cyrilzakka/clinical-trials huggingface dataset:
Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe

This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as an imaging technique to assess arthritis in the foot and ankle.

The overall goal of this study is to improve radiologic evaluation of foot and ankle arthritis. Today's standard of care, radiography, provides limited two-dimensional evaluation of joint alignment, arthritic changes, posttraumatic changes, and congenital deformities due to overlapping bone densities. Evaluation is even more limited in post-surgical patients due to overlapping metallic hardware. Computed tomography (CT), the current problem-solving tool, offers more "level-by-level" three dimensional information, but is fraught with additional cost, additional radiation dose, beam-hardening artifacts from hardware, and the need for additional equipment. Most importantly, patients are not weight-bearing during conventional CT, therefore masking the true extent of malalignment or arthritic joint space narrowing. At the University of Washington, physicians attempt to overcome the last problem by performing simulated weight-bearing CT. The study proposes an alternate solution to this problem using a novel application of an old method, digital tomosynthesis. Specific aims of the study are 1) to compare radiography, tomosynthesis, and simulated-weight bearing CT in their ability to detect foot/ankle malalignment, 2) to compare the abilities of these three modalities to detect arthritis changes such as joint space narrowing, osteophytes, and subchondral cysts, and 3) to compare their abilities to detect bony deformities such as acute fracture, old fracture deformity, or partial fusion (post traumatic or post surgical). Radiographic assessment will be correlated with clinical outcome using clinical notes and functional outcome such as the Lower Extremity Functional Scale (LEFS) questionnaire. Successful results from this initial study will have the potential to change practice paradigm in how to image foot and ankle arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. adult age (18 years or older)
2. clinical orthopedic surgery follow-up notes available at University of Washington
3. ability to complete the Lower Extremity Functional Scale (LEFS) or equivalent questionnaire at the time of the study, a well established survey to test for functional ability in lower extremity

Exclusion Criteria:

1. inability to use the simulated weight bearing CT machine due to pain
2. prior complete osseous fusion of foot/ankle joints
3. prior total ankle arthroplasty
4. Pregnancy
Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia

People with schizophrenia often have problems with attention, learning and memory and other cognitive abilities that interfere with their work and school performance. Unfortunately, even our best treatments often do not significantly reduce these cognitive problems. The current study investigates whether or not delivering a very small electrical current to people's foreheads (called, transcranial direct current stimulation; (tDCS)) might improve functioning in the front part of the brain and reduce these cognitive problems in people with schizophrenia. tDCS is non-invasive and has been shown to improve cognitive functioning in some preliminary studies. The current study will investigate whether giving tDCS during a task is more effective than giving it during rest (Aim 1), whether delivery of tDCS to the front of the head is more effective than delivery to the back of the head (Aim 2), and whether tDCS delivery will alter levels of a major inhibitory neurotransmitter in the brain (GABA; Aim 3) that is important to cognitive functioning and may be disrupted in people with schizophrenia. Although this study is not intended to diagnose, cure or treat schizophrenia or any other disease, if results are positive it will encourage future large-scale studies to determine if tDCS can become an effective treatment for cognitive problems in people with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
* All subjects must have the ability to give valid informed consent.

Inclusion Criteria for Patients with Schizophrenia Only:

* Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
* No medication changes in the prior month
* No medication changes anticipated in the upcoming month
* Stable outpatient or partial hospital status
* Normal IQ (\>70; IQ will be measured by administering the Wechsler Abbreviated Scale of
* Intelligence (WASI) test)
* Must not be currently taking the antipsychotic clozapine

Exclusion Criteria:

* Pacemakers
* Implanted electrical (brain and spinal) stimulators
* Implanted defibrillator
* Metallic implants
* Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
* Hair styles hindering the placement of electrodes
* Cranial pathologies
* Head trauma
* Epilepsy
* Mental retardation
* Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)
* Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance)
* Pregnancy
* Substance dependence in the past six months
* Substance abuse in the past month
Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (\<33 weeks gestation) VLBW (birth weight \<1500g) and fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal illness were excluded. Gestation was assessed from history of last menstrual period and after birth by new Ballard scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G Osmani Medical College, Sylhet.

