cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches

This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score \>=7 or cancer core length \>=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.

The feasibility of outpatient TPM has been well demonstrated.(Bianco \& Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, \& Moore, 2013)

This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI
* Men on active surveillance with indication for biopsy

Exclusion Criteria:

* Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula
* Men unfit to undergo prostate biopsy under local anesthesia
* Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
* Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)

The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 60 years.
* Patient with a diagnosis of probable AD
* Progressive decline in cognition for more than six months which story is documented in patient medical records
* A Mini-Mental State Examination (MMSE) score of 20-26
* With a minimum of educational background
* Naïve to anti-dementia treatment
* MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions
* If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis
* Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product
* Absence of major or severe depressive disease
* Patient with a willingness to participate in this study and who have signed an informed consent form

Exclusion Criteria:

* Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms
* Significant neurological disease other than AD
* Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)
* Seizure disorders
* Other infectious, metabolic or systemic diseases affecting central nervous system
* Other active clinically significant illness
* Hospitalization or change of chronic concomitant medications one month prior to screening
* Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening
* Known hypersensitivity to the tested treatment including active substance and excipients.
* Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study.
* Patient without medical care insurance
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 45 years
* BMI score 19 kg/m2 to 28 kg/m2
* SBP \< 140 mmHg and ≤ 90 mmHg or DBP \< 90 mmHg and ≥ 50 mmHg
* Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
* Voluntarily signed the informed consent form

Exclusion Criteria:

* Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
* History of hypersensitivity
* history of Cardiovascular disease
* History of degenerative Retina disease
* Lactose intolerance
* Medical history of vision loss
* Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
* Donated whole blood (transfusion, apheresis etc..) within 60 days
* Participated and administered the investigational products in other clinical trial within 90 days
* Taking drugs which may affect Clinical trial within 30 days
* Smoked more than 10 cigarettes a day for past 30 days
* Excessive alcohol consumption (\> 3 units/week, 1 unit)
* Taking food which may affect Clinical trial within 7 days
* Positive result from Urinary test
* Positive result from Serum test
* Clinically significant disorders result from Electrocardiography test
* Not eligible due to investigator's judgments
The Effect of Angiotensin Receptor-Neprilysin Inhibition on Cardiac Fibrosis in Patients With HFpEF

The effectively therapeutic approaches for Heart failure with preserved ejection fraction (HFpEF) remain limited. The PARAGON-HF trial found that Angiotensin Receptor-Neprilysin Inhibition (ARNI) has potential benefits for the management of HFpEF. Nevertheless, the role of ARNI in cardiac fibrosis in HFpEF are still unclear. We will conduct a prospective randomized controlled trial to evaluate the effect of ARNI on cardiac fibrosis in patients with HFpEF by cardiac magnetic resonance (CMR).

Heart failure with preserved ejection fraction (HFpEF) comprises approximately 50% of all heart failure. The effectively therapeutic approaches for HFpEF remain limited. The PARAGON-HF trial found that Angiotensin Receptor-Neprilysin Inhibition (ARNI) has potential benefits for the management of HFpEF. Nevertheless, the role of ARNI in cardiac fibrosis in HFpEF are still unclear. We will conduct a prospective randomized controlled trial to evaluate the effect of ARNI on cardiac fibrosis in patients with HFpEF by cardiac magnetic resonance (CMR). We will randomly assign 60 patients with HFpEF (NYHA II-IV) class, ejection fraction ≥ 50% and elevated level of natriuretic peptides to receive sacubitril-valsartan (target 100mg bid) or placebo (100mg bid). The primary endpoint is change in extracellular volume \[ECV\] measured by CMR. The secondary endpoints were 6-minute walking distance(6-WMD), KCCQ, hospitalizations for heart failure, myocardial infarction and death.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent
* Age ≥ 45 years at time of screening
* Preserved systolic left ventricular function, defined by left ventricular ejection fraction (LVEF) ≥ 50%
* NYHA classes II-IV
* H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5

