cyrilzakka/clinical-trials huggingface dataset:
FungiScope - A Global Emerging Fungal Infection Registry

The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.

The specific objectives are:

1. To determine the fungal species causing invasive fungal infection in different parts of the world.
2. To determine the clinical pattern of disease and document procedures performed for confirmation of the diagnosis.
3. To describe the therapeutic regimens used and their efficacy.
4. To share clinical isolates among the contributors of Fungiscope.
5. To develop molecular biology tools for identification of strains in histopathologically proven invasive fungal infection.

Eligibility Criteria:
Inclusion Criteria:

* Cultural, histopathological, antigen or DNA evidence of invasive fungal infection

Exclusion Criteria:

* Infection due to Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci
* Endemic fungal infection such as coccidioidomycosis or histoplasmosis
* Colonisation or other non-invasive infection
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin

The aim of this study was to analyse usefulness of \[68Ga\]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.


Eligibility Criteria:
Inclusion Criteria:

* primary lesion found in CT/MRI with radiological features of glial neoplasm
* untreated disease, planned surgery
* negative medical history of other neoplastic diseases
* age over 18
* informed, voluntary consent to participate in the study

Exclusion Criteria:

* pregnant women, breastfeeding women
* persons with a known allergy to PSMA
* age under 18
* patient's lack of cooperation
Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes

There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.

A pre-test and post-test experimental design will be used to evaluate the efficacy of the self-compassion tool kit on distress, coping, testing glucose, sleep, and wellness in adults living with T2D.

For this 4-week study, participants will receive education on Sleep Hygiene practices during the first week of the intervention. Mindfulness meditation will be offered to participants using the Headspace app and four, ten-minute sessions will be prescribed per week. For exercise, 30-60 minutes of daily physical activity will be prescribed and participants can select the exercise of their choice. Additionally, participants will receive a journal in the mail with prompts associated with each day of required journalling. Prompts will elicit reflections, gratitude and growth. Participants will be followed by telephone every week. Baseline and week four data will be collected using the Demographic Form, T2DDAS, the Pittsburgh Sleep Quality Index (PSQI) and the SF-20. In addition, participants will be instructed to maintain a glucose testing, meditation, and exercise adherence log. The glucose testing log will permit measuring consistency and adherence to treatment over the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes
* Has a score above 2 on the T2D Distress Assessment Scale

Exclusion Criteria:

* Does not have type 2 diabetes
* Has a score above 2 on the T2D Distress Assessment Scale
* Cannot safely exercise
* Cannot complete the requested tasks
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects

* Objective:

  * A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.
* Study Design:

  * Randomized,single-dose,2-way crossover.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old.
* Subject had no clinically significant abnormal lab values at the screening evaluation.
* Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.
* Acceptable screening of ECG.
* Female subject's pregnancy test at screening is negative.
* Subject had no evidence of underlying disease at the pre-entry physical examination.
* Subject has given written consent to participate.
* Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.
* Agreed to undergo at least a 14-day pre-dose washout.
* Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

  1. Condom and topical spermicide
  2. Condom and diaphragm
  3. Intra-uterine device (I.U.D)
  4. Complete abstinence.
* Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion Criteria:

* History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
* History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
* Subject is pregnant or lactating.
* History of drug hyper sensitivity.
* Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
* Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.
New Use of the ViKY Device for Uterus Positioning

Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites

The ViKY device "Vision Control for endoscopy" was initially a compact motorized endoscope holder for laparoscopic surgery. It holds the endoscope and is controlled by either a foot pedal or voice activation. It received FDA approval in December 2008 and since that time has been used to facilitate laparoscopic surgery in multiple specialties.

EndoControl now considers using the technology for uterus manipulation in laparoscopic-assisted hysterectomies. Most gynecologic surgeries require displacement of the uterus out of the anatomic location to optimize the surgery. During an abdominal hysterectomy clamps are placed on the uterine cornua allowing easy manipulation of the uterus. The development of laparoscopic surgery required new techniques to manipulate the uterus. Typically a uterine manipulator is placed vaginally and controlled by the surgeon or the surgical assistant during the procedure.

