cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Today, haemodialysis is a recognized standard treatment for patients with chronic kidney disease stage 5. During the haemodialysis treatment session, blood passes from the patient through the extracorporeal circuit and is then returned. The dialyzer represents the greatest surface are of the extracorporeal circuit, as dialysis treatment is essentially based on the removal of small molecular weight solutes down along a concentration gradient, and this depends upon surface area. The ELISIO-H dialyzer differs in design to our current standard dialyzer, the FX100, by having fibers of a greater internal diameter, which potentially allows more internal haemofiltration, leading to an improved clearance of larger molecular weight solutes. It is now thought that these so called "middle molecular weight" solutes are more important in contributing to the clinical condition termed azotaemia, rather than smaller solutes such as urea.

The investigators therefore wish to study the clearance of middle sized molecules between the different dialyzers.

Stable chronic kidney dialysis patients, currently dialyzing on the main Royal Free hospital dialysis unit will be asked to participate in the study. It is aimed to recruit 15 patients currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone membranes for \> 3 months.

During a mid week dialysis session, dialysis adequacy will be assessed by on line clearance, and samples of both blood and dialysate taken to assess, both clearances and bio-compatibility.

Thereafter patients would be switched to dialyse using the ELISIOTM-H dialyzer, but continue with the same dialysis prescription, and after 3 months, measurements repeated

Assessments Primary Clearances : on-line Kt/V, dual pool Kt/V, phosphate, b2microglobulin, cystatin C Secondary Serum :isoprostane generation complement activation platelet activation - coagulation activation - thrombophilic markers - Other Anticoagulation requirements \& clotted circuits erythropoietin requirements, phosphate control therapy CRP

Eligibility Criteria:
Inclusion Criteria:

* 15 adult patients currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone membranes for \> 3 months, who are stable and able to provide informed consent.

Exclusion Criteria:

* using other dialyzers, unable to provide informed consent, unstable on dialysis or have problematical vascular access
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 6 patients will be offered participation within an untreated control Group.


Eligibility Criteria:
Inclusion Criteria:

* Prior participation in AFF008, AFF008E and AFF008A
* Written informed consent signed and dated by the patient and, preferentially, the caregiver
* In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for These
* Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
* All changes in conventional PD therapies must be available to the sponsor; in particular pharmacologic symptomatic PD medication allowing transformation to a Levodopa standard dose
* A potential participant should be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion Criteria:

* Women of childbearing potential without birth control or pregnant women
* Participation in another clinical trial within 3 months before Visit 1 (except AFF008A)
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
* Autoimmune disease or allergy to components of the vaccine
* History of cancer (Exceptions: non-melanoma skin cancer, intraepithelial cervical neoplasia)
* Active infectious disease (e.g., Hepatitis B, C)
* Immunodeficiency
* Significant systemic illness
* Alcoholism or substance abuse
* Prior and/or current treatment with experimental immunotherapeutics including IVIG with the exception of AFFITOPE® PD01A, with immune modulating drugs or treatment with deep brain stimulation
* Venous status rendering it impossible to place an i.v. access
Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives

Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic recurrent pregnancy loss
* Genetic predisposition to celiac disease

Exclusion Criteria:

-
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer

This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:

1. Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment.
2. Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients.
3. Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.

Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC)
* No response after 2 cycles of GC neoadjuvant chemotherapy
* No prior use of systemic immunotherapy or target therapy
* Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline
* ECOG (ZPS, 5-point scale) 0-1

Exclusion Criteria:

* Age less than 18 years
* Patients with severe cardiac, cerebral, hepatic, or renal disease
* Severely malnourished patients
* Patients with mental illness and those without insight and unable to express exactly
* Combined with malignant tumors of other organs
* Systemic infectious diseases
Ocular Coherence Tomography During Cataract Assessment

Many patients will have underlying maculopathy present when undergoing cataract surgery, which are not visible on fundoscopy alone. Knowledge of this underlying pathology will allow an improved consenting process and discussion with the patient regarding the risks, visual prognosis and recovery following cataract surgery. Incidental findings in the fellow eye would also allow for improved diagnosis and management of these patients without adding significant additional time to specialist high volume cataract assessment clinics.

The majority of anterior segment pathology may be diagnosed with simple slit lamp biomicroscopy, but posterior segment pathology may not be quite so obvious and can be missed on simple examination especially if a visually significant cataract is present impeding the view. There is also a degree of subjectivity from how much the cataract impairs the vision in comparison to the other elements of the optical pathway within the eye, and whilst there is no single way to evaluate this.

Optical coherence tomography (OCT) has been widely present in ophthalmology clinics since it's development 20 years ago although it is not commonly used in all units for the pre-operative assessment of patients referred for cataract surgery in high volume set ups such as the National Health Service (NHS) in the United Kingdom. There may still be reluctance to use OCT in a normal cataract assessment clinic as it may be perceived as an additional step that decreases time efficiency and increase financial investment in the services.

