cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients

Assessment of the expression of galectin-3 in serum and saliva of pemphigus patients and compare it with age and sex matched controls. We want to detect whether a correlation exists between galectin-3 level in serum, as well as saliva and disease activity score by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS).

Pemphigus is a potentially life- threatening immune mediated bullous disease that affects the skin and mucous membranes with a significant impact on quality of life (1). It is due to production of autoantibodies against desmogleins (adhesion molecules of the epidermis) leading to disruption of junctions between keratinocytes and subsequently acantholysis (2).

Pemphigus diseases are classified based on the clinical, histopathological features, as well as on the specific antigens against which the autoantibodies are produced. The main forms are pemphigus vulgaris (PV) and pemphigus folia¬ceus (PF), but other non-classical forms of pemphigus have also been described as paraneoplastic pemphigus, pemphigus herpetiformis, and IgA pemphigus (3). PV is the main clinical form of pemphigus, accounting for approximately 70% of cases; it is also considered the most severe form of the disease (4).

IgG is the main immunoglobulin seen along the dermal-epidermal junction in pemphigus patients, in addition most patients generate IgE autoantibody response. Soluble CD23 and galectin-3 are the two main elements of the IgE (5).

Galectin-3(Gal-3) is a beta galactoside-binding lectins that is essential in the cell-to-cell or matrix adhesion, as well as plays an important role in cell growth, differentiation, macrophage activation, antimicrobial activity, angiogenesis, and apoptosis. It broadly exists in the nucleus and cytoplasm of various cell types or may be found extracellularly on the cell surface (6) .Gal-3 is readily secreted to the cell surface and into biological fluids as serum, urine, tears and saliva from injured and inflammatory cells. So, it can be used as a sensitive diagnostic or prognostic biomarker for various pathological conditions (7).

Gal-3 has been used as a novel biomarker in the early detection of myocardial dysfunction and heart failure. Many cardiac biomarkers which reflect cardiac inflammation and fibrosis may also contribute to the progression of kidney disease (8, 9) A previous study reported a significant decrease in galectin-3 cytoplasmic and nuclear expression around blisters compared with adjacent unaffected skin in PV, which may play a role in extension of acantholysis (5). To the best of our knowledge, no previous studies assessed the role of Gal-3 in serum or saliva of pemphigus patients.

Eligibility Criteria:
Inclusion Criteria:

Patients with active stage of pemphigus.

Exclusion Criteria:

1. Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive drugs in the last one month.
2. Patients with disease attack duration more than 1 week.
3. Patients with any other concomitant dermatological or chronic systemic diseases.

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Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.


Eligibility Criteria:
Inclusion Criteria:

* Non-treatment seeking heavy drinking men and women with AUD
* Age range 18-55,
* Body Mass Index (BMI) of 18-35
* Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
* Able to provide informed written and verbal consent
* Able to read English and complete study evaluations
* Good health as verified by screening examination.

Exclusion Criteria:

* Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
* Unable to remain abstinent for five days
* Need for a medically assisted detoxification
* Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
* Psychotic or severely psychiatrically disabled
* Significant underlying medical conditions which would be of potential harm
* Pregnancy or breast feeding women;
* Women using monophasic contraceptives
* Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of \>450 msec for men and QTc\>470 msec for women).
Substrate Metabolism During Exercise Following Ingestion of Ethanol

This study will investigate how ethanol (pure alcohol) influences carbohydrate and fat metabolism during prolonged, moderate intensity exercise. Participants will perform two bouts of cycling exercise with or without prior ingestion of ethanol, in a randomised order, separated by one week.

Very little research has investigated the influence of ethanol on metabolism during prolonged exercise. Evidence suggests that delivery of fat to the working muscles during exercise may be limited with ethanol and therefore this may shift the relative proportions of energy derived from muscle stores of carbohydrate as a result (Jorfeldt \& Juhlin-Dannfelt, 1976).

