cyrilzakka/clinical-trials huggingface dataset:
Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

To detect the effect of second-generation antipsychotic drug on the neural activity.

To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 60 years of age
* Subject is competent to provide informed consent

Exclusion Criteria:

* Mini Mental Status Exam is less than 28
* Past or current history of any psychotic illness in the subject or in first degree family members
* Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month...
* Any use of antipsychotic in the past.
* Any neuro-anatomical lesions on previous brain imaging
* Any use of D2 receptor blocking agent (such as antiemetics) in the last two weeks.
* Any use of any psychotropic medications (SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.
* MRI contraindications
* Any cardiovascular or cerebrovascular diseases or conditions that predispose patients to hypotension (eg. dehydration, hypovolemia, antihypertensive medication)
* Subjects with diabetes mellitus, metabolic syndrome, hepatic or renal impairment, seizure disorder and any neurological disorder
* QTc interval longer than 450 ms for male and 470 ms for female
* Subjects who used any medications in the last two weeks (to avoid any possible drug-drug interactions)
* Pregnancy
* Individuals who are illiterate and/or visually impaired
Discount Generic Prescription Study

The goal of this study is to learn about the factors that influence people to take part in discount generic prescription programs.

The primary objective of this study is to identify the factors associated with awareness and utilization of discount generic prescription programs and how two low-income populations in Houston utilize the $4 for a 30-day supply or $10 for a 90-day supply, Generic Prescriptions Program offered by Kroger, Randalls, Target, Walmart, HEB, CVS, and Walgreens.

If you agree to take part in this study, you will take part in a focus group. The focus group will consist of about 8 people who will discuss beliefs about generic medication, awareness of discount generic prescription programs, and use of the discount generic prescription program. The focus group will last about 90 minutes.

During the focus group, you will complete a form that asks for basic demographic information (such as your age and sex).

The focus group discussions will be taped, and the recorded tapes will be transcribed word-for-word. The taped recording of the focus group study will be stored in a safe and secured locker by the study chair. The taped recordings will be destroyed after 5 years.

Length of Study:

Your participation on this study will end once you complete the focus group.

This is an investigational study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Low-income (less than $30,000/year)
* Ability to speak English
* Ability to read and write in English
* Chronic health condition requiring prescription medication or family member with chronic health condition requiring prescription medication.

Exclusion Criteria:

* None
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.


Eligibility Criteria:
Inclusion Criteria:

* Both profit and non-profit long-term care homes in Ontario and Alberta.
* Homes must have a minimum of 70 occupied beds to participate; there is no maximum home size for participation.
* For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.

Exclusion Criteria:

* Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).
Effect of NNS on Metformin/GDF15, Pilot

Metformin use for diabetes has the benefit of causing weight loss in some. The investigators in a preclinical trial, demonstrated that mice consuming non-nutritive sweetened (NNS) drinks had worse glucose improvements and weight loss than mice consuming sugar drinks or water. This study will conduct a pilot to determine if this translates into pediatric clinical practice. The hypothesis is that NNS drinks impair metformin-induced satiation, weight loss, and glucose tolerance.

This study will enroll 40 children ages 10-21 years (will be recruited from the University of Florida (UF) Pediatric Obesity\& Metabolic clinic in Gainesville) and randomize eligible participants into a 2-arm, 12-week Metformin (500mg BID) intervention (n=20/group) in which one arm will be randomized to receive education and counseling to avoid all sweetened drinks (drink water only) and the other to avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS). Participants will be asked to consume minimum of 3 drinks/day In the initial visit (baseline visit) the investigators will do a complete evaluations of physical health and eating behaviors. The investigators will draw lab work including A1c and GDF15 levels. The investigators will also get anthropometric measurements of height and weight to calculate body mass index (BMI). For assessment of beverage intake, the investigators reviewed questionnaires validated in children and adolescents in the past 10 years to better reflect currently available beverages. The investigators combined data from BEVQ-15 (that was validated in children aged 6-18 years) and BFQ(17 items questionnaire validated in young adults, aged 16-30 years),and edited further to make the important distinction between unsweetened and artificially sweetened drinks while adding several examples to each category to help improve correct selection. The investigators will also limit to weekly intake assessments. Data will be collected biweekly. Following completion of the 12-week intervention, participants will return fasting to assess the effectiveness of the metformin treatment on the following: hemoglobin A1C (A1c), Growth Differentiation Factor 15 (GDF15), with BMI and 24-hour dietary recall, including questions about change in hunger while on metformin. The investigators predict that metformin-induced GDF15 levels will be blunted in participants consuming NNS beverages. To improve compliance and decrease attrition, The investigators will provide performance feedback and interpretation of physiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will have already been prescribed Metformin as part of their normal clinical care
* Must also be aged 10-21 years
* Have a diagnosis of obesity (BMI \> 95th%ile or \>30 kg/m2 - whichever is lower) and pre-diabetes (A1c between 5.7 and 6.4%)