In this study we sought to investigate the prevalence of retinal pathology in the patient cohort, the comparison of subjective clinical slit lamp fundoscopy assessmenet with OCT findings and the co-incidental OCT findings in the fellow eye at the time of cataract assessment. OCT was chosen as the most efficient way to support clinicians in the assessment clinics, and to see if the addition of this step added value to the patient consultation and pre-operative assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for cataract surgery

Exclusion Criteria:

* Patients unable to attend the cataract assessment clinic
* Morbid patients who cannot be assessed on OCT or slit lamp
Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis

The aim of this study is to determine and compare the effects of static and PNF hamstring stretching exercises on joint pain, hamstring flexibility and functional status in patients with knee osteoarthritis.

A total of 36 patients between the ages of 40 and 75 who were diagnosed with Kellgren-Lawrence Stage II and III knee OA by the physician were included in the study. Participants were divided into two groups as static stretching group or PNF stretching group. Patients' demographic and clinical information was recorded. Pain intensity was evaluated with visual pain scale, hamstring flexibility with Active Knee Extension Test, functional status with Western Ontario and McMasters University Osteoarthritis Index and Timed Get Up and Go Test. In addition to the standard physiotherapy program, the subjects practiced stretching exercises according to the groups that they've been separated. Evaluations were repeated in the end of the treatment and in the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with knee osteoarthritis severity II, III, or IV according to the Kellgren-Lawrence Classification,
* Individuals with positive active knee extension test,
* Individuals with a body mass index of 30 or less,
* Individuals with a pain severity of at least 3/10 according to the visual pain scale.

Exclusion Criteria:

* Individuals with health problems that prevent them from doing the evaluations and exercises to be used in the study,
* Individuals who exercise regularly for the last six months,
* Individuals with a diagnosis of neurological disease affecting the lower extremity.
A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury

Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive impairment in young people worldwide. The majority of the traumatic deaths in developed countries results directly from lesions in the central nervous system. Furthermore, due to the persistence of disabling effects of TBI for many years, personal and public costs of supporting survivors have to be taken in consideration.

Many patients rescued by ICU treatment may have been severely disabled or vegetative because of trauma. These data suggest that, despite improvement in medical and surgical treatments, other factors related to trauma itself and to patient's condition could have an impact on the final outcome.

Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).

All patients admitted to the ICU with a diagnosis of moderate-to-severe TBI, with or without polytrauma, are recruited. Bergamo hospital is the main Trauma Centre (Level I) and the only referring neurosurgical center within a population of 1.2 million inhabitants of Bergamo area. This hospital is also a Regional Pediatric Trauma Centre.

Eligibility Criteria:
Inclusion Criteria:

* admission to ICU
* diagnosis of moderate-to-severe TBI

Exclusion Criteria:

Patients who died in the first couple of hours after hospital admission are not included.
The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants

SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.


Eligibility Criteria:
Inclusion Criteria:

Premature Infants (GA\<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding\>100 ml/kg/day

Exclusion Criteria:

Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.

Instability because of:

Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Effects of Head Elevation by a Bed on Sleep-disordered Breathing

Sleep is known to be a dynamic state of consciousness that is characterized by rapid fluctuations in autonomic activity as well as changes in body postures. Body postures during sleep influence the severity of sleep-disordered breathing because a supine position is associated with an increase in upper airway collapsibility and thus an increase in frequency and duration of snoring and apnea. Use of an adjustable bed to elevate patients' head might improve those conditions. The purpose of the present study is to determine whether use of an automatic adjustable bed is associated with reducing sleep-disordered breathing in patients with suspected obstructive sleep apnea (OSA) due to upper airway problems.

From the Chest and Otorhinolaryngology Department, patients with symptomatic sleep-disordered breathing will be referred to the Sleep Center. After an interview these subjects will undergo a full-night polysomnography (PSG). Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. The automatic device is initiated when the patient suffers from apnea ≥ 10 seconds, which is detected by an ultra-wideband (UWB) sensor placed under the bed. The head will be slightly elevated at an angle of 10 degrees lasting 10 seconds and then be put down softly. Parameters of sleep efficiency and architecture, apnea-hypopnea index (AHI), and oxygen saturation will be obtained during each PSG. According to the severity, enrolled patients will be classified into 4 groups as normal (AHI \< 5), mild OSA (AHI between 5 and 15), moderate OSA (AHI between 15 and 30) and severe OSA (AHI \> 30).

Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed. The minimal sample size is estimated to be 14 subjects per group with the intention of providing 80% power and an overall two-sided 5% type I error. A total of 60 subjects (15 subjects per group) will be enrolled to achieve the necessary number of evaluable subjects, anticipating roughly a 10% drop-out rate.