In conventional operations, the constant physical force decreases the surgical team's efficacy and increases fatigue levels. The use of the ViKY device to control the position of the uterus facilitates surgery by enabling the surgeon to maintain a constant "locked" position or by allowing the surgeon to remotely move the uterus at any point of the surgery. The ViKY device also eliminates the need for an extra surgical assistant during laparoscopic-assisted hysterectomies.

The aim of this study is to collect data to demonstrate safety and effectiveness of the use of the ViKY device for uterine manipulation during conventional laparoscopic-assisted hysterectomies or computer-controlled laparoscopic hysterectomies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Candidate for conventional laparoscopic-assisted hysterectomies procedures
* patient has a cervix and a uterus

Exclusion criteria

* Difficulty understanding the English language
* Anatomy that precludes the use of a uterine manipulator
* Current inclusion in another research study
Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.

This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1) Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours following exposure to radiocontrast. Secondary endpoints include the length of hospitalization and in-house mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min
2. Scheduled for diagnostic, elective cardiac angiography

Exclusion Criteria:

1. Serum creatinine levels \>8.0 mg/dL
2. Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours
3. Preexisting dialysis
4. Multiple myeloma or other myeloproliferative disease
5. Current CHF or recent history of flash pulmonary edema
6. Current myocardial infarction
7. Symptomatic hypokalemia
8. Uncontrolled hypertension (treated systolic blood pressure \>200 mmHg or diastolic blood pressure \>100mmHg)
9. Exposure to radiocontrast within 7 days the study
10. Emergency Catheterization
11. Allergy to radiographic contrast
12. Pregnancy
13. Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study
14. Severe COPD
15. Serum Bicarb \> 28
16. Sodium \<133
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level, change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30 to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.

Tolvaptan is an effective treatment for hyponatremia. However, cirrhotic patients were underrepresented in previous studies. The pattern of use and efficacy of tolvaptan in real-life clinical practice are currently unknown.The objective of this study is to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia. The secondary objective is to evaluate the short- to intermediate-term safety of tolvaptan in cirrhotic patients.This will be a phase IV, open-label, prospective cohort study for 7 days. Although not mandatory, study subjects are encouraged to undergo follow-up assessments at 1 month.Subjects will be evaluated at designated time points after initiation of therapy. The primary efficacy endpoint is the proportion of subjects with normal serum sodium level (135-145 mmol/l) on day 7. The secondary efficacy endpoints are serum sodium level, change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30.

Eligibility Criteria:
Inclusion criteria:

1. Age no less than 18 years;
2. Confirmed cirrhosis by histology or radiological features of cirrhosis and clinical features of portal hypertension;
3. Serum sodium level less than 135 mmol/L;
4. Inpatients.

Exclusion criteria:

1. Clinical features of hypovolemia;
2. Systolic blood pressure less than 90 mmHg;
3. Life expectancy less than one month;
4. History of variceal bleeding in the last six months;
5. Hepatic encephalopathy or peritonitis in the last two weeks;
6. Serum creatinine more than 3.5 mg/dl;
7. Severe cardiopulmonary disease;
8. Urinary tract obstruction.
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer

The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative therapy
* Measurable disease according to the RECIST criteria
* Documented estrogen receptor-positive and/or progesterone receptor-positive tumour
* Postmenopausal women

Exclusion Criteria:

* Prior chemotherapy and/or endocrine therapy for advanced breast disease
* Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting
* Unknown hormonal receptor status
* Known HER2/neu-positivity
New York Blood Center National Cord Blood Program

Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.

Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.

Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.

Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for bone marrow transplantation

Exclusion Criteria:

-
Blood Transfusions and Immune Response

* We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery.
* The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied.
* The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery

Exclusion Criteria:

* history of bleeding diathesis
* hereditary hemostatic defects such as hemophilias
* chronic anticoagulant administration
* refusal of transfusions for religious reasons
* ischemic heart disease (unstable angina or myocardial infarction within the last six months)
* preexisting infectious diseases
* preexisting autoimmune diseases
* use of corticosteroids or immunosuppressive drugs within the last six months
Pediatric Obesity and the Infant Microbiome (BEACH)

The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.

Design: Normal weight (NW; pre-pregnant BMI \<25.0 kg/m2), obese (Ob; pre-pregnant BMI \>30.0 kg/m2), gestational diabetes (GDM), Type 2 diabetes (T2D), and Type 1 diabetes mothers during the 3rd trimester (34-36 weeks) of pregnancy that will be followed -along with their respective offspring- through the first 12 months of life will be recruited from the University of Florida (UF) Health Shands Hospital. Stool, saliva, blood, vaginal swab, human milk, urine, body composition and clinical variables will be collected from mother and infant at 34-36 weeks of gestation (mom only), 2-weeks, 2-months, and 1-year at the UF Clinical Research Center.

Infant body composition is the primary outcome and will be monitored via anthropometry. Follow-up data points will be collected from electronic health records (EHR) and include but are not limited to wellness visits by 1 month, 2 months, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 2 years, 2 ½ years, 3 years, and each year after that until 17.9 years. Planned data analysis includes linear regression using the R statistical program. The primary data analysis will test maternal health status and human milk bioactive components for associations with the infant microbiome and pediatric outcomes collected by clinical visits and EHR.

The study team will recruit equal samples of pregnant mothers in each the following groups (n=50 in each group; 1800 total participants): 1) NW vaginal deliveries; 2) NW C-section deliveries; 3) Ob vaginal deliveries 4) Ob C-section deliveries; 5) GDM vaginal deliveries; 6) GDM C-section deliveries; 7) T2D vaginal deliveries; 8) T2D C-section deliveries; 9) T1D vaginal deliveries; 10) T1D C-section deliveries.

Stool, saliva, and vaginal swab samples collected from participants may be used for animal studies whereby germ-free mice are inoculated with stool samples to evaluate a causal role of the microbiome in clinically relevant phenotypes (i.e. pediatric obesity).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 45 years of age.
* Pre-pregnancy BMI is greater than 30 kg/m2
* Pre-pregnancy BMI is less than 25 kg/m2
* At risk for gestational diabetes
* Pregnant and have Type 1 diabetes (T1D)
* Pregnant and have Type 2 diabetes (T2D)
* pregnant and within the 3rd trimester (34-36 weeks of gestation)-You plan to deliver in the Greater Gainesville area
* Plan to deliver via vaginal or cesarean section
* Plan to exclusively breastfeed your infant for at least 2 months
* Child will receive their pediatric care through UFHealth

Exclusion Criteria:

* Smoking
* Pre-eclampsia
* History of pre-term delivery (\<35 weeks)
* Only one breast capable of lactation and milk production inadequate
* Age \<18 yrs, \>45 yrs
* Any maternal antibiotics in the last 2 weeks during delivery
* Any alcohol consumption
* Drug use
OCS-05 in Patients with Acute Optic Neuritis

To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care

ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. The study randomized 36 eligible patients aged between 18 to 60 with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosed with a unilateral acute optic neuritis with a demyelinating origin
* Onset of visual loss symptoms in the last 12 days before randomization

Main Exclusion Criteria:

* Optic neuropathy of non-demyelinating origin
* Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs)
* Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
* Active, chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS) or Myelin Oligodendrocyte Glycoprotein Antibody associated Disorder (MOGAD)(e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency)
* An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss.
* Diagnosed with macular edema, severe myopia (\>6 δ) or other disease of the retina at inclusion
* Known diabetic retinopathy
* Known glaucoma
* Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study.
* Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration.
* Breastfeeding or pregnant women