cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU Langone Transplant Institute is a feasible and acceptable alternative to a traditional in-center follow-up visit.

A six-month prospective randomized-controlled clinical pilot study to evaluate a new intervention for the transplant program: telemedicine (TM) visits. Researchers will target patients on the transplant waiting list who are currently undergoing dialysis. Currently, there are 234 patients on the transplant waiting list who receiving care at dialysis centers in the New York City area. Researchers will select the 10 dialysis centers having the highest number of patients on the transplant list in order to yield a target sample of 45.

Eligible participants will be randomized to 1 of 2 groups: (1) usual care (UC) which is the routine 6-month follow up appointment at the NYULMC transplant center or (2) TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit. Patients will be followed for 4 months post randomization to determine the number of days that elapse between randomization and routine transplant evaluation. As new clinic appointments are currently experiencing 80-day wait, a 4-month follow-up should be more than adequate to evaluate this primary outcome.

The intervention will be evaluated primarily in terms of efficiency, and secondarily in terms of patient/physician experiences, changes in waiting list status, and referral for living donation.

Eligibility Criteria:
Inclusion Criteria:

* Receiving thrice-weekly hemodialysis treatment for 6 months
* On NYULMC kidney transplant wait list

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable to read or otherwise use an iPad (e.g. blind)
Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored

Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* ICD of pacemaker implantation fo any indication
* Followed by remote monitoring
* Age \>18 years

Exclusion Criteria:

* life expectancy of less than one year
Online Psychoeducation for Sexual Dysfunction in Cancer Survivors

The purpose of this study is to test an online psychoeducational intervention for men and women with sexual difficulties after surgery for colorectal (men and women) or gynecological (women only) cancer. A psychoeducational intervention is a brief, educational treatment that encourages participants to also pay attention to, and modify, their thoughts, feelings, and behaviour.

Experiencing a diagnosis of cancer may dramatically alter the way a person feels about themselves, their body, and their significant relationships at sexual and intimate levels1. Cancer and its treatments affect the physiological, psychological, and sociological realms of a survivor's life and his/her ability to experience sexual health. Sexual health is recognized as an integral aspect of quality of life (QOL) during cancer and is increasingly receiving research and clinical attention. Sexual changes following the treatment of gynaecologic (i.e.: ovarian, endometrial, cervical) and colorectal cancers are common though often not discussed. Moreover, cancer survivors express dissatisfaction that sexual concerns, and treatment of them, are not discussed in the context of their cancer care. Oncologists frequently are faced with patients inquiring about sexual changes with cancer treatment, but are usually not equipped with accurate and comprehensive data on the precise sexual symptoms to expect or where to refer patients with sexual concerns.

The aims of the study are to assess the efficacy of a 12-module online psychoeducational intervention for sexual health (OPES) on (1) the primary endpoint of sexual distress in male and female cancer survivors with sexual problems; (2) the secondary sexuality-related endpoints of sexual desire, arousal (women) or erection (men), orgasm, and sexual pain; (3) on mood, relationship satisfaction, and quality of life; and (4) to assess gender differences in the proportion of survivors improved on sexual distress.

Eligibility Criteria:
Inclusion Criteria:

1. aged 19-70,
2. treatment of gynaecologic or colorectal cancer by one of the surgical oncologists of the gynaecology or colorectal teams of the BC Cancer Agency centres or satellite sites,
3. received treatment in the past 5 years
4. currently in a relationship
5. currently experiencing sexual dysfunction, and
6. able to participate (both physically and emotionally) in completion of an online psychoeducational treatment.

Exclusion Criteria:

-
Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD

The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.

The goal of this clinical trial is to evaluate the effects of the time in which food intake is restricted (morning or evening hours or no restriction in time) on glucose metabolism and liver steatosis in the context of a hypocaloric diet plan in 54 patients with non-alcoholic fatty liver disease (NAFLD). The participants will be divided into 3 groups of 18 individuals each and will be randomly assigned to one of the 3 dietary interventions. In the first group (control group), participants will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week) with the instruction to consume their meals throughout the day, without time restriction. In the second group (early eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 07:00-09:00 and 17:00-19:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. In the third group (late eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 11:00-13:00 and 21:00-23:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>25 kg/m2
* Liver steatosis with Magnetic Resonance Elastography (MRE)

Exclusion Criteria:

* Other chronic liver diseases
* Alcohol consumption \>20 g/day (female) and \>30 g/day (male)
* Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
* Changes in body weight ± 3 % in the last 3 months
* Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
* Unstable glucose-lowering medications in the last 6 months
* Body weight lowering medications and/or history of bariatric surgery
* Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
* Uncontrolled type 2 diabetes mellitus defined as HbA1c value \> 9.0% or insulin depending type 1 and 2 diabetes mellitus
* Pregnancy
* Lactation
* Immunologic or inflammatory diseases
* Depression and other psychiatric diseases
* Patients working in shifts
* Cancer
Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

The smart trainer ergometer is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals with post-stroke limb impairment.

Individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers. Much of the reason for the low rates of activity among this population comes from the presence of barriers. Lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities. Based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. The smart trainer ergometer (also known as the Advanced Virtual Exercise Environment Device) is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways.

In our previous protocol (IRB-300001384) we explored the power output curves of people post stroke compared with non-impaired individuals during one arm versus two arm cycling exercise using the smart trainer arm ergometer. The work demonstrated the potential benefit of interactive exercise for those with physical disabilities. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals who have a stroke-based limb impairment.

Eligibility Criteria:
Inclusion Criteria:

* Males and females post-stroke
* Age 40-70 years
* Able to use both arms during arm cycling exercise (i.e., able to complete the 10 revolution pre-test)

Exclusion Criteria:

* Younger than 40 and older than 70 years
* No movement in one arm or have an injury that prevents safe use of one arm during exercise
* Unable to complete the 10 revolution pre-test
* Unstable cardiovascular conditions
* Unable to understand study directions
Myocardial Perfusion, Risk Factors, and Coronary Calcium

To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.

BACKGROUND:

Impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (CHD). The impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown.

DESIGN NARRATIVE:

The cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (CHD) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for CHD. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis ("MESA"), which is an NHLBI funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. In MESA new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. Myocardial perfusion reserve (MPR)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. An impaired MPR appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. Magnetic resonance imaging (MRI) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 MESA participants. The study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Embryo Migration in Fresh Oocyte Donation Cycles

The investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(ET), on clinical pregnancy rates(CPR) and live birth rates(LBR) in fresh oocyte donation(OD) cycles.

Embryos were considered to be staying at the initial expulsion site for long years. However, in 1976 Edwards and Steptoe reported a tubal ectopic pregnancy after in vitro fertilization (IVF) with a day-3 embryo transfer, which may be accepted as the earliest evidence for migration of embryos from the cavity. The migration concept is very recently taken into consideration by few authors, with studies on fresh IVF and frozen ET cycles.

Oocyte donation (OD) is a method of ART, in which by using young oocytes from donors the embryo quality is optimized. OD cycles have high LBRs, and are the choice of treatment in advanced reproductive age, repeated IVF failure, premature ovarian insufficiency(POI) and particular heritable genetic diseases. Donor oocytes can be used as fresh or cryoprotected-thawed, where fresh oocytes have higher LBRs.

In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on CPR and LBR.

Therefore, the investigators conducted this study to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal USG guided ET, on CPR and LBR in fresh OD cycles. In literature, this study is first to focus on embryo migration and LBR in fresh OD cycles.

Eligibility Criteria:
Inclusion Criteria:

* fresh oocyte donation cycles
* Anatomically anteverted-anteflexed recipient uterus
* partners with normal sperm parameters

Exclusion Criteria:

* Data of women who did not give approval
* IVF cycles
* frozen-thawed embryo transfer cycles
* cryopreserved-thawed OD cycles
* abnormal sperm parameters or need of any testicular interventions
* Anatomically retroverted-retroflexed recipient uterus
* teneculum required embryo transfers
* difficult transfers
Docetaxel in Locally Advanced Gastric Adenocarcinoma

Study objectives:

To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric adenocarcinoma diagnosis
* Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.
* ECOG performance status between 0 and 2
* Acceptable hematological profile :

  * WBC (White Blood Cell) count ≥4000/mm3
  * Platelet count ≥100 000 mm3
  * Hemoglobin ≥9 g/100 mL (if lower, may be included following transfusion)
* Adequate renal function

  * Serum creatinine \<1.2 mg/dl or calculated creatinine clearance in 24-hours urine \>60 mL/min.
* Adequate hepatic function

  * Bilirubin \< UNL
  * Transaminases (ALT, AST) \<2.5 x UNL
  * Alcaline phosphatase \<2.5 x UNL
* Adequate pulmonary function
* Adequate cardiac function
* No prior chemotherapy for gastric cancer

Exclusion Criteria:

* Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma
* Pregnant or lactating patients
* Patients with brain, bone or other metastases; peritoneal involvement
* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry
* Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years
* Active infection and other serious disease
* Any other experimental drugs within a 4-week period prior to the study
* Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pentosan Polysulfate Treatment's Effectiveness

To examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (PPS) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (IC/BPS).

Demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between January 2018 and December 2021 and were diagnosed with IC/BPS were retrospectively analyzed. Adult male and female patients with IC/BPS who received 300 mg/day PPS at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. In addition, pre- and post-treatment symptoms, ICSI scores, quality of life (scored between 1-4), and satisfaction were compared.

Eligibility Criteria:
Inclusion Criteria:

* Chronic interstitial cystitis
* Bladder Pain Syndrome

Exclusion Criteria:

* Acute cystitis
* Bladder cancer
* Chronic prostatitis
* Bladder stone
* Stress incontinence
Developing the Physical Performance in Youth Soccer

Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination.

Nowadays, research in youth soccer consists of methodological choices that can raise ac-tivity volumes and exercise intensity to promote proper training for youth soccer de-mands. Therefore, the present cluster randomised trial aims to evaluate the effects on physical performance parameters of the dynamic-ecological approach compared with a traditional one in a group of sub-élite U13 players. Thirty-five male children (age 12.16 ± 0.55 years; weight 45.59 ± 7.15 kg; height 145.5 ± 4.2 cm; BMI 15.8 ± 2.1 kg\*m-²) were re-cruited for this trial from two teams belonging to sub-élite soccer schools and randomly assigned in a dynamic-ecological approach (DEA) or a traditional training (TTG) group. The training program lasted six weeks and consisted of 18 training sessions of 90 minutes each (3 sessions per week). The sample was evaluated by Standing Long Jump (SLJ), hop test (HT), 10 m sprint (10m), 10 x 5 m shuttle run test (SRT) and Leg Raise test (LR). The DEA group showed significantly higher results in the SLJ (p\&lt; .001), HT left leg (p\&lt;.001), 10m sprint (p\&lt;.001), and SRT (p\&lt;.001). In conclusion, the dynamic-ecological approach provides higher performance adaptations. Therefore, this approach can be considered a suitable method to optimise prepubertal player training, mainly when no fitness or strength coach is available.

Eligibility Criteria:
Inclusion Criteria:

* had not suffered an injury in the previous 6 months;
* who, in the 4 weeks before the study, had systematically performed the training sessions without interruptions or absences;
* all those who, upon medical evaluation, fell within stages 3 and 4 of Tanner's classification

Exclusion Criteria:

-Goalkeepers and players who had been injured in the previous six months or did not meet the established minimum compliance were excluded from this study
Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Chlorhexidine is a local antiseptic that has an important role in the prevention of catheter-associated bloodstream infections. Its application to a newborn's umbilical cord reduces all-cause neonatal mortality.

Skin disinfection by an appropriate antiseptic agent is essential to prevent healthcare-associated infection. Common pathogens responsible for sepsis have been detected in skin microbiota of hospitalized neonates. Such skin inhabitants can cause sepsis and also lead to blood culture contamination resulting in unnecessary antibiotic use. Strict asepsis bundles have been shown to reduce catheter-related blood stream infection (CRBSI) and contamination rates. The choice of appropriate skin disinfectant is, however, based on low-quality evidence, even in adults.

Chlorhexidine gluconate (CHG) is a broad-spectrum antiseptic which is effective against a host of neonatal pathogens. CHG-based products are used frequently in the healthcare setting for peripheral and central venous catheter (CVC) site skin preparation, daily bathing of intensive care unit patients, full-body newborn skin cleansing, umbilical cord care, and Staphylococcus aureus decolonization.

In neonates, CHG used as antiseptic for CVC insertion site preparation and maintenance decreases CVC tip microbial colonization. Trials of full-body skin cleansing and umbilical cord care with CHG in the developing world, which included infants less than 34 weeks gestational age, have demonstrated reduced risk of neonatal mortality. Despite proven efficacy of CHG in neonates, current guidelines acknowledge that no recommendations with regards to CHG antisepsis can be made for infants less than 2 months of age due to incomplete safety data in this population.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with gestational age 28 weeks or more.
* Neonates needing the insertion of a peripherally inserted central catheter (PICC line) or CVC or umbilical catheter.

Exclusion Criteria:

* Extremely preterm (GA less than 28 weeks).
* Babies who have an allergy to chlorhexidine 2%.
Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery

In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for abominal surgery

Exclusion Criteria:

* Emergency surgery
* end-stage renal disease
* pregnancy
* obesity
* atrial fibrillation
* previous cerebral ischaemia
* central nervous system disorders
* severe cardiac valvular disease