Exclusion Criteria:

* Previous treatment with oral hypoglycemic medications, (2) resting systolic blood pressure (SBP)\>180 mm/Hg or diastolic blood pressure (DBP)\>100mm/Hg, (3) self-reported pregnancy
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

This is a study of a new medication for the treatment of cognitive impairments (thinking difficulties) and negative symptoms in people with schizophrenia. The new medication is rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration for the treatment of Parkinson's disease. It is used to treat cognitive problems.

The study will consist of two phases: a 4-week continued stability phase (lead-in phase) and a 12-week double-blind treatment phase. In the lead-in phase, subjects receiving antipsychotic medication, who manifest moderate to severe and persistent negative symptoms, will remain on their maintenance regimen for at least four weeks. The treatment phase will be a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline (1 mg/day), a selective MAO-B oxidase inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
* Current treatment with one or more second generation antipsychotics, except ziprasidone
* On same second generation antipsychotic(s)for at least 56 days
* On same dose of second generation antipsychotic(s)for at least 30 days
* 22-item SANS: Total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global Rating of Affective Flattening greater than or equal to 3 or global Rating of alogia greater than or equal to 3
* BPRS: Sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
* BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items 1,2,5,9)
* Simpson-Angus Scale: Total score less than or equal to 8

Exclusion Criteria:

* DSM-IV Major Depressive Disorder within last 6 months
* Current treatment with ziprasidone
* DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
* DSM-IV criteria for alcohol or substance abuse within the last month
* evidence of illicit substance use, as identified with urine toxicology screen
* History of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. See those listed below
* Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
* Pregnancy or lactation in females
* Pheochromocytoma
* Melanoma
* Hepatic insufficiency
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.

Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
* At least 4 weeks since last surgery or radiation therapy.
* Must have had a treatment-free interval of greater than 6 months following response to platinum.
* ECOG performance status of 0,1, or 2.

Exclusion Criteria:

* Women of child-bearing potential that do not practice adequate contraception.
* Pregnant or lactating.
* Received more than one primary chemotherapy regimen.
* Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.
* Active uncontrolled infection requiring antibiotics.
* Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.
* Received radiation to more than 10% of bone.
* Prior treatment with topotecan or gemcitabine.
* Hypersensitivity to camptothecin or nucleoside analogues.
* Use of an investigational agent within 30 days.
Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care

The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 65 to 75 years of age
2. Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
3. Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
4. Ability and willingness to follow scheduled visits with requested biological samples

Exclusion Criteria

- Patients previously treated with intravenous biphosphonate
A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin

Dry skin is characterized by a lack of moisture in the outer layer of the skin and can occur as a result of numerous factors including cold weather, low humidity, age, etc. In this study, the moisturizing benefits of two formulas were evaluated for barrier function improvement/impact when used by women with moderately to severely dry skin on their lower legs.


Eligibility Criteria:
Inclusion Criteria:

* moderately to severely dry skin on both leg legs, as determined by the investigator.
* Fitzpatrick skin types I-IV
* generally in good health
* routinely uses moisturizers on the legs at least 1-3 times per week.
* if of reproductive potential: using a medically acceptable form of birth control for at least 3 months before the study and willing to continue it for at least 1 month after study completion.
* able to read, write, speak, and understand English.
* willing and able to complete all study instructions.
* has completed the informed consent document including a HIPAA disclosure and photograph release.

Exclusion Criteria:

* known allergies/sensitivities to adhesive tapes or study product ingredients.
* known skin conditions, uncontrolled medical conditions, or any other condition that could interfere with evaluations/data interpretation or increase risk to the subject.
* any active bacterial/fungal/viral skin infections or susceptibility to such infections.
* females who are pregnant, breastfeeding, or planning to become pregnant in near future.
* compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk to the subject.
* current participation in another study.
* participation in another study in past 4 weeks.
* employees or relatives of the investigator or study site.
Goodness of Clinical History During Stemi PCI

The purpose of this study is to confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, the investigators created a clinical registry in which the investigators collect current or previous medical history relevant to DES utilization , in two distinct times.

