cyrilzakka/clinical-trials huggingface dataset:
The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery

The purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of femoral fractures.

The research will be carried out at the Department of Surgery at Clinical Hospital Centre(CHC) Osijek after approval by the Ethics Committee of CHC Osijek and will be organized as a prospective randomized trial. Respecting the including and excluding criteria for participation in the study, the research will include 70 patients aged 65 years and over who are undergoing surgery for proximal femur fractures and will be operated with the same operating technique (osteosynthesis with nail). All participants will receive the same type of anesthesia and one of two forms of post-operative analgesia, so it will be divided into two groups (35 patients) depending on which form of post-operative analgesia receive. Randomization will be performed by drawing an envelope in which the specified one or other form of post-operative analgesia will be written. The study will be stopped in case of serious complications life-threatening (excessive sedation, respiratory insufficiency, hemodynamic instability and profound hypotension, heart rhythm disorders), which could possibly be related to the administration of drugs used for postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* patients age 65 and over
* fracture of the proximal femur
* preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
* a written consent of the patient to participate in research

Exclusion Criteria:

* patient non-compliance
* ASA status IV and IV above
* patients younger than 65 years
* dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class C according to Child-Pugh's classification); severe kidney disease that require dialysis
* result of MMSE test (Mini-Mental State Examination) under 17
* the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.
Magnesium Treatment in Hypoparathyroidism

Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.


Eligibility Criteria:
Inclusion Criteria:

* primary or secondary hypoparathyroidism
* treatment with calcium plus vitamin D analogue
* ionized calcium 1,0-1,29 mmol/L
* magnesium level 0,7-1,05 mmol/L
* TSH 0.1- 10 imU/L

Exclusion Criteria:

* any other disease known to influence plasma Ca level
* pregnancy
* creatinine \> 150 microM/L
* patient has used supplementary magnesium within 2 previous months
Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears

The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Thus, it is aimed to compare these exercise types with different mechanisms on treatment, to determine the place of neuromuscular control exercises in treatment and whether they are more effective than conventional exercises.

Rotator cuff (RC) tear shows different symptoms or sometimes can progress asymptomatic. The most common symptoms associated with rotator cuff tears are loss of shoulder range of motion (ROM), shoulder pain exacerbated by overhead activities, nocturnal pain, shoulder dysfunction, and functional limitations. Conservative treatment is the first and most preferred procedure in the treatment of partial tears. Conservative treatment includes patient education, activity modifications, medication, and physiotherapy and rehabilitation programs. In the literature search, it is seen that the studies on the conservative treatment of partial RC tears often include open kinetic chain-weighted standard exercises and strengthening exercise types. It is seen that stabilization and proprioception-based neuromuscular control exercises of the shoulder, which have an important role in restoring neuromuscular control, which is reported to be impaired in shoulder pathologies, are included in some studies and these exercises are generally added to standard treatment. However, it is not known whether neuromuscular control exercises are more effective than other exercises in the standard rehabilitation programs as a result of the combined application of these exercises in this patient group. For this purpose, it is aimed to compare the treatment efficacy of a group consisting of neuromuscular control exercises for the shoulder and a group consisting of conventional exercises and to determine the place of neuromuscular control exercises in treatment.

Eligibility Criteria:
Inclusion Criteria:

* Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.

Exclusion Criteria:

* Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.
Persistence of Airway Inflammation and Remodeling in Subjects With Symptomatic or Complete Asthma Remission

This study aims at determining the patterns of asthma remission, the prevalence of these different patterns, the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.

The investigators therefore want to document these specificities in subjects in complete remission of their asthma, and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.

Primary Outcome Measures :

* Airway inflammation (% induced sputum eosinophils)

Secondary Outcome Measures:

* Perception of induced respiratory symptoms
* Airway response to methacholine and AMP, and perception scores
* Diurnal variation in Peak Expiratory Flows
* Profile of regulatory T cells in the peripheral blood
* Changes in these parameters over time (baseline, 6 months, 1 and 2 years)

Eligibility Criteria:
Inclusion Criteria:

* In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 \> 90%) and normal PC20 methacholine for more than two years (with no current treatment).
* With a proven past history of asthma from medical files (reversible airway obstruction (\> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
* Agree to sign the consent form.
* No other condition that could interfere with the study measurements.

