cyrilzakka/clinical-trials huggingface dataset:
Serum Esnophilic Cationic Protein Level as Diagnostic Marker in Cow Milk Protein Allergy Infants

Characterize the degree of the activation of serum eosinophilc cationic protein (sECP) by measuring its level and establishing whether it is a useful parameter in monitoring oral cow's milk allergy Measure the MPV and NLR levels in infants with CMPA and to determine the suitability of these parameters as biomarkers in diagnosis of CMPA.

Cow's milk protein allergy (CMPA) is the most common cause of food allergies in children with incidence estimated as 2% to 7.5% in the first year of life and is characterized by an inflammatory reaction to milk proteins, Formula and exclusively breast-fed babies can develop CMPA.

The immunologic mechanism behind the development of CMPA is not yet clear. However, it is clear that CMPA is caused by IgE- as well as non-IgE-mediated immune reactions, IgE-mediated CMPA is better described and it is typically immediate, type 1 hypersensitivity (minutes to 2 hours after consumption of cow's milk) while non IgE- mediated CMPA is delayed, type 4 hypersensitivity. a diverse range of symptoms of variable intensity in infants.

Combinations of immediate and delayed reactions to the same allergen may occur in the same patient, symptoms and signs related to CMPA may involve many different organ systems, mostly the skin and the gastro- intestinal and respiratory tracts. The involvement of two systems increases the probability of CMPA, whereas some symptoms are more likely to be present in infant with a positive test for CMP-specific IgE (eg, angioedema, atopic eczema); however, there is a large overlap. The same symptoms may appear in CMP IgE-positive and IgE-negative patients, particularly in infant with gastrointestinal manifestations.

Studies in unselected infants with CMPA show that approximately half of them have atopic eczema, and 25% to 50% are affected by some gastrointestinal tract involvement whereas other clinical manifestations are less common.

It is important to accurately diagnose CMPA to avoid the consequences of either under- or overdiagnosis, skin prick test and serum specific IgE tests are helpful for diagnosis, mainly in IgE-mediated forms . On the other hand, in cases of CMPA with gastrointestinal chronic signs and symptoms, skin prick test and specific IgE tests are usually negative.

This is the reason why the only reliable method of diagnosis in such cases is a food challenge that need to be done in hospital and could be also dangerous, this explain why there is a growing interest to find new biomarkers for diagnosis and follow up.Eosinophil cationic protein (ECP) is a cytotoxic protein released from eosinophils upon activation the measurement of ECP levels can be used as a non invasive indicator to detect active inflammation in the body.

Eligibility Criteria:
Inclusion Criteria:

- All infants (0-12 month) suspected with CMPA

Exclusion Criteria:

* Infants with genetic, metabolic, haematological, or infectious (e.g. :infectious gastroenteritis) diseases will be excluded from the study
Nebivolol in the Supine Hypertension of Autonomic Failure

The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine hypertension.

Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO) bioactivity. The contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. Autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to determine the effect of nebivolol on blood pressure in this patient population. A decrease in blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).

Eligibility Criteria:
Inclusion Criteria:

* Male or female and aged 18 years or over.
* Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
* A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
* Supine hypertension, defined as a systolic blood pressure \>150 mm Hg or diastolic blood pressure \> 90 mm Hg.
* Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

Exclusion Criteria:

* Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
* Women of childbearing potential who are not using a medically accepted contraception.
* Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
* Diabetes mellitus or insipidus.
* In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
* In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
* In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
* Are not able or willing to comply with the study requirements for the duration of the study.
* Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
Prehospital Severe Traumatic Brain Injury

The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. The aim of the second study is to identify prehospital factors influencing the prognosis of prehospital TBI patients.

A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Eligibility Criteria:
Inclusion Criteria:

* TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital

Exclusion Criteria:

* Multiple trauma
Multi-physics Modeling the Physiology of a Patient in Critical Condition

The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation.