The current study aims to investigate how a small-moderate dose of ethanol influences where energy is derived from during a prolonged bout of moderate intensity cycling exercise.

Participants will visit the lab on three occasions, once for preliminary measurements of fitness and body composition, and twice for the experimental bouts of exercise. Body composition will be assessed using a dual-energy x-ray absorptiometry (DEXA) scan, which will measure lean mass, fat mass, and bone mineral density. Participants will then perform an incremental maximal oxygen uptake test to determine intensity for the experimental bouts of exercise.

The two experimental bouts of exercise include cycling on an exercise bike for 2 hours at 55% of their maximal oxygen uptake (i.e. fitness) following 1 hours rest. This will be performed under two conditions: with and without ethanol ingestion. Pre and post exercise muscle biopsies will be collected to assess muscle metabolism, with regular blood samples and expired breath samples being collected to further investigate fuel delivery and use by the working tissues. The experimental bouts of exercise will be performed 1 week apart in a randomised order.

Eligibility Criteria:
Inclusion Criteria:

* Habitual alcohol consumer (average 1-14 units per week)
* BMI 18.5 - 29.9 kg/m2
* Be able to attend the laboratory and willing to participate in necessary protocols
* Be willing to undertake the durations of the exercise protocol (2 hours) \]
* Have the capacity and willingness to provide informed consent (oral and written)

Exclusion Criteria:

* Non-or excessive alcohol drinkers (0 or \>14 units per week)
* History of substance abuse
* Habitual/previously habitual smokers
* BMI \>30.0 kg/m2
* Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
A Phase 1 PK Study of Tolperisone in Healthy Subjects

This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects

This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.

Eligibility Criteria:
Inclusion Criteria:

* Generally Healthy Subjects
* BMI between 18.5 and 32.5 kg/m2

Exclusion Criteria:

- pregnant or breastfeeding
Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes

Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1). The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the past three decades.Despite the advances in medical treatment and technology, nutritional therapy continues to be the main component of diabetes treatment. Medical nutrition further improves metabolic control outcomes when T1DM care is combined with other treatments.This study was conducted to examine the effect of family-based behavioral medical nutrition therapy training on nutritional status and metabolic control in children and adolescents with Type 1 diabetes.

The research was carried out with children and adolescents aged 8-18 years who were followed up with the diagnosis of Type 1 Diabetes Mellitus in Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method. Medical nutrition therapy and carbohydrate counting training were given to mothers and children in the Intervention 1 group, and only to children and adolescents in the Intervention 2 group. The control group did not receive medical nutrition therapy and carbohydrate counting training. At the beginning (0. month) and at the end (6. month) of the study, 3 consecutive day/24-hour food consumption records and anthropometric measurements of the individuals were assessed, BMI z-scores and height z-scores were calculated, Mediterranean Diet Quality Index Scale (KIDMED), Diabetes Eating Problems Survey-Revised (DEPS-R), Physical Activity Questionnaire for Children and Adolescents (PAQ-C and PAQ-A) were administered and Healthy Eating Index 2015 (HEI-2015) scores were calculated. Routinely assessed blood findings of the individuals were checked at the beginning (0. month), 3rd month and 6th month of the study.

Eligibility Criteria:
Inclusion Criteria:

* 8-18 years old,
* Being diagnosed with T1DM for at least ≥1 year, maximum ≤5 years,
* Latest HbA1c ≥6.5% - \<13.5%,
* Receiving intensive insulin therapy (at least 3 times a day bolus and 1 time basal insulin administration or using an insulin pump),
* No communication problems
* Children and adolescents without any other disease accompanying diabetes were included in the study.

