cyrilzakka/clinical-trials huggingface dataset:
Polyacrylamide Injection in Patients Ineligible for Surgery

Transurethral injection using polyacrylamide hydrogel (Bulkamid®, Contura A/S, Denmark) is an established treatment for stress urinary incontinence. The rates of women reporting improvement or cure after Bulkamid injection for stress urinary incontinence range between 64-77% with a very low morbidity. However, the indications for use are unclear. Although transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with regard to expected cure rates, the procedure is associated with very low rates of adverse events in general and serious adverse event in particular. As such, it may be an important alternative for patients where surgery is not considered a safe option either because of co-morbidity or because of complicated incontinence. The investigators performed a prospective study to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery.

In this prospective observational study the investigators included female patients who received treatment with transurethral polyacrylamide hydrogel injection (Bulkamid®). Patients were considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy. At the baseline visit patients underwent a routine gynecological exam including pelvic ultrasonography. Patients completed validated questionnaires at the baseline visit and follow-up for evaluation of subjective treatment success. At baseline, women were asked to self-report any concomitant diseases or health conditions which were noted in the patient records together with a standard gynecological, urological and general health history. Follow-up visits were scheduled at 2 and 6 months after first injection at which time a second injection was administered at patients' discretion.

Eligibility Criteria:
Inclusion Criteria:

* Women with stress urinary incontinence considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy.

Exclusion Criteria:

* Patients who do not want treatment or to participate in study follow-up
* Below 18 years of age
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17

This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects from 11 to 17 years old at the time of they start the study.
* Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B vaccine.
* Previous vaccination with any HPV vaccine.
* Contraindication to vaccination with Gardasil or any HPV vaccine.
Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment.

The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18-75 years of age.
* Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
* Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
* Patients may be on any class of IBD-related medication (excluding steroids)
* Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
* Ability to understand and willingness to sign informed consent document

Exclusion Criteria:

* Patient who are asymptomatic
* Patients with severe, refractory disease (defined as Mayo scores of \> 10, or endoscopic disease activity score of \> 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
* Prior colectomy
* Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
* Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
* Systemic antibiotic use within prior 6 weeks to enrollment
* Regular probiotic supplement use within prior 48 hours to enrollment
* Pregnancy or breastfeeding
* Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
* History of anaphylaxis (severe allergic reaction)
* Documented allergy to fluoroquinolones, metronidazole
* Life expectancy less than 12 months
* Age less than 18 or greater than 75 years of age
* History of esophageal or gastric motility disorders.
Awake Nasal Intubation in Laryngopharyngeal Tumors

This study evaluates the efficiency of awake naso-tracheal intubation and patient satisfaction when using a small diameter flexible nasolaryngoscope together with topical anaesthesia and light sedation with a combination of benzodiazepine and fentanyl. The selected patients will have difficult airway access because of obstructing oro- and hypo-pharynx tumours.

Awake naso-tracheal fiberoptic intubation is an established method of securing a difficult airway. The patient's comfort and optimum intubation conditions are paramount for success. The study proposes to analyse a series of patients with obstructive pharyngo-laryngeal pathology, following the degree of satisfaction, reliability of the procedure and any incidents or complications.

Awake intubation could be the safest way to control difficult airway as the patient maintains spontaneous respiration and intact reflexes. Main concerns for the success of this procedure should be a good technique, a calm and cooperative patient and good preparation with careful topical anaesthesia and appropriate sedation. The tool used in this study will be a flexible nasolaryngoscope of 2.9 mm diameter and 300 mm working length which might offer an advantage over lengthier fiberscopes in matter of manoeuvrability and patient comfort. Prior intubation the patients will have an upper airway fiberscopic exam from nostrils to tracheae with the same tool.

Eligibility Criteria:
Inclusion Criteria:

* patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access.

Exclusion Criteria:

* Patients who refuse the procedure, with bleeding disorders, acute respiratory failure manifested by stridor or the impossibility of nasal passage are excluded from the study.
Pregnancy Tracking Pilot

This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.


