cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome

A multicenter, randomized, study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly assigned to an open label treatment with either prednisone

1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The outcome will be compared during one-year follow up

The treatment for minimal change nephrotic syndrome (MCNS) is empirically based on high dose steroid. However, the side effects in adult patients are often significant and induce a lot of complications. This prospective study aimed to compare low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in the treatment of the first episode of MCNS.

Treatment Plan

After baseline evaluation including clinical biological and histological analyses, all eligible patients will be an open label assigned to two groups:

Group A: patients will receive prednisone 1 mg/kg/day for 4 weeks. Then, the dose will be progressively tapered if the remission will be achieved. For patients who exhibit incomplete remission at this time, high dose steroid will be continued for 4 weeks again before the tapering.

Group B: patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. The management of steroid therapy will be identical in both groups, while MyforticR will be continued for six months.

In both groups, patients who will not achieve remission after 8 weeks of steroid therapy at full dose will be excluded from the study.

Statistical Analysis In this multicenter, randomized trial, the primary and secondary end points will be the rate of complete remission within 4 and 8 weeks of the start of induction therapy, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic nephrotic syndrome
* Flare of idiopathic syndrome without treatment from one year
* Confirming by Renal Biopsy

Exclusion Criteria:

* Secondary nephrotic syndrome
* Pregnancy
* Focal Segmental Glomerular sclerosis lesion in the Biopsy
* Neutropenia \< 2000/mm3
* Hb\<9gr/dl
Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis

The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach.

Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years
* Pain on the lateral side of the elbow for at least 4 weeks
* Tenderness over the lateral epicondyle
* Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)

Exclusion Criteria:

* Be younger than 18
* Having had ESWT treatment in the elbow area before
* History of injection, surgery, physical therapy in the elbow area in the last 3 months
* Previous elbow surgery
* History of radius/ulna fracture
* A history of cervical and shoulder problems
* having bilateral symptoms
* concomitant medial epicondylitis
* Malignancy
* Pregnancy
* Systemic rheumatologic disease or systemic infection
* inserted cardiac pacemaker
* presence of coagulation disorders
* Cognitive disfunction
Bioequivalence Study Of Pediatric Appropriate Formulation

To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Determination of Bioequivalence

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female volunteers
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable and receiving stable PD for ≥ 3 months;
* BMI ≤ 45;
* Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
* On Glucose lactate-buffered PD solutions with consistent glucose exposure.

Exclusion Criteria:

* Pregnancy or breast-feeding;
* Intolerance to the study protocols;
* Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
* Chronic use of anti-inflammatory medication except low dose (\< 10mg/d) prednisone;
* Severe hypokalemia (K+ level \< 3.0 mEq/L);
* Hypercalcemia (Ca++ level \> 11.0 mg/dL);
* Have a glycogen storage disease;
* Intolerant to maltose or isomaltose;
* Allergic to cornstarch or icodextrin;
* Recent abdominal surgery in the past 30 days;
* Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease;
* Insulin-Dependent Diabetes Mellitus (IDDM).
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Primary Endpoint: Change in 6 minute walk distance.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven sarcoidosis
* Mean pulmonary artery pressure \> 25 mmHg at rest and greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
* Pulmonary capillary wedge pressure ≤ 15 mmHg
* PVR values \>3.0 Woods units
* Forced vital capacity (FVC) \>40%
* WHO functional class II or III
* Stable sarcoidosis treatment regimen for three months prior to entry into study
* 6 minute walk distance between 150-450 meters
* Stable dose of antihypertensive medications
* On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
* Non-pregnant females

Exclusion Criteria:

* Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
* Severe systemic hypertension \> 170/95
* Patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
* Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
* Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, etc.)
* Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
* WHO functional class IV status
* Patients with significant left ventricular dysfunction
* Significant liver dysfunction not due to sarcoidosis.
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
Neurophysiological Reserve With Caffeine Manipulation

The objective of this study is to verify if there is a neurophysiologic reserve when caffeine and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises. Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and peripheral metabolism will be measured

A neurophysiological reserve related to central mechanisms is supposed to be present, which should be observed when an increased central drive occurs. In theory, according to the central regulation model of effort, an increased performance could be due to the elevation on Central Nervous System excitability and activity, since exercise is not peripherally limited. Conversely, the absence of muscle performance improvement to the increased central drive promoted by caffeine would be an evidence for a peripherally localized neurophysiological limit and would indicate the absence of reserve. Therefore, if present, this reserve could be verified by using peripheral and central measures derived from electric-stimulation, evoked twitch and interpolated twitch techniques, associated to measures of EMG and peripheral metabolism, when caffeine is manipulated during closed- and opened-loop exercise.

