cyrilzakka/clinical-trials huggingface dataset:
Tele-assessment in Individuals With COVID-19

In most countries, after the measures taken to reduce the effects of the epidemic and quarantine practices, a remote screening tool has emerged in order to screen the needs developing after COVID-19 and to make the necessary rehabilitation applications in time. Sivan et al. A comprehensive multi-system phone scan of the COVID-19 Yorkshire Rehabilitation Screening Tool (C19-YRS) has been developed by a multidisciplinary rehabilitation team.

This study, which will be carried out using the C19-YRS tool and the 30-second sit-and-go test that evaluates functional capacity and mobility conditions, is expected to contribute to the clinical and literature since most of the studies on COVID-19 focused only on the acute and subacute periods. In addition, considering the pandemic conditions all over the world, it will be possible to benefit from the advantages of the tele-assessment application and by reaching more people, possible clinical problems/needs and whether there is a change functional capacities in individuals after COVID-19 will be identified.


Eligibility Criteria:
Inclusion Criteria

* being 18 years of age or older,
* Patients who have had COVID-19 and whose treatment was completed and the PCR test was negative for 2 times or who passed the positive PCR test for 28 days,
* Individuals who can take and execute verbal orders,
* giving consent on a voluntary basis

Exclusion Criteria:

* individuals who have not had covid 19 or Acute-stage patients with COVID-19
* individuals who refuse to participate in the tele-assessment
* individuals with dementia, cognitive problems or communication problems
Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis

Rheumatoid Arthritis (RA):

RA is a chronic inflammatory autoimmune disease that primarily affects the small joints, eventually leading to bone erosion and an inability to move (1). Several immune cells participate in the pathogenesis of RA. One of those cells is B cell.

B cell population:

B lymphocytes play several critical roles in the pathogenesis of rheumatoid arthritis. They are the source of the rheumatoid factors (RF) and anti-cyclic-citrullinated peptide (anti-CCP), which contribute to immune complex formation and complement activation in the joints (2).

There is different B cell subpopulation according to the stage of maturation and activity. Distinction of this subpopulation can be done by detection of different CD molecules expressed on cell surface (3). From all sub-population this research will focus on these immunophenotypes; immature, mature, memory and B-reg cells by using CD 19, CD24, CD38 \& CD27 respectively.

Joa˜ o E. Fonseca and his team found the reduction in B cell subpopulation especially (Pre- switched memory B cells) both in RA and Arthritis in the early stage. This observation not related to using methotrexate or corticosteroid in the treatment. They used the classification of B cells with CD 19 mainly and then IgD and CD27 to identify B cells (4).

Gabriella Sármay team found that the number of B-reg CD19+ CD27+ IL-10+ cells in peripheral blood is fewer in RA patients compared with healthy controls (5).

Interleukin 10:

Interleukin (IL)-10 functions as an anti-inflammatory cytokine in rheumatoid arthritis. IL-10 mRNA levels were significantly elevated in synovial fluid mononuclear cells (SFMCs) from patients with RA compared with PBMCs peripheral blood mononuclear cells (PBMCs) from RA patients or healthy volunteers according to Isomäki P (6).

IL 10 is primarily produced by monocytes mainly and, then by lymphocytes; type 2 T helper cells (TH2), mast cells, CD4+CD25+Foxp3+ regulatory T cells, and in a certain subset of activated T cells and B cells (7).

Eligibility Criteria:
Inclusion criteria:

* Patient diagnosed as Rheumatoid arthritis that fulfilled ACR/EULAR Criteria (American College of Rheumatology/European League Against Rheumatism).
* (8) Age \>18 Years.

  b. Exclusion criteria:
* Diagnosed patients with other autoimmune disease or other infections.
* Pregnant patients.
Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer

The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.

Twenty adult individuals underwent a standard blood volume measurement. The specimens for this determination are normally collected over a period of approximately 40 minutes. For the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. Calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. The ratio of albumin in the intravascular to the extravascular space is available in the medical literature. The total volume in which the tracer is distributed can be determined from the dilution determined. A calculation of total body albumin is therefore possible. Computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. The purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

Eligibility Criteria:
Inclusion Criteria:

* Normal adult males and females.
* Females in the childbearing age group to have test to exclude pregnancy

Exclusion Criteria:

* Children,
* pregnant females
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium


Eligibility Criteria:
Inclusion Criteria:

* signed an Informed Consent Form
* stable COPD according to current guidelines (GOLD 2013)
* airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \<0.70 and a post-bronchodilator FEV1 of ≥30% and \<80% of predicted normal values at Visit 2.
* current or ex-smokers who have a smoking history of at least 10 pack years
* Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
* Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).

Exclusion Criteria:

* Pregnant or breast feeding mothers
* Patients with conditions contraindicated for treatment
* Patients with a history of clinically significant diseases
* Patients who have a clinically significant renal disease
* Patients with myocardial infarctions less than 6 months prior to study entry
* Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
* Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
* Patients with a history of malignancy of any organ system
* Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
* Patients who have had a respiratory tract infection within 6 weeks prior to Screening
* Patients with any history of asthma.
Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study

The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.

Investigators intend to transplant 4 Type 1 Diabetes mellitus patients with compromised vision in one or both eyes due to diabetic or other complications, and who have already received kidney transplantation (i.e., already on immunosuppression). Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with compromised vision. Since the recipients are already immunosuppressed due to maintenance therapy for the kidney graft, investigators will only use non-steroidal anti-inflammatory drug (NSAID).

Only in case of uncontrolled reaction, steroid should be used under guidance of the ophthalmologists. Investigators will neither inject local immunosuppressive drugs nor change ongoing immunosuppressive medication in the pilot study.

