cyrilzakka/clinical-trials huggingface dataset:
UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes

The aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes

This is an IIT study, where the first part is an open, dose escalating study consisting of 9 patients, 8-18 years of age. The second part is a randomized, double-blinded, placebo-controlled, IIT study in parallel design comparing allogeneic UCMSCs treatment to placebo in pediatric patients diagnosed with newly onset type 1 diabetes. Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.

A total number of 24 patients will be enrolled in the study and followed for one year after UCMSCs/placebo treatment. Patients 8-18 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within 6 months of diagnosis be randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Meets the diagnostic criteria for diabetes according to the World Health Organization (WHO) guidelines from 1999.
2. Presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (T1DM) with negative autoantibody testing.
3. Ages 8 to 18 years, regardless of gender.
4. Newly diagnosed T1DM within the past 6 months.
5. Fasting C-peptide ≥0.1 nmol/L and postprandial 2-hour C-peptide \>0.2 nmol/L.
6. Voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form.

Exclusion Criteria:

1. Diabetic ketoacidosis is not under control.
2. Severe allergic constitution.
3. BMI \<14 or \>35.
4. History of other autoimmune diseases, hematologic disorders.
5. HIV positive, carrier of viral hepatitis, active phase of viral hepatitis, or other uncontrolled infectious diseases.
6. History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe diseases of the heart, liver, kidneys, respiratory system, nervous system, etc.
7. Suffering from gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction, or acromegaly-induced diabetes);
8. Pregnancy or planning pregnancy within 3 months before or after treatment, as well as breastfeeding women.
9. Mental illness, alcohol or drug abuse, inability to comply with treatment.
10. Known or suspected tumors.
11. According to the investigator's judgment, there are other clinical conditions that may endanger the safety of the subjects.
Recognition of Serious Infections in the Elderly

The aim of this diagnostic accuracy study is to develop a clinical prediction rule based on signs, symptoms, patient characteristics and blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient.

It will be performed in general practices and emergency care departments across Flanders (Belgium).

This is a cross-sectional diagnostic cohort study in older adults presenting to ambulatory care, including a follow-up period of 30 days. This study will be used to construct an algorithm consisting of clinical features and blood test results to identify serious infections.

The study will run in ambulatory care in Flanders. Recruitment is expected to last 2.5 years, with each patient entering the study only once. Older adults will be approached for possible participation in the study by practice staff. There is only one study visit.

Those who agree to participate via written informed consent will have demographics and clinical features recorded. A blood sample will be taken in all participants on study entry. Follow-up information for all participants will be collected using electronic medical record notes (EMD) and patient diaries.

Treatment and other management decisions will be left to the treating physicians' discretion.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Presenting to a general practice with an acute illness with a maximum duration of 10 days since onset
* Suspicion of infectious disease (this may include suspicion of an acute exacerbation of COPD)
* Patient or proxy of the patient is willing and able to give informed consent for participation.

Exclusion Criteria:

The participant may not enter the study if any of the following apply:

* Too clinically unstable to waste time on study procedures
* Indwelling catheter in situ
* Immunocompromised or currently receiving medication for systemic immune-suppression, including corticosteroids
* Being admitted to hospital for longer than 24 hours less than 7 days before study entry, or having undergone surgery in the previous 30 days
* Living in a nursing home (both short term and long term stay) (only in general practice cohort)
* Patient was already included in the study
FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.

To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.


Eligibility Criteria:
Inclusion criteria:

* All patients with traumatic rupture of FDP-tendon in zone II.

