cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes

This is a prospective, single arm, open-label, single-center pilot study to assess the safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients with Type 1 Diabetes.

Our previous work demonstrated that human cord blood-derived multipotent stem cells (CB-SCs) are a unique type of stem cell identified from human cord blood, distinct from other stem cell types including hematopoietic stem cells (HSCs), and mesenchymal stem cells (MSCs). The stem cells and harnessed some of their unique properties with Stem Cell Educator therapy by using CB-SCs in a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and returns the "educated" lymphocytes (but not the CB-SCs) to the patient's circulation . This treatment leads to global immune modulations and immune balance as demonstrated by clinical data and animal studies. The Stem Cell Educator therapy may revolutionize the clinical treatment of diabetes and other immune-related diseases through CB-SCs' immune education and induction of immune balance, without the safety and ethical concerns associated with conventional stem cell-based approaches

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years
* Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes
* Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells (IAA, IA2, GAD 65, ZnT8)
* Fasting C-peptide level \> 0.3 ng/ml
* Adequate venous access for apheresis
* Ability to provide informed consent
* Must agree to comply with all study requirements and be willing to complete all study visits

Exclusion Criteria:

* AST or ALT 2 \> x upper limit of normal.
* Creatinine \> 2.0 mg/dl.
* Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
* Known active infection
* Pregnancy or breastfeeding mothers
* Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
* Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
* Anticoagulation other than ASA.
* Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
* Is unable or unwilling to provide informed consent
* Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

This study is designed to observe the occurrence of failure or difficulty during placement of supraglottic airway devices (SGAs) and its associated risk factors in pediatric patients. Despite wide use in pediatric practice, not much is known related to problems during SGA insertion unlike adults. The main information regarding pediatric SGA comes from either small comparative studies or retrospective studies reporting increased risk of failure. Thus the main aim of this prospective, multicentric, observational study is to determine the incidence of "difficult" or "failed" SGA placement in children and clarify the possible risk factors for difficulty.

Inclusion criteria

* 1- 12 years old peditatric patients
* ASA class I- III
* Scheduled for elective surgery under general anaesthesia, in whom a SGA would be used for airway maintenance
* Planned surgery under general anesthesia with SGA
* Patients whose legal guardians provide informed consent

Exclusion criteria

* Refusal to participate in the study.
* Inability of patient or parents to understand the study or consent process
* Orotracheal intubation requirement
* Pathology of airway, neck, respiratory tract, upper gastrointestinal tract
* Increased risk of regurgitation or aspiration
* Emergency surgeries
* Requirement for intensive care follow-up after the surgery

Eligibility Criteria:
Inclusion Criteria:

* 1- 12 years old peditatric patients
* ASA class I- III
* Planned surgery under general anesthesia with supraglottic airway
* Patients whose legal guardians provide informed consent

Exclusion Criteria:

* Refusal to participate in the study
* Inability of patient or parents to understand the study or consent process
* Orotracheal intubation requirement
* Pathology of airway, neck, respiratory tract, upper gastrointestinal tract
* Increased risk of regurgitation or aspiration

  * Emergency surgeries
  * Requirement for intensive care follow-up after the surgery
RTMS for Apathy Clinical Trial

Apathy is a common, early, and disabling symptom in dementias such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in AD in individuals receiving methylphenidate and individuals not receiving medication for apathy.


Eligibility Criteria:
Inclusion Criteria:

* Major neurocognitive disorder
* Apathy for at least 4 weeks
* Stable dose of medication (\>4 weeks) that may affect cognition or behaviour
* Care partner who spends at least 10 hours a week with the subject

Exclusion Criteria:

* Current major depressive episode
* Agitation, delusions, hallucination
* Medical contraindications to rTMS
* Currently taking an amphetamine product
* Central nervous system abnormalities, Tourette's syndrome, or motor tics
* Current participation in another clinical trial
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.


Eligibility Criteria:
Inclusion Criteria:

* Muscle invasive bladder cancer
* Male/Female gender

Exclusion Criteria:
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed that arteries are thin and overloaded in this patients. We test the protective effect of celiprolol on cardiovascular events in a 5 years, randomized, PROBE design

100 patients with verified EDS-IV syndrome are included. Patients are randomized to either celiprolol (50 to 400 mg BID)or no treatment. Patients who are not randomized enter a longitudinal survey of events. The hypothesis is a 50% reduction in the occurrence of cardiovascular events under treatment, assessed by a blinded, independent events committee.

