cyrilzakka/clinical-trials huggingface dataset:
Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
* Patients with urgency episodes and frequent micturitions
* Written informed consent has been obtained
* Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume \< 50 mL

Exclusion Criteria:

* Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
* Patients with obvious stress urinary incontinence
* Patients with complications or who have a past history of a bladder tumor
* Patients with urethral stricture or bladder neck stenosis
* Patients with a history of surgery causing damage to the pelvic plexus
* Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
* Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder
Haemoadsorption During Heart Transplantation

To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing heart transplantation

Exclusion Criteria:

* Declined informed consent
* Age \< 18 years#
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
* DCD
* Ex-vivo perfusion
Evaluation of Nutrition and Metabolism in Breast Cancer Patients

With the increased success in breast cancer therapies, survivors develop unhealthy changes in body composition, such as muscle loss and fat gains, which lead to increased risk of cardiovascular disease and diabetes in survivorship. This study will examine the effects of a nutrition, cardiovascular and strength exercise program compared with a yoga program (representing usual care) on body composition and metabolism in recently diagnosed breast cancer patients. Nutrition and exercise may improve various body composition and metabolic parameters, which may improve quality of life in survivorship, reduce risk of recurrence and reduce the risk of developing cardiovascular disease and diabetes in survivorship.

Despite the increased success of novel anti-neoplastic therapies, breast cancer patients receiving chemotherapy develop unfavourable changes in body composition, including lean tissue loss and fat gains (1,2). These detrimental changes associate with poor quality of life (3,4) and may lead to treatment complications (5,6) during the cancer trajectory. In non-malignant populations, fat gain and muscle loss associate with increased risk of cardiovascular disease and diabetes (7). Cancer survivors who gain fat and lose lean mass are not only predisposed to these diseases but also have an increased risk of cancer recurrence (3). Proper nutrition as well as exercise can independently improve metabolic profiles (i.e. immune function, lipid and glucose metabolism) and overall health outcomes in non-malignant populations (7-9). While exercise has enhanced quality of life in breast cancer patients (4), overall nutritional needs and the metabolic benefits of exercise are unclear in this patient group. Understanding the effects of nutrition and exercise interventions in breast cancer patients will form the basis for future studies and programs that integrate nutrition, exercise, and metabolism to reduce cancer recurrence and other morbidities in survivorship. This study will examine the effects of nutrition and exercise intervention on body composition and metabolism in recently diagnosed breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years old or older
* Recent diagnosis of breast cancer and up to 4 weeks following the first cycle of chemotherapy or up to the first 4 weeks of radiation therapy
* Clinical Stages I-IIIa
* Able to communicate freely in English
* Have sufficient cognitive ability to participate and provide informed consent

Exclusion Criteria:

* Any known diagnosis of cardiovascular disease and thyroid disease that is not currently managed with medication or other therapies
* Any known diagnosis of diabetes or HIV
* Pre-existing injuries or health conditions that prevents the patient's safe participation in exercise
* Any previous diagnosis of cancer within the last 5 years (other than carcinoma in situ)
* Fasting glucose \>7.0 mM at baseline of the study
* Pregnant individuals will be excluded from this study
Multimodal Analgesia in Cardiac Surgery (Pilot Study)

The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Cardiac surgery is associated with significant acute pain and a proportion of these patients will develop chronic pain.

Opioids are the main stay of analgesia in cardiac surgery because of the safer hemodynamic profile and sedation. However high dose narcotic use is associated with a variety of unwanted side effects prolonging postoperative recovery. There is growing evidence for the effectiveness of multimodal approach utilizing opiate sparing techniques for enhancing patient recovery following surgery. Early extubation has been associated with improved patient outcome and cost effectiveness in cardiac surgery. The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. All of the above anesthetic drugs have opioid sparing effect in surgical Patients.

Dexmedetomidine use has been associated with decreased cardiac arrhythmias and improved neurological outcome in cardiac surgical patients. Ketamine has been linked with attenuation of postoperative cognitive dysfunction after cardiac surgery. Both intravenous lidocaine and spinal morphine have been shown to reduce opioid consumption in the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

* Elective CABGs and/or Valve replacements, ≥ 18 years old

Exclusion Criteria:

* Re-do cardiac surgery, Acute endocarditis, Circulatory arrest, Emergent cases, Shock, Left Ventricular Assist Device, Transplantation, Transcatheter Aortic Valve Replacement, contraindications for Spinal including coagulopathy and Clopidogrel \<7days, psychosis, known allergy to any of the study drugs, Preoperative liver dysfunction (AST/ALT \> 2 times normal) and Renal dysfunction (Cr \> 2 mg/dL), inability to administer spinal anesthetic, preoperative opioid use, patients who are unable to give their own consent, expected prolonged intubation postoperatively (\>12 hrs), prisoners, pregnancy
Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study

Bariatric surgery provides a strong and long-term effect in reducing weight in obese subjects. Studies showed that obesity and its comorbidities are associated with a lower cognitive performance. The aim of the researchers study is to examine the cognitive performance of the patients before and after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40
* Age: 18-60

Exclusion Criteria:

* BMI \< 40
* Age \< 18 and \> 60
* Presence of Cancer
* Presence of Chronic Inflammatory Diseases
* Presence of Addiction
Gastric Ultrasound Assessment for Patients Taking Cannabis

The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who report cannabis use.

