cyrilzakka/clinical-trials huggingface dataset:
Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

To determine if a protocolized approach to converting hemodialysis central venous catheters (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.

In order to receive dialysis, patients require repeated access to their bloodstream. This access can be either via a central venous catheter (CVC) or a surgically created arteriovenous fistula (AVF) or graft (AVG). This is a pilot randomized control trial of prevalent hemodialysis patients with a central venous catheter (CVC), to determine if a systematic approach using an algorithm protocol to convert the CVC to an AVF (arteriovenous fistula) will improve rates of functioning AVF and decrease CVC use. The algorithm (intervention group) will be compared to current practice (control group), a non-standardized approach at the discretion of the caring nephrologist and/or surgeon.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Dialyzing with a CVC
* Receiving hemodialysis three times weekly for \> 3 months

Exclusion Criteria:

* Awaiting peritoneal dialysis catheter insertion
* Scheduled living donor transplant
* Transient patients from out of province
* Expected transfer to satellite dialysis unit within 6 months
* Surgical plan for AVF (i.e. scheduled date)
* Documented lack of suitable vasculature for AVF
* Refusing AVF
Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each.

Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation

Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* hysterectomy on benign indication,
* American Society of Anesthetists group 1 or 2,
* BMI less than 35 kg/m2
* uterine size less than 300 g estimated by ultrasound, using Ferraris formula.

Exclusion Criteria:

* adhesions
* prior extensive abdominal surgery
* prior midline incision,
* cutis laxa of abdomen surgery
* endometriosis
* more than 1 cesarean section
* malignant disease
Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.

Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals with normal 12-lead electrocardiogram at rest.

Exclusion Criteria:

* systolic blood pressure below 90 mmHg;
* bradycardia (\< 45 heart beats/minute);
* intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
* impaired renal function assessed by venous blood sample.
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:

  1. Body Surface Area (BSA) affected by psoriasis ≥10 %
  2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
  3. Psoriasis Area and Severity Index (PASI) score is ≥12 or
  4. PASI score is ≥10 and \<12 with at least one of the following:

     * Clinically relevant facial or scalp involvement
     * Clinically relevant genital involvement
     * Clinically relevant palm and sole involvement
     * Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
* Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Exclusion Criteria:

* Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
* Study participant has generalized pustular or erythrodermic psoriasis (PSO)
* Study participant has guttate PSO without plaque PSO
* Study participant has had a primary failure to an anti-tumor necrosis factor agent
* Study participant has had prior exposure to \>2 biologic therapies
* Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.

Attention Deficit Hyperactivity Disorder(ADHD) is an important comorbid condition in patients with substance use disorders (SUD). The prevalence of ADHD in patients with SUD is estimated 23%, and ADHD is associated with an untoward prognosis of SUD. However, adequate treatment programs for patients with ADHD and SUD are not available. Results of medication trials for patients with ADHD and SUD are disappointing, and cognitive behavioral therapy (CBT) has not yet been investigated in this population. In patients with ADHD without comorbid SUD, the results of CBT in randomized trials are positive. The purpose of this study is to investigate if CBT is effective in treating ADHD symptoms in patients with ADHD and SUD.

Eligibility Criteria:
Inclusion Criteria:

* substance use disorder
* ADHD
* able to comply with study activities

Exclusion Criteria:

* severe neurological or psychiatric diseases (for example Parkinson, dementia, psychosis, bipolar depression) which require medication
* unable to read or write Dutch language
Rehabilitation for Post-COVID-19 Syndrome Through a Supervised Exercise Intervention

This is a randomized controlled trial of the efficacy of a tailored exercise program, based on multicomponent exercise training and/or inspiratory muscle training, compared to the WHO self-management leaflet commonly used in outpatient scenarios, on the recovery of persistent symptoms and functional limitations after COVID-19.

. The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in ambulatory patients.

