cyrilzakka/clinical-trials huggingface dataset:
Home Monitoring in Pediatric Heart Failure

Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology. In pediatric population, it is particularly challenging to manage because of the heterogeneity in age, primary cardiac disease, and the broad range of clinical signs and symptoms. Frequent hospitalizations are current problem. Hospitalization within the first year since the first episode, lack of adherence to medical therapy and diet difficulties are the main issues in this population of patients, and they rebounds on prognosis and public health costs. Actions aimed to prevent and manage these matters will improve outcome in patients with chronic heart failure. Telemedicine proved its usefulness in adult population, but, nowadays, no studies have been conducted in children. From the beginning of 21th century, remote monitoring attempts have been adopted, initially by phone calls. Currently, the e-care monitoring fits in the context of telemedicine 2.0 based on new communication models. The aim of this study is to affirm the feasibility and efficacy of a new model of tele monitoring in pediatric population. High-risk patients need a strict clinical control normally difficult to adopt. A telematics system capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients. All of these data permits to physician to early detect critical signals of a deteriorated status, modify adherence to care and implement therapeutic strategies in order to prevent frequent hospitalizations. Our project provides a system of continuous tele-monitoring of vital parameters through a patch applied on the chest of the baby. Data are sent to a service center, "virtual clinic" and daily analyzed in multiparametric system by a specialized nurse. On the basis of pre-established alarms, the virtual clinic will notify to physician. Feasibility and tolerability of this new monitoring system will be evaluated after a 3 months period on a cohort of 20 patients affected by chronic, high-risk, heart failure.


Eligibility Criteria:
Inclusion Criteria:

* NYHA/Ross class III or IV
* Severe impairment of ventricular function (EF \< 40%) both for left or univentricular
* Prior hospitalization for acute heart failure within 1 year
* At least 2 prior hospitalization for acute heart failure
* Patients on waiting list for orthotopic heart transplantation (UNOS 1B,2)
* Informed consent obtained

Exclusion Criteria:

* PMK or ICD
* hospitalized patients
* neurological or psychiatric impairment
* urgent waiting list for heart transplantation (UNOS 1A)
A Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.

Eligibility Criteria:
1. Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study
2. Male or female subjects 18 years of age and up
3. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
4. Diagnosis of COVID-19 by RT-PCR

Exclusion Criteria

1. Refusal to provide informed consent
2. Diarrhea prior to infection
3. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
4. Any contraindications for treatment with hydroxychloroquine

   1. Hypoglycemia
   2. Known G6PD deficiency
   3. Porphyria
   4. Anemia
   5. Neutropenia
   6. Alcoholism
   7. Myasthenia gravis
   8. Skeletal muscle disorders
   9. Maculopathy
   10. Changes in visual field
   11. Liver disease
   12. Psoriasis
5. Anemia from pyruvate kinase and G6PD deficiencies
6. Abnormal EKG with QT prolongation acquired or from birth
7. Allergies to 4-Aminoquinolines
8. History of jaundice or high fevers prior to developing COVID-19
9. Treatment with any of the medications listed in Appendix II
10. Treatment with any other drug not listed that affects the QT interval
11. Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
12. Pregnant or breastfeeding women
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.

PRIMARY OBJECTIVES:

I. To evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphoblastic leukemia (ALL) patients or those at high risk to become so (body mass index \[BMI\] \>= 50th percentile).

II. Assess changes in BMI z-score, waist circumference, body composition, blood pressure exercise tolerance and physical activity at baseline, immediately post intervention and three months later.

III. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention.

IV. Assess changes in self-reported quality of life, physical activity, caloric intake, and fatigue associated with the nutrition and exercise program in the participant and their primary caregiver.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.

ARM II: Patients receive standard of care individualized diet and exercise plan.

After completion of study treatment, patients are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion
* English speaking patient and primary caregiver
* BMI \>= 75th percentile at time of study enrollment; (patients \>= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy)
* Provision of informed consent by primary caregiver

Exclusion Criteria:

* Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)
* As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.
Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects

The investigators intend to determine if patients that are already undergoing Hyperbaric Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck cancer, experience improvement in xerostomia and/or taste alteration. The investigators will enroll a similar demographic one year post treatment with radiation therapy that does not receive HBO therapy. This is a quality of life study.

