cyrilzakka/clinical-trials huggingface dataset:
ACP-204 in Adults With Alzheimer's Disease Psychosis

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP

* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.

All 3 substudies will be analyzed independently of each other.

Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).


Eligibility Criteria:
Inclusion Criteria:

* Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
* Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
* Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
* Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
* Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
* MMSE score ≥6 and ≤24
* Psychotic symptoms for at least 2 months
* Lives in a stable place of residence and there are no plans to change living arrangements
* Has a designated study partner/caregiver
* Able to complete all study visits with a study partner/caregiver
* Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable

Exclusion Criteria:

* Requires treatment with a medication prohibited by the protocol
* Is in hospice and receiving end-of-life palliative care, or has become bedridden
* Requires skilled nursing care
* Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
* Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
* Atrial fibrillation
* Symptomatic orthostatic hypotension
* Protocol-defined exclusionary clinical laboratory findings
* Treatment with anti-tau therapy or donanemab within 2 months prior to Screening

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer

This is a two arm RCT evaluating the effect of intravenous vitamin C versus placebo in patients with incurable non-small cell lung cancer. Participants in both arms will be receiving platinum doublet chemotherapy with or without concurrent immunotherapy as standard care. We plan to enroll 90 patients over 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer
2. Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy

Exclusion Criteria:

1. ECOG status greater than 2
2. Previously received IVC within 6 months prior to randomization
3. Biochemical deficiency in G6PD
4. Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
5. Currently taking insulin or warfarin
6. History of severe renal dysfunction or hemochromatosis
7. Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
8. If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency
9. Currently taking an investigational product or participation in an investigational study within the past 30 days
10. Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Prevalence of Perimyocarditis After Covid-19 Vaccine

The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

Exclusion Criteria:

* Patients infected with Covid19
Cognitive Engagement and Aging Mind

The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age. The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about neural plasticity and cognitive plasticity from these engagement techniques. Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training. In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.

The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age (such as, speed of information processing, working memory capacity, episodic memory, and executive functions). The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about the extent of transfer, if any, and the underlying cognitive constructs that may be trained in the process. Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training. In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* over 50 Years of Age
* native or fluent English speaker
* not Color-blind
* Magnetic Resonance Imaging eligible
* Mini Mental Status Examination Score \>24

Exclusion Criteria:

* Left-handed or ambidextrous
* younger than 50
* cannot distinguish colors during color blindness test
* claustrophobia
* metal artifact in body
* over 300 lb
* pacemaker
* MMSE score lower than 24
* history of stroke
* history of substance or alcohol abuse
* currently taking anti-psychotic or anti-depression medication
PK Analysis of Moxifloxacin in the Treatment of CAP

At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the empirical treatment of severe community-acquired pneumonia (CAP). This study was designed to determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically for CAP. To accomplish this aim, we established a pharmacokinetic population model. This approach was adopted with the dual purpose of assessing the potential efficacy of the drug and performing Monte-Carlo simulations to characterize the maximal MICs for which recommended pharmacokinetic-pharmacodynamic (PK-PD) targets are obtained for pathogens commonly known to cause CAP.

We determined the pharmacokinetic profile of moxifloxacin 400 mg/day in 18 patients treated empirically for community-acquired pneumonia. . Moxifloxacin plasma concentrations were determined the day after therapy initiation using ultra high performance liquid chromatography. The moxifloxacin plasma concentration-time profiles were described with a one compartment model, using NONMEM. Peak drug concentrations (Cmax) and 24-hour area under the free drug concentration-time curve values (fAUC0-24) predicted for each patient were evaluated against epidemiological cut-off MIC values for Streptococcus pneumoniae, Haemophilus influenzae and Legionella pneumophilia. PK-PD targets adopted were Cmax/MIC ≥ 12.2 for all pathogens, fAUC0-24/MIC \> 34 for S. pneumoniae and fAUC0-24/MIC \> 75 for H. influenzae and L. pneumophilia. The same PK-PD estimates were used in the simulations of probability of target attainment (PTA) versus MIC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with community-acquired pneumonia, treated with moxifloxacin

Exclusion Criteria:

* Under 18 years of age
The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)

The study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.

The nutritional pre-study had the following key objectives:

Primary objective:

- Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater extent than whey protein.

Secondary objective:

- Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.

Eligibility Criteria:
Inclusion Criteria:

* Female and male volunteers
* Age: between 20 and 45 years
* Body mass index (BMI): 20-28 kg/m²
* Fasting blood glucose within normal ranges (70-99 mg/dl; 29-42 mmol/mol Hb)
* Glycated hemoglobin HbA1c within normal ranges (4-6%)
* Agreement and signed informed consent before the study

Exclusion Criteria:

* Diabetes mellitus
* Increased bleeding tendency (hemophilia, regular use of anticoagulants)
* Allergy to nuts, legume or milk protein
* Drug, medication or alcohol abuse (frequent consumption of more than 20-30g alcohol/day)
* Intake of medication during the study
* Smoker
* Competitive athletes
* Extreme eating habits (vegan, special diets)
* Any other condition classed as unsuitable by the executive medical director
Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors

This study will develop and test the benefits of a new ICCS (Interactive Cancer Communication System), a mobile Comprehensive Health Enhancement Support System (Survivorship CHESS) in colon cancer survivors. Survivorship CHESS will provide information, tools, and a support system based on our previous work with FRESH START and CHESS, two highly successful interventions that have promoted lifestyle change among cancer patients and survivors. Survivorship CHESS will be designed to help subjects develop 1) competence in information gathering, decision-making, and behaviors they are trying to change, 2) social support systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a sense of control over their lives; this in turn, will help them adopt or maintain healthy lifestyle behaviors and improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I-III loco-regional colon cancer within the previous 12 months with no evidence of recurrence or new cancers. Participants may be recruited at any time after the initial diagnosis (up to 12 months). Baseline data collection will occur no earlier than 6 weeks after completion of adjuvant treatment
* At least 21 years of age
* Able to speak and read English (educational attainment of at lease 6th grade)
* Engaged in physical activities less than 8 metabolic equivalent tasks (METs) per week
* Not Homeless

Exclusion Criteria:

* Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program which includes subjects with severe orthopedic conditions or scheduled for a hip or knee replacement within six months; paralysis; end-stage renal disease; dementia; as well as subjects who have unstable angina or who have experienced a heart attack; congestive heart failure or pulmonary conditions that require oxygen or hospitalization within six months; or uncorrected vision or hearing problems or other ergonomic conditions that would preclude the use of the smart phone.
Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices

The goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult dentistry settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).


Eligibility Criteria:
Clinical Site Inclusion Criteria:

* Dentistry clinic within Montefiore Medical Center

Patient Inclusion Criteria:

* Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months

Exclusion Criteria:

* None
Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone

Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement

It was conclude that SCTG is the gold standard for soft tissue augmentation up till now, However ADM can be alternative to autogenous soft tissue graft.

Eligibility Criteria:
Inclusion Criteria:

Medically free

Exclusion Criteria:

Heavy smoking
Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma

In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
* Predicted life expectancy over 2 months
* Standard imaging evaluation 12 weeks prior to inclusion
* Planned for standard imaging within 16 weeks after start of therapy

Exclusion Criteria:

* Lack of proper compliance to accept continuous samplings.
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin

The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.

The investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. This study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. Three drugs will be used in this study: acyline, given by injection; testosterone (T) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). Acyline inhibits the production of luteinizing hormone (LH) and follicle stimulating hormone (FSH). When acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. Adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. One group of men will receive T gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. This design will enable determination of the respective metabolic effects of testosterone and estrogen.

Eligibility Criteria:
Inclusion Criteria:

* Prostate-specific antigen (PSA) ≤ 3 ng/mL
* Age 25-55 years
* Ability to understand the study, study procedures and provide informed consent
* Serum total T \> 300 ng/dL
* Normal reproductive history and exam
* International Prostate Symptom Score (IPSS) \< 11

Exclusion Criteria:

* A history of prostate cancer including suspicious digital rectal exam (DRE) or history of highgrade prostatic intraepithelial neoplasia (PIN) on prostate biopsy
* Invasive therapy for benign prostatic hyperplasia (BPH) in the past
* History of acute urinary retention in the previous 3 months
* Current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months)
* Current use of statins or glucocorticoids
* Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease
* A history of or current breast cancer
* Known, untreated obstructive sleep apnea
* Hematocrit \> 50 or \< 34
* Hypersensitivity to any of the drugs used in the study
* History of a bleeding disorder or anticoagulation
* Participation in any other drug study within past 90 days
* History of drug or alcohol abuse within the last 12 months
* Weight \> 280 lbs. or BMI ≥ 33
* Desire for fertility in the next 6 months or current pregnant partner
* Sperm concentration \<14 million/ml
* Significant, uncontrolled hypertension (BP \>160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate
Music Therapy on Cognition in Neurorehabilitation

Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

Thirty subjects participated in this study. Each participant received one session of each of the following: active music therapy intervention, passive music therapy intervention, and standard card. Mini-Cog tests were conducted before and after each session and the scores were collected for data analysis. Throughout the study, observations ensured the troubleshooting of any potential flaws for future recommendations.

Eligibility Criteria:
Inclusion Criteria:

* NeuroRehabilitation Needs

Exclusion Criteria:

* obtain a score of above 22 or below 10 on the MMSE
* have documented current/active episodes of hallucinations and/or delusions
* have documented hearing impairments with or without hearing aid(s)
* have language barrier, i.e. do not speak or understand English, Mandarin or Malay
Intestinal Microbiota Survey of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.

The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:

Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.

1. Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
2. Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.

Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal between 18-40 years of age.
2. Exclusion of other etiologies for infertility.

Exclusion Criteria:

1. During the pregnancy and lactation period.
2. Use of antibiotics within 3 months.
3. Regular use of proton pump inhibitors, laxatives or pro-prebiotics.
4. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
5. Major changes in eating habits within the past 3 months.