A fraction \~10% of the COVID-19 patients who undergo a variable acute symptomatic phase of the disease are coming forward with continuing effects of the disease over a month, with chronic complaints like mental fog, delayed latent periods in recalling events of recent past, tachycardia, extreme fatigue, inability to perform daily physical tasks and likely to develop stress, depression, irritability, insomnia, fear, confusion, anger and frustration. This condition is defined as post-COVID-19 syndrome and increasingly affecting a high number of people as the pandemic evolves.

The post-COVID-19 syndrome has become a usual situation in the evolutionary course of the disease with its own entity. The National Health Service (NHS) of UK has recently published a clinical guide for long-term management of the effects of COVID-19 with a comprehensive plan for the assessment and care of patients who present or develop symptoms from the fourth week after diagnosis.

The effective long-term management of the effects of COVID-19 is a challenge that requires awareness. The RECOVE project aims at determining the role of exercise in the treatment of post-COVID-19 syndrome ambulatory patients.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen \>90 days before randomization.
* Still present a chronic symptomatic phase lasting \>90 days since debut of symptoms
* Have not been hospitalized
* There is no evidence on clinical records of pneumonia or any other organ failure related to SARS-CoV-2
* Non-coincident participation in any intervention trial
* Capable and willing to provide an informed consent

Exclusion Criteria:

* Refusal to participate expressed by patient or legally authorized representative if they are present
* Pregnancy or breast-feeding.
* Acute heart attack (recent 3-6 months) or unstable angina
* Uncontrolled atrial or ventricular arrhythmias
* Aortic dissecting aneurysm
* Severe aortic stenosis
* Acute endocarditis / pericarditis
* Uncontrolled high blood pressure (\>180/100 mmHg)
* Acute thromboembolism
* Acute or severe heart failure
* Acute or severe respiratory failure
* Uncontrolled acute decompensated diabetes mellitus or low blood sugar
* A recent fracture in the last month.
* Conditions preventing cooperation
Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction

Optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) is done before and after cataract extraction in patients with or without primary open angle glaucoma (POAG)

The investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with POAG controlled on medical treatment with cataract and planned for cataract extraction only.

The OCT scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation)

Eligibility Criteria:
Inclusion Criteria:

• patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided onto two groups

Exclusion Criteria:

* Patients having any retinal or optic nerve pathology that might have affected nerve fiber layer thickness other than POAG eg: high myopia
* POAG patients who are planned for combined surgery
* Refractive errors greater than spherical equivalent of 6 diopters (myopia or hypermetropia)
* Dense cataract hindering OCT imaging
* History of previous ocular surgery or trauma
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
* Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1
* Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria:

* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
* Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid
Transcranial Direct Current Stimulation (tDCS)

Cognitive impairment refers to when an individual struggles to learn, concentrate, remember, or make decisions. This can be due to underlying neurological diseases (i.e. Alzheimer's disease, dementia, etc.), caused by viral illness (i.e. brain fog experienced by COVID-19 survivors) or physical trauma (i.e. concussion). Recent reports indicate that two out of three Americans experience some amount of cognitive impairment in their lifetime.

There are a number of therapies that have been used to help address this condition. One of these is transcranial direct current stimulation (tDCS), which delivers sustained direct current to to the head area via electrodes. A number of studies have indicated that this form of therapy is safe and efficacious at inducing neuroplasticity and exciting neuronal activity. These factors can help improve aspects of cognitive functioning such as working memory, learning, and task performance.

The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless, transcranial direct current stimulation for people with cognitive impairments.

Sample size (n=10) is convenient and designed to explore acceptability and feasibility. Participants who are enrolled will be provided a tDCS device to use for a period of four weeks. They will have two study visits, baseline (BL) and the 4th week visit (W4). During each visit participants will answer various questionnaires to assess patient-reported outcomes such as sleep quality, cognitive impairment, depression, anxiety, fatigue, and user acceptability.

