cyrilzakka/clinical-trials huggingface dataset:
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

The purpose of this research study is to determine whether two different types of forearm exercise, performed before fistula creation surgery, can improve surgery success and fistula maturation.

This is a randomized, double blinded controlled trial to study the impact of handgrip exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and fistula maturation in chronic kidney disease patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age\>18 years old) with chronic kidney disease
2. Hemodialysis is their renal replacement therapy (RRT) modality
3. Deemed eligible for an arteriovenous fistula
4. Anticipated RRT start \< 3 months (from the time of vascular surgery assessment) if predialysis
5. Scheduled surgical creation of fistula aniticpated \>= 8 weeks
6. Able to follow instructions for an exercise intervention
7. Able to provide informed written consent

Exclusion Criteria:

1. Life expectancy \< 6 months
2. Need for urgent vascular access (i.e. \<4 weeks)
3. Pre-existing fistula distal to site of newly scheduled fistula
4. Ipsilateral central stenosis or occlusions not amenable to correction
5. Contraindications or unable to perform handgrip exercise

   * Unable to withstand transiently raised systolic blood pressure (SBP) by 35 mmHg, and diastolic (DBP) by 25 mmHg
   * severe upper extremity arthritis or other pain
6. Contraindications to general exercise

   * Poorly controlled blood pressure - SBP\>180, DBP\>90; SBP\<110, DBP\<50
   * NYHC IV heart failure
Implementation of Academic Detailing Interventions on Prescribing of Antimicrobial Drugs in Primary Health Care

World increase in mortality from consequences of antimicrobial resistance (AMR) represents a significant public health problem. Irrational prescribing of antimicrobial drugs (AMD) in general population is one of the main causes of development AMR. This is also contributed by fact that up to 90% of total antimicrobial consumption in Europe is related to the general population. Problem of AMR has been recognized by World Health Organization and Council of European Union, which support the establishment of the antimicrobial stewardship team (A-team). A-team provides co-ordinated interventions that promote rational use of AMD. To date, no study has been carried out in which A-team from hospital environment goes to primary health care for the purpose of rationalization prescribing of AMD by primary health care practitioners. Project for implementation of hospital A-team in primary health care in Koprivnica-Križevci County was initiated using academic detailing method aimed at rationalization of the consumption of AMD.


Eligibility Criteria:
Inclusion Criteria:

* All primary care physicians in Koprivnica Križevci County that agree to participate in the study

Exclusion Criteria:

* Primary care physicians outside Koprivnica Križevci County
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.

Exclusion Criteria:

1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
2. Any of the following:

   1. Platelet \<50,000/mm3
   2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
   3. Total bilirubin \>2xULN
   4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/min (adults)
3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
4. Concomitant use as well as use within 14 days before the start of the first study intervention of strong CYP3A4 inhibitors or inducers, strong P-gp inducers and sensitive CYP3A4 substrates (detailed list of prohibited medication is provided in Section 6.5.1).
5. Concomitant use of metronidazole from 2 days before the start of the first study intervention until 24 hours after last administration of study intervention.
6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
7. Known allergy/hypersensitivity to mebendazole and/or emodepside
Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE

With the advent of multiparametric MRI (mpMRI), the concept of focal therapy continues to develop as a compromise between active surveillance and radical tratment. However, it must be combined with the most stringent quality control measures, such as exceptional Imaging, to allow close management of the index tumor. the choice of the energy is also crucial. Several have been tested such as HIFU, electroporation or cryotherapy. A new therapeutic alternative currently Under investigation resides in the use of microwaves delivered through a thin needle inserted precisely into the index lesion according to the same procedure as targeted biopsy under image fusion to induce coagulation necrosis and lead to the tumor destruction. Through an ablate, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).

Patients with a detectable index lesion on mpMRI, PSA level \<20 ng/mL and wishing to undergo a prostatectomy due to significant PCa on biopsy are elibible for this study approved by the Ethics Committee. Targeted biopsies of the index lesion are performed by using an ultrasound-MRI image fusion system with Organ based Tracking (OBT)-registration (Trinity\*, KOELIS, France) to provide quality control. Targeted cores are analyzed intraoperatively with an extemporaneoux analyses. If positive, a targeted focal microwave ablation is achieved during the same session by a single 18G needle inserted transrectally Under sedation. Predictive ablation charts obtained with the 2.45 GHZ frequency microwave generator (TATO, Biomedical Srl, Italy) through ex vivo experiments were used to choose the duration and power of the treatment.