In addition, there should also be possible to access the reserve without stimulant substance manipulation (placebo effect). By teleological argument derived from the central regulation model of effort, a neurophysiological reserve would be a natural mechanism to protect the cellular integrity. Therefore, it would be reasonable to hypothesize that, if present, a reserve would be observed by an increase in performance promoted by an elevation in central drive when placebo is perceived as caffeine. Unfortunately, however, no study utilized this experimental approach, including measures of central and peripheral activity during closed- and opened-loop exercise, to consistently respond the reserve question.

Eligibility Criteria:
Inclusion Criteria:

* trained cyclists
* trained in long distance races

Exclusion Criteria:

* Maximum oxygen uptake lower than 55 ml/kg/min
Promoting Informed Choice for Breast Cancer Screening

Identify the prevalence and predictors of reactance, self-exemption, disbelief, source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust.

In this study, the goal is to identify the prevalence and predictors of reactance, self-exemption, disbelief, and source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust. Research has not yet systematically identified the proportion of women who respond negatively (vs. positively) to evidence about the benefits and harms of mammography screening, or attempted to explain these responses by examining theory-driven predictors. The Investigator will develop and conduct a probability-based nationally representative survey in which mammography evidence is communicated using current best practices in risk communication. The Investigators will identify theory-driven predictors of negative and positive responses to that evidence, and identify consequences of these responses for screening decision-making and trust.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between 39-49 years of age
* No history of breast cancer
* No known BRCA 1/2 mutation

Exclusion Criteria:

* Non-English or Spanish Speaking
* Persons unable to provide informed consent (e.g. sever dementia or cognitive disability or illiterate
* History of breast cancer
* Known BRCA 1/2 mutation
Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use

The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.

Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI).

For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8 mg twice daily (or up to three times daily). This is the current standard of care.

For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8mg twice daily (or up to three times daily).

The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Male, female, transgender, or non-binary
* DSM-5 criteria for opioid use disorder, moderate to severe
* Fentanyl positive on urine drug test
* Able to provide written informed consent in English prior to any study-related procedure

Exclusion Criteria:

* Pregnancy or actively lactating
* Previously documented hypersensitivity or allergy to buprenorphine or naloxone
* DSM-5 criteria for substance use disorder other than opioid use disorder (e.g., cannabis, cocaine, alcohol)
* Current benzodiazepine use
* Urine drug testing at screening positive for buprenorphine and/or methadone
* AST and/or ALT \>3x upper limit of normal or total bilirubin \>1.5x upper limit of normal
* eGFR \<30 mL/min
* Use of CYP3A4-metabolized agents such as azole antifungals, macrolides, and protease inhibitors
* Significant medical symptoms (e.g. severe respiratory insufficiency), psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participate in the study
* Pending legal action that could prohibit participation and/or compliance in study procedures
Community Based Rehabilitation After Knee Arthroplasty

Background The CORKA study was developed in response to a commissioned call by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme for research into a functional home based rehabilitation programme for patients who may be at risk of poor outcome after knee arthroplasty.

Design The CORKA trial is a prospective individually randomised controlled trial with blinded outcome assessment at baseline, 6 and 12 months. The study will also include a qualitative and a health economic analysis. Participants will be randomised to one of two arms, 'home-based rehabilitation' or 'Usual Care'. Those in the usual care arm will receive a minimum of 1 and a maximum of 6 sessions of physiotherapy as delivered locally, e.g. class, one to one, etc. Those in the intervention arm will receive 7 sessions of a functional rehabilitation programme over a 12 week timescale. The intervention will be delivered using physiotherapists and physiotherapy assistants in the participants' home. Participants will be followed up at 6 months and 12 months


Eligibility Criteria:
Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study Male or Female, aged 55 years or above Primary unilateral KR as a scheduled procedure Deemed by study screening tool developed to be at risk of poor outcome Happy to allow physiotherapy teams to attend their home to deliver the Community based rehabilitation programme if randomised to the intervention arm.