Informed written consent will be obtained from all subjects. This study was approved by the Mackay Memorial Hospital Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

* Subjects known to have snoring or sleep-disordered breathing

Exclusion Criteria:

* Refusal to participate
* Pregnancy
* Psychiatric disorders
* Clinical instability in the previous month
Effect of Probiotics on the Digestibility and Immunity in Infants

The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants;
* Single birth;
* Gestational age ≥ 37 weeks (=non-preterm infant, WHO);
* Birth weight: \> 2500g
* Appropriate weight between P20-P80 in accordance with the weight percentile standards of the children ages 0 to 6 years in Shanghai urban areas at inclusion visit ;
* Aged \> 4 months and \< 6 months;
* Infants being exclusively formula-fed(no breast milk meal) at inclusion visit;
* No suffering of gastrointestinal diseases within 1 month (CCDC recommendations);
* Parents agreeing to use one of the recommended infant formulas (no probiotic, if with prebiotics, exclude it when there is GOS over 2g/100g or FOS inside);
* Consent form signed by at least one of the parents or by the legal tutor properly informed of the study;
* Parents able to understand the protocol requirements and to fill out the infants' diary.

Exclusion Criteria:

* Congenital illness or malformation;
* Significant pre-natal and/or post-natal disease;
* Mothers with metabolic or chronic diseases;
* Infants with allergic constitution and sensitive to the probiotics (CCDC recommendations);
* Infants with serious diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases and internal secretion diseases, and those with mental disorder (CCDC recommendations);
* Infants administering other drugs during the administering of the study products, thus impossible to judge the efficacy or influencing the judgment of results (CCDC recommendations);
* Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgment;
* Infant under oral antibiotic treatment at V1 visit and within the 4 weeks before V1
* Infants who used any medication or nutritional supplements (including probiotics, prebiotics etc, except for infant formula) in the 4 weeks preceding study start;
* Infants who have ever consumed the test product;
* Infants who have medical conditions for which a special diet other than standard (non hydrolyzed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia);
* Currently participating or having participated in another clinical trial during the last month.
* Infants whose legal representatives have psychological or linguistic incapability to sign the informed consent form
* Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc.)
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of malignant mesothelioma
* Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)
* At least one evaluable or measurable CT-lesion
* Availability for participating in the detailed follow-up of the protocol
* Signed informed consent

Exclusion Criteria:

* Patients who are candidates for surgery with curative intent
* Patient who were previously treated with anthracyclin derivatives
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
* A history of prior HIV infection
* Polynuclear cells \< 2,000/mm³
* Platelet cells \< 100,000/mm³
* Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
* Serum bilirubin \>1.5 mg/100 ml
* Transaminases more than twice the normal range
* Serum creatinine \> 1.5 mg/100 ml
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure (ejectional fraction of the left ventricle \< 50%) or uncontrolled cardiac arrhythmia
* Uncontrolled infectious disease
* Active epilepsy needing a specific treatment
* Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
* Pregnancy or refusal to use active contraception
* A known allergy to valproate acid and/or doxorubicin
* Serious medical or psychological factors which may prevent adherence to the treatment schedule
Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes

The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.

Type 2 diabetes is a major public health concern in Western societies. Type 2 diabetes is associated with high morbidity and shorter life expectancy. In patients with type 2 diabetes maintaining glycemic control is associated with lower rates of complications and mortality associated with the disease. Thus, there is a great need to recognize nutritional elements that improve glycemic control and insulin sensitivity in patients with type 2 diabetes. Mankai, a strain of Wolffia globosa recently developed under controlled conditions, is characterized by high protein content and good bioavailability of proteins, rich in soluble fiber, vitamins (including vitamin B12), minerals (including iron and zinc), omega 3 fatty acids, and polyphenols. The 18-month long DIRECT PLUS trial was a weight-loss intervention conducted among 294 participants with abdominal obesity or dyslipidemia. 98 of the study participants were assigned to the intervention of a green Mediterranean diet and were instructed to consume four frozen cubes of Mankai daily. Main conclusions from the DIRECT PLUS refer to the beneficial effect of the green-Mediterranean diet on cardiometabolic risk, gut bacteria, and liver fat, with no evidence of disadvantages or adverse effects of long-term Mankai consumption. In 2019, the investigators reported that among non-diabetics and those with fasting glucose levels within the normal range, consuming a Mankai smoothie in the evening led to lower glucose levels after the meal and lower fasting overnight compared to a yogurt smoothie. The investigators now plan to explore the effect of Mankai daily supplementation on post-meal glycemic response in participants with type 2 diabetes. The investigators hypothesize that the addition of Mankai consumption after a meal may mitigate glucose excursions compared with control.

Eligibility Criteria:
Inclusion Criteria:

* Age =\> 30 years
* A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c=\>6.5%) or taking T2D medications.

Exclusion Criteria:

* Treatment with coumadin (warfarin)
* Advanced renal failure
* A significant illness that might require hospitalization
* State of pregnancy or lactation
* Presence of active cancer or chemotherapy treatment in last three years
* Participation in another trial.