cyrilzakka/clinical-trials huggingface dataset:
Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate

The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.

Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.

Eligibility Criteria:
Inclusion Criteria:

* Qmax \< 10 mL/s, IPSS \>19
* Age between 50 and 70 years
* Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.

Exclusion Criteria:

* Patients with neurogenic bladder
* Urethral stricture
* Bladder tumor
* Prostate cancer and previous prostate bladder neck
* Urethral surgery
* PSA\>4ng/ml, or receiving prostate biopsy within 3 months
Indomethacin PK-PD in Extremely Preterm Neonates

This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates \<27 weeks' gestational age.

Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female infant born between 23 (0/7) and 26 (6/7) week GA
* Infant diagnosed with PDA according to clinical protocol criteria
* Able to adhere to indomethacin administration protocol
* The patient is born in the study center.
* Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
* In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

Exclusion Criteria:

* known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system)
* genetic syndromes-inborn errors of metabolism
* severe renal compromise
* intrauterine growth retardation with birth weight \<3rd centile
* thrombocytopenia \<50,000/mm3
* moderate to severe pulmonary hypertension
* clinical sepsis -meningitis- hepatitis
* anticipated drug-drug-interactions (specifically CYP2C9, CYP2C19 and UGT 1-1)
Renal Mechanism of Action/Splay vs. TmG

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age 18 to 65 years
* BMI 18 to 35 kg/m2
* Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
* No evidence of impaired renal function

Exclusion Criteria:

* Unwilling or unable to use an acceptable method of birth control
* Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
* Exposure to insulin
* Use of exclusionary concomitant medications
* Evidence of significant kidney disease or any other significant medical or psychiatric disorder
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject provides written informed consent
* Subject is ≥ 18 years
* Subject is end-stage renal disease patient on hemodialysis.
* Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)

Key Exclusion Criteria:

* Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
* Subject has a topical or subcutaneous infection associated with the implantation site
* Subject has known or suspected systemic infection, bacteremia or septicemia
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir

The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound.

The study is seeking participants who:

* Have completed treatment with nirmatrelvir/ritonavir
* Have a rebound in COVID-19 symptoms
* Are SARS-CoV-2 (COVID-19) positive

All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home.

We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective.

People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.


Eligibility Criteria:
Inclusion Criteria:

* Documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. Symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
* Onset of rebound in COVID-19 symptoms within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
* Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and ≥1 sign/symptom attributable to COVID-19 present on the day of randomization.
* SARS-CoV-2 infection as determined by rapid antigen testing within 24 hours prior to randomization
* At least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

Exclusion Criteria:

* Current need for hospitalization, hospitalized for the COVID-19 infection or anticipated need for hospitalization within 24 hours after randomization
* History of severe chronic liver disease
* Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) \<30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device
* Oxygen saturation of \<92% on room air obtained at rest within 24 hours prior to randomization
* Immunocompromised.
* Current use of any prohibited concomitant medication(s)
* Females who are pregnant and \<14 weeks gestation
A Relation of Morphine-induced Itch and Pain Processing

In This experiment, the investigators would like to test the two following hypotheses regarding the mechanisms by which opioids cause itch:

1. Opioids cause itch by a spinal disinhibition mechanism (central nervous system (CNS) effect).
2. Opioids cause itch through a mast cell-destabilizing effect leading to release of histamine and tryptase in the skin where itch is evoked (peripheral mechanism).

Intrathecal and orally administered opioids are heavily used for the treatment of several acute pain conditions. However, while opioids are effective analgesics for acute pain, they are well-known to frequently cause itch (pruritus) as a side effect according with the two hypotheses stated above. So far, these two hypotheses have never been tested in humans.The present study describes a proposed study design for the purpose of confirming these two hypotheses in parallel in human subjects.

Primary endpoints of the study:

To evaluate changes itch and pain perception, and superficial perfusion after each itch provocations.

