cyrilzakka/clinical-trials huggingface dataset:
Intrauterine Embryo Development With ANECOVA Device

We aim to compare the morphological and chromosomal features of human embryos cultured In Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as well as implantation and pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Women age below 37
* Hormonal serum levels within normal ranges (FSH, LH, E2, PRL, P4, T4, TSH)
* Negative serologic screening for HIV, Hep B and C
* No uterine or ovarian alterations found by ultrasound
* Normal BMI (19 - 29 kg/m2).

Exclusion Criteria:

* At least 8 stage MII oocytes are not retrieved
* Endometriosis or PCO
* Severe male factor in the partner
A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

The objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.


Eligibility Criteria:
Cohort A

Inclusion Criteria:

1. Apparently healthy adults (age \> 21 years);
2. Provide written informed consent for study participation.

Exclusion Criteria:

1. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
2. Any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for Cohort B;
3. Trauma-related surgery within the last 6 months;
4. Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
5. Received any blood product transfusion within the previous 2 months;
6. Pregnant women or children;
7. Prisoners or institutionalized individuals;
8. Already provided a urine sample for this study.

Cohort B

Inclusion Criteria:

1. Adults (age \> 21 years);
2. One or more of the following chronic, stable morbid conditions:

i. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. Chronic coagulation abnormality iv. Chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma) v. Chronic pancreatitis vi. Chronic renal insufficiency vii. Congestive heart failure viii. Coronary artery disease ix. Diabetes mellitus (Type 1 or Type 2) x. Gout xi. Hyper- or hypothyroidism xii. Hyperlipidemia (includes hypercholesterolemia) xiii. Hypertension xiv. Immunocompromised xv. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) xvi. Liver cirrhosis xvii. Neuromuscular disease xviii. Peripheral vascular disease (a.k.a. peripheral artery disease) xix. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus c. Provide written informed consent for study participation.

Exclusion Criteria:

1. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
2. Any new onset or unstable morbidities;
3. Trauma-related surgery within the last 6 months;
4. Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
5. Received any blood product transfusion within the previous 2 months;
6. Pregnant women or children;
7. Prisoners or institutionalized individuals;
8. Already provided a urine sample for this study.
Flavopiridol in Treating Patients With Recurrent Prostate Cancer

Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.

II. Assess the toxic effects of flavopiridol in this patient population.

OUTLINE:

Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.

Eligibility Criteria:
PATIENT CHARACTERISTICS:

* Performance Status: ECOG 0-2
* Life Expectancy: At least 3 months
* WBC at least 3,000/mm3
* Absolute neutrophil count at least 1,200/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 8 g/dL
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2.5 times normal
* Creatinine no greater than 1.5 mg/dL
* Prostate-specific antigen at least 10 ng/mL (if bone only disease)
* No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer
* No serious medical illness
* No cord compression symptoms

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior suramin therapy
* Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other concurrent hormonal therapy)
* No prior anti-androgen therapy within 4 weeks of study
* At least 4 weeks since prior radiotherapy
* No prior strontium therapy
Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD

The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.

PTSD Family Coach is a mobile phone app for family members of individuals with PTSD. This application provides:

* education about PTSD
* a self-assessment tool measuring life stress
* self-management skills to address acute distress and stress
* direct connection to support and
* information about VA and community resources for family members of individuals with PTSD

From this research, the investigators wish to learn whether family members of someone with PTSD find the PTSD Family Coach to be satisfactory and feasible to use. The investigators would also like to know if use of the app increases family members' knowledge of PTSD, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a Veteran with PTSD.

Currently, there are very few resources for family members of Veterans with PTSD. If this research demonstrates that PTSD Family Coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution.

Eligibility Criteria:
Inclusion Criteria:

* currently living with a Veteran with significant PTSD symptoms
* age 18 or older
* own an iPhone, iPad or other iOS compatible device
* currently experiencing at least moderate symptoms of stress

Exclusion Criteria:

* currently enrolled in another study related to PTSD
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Eligibility Criteria:
Inclusion criteria:

* Moderate to severe pain due diabetic polyneuropathy
* Opioid-naive subjects

Exclusion criteria:

* Females who are pregnant or lactating
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract
* Subjects with evidence of impaired liver/kidney function upon entry into the study
NPO and Patient Satisfaction in the Cath Lab

The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.

After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
* ability to provide written informed consent

Exclusion Criteria:

* Age less than 18 years
* emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
* patients not alert and oriented to person, place, and date,
* concurrent surgical procedures on the day of TAVR or arrhythmia ablation.
Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology

This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.

Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years at the time of enrollment.
* Women diagnosed with PCOS according to the Rotterdam criteria indicated by oligoamenorrhea (six or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan.
* Planned IVF/ICSI treatment.
* Normal uterine cavity (as assessed by hysteroscopy or HSG).
* Normal hormonal investigation: TSH and PRL.