The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of "physios" program,


Eligibility Criteria:
Inclusion Criteria:

* Patient in intensive care unit ward

Exclusion Criteria:

* Patient or familly refusing participating to the study
Postpartum Outcomes in BC

For every case of maternal death, many more women experience life-threatening complications during pregnancy and childbirth. Yet, severe maternal morbidity (SMM) cases are often overlooked post-delivery. Women have reported that roughly 15% of SMM cases first occurred in the six weeks following delivery. The underlying factors associated with these morbidities are likely different than those occurring antenatally and at the time of delivery. Further research is required to elucidate the exact burden of SMM in the postpartum period in British Columbia (BC).

The ratio of maternal morbidity to maternal mortality is increasing globally (Geller 2018). In high-income countries, the World Health Organization (WHO) recommends routinely surveilling SMM to assess maternal health and quality of care (Geller 2018). To our knowledge, this is the first study conducted among pregnancies in BC aiming to examine the cumulative incidence, timing, and factors associated with postpartum maternal morbidity and hospital readmissions.

This is a retrospective cohort study will use data from the BC Perinatal Data Registry (BCPDR), which contains maternal, fetal and neonatal health information from 99% of all deliveries in BC. The primary outcome assessed will be the cumulative incidence of hospital readmissions and SMM events occurring after delivery discharge within the first six weeks (42 days) of delivery. Secondary outcomes will include SMM-diagnosis, the rate and timing of postpartum SMM and readmissions, and maternal characteristics associated with these events. A multinominal logistic regression model will examine the association between postpartum SMM or readmission and determinants.

Eligibility Criteria:
Inclusion Criteria:

* Delivered in BC from April 1, 2008 to March 31, 2021
* Consented to data collected by the BCPDR

Exclusion Criteria:

• None
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

- Adult (\>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria

Exclusion Criteria:

- Children \< 18 years old

Patients with following psychiatric disorders:

* Psychosis or history of acute psychosis
* Schizophrenia
* Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed.

Pregnant patients
Diagnostics in Diverticulitis (DIDit)

This study focuses on if low dose CT without intravenous contrast has a high enough specificity and sensitivity for acute diverticulitis that it can be used as the primary diagnostic method instead of a full dose CT with intravenous contrast which is the standard method in Sweden.

Patients will be recruited from the emergency departments in Mora and Vastmanland hospitals. All patients over the age of 50 with clinically suspected acute diverticulitis that meet inclusions criterium will be asked for participation. A Clinical examination and blood samples will be drawn.

Subjects will be sent to the radiology department where they will undergo computed tomography (CT) of the abdomen. The CT protocol consists of a low dose non contrast enhanced CT followed by a normal dose CT with intravenous contrast. This is needed as randomization of patients is not possible due to the fact that the Clinical diagnosis of diverticulitis is difficult and unreliable. This would lead to the situation that we would not know if a participant in the low dose CT Group has diverticulitis which was not seen with the low dose protocol or if the patient did not have diverticulitis.

The radiologist on call will examine the full dose CT examination and write a report as routine. At a later date Three blinded radiologists will examine first all low dose CT examinations and grade them according to our CT protocol. At a later date the radiologists will evaluate all full dose CT examinations using the same CT protocol.

Findings will then be compared between the two different CT methods and sensitivity and specificity for low dose CT will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 50
* Clinically suspected acute diverticulitis
* Low abdominal pain
* WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L

Exclusion Criteria:

* Pregnancy
* Previous allergy to intravenous contrast
* Renal failure or other reasons that the patient cannot undergo CT with iv contrast
* Unable to give informed consent
* Dementia
* Language barrier
NXT Post-Market Clinical Follow-up

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Eligibility Criteria:
Inclusion Criteria:

* Patients medically indicated for urodynamic study
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria:

* Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
* Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
* Pregnant women
* Patients with recent (less than 2 weeks) pelvic floor surgery
* Requires use of suprapubic catheter
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness in Stroke Patients

Background:

Aerobic exercise training has favorable effects on quality of life, motor recovery, and aerobic endurance after stroke.