Secondary endpoints of the study:

To evaluate the existence of a correlation between itch sensitization and analgesic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women in the age of 20-65 years
* The participants must be able to speak and understand English

Exclusion Criteria:

* Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
* Pregnant or lactating female persons
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous or present neurologic, musculoskeletal or mental illnesses
* Current pain and itch causing diseases or psychiatric disorders
* Participants unable to understand or follow the instructions
* Participating in another study where investigational drug is used
* Participants had known allergy/discomfort to morphine
* Lack of ability to cooperate
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

We have fulfilled our enrollment requirements for this study.

This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.

Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).

Eligibility Criteria:
Inclusion Criteria:

* fulfilling Rome III criteria for IBS-D

Exclusion Criteria:

* major cardiovascular disease
* psychiatric illness except mild or moderate depression
* pregnancy
* presence of other GI disease that could explain IBS-like symptoms
* history of major gastric, hepatic, pancreatic or intestinal surgery or perforation
Montmorency Cherry Supplementation, Sleep, and Inflammation

This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of ≥ 25.0 kg/m2;
* sleep issues as identified by a global score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) and/or a score 8 or higher on the Insomnia Severity Index (ISI);
* ability to adhere to a diet low in antioxidants during the study period; and
* willingness to wear a Fitbit for the duration of the study and to wear the Zmachine on selected nights.

Exclusion Criteria:

* unwilling or unable to stop the use of sleep medication
* unable to attend laboratory visits on the East Lansing, Michigan campus
Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

The purpose of this study is to assess the efficacy of inspiratory muscle strength training for lowering blood pressure and improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults with elevated systolic blood pressure.

Over, the proposed research project has the long-term potential to influence clinical practice by establishing a novel lifestyle intervention for treating multiple domains of age- and hypertension-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Willing to accept random assignment to condition
* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.
* Resting systolic blood pressure 120-159 mmHg
* Resting diastolic blood pressure \<100 mmHg
* Subjects taking anti-hypertensive medications will be included provided they meet the other inclusion criteria, including elevated systolic blood pressure. These medications will not be withheld prior to experimental protocols.
* Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)

Exclusion Criteria:

* Current smoking
* Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive function \[multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia, or other brain diseases of aging\]), except hypertension
* Postmenopausal \<1 year
* Scoring \<21 on the mini-mental state examination
* Moderate or sever peripheral artery disease (ankle-brachial index 0.7)
* Taking a medication that your doctor deems unsafe to hold for \>1 week
* A graded exercise test will be performed by all subjects. If there is physician concern or an adverse event, the subject will not participate in the study.
* No weight stable in the prior 3 months (\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)
Reducing Vertical Transmission of Hepatitis B in Africa

Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.

The REVERT-B trial is a multi-center, phase III, randomized 2x2 factorial study designed to test the efficacy of early maternal TDF vs standard duration and neonatal 3TC prophylaxis compared to matching placebo in preventing HBV MTCT. Eligible pregnant women with HBV in prenatal care (n=450) will be randomized 1:1:1:1 to one of four maternal and neonatal prophylaxis combinations (shown as A-D in the figure below). Women will initiate daily oral TDF early (2nd trimester) or at the standard time per WHO guidelines (3rd trimester) and will continue TDF until delivery. The current WHO standard of care in pregnant women with HBV (EAg+) in Cameroon is TDF prophylaxis from 28 weeks until delivery. Newborns will receive liquid 3TC or matching placebo for the first six months of life to provide coverage until the vaccine series is complete. All infants in the study will be offered the 4-dose HBV vaccine series starting at birth.

The 2x2 factorial design allows for two simultaneous studies where we first assess efficacy of early maternal prophylaxis (Aim 1) and secondarily assess efficacy of neonatal prophylaxis (Aim 2). The study endpoint for both aims is the MTCT rate (proportion of infants HBsAg+) at 6-9 months of age. Women and infants will be followed until 6-9 months after delivery and subaims will assess safety and adherence to maternal TDF and neonatal 3TC. Plasma testing will be used to measure medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* prenatal clinic patient,
* age ≥16 years,
* 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
* active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA \>1000 IU/ML),
* plan to receive follow up care and deliver at study facility,
* capable of providing informed consent.

