cyrilzakka/clinical-trials huggingface dataset:
Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial

Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.

Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.

The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.

Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.

Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.

The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 1- Adult patients (aged \>18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.

Exclusion Criteria:

1. Residual ureteral or renal stones after the procedure as documented by the surgeon
2. Patients who will need auxiliary procedures (ESWL , re-FURS or PCNL)
3. Preoperative febrile UTI
4. pregnancy or breastfeeding
5. Bilateral ureteroscopic surgery
6. Single kidney
7. Chronic kidney disease
8. Cardiovascular or cerebrovascular disease
9. Hepatic dysfunction
10. Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Newborns ≥35weeks gestation with chronic in-utero opioid exposure (\>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care
* Neonates born at Penn State Hershey Medical Center or transferred at \<48 hours after birth
* Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)

Exclusion Criteria:

* \<35 week gestation
* Infant required mechanical ventilation or non-invasive mechanical support
* Infant exposure to magnesium sulfate
* Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\<48hours after birth).
* Infant with major congenital anomalies
* Parent or guardian unable to provide consent
* Mothers and neonates without history of opioid exposure/dependence
Online Intervention Based on Pain Neuroscience Education for Women with Pregnancy-related Lumbopelvic Pain

60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.

60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial origin makes it difficult to establish an appropriate treatment for pain control. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. This type of education is based on reconceptualizing pain through teaching the neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in pregnant women with pregnancy-related low back and pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women older than 18 years, who are in the early third trimester of pregnancy;
* minimum score of 3/10 on the numerical pain scale over the past week.

Exclusion Criteria:

* multiple pregnancy;
* previous spinal surgery;
* presence of psychiatric disorders;
* women who have participated in similar programs or interventions before enrollment.
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor

The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18 to 75 years of age, inclusive at screening.
2. Body mass index (BMI) between 18 and 35 kg/m², inclusive, at screening.
3. Diagnosis of Essential Tremor (inclusive of Essential Tremor plus) as defined by the Movement Disorders Society Consensus Criteria for Tremor.
4. Confirmation of bilateral upper limb action tremor in the absence of overt dystonia, ataxia, or parkinsonism.
5. History of onset of tremor before 65 years of age.
6. Tremor Performance score of ≥ 2 on at least 2 of the 6 upper limb manoeuvres (Item 4) on the TETRAS Performance Subscale and a total TETRAS Performance score ≥15 at screening.
7. All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study drug.

Exclusion Criteria:

1. Evidence of any acute (at screening or prior to first dose) or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator.
2. Have direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
3. Have known history of other medical or neurological conditions that may cause or explain subject's tremor.
4. Have had prior magnetic resonance guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
5. Have a history or evidence of clinically significant cardiac conduction abnormality, uncontrolled bradyarrhythmia, heart failure, or long QT syndrome.
Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap in Lusaka, Zambia

The goal of this study is to assess the individual and combined effects of hand hygiene promotion and hardware provision on handwashing with soap behaviour at critical handwashing timepoints in households in peri-urban communities in Lusaka, Zambia.

Households will be randomly allocated to one of the four groups: AB) Hand hygiene promotion + Hardware provision, A) Hardware only, B) Hand hygiene promotion only or C) No intervention.

Researchers will compare handwashing behaviour between the four groups to see which is most effective.

This study is a factorial randomised-controlled trial. A total of 1800 households within five wards in Lusaka will be enrolled. Eligible households include households with at least one child under the age of 5, with no fixed handwashing facility, and at least one adult (18+) who can consent to the study. Households must also be permanent residents of the communities.

Households will be randomly assigned to one of four arms (450 households per arm) (1:1:1:1): (AB) hand hygiene promotion + handwashing hardware provision, (A) handwashing hardware provision only, (B) hand hygiene promotion only, (C) control group (receive most effective intervention after the study ends).

For households receiving the hardware intervention, a handwashing facility with supplies to make liquid soap (soapy water) will be provided and left with households for six months, with a visit at 3-months to check the handwashing facility is functioning and to provide more soap supplies. For households receiving the hand hygiene promotion intervention, bi-weekly household visits (30 minutes) will be conducted over a three-month period for a total of 5 planned "touch points".

Handwashing with soap (HWWS) at critical handwashing junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) will be measured using 3-hour structured observations of one household member per household, conducted at baseline and endline (6-months are intervention delivery begins).

Eligibility Criteria:
Eligibility is assessed at the household level.

Inclusion Criteria:

* At least one adult (aged 18 or older) who can consent to the study on behalf of all members of the household.
* At least one child under the age of 5.
* No fixed handwashing facility (e.g., sink or handwashing station)
* Permanent residents of the selected community.

Exclusion Criteria:

* No adult (aged 18 or older) can provide consent.
* No child under the age of 5.
* Already own a similar handwashing facility (e.g., sink, handwashing station).
* Not permanent residents of the selected community.
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.

The primary objectives of this study are as follows:

* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1.


Eligibility Criteria:
Key Inclusion Criteria:

* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.