Radiation therapy is a commonly utilized treatment modality for head and neck cancer patients. Xerostomia (i.e. dry mouth) (and taste change) are common and most significant side effects of this treatment. Xerostomia leads to several complications for patients including difficulty in chewing, speaking, swallowing, taste and smell abnormalities, oral infections and inflammation, osteoradionecrosis, dental caries and periodontal disease. These conditions tend to lead to an overall decreased quality of life for patients affected.

A possible modality for the treatment of xerostomia is the use of hyperbaric oxygen (HBO) therapy. HBO is the medical use of oxygen at a level higher than atmospheric pressure. It has been proposed that HBO results in accelerated blood vessel growth and repair in tissue injuries by increasing the oxygen partial pressure gradient (Bennett, 2005). Today, the use of HBO is widely accepted for both the treatment and prevention of radiation induced toxicities such as osteoradionecrosis and soft tissue necrosis.

Here at Upstate University Hospital, the investigators treat approximately 20 patients each year with hyperbaric oxygen for either the prevention or management of radiation induced complications such as osteoradionecrosis and /or soft tissue necrosis. The investigators would like to use this group of patients to evaluate the effect of HBO in the improvement of radiation induced xerostomia (and or taste change). The investigators' data will be collected from patients with the use of periodic quality of life questionnaires at 5 timepoints, as well as data relating to the treatment each patient was given. .

Eligibility Criteria:
Inclusion Criteria:

* males and females age \> 18 previous radiation therapy to the head and neck region at least one year from end of treatment

Exclusion Criteria:

* history of parotidectomy history of dementia
Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System

The study aims to compare two different cochlear implant sound processing strategies. All the participants will start off with a sound processing strategy called the XDP (extended performance). At the 3 month stage, half of the participants would randomly be selected and offered a sound processing strategy called the Voice Guard. Following that, the sound processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th month of cochlear implant use.

Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear implant based on the levels of the listening environment. Hence, it can adapt to soft, medium or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot alter the cochlear implant output according to the levels of the listening environment.

In the study we are hypothesising that the Voice Guard sound processing strategy will perform better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels. Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study design has been adopted.

In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track will also be evaluated. The Voice Track is designed to reduce the adverse effect of background noise on cochlear implant speech perception.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 70 years
* Individuals with post-lingual hearing loss
* Individuals with no language and speech production disorders
* Individuals who are native speakers of English
* Individuals meeting NICE candidacy criteria for CI surgery
* Individuals undergoing primary unilateral cochlear implantation

Exclusion Criteria:

* Medical conditions contraindicating CI surgery
* Individuals with anatomical anomalies of the auditory system
* Individuals with additional mental health issues or and/or cognitive impairment
Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD

Aim of this study is to investigate the effects of treadmill versus cycling endurance training on Balance, gait performance and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. Walking intensity in the treadmill group will be set at 80 percent of the average speed of the 6-minute walking test. The cycling group will exercise at an intensity of 60 percent according to an Initial incremental cycling test.

Patients will perform 5 to 6 training sessions per week. The total exercise duration will be progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be progressively increased if perceived exertion during exercise is rated below 3 on the modified 10-point Borg scale.


Eligibility Criteria:
Inclusion Criteria:

* COPD Stage III or IV according to the global initiative for chronic obstructive lung disease
* impaired exercise capacity (6 Minute walk distance of less than 70% of the reference values from Troosters et al.)

Exclusion Criteria:

* acute, severe exacerbation of COPD
* carbon dioxide of more than 45 mmHg at rest
* any disabilities that prevent patient form walking or cycling
* Patient is not able to walk 20 meters without any aid (for example rollator)
International Ataxia Rating Scale in Younger Patients

The project will collect information on the mapping of clinical ratings on a number of scales that are used in the assessment of patients with ataxias.