Exclusion Criteria:

Any absolute contraindications to exercise Severe cardiovascular or pulmonary disease (New York Heart Association III-IV) Severe dementia, assessed using the hospital dementia screening tool Rheumatoid arthritis Further lower limb arthroplasty surgery planned within 12 months. Serious perioperative complications
Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia

Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development of cervical cancer. There is a vaccine available to prevent cervical lesions associated with high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination distribution of HPV genotypes in women with high grade cervical squamous intraepithelial lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is the most frequently found genotype but the distribution of other HPV genotypes is heterogeneous and includes genotypes currently not covered by vaccination.

This is a single-center cross-sectional study on the molecular virology of human papillomavirus (HPV) in Croatia. The study will enroll women aged 18-65 years of age with cervical intraepithelial neoplasia (CIN2+)cervical lesions that received clinical care at the Croatian Center for Pre-malignant and Malignant Diseases of the Cervix. Women with abnormal cytology (high grade cervical squamous intraepithelial lesion-HSIL, cervical cancer) in the period from 2010 to 2012 will be included. Relevant epidemiological and clinical data will be collected. Biological samples will include both biopsy specimens from cervix and cervical swab. Biological samples will be put in Digene Specimen Transport Medium (Qiagen, Gaithersburg, MD) and further analyzed at the Department of Molecular Diagnostics at the University Hospital for Infectious Diseases in Zagreb. HPV genotyping will be performed by using a standardized molecular assay INNO-LiPA HPV Genotyping Extra Test (Solvay S.A., Brussels, Belgium). Analysis of genomic variants of HPV 16 genotype will be performed by population-based sequencing of L1 genome region.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over Croatia that are referred to National Reference Center because of HSIL or malignant cytology findings

Exclusion Criteria:

* Women younger than 18 or older than 65
* Pregnant women
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.


Eligibility Criteria:
Inclusion Criteria:

* Person or parent who has given his or her non-opposition
* Person over 10 years of age
* Sick Subjects Group :

diagnosis of chronic infection by an ENT specialist doctor if patient already included: new episode \> 3 months after the complete clinical recovery from the previous episode observed by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics in the previous month.

Exclusion Criteria:

-
Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery

Upper aerodigestive tract neoplasms surgery results in important trauma, including swelling (oedemas) that can lead to respiratory tract obstruction and death from suffocation. To prevent this, protective tracheostomy is performed, allowing patients to breathe through a cannula during the critical phase. Although tracheostomy is reassuring, it presents complications, including swallowing disorders, refeeding delay and pulmonary infections. It generates anxiety for patients and can prevent them from communicating, which can affect their psychological well-being during hospitalization.

In Sainte Musse Hospital, patients who undergo upper aerodigestive tract neoplasms surgery are continuously monitored in intensive care unit. For some "at risk" patients, tracheostomy preparation is performed during operation with tracheal exposure but no incision. If dyspnea occurs, reanimators can quickly access to trachea and proceed to tracheostomy completion. This method, called PREPA-TRACH, avoids unnecessary tracheostomies while minimizing risks for the patients who would need it. Study purpose is to assess the security and reliability of this PREPA-TRACH protocol.

This retrospective descriptive monocentric study aims at producing a descriptive series of patients who underwent tracheal exposure in case of tracheostomy hoping to avoid them a complete tracheostomy. Its purpose is to demonstrate on one hand the reliability and security of this technique and on the other hand to define some imperative criteria of surgical indication for tracheostomy or no tracheostomy. The number of patients included corresponds to the eligible patients cohort of Hôpital Sainte Musse ENT surgery department over the 10 last years.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years)
* All patients managed for an upper airway and digestive tract carcinoma with trans-oral robotic surgery, with tracheal exposure performed during the surgical procedure without immediate tracheostomy completion.

Exclusion Criteria:

* Patients with immediate complete laryngectomy or complete pharyngolaryngectomy
* Patient opposition
* Patient under legal guardianship