The entire cohort will receive a transcranial direct stimulation (tDCS) device which uses LIFTiD Neurostimulation technology (RPW TECHNOLOGY, LLC, New York, USA). Participants will take the device home and daily, they will use the device for a maximum of 20 minutes to stimulate neuroplasticity. During the stimulation period they will be asked to perform a light activity such as reading, checking emails, etc. The participants will return to the McNair Campus for their final visit after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18+) suffering from poor working memory, brain fog, or cognitive impairments (such as dementia, Alzheimer's, concussions, etc); ability to attend to the clinic for visits

Exclusion Criteria:

* Severe cognitive decline that reduces their ability to interact with the tDCS device; Major visual or hearing weakness reduces the ability to interact with tDCS device; Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication; Demand-type cardiac pacemaker, implanted defibrillator, implanted metal plate in the brain or head, or other implanted electronic devices; Epilepsy, seizures, brain lesions, or severe heart disease; Sensitive skin or rash, broken skin, or open wounds; Pregnancy; and any conditions that may interfere with outcomes or increase the risk of the use tDCS based on the judgement of clinicians
Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors

INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Thus, rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE: To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study. Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED RESULTS: This work will bring important information to the scientific community and health professionals, about the best forms of intervention and its repercussions on the surviving individuals of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both genders;
* With a diagnosis of COVID-19 confirmed by a laboratory through RT-PCR means;
* Have to access to the internet and some device (smartphone, computer or notebook) that allows them to participate in the call centre.

Exclusion Criteria:

* Individuals with orthopaedic or neurological diseases;
* Individuals with difficulties in understanding and that present psychological changes that make it difficult or impossible to understand the information presented.
Testing Two Models of PrEP Delivery in OBGYN Clinics

The HIV Center for Clinical and Behavioral Studies, the Albert Einstein College of Medicine and the Alliance for Positive Change will test two healthcare models that integrate PrEP into OBGYN services. Model 1 is OBGYN-PrEP with 4 parts: (1) prioritize PrEP; (2) train providers in PrEP and intervention; (3) identify PrEP-appropriate women through a risk screen; and (4) monitor progress and fidelity to protocol. Model 2 is NP-PC PrEP in which PrEP provider burden is shifted to a Nurse Practitioner (NP) who will use a sex-positive approach to deliver PrEP services via telemedicine.

The Albert Einstein College of Medicine (Einstein), the HIV Center for Clinical and Behavioral Studies (HIV Center), the Montefiore Medical Center Department of Obstetrics and Gynecology (OBGYN, Implementing Partner) and the Alliance for Positive Change (Alliance, Implementing and Community Partner) will compare two healthcare models that integrate PrEP into OBGYN services. Both models are acceptable standards of care and represent evidence-based approaches to the provision of care. This study is the first example of comparing these interventions in a head-to-head, comparative-effectiveness model. Both groups will benefit from maintained access, enhanced assessment with the PrEP screening tool, and physicians will all receive an evidence-based PrEP education seminar with supporting materials and ongoing access to education and resources. MODEL 1, OBGYN-PrEP is based on PC4PrEP (R01MH107297) that has four steps: announce the policy that PrEP counseling is the responsibility of OBGYN providers to address the "purview paradox"; train providers to manage patients on PrEP; use a screening tool to identify women appropriate for PrEP; and implementation coaching to monitor and encourage PrEP counseling. The goal is that PrEP be provided by a trusted provider with whom the patient has an ongoing relationship. In MODEL 2, NP-PC PrEP, all the same provisions and practices present in Model 1 will be present however, a telehealth opportunity with a Nurse Practitioner (NP) will be provided. A skilled and PrEP-trained NP will deliver PrEP services via telemedicine visits

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age Female (biological female at birth) Ability to speak and read English or Spanish Patient at Montefiore Medical Center, Eastchester Professional Center (EPC). No gross evidence of cognitive impairment precluding consent and participation Willing to have interview digitally recorded

Exclusion Criteria:

* \<18 years of age Not a female (biological female at birth)- We have excluded transgender women because their sexual and reproductive health issues and PrEP use differ from those of biological females. Does not speak English or Spanish Not a patient at Montefiore Medical Center, Eastchester Professional Center (EPC). Gross evidence of cognitive impairment precluding consent and participation Not willing to have interview digitally recorded