cyrilzakka/clinical-trials huggingface dataset:
KTRSensor Scotland Study: an Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection

An observational study capturing real world transplant patients in the post-operative setting aiming to further determine the utility of biomarkers to improve outcomes.

A prospective longitudinal observational study capturing patients receiving kidney transplants in Scotland. The primary objective is to assess whether there are clinical biomarkers present in the urine that determine the outcome of kidney transplants and predict early graft rejection.

Eligibility Criteria:
Any patient within a Scottish Transplant centre who has undergone renal transplant (+/- pancreas/islet) and is due to attend routine follow-up appointments at the index centre.

Exclusion criteria:

* no previous kidney transplant
* patient attending follow-up at a peripheral site
* unable to provide urine samples across the study duration
Clarifying the Optimal Application of SLT Therapy Trial

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older and in good health
2. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):

   1. High-risk ocular hypertension (OHT): IOP \> 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of \>0.2 between eyes)
   2. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° \<15 dB (see figure on next page)
   3. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points \<15 dB or mean deviation -12.0 dB or better with 1 central 5° points \<15 dB (see figure on next page).
3. Each eye with BCVA 20/200 (UK 6/60) or better

Exclusion Criteria:

1. Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years (this is a modification implemented during active enrollment)
2. Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
3. Advanced POAG in either eye (worse than moderate POAG as defined above)
4. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
5. Mean IOP \> 35 mmHg at either the screening or baseline visit in either eye
6. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
7. Contraindications to SLT or any other study intervention
8. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
9. Any intraocular surgical procedure within the past 6 months in either eye
10. Inability to attend all scheduled study visits
11. Pregnant or planning to become pregnant in the next 4 years
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients

The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
* 3 - 18 years of age
* Patient has had prior bone marrow procedures
* English speaking

Exclusion Criteria:

* History of allergy to investigational agent: ropivacaine or other amino amide analgesics
* History of allergy to standard agent: propofol
* Chronic daily opioid requirement
* Lansky/Karnofsky Score \< 60
* Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use
* Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure
Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea

Polysomnography (PSG) has some disadvantages, such as time-consuming, effort-consuming, long appointment time and high cost. During PSG examination, multiple sensors need to be placed in the patient's head, face, neck, chest and limbs, and sensors are needed to monitor data throughout the night. It is difficult for young children to cooperate, and it is easy to fail due to inaccurate sensor signal acquisition. PSG examination may miss diagnosis or underestimate the disease due to the first night effect. Based on the above reasons, the application of PSG in clinic, especially in pediatric patients is limited. The reflective optical path detection can be used to measure the peripheral blood oxygen saturation in the flat part of human skin. The investigators intend to use a reflectance pulse oximeterto evaluate its reliability and validity in the diagnosis of OSA in children at the same time as PSG.

During PSG examination, the participants wear reflectance pulse oximeter for continuous monitoring. Use PSG to record EEG, oculogram, chin electromyography, body movement, chest and abdomen movement, nose and mouth airflow, snoring, electrocardiogram, blood oxygen saturation and finger pulse monitoring. The effective monitoring time should be at least 6 hours. Oxygen desaturation index (ODI), average blood oxygen saturation, minimum blood oxygen saturation, percentage of blood oxygen saturation less than 90% in the whole recording time (TS90%), fastest heart rate, slowest heart rate and average heart rate are recorded by reflectance pulse oximeter. To compare the effective time (TST), the total number of hypoxemia events, the coincidence rate of comparing each hypoxemia event, identifying OSA, and identifying moderate and severe OSA by PSG and reflectance pulse oximeter.

Eligibility Criteria:
Inclusion Criteria:

1. Snoring more than 3 nights per week in the last month
2. Pediatric sleep questionnaires score ≥ 0.33

Exclusion Criteria:

1. Acute exacerbation of asthma
2. Pulmonary infection
3. Heart disease
Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia

Genetic disorders, such as thalassemia, can lead to iron overload and severe adverse health outcomes. In iron-loading thalassemia, iron overload is due to increased iron absorption. Iron accumulates in the body organs causing widespread damage. The standard treatment is iron chelation therapy and/or periodic phlebotomy to remove iron from the body; frequency of phlebotomy or chelation therapy is dependent on how quickly body iron stores accumulate.