Objectives: In this study, the investigators aimed to explore the effects of anti-gravity treadmill gait training and underwater walking therapy on cardiorespiratory fitness in stroke survivors.

Methods: Seventy patients with a history of stroke were admitted to our center between July 2017 and January 2018. Subjects who participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy, and control group. Investigators examined the aerobic capacity of participants by using the 6-minute walk test and cycle ergometer testing before starting the treatment along with a one-month follow-up. The patient's balance was examined by using the Berg Balance Scale (BBS).

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 80 and diagnosed with stroke and time from stroke onset to admission were longer than three months
* Independent walking ability more than 10 meters with or without assistance
* Patients whose cognitive and functional status were suitable for the training program

Exclusion Criteria:

* Had a previous history of stroke
* Bilateral hemiplegia
* Leg-length difference \>2.0 cm
* Fixed flexion contracture or severe joint deformity
* Bladder or bowel incontinence
* Open wound
* Cardiovascular complaints and can not tolerate exercise training
* Other neurological comorbidities including, multiple sclerosis (MS), spinal cord injury (SCI), traumatic brain injury (TBI), Parkinson's disease, and intracranial tumors
* Congestive heart failure
* Atrial fibrillation (AF), use of antiarrhythmic drugs affecting QT duration, any type of bundle branch block on electrocardiogram (ECG)
MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach using 68Ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.

Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Eligibility Criteria:
Inclusion Criteria:

1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
2. age ≥18 and ≤75 years old, male or female;
3. ECOG score 0 or 1;
4. expected survival time ≥6 months;
5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
7. patients recommended by clinicians to undergo PET/CT examination for tumor staging;
8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Able to understand the informed consent and baseline/follow-up questionnaires
* Chronic low back pain \> leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
* No clinical evidence of SI joint mediated pain
* Concordant pain reproduced on provocative discography at an intensity of \>6/10 at low pressure (\<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
* Preservation of at least 50% height of the symptomatic disc(s)

Exclusion Criteria:

* Active radicular pain
* Nucleus pulposus herniation \> 5 mm, extrusion or sequestration on MRI
* Spondylolithesis at the symptomatic level
* Prior surgery at the symptomatic level
* Concomitant cervical or thoracic pain \>2/10 (VAS) in severity
* Other chronic pain conditions (i.e. Fibromyalgia Syndrome)
* Immunosuppression (i.e. Cancer, AIDS, Rheumatoid arthritis)
* Third-party (WSIB, litigation or insurance) involvement
* Psychological issues impeding recovery by history, examination and/or a Beck Depression Inventory score of \>20
* Systemic or localized infection (at the anticipated needle entry sites)
* BMI \> 35 (Obesity)
* Substance or opioid abuse
* Coagulopathy
Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study

To learn if an 8-week, phone-based texting intervention program will reduce sedentary (non-mobile) behavior.

Primary Objective: To test the effect of two text messaging strategies, responsive texts and standard scheduled texts, on sedentary behavior in a racially and geographically diverse sample of adults.

Secondary Objective: To assess participant engagement with the program and with the educational content delivered via text messaging.

Exploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts, increases physical activity in a racially and geographically diverse sample of adults.

Exploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts are associated with changes in corresponding patient attitudes as assessed by surveys of exploring sedentary behavior, readiness for exercise change, and physical functioning.

Eligibility Criteria:
Inclusion criteria:

1. \>18 years old;
2. owns a smart phone;
3. has access to WiFi or willing to use mobile data;
4. has an email address or willing to create an email address;
5. able to read and understand English;
6. able to give informed consent;
7. willing to receive text messages and complete brief questionnaires on their smart phone.
8. self-reports sedentary behavior (\> 6 hours/day of sitting time).

Exclusion criteria:

1. unwilling to have sedentary behavior and activity tracked
2. unable to walk without ambulatory assistance device (i.e. cane or walker) or due to underlying medical condition
3. MD Anderson employees that report to the Principal Investigators of this study
4. not sedentary based on \< 6 hours/day of sitting time.