cyrilzakka/clinical-trials huggingface dataset:
TCR Alpha/Beta and CD19-deplete Haplo-HSCT

This is an open label, interventional, non-randomized, phase II trial of TCR alpha/beta and CD19-depeleted allogeneic HCT in pediatric patients with hematologic disease.

This is a single-site, open label, interventional, non-randomized, phase II trial of TCRαβ/CD19 deplete allogeneic HCT as donor source and sole GVHD prophylaxis in pediatric patients with either malignant or non-malignant hematologic disease who are eligable for allogeneic HCT, but lack a HLA-matched sibling donor.

Eligibility Criteria:
Inclusion Criteria:

1. Age 31 days to \<30 years
2. Have a malignant or non-malignant hematologic disease, defined as disease resulting from abnormal function of a cell of the hematopoietic stem cell lineage, that could benefit from an allogeneic HCT. Examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias/marrow failure, white blood cell abnormalities, red blood cell abnormalities, and platelet abnormalities.
3. Clinical remission for patients with acute leukemia (MDS/AML excluded) or lymphoma
4. Lack a healthy and willing HLA-identical related donor, with the exception of patients with FA who will be eligible with a willing HLA-identical related donor given the standard use of T-cell depletion in matched sibling donor HCT in FA
5. Have a related or an unrelated donor who meets the donor selection criteria, is healthy, willing, and able to receive GCSF with or without Plerixafor, and undergo apheresis through placement of catheters in the antecubital veins or a temporary central venous catheter
6. Able to give informed consent if ≥ 18 years, or with legal guardian capable of giving informed consent if \< 18 years
7. Provision of signed and dated informed consent form

Exclusion Criteria:

1. Uncontrolled, active infection at time of HCT
2. HIV positivity
3. Cardiac ejection fraction \<45%
4. Creatinine clearance \<60 mL/min/1.72 mL
5. Pulmonary diffusion capacity (adjusted for hemoglobin), FEV1, or FVC \<60% of predicted or an O2 saturation \<94% on room air if unable to perform pulmonary function testing
6. Serum ALT \>5x upper limit of normal or bilirubin \>2
7. Performance score (Lansky or Karnofsky) \<50
8. Pregnant or lactating females, as many medications necessary for a successful HCT are potentially harmful to unborn babies and infants.
Oral Lactobacillus Rhamnosus TCELL-1 and Colorectal Cancer

Emerging evidences have shown that gut microbiota have played roles in the modulation of chemotherapy agents for cancer patients receiving chemotherapy. Probiotics are gut microbiota beneficial to human body. However, little was known about the role of probiotics for cancer patients receiving chemotherapy. Lactobacillus rhamnosus TCELL-1 is a kind of probiotics which were isolated from the gut mucosa of healthy Taiwanese. The aim of the study was to evaluate the effect of Lactobacillus rhamnosus TCELL-1 upon staged III colorectal cancer patients receiving adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged older than 20 years (inclusive) of either gender
2. Expressed interest and ability to fulfill the study requirements.
3. Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
4. Able to ingest the study drug (Lactobacillus Rhamnosus TCELL-1) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
5. Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
6. Willing to comply with protocol and report on compliance and side effects during study period.
7. Informed consent obtained and signed prior to screening.

Exclusion Criteria:

1. Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
2. With uncontrolled infection or serious infection within the past 4 weeks
3. Patients who took antibiotics for some reasons within the past 4 weeks
4. Patients who must eat probiotics product for some reasons
5. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
6. History of allergy to any substance of investigational products
7. With known human immunodeficiency virus (HIV) infection
8. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
9. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
10. Having participated other investigational study within 4 weeks of entering this study
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)

Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative Colitis confirmed by endoscopy and histology.
* Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
* Duration of the disease \>7 years (or any duration if concomitant with PSC).

