home setting
Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Nucleoside reverse transcriptase inhibitors (NRTIs) are a class of anti-HIV (Human Immunodeficiency Virus) drug that can be an important part of an HIV treatment regimen. Because anti-HIV therapy may have negative side effects, there is a great need to carefully study HIV infected patients on such regimens. One negative side effect observed in many HIV infected patients is lipoatrophy, a condition that results in fat loss in the body. It is unclear if NRTIs also have a role in the development of mitochondrial toxicity, a condition that affects the body's ability to produce energy. The purpose of this study is to observe the effects of an NRTI-based, protease inhibitor (PI)-sparing drug regimen on fat loss in HIV infected, treatment-naive adults.

Study hypothesis: The initiation of NRTI-containing, PI-sparing therapy will inhibit mitochondrial DNA (mtDNA) synthesis and lead to a decrease in mtDNA content in adipose tissue, skeletal muscle and peripheral blood mononuclear cells (PBMCs), will cause deterioration in mitochondrial function, will increase fat apoptosis and oxidative damage biomarkers, and will lead to progressive decrease in body fat content.

NRTIs are a mainstay of HIV treatment regimens, often part of initial treatment regimens for newly diagnosed patients. Recent data suggest that NRTIs are responsible for lipoatrophy, a condition marked by progressive fat loss. Another negative side effect to antiretroviral (ARV) regimens is mitochondrial toxicity, which can damage the heart, nerves, muscles, kidneys, pancreas and liver, as well as affecting the body's ability to produce energy for important life processes. It has been hypothesized that lipoatrophy may be related to mitochondrial toxicity, but a causal relationship between the two has yet to be established. This study will examine HIV infected treatment-naive patients who are initiating their first ARV regimens. The regimens will contain 2 NRTI, one of which being zidovudine and a non-nucleoside reverse transcriptase inhibitor (NNRTI). The regimens will not contain any PIs.

Patients will participate in this study for 96 weeks. There will be 4 study visits at Weeks 12, 24, 48, and 96. Dual-energy x-ray absorptiometry (DEXA) scans and fat biopsies will occur at all visits. Additionally, blood collection for metabolic testing will occur at Week 12. ARVs will not be provided by this study.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Treatment-naive
* Plan to initiate first ARV regimen with 2 NRTIs and an NNRTI
* Plan to include zidovudine as part of first ARV regimen

Exclusion Criteria:

* Current use of steroids or growth hormone
* Coagulopathies or other bleeding disorders
* Pregnancy or breastfeeding
Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease

The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.

Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.

Eligibility Criteria:
Inclusion criteria

1. PD patients ages up to age 85.
2. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported

Exclusion criteria

1. Evidence for dementia that would preclude the patient from signing informed consent
2. History of bleeding diathesis or hematologic disorders
3. Medically unable to undergo a core needle biopsy of the submandibular gland
4. Prior treatment of the submandibular gland with botulinum toxin injections.
5. History of past or current acute infection or abscess of the submandibular gland.
6. History of past or current neoplastic process within the submandibular gland.
7. History of peripheral neuropathy.
Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria

The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to their demographics, including evaluation of their malaria immune status, treatment effectiveness, prior and concomitant medication use, and the occurrence of adverse events in association with artemether-lumefantrine treatment, based on the information collected in the CDC Malaria Case Surveillance Report Form.


Eligibility Criteria:
Inclusion Criteria:

* Any male or female infant, child or adult patient diagnosed with malaria who received artemether-lumefantrine and was reported to the CDC. Malaria may be clinically suspected or confirmed (microscopically, and/or by polymerase chain reaction \[PCR\], and/or rapid diagnostic test \[RDT\]).

Exclusion Criteria:

* NA
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis

People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.

In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.


Eligibility Criteria:
Eligibility Criteria for Participants with axSpA

Inclusion criteria. Participants will fulfil ALL of the following:

* Diagnosis of axSpA (fulfilling the ASAS criteria)
* Active disease (BASDAI score ≥4) on day of study visit
* Stable on treatment \[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\]
* Age ≥ 16 years
* Willing and able to give informed written consent.

Exclusion. Participants will have NONE of the following:

* Pregnancy or breastfeeding
* Prior diagnosis of IBD
* Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
* Recent systemic antibiotic use (within last 1 month)
* Current eating disorder
* Food allergy incompatible with diet (e.g. cow's milk allergy)
* Following a vegan diet
* Major surgery in prior 3 months or planned in forthcoming 3 months.
* Unable or unwilling to give informed consent
* Unable or unwilling to try the PEN diet.

Eligibility Criteria for Healthy Volunteer Participants

Inclusion criteria. Participants will fulfil ALL of the following:

* Age ≥ 16 years
* Current student and/or staff member at the University of Glasgow
* Willing and able to give informed written consent

Exclusion. Participants will have NONE of the following:

* Pregnancy or breastfeeding
* Prior diagnosis of an immune-mediated inflammatory condition
* Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
* Recent systemic antibiotic use (within last 1 month)
* Current eating disorder
* Food allergy incompatible with diet (e.g. cow's milk allergy)
* Following a vegan diet
* Major surgery in prior 3 months or planned in forthcoming 3 months.
* Unable or unwilling to give informed consent
* Unable or unwilling to try the PEN diet.
McKenzie Exercises for Chronic Neck Pain: Stabilization vs. Non-Stabilization

PURPOSE: To compare the effects of mckenzie exercises plus stabilization exercise to those of mckenzie exercises alone on disability, pain, range of motion (ROM) in patients with nonspecific chronic neck pain (NSCNP).