Eligibility Criteria:
Inclusion Criteria:

* Proven disease,
* No betablocker at inclusion if previous CV event

Exclusion criteria:

Criteria of not inclusion for the RIGHTEOUS group:

* Patient having already presented an arterial break or a dissection and treated(handled) by bétâ-blocking(surrounding).
* Against indication in the use of CELIPROLOL:
* Unchecked cardiac insufficiency by the treatment
* cardiogenic shock
* BAV of 2nd and 3rd not sailed degrees
* angor of Prinzmetal
* disease of the sine
* bradycardia
* pheochromocytoma untreated
* low blood pressure
* sentimentality in the CELIPROLOL
* Antecedent of anaphylactic reaction
* myasthenia
* treatment by FLOCTAFENINE ( Idarac), Sultopride ( interactions ) In these two cases, the patient can be included in the group followed by troop.

Criteria of not inclusion for both groups:

* Refusal to participate in the study.
* Impossibility to move.
* Pregnancy
* Woman in age to procreate without means of effective contraception.
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.

Observational prospective study Purely descriptive

Eligibility Criteria:
Inclusion Criteria:

Patients who:

* Are active RA patients (as judged by treating MD)
* Are 18 years of age or older at time of consent
* Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Exclusion Criteria:

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.

Participation in other clinical or observational trials
Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients

* The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia.
* The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing iron overload in pediatric patients with transfusion-dependent anemia.

This will be a multi-centre, open label, single treatment, uncontrolled study. A total of 100 iron-overloaded pediatric patients with transfusion-dependent anemia will be enrolled in the study.Eligible patients will receive Ferriprox (deferiprone) oral solution, 100 mg/mL, at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided in three (3) doses, for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are ≤ 10 years of age.
* Patients who have a confirmed diagnosis of transfusion-dependent anemia, other than Blackfan-Diamond anemia, and have chronic iron overload requiring chelation therapy.
* Patients who are in a chronic transfusion program, and who have received at least eight (8) red blood cell transfusions per year for a minimum of one year.
* Patients who are iron overloaded as assessed by serum ferritin concentration greater than 1000 µg/L.

Exclusion Criteria:

* Patients who have a diagnosis of Blackfan-Diamond anemia.
* Patients who have experienced neutropenia/agranulocytosis (absolute neutrophil count (ANC) \< 1.5 x 109/L) or thrombocytopenia (platelet count \< 50.0 x 109/L).
* Patients who have had previous treatment with Ferriprox and presented serious adverse reaction or intolerance requiring withdrawal of Ferriprox.
* Patients with evidence of abnormal liver function (ALT level \> 3 times the upper limit of normal; entry may be delayed until values return to normal).
* Patients with evidence of renal failure, characterized by serum creatinine level \> 2 times the upper limit of normal; entry may be delayed until values return to normal.
Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Colonic diverticula are common in Western countries, affecting up to 60% of subjects over 70 years of age. In about 80% of patients, colonic diverticula remain asymptomatic (diverticulosis), while approximately 20% of patients may develop abdominal symptoms (symptomatic uncomplicated diverticular disease, SUDD) and, eventually, complications such as bouts of diverticulitis or bleeding.

A small proportion of patients with colonic diverticulosis may develop segmental colitis associated with diverticulosis (SCAD). SCAD is separate clinical disease with specific macroscopic (erythema, friability and ulcerations) and microscopic features characterized by chronic, mucosal inflammation involving the inter-diverticular mucosa (usually sigmoid colon) sparing the proximal colon and rectum colon.

The most common symptoms of SCAD are rectal bleeding, diarrhoea and abdominal pain.

To achieve SCAD diagnosis a correct biopsies sampling is mandatory. It is necessary to take biopsies on the borders of the diverticula and in the apparently normal adjacent mucosa as well as biopsies in both the colon proximal to the diverticular area and the rectum in order to exclude chronic inflammatory bowel disease. The spectrum of histological lesions associated with SCAD is variable, including mild non-specific inflammation and inflammatory bowel disease (IBD)-like changes.

Currently, data regarding prevalence of SCAD are scarce. It has been estimated that in patients with diverticulosis, SCAD prevalence ranged from 0.3-1.3%.

The aim of the present study is to assess prospectively the prevalence of segmental colitis associated with colon diverticulosis (SCAD), in consecutive patients with colic diverticulosis, in a tertiary university centre.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopic finding of colonic diverticulosis associated with macroscopic signs of inflammation (erythema, friability and ulcerations) of the interdiverticular mucosa

Exclusion Criteria:

* inability to sign informed consent;
* impossibility to perform biopsies during colonoscopy (e.g. anticoagulant therapy/ conditions predisposing to high risk of bleeding);
* Diagnosis of chronic inflammatory bowel disease.
Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration

Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.