Exclusion Criteria:

* Patients with a known history of angioedema
* History of hypersensitivity to ARNI
* Any prior echocardiographic measurement of LVEF \<45%
* Significant congenital heart disease
* Rheumatic valvular heart disease
* Acute coronary syndrome, cardiac surgery, other major cardiovascular surgery
* Probable alternative diagnoses could account for the patient's HF symptoms
* Systolic blood pressure(BP) \>180 mm Hg or diastolic BP \>120 mm Hg at visit
* Diastolic BP \<90 mm Hg at visit 1, or symptomatic hypotension
* Patients with a cardiac pacemaker therapy device
* eGFR \<30 ml/min/1.73 m2
* Serum potassium \>5.2 mmol/l at visit 1
* Pregnant or nursing women
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months

OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patient who had endophtalmitis following an OZURDEX implant injection within 2 months

Exclusion Criteria:

* Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis
Influence of Pb&Cd Seminal Plasma Level & ICSI

To evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

The inability to have children, both by natural procreation and medically assisted reproduction, is not only a challenge for medical science but also an economic and social problem. Infertility is a complex disorder with multiple genetic and environmental causes (Gill et al.,2018) One of the factors that may be responsible for this phenomenon is contamination of the environment with heavy metals Two of the most widely-recognized reproductive toxins are lead (Pb) and cadmium (Cd) (Wdowiak et al., 2018).

Food, water and tobacco and smoking are the primary source of baseline exposure to lead and cadmium (Tong et al., 2000; Bernard, 2008) Each of cadmium and lead were inversely correlated with semen parameters as, ejaculate volume, sperm count, sperm concentration, live sperms and rapid mobility. ( Zaki et al.,2018).

Reproductive contaminants found in follicular fluid (FF) and seminal plasma may compromise the quality of oocytes and or sperm, which may become one of the risk factors for reproductive outcome. The data available suggests certain chemicals or their metabolite reaches the seminal plasma and/or FF, indicating their possible impact in In Vitro fertilization (IVF) outcome ,However, more studies are needed with regard to relationship between exposure level and affected parameters. (Kumar et al., 2010).

Eligibility Criteria:
Inclusion Criteria:

* Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
* First ICSI cycle
* Female partner ≤ 35 y-old

Exclusion Criteria:

* • Wife age \> 35 years

  * Frozen semen samples
  * Male partner with severe oligoasthenoteratozoospermia \<5 × 106 / mL and 5% progressive motility, included globozoospermia and pinhead samples, and surgically retrieved sperms
  * Poor responder women
  * Women with abnormal endometrium at hCG trigger day.
  * Women with BMI \> 31
  * Women with PCOS
  * Previous failed ICSI
  * OHSS)overian hyperstimulation syndrome)
  * Patients with systemic diseases affecting fertility
  * Patients on radiotherapy or receiving medications with gonadotoxic effect eg., chemotherapy
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
* Neurologic stability for greater than or equal to (\>=) 30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

* Primary progressive multiple sclerosis
* Disease duration of more than 10 years in participants with EDSS less than or equal to (\<=) 2.0 at screening
* Contraindications for MRI
* Known presence of other neurological disorders which may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection (e.g., hepatitis B or C, human immunodeficiency virus \[HIV\], syphilis, tuberculosis)
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or iv corticosteroids
* Contraindications to Rebif or incompatibility with Rebif use
The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation

The aim of this study was to research the effect of the Lumbar Spinal Rotational Mobilization technique on radiological findings, pain, disability and joint range of motion (ROM) in patients with lumbar disc herniation