Polyphenolic compounds are very strong inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron in the gastrointestinal tract that cannot be absorbed.

The investigators have recently shown in European subjects with hereditary hemochromatosis (another iron-loading disorder) that our newly-developed natural polyphenol supplement (PPS) that is rich in polyphenols, when taken with iron-rich meals or with an iron-fortified drink, reduces iron absorption by \~40%. Decreasing non-heme iron absorption in adults with iron-loading thalassemia could potentially lead to an extension of the time period between phlebotomies or chelation therapies, and therefore an improved quality of life.

Therefore, in this stable iron isotope study, the investigators will study the effect the natural PPS on oral iron absorption from an iron-rich test meal or iron-fortified drink in Thai adults with iron-loading thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of thalassemia minor or intermedia (β-thalassemia with or without α-globin gene mutations, Hb E/β-thalassemia with or without α-globin gene mutations, or α-thalassemia Hb H disease) based on Hb electrophoresis/HPLC and/or DNA analysis from the subject's medical record.
* Hemoglobin (Hb): 7.0-13.5 g/dL for males; 7.0-12.0 for females
* Serum ferritin (SF): 300-800 ug/L for males; 200-800 ug/L for females
* Not having had a blood transfusion within 6 months prior to the study start
* Age 18-49 y, not pregnant or lactating
* Body weight \<75 kg and body mass index (BMI) between 17 and 25 kg/m2
* No acute illness/infection (self-reported)
* No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported)
* No scheduled phlebotomy or blood transfusion during the study period
* The last phlebotomy will be at least 4 weeks prior to first study visit
* No intake of iron chelators 4 weeks prior to first study visit and throughout the study period
* No use of medications affecting iron absorption or metabolism during the study
* No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study
* No participation in any other clinical study within the last 30 days and during the study
* Expected to comply with study protocol
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients

Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Diagnosed by fibromyalgia
* No other known physical, neurological and psychological illness
* Literate
* Volunteers to participate in the study

Exclusion Criteria:

* Not compliant with inclusion criteria
Organ Donation Survey Among Health Care Professionals in Argentina

The aim of this study is to gather information about knowledge, professional experience and attitude toward organ donation among health care professionals involved in the care of potential donors about the procurement process and potential lung donor management nationwide.

The shortage of cadaveric organ donors for transplantation is a global problem. This fact prolongs the time on the waiting list and, therefore, the mortality, which rise to 21.15% in Argentina compared to a world average of 16%. Many reasons can explain the low procurement rate. It has been stated that the conventional ventilatory management for potential lung donors is suboptimal for lung preservation before harvest.

In Argentina there is limited research regarding the attitude toward organ donation among health care professionals, knowledge of the federal organ procurement program and professional experience in diagnosing brain death and lung donor management. Knowing the Argentinian current situation will make it possible to detect possible organ shortages causes, evaluate strategies to increase the national procurement rate and to instruct the health team that assists neurocritical patients who die of brain death. So we propose the following research.

The aim of this study is to gather information about knowledge, professional experience and attitude among health care professionals involved in the care of potential donors toward organ donation, procurement process and potential lung donor management nationwide.

A online questionnaire was designed and distributed among health care professionals register to different scientific societies related to the care of neurocritical patients between febrary 16th and september 1st. The questionnaire consisting of 37 ítems: 6 items measuring attitudes, 6 items measuring knowledge, 16 items investigating professional experience and 9 ítems assessing demographics.

Eligibility Criteria:
Inclusion Criteria:

* health care professionals
* register to the Sociedad Argentina de Terapia Intensiva (SATI)
* related to the care of neurocritical patients
* between febrary 16th and september 1st.

Exclusion Criteria:

* unrelated to the care of neurocritical patients
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury

We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.

We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.