Background: Necrotizing enterocolitis (NEC) is the most common acquired disease of the gastrointestinal tract in preterm very low birth weight infants and associated with increased morbidity and mortality. Prophylactic enteral probiotic supplementation may play a role in reducing NEC and potentially provide benefits to preterm very low birth weight neonates. The objective was to evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis (NEC) in preterm very low birth weight (VLBW) infants.

This prospective, randomized double blind controlled trial is undergoing in 102 preterm (28-33 weeks gestation) VLBW (birth weight 1000-1499g) neonates fulfilling the inclusion criteria. The study group was fed with probiotics once daily with breast milk from first feeding and the control group only breast milk without the addition of probiotics. The primary outcome was the development of NEC (stage II and III). NEC is categorized by modified Bell's classification.

Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight. It is also associated with faster achievement of full enteral feeding and shorter duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* All newborn infant preterm (\<33 weeks gestation to 28 weeks gestation) VLBW (birth weight \<1500gm to 1000 gm)
* Able to tolerate oral feed
* Informed consent by the parents or guardian

Exclusion Criteria:

* Evidence or suspicion of clinical sepsis before the baby is randomised
* Presence of perinatal asphyxia
* Presence of major congenital anomali
* Death within first week of life due to other neonatal illness
Intravenous Iron in Patients with Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

The clinical trial is designed as an international, prospective, multi-centre, double-blind, parallel group, randomised, controlled, interventional trial to investigate whether a long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can extend the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death (in the full population and in the population of patients with TSAT\<20%) and reduce the rate of recurrent events of heart failure hospitalisations.

I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out according to the Summary of Product Characteristics (SmPC). Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is \> 16.0 g/dL or ferritin is \> 800 µg/L.

In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above. Patients originally assigned to the placebo group will receive a saline administration at all visits.

In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all visits will be administered in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF\<45%.
2. Confirmed presence of ID (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT \< 20 %)
3. Serum haemoglobin of 9.5 - 14.0 g/dL
4. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP \> 100 pg/mL or NT-proBNP \> 300 pg/mL or MR-proANP \> 120 pmol/L (NYHA 2-4)
5. Written informed consent

Exclusion Criteria:

1. Hypersensitivity to the active substance, to FCM or any of its excipients
2. Known serious hypersensitivity to other parenteral iron products
3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
4. Evidence of iron overload or disturbances in the utilisation of iron
5. History of severe asthma with known FEV1 \<50%
6. Acute bacterial infection
7. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
8. Use of renal replacement therapy
9. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation.
10. More than 500 meters in the initial 6-minutes walking-test
Meta-analysis of Stannous Fluoride and the Effects on Enamel Erosion

The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
Community Characteristics and Physical Activity Among Adolescent Girls - Ancillary to TAAG

To investigate the role of community characteristics in physical activity levels of adolescent girls.

BACKGROUND:

The NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG) is a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years.

DESIGN NARRATIVE:

Because environmental factors can influence the likelihood that a person will engage in physical activity, the study investigates the role of community characteristics in physical activity levels. The research forms an ancillary study to the NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG), a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years. The parent TAAG study will be collecting measures of physical activity using both self-report and CSA accelerometers, small monitors worn at the hip that record acceleration and deceleration of movement without the need for any reporting from the participants. Using a radius of 5 miles around each participating TAAG school and around the homes of each study participant, the investigators plan to use geographic information systems (GIS) to gather information documenting proximity of recreational facilities, street design, population density, population mix (ethnic/age distribution), crime, availability of mass transit, neighborhood socioeconomic status (SES), geographic elevations and topography and types of land use. Using hierarchical linear modeling, with girls nested within neighborhoods, while controlling for individual level factors such as race and socioeconomic status, they plan to investigate the relationship of the environment to individual physical activity. In addition, by following girls over time, they plan to investigate whether the effect of the TAAG intervention will be modified by community characteristics. This study will be unique in its scope of exploring the role of community environments in physical activity across six very different urban, suburban, and rural areas: San Diego, CA, Minneapolis, MN, Baltimore, MD, New Orleans, LA, Tucson, AZ and Columbia, SC.