Cannabis use in the United States has continued to increase in recent years, particularly in the adult population. Ease of access through legalization paired with improved public perception has contributed to the uptick in cannabis use. The subset of cannabis users suffering from pain who present for surgery pose a risk for perioperative aspiration due to the slowing of gastric motility due to cannabis use. There is currently no adapted NPO guideline to account for cannabis use.

Gastric Ultrasound (GUS) can be used as a bedside tool for assessing a patient's stomach contents and risk of aspiration. GUS can identify whether a patient's stomach is empty or filled with clear liquid, thick liquid, or solid food. The volume of the stomach can be accurately calculated if there is clear liquid content. A full stomach is categorized as those with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight. As GUS is noninvasive and does not pose risk to patients, it is a useful tool assessing aspiration risk in the preoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Any patient reporting preoperative cannabis usage within 1 month of surgery date

Exclusion Criteria:

* Patient refusal to participate
* Patient with gastric bypass or any other gastric surgery
* Large hiatal hernia
* Patients with large ascites
* Patients on peritoneal dialysis
* Emergency surgery
* Pre-existing diagnosis of gastroparesis
* Parkinson's disease
* Diabetes
* Currently taking metformin
* Chronic kidney disease stage 3 or higher
* Creatinine ≥ 1.2
* Esophageal surgery
* Currently taking GLP1 agonist medication
Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction

This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin wax chewing gum replaced the originally planned coconut oil and served as a placebo comparator.

The study was a randomized controlled clinical trial, unblinded. After obtaining consent and assent, respectively, and following review of medical history with regard to inclusion/exclusion criteria, if the participant met eligibility criteria, the participant was randomly assigned to one of four groups being studied: chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar-free) or deionized water with a randomization ratio of 1:1:1:1. A pre rinse/chew salivary sample was obtained by having the participant spit into a sterile test tube. The participant then either rinsed with 10mL of the assigned rinse for a timed 30 seconds and expectorated, or chewed paraffin wax chewing gum for 2 minutes. A post rinse/chew salivary sample was taken similarly to the pre rinse/chew sample. The samples were transported to a microbiology lab for incubation and quantitative analysis of Streptococcus Mutans. Morphological identification of the bacterial colonies was then confirmed using Matrix Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the dental clinic for routine dental treatment (including recall exams, new patient exams, and operative appointments) who are American Society of Anesthesia (ASA) class I or II
* Cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating Scale,
* No known allergies or sensitivities to products or ingredients being tested
* Had untreated cavities
* Nothing to eat/drink for 1 hour prior to dental appointment

Exclusion Criteria:

* Patients who are ASA class III, IV, V or VI
* Known allergies or sensitivities to any of the mouth rinses or any of the ingredients in the mouth rinses to be tested
* Non-English speaking parent/participant
* Patient presenting to the clinic as a walk in or emergency appointment
* Patient experiencing any pain or sensitivity
* Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to the Frankl Behavioral Rating Scale
Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for non-emergency bronchoscopy
* Must provide signed informed consent
* Male or female above 18 years old
* Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope

Exclusion Criteria:

* CT done over a month before the bronchoscopy procedure
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care

Eurobact II will investigate the mortality and morbidity of hospital-acquired blood stream infections in patients treated in intensive care units (ICU). It will investigate the effects of the micro-organism and its characteristics, such as type and resistance to antibiotics on the infection and its consequences. It will also investigate the effects of the antibiotics and other treatments on survival of patients. Eurobact II will include patients from multiple ICUs in multiple countries.

Eurobact II is a multinational multicentre cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs around the globe. It will provide with an update of the epidemiology of HA-BSI since the Eurobact I study. It is designed to investigate the effects of HA-BSI on mortality at day 28. To describe the determinants of outcomes of HA-BSI, specifically the effects of the source of infection, the microorganism, the characteristics of antimicrobial therapy and of source control. It will investigate patient specific and organizational factors and will describe the determinants of management of HA-BSI in ICUs.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Years.
* Hospital Acquired Bloodstream Infection (HA-BSI).
* Treated in the ICU.