Treated patients are followed-up for 4 to 6 weeks and the planned radical prostatectomy is performed. All treated patients complete uroflowmetry test and questionnaires (IPSS, IPSS-QQL, IIEF-5, and MSHW-EJD-SF) befor, at 7 days and 1 month after the procedure. A mpMRI of the treated prostate is performed at 7 days after the ablation to identify the devascularized area, but also to verify that no organ at risk is affected by the microweve treatment. After radical prostatectomy, whole-mount histology serves to define the ablation boundaries and dimension in the prostate. It also allows to determine the impact of the use of microwaves on cancerous tissue. A total of 10 patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients with detectable index lesion on mpMRI, PSA level \<20 ng/mL and wishing to undergo a prostatectomy due to significant PCA on biopsy.
* Life expectancy up to 10 years or plus.

Exclusion Criteria:

* Past history of prostate surgery or pelvic radiotherapy, prostatitis, extra-capsular extension on MRI or index lesion above 25 mm, distance between rectum and index lesion less than 5 mm.
Interval Versus Continuous Training in Healthy Adults

Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic high intensity interval training may lead to greater increases in CF compared with continuous moderate-intensity training.

The main objective of this study is to examine the effects of an aerobic high intensity training program versus a continuous moderate intensity training program on CF in men 18 to 44 years.

Forty-four individuals will be randomly assigned to one of two aerobic training programs on a treadmill. Both groups will performed three times a week for eight-weeks (on alternate days). Half will run 40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate, and the remaining 22 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of maximum heart rate, with recoveries between 50-55 % of maximum heart rate. After each session both groups will complete eight strength exercises mainly including large muscle groups for two sets and 8-12 repetitions at an intensity equivalent to 60-70% of one repetition maximum (controlled by perceived effort). Rest between sets will be kept between 60 and 90 seconds.

All participants will be evaluated at the start and completion of the intervention for their maximal oxygen consumption, blood pressure, waist circumference, BMI, body composition, and steps per week.

Eligibility Criteria:
Inclusion Criteria:

* Perform aerobic exercise maximum 3 sessions per week

Exclusion Criteria:

* Currently participating in an aerobic high intensity training program
* Smoker
* History of cardiovascular disease
* History of coronary heart disease
* Arrhythmias
* Heart failure/insufficiency
* Hypertension
* Diabetes
* Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids
* Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.
Neurologic Manifestations of COVID 19 in Children

The purpose of this study is to perform a secondary analysis of pre-existing de-identified limited datasets obtained from sites participating in Tier 1 (STUDY20040154: Neurologic Manifestations of COVID 19 in Children) and Tier 2 (STUDY20040278: Neuro COVID - Outcomes). The data will be used to determine the prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed or suspected novel coronavirus (COVID-19) and to determine the predictors for limitation of care in the study population, as well as, the prognosis of neurologically injured patients admitted to the ICU during the COVID-19 crisis.

This study is sponsored by the Pediatric Neurocritical Care Research Group (PNCRG) and sponsored and funded in part by the Neurocritical Care Society.

Early reports of COVID-19 indicate that adults experience a variety of neurological symptoms and diagnoses in approximately 36% of patients, including headaches, seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In children, recent evidence highlights acute and long-term neurological manifestations due to other viral illnesses including Guillain Barre syndrome and neonatal microcephaly with Zika virus, encephalitis with H1N1 influenza, and acute flaccid paralysis with enterovirus-68. However, COVID-19 reports in children published thus far lack detailed information on the frequency and outcomes of neurological findings.

COVID-19 cases are rapidly rising internationally, with experts forecasting subsequent global surges and continued activity. Thus, it is imperative to accurately document prevalence and outcomes of the neurological aspects of COVID-19 specifically in children. Such data will serve to alert clinicians and families about the possibility that children may present with neurologic rather than "classic" symptoms of COVID-19 who nevertheless would warrant testing, and that neurologic events can occur subsequent to the diagnosis that may impact long-term outcomes (e.g., cognitive, emotional, physical health). The investigators anticipate that improved knowledge about neurologic manifestations in children will bolster personalized treatment and rehabilitation strategies to optimize child outcomes and inform future interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Infants, children, and young adults age \< 18 years
* Admitted to the hospital with confirmed or presumed COVID-19 infection (includes admissions to emergency, ward, intensive care etc.)

Exclusion Criteria:

* none
Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

The investigators anticipate that the use of Glargine will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
* Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
* Patients with both types of diabetes will be among those treated with the insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition.
* Patients will be of age 19 to 80.