Eligibility Criteria:
Inclusion criteria

1. Patients aged 6-18 years with diagnosed with ataxia, preferably AT will be included. The diagnosis of AT will be made based on the criteria: typical clinical picture plus one of the following: 1. a proven mutation in the ATM gene 2. Deficient ATM protein proven by Western blotting 3. Elevated α-fetoprotein, cerebellar atrophy on MRI and immune deficiency/ chromosomal breakage/ T- cell lymphoreticular malignancy.
2. Children aged 6-18 years with suspected AT (fulfilling partially the above criteria will be included)
3. Children aged 6-18 years with AT like disease, with or without proven mutation in the MRE11 gene will be included
4. Children aged 6-18 years of age with ataxia of other known or unknown etiologies might be included, but their total number should not exceed 20% of the cohort in each site
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases

A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.

Study population: patients with painful spinal metastases from solid tumors without spinal cord compression or cord instability.

Objective: This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for the patient.

Study design: Complaints due to pain will be analysed using the validated Dutch Brief Pain Inventory (BPI) and side-effects will be recorded using the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be used.

Eligibility Criteria:
Inclusion Criteria:

* solid tumor with radiological diagnosis of spinal metastases
* pain score minimum 2 on 11-point scale
* maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest
* No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity)
* Karnofsky performance ≥60
* WHO ≤2
* life expectancy \> 6 weeks
* age ≥18
* non-pregnant, non-lactating female patients

Exclusion Criteria:

* history of previous radiotherapy to the spine at current level of interest
* spinal instability or neurological deficit
* pathological fracture or impending fracture needing fixation
* prior surgery to the spine at current level of interest
* clinical signs of spinal cord compression or severe neurological deficits
* patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
* patients unable to undergo MRI
* earlier nuclear medicine treatment
* pregnancy
* altered mental status that would prohibit the understanding and giving of informed consent
Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ESRD who currently require treatment for hyperphosphatemia
* Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study

Exclusion Criteria:

* Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
* Hypocalcaemia
* Treatment-naive to any phosphate binder with a serum phosphorus \< 5.5 mg/dL
* Any significant gastrointestinal surgery or gastrointestinal disorders
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or
* Newly diagnosed patients with non-exposed MRONJ (stage 0), or
* Newly diagnosed patients with exposed MRONJ, i.e:

  * Current or previous treatment with antiresorptive or antiangiogenic agents.
  * Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks
  * No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw
* Ability to understand the content of the patient information/ Informed Consent Form
* Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
* Signed and dated IRB/EC-approved written informed consent
* Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria:

* Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
Thymoglobulin Induction in Kidney Transplant Recipients

The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline) administration in the kidney transplant recipient is able to reduce the amount of damage that kidneys transplanted from deceased donors sustains on reperfusion.

The increasing disparity between organ availability and the number of patients on waiting list for a transplant has led to different strategies to improve half life of all transplants. One such method is to reduce the amount of damage the organ sustains during the period of preservation and reperfusion in the recipient. Thymoglobulin, an anti-lymphocyte antibody has been shown to have the ability to reduce this damage in experimental studies. This study aims to ascertain the role of Thymoglobulin in kidney transplants from donors after cardiac death, the type of kidney transplants at highest risk of sustaining injury during preservation. The study will involve comparison with conventional immunosuppressant therapy, comparison between Thymoglobulin administered in different doses, and observation of the patterns of blood cell repopulation (lymphocytes mainly) in the first year following kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above
* Recipient of DCD kidney transplant
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the first 12 months of the study
* Able (in the Investigators opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

* The participant may not enter the study if ANY of the following apply:
* Failure of either recipient of a pair of kidneys to give consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* History of specific viral infection that would contraindicate depleting antibody therapy e.g. hepatitis B\&C, HIV
* Significant hepatic impairment-.i.e. Values 3 times upper limit of normal (unless this is usual for the subject)
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
* Participants who have participated in another research study involving an investigational product in the previous 12 weeks
* Previous administration of Thymoglobuline
* Patients with functioning non-renal transplants and on immunosuppression
* The patient is not suitable, in the opinion of the Investigator, to take part in the trial