Exclusion Criteria:

* Celiac, cystic fibrosis etc. with gastrointestinal diseases,
* Using any drug that may affect glucose metabolism,
* Switched from an insulin pen to an insulin pump in less than 6 months,
* Involved in any other intervention work in the last 6 months,
* and individuals with communication problems were not included in the study.
Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

The purpose of this clinical trial is to demonstrate the clinical performance of the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay in detecting SARS-CoV-2, Flu A, Flu B and RSV in symptomatic population. The primary aim is to determine the PPA/NPA against a comparator assay. The secondary aim is to determine the diagnostic sensitivity, specificity, PPV and NPV against the standard-of-care test. Each subjects will be asked to provide both nasal swab (NS) and nasopharyngeal swab (NPS) for testing purposes.

The study is designed as a multisite, observational, prospective study. Subjects will be prospectively recruited from the target population, specifically individuals displaying signs and/or symptoms of respiratory tract infections. Consent for participation will be obtained prior to any eligibility confirmation or sample collection. Subsequently, both nasal swab (NS) and nasopharyngeal swab (NPS) specimens will be collected from each subject. These specimens will be tested using both the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay and the Cepheid Xpert Xpress CoV-2/Flu/RSV plus assay (comparator) to determine the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).

Subjects will be recruited across up to 20 sites, targeting the following intended user groups:

Trained laboratory professionals in a central laboratory setting Trained healthcare practitioners in a point-of-care (POC) setting under CLIA moderate and high complexity.

If a standard-of-care (SOC) diagnosis is available, the sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) will also be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:

  1. Fever
  2. Cough
  3. Nasal Congestion
  4. Shortness of breath
  5. Difficulty in breathing
  6. Runny nose
  7. Sore throat
  8. Muscle pain
  9. Headache
  10. Chills
  11. Nausea
  12. Diarrhoea
  13. Vomiting
  14. New loss of taste/smell
* If age 18 or over, subject is willing and capable of providing written informed consent. If under the age of 18, parent or legal guardian is willing to and capable of providing consent/assent. Assent should be obtained from minor subjects of appropriate intellectual age as defined by the IRB.

Exclusion Criteria:

* Subject is unable to provide consent and assent (as appropriate) or parental/legal guardian consent permission and assent (as appropriate) cannot be obtained.
* PI determines that specimen collection represents an unacceptable risk.
* Subjects who have already been enrolled in the study previously.
Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

Osteoarthritis (OA) is a disease that affects the joints of the body, causing pain, stiffness, and reduced mobility. To treat knee OA, a therapy called platelet-rich plasma (PRP) is used, which involves making a concentrated substance from the patient's own blood and injecting it into the joint. It has been shown that this therapy is effective in reducing pain; however, more research is needed to optimize the preparation and identify which patients are more receptive to the treatment. The primary objective of this study is to evaluate two modalities of PRP application and determine whether these treatments result in better pain reduction and improved functionality. The secondary objective is to explore the association between changes in LEFS questionnaire scores and/or maximal quadriceps isometric strength and possible clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of knee OA
* Age over 35 years old
* WOMAC value of 24 or higher at the time of recruitment

Exclusion Criteria:

* Patients with knee prosthesis, rheumatoid arthritis, contralateral lower limb amputation, any type of blood dyscrasia, hypofibrinogenemia, depot pool syndrome, or any other form of thrombocytopathy or chronic leukocytosis will be excluded from the study.
* Patients with anticoagulant or acute coagulopathies, as well as carriers of any infectious disease or superficial infection at the puncture site, will be temporarily excluded from the study until their clinical recovery is confirmed by laboratory testing.
The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance

As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.