BACKGROUND: Little is known about the efficacy of providing mckenzie exercises in addition to cervical and scapulothoracic stabilization exercises in people with NSCNP.

HYPOTHESES We hypothesize that there will be no significant effect of adding stabilization exercises to mckenzie exercises than mckenzie exercises alone in patients with NSCNP.

RESEARCH QUESTION: Is there a statistically significant effect of adding stabilization exercises to mckenzie exercises on outcomes of patients with NSCNP?


Eligibility Criteria:
Inclusion Criteria:

1. Ages between 30 and 50 years
2. Localized chronic neck pain without an exact etiology
3. Absence of any arm pain or discomfort that could be replicated by neck mobility or irritant assessment
4. Pain exists in the dorsal area, between two horizontal lines: the first line passes through 5) the lower half of the occipital area, and the second line runs through the spinous process of the first dorsal vertebra

Exclusion Criteria:

1. Neck pain caused by any other complications, such as a neoplasm, neurological diseases, or vascular diseases
2. History of neck surgery or fracture
3. Serious medical conditions that could affect participation in the study, such as cardiovascular disease, cancer, or autoimmune disorders
4. Use of medication that could affect neck pain or exercise tolerance, such as opioids, muscle relaxants, or corticosteroids
5. Participation in other treatments or interventions for neck pain during the study period
6. Inability to understand or comply with study procedures or interventions, such as language barriers or cognitive impairment
Effects of Frequent Decision Making Among Patients With Serious Illnesses

Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The result is decision fatigue, in which subsequent decisions are altered toward the status quo. Patients are at risk for decision fatigue yet it has not been studied. The Investigator proposes a randomized study in the outpatient setting in patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on participant self-control and subsequent choices.

Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made. This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue. (1) People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo. By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities. Patients and their surrogates often make complex medical decisions for which they may have little experience. Although clearly at high risk, decision fatigue has not been studied this population. To elucidate these questions, we propose a four arm study of patients in a population at high risk for making complex decisions. Participants will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.

Eligibility Criteria:
Inclusion Criteria:

* aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma
* All participants must be over the age 18
* All participants must be fluent in English

Exclusion Criteria:

* Any medical condition known to alter Stroop performance; i.e. significant visual impairment, blind or colorblind, sedating medications during appointment, history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness
* Patients will also be ineligible if they are illiterate
* Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the hypothetical medical scenarios/decisions
Yoga for Caregivers and Persons With Dementia

The purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (PLWD) and their care partners. A secondary aim of this study is to examine the impact of yoga on caregiver burden.

Participants will be recruited from the D-Care Study in dyads. Both the caregiver and person with dementia must agree to participate. Screening will be done either in clinics or by telephone in the participants' homes. The intervention will be conducted in community facilities and participants' homes. The sample size will consist of 10 caregiver/person with dementia dyads. This number was chosen to provide evidence of feasibility of conducting yoga classes with dyads.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers: Providing unpaid care to a family member of friend diagnosed Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
* Persons with dementia: A diagnosis of dementia; live in the community (assisted living facility is allowed); cognitively able to participate in yoga as determined by study staff

Exclusion Criteria:

* Non-English-speaking; and practicing yoga or meditation within the last 30 days.
Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.

Study population:

30 patients will be included who meet all the following criteria: ALT \> 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.

All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.

Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic \> 7% during study will be withdrawn.

Intervention:

All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.

Outcome:

* Improvement of liver enzymes (ALT, AST, GGT)
* Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
* Liver histology (repeated liver biopsy after 1 year).
* Soluble TNF receptors- TNF-receptor P55 and P75.

Eligibility Criteria:
Inclusion Criteria:

* ALT \> 2 times normal range.
* Liver histology revealing non-alcoholic steatohepatitis \[NASH\] (type 2-4), without cirrhosis.
* Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
* Negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.

Exclusion Criteria:

* Diabetes mellitus.
* Alcohol intake \> 40 g per week.
The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)

The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 75 years
* Able to read and write English at an elementary level
* Diagnosis of metastatic tumor of the spine

Exclusion Criteria:

* The primary cancer site is central nervous system or spine
* History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
* Is a prisoner
* A disease or condition that would, in opinion of the investigator, preclude accurate evaluation (e.g. significant psychiatric disease)
N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU
* Presenting hypothesion (MAP \< 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion

Exclusion Criteria:

* Age lower than 18 years old
* Chronic renal failure
* A known history of allergy to any of the study drugs
* Using n-acetylcysteine to paracetamol overdose
* Pregnant women
* Patients who used iodinated contrast medium
* Hemoglobin less than 6.5 mg/dl
* Cancer patients