Eligibility Criteria:
1. non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C;
2. 21 - 70 years of age;
3. greater than 2 years post injury;
4. stable medical condition;
5. unable to voluntarily move all single joints of the legs;
6. cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and
7. respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes;

Exclusion Criteria:

1. ventilator dependent;
2. painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
3. clinically significant depression or ongoing drug abuse;
4. cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
5. severe anemia (Hgb\<8 g/dl) or hypovelemia; and
6. HIV or AIDS related illness.
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG score of 0 or 1;
2. Expected survival of not less than 3 months;
3. Important organ functions meet the following criteria:

   * Absolute neutrophil count (ANC) ≥1.5×109/L (1,500/mm3);
   * Platelet count (PLT) ≥100×109/L (100,000/mm3);
   * Hemoglobin (Hgb) ≥9.0 g/dL (90g/L);
   * Albumin level ≥3.0 g/dL;
   * Total serum bilirubin ≤1.5× the upper limit of normal (ULN);
   * Prothrombin time and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN);
   * Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
   * QTcF ≤470 msec;
   * Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria:

1. Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for \>2 weeks;
2. Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc.
3. Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.);
4. Having contraindications to ritonavir or itraconazole use;
5. Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
Outcomes of Covid-19 Protective Measures in Endoscopy

Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.

Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.

The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.

The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.

A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing an endoscopic procedure with written informed consent given.
* Staff allocated in the endoscopy unit.

Exclusion Criteria:

* Refection to participate in the study.
Short-term Evaluation of Motor and Sensory Function in Post-COVID-19 Patients

SARS-COV-2 infection reframed medical knowledge in many aspects, yet there is still a lot to be discovered. our aim is to evaluate neurological impact of covid-19; if there is any.

Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial impairments. Literature regarding the sensory and motor affection of COVID-19 is still limited.

Public health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts. Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms.

in a study; Neurological manifestations described in 36.4% of 214 patients with confirmed COVID-19. However, the symptoms described \[dizziness (not further defined), headache, and impaired consciousness\] are commonplace in many severe infections and represent disturbances in neurological function rather than a neurological disease per se. Anosmia and ageusia have received much attention, but are ubiquitous in other common upper respiratory tract infections. While a reported increased risk of cerebrovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed RT-PCR COVID-19 infection with mild to moderate severity based on the Egyptian ministry of health (MOH) protocol (version 1.4, November 2020) with neurological symptoms suggestive of peripheral neuropathy

Exclusion Criteria:

* patients presenting with neurological manifestations other than peripheral neuropathy, such as stroke, cerebral hemorrhage, encephalitis, or meningitis.
* Patients with any medical condition or comorbidities that may affect the result of the study as diabetes, arthritis, and carpel tunnel syndrome.
* Severe COVID-19 patients with a critical condition that needs hospitalization and ventilatory support were also excluded from the study.
Evaluation of the Effect of Cognitive Behavioral Therapy in Individuals Exposed to Earthquakes

Earthquake is a process that affects the lives of many people. It is very important to evaluate the psychological state of individuals after the earthquake and take appropriate action. When studies conducted after the earthquake were examined, no study was found that evaluated the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. For this reason, this thesis was conducted to evaluate the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes.

Earthquake is a process that affects the lives of many people. It is very important to evaluate the psychological state of individuals after the earthquake and take appropriate action. When studies conducted after the earthquake were examined, no study was found that evaluated the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. For this reason, this thesis was conducted to evaluate the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. In this thesis, a mixed design will be used in which quantitative and qualitative research methods will be used together.

* The quantitative dimension of the research will be carried out in an experimental design with pre-test, post-test control group and repeated measurement, and the qualitative dimension will be carried out with semi-structured questions that have a certain contact with individuals.
* The population of the research will be individuals in the container city in Osmaniye.
* The sample size will be determined by power analysis, and equal numbers of individuals will be included in the intervention and control groups.
* There will be 8-10 sessions for each individual, each session lasting 45-60 minutes.
* Sessions will be held between November 2023 and December 2023. The 3rd month follow-up will be done in March 2024.
* In this thesis, quantitative data, Socio-demographic Data Form, ruminative thought style scale and cognitive distortions scale will be used.
* Qualitative data were collected through semi-structured questions and therapy interviews.

will be collected.

* SPSS Statistics 20 program will be used in the analysis of qualitative data. MAXQDA Analytics Pro 2020 program will be used.
* Informed consent will be obtained.

Eligibility Criteria:
Inclusion Criteria:

being over 18 years old exposure to earthquake living in a container Ability to communicate

Exclusion Criteria:

Not being able to communicate