cyrilzakka/clinical-trials huggingface dataset:
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP\>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years
* Meet 1984 NewYork modified criteria for AS
* BASDAI≥4 or ASDAS score ≥ 2.1
* CRP\>6 mg/L or ESR\>28 mm/h
* Syndesmophyte quantity ≥2 and \<16 of spine
* Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception
* No active or latent tuberculosis infection.

Exclusion Criteria:

* Pregnant or breastfeeding women
* current or previous history of psoriasis or inflammatory bowel disease.
* infection with clinical significance within 24 weeks before screening
* receipt any bio-agents treatment within 12 weeks before screening
* corticosteroids intra-articular injections in last 3 months before the trial
* Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.
* Alcohol and drug abuse
Physical Therapy on Pelvic Organ Prolapse

OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be randomly assigned to one of these groups: Experimental group: physical therapy + training in lifestyle advice; Control group: just training in means of lifestyle advice. In both groups several physical therapy assessments will be undertaken: 1st before intervention; 2nd immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24 months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the variables, as well as bivariate analysis in order to find all the possible relationships between the variables. A confidence level of 95% (p\<0.05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.


Eligibility Criteria:
Inclusion Criteria:

* Women with POP of any stage I or II according to POP-Q system.

Exclusion Criteria:

* Women diagnosed with POP stage III or IV according to POP-Q system
* Women with a history of conservative POP treatment or surgery
* Women with concomitant disease that may affect treatment (neurological, gynecological or urological) or urinary tract infection or recurrent hematuria
* Women who are pregnant or have had a vaginal birthing the last six months
* Women with cognitive limitations in understanding the information, answer questionnaires, consent and / or participate in the study
TREAT-BE Study (Treatment with Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)

A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).

Patients will be enrolled in this study at the participating centers when evaluated in gastro-intestinal (GI) clinics and endoscopy suites. Initial evaluation of patients will include collection of data on demographics, assessment of risk factors such as smoking, metabolic syndrome, family history and detailed medication history, and past surgical history. All patients will be complete questionnaires regarding Gastroesophageal Reflux Disease (GERD) symptoms, GERD related quality of life (QOL) and overall health related QOL. Details of all previous endoscopic and surgical evaluation along with histopathology data will be documented. Patients undergoing endoscopic evaluation at the participating centers will have their endoscopic and histopathology results documented. This will include data collection regarding use of advanced imaging techniques, details regarding tissue acquisition, EET and adverse events. Patients undergoing esophagectomy will have surgical details documented along with complications related to surgery. Similarly, details regarding chemoradiation treatments will be documented .

Eligibility Criteria:
Inclusion Criteria:

* Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer

Exclusion Criteria:

* Patients with squamous cell carcinoma
Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant.

Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant.

Study Objectives:

Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year.

Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.


Eligibility Criteria:
Inclusion Criteria:

* Durie-Salmon Stage II or III multiple myeloma
* Newly diagnosed either prior to receiving treatment or having completed induction therapy
* Relapsed myeloma not previously transplanted within the past 5 years
* Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable
* Age greater than 18 years old
* ECOG performance status of 0 - 2
* Meet all institutional requirements for autologous stem cell transplantation
* The patient must be able to comprehend and have signed the informed consent

Exclusion Criteria:

* Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
* Plasma cell leukemia
* Amyloidosis
* Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
* Use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
* In a complete remission at the time of bone marrow collection
* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
* Participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
* History of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
* Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted
* Evidence of spinal cord compression at time of transplant
Plasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache

This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter and epidural blood patch in Post dural puncture headache.

Post-dural puncture headache (PDPH) is also known as post-lumbar puncture (LP). PDPH is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent dural puncture during epidural anesthesia.

Traditional management strategies include conservative measures such as oral analgesia, bed rest, oral or intravenous hydration, oral or intravenous caffeine, and administration of epidural crystalloid before catheter removal, but in refractory cases, more invasive techniques may be necessary. An epidural blood patch (EBP) has been the most favorable treatment for PDPH after an accidental dural puncture.

One innovative approach is the use of plasma-rich fibrin (PRF) derived from autologous whole blood, which contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation. This approach has recently gained popularity in pain management. Another is the Racz catheter, a thin and flexible catheter used for targeted delivery of therapeutic agents.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from post-dural puncture headache.

Exclusion Criteria:

* Uncooperative patients.
* Severe comorbid conditions.
* Pregnancy.
* Anticoagulant therapy.
* Known allergies to plasma-rich fibrin or epidural blood patch components.
* Body mass index (BMI) ≥35 kg/m2.
A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females

A study to compare two different tablet formulations of AZD8931 in healthy males and females.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 55 years
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
* Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
* Male subjects must be willing to use barrier methods of contraception
* Be willing and able to comply with study procedures, restrictions and requirements

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant abnormalities at screening
* Use of any prescribed or non-prescribed medication within 2 weeks
* Receipt of another NCE or participation in any other clinical trial within 3 months
* Subjects who have previously received AZD8931
Pulmonary Rehabilitation in Asthma Control

The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.

Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma.

Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines

Exclusion Criteria:

* If the initial diagnosis cannot be confirmed, the patient excluded from the study
* Patients were under medical treatment of -6 months and considered clinically stable.
* Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
* Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study
The Impact of Opioids in Fractures - a Case Control Study

In this study, the risk of opioid medications on fractures in older adults is investigated. Patients from the surgical department with fractures and control patients from the internal department of the same hospital are inquired with a standardized questionaire about demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed using quantitative ultrasound. An impact of recent opioid medications on fractures is hypothesised.


Eligibility Criteria:
Inclusion Criteria for both groups:

* age \> 60 years
* written informed consent

Exclusion Criteria for both groups:

* malignant Disease within the last 12 month
* troubles with memory, dementia or Parkinsons disease
* other fractures within the last 6 month

Exclusion Criteria for the fracture group:

* alcoholised during the fall
* fracture older than 14 days
Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Plan to have routine prenatal examinations and give birth in the research center
* GDM was diagnosed at 24-28 gestational weeks
* Singleton pregnancy
* Without other pregnancy complications
* Willing to cooperate with the hospital to follow up

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data
Use of High Flows in Pediatric Cardiac Surgical Patients

Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD.

The investigators working hypothesis is that the use of post-extubation CPAP delivered via nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2 values than infants extubated on to oxygen therapy.

After CICU admission, infants with no bleeding, normothermic and hemodynamically stable will be switched from PRVC to SIMV+PSV (10-15cmH20) which should be maintained for 4 hours. An arterial gas analysis will be performed after 20 minutes. Infants with normal gas-exchange are gradually weaned from mechanical ventilation At each weaning step an arterial hemogasanalysis is performed after 20 minutes, to assess if the decreased ventilatory support is tolerated. Increased work of breathing and respiratory acidosis (ph\< 7.3 or pCO2 \> 60 mmHg) are considered criteria to withhold the weaning process. After a 4 hour period on SIMV+PSV the child should be switched to PSV for 30 minutes and then extubated. The following extubation criteria should be reached:

* Satisfactory blood gases with PCO2 under 45mmHg, pH greater than 7.30.
* Fractional inspired oxygen concentration of 65% and or less than the baseline value
* Adequate respiratory frequency according to age without dyspnea

At this point criteria for extubation are reached. Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age: 0-18 months
* Mechanical Ventilation via an endotracheal tube
* Elective surgery
* Post-bypass procedure
* Rachs 2 and above

Exclusion Criteria:

* Presence of major congenital malformations
* Presence of neuromuscular disease
* Presence of non drained pneumothorax
* Absent respiratory drive or recurrent apneas
* Hemodynamic instability
* Glasgow coma score (GCS) less than 8
* ECG with evidence of ischaemia or arrhythmias
* Active bleeding
Virtual Reality on Pain and Range of Motion on Burn

The Purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.

Burns are an important cause of injury to young children, being the third most frequent cause of injury resulting in death behind motor vehicle accidents and drowning. Burn injuries account for the greatest length of stay of all hospital admissions for injuries and costs associated with care are substantial. The majority of burn injuries in children are scald injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years. Other types of burns include electrical, chemical and intentional injury. Mechanisms of injury are often unique to children and involve exploratory behavior without the requisite comprehension of the dangers in their environment.

Immersive virtual reality (VR) is a new form of cognitive distraction and has been found to be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. The VR gives the individual the illusion of "going into" the 3-dimensional computer generated environment, as if it were a place in which they are actually physically present. The strength of the presence is thought to reflect the amount of attention that is drawn into the virtual world. Because VR is a highly attention-grabbing experience, it can be an effective psychological pain control technique. Less attention to pain can result in reductions in pain intensity, unpleasantness, and the amount of time patients spend thinking about their pain.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 9-16 years.
* Both sexes will participate in the study.
* Patients who suffered from anterior shoulder burns with involvement of axillary fold.
* patient who suffered from second degree burns.
* all patients are acute cases .

Exclusion Criteria:

* injuries to the face or head
* Injuries in hands
* Cognitive impairment
* A history of severe motion sickness
* Mental health problems.
Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period.

Failure of eradication treatment against Helicobacter pylori (H. pylori) is mainly caused by antimicrobial resistance. However, there is no relevant studies have been conducted on the prevalence and trend of antimicrobial resistance, which is considered to have a major determinant of eradication failure. In addition, studying the trend of resistance rate is an important basis for establishing an appropriate strategy for eradication treatment in the future.

Patients who had H. pylori colonies isolated from culture were consecutively enrolled from 2003. From each patient, 1 to 10 H. pylori isolates were isolated. Trends in MIC distribution and prevalence of resistance were investigated for each antimicrobial agent according to time period. Antimicrobi resistances suspected to related with failure of empirical PPI triple, quadruple, and rescue fluoroquinolone-containing treatment were also investigated. Multiple resistance, which is simultaneously resistant to various antibiotics, will also be investigated. Risk factors for the antibiotic resistance will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had a H. pylori infection and had consented to undergo culture analysis via endoscopic resection, in order to determine the minimal inhibitory concentration (MIC) of various antibiotics.

Exclusion Criteria:

* Patients with a concurrent critical illness, who abused drugs or alcohol, who were pregnant or nursing, or those who had received antibiotics, PPIs, or bismuth salts within 4 weeks, were excluded.
Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients

Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .

Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy women who were matched with respect to BMI (\<25 kg/m2 and ≥25 kg/m2).

Eligibility Criteria:
Inclusion Criteria:

the patients with PCOS

Exclusion Criteria:

Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol

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