Exclusion Criteria:

* Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment
Resistance Training and Diet in Patients With Chronic Renal Failure

This study will examine the effects of long-term adherence to a low protein diet (LPD) of 0.6 g/kg-1/d-1 with and without progressive resistance exercise training in patients with impaired renal function on body composition, renal function (glomerular filtration rate), nitrogen balance, muscle strength and size, and functional capacity. The hypothesis is that adherence to a LPD will result in a reduction in skeletal muscle mass and reduced strength and functional capacity while those patients who adhere to the LPD and exercise will demonstrate a similar preservation of renal function but will have greater fat free mass, muscle mass and strength. The intervention trial will last 18 months in which patients with moderate renal failure will be randomly assigned to one of 4 interventions: standard care, standard care + exercise, LPD, and LPD with exercise. In this way the independent and combined effects of diet and exercise on the progression of renal disease and body composition will be monitored. This study will have important implications for the treatment of patients with chronic renal failure. New strategies of combining exercise with recommendations of a low protein diet may slow the progression of renal disease and improve strength and functional capacity in these at-risk patients.

Management of dietary protein intake of the CRF patient represents a critical balance between providing adequate protein to meet nutritional requirements, and limiting protein intake in the hope of slowing or abating the progression of CRF. A number of studies have demonstrated that reduced dietary protein intake can slow the progression of chronic renal failure. Finding effective ways to increase nitrogen retention and decrease urinary nitrogen excretion may help CRF patients maintain a more positive nitrogen balance and lessen the nitrogen load on the kidneys for a given dietary protein intake. Our laboratory has demonstrated that in older men and women, the consequence of adherence to a low protein diet is an accommodation that results in decreased muscle mass, strength,and compromised immune function. We have also demonstrated that when healthy, free living older men and women consume a weight maintenance diet providing the RDA for protein of 0.8 g/kg-1/day-1 for 15 weeks they lose skeletal muscle mass. These data clearly indicate that elderly people have an increased need for dietary protein (compared to young people). Data has also demonstrated that progressive resistance exercise improves nitrogen balance in older healthy individuals as well as in patients with mild to moderate chronic renal failure.

Eligibility Criteria:
* Men and women 50-89 years with chronic renal failure (defined as creatinine clearance of 25-65).
* Volunteers must be able to fulfill the requirements associated with this protocol.
* Volunteers may be hypertensive and/or diabetic.
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B

The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

At the Baseline visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FIX over 10 (±5) minutes in the clinic under medical supervision at a dose of 50 IU/kg. A washout period with no FIX treatment is required prior to administration of prestudy FIX and prior to rFIXFc. A PK assessment is done with prestudy FIX and also done with rFIXFc on Day 1. After completing the PK assessments, participants begin weekly prophylactic treatment with rFIXFc for approximately 50 weeks, to obtain 50 EDs. One ED is defined as a 24-hour period in which a participant received 1 or more doses of rFIXFc, with the time of the first injection of rFIXFc defined as the start of the ED.

Eligibility Criteria:
Key Inclusion Criteria:

* Severe hemophilia B defined as ≤ 2 IU/dl (≤ 2%) endogenous FIX
* Male \< 12 years and weight ≥ 13 kg
* History of at least 50 documented prior exposure days to FIX
* No history of, or currently detectable, inhibitor

Key Exclusion Criteria:

* Other coagulation disorders in addition to Hemophilia B
* History of anaphylaxis associated with any FIX or IV immunoglobulin administration

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0

One of the major changes occurring in developed societies is a significant ageing of the population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. Aging is characterized by a gradual lifelong accumulation of molecular and cellular damage that results in a progressive and generalized impairment in several bodily functions, an increased vulnerability to environmental challenges and a growing risk of disease and risk of death. These facts led to an increase on the prevalence of diseases such as osteoporosis diabetes, sarcopenia, obesity or frailty. However, lifestyles such as physical activity could attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated that even implying guided exercise programs could reverse this condition of frailty and dependence.

In this way, the main aims of this research project are to analyze the effect of a multicomponent exercise program in frailty and pre-frailty people above 65 years and without cognitive impairment. Thus, it is going to be evaluated at the beginning and the end of the study; body composition, physical fitness, blood parameters including vitamin D and other health related parameters included in a questionnaire. Secondly, to study the perdurability of training-related gains over time.

The training will consist in a multicomponent exercise program, 3 days a week (Monday, Wednesday and Friday). It will take place during morning in groups of 10-14 and trainers will be qualified. Alll the exercise will be adapted for different levels of frailty and for their functional capacity.

Eligibility Criteria:
Inclusion Criteria:

* Above 65 years
* frailty of pre-frailty by SPPB.

Exclusion Criteria:

* Severe cognitive impairment
Performance Developement of Patients With Paraplegia During First Rehabilitation

A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)
* Age 18-65 years
* Manual wheelchair user
* Patient during first rehabilitation

Exclusion Criteria:

* BMI ≥ 30
* unable to use an arm-crank Ergometer due to e.g. spasticity
* physical impairment, which makes it impossible to perform an arm-crank ergometry
* Progressive disease (g.g. tumor, MS)
* Ventilator dependent
* existing cardiopulmonary disease
* Unstable medical situation