Exclusion Criteria:

* Personal history of colorectal cancer or high-grade dysplasia.
* Previous colectomy (partial or complete).
* Coagulopathy that prevents biopsies or polypectomy.
* Colonoscopy performed in the previous 6 months.
* Pregnant or nursing women.
* Inadequate bowel preparation.
* Presence of endoscopic Ulcerative Colitis activity.
* Colonic stenosis and incomplete colonoscopy.
Adolescent Idiopathic Scoliosis and Mental Health

The purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.

This study is a cross-sectional pilot study investigating the prevalence of psychiatric illness at various time points in the course of treatment of AIS. Three independent sets of questionnaires will be administered during a single scheduled clinical visit. There will be no clinical visits for the exclusive purpose of completing questionnaires. The first questionnaire will be the SRS outcome instrument. The second questionnaire will be the Achenbach YSR, completed by the adolescents, and the parents will be asked to complete the CBCL. Finally, a generic outcome measure specific to children and adolescents, the Pediatric Outcome Data Collection Instrument, will be administered. The time requirement to complete these questionnaires is anticipated to be approximately 45 minutes. The Achenbach questionnaires will be scored promptly after each is completed using the provided scoring templates. This data will be used to identify those at risk and make appropriate resources available. This would provide appropriate care for adolescents at high risk of mental health disorder by identifying those at risk via a non-invasive screening tool.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with AIS, between the ages of eleven and sixteen, who are scheduled to undergo surgical intervention, will be eligible to participate in the study. The patient and one parent will be required to complete the questionnaires in their entirety at the predetermined time points. There are several different methods of surgical intervention for AIS, however there will be no selection on the basis of the type of intervention. Curve pattern and severity will, similarly, not be used as inclusion criteria.

Exclusion Criteria:

* All types of scoliosis besides AIS will be excluded. This includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis.
* Children younger than eleven years or older than sixteen years will be excluded.
* Those with additional chronic disease will be excluded, due to the possibility of confounding.
* Those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded.
* Existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.
Genetic Basis of Rosacea Study (Control)

Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.


Eligibility Criteria:
Inclusion criteria include:

1. Fitzpatrick skin type II or III
2. Age greater than or equal to 18 years
3. Individuals without a history of rosacea

Exclusion criteria include:

1. Women who are pregnant or lactating
2. Use of topical prescription medications or procedures to the face within one month of enrollment
3. Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)
Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance

Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.

Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.

Aims of the study:

1. To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in PS and in NAVA in intubated spontaneously breathing patients
2. To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique

Eligibility Criteria:
Inclusion Criteria:

- Patients admitted to the ICU, intubated for acute respiratory failure, and ventilated in PS mode will be eligible for inclusion in the study.

Exclusion Criteria:

* Severe hypoxemia requiring an FIO2 \> 0.5
* hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-)
* oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery;
* active upper gastro-intestinal bleeding;
* known coagulation disorder;
* any other contraindication to the insertion of a naso-gastric tube;
* poor short term prognosis (death expected within the next seven days)
* age \< 18 years old.
Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction

Study, Prof. Dr. It will be performed on patients diagnosed with UVH who apply to Mete İşeri Ear Nose and Throat Diseases Clinic and Güneşli Erdem Hospital Ear Nose Throat and Vestibular Rehabilitation Unit. Participants were selected by simple randomization (sealed envelope) method; will be divided into two groups: control group and study group. Criteria for inclusion in the study; While he was diagnosed with unilateral vestibular hypofunction with the VNG test, was between the ages of 18-65, was in the A+ class in the System Usability Scale (SCS), and had a percentage range between 96-100; Exclusion criteria of the study; Bilateral vestibular hypofunction, visual impairment, neurological disorder, and inability to communicate. To the control group; A conventional rehabilitation program based on structured Cawthorne Cooksey exercises will be applied for 45 minutes with the support of a physiotherapist, once a week for 8 weeks. As for the working group; In addition to the program of the participants in the vestibular exercise group, optokinetic stimulation will be given through oculus glasses. Application will be made 1 day a week for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with unilateral vestibular hypofunction with VNG test,
* Being between the ages of 18-65,
* Being in the A+ class on the System Usability Scale (SCS) and having a value between 96-100 percentile

Exclusion Criteria:

* Having bilateral vestibular hypofunction
* Having a visual impairment,
* Having a neurological disorder
* Inability to communicate
Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis

The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. Echocardiography provides the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Must have an interpretable Tc-99m myocardial perfusion scan and an interpretable echocardiogram.

