cyrilzakka/clinical-trials huggingface dataset:
Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study

Description of the use of fostamatinib in patients with PTI in the Andalusian region.

Fostamatinib is a splenic tyrosine kinase (SYK) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (PTI) refractory to first-line treatments. Data from two phase 3 studies in PTI, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the US and in Europe.

Given the recent commercialization of fostamatinib for PTI, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. These studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy, and safety results in real clinical practice in our environment, the Andalusian region. The pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in the Andalusian region as of December 31st being greater than 40 cases. For all these reasons the Andalusian Group of Congenital Coagulopathies proposes collecting what the experience has been like in their environment. Participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. No clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. This is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients with ITP criteria according to clinical practice guidelines.

Exclusion Criteria:

1. Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
2. Subjects with other concomitant hemostatic defects.
3. Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
4. Diagnosis of secondary immune thrombocytopenia.
5. Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
ToleroMune House Dust Mite (HDM) Tolerability Study

House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.

This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years.
* Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
* Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
* No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
* A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
* Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
* ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.

Exclusion Criteria:

* History of life-threatening asthma
* Asthma exacerbation in the 12 weeks prior to randomisation
* Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) \< 80 % of predicted, regardless of the cause.
* Post-bronchodilator FEV1/Forced Vital Capacity ratio of \< 0.7.
* Concurrent respiratory disease that would confound study participation or affect subject safety.
* Non-HDM allergy that may significantly interfere with the results of this study.

  7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability

Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery

Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.

Eligibility Criteria:
Inclusion Criteria:

* \>18
* Acute Coronary Syndrome treated in the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
* Initial CPETt: MPA ≥ 60w in women and ≥80w in men
* French
* Informed consent

Exclusion Criteria:

- Significant co-morbidities limited practice of physical activity
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.


Eligibility Criteria:
Inclusion Criteria:

* All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
* All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (\>=) 3, face with facial psoriasis IGA \>=3, intertriginous with intertriginous psoriasis IGA \>=3, or genital with static physician global assessment of genitalia (sPGA-G) \>=3
* All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
* All participants be a candidate for phototherapy or systemic treatment for psoriasis

Exclusion Criteria:

* Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
* Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
* Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
* Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.

We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.

Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.

All response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.

X-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed aNSCLC patients
* Having received anti-PD-1/PD-L1 therapy
* Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)

Exclusion Criteria:

* Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation
* Without measurable lesions at baseline CT scan
* Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation
Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome

Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups. It is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture. Trigger point injection is the application of low dose local anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused by muscle spasm.However, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.Trigger point injection can reach trigger points in superficial muscles With the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points. With this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.

Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups. It is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture. Trigger point injection is the application of low dose local anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused by muscle spasm.However, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.Trigger point injection can reach trigger points in superficial muscles With the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points. With this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Myofascial pain

Exclusion Criteria:

Cervical radiculopathy fibromyalgia
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT)\>1.5 times upper limit of normal range
* MDRD eGFR \<80mL/min/1.73m2
* Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery

The aim of the researchers in this prospective study is to determine the differences, if any, in terms of anesthetic parameters among pregnant women who live at different altitudes and undergo cesarean section under neuraxial anesthesia under elective conditions and to contribute to the literature.

Increased intra-abdominal pressure during pregnancy increases the pressure in the epidural and spinal space and causes enlargement of the epidural veins. This may lead to easier increases in the anesthetic blockage level. For this reason, it is necessary to use the lowest possible dose of local anesthesia in these individuals compared to normal healthy individuals.

The literature on the effect of altitude difference on central neuraxial block is limited. Based on studies showing changes in CSF volume and content in hypoxic conditions, According to the researchers, with the same amount of local anesthetic, the duration of sensory and motor blockade at sea level is thought to be equal to or longer than in mid-high regions.

This study will be carried out among pregnant women who live in the city center at 3 different altitudes \[0-10 m (Giresun), 810 m (Çorum), 1725 m (Van)\] and undergo cesarean section under elective conditions. It will be performed in a multicenter, prospective, controlled, randomized manner in order to determine the differences, if any, among these pregnant women in terms of anesthetic parameters.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* Pregnant women 160-170 centimeters tall
* Be residing in the place of participation for at least 1 month

Exclusion Criteria:

* \>ASA 2 pregnant women
* Contraindicated for spinal anesthesia, such as infection or coagulation disorder at the needle insertion site
* Pregnant women to be taken under emergency conditions
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 Diabetes mellitus (T1DM)
* Central laboratory C-peptide \< 0.7 ng/ml (0.23 nmol/L)
* Insulin use for at least 12 months per patient reported or medical records
* Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
* Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
* If on MDI insulin administration, subject must be on ≥ 3x injections per day
* Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
* Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion Criteria:

* History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
* Taking metformin and/or thiazolidinediones within 2 months prior to screening
* Taking any antidiabetic medication (other than insulin), within 1 month prior to screening

  - Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
* History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
* History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
* Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
* History of Addison's disease
An OCD Prevention Programme for at Risk Adults

The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention.

After being informed about the study and giving written informed consent, all eligible participants will be randomised into the experimental group or the control group (TAU). Participants will be blind to the group allocation.

The experimental group will undergo a two weeks OCD prevention program, consisting of three group sessions per week.

The control group will not receive any intervention.

Researchers will compare the experimental group to the control group to test wether the prevention programme is efficient in reducing OCD symptomatology.

Eligibility Criteria:
Inclusion Criteria:

- age over 18

Exclusion Criteria:

* clinically diagnosed OCD
* current psychiatric/psychotherapeutic treatment
* personality disorder diagnosis
* suicidal ideation
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia

The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in their first year of life according to National Calendar of Prophylactic Immunisation of Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 3 months including at the time of the vaccination.
* Written informed consent obtained from the parent of the subject.
* Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth.
* Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.
* Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device).
* Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.
* Medical history of convulsions and progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Chronic diseases and serious congenital defects.
* Acute disease at the time of enrolment.