Exclusion criteria:

* \< 18years;
* Fracture;
* crush injury; (partial) amputation;
* RA;
* CPPD;
* CP;
Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
* Prior treatment with at least 2 systemic chemotherapy regimens for CLL
* Life expectancy of \>3 months
* Adequate liver and kidney function
* Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL
* Willing to use accepted method of contraception during the course of the study
* Negative pregnancy test (females)
* Written informed consent

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
* Investigational drug within 30 days of the start of treatment
* Uncontrolled intercurrent illness such as infection or cardiovascular disease
* Pregnant or breastfeeding women
* Subjects known to be HIV positive
Effects of Creatine Supplementation on Renal Function

Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal function remain controversial. The aim of this study was to evaluate the effects of creatine supplementation on renal function and oxidative stress in healthy sedentary males (18-35 years old) submitted to exercise training. Our hipothesis is that creatine supplementation does not affect renal function in this population.

Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal function remain controversial. Purpose: The aim of this study was to evaluate the effects of creatine supplementation on renal function and oxidative stress in healthy sedentary males (18-35 years old) submitted to exercise training. Methods: Subjects (n = 18) were randomly divided in two groups and were allocated to receive treatment with either creatine (CR) (\~10g • day-1 over three months) or placebo (PL) (dextrose). All subjects undertook moderate intensity aerobic training, in three 40-minute sessions per week, during 3 months. Serum creatinine, TBARS, serum and urinary sodium and potassium were determined at baseline and at the study endpoint. Furthermore, cystatin C was also assessed prior to training (PRE), after 4 (POST 4) and 12 weeks (POST 12). Results: There were decreased in both oxidative stress (evaluated by TBARS - µM/24 h) (PRE CR: 8.2  4.4; PL: 6.4  0.8 vs. POST 12 CR: 2.5  1.8; PL: 2.1  1.6, p=0.0001) and cystatin C levels (mg/L) (PRE CR:0.82  0.09; PL: 0.88  0.07 vs. POST 12 CR: 0.71  0.06; PL: 0.75  0.09, p=0.0001) over the time, suggesting an increase in glomerular filtration rate. There were no significant differences between groups in other renal parameters investigated. Conclusions: These data indicate that high-dose creatine supplementation throughout three months does not provoke renal dysfunction in sedentary healthy males urdergoing aerobic training. Moreover, our results suggest that moderate aerobic training per se could improve renal function.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary healthy males,
* Euthrofic,
* Age beteween 18-35 y

Exclusion Criteria:

* Food supplement users,
* Pre-existing renal dysfunction,
* Pre-existing cardioavascular disease,
* Subjetcs physically active or athletes,
* Obesity,
* Drugs users
The Moms Online Video Exercise Study

The purpose of this study is to test feasibility and acceptability of an online platform that uses mobile apps and videoconferencing tools to increase activity levels in mothers with young children.

The investigators are testing the feasibility and acceptability of a digital health platform using a randomized parallel wait-list control design for mothers with young children. The platform incorporates home based supportive group exercise sessions using video conferencing tools, shared online activity tracking and exercise mobile apps for individualized exercise routines will help mothers increase their physical activity levels and be successful at maintaining this increase.

The intervention arm consists of two main parts: home based video conferencing virtual exercise sessions and mobile exercise apps, which women use to tailor exercise routines to their own skill level and preferences. Both arms will receive an activity monitor that they collect continuous activity data throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Mother to at least one child that is less than 18 years old
* Owns a smart phone (iPhone or Android) and can download mobile applications
* Sufficient data to use mobile applications on a mobile device
* Owns a mobile device with a web camera

Exclusion Criteria:

* Inability to provide informed consent
* Inability to speak or understand English
* Any medical restrictions where vigorous activity is not recommended
* Any history of heart conditions including cardiovascular disease or coronary artery disease
* Any history of heart conditions including cardiovascular disease or coronary artery disease
* Meets federal guidelines for exercise for either aerobic (150 minutes of moderate activity per week, 75 minutes of vigorous activity per week, or some combination)
* Pregnant or planning to get pregnant during study duration
Varicella Vaccination With Pulmicort

A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine


Eligibility Criteria:
Inclusion Criteria:

* Children between the age of 10 months and 8 years,
* have asthma or shown recent signs suggesting asthma,
* have a parent or guardian willing to comply with study requirements

Exclusion Criteria:

* Varicella zoster immune globulin (VZIG) within 5 months prior to immunization,
* Previous varicella immunization,
* an immunization or allergy immunotherapy 4 weeks prior to immunization,
* Severe asthma,
* have another persistent lung disease,
* have a planned hospitalization for the duration of study
Mother Matters Online Postpartum Support

Postpartum depression is common, yet only 20% of women seek treatment. Online support groups are a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online psychotherapy group for women with postpartum depression \& anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of proceeding to a large-scale RCT evaluation of the Mother Matters intervention.

The postpartum period is a particularly vulnerable time for the development of mental health concerns; postpartum depression (i.e. depression with onset between 0-12 months postpartum) affects approximately 13% of mothers in Canada. There are serious negative consequences to both mother and child during this period, yet only 20% of women seek treatment, citing significant systematic and personal barriers. Online support groups have been identified as a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online support group for women with postpartum depression and anxiety, run trained psychotherapists in the Reproductive Life Stages (RLS) program at Women's College Hospital in Toronto, Ontario. Mother Matters was designed to address barriers related to accessing postpartum mental health services: it can be accessed anywhere (online group), at any time (available 24/7), and with anonymity (to address the barrier of shame/stigma). The overall objective of the current pilot RCT is to determine the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the group, comparing outcomes among those with and without access to the program.

Eligibility Criteria:
Inclusion Criteria

The specific inclusion criteria for this group are women who are:

1. Mothers of a baby/babies between 0 and 12 months old at enrollment, and
2. Over 18 years old, and
3. Have an Edinburgh Postnatal Depression Scale (EPDS) score of \>9, and
4. Reside in Ontario.

Exclusion Criteria

Women will not be eligible to participate in the study if they are:

1. Experiencing active suicidal ideation, or
2. Have active substance use, mania or psychosis, or
3. Unable to access the internet, or
4. Unable to participate in English.
Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Healthy male and female (of non childbearing potential)
* Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Self-Advocacy for Independent Life (SAIL) After TBI

Traumatic brain injury (TBI) has been conceptualized as a chronic health condition, warranting self-advocacy for health management services across the lifespan. Successful self-advocacy requires a combination of cognitive and communication skills (problem solving, organization, negotiation, etc), which may be impaired following TBI. This project focuses on developing and testing the efficacy of an intervention to enhance self-advocacy skills in individuals who have sustained TBI. This two-arm, randomized controlled trial will include approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with each wave recruited from a different geographic area of the state. The primary hypothesis states that participants receiving the treatment intervention will demonstrate significantly greater improvements in self-advocacy beliefs (SAS) from baseline to post-intervention as compared to participants in the control group. Treatment will consist of interactive 4-session workshops along with 2 booster phone calls. Control participants will receive a copy of a self-advocacy workbook after all assessments are completed. Baseline, post-treatment and two follow-up assessments will take place.


Eligibility Criteria:
Inclusion Criteria:

* Documented TBI due to an external mechanical force
* Received inpatient or outpatient rehabilitation for TBI
* At least 9 months post TBI
* Able to travel independently in the community
* Able to attend intervention sessions

Exclusion Criteria:

* Unable to read or speak English well enouth to complete assessments and actively participate in study intervention
* Currently in inpatient TBI rehabilitation
* Previously participated in a SAIL program
* Participating in another research trial
* Unable to perform neuropsychological baseline assessment
* Score of 30 or above on GSES
Tree Branch Penetrating Injury

Penetrating trauma to the neck can result in severe morbidity and mortality. Location of the injury dictates the appropriate clinical management. Challenging traumatic injuries require resourceful treatment options

A complex traumatic case of a foreign body penetrating the neck, the parotid gland, disrupting the internal jugular vein, with the tip resting at the anterior aspect of the C1 ring is reported. In this case, the authors seek to describe the clinical management of a vascular injury that resulted from penetrating zone III of the neck.