GHOST Registry

Use of drug-eluting stent (DES) in STEMI is sometimes limited, by the concern that adequate information, relating to the current or previous medical history, can not be obtained due to the patient's critical condition. A less than adequate medical history would expose patients treated with DES to a particular risk in case that an absolute or relative contraindication to the required long-term double antiplatelet therapy is not fully elucidated before DES implantation.

To confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, we created a clinical registry in which we collect current or previous medical history relevant to DES utilization , in two distinct times:

Time zero in which the medical history collection is taken in the cath-lab during the primary pci

Time one in which the second medical history collection is taken 4 days after the index procedure when the patient clinical conditions no longer impede an adequate medical history collection.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients presenting with STEMI treated with primary or rescue PCI

Exclusion Criteria:

* Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking
Comparison of Surgical Outcomes Between MPCNL and RIRS

The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.

It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.

Eligibility Criteria:
Inclusion Criteria:

* The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
* The person who signed up for participation and agree with intention of clinical test.

Exclusion Criteria:

* The patient whose medical record has been omitted from database.
* The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
* The patient who do not agree with the intention of the clinical study.
Advancing Cervical Cancer Screening Through the Emergency Department - IIS

Cervical cancer screening in the Emergency Department

This will be an effort to deploy HPV self-sampling among Emergency Department patients. Emergency Department patients, in the US and worldwide, are disproportionally under-screened for cervical cancer relative to the general population.

Eligibility Criteria:
Inclusion Criteria:

* Cisgender women and transgender/non-binary individuals with a cervix,
* Age 25-65,
* Able to demonstrate decisional capacity to participate.

Exclusion Criteria:

* Past hysterectomy with cervical removal,
* Known infection with HIV (as screening recommendations for people with HIV differ from the general population),
* Non-English speaking.
Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes

Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.

The epidemic of coronavirus disease-2019 (COVID-19), a disease caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus, rapidly spread worldwide and was declared a pandemic by the World Health Organization on 11 March 2020.

It is well known that people with diabetes have increased infection risk, especially for influenza and pneumonia. Moreover, diabetes was previously reported as a major risk factor for mortality in people infected with the H1N1 pandemic influenza and, more recently, with the Middle East respiratory syndrome-related coronavirus (MERS-CoV) . Epidemiological studies have quickly and consistently pointed out diabetes as one of the major comorbidities associated with COVID-19 and affecting its severity.

The prevalence of diabetes in patients with COVID-19 was first reported to range from 5% to 20%. Furthermore, the COVID-19-Associated Hospitalisation Surveillance Network (COVID-NET) reported a diabetes prevalence of 28.3% in hospitalised patients in the USA.

More importantly, all studies published so far have reported a two- to threefold higher prevalence of diabetes in patients in ICUs compared with those with less severe disease and an increased mortality in people with diabetes. A recent meta-analysis further demonstrated that diabetes was associated with a more than doubled risk for ICU admission and a more than tripled risk for death.

However, precise data regarding diabetes characteristics in hospitalised people with COVID-19 are still lacking. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This study aims to identify the clinical and biological features and potential interactions of diabetic therapies associated with disease severity and mortality risk in people hospitalised for COVID-19. Hospital medical records of inpatients, hospitalized between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* admission with COVID-19 to the Internal Medicine Unit dedicated to COVID-19 (Macrounit 1), academic hospital in Parma (Italy) between February 23 to March 31 2020.

Exclusion Criteria:

* during hospitalization inter or intra-hospital transfer of inpatients
Autologous Conditioned Serum: Functional and Clinical Results

The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA).

Fifteen patients with clinical and radiological signs of OA of the hip or knee were recruited for this study. Each patient received 4 injections of ACS (Orthokine®) at the site of OA once per week for 4 weeks. Clinical and functional evaluation were performed using VAS scale for pain, WOMAC scale and KSS functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. Statistical analysis was done with the Wilcoxon Signed-Rank Test.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis \>3 months in clinical and radiographic signs
* VAS for pain \>50mm

Exclusion Criteria:

* Hepatitis B
* Hepatitis C
* HIV
* pregnancy
* drug abuse
* other intra-articular injections \<6 months
* surgery on affected knee \<12 months