Exclusion Criteria:

* Technically inadequate noninvasive test.
Comparison Between the Effectiveness of Different Commercial Bracket Brands

There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with Class I molar relation and teeth crowding, in which different bracket brands will be compared.

Bracket effectiveness can be measured in a variety of ways, including torque, tip, time required for levelling and alignment, bracket failure, and the patient's visual analogue scale. All are viable options; therefore, we want to complete the orthodontic treatment and determine which brackets fulfilled the built-in bracket prescription and achieved success in terms of aesthetics, better smiles, better patient judgement, and function.

Eligibility Criteria:
Inclusion Criteria:

* Patient with full set of permanent teeth
* Male and female (14-19 years old).
* Positive patients' acceptance for the study
* Patients have no history of previous orthodontic treatment.

Exclusion Criteria:

* Patients with enamel or dentin defect or any teeth anomaly will be eliminated.
* Patients having canine or lateral incisors peg shaped will be excluded from the research. - Medically compromised patients
* Patients unable to give an informed consent
* Patient with periodontal disease
* Patient taking long term medication
* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth Breathing)
Multicenter Continuous Peripheral Nerve Block Surveillance Study

This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.

Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.

This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
* Age \>18
* Able to give consent

Exclusion Criteria:

* Morbid obesity (BMI\> 40)
* Uncooperative or having psychological or linguistic difficulties
* Previous damage to the nerve or plexus
* Significant comorbidities which the primary investigator feels would limit the quality and collection of data
* Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia

This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.

The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Self-reporting informal caregivers of persons with dementia

Exclusion Criteria:

* Self-reported major depressive disorder with psychotic features
* History of schizophrenia
* Bipolar disorder
* Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
* Previous MBSR training or regular meditative practice within previous 6 months
Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin.

A non-interventional, multicentre study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data will be collected by reviewing the medical records of patients with type 2 diabetes and add-on therapies at the time of presenting to endocrinologist according to clinical practice. The patients will participate in only one study visit, at the time of enrolment. Two study groups are to be defined at two time-points.

A non-interventional, multicenter study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. The study will enrol a minimum of 500 patients in each time point, resulting in a total of at least 1000 from approximately 50 investigators from Bulgaria. Each investigator will recruit approximately 10 subjects.

The assignment of the patients to a particular add-on therapy is not decided in advance by the NIS protocol, but falls within current practice and the prescription of medicine is clearly separated from the decision to include the subject in the study. No additional diagnostic and monitoring procedures shall be applied to patients, other than daily clinical practice and the epidemiological methods shall be used for the analysis of collected data. The intention of the study is to collect data on patients with type 2 diabetes and add-on therapies under routine clinical care.

The patients will participate in only one study visit, at the time of enrolment, when they provide the written informed consent, thus allowing the access to their data. Data will be collected by reviewing the medical records of patients.

Two study groups are to be defined at each time-point - one study group enrolled in moment 1 of evaluation (Feb - Mar 2015) and one study group enrolled in moment 2 of evaluation (Feb - Mar 2016). A patient enrolled in study moment 1 may not be enrolled in study moment 2. No patient will be prospectively followed-up during the study.

Investigators participating in this non-interventional study will be diabetologists in outpatient settings, as this group of specialists treats most of the T2DM patients in Bulgaria.

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Female and/or male aged 18 years and over
* Diagnosis of type 2 diabetes mellitus
* Patients considered inadequately controlled with metformin with a current treatment based on any add-on diabetes therapy

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Current antidiabetes treatment with oral monotherapy
* Insulin treatment for type 2 diabetes
* Current participation in any clinical trial
* Patient who have been enrolled in the study at point 1 can not be enrolled at point 2