Exclusion Criteria:

* HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
* known liver cirrhosis or end-stage liver disease,
* elevated liver enzymes (ALT \>5x upper limit of normal),
* elevated serum creatinine (\>1.4 mg/dl)
* currently taking tenofovir medication
* allergy or intolerance to tenofovir study medication,
* known fetal anomaly in the current pregnancy,
* clinical illness requiring hospitalization at the time of enrollment
* evidence of early labor at the time of enrollment.
Cortisone and QTc-Interval

Scientific and clinical data report about shortening of QTc-interval in patients treated with cortisone. Peal et al. analyzed chemical suppression of long QT syndrome (Type 2) in an in vivo zebrafish model. Their study revealed that flurandrenolide reproducibly suppressed the long QT phenotype via the glucocorticoid signaling pathway. In contrast to treatment with dexamethasone and testosterone, treatment with pure mineralocorticoid deoxycorticosterone acetate did not suppress long QT phenotype. Knockdown of the glucocorticoid receptor or, conversely, of the androgen receptor showed that flurandrenolide acting through the glucocorticoid receptor shortens ventricular action potentials. The mechanism is distinct from trafficking rescue of the defective zebrafish-ERG channel. The authors discuss that a drug normalizing repolarization would be a novel therapeutic tool in long QT syndrome and conclude that glucocorticoids could be expected to aid in the acute management of patients with long QT syndrome, e.g. in episodes of arrhythmic storm. In addition, corticoid induced normalization of the QT interval is reported in a patient with drug-induced prolongation of the QTc interval. Brostoff et al. report on a patient suffering from mucocutaneous leishmaniasis treated with sodium stibogluconate. During therapy, the QTc interval prolonged and returned to normal within 4 days after starting glucocorticoid therapy with prednisolone 20 mg twice daily.

Interrogation of the study:

* shortens cortisone the QTc-interval?
* how long is the interval until shortening of QTc-interval?
* is the effect prolonged?
* is the effect dose dependend?


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent therapy with cortisone (\>=40mg/d)

Exclusion Criteria:

* patients with elevated intracranial pressure
* myocardial infarction within the last 6 months
* untreated stenosis of the coronary arteries
* right bundle branch block
* autoimmune disease
Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone

The investigators have performed colposacropexy in women with uterovaginal prolapse for many years with satisfactory results.

This study was designed to compare whether, in the treatment of patients with uro-genital prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure such as mini-sling is associated with a reduction of post-operative urinary incontinence (correction of pre-existent urinary incontinence and prevention of masked urinary incontinence).


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by III-IV grade urogenital urogenital prolapsed and urinary incontinence
* Candidates for pelvic organ prolapsed repair using sacropexy
* Prospectively randomized, using a predetermined computer-generated randomization code (4 blocks), to sacropexy plus anti-incontinence procedure (mini-sling) or sacropexy alone

Exclusion Criteria:

* fertile patients
* contraindication to major surgery
* uterine cancer
Cardiovascular Risk Predictors in Patients With Psoriasis

The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. The traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. As it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Written informed consent of the patient to participate in the study

Exclusion Criteria:

* Age under 18
* Pregnancy, lactation
* Very high cardiovascular risk
* Life-threatening, independently influencing prognosis and disabling diseases,
* Mental disorders that do not allow to give informed consent or answer questions adequately
* Refuse of the patient to participate in the study
Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy

To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).

This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.

This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years;
* Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
* WHO score \< 2
* Mastery of the French language;
* Patient affiliated with a social security system;
* Signature of informed consent prior to any specific procedure related to the study.

Exclusion Criteria:

* Patient with another cancer previously treated with radiation therapy;
* Simultaneous participation in a therapeutic clinical trial;
* Patient deprived of liberty or under guardianship;
* Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
* Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.