Exclusion Criteria:

* Azoospermia.
* Other medical conditions causing ovulatory disorders, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia.
* Hypersensitivity to Myo-Inositol or its derivatives.
Effect of High-Dose Vitamin D3 in Smokers and Non-Smokers With and Without HIV

Supplementation with vitamin D improves HIV+ macrophages phagocytosis in vitro. There is evidence to suggest that administering vitamin D can in fact improve immune function in individuals. The study will evaluate the impact of high dose vitamin D in HIV+ smokers' and HIV- smokers' in vivo. The primary goal is to improve innate immune host response to infection in patients already at high risk by virtue of HIV and smoking status.

Tobacco smoke suppresses the lung's ability to fight infection. Smoking is three times more prevalent in the HIV+ compared to HIV- patients. Viral load was found to be significantly increased in HIV+ smokers compared to HIV+ non-smokers, suggesting that smoking enhances HIV-1 viral replication in macrophages, which contributes to disease progression. Vitamin D deficiency has been associated with increased mortality in HIV+ persons, but there is limited research on how this is impacting the health of these highest risk patients and if aggressive repletion with vitamin D can improve overall health.The study team hypothesizes that vitamin D administration will increase pathogen clearance and improve innate immune function.

The proposed pre and post interventional study is designed to characterize alveolar macrophage function and lung immunity according to tobacco use and HIV status, and determine the impact of high dose oral vitamin D3 on AM phagocytic function and innate immunity.

Eligibility Criteria:
Inclusion Criteria:

* Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART) for a minimum of 12 months and are followed longitudinally for their HIV healthcare;
* Ability to give informed consent.

Exclusion Criteria:

* Age \<18 yrs old;
* Known or possible pregnancy or breastfeeding;
* Documented history of cirrhosis or a direct bilirubin ≥ 2.0 mg/dL;
* Documentation of left ventricular ejection fraction \< 40% or myocardial infarction within the past 6 months;
* End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/d;
* Spirometry with forced vital capacity (FVC) or forced expiratory volume (FEV1)\< 70% of predicted value;
* Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year;
* Inability to undergo bronchoscopy safely;
* High risk behaviors without known HIV status.
The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 40-80 years;
2. diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
3. patients were stable on dopaminergic treatment for at least 3 months;
4. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
5. Patients experienced FOG during an interview.

Exclusion Criteria:

1. comorbidities of major neurologic diseases other than PD;
2. suffer from musculoskeletal disorders that could have interfered with their ability to walk;
3. presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
4. marked tremor interfered with TMS detection;
5. previously receiving any kinds of TMS interventions;
6. severe cognitive impairment making cooperation impossible \[Mini Mental State Examination (MMSE) \< 24\];
7. were unable to walk independently during the OFF state.
Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy

The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is very sensitive for changes in bone. By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.

The study will look at how repeatable the NaF PET scans are before treatment. Scans will also be performed after standard chemotherapy or hormone-directed treatment. This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy. In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA). This information could be used to develop better ways to measure prostate cancer bone lesions. In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone
* Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR
* Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate

Exclusion Criteria:

* Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen
* Patients who have received radiotherapy less than 4 weeks prior to registration.
* Patients who have received prior Strontium-89, Samarium-153, or other radioisotope.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
Supported Ventilation in ARDS Patients

Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV.

Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 year
* informed consent
* ARDS according to the Berlin definition
* RASS -4/-5
* tidal volume \> 8 ml/kg during supported ventilation
* double balloon esophageal EMG NAVA catheter

Exclusion Criteria:

* recent use of muscle relaxants / NMBAs (\< 3 hours)
* pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases
* phrenic nerve lesions
* elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma)
* open chest or abdomen
* pregnancy
* systolic blood pressure \< 90 mm Hg / MAP \< 65 mm Hg
FIT4Life Text Message Program

FIT4Life is a text message based physical activity project that includes one baseline week and 26 weeks of intervention delivery. Study participants will be provided with fitness trackers to support their physical activity goals. The text messages are intended to motivate participants to engage in physical activity throughout the week, but do not prescribe specific exercises/workout regimens for participants to follow.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read, write, and speak English
* Currently a Diabetes Prevention Program group or in a similar group that is recruited by the external community partner (Our Healthy Jackson County)

Exclusion Criteria:

* Does not meet the inclusion criteria listed above
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.

Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030. Diabetes related complications manifest in many body parts, often in the foot, due to reduced blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar pressures during walking contribute to the development of foot ulcers and foot ulcer recurrence. Emerging studies also point skin temperature as another predictor of foot ulceration. However, the number of studies including prediction models of plantar pressure and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue, foot deformities and other diabetes related characteristics have been related to plantar pressure measurements but not to foot skin temperature measurements, and the relation between skin temperature and plantar pressure has not been much explored in the literature. The role of these variables in the development of foot ulceration needs further attention, especially in patients with history of foot ulcers has they are at the highest risk to develop a foot ulcer.

Therefore, the goal of this research is to determine which variables can be used to predict plantar pressure and skin temperature and which factors are associated with the development of foot ulcers in patients with established diagnosis of diabetic foot. The associations between skin temperature and plantar pressure will also be addressed.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years)
* Diagnosed as diabetic foot patient
* Able to walk 10 meters without assistance

Exclusion Criteria:

* Non-cooperating patients
* Patients with major amputations
* Patients with a draining ulcer and/or infection
* Patients with cognitive impairments