Exclusion Criteria:

* Unable to adhere to the protocol requirements.
* Other current respiratory disease.
* Upper or lower respiratory tract infection or use of antibiotics \< 1 month.
* Use of oral corticosteroids within the last 3 months.
* Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
Study on the Effectiveness and Feasibility of Prone Position Ventilation Technology in Congenital Heart Disease

The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. To explore the effectiveness and feasibility of prone position ventilation for children with acute lung injury after congenital heart disease surgery.

The prone position has been used to treat severe hypoxemia in patients with acute respiration dysfunction syndrome (ARDS) since the 1970s, and it has significant effectiveness in improving gas exchange. Acute lung injury (ALI) is a common complication after congenital heart disease. The clinical manifestation is refractory hypoxemia. At present, mechanical ventilation is one of the main methods for the treatment of acute lung injury-induced respiratory distress syndrome. Prone position ventilation refers to placing the patient in the prone position during mechanical ventilation to expand the lungs in the atelectasis area and improve the ratio of lung ventilation and perfusion.

Prone position ventilation technology as an important lung protection ventilation strategy has been widely used clinically at home and abroad. Compared with adults, children are more convenient and easy to implement. Due to the exact mechanism of improving oxygenation function, the current domestic and foreign development of pediatric prone ventilation technology is mainly focused on children with ARDS. There are few studies on high-quality application effects after pediatric cardiac surgery, and almost no research has been carried out, especially for pediatric heart The indications for the implementation of the prone position after the disease surgery, the specific standardized process including the position angle, the prone duration plan, etc. all need to be studied. Therefore, there is an urgent need to develop prone position ventilation technology for critically ill children with congenital heart disease after surgery to reduce postoperative pulmonary complications and shorten the time of mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lung injury after congenital heart disease or chest X-ray CT suggest that pulmonary complications need to strengthen body drainage
* Establish artificial airway, such as tracheal intubation
* Children aged 0-12 months
* Stable hemodynamics, more than 72 hours after surgery
* Informed consent of family members

Exclusion Criteria:

* Unstable hemodynamics, severe hypotension, ventricular arrhythmia
* Intracranial hypertension
* Active acute bleeding
* Spinal injuries and untreated unstable fractures, orthopedic surgery or recent abdominal surgery
* Facial trauma
* Severe pneumothorax
* Delayed chest closure and wound infection, children who need to be immobilized
Connective Tissue Matrix for Rotator Cuff Tendinopathy

The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.

Rotator cuff tendinopathy (RCT), is a chronic degenerative process which causes both shoulder pain as well as limited range of motion. It is currently estimated that approximately 5% of RCT is being managed surgically, which highlights the importance of effective non-operative treatment strategies.

The advent of platelet rich plasma (PRP), a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing, has shown promise as another treatment modality when injected at the site of tendon damage. Placenta-derived decellularized connective tissue matrix (CTM) may represent an alternative therapy for RCT. Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro, thus potentially accelerating and enhancing tendon healing.

This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old with rotator cuff tendinopathy
* A PRP or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection

Exclusion Criteria:

* Patients with adhesive capsulitis
* Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
* Patients with joint instability
* History of shoulder surgery or corticosteroid injection in the past 3 months
* Patients with any medical conditions that affect healing, such as end-stage renal disease or uncontrolled diabetes
Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise

The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation on redox status, physiological and biochemical parameters in G6PD deficient individuals after acute exercise.

In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of both sexes will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2max test will be performed.

Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion) before and after each condition. Blood samples will be collected before, immediately after and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and physiological parameters will be performed before and after each condition. There will be a washout period of at 4 weeks between conditions.