Key Exclusion Criteria:

* Individuals planning to switch to B/F/TAF on Day 1 cannot have plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.

  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
* Individuals planning to switch to B/F/TAF must not have any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
* For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
* For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
* Ongoing treatment with or prior use of any prohibited medications.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.


Eligibility Criteria:
Major Inclusion Criteria:

Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy

Major Exclusion Criteria:

1. intolerance of or allergy to ticagrelor or prasugrel
2. history of any stroke, transient ischemic attack or intracranial bleeding
3. known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm
4. active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding
5. fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
6. known platelet count \< 100.000/μL at the time of screening
7. known anemia (hemoglobin \<10 g/dL) at the time of screening
8. oral anticoagulation that cannot be safely discontinued for the duration of the study
9. INR known to be greater than 1.5 at the time of screening
10. chronic renal insufficiency requiring dialysis
11. moderate or severe hepatic dysfunction (Child Pugh B or C)
12. increased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)
13. index event is an acute complication (\< 30 days) of PCI
14. concomitant medical illness that in the opinion of the investigator is associated with a life expectancy \< 1 year
15. concomitant oral or i.v. therapy with strong CYP3A Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \> 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued
16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
17. no written informed consent
18. participation in another investigational drug study
19. previous enrolment in this study
20. for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
21. Pregnancy, giving birth within the last 90 days, or lactation
22. inability to cooperate with protocol requirements
Pentoxifylline for Primary Biliary Cirrhosis

Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.

Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC patients.

Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1) are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known clinical and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline (PTX) will result in improvement of liver disease in PBC patients who are incomplete responders to UDCA.

The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters of liver disease and levels of cytokines involved in the pathogenesis of the disease in patients with PBC.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ages 18 to 76 years.
* Established diagnosis of PBC based on at least three of the following criteria:

  * Detectable anti-mitochondrial antibodies (AMA)
  * Cholestatic biochemical pattern
  * Liver biopsy compatible with PBC
  * Appropriate exclusion of other liver diseases.
* Therapy with UDCA at adequate dose (13-15mg/kg/d) for at least six months and evidence of suboptimal response defined by alkaline phosphatase levels that did not normalize and remain elevated by at least 1.5 times the upper limit of normal.
* No history or present hepatic decompensation (e.g. variceal hemorrhage, encephalopathy, or poorly controlled ascites).

Exclusion Criteria:

* Findings highly suggestive of liver disease of other etiology.
* A score \>=10 points on the Revised Scoring System for autoimmune hepatitis (AIH), supporting a diagnosis of PBC/AIH overlap.
* Patients on steroids (systemic), immunosuppressants, or immunomodulatory agents within the previous 6 months.
* Patients with clinical or laboratory evidence suggestive of decompensated cirrhosis.
* Hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, theobromine).
* History of cerebral or retinal hemorrhage.
* Other medical comorbidities (such as cardiac, renal, cancer) that would interfere with completion of the study.
* Patients taking Theophylline or Coumadin because of potential drug-drug interactions with PTX. In addition, patients taking low molecular weight heparin preparations.
* Pregnant or nursing women.
Effects of an Acute and Chronic Training Protocol Associated to the Inter-set Velocity Loss

This study evaluates different performance, physiological and neuromuscular changes after acute and chronic resistance training intervention in physically active men. The participants will train with a single exercise (full squat) and will be monitored with a linear encoder. The experiment will consist of between 3 to 6 sets between 70% to 85% of 1RM in the full squat exercise. Two main groups will form the intervention: one group will perform inter-set repetitions until there will be a 20% of velocity loss compared to the first repetition, while the second group will have a 40% of velocity loss.

The main dependent variables and instruments will be:

1. Tensyomiography: neuromuscular properties of the vastus lateral (VL), rectus femoris (RF) and vastus medialis (VM) from the dominant leg.
2. Force platform: kinetic variables in relation to a countermovement jump.
3. Near-infrared spectrography: oxygen saturation in the VL and VM.
4. Termographic camera: low limbs temperatura.
5. Linear encoder: mean propulsive velocity from each repetition
6. Electromyography: amplitude and frequency parameters related to a knee extension maximum voluntary contraction test.
7. Strain gauge: maximum isometric force.

Eligibility Criteria:
Inclusion Criteria:

* To be healthy
* Without injuries or actual illnesses
* More than 2 years of experience in resistance training or federative sports

Exclusion Criteria:

* To be sick or injured
* To have programmed during the intervention phase a dramatic change in the lifestyle
Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status

These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).
* Patients who are to be treated with clinically approved or experimental regimens where ER has an important role
* ECOG performance status of 0-2.
* Patients must provide written informed consent

Exclusion Criteria:

* Age \<18 years
* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)
* Pregnancy or lactation
* Total serum bilirubin \> 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.
* Serum creatinine \> 1.5 times upper limit of normal.
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.

This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection in female patients, age ≥18 years
* Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
* Plasma HIV viral load \<50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
* Fasting LDL cholesterol \>130 mg/dl
* Fasting triglycerides \<450 mg/dl

Exclusion Criteria:

* History of virological failure during previous antiretroviral therapy