  * ICU acquired OR
  * Hospital acquired prior to ICU admission

Exclusion Criteria:

* Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI.
* Previous inclusion in the study.

  * HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.
Adjunct Inversion for Lower Pole Stone

This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.


Eligibility Criteria:
Inclusion Criteria:

1. Solitary lower pole caliceal stone which is \> 5 mm and \< 20mm
2. Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
3. Patient able to comply strictly with visits/medications
4. Patient willing and agrees to enter study

Exclusion Criteria:

1. Impaired function of the affected kidney
2. Gross hydronephrosis of the affected kidney
3. Associated distal obstruction
4. Multiple stones
5. Stone more than 2 cm in size
6. Diverticular stone
7. Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
8. Patients who are unable to tolerate the procedure
9. Significant cardiac condition that does not allow the administration of force hydration or inversion.
10. Uncontrolled hypertension
Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

The loop electrosurgical excision procedure (LEEP) is a modified cervical conization that is performed with an electrosurgical loop. It may be performed under local anesthesia (LA) or under general anesthesia (GA), and practice patterns differ widely. In some countries, specific guidelines for the choice of anesthesia during LEEP are provided, whereas, in other countries, the choice of anesthesia is not specified. LEEP under LA is more economical, obviating the need for anesthesia staff, equipment, and operating room fees. However, LEEP under LA may be more difficult to perform, may be more difficult to learn, may lead to inferior surgical results, and may result in more pain and patient dissatisfaction. This study aimed to compare loop electrosurgical excision procedures under local anesthesia vs general anesthesia regarding patients' satisfaction, histopathologic results, and short-term morbidity


Eligibility Criteria:
Inclusion Criteria:

Patients were \> 21 years old; were not pregnant

The patient had one of the following indications for LEEP:

1. histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL);
2. a histology-proven high-grade squamous intraepithelial lesion (HGSIL);
3. discrepancies between cytological reports and colposcopic impressions;
4. investigation for unsatisfactory colposcopy;
5. microinvasion or adenocarcinoma in situ on cervical punch biopsy.

Exclusion Criteria:

Patients with cervical or vaginal infection; Patients with an abnormal menstrual cycle; who were taking anticoagulants, Patients with a coagulation defect Patients with mental incapacity Patients with previous hysterectomy with removal of the cervix Patients with a history of cervical cancer.
Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients

The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

We already know that tracheal intubation increased intraocular pressure. We tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the I-gel and LMA Supreme supraglottic airway devices. We enrolled the pediatric patients who are undergoing to strabismus surgery.

Eligibility Criteria:
Inclusion Criteria:

* pediatrics \> 2 years
* pediatrics \< 7 years
* undergoing strabismus surgery

Exclusion Criteria:

* pediatrics \< 2 years
* pediatrics \> 7 years
* neuromuscular blockage using
A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.


Eligibility Criteria:
Inclusion:

The main inclusion criteria include but are not limited to the following:

- Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression \[Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \<50 copies/mL\] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.

Exclusion:

The main exclusion criteria include but are not limited to the following:

* Has Human immunodeficiency virus type 2 (HIV-2) infection.
* Has a diagnosis of an active Acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
* Has active hepatitis C virus (HCV) coinfection.
* Has hepatitis B virus (HBV) coinfection.
* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
* Has prior exposure to Islatravir (ISL) or Ulonivirine (ULO) for any duration any time prior to Day 1.
Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity

This protocol is for the treatment of toxic plasma methotrexate concentrations (\>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

This treatment protocol will be available on a cost recovery basis to IRB-approved Investigators treating an eligible patient at any site in the US. In order to continue to make Voraxaze™ available following FDA approval and prior to being commercially available. Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™ under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations (21 CFR 312.8) to charge for Voraxaze, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit).

Patient eligibility is based on MTX concentrations and laboratory values obtained per standard of care. Once an Investigator identifies a potential patient, he/she will contact the Voraxaze central call center (1-877-398-9829) to receive information regarding drug shipment. Eligible patients will have routine demographic, MTX, and Voraxaze therapy information collected.

Each patient will receive a single dose of Voraxaze 50 Units/kg in a bolus intravenous injection over 5 minutes. In addition to Voraxaze, patients will continue to receive standard of care treatment including leucovorin therapy, and supportive care such as hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any age who are experiencing delayed MTX clearance due to impaired renal function will be eligible to receive Voraxaze if the have toxic plasma MTX concentrations (\>1 micromole per liter).

Exclusion Criteria:

* Voraxaze is not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to MTX.
* Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)

Patients intolerant to lactose in food (e.g., dairy products) can still receive Voraxaze.