The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.

In this pilot study investigators aim to gain experience in the technique, to obtain preliminary data on the amount of insulin that can be expected per transplanted islet equivalent (IEQ) and observe possible local reactions. These data will help to design a future larger study in patients without visual impairment.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Diabetes (American Diabetes Association criteria)
2. Kidney transplant recipient with ongoing immunosuppression
3. At least one eye with extensive loss of vision from hand motion to no light perception due to damage of retina or optic nerve
4. Age ≥ 18 years
5. Normal cornea with good visualization of the anterior segment
6. Patient not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation

Exclusion Criteria:

1. Uncontrolled diabetic retinopathy
2. Signs of current infection
3. Poor visualization of the anterior chamber
The Effect of Unripe Carob Fruit in Celiac Patients

The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction.

Between 01.02.2022 and 30.05.2022 by Specialist Dr. Orhan SEZGİN

The study will be conducted with 30 volunteers who present to the Mersin University Faculty of Medicine Hospital Gastroenterology Department in Mersin.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with celiac disease within a maximum period of 1 year,
* Have not received dietary treatment by a dietitian before
* Body Mass Index value between 18.5-25.0 kg/m2,
* Who have consumed carob fruit and have not had any allergies,
* Signed the Informed Consent Form,
* Between the ages of 19 and 64,
* Who has not had gastrointestinal tract surgery,
* Without mental disorder,
* Without inflammatory disease,
* No antibiotics or probiotics for the last 1 month,
* Not taking prescription drugs and/or fiber supplements,
* Not taking vitamin, mineral supplements,
* Not during pregnancy and lactation,
* Without excessive alcohol consumption (\>2 drinks/day)

Exclusion Criteria:

* Diagnosed with celiac disease for more than 1 year,
* Have gastrointestinal diseases other than celiac disease,
* Have previously received dietary treatment by a dietitian, following a diet other than a gluten-free diet,
* Body Mass Index values below 18.5 kg/m2 and above 25.0 kg/m2,
* Who have consumed carob fruit and have had any allergies,
* Not signing the Informed Volunteer Consent Form,
* Not between the ages of 19-64,
* Gastrointestinal tract surgery,
* With a mental disorder,
* With inflammatory disease,
* Taking antibiotics or probiotics for the last 1 month,
* Taking prescription medication and/or fiber supplements,
* Taking vitamin and mineral supplements,
* During pregnancy and lactation,
* Excessive alcohol consumption (\>2 drinks/day)
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)

Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a histologically confirmed NKTL at study site.
2. Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
5. Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
6. Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
7. Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

Exclusion Criteria:

1. Invasive natural killer leukemia.
2. Concomitant with hemophagocytic syndrome.
3. Primary site in central nervous system (CNS) or CNS involvement.
4. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
5. Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
6. Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001.
7. Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001.
8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
9. Subjects with active hepatitis B or C infection.
10. Subjects with active tuberculosis infection.
11. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
12. Female subjects who are pregnant or breast-feeding.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb

This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.

In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.

Eligibility Criteria:
Inclusion Criteria:

* Age within 18-80 years old
* Visible GSV varicose veins
* Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
* Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
* Consent to participate in the study.

Exclusion Criteria:

* - CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
* Failure to language communication
* Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
* Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
* Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children

This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 11 years 11 months.
* ADHD diagnosis according to DSM-IV-TR criteria
* Children whose parents are able to reliably meet all visits and all the tests required for this study based on the researcher judgment
* Patient representative (either parents or legal guardians) must understand the conditions of the study and sign the informed consent

Exclusion Criteria:

* Patients who do not meet diagnostic criteria for ADHD
* Patients with a previously known allergy or intolerance to the components of Omega- 3 supplement
* Patients with underlying diseases that, according to medical criteria , are not eligible for supplementation with Omega-3 fatty acids : fatty liver disease (or other liver disease), bleeding disorders and cardiovascular disease
* Patients with allergies to fish and /or shellfish
* Patients who have received ADHD pharmacological treatment or fatty acid supplements at any dose for more than 7 consecutive days within the last 3 months
* Patients who have received psychological or psycho-educational treatment in the past 3 months
* Patients who have had some kind of psychometric diagnostic tests in the last year
* Patients with scores corresponding to a lower mental age (more than 1 year less) according to the Wechsler Intelligence Cubes Scale for Children (WISC-IV)
* Patients with severe emotional problems according to the CAS or STAIC tests
* Patients participating in another clinical trial
Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel .

Insulin as an adjuvant to local anesthetic and cortisone to decrease pain recurrence


Eligibility Criteria:
Inclusion Criteria:

- Diabetic patients with mild to moderate carpal tunnel syndrome

Exclusion Criteria:

* Refusal to participate
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
* Subject has reliable family/legal guardian support available for outpatient management
* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
* Subject must not be a danger to self or others (per Investigator judgement)

Exclusion Criteria:

* Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
* Subject has a BMI percentile \>98th or \<5th
* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%)
* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening
Comparison of On-line and Off-line Measurements of Exhaled Nitric Oxide (NO)

Asthma is a major health problem worldwide. The measurement of fractional exhaled nitric oxide (FENO) has been established as a valuable non invasive and simple tool in the diagnosis of asthma and may also act as a useful surrogate inflammatory marker on which to base treatment decisions in asthma management algorithms. The measurement is useful also in other respiratory diseases. Current methods of measuring FENO include on line measurements by heavy duty expensive analyzers which are not widely and easily available. Off line measurements of breath samples which can be analysed later may be a simple solution. We hypothesize tha toff line measurements of NO will be as reliable and valid as those measured on-line


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate
* Filed a short health questionnaire

Exclusion Criteria:

* None