Eligibility Criteria:
Inclusion Criteria:

* G6PD deficiency

Exclusion Criteria:

* Any uncontrolled health condition for which exercise is contraindicated
* Current use of dietary supplements or drugs
* Pregnant, pregnancy intention or breast feeding
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral pulmonary solid nodules, with diameter 1-3 cm.
* Suitable for surgery and signed informed consent.

Exclusion Criteria:

* Liver dysfunction.
* Allergic to indocyanine green.
* Can't tolerate thoracoscopic surgery.
Tracking and Exploring the Source of Viral REbound

Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption


Eligibility Criteria:
Inclusion Criteria:

* - Age\>18year old
* Nadir CD4\>200/mm3
* CD4/CD8 ratio\> 0.5
* Continuous antiretroviral therapy for more than 2 years
* Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic acid (RNA) \<50 copies/ml in the last 2 years
* Viral Load (VL)\<20copies at inclusion
* Patients who are willing to participate and who understand the trial (particularly, the obligation to have protected intercourse during the study).
* Informed consent
* Short half-life treatment
* Health insurance
* A subset of CD4 (T4cells) express CD32a.

Exclusion Criteria:

* - Acquired Immune Deficiency Syndom (AIDS)
* Pregnancy
* Human immunodeficiency virus (HIV)-2 co infection
* Thrombopenia
* Neurological events during primary infection
* Hepatitis B + (HBV+)
* Hepatitis C + (HCV+)
* Cancer during the last 5 years.
* Life expectancy \< 12 months
* Autoimmunity
* Acute infectious disease in the last 60 days.
* Hemoglobin\<7g/dl
* Glomerular filtration \< 60ml/min
* Refusing protected intercourse
* Risk of HIV transmission
* Psychiatric disorders.
* Alcool and drug abuse
* Involvement in another clinical trial evaluating a therapeutic.
* Being under tutorship
* Being deprived of liberty
Saxagliptin Triple Oral Therapy

The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c \> or = 7% and \< or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
* BMI \< or = 40 kg/m2

Exclusion Criteria:

* Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with \> 10% weight loss in 3 months prior to entry, or other signs and symptoms
* History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
* Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
* Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
* Estimated CrCl \< 60 ml/min at Visit 2
* CHF (NYHA class III or IV) and/or LVEF \<40%
* Active liver disease and/or significant abnormal liver function defined as AST and/or ALT \> 3 x ULN and/or bilirubin \> 2.0 mg/dL at Visit 2.
* Creatine kinase \> or = 10 x ULN at Visit 2
Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

The purposes of this study are:

1. To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning)
2. To improve the success rate of escitalopram treatment response for depressed patients

Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.
High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem cell transplantation in treating patients with refractory cancer.

OBJECTIVES:

* Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell support, when administered to patients with refractory malignancies for which no effective therapy exists.

OUTLINE: This is a dose-escalation study.

Prior to stem cell harvesting, patients receive 1-2 courses of mobilizing salvage chemotherapy.

After stem cell harvest, high-dose topotecan is administered according to an escalating dosage scale. Topotecan is given over 30 minutes daily for three days. A minimum of 3 patients are entered at each dose level. The MTD is defined as the dose immediately below that at which 2 patients experience dose limiting toxicity.

Peripheral blood stem cells (PBSC) are infused at least 24 hours after treatment with topotecan is complete. Filgrastim (G-CSF) is administered subcutaneously beginning on the day PBSC are infused and continuing until blood counts recover.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed refractory malignancies for which no effective therapy is currently available

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3

Hepatic:

* Total bilirubin no greater than 2.0 mg/dL
* No chronic active hepatitis

Renal:

* Creatinine clearance at least 60 mL/min

Cardiovascular:

* Left ventricular ejection fraction greater than 45%

Pulmonary:

* DLCO greater than 60% of predicted

Other:

* HIV negative
* No active infection
* No concurrent medical condition that would preclude therapy
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin)

Endocrine therapy:

* Not specified

Radiotherapy:

* No radiotherapy to greater than 30% of bone marrow
* No wide field radiotherapy

Surgery:

* Recovered from any prior surgery