Eligibility Criteria:
No eligibility criteria
Endothelial Protection in Convalescent COVID-19 Patients

This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Survived inpatients with severe-to-critical COVID-19 within 14 days after discharge are randomized to receive sulodexide 250 LSU 1 oral capsule twice daily or no treatment for 8 weeks. Biomarkers of endothelial dysfunction, inflammation, and prothrombotic changes are assessed at 0, 4, and 8 weeks. The hypothesis is that affected endothelial function, pro-inflammatory, and pro-thrombotic changes could be improved with sulodexide treatment in convalescent COVID-19 patients who suffered a severe-to-critical clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* male or female
* documented PCR SARS-CoV-2 positive test
* COVID-19 convalescence (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms)
* informed consent signed
* clinical severity presentation of

  1. Severe the disease is classified as severe if one of the following conditions is met:

     Respiratory distress, respiratory rate ≥30/min Oxygen saturation on room air at rest ≤93%. Partial pressure of oxygen in arterial blood/FiO2 ≤300 mm Hg. Or
  2. Critical if one of the following conditions is met. Respiratory failure and mechanical ventilation are required. Shock occurs Another organ dysfunction is present
* risk of health complication \>50% according to the health risk calculator
* less than 14 days of hospital discharge.

Exclusion Criteria:

* concomitant use of another anticoagulant
* known pregnancy
* known hypersensitivity to sulodexide
* need for hospital care at screening
* renal insufficiency with CrCl \<30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
* blood platelet count \< 30 000/µL
* other conditions that are judged to carry an increased risk of bleeding as judged by the Investigator
* more than 30 days of clinical onset
Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.


Eligibility Criteria:
Inclusion Criteria:

- Subjects who have the following samples collected and submitted for culture as part of routine clinical practice: Expectorated sputum, induced sputum, tracheal secretions, bronchoalveolar lavage.

Exclusion Criteria:

* Subjects who do not have MN Research Authorization on file
* Rejected sputum culture (i.e., due to low quality)
* Positive respiratory cultures within prior 7 days
* Deceased at time of sample randomization
* Any subject affected by Global Data protection Regulation (GDPR)
* Previous enrollment in the study.
* Outpatient status
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.

Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV).

Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective hysterectomy at Mayo Clinic in Arizona
* ASA I, II, or III

Exclusion Criteria:

* Pregnancy
* Concomitant bowel surgery other than appendectomy
* Hypersensitivity to study drug or rescue medication
* Preoperative score for nausea greater than 4 out of 10 points
* Severe hepatic insufficiency (Child-Pugh score \> 9)
* Any condition which impairs the patient's ability to complete study assessments
* Intraoperative hemodynamic instability
* ICU admission
* Prolonged postoperative intubation
* Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
* Other antiemetic within 12 hours prior to surgery
* Participation in a clinical trial using an investigational product
A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as non clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of 50 to 100kg inclusive
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
* History of febrile illness within 5 days prior to the first dose
* A positive urine drug screen
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing remitting Multiple Sclerosis
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

Exclusion Criteria:

* Patients with MS other than relapsing remitting MS
* Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
* Patients who have been treated with:

  * systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
  * immunosuppressive medications within 3 months prior to baseline;
  * monoclonal antibodies within 3 months prior to baseline;
  * cladribine, mitoxantrone or alemtuzumab at any time.
* Uncontrolled diabetes mellitus at screening
* Diagnosis of macular edema during Screening Phase
* Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
* Patients who have received total lymphoid irradiation or bone marrow transplantation.
* Patients with certain cardiovascular conditions and/or findings in the screening ECG
* Patients with certain liver conditions
* Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
* Other protocol-defined inclusion/exclusion criteria may apply.