Due to the complex and dense presence of various structure in the neck, injuries can be difficult to manage. Thus, an algorithm identifies management strategies that are suggested based on the location of the injury, signs of vascular injury, identified injured structures and the hemodynamic stability of the patient. Balloon tamponade has been described in other organs of the body and it might be a therapeuticn option in patients were venous injuries are difficult to access.

Penetrating neck injuries continue to result in significant morbidity and mortality. However, with appropriate and efficient evaluation and management, better outcomes are expected as demonstrated in this case.

Eligibility Criteria:
Inclusion Criteria:

* Penetrating Injury to the Neck

Exclusion Criteria:

* N?A
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules

Shear wave ultrasound elastography is a new technique of finding the softness or hardness in tissue by applying a "push" generated by the machine. This technique will help in diagnosing malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.

Thyroid nodules are a common medical problem. With the wide use of various imaging modalities, incidentally detected thyroid nodules are becoming more common. However most of these nodules are benign with only a small proportion of 5-10% being malignant. With the increasing number of nodules detected, evaluation of these thyroid nodules presents a diagnostic challenge since the imaging modality used for evaluation at present, i.e., ultrasound (US) alone, has a low specificity of approximately 50-70%. In order to improve specificity to confidently diagnose malignancy in the thyroid nodule, a fine needle aspiration (FNA) biopsy is performed.

In recent years, US elastography has been shown to have high specificity of 90- 98% in various studies in differentiating between benign and malignant nodules. US elastography works on the principle of detecting the stiffness within a tissue by applying compression which can be manual compression or by generation of a remote radiation force by focused ultrasonic beams called as shear waves. Shear Wave Ultrasound (SWUS) elastography is an objective method of US elastography that detects the stiffness within the nodule since the strength of the shear wave generated is known and can be controlled. SWUS elastography has shown promise in being able to noninvasively diagnose papillary carcinoma in previous studies involving preoperative patients.

The investigators propose to perform a study to investigate the efficacy of SWUS elastography in diagnosing malignant thyroid nodules and noninvasively decreasing the number of FNAs performed by avoiding FNA in benign nodules. The Investigators will enroll patients with thyroid nodules before they undergo FNA biopsy or surgery. We also propose to compare routine US and SWUS elastography and their combined use in differentiating malignant from benign nodules. The investigators hypothesize that SWUS elastography can be used as a noninvasive screening tool, prior to an FNA, to screen out benign and malignant nodules with high level of confidence and reduce the number of biopsies in the future.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of thyroid nodule
* Referred for thyroid FNA or surgery

Exclusion Criteria:

* Minors; age \<18
* Unable to provide informed consent
TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study

The social, psychological, economic burden of Spinal trauma with deficit is great, and there is no curative treatment.

Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke.

The study primary end point is to find out the maximum tolerated dose of EPO. This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection. Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts.

The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method (CRM). The sample size is expected for less than 20 patients.

Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within 12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up lasts 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 15 to 65 years, covered by a social insurance system, having given an informed consent (or attested by a third person if unable to sign, or parents consent in minors), within 12 hours of a spinal trauma, without vital organ deficiency from a non spinal origin

Exclusion Criteria:

* Impaired consciousness,
* Treatment not given within 12 hours,
* Cervical arthritis,
* Respiratory failure requiring artificial ventilation,
* Patient requiring blood transfusion superior to 2 units,
* Uncontrolled severe hypertension,
* Unstable hemodynamics,
* Patient suffering from epilepsy,
* Recent or uncontrolled angina pectoris,
* Having received high doses of glucorticoïds,
* Pregnant or breasting,
* With more than 15 g/ml of haemoglobin,
* With previous thrombo embolism disease,
* With allergy to Low molecular Weight heparin, or
* Participating in another interventional study