Eligibility Criteria:
Inclusion Criteria:

* women ages 18-34
* first pregnancy and at 13-20 weeks' gestation
* low-risk uncomplicated pregnancy
* overweight or obese at the time they became pregnant
* willing to receive emails.

Exclusion Criteria:

* Individuals who are not pregnant
* not willing to receive emails
* pregnant women expecting more than a single birth,
* outside the window of 13-20 weeks' gestation
* high-risk or complicated pregnancy for which participation would be contraindicated
* advanced maternal age according to obstetric guidelines (i.e., age 35 or older)
* diabetes
* history of eating disorders
* pre-pregnancy weight less than 25 kg/m2or greater than 36 kg/m2 (either not overweight or with extreme obesity)
Perioperative Continuous Glucose Monitoring

To evaluate use of continuous glucose monitoring (CGM) technology in the preoperative setting: evaluate feasibility of placement of CGM during preoperative clinic visit with intent to utilize CGM throughout perioperative period.

To further study potential barriers related to loss of continuous glucose monitoring (CGM) data as it relates to use of electrocautery and grounding devices utilized in the perioperative setting. To assess how CGM technology could improve glycemic management in the perioperative setting, specifically in predicting and preventing hypoglycemic episodes as well as utilization for treating hyperglycemia with resultant improvement in patient morbidity, mortality, length of stay, and overall quality of life. CGM technology aids tremendously in data collection with recognition of glycemic patterns, as well as evaluating prediction of blood glucose changes including both hyperglycemic and hypoglycemic events. The availability of such a large volume of glycemic data has been shown to make a tremendous impact in patient care, resulting in statistically significant reductions in hemoglobin A1c, a decrease in hypoglycemia, a decrease in hospital admissions for diabetes complications, and improved overall quality of life and fear of hypoglycemia in patients using CGM technology.

Eligibility Criteria:
Inclusion Criteria:

* Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus who will be undergoing surgery at Atrium Health Wake Forest Baptist
* smartphone compatible with Libre 2 phone application

Exclusion Criteria:

* Pregnant women will not be excluded from this study
* Participants undergoing surgery that would limit the placement of Continuous Glucose Monitoring (CGM) to the posterior aspect of the upper extremity will be excluded from this study
* neurosurgical type of surgery
Bleeding Prediction in Thrombocytopenia

The purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.

Thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. This prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.

Eligibility Criteria:
Inclusion Criteria:

* Admitted patients with thrombocytopenia
* Age ≥18 years
* Platelet count below 80 x109/L

Exclusion Criteria:

* Platelet transfusion within the previous 14 days,
* surgery or trauma within the previous 7 days
* Unable to give informed consent.
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients who have completed treatment on study NC19453.

Exclusion Criteria:

* any significant lymph node abnormalities at the end of study NC19453.
Rad Predictors for WON

This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who underwent endoscopic drainage of walled off pancreatic necrosis
* Patients who did not require further intervention (either surgical, percutaneous, or endoscopic) following endoscopic drainage
* Patients who required further intervention for walled off pancreatic necrosis (either surgical, percutaneous, or endoscopic) following endoscopic drainage.
* Patients who underwent percutaneous or surgical interventions prior to endoscopic drainage

Exclusion Criteria:

* Pancreatic pseudocysts without any solid debris
* Under 18 years of age at the time of endoscopic drainage
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
* Subject is a recipient of a de novo kidney transplant
* Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor

Exclusion Criteria:

* Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of \< 250 cells/µL
* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
* Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:

  * History of hypertension and a terminal serum creatinine \> 1.5 mg/dL
  * Cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
  * History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
L. Brevis CD2 Strain Persistence in Oral Cavity