Chronic Obstructive Pulmonary Disease is a multifaceted disease that results from the interaction between genetic susceptibility and exposure to environmental stimuli. Due to the slow progression and chronic nature of the disease, it creates a growing disease burden on the individual. Considering the data of the Turkish Statistical Institute, the third most common cause of death in Turkey in 2010, 2011 and 2012 was respiratory system diseases. 61.5% of respiratory system deaths in 2012 were due to Chronic Obstructive Pulmonary Disease. Due to the progressive airway obstruction that occurs in Chronic Obstructive Pulmonary Disease, the level of inspiratory muscle strength is restricted and there is an increasing deterioration in the level of functional performance. However, with increasing age, postural problems can be observed in individuals with Chronic Obstructive Pulmonary Disease. Postural problems such as rounded shoulders, increase in thoracic kyphosis and muscle shortness can be observed especially in patients who start to use the auxiliary respiratory muscles continuously due to inspiratory muscle strength. There are few articles investigating the changes in posture, physical performance and inspiratory muscles with the addition of a chronic disease such as Chronic Obstructive Pulmonary Disease to the normal aging process. For this reason, a study titled "The effect of respiratory muscle strength and functional capacity on posture and balance in individuals with Chronic Obstructive Pulmonary Disease with Different Phenotypes" was planned.

As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, and suggestions will be made to help individual postural smoothness and improve physical performance.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria
* Not having vision, hearing and speech problems
* Volunteering to participate in the research

Exclusion Criteria:

* Have had major surgery in the past few months
* History of recurrent significant clinical infection
* Having cognitive problems
* Unstable angina, previous myocardial infarction (MI),
* Severe congestive heart failure resistant to medical treatment,
* Having uncontrolled hypertension,
* Get cancer
* Having neurological or musculoskeletal diseases with functional limitations
* Having suffered an injury, such as a sprain, sprain or fracture of the lower extremity in the last 6 months, unable to perform independent ambulation
Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disorder most commonly affecting the older population between 60-80 years old. The characteristic feature of BP is itchy patches associated with blisters and erosions. BP significantly affects the patient's quality of life as it causes physical discomfort with itchy patches, blisters, and erosions. Several pieces of evidence from previous studies showed that the production of autoantibodies against the hemidesmosomal anchoring proteins BP180 (Bullous Pemphigoid antigen (BPAG 2)) and BP230 (BPAG 1) is the most common cause for bullous pemphigoid.

Therapeutic latency, lack of efficacy in many patients, and adverse drug reactions are the primary concerns in the current bullous pemphigoid treatment paradigm, including high-dose steroid treatment. To overcome these treatment challenges, combination therapy with agents having a steroid-sparing effect like mycophenolate mofetil, cyclophosphamide, azathioprine, and Methotrexate are tested as an add-on to low-dose steroids. 8So other immunosuppressive agents with better safety profiles and more efficacy, like Dapsone and Methotrexate as an add-on to low-dose steroids, can be used.

Investigator's literature search found no randomized controlled trial with Dapsone versus Methotrexate as an add-on to first-line steroid has been conducted to compare the efficacy and safety in bullous pemphigoid patients. So, a randomized controlled trial has been planned to evaluate the safety and efficacy of add-on methotrexate versus Dapsone in bullous pemphigoid patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 of either sex with the clinical diagnosis of Bullous pemphigoid.
* Patients with BPDAI score ≥ 20 (moderate and severe BP).
* Patients must have characteristic clinical features of bullous pemphigoid at the screening and baseline visits. (Urticaria, bullae, pruritis).
* Patients who are willing to give informed written consent.

Exclusion Criteria:

* Patients on any steroid-sparing agents within one month of recruitment.
* Treatment with a systemic corticosteroid, sulfones, within the last week.
* Patients with Glucose 6 phosphate dehydrogenase deficiency.
* Decreased liver or renal function (creatinine \> 2.0mg/dl, total bilirubin \> 2.5 mg/dl).
* Severe acute infection, severe diabetes mellitus, untreated glaucoma, congenital or acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or depression.
* Malignancies treated by cytotoxic or immunosuppressive medications.
* Anaemia (Hb \<9 gm/dl), leucopenia (\< 3 ×10 9 cells /L) or thrombocytopenia (\< 100 × 10 9 cells/ L), and H/O porphyria.
* Patient with a history of hypersensitivity to Methotrexate or Dapsone.
* Vaccination in the last two weeks.
* Patients with HIV, Hepatitis B, and C infection.
* Pregnancy and lactation, women of childbearing age without effective contraception.