The investigators would like to see whether non-invasive measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk of it happening.

Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.

The aim is to investigate whether non-invasive physiological measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk.

Eligibility Criteria:
Inclusion Criteria:

HEALTHY VOLUNTEERS:

* Able to give consent
* Male or female
* Over the age of 18 years
* No known peripheral vascular disease
* No known tissue damage
* Able to read and understand basic English language

PATIENTS:

* Able to give consent
* Male or female
* Over the age of 18 years
* Either at risk (Braden scale \<17) or confirmed Category 1 or 2 PU or confirmed DTI
* Well enough to attend lab without any attachments (IV fluids, IV medications, oxygen)
* Able to transfer to bed with assistance of one
* Able to read and understand basic English Language

Exclusion Criteria:

HEALTHY VOLUNTEERS:

* Presence of tissue damage or ulceration in the foot
* Known peripheral vascular disease
* Known hypersensitivity to fixation tape
* Presence of a pacemaker
* Participants unable to or refusing to give informed consent

PATIENTS:

* Known hypersensitivity to fixation tape
* Participants unable to or refusing to give informed consent
* Unable to transfer to bed with assistance of one.
* Requiring more than routine observations and requiring attachments (IV fluids, IV medications, oxygen)
* Presence of a pacemaker
Effectiveness of Ultra-low-dose Chest CT With AI Based Denoising Solution

The main objective of the study is to evaluate the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of ULDCT coupling with innovative vendor-neutral CT denoising solution based on deep learning technology.

Considering lung cancer-related public health challenges, a reliable lung cancer screening method for high-risk cohorts in Mongolia is needed. Thus, our study aims to assess the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of ULDCT coupling with artificial intelligence based CT denoising technique among various patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18-year-old
* Patients undergoing CT Chest for all purpose

Exclusion Criteria:

* Age less than 18 years
* Any suspicion of pregnancy
* History of thoracic surgery or placement of the metallic device in the thorax
* An inability to hold respiration during CT
The Impact of Frailty in Type 2 Diabetes

The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in which participants demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale and balance assessment will be made with the Tinetti Balance. participants will not need to spend a long time for all assessments. The time required for the assessment will be around 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes
* Being 65 years or older
* Not having a cooperation problem,
* No communication difficulties or problems voluntarily accepting participation in the research

Exclusion Criteria:

* - Those with uncontrollable hypertension, heart disease, cardiac arrhythmia
* Those with cardiovascular disease
* Those who have malignancy and cause malignancy, chemotherapy, radiotherapy
* Those with any neurological or orthopedic disorders
* Those who have had an operation in the last 6 months
* Those on bed rest
* Individuals addicted to alcohol and drugs
* Those who do not agree to participate in the research
Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.


Eligibility Criteria:
Inclusion Criteria:

* must be eligible for cochlear implantation
* must be 18 years of age or older

Exclusion Criteria:

* \<18 years of age
* not eligible to undergo vestibular tests, especially videonystagmography
* contra-indication for MR or CT
Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects

The purpose of this study is to evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 and older
* Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health
* Patient able to understand requirements of the study and risks involved

Exclusion Criteria:

* A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc.
* A known history of photodermatoses
* A known history of photosensitivity disorders
* A known history of melanoma or non-melanoma skin cancers
Long-term Effects of AAT in Patients With ABI

The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual.

70 patients will be allocated randomly to one of two groups (control group and intervention group). During 6 weeks, all patients get two therapy sessions (AAT vs. TAU) per week. The 35 patients in the control group will get treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions.

The main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding.

Measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. The follow-up measurement will be done 6 weeks (follow-up I, t2) and 12 weeks later (follow-up II, t3).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented signed by the patient or his/her legal representative
* Inpatients of REHAB Basel with acquired brain injury and FIM-score over 60 (Funktionale Selbstständigkeitsmessung, Internationale Vereinigung für Assessment in der Rehabilitation, 1997)
* Minimum age of 18 years

Exclusion Criteria:

* Enrolment of the investigator, his/her family members, employees and other dependent persons
* medical contraindications for contact with animals as allergy, phobia etc.
Changes of Body Temperature During Shoulder Arthroscopy

The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

On the control group, use only routine anesthetic respiratory circuit for mechanical ventilation On the comparative group, use electrically heated humidifier for mechanical ventilation And compared the changes of body temperature durgin shoulder artheroscopy.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologist physical status 1 or 2
* 20-60 years old

Exclusion Criteria:

* body mass index over 30 kg/m2
* peripheral vascular disease
* uncontrolled cardiovascular disease