In our study, it was aimed to investigate the acute effect of Lumbar Rotational Spinal Mobilization Technique on radiological findings, pain, disability and range of motion in 26 patients diagnosed with lumbar disc herniation(LDH) by magnetic resonance imaging(MRI) and physical examination. Disc height, herniation distance and facet joint distance of the patients were measured with MRI. Pain was assessed with the Visual Analogue Scale. Disability was measured with the Oswestry Low Back Pain Disability Questionnaire and Lumbar range of motion(ROM) was measured with a goniometer and tape measure. Rotational Spinal Mobilization Technique was applied to the patients in 2 sessions with a one-week interval, slowly and with 30 repetitions in both directions. All assessments were repeated within 1 week after treatment. It was observed whether there was an improvement in terms of radiological, pain, disability and ROM in the patients. 2 months after the 2nd evaluation, other parameters except the radiological evaluation were reapplied and it was tried to determine whether the effect persisted.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with LDH by MRI and physical examination
* Having pain due to LDH
* Be between the ages of 18 and 65

Exclusion Criteria:

* History Of Spinal Surgery
* History Of Autoimmune Disease (Ankylosing Spondylitis, Rheumatoid Arthritis Or Other Disease)
* Spondylolysis Or Spondylolisthesis
* Spinal Fracture
* Cardiac Pathology
* Stroke History
* Cauda Equina Syndrome,
* Continuous Painkiller Drug Use
* Spinal inflammation
* Spinal Tumor
* Corticosteroid Drug Use İn The Last Month
* Osteoporosis
Register of Blood Stem Cell Transplantation

Register of patients with blood stem cell transplantations (autologous, allogen).

Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation.

It's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy.

The inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient.

Eligibility Criteria:
Inclusion Criteria:

* signed IC
* patients eligible for stem cell transplantation

Exclusion Criteria:

* unable to consent to study participation
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers

This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that will have two parts; Part A and Part B.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - History of regular bowel habits
* Male or Female of non-childbearing potential.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions.

Exclusion Criteria:

* ALT and bilirubin \>1.5 x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Previous Diagnosis of IBS
* Estimated Glomerular Filtration Rate \<60 millilter per minute per 1.73 square meter (mL/min/1.73m\^2)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI) bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI surgery that could affect motility
* Unwillingness or inability to follow the procedures outlined in the protocol
Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?

For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.

Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral).

This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Meet ICHD-3 Migraine Headache Criteria
* Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2
* Nerve block performed with bupivacaine 0.5%

Exclusion Criteria:

* Head trauma
* Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)
* Headache in the setting of viral syndrome
* Chronically on steroids
* Known allergy to dexamethasone
* Unable to reach the patient by phone or text for follow-up
* Gestational diabetes or other uncontrolled diabetes
* Known to be immunocompromised
Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.

Recently, there has been much interest in the gamification of healthcare, such as virtual incentive spirometry gaming. Several studies have examined the addition of gamification e.g. virtual incentive spirometry devices. There is a paucity of data regarding the gamification of incentive spirometry, and there is no data involving trauma patients. Previous studies have enrolled either healthy volunteers or patients with specific lung pathology. This study to assess the safety, feasibility and efficacy of respiratory interventions in chest trauma patients using a therapeutic gamification platform.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if informed consent can be obtained from patient themselves and first session of incentive spirometry gamification can be performed within 48 hours of Trauma Intensive Care Unit (TICU) admission
* Adult patients (≥ 18 years of age) in the TICU with rib fractures or flail segment or a sternal fracture

Exclusion Criteria:

* Trauma patients in the TICU who are mechanically ventilated or requiring bilevel positive airway pressure (BiPAP)
* Glasgow Coma Scale (GCS) \< 15, at the time of enrollment
* Facial fractures precluding the use of incentive spirometry
* Any organ injury that precludes use of respiratory therapies in the clinical judgement of the clinical team
* Patients who are expected to be transferred out of the TICU or discharged from the TICU in the next 24 hours based on treating physicians judgment
* Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physician's judgment will not be included
* Patients unable to consent for themselves
* Patients unable to use the mouthpiece of the Omniflow system, and those who have visual or hearing impairments that could limit their ability to evaluate the games