The aim of this study is to select the optimal conditions for quantification in the oral cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available dietary supplement and to assess its persistency after oral administration. Different sets of primers for L. brevis detection will be tested in real-time PCR reactions to find optimal amplification efficiency and target specificity. Primers ability in the identification of L. brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last tablet. The quantities of L. brevis DNA will be compared to the total number of bacteria present in the samples. The activity of the enzyme arginine deiminase, responsible for oral pH homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva samples before and after treatment, by HPLC measurements.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Healthy subjects with no oral cavity pathologies
* Written informed consent

Exclusion Criteria:

* Patients with oral diseases
* Patients with systemic diseases
* Celiac patients or subjects affected by allergic reactions to soy proteins
* Use of antibiotics or other probiotics
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
* subjects who are not currently receiving any PD treatment

Exclusion Criteria:

* female of child-bearing potential
* history of neurosurgical procedures for PD
* history of severe psychiatric illness
Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.

The investigators will address the hypothesis in the following Specific Aims:

Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat-free mass in toddlers. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP).

Specific Aim 2: Determine the effect of a handheld Force-Measuring Ultrasound Probe on intra- and inter-observer variability in ultrasound measurements. A device which measures the force applied to the ultrasound probe will be used to obtain measurements of muscle and adipose tissue thickness (biceps, abdomen, and quadriceps) in toddlers.

Eligibility Criteria:
Inclusion Criteria:

* toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
* written consent obtained from a parent before or at time of visit

Exclusion Criteria:

* toddlers who require medical support that prevents them from having ADP measurements taken
* those with an inability to sit in a supported seat for 5 minutes
* those weighing less than 10 kg
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease

After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.

Patients will be categorized into three Groups, according to DED severity. Group I comprises of subjects without DED, Group II of patients are evaluated as non-severe DED, and Group III consists of patients suffering from severe DED.

The day before cataract surgery will be performed patient examination, during standard cataract preoperative evaluation. Briefly, symptom-based assessment will be delivered by scoring the Ocular Surface Disease Index (OSDI) questionnaire, and evaluation of ocular surface damage will be performed by corneal fluorescein staining using the Oxford scale.

Before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (Oxatrex, Zwitter Pharmaceuticals, Greece) four times at fifteen minutes intervals starting 2 hours before surgery. The eye drops will be applied in the middle of the inferior lower fornix. Patients who miss any of the 4 doses will be excluded from the study. Aqueous humor will be collected after 1 hour of the last administration, intraoperatively, at the beginning of cataract surgery.

A paracentesis track will be made with a 15ᵒ superblade, a 30G cannula, connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn. AqH samples will be collected in an Eppendorf tube. All samples will kept frozen at -20ᵒC.

Ofloxacin concentrations will be determined by HPLC-MS/MS.

DED severity, symptoms (Ocular Surface Disease Index) and signs (corneal staining using the Oxford score) will be correlated to ofloxacin's concentration in the AqH.

Eligibility Criteria:
Inclusion Criteria:

* cataract surgery
* willing to participate

Exclusion criteria:

* presence of exfoliation material within the anterior segment of the eye
* pigment dispersion syndrome
* anterior chamber angle \< 20ᵒ
* other ocular pathology than cataract
* abnormal eyelid function
* diabetes mellitus, renal or hepatic failure
* chronic topical ocular treatment
* systematic antibiotic treatment
* allergy to fluoroquinolone antibiotics
* contact lens use
LensAge to Reveal Biological Age

Assessment of aging is central to health management. Compared to chronological age, biological age can better reflect the aging process and health status; however, an effective indicator of biological age in clinical practice is lacking. Human lens accumulates biological changes during aging and is amenable to a rapid and objective assessment. Therefore, the investigators will develop LensAge as an innovative indicator to reveal biological age based on deep learning using lens photographs.


Eligibility Criteria:
Inclusion Criteria:

* ages from 20 to 100 years
* have anterior segment photographs
* have ophthalmic and physical examination records

Exclusion Criteria:

* have a history of previous eye surgery, eye trauma, or ocular diseases that can cause complicated cataracts
* baseline information missing