cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis

This study looked at parenteral administration of selenium to septic patients and subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the development of clinical status.

Patients will be divided into two groups. Se-group who received selenium supplementation during hospitalization in the form of sodium selenite pentahydrate at 750 mg/day for 6 days immediately after admission to our department (1000 mg of sodium selenite pentahydrate = 333 micrograms of selenium) (Selenase, Vivax; selenium hereinafter).

The placebo group will receive continuous saline NaCl 50 ml/day for 6 days as a continuous infusion (excluding additional infusion therapy). Patients will be further divided into subgroups according to OI on the day of admission to ICU. The oxygenation index (OI) PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) ratio in patients will be calculated daily.

The determination of biochemical and hematological parameters of blood samples will be as a part of the routine diagnostic methods. Data collection for the Se-AOX study will be performed at two-day intervals: T1 (1st-2nd day), T2 (3rd-4th day) and T3 (5th-6th day). Kinetic methods for estimating the activities of glutathione peroxidase (GPx, E.C. 1.11.1.9), glutathione reductase (GR, E.C.1.6.4.2) will be performed using a kit (Sigma-Aldrich, Germany) and that of superoxide dismutase (SOD, E.C. 1.15.1.1) by means of the SOD-Assay Kit-WST (Fluka, Japan) following the user manual provided.

Eligibility Criteria:
Inclusion Criteria:

* sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission

Exclusion Criteria:

* mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:

* To confirm the superiority of TRK-100STP over placebo
* To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
* To assess the safety of TRK-100STP


Eligibility Criteria:
Inclusion Criteria:

* The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
* The patient with progressive CRF

Exclusion Criteria:

* The patient with secondary glomerular disease
* The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis
Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication

The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.

This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication placement in roots of permanent molars, having PAI score ≥ 2.

Eligibility Criteria:
Inclusion Criteria:

* healthy males and females.
* age range between 21-49.
* patients with no physical disability or psychological problems.
* patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.

Exclusion Criteria:

* pregnant women.
* patients with immune-compromised disease.
* patients with complicated systemic diseases.
* patients who took antibiotics within a period of 1 month.
* patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
* Non-restorable teeth including root fractures, and/or advanced periodontal involvement.
Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement

The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta.

The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers.

Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement.

The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.


Eligibility Criteria:
Inclusion Criteria:

* all patients after implantation of a biological Medtronic Freestyle root prosthesis in the time frame from November 2007 till April 2017
* elective, urgent and emergency operations on ascending aneurysms, aortic dissections, endocarditis and aortic root pathologies
* combination of other procedures (coronary artery bypass grafting, operations on mitral and tricuspid valve, ablations)

Exclusion Criteria:

* refused patient consent
Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women

The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .

When looking at the literature, it is seen that physiological and hormonal changes that occur in pregnant women affect the musculoskeletal system and pain threshold of women. These changes seen in pregnant women and their psychological levels throughout the process also contribute negatively to the process.Due to the insufficiency of studies examining temporomandibular joint (TMJ) problems and oral habits in pregnant women and the contradictory results in existing studies, it is seen that new studies are needed.

Eligibility Criteria:
Inclusion Criteria (Pregnancy women):

* Being between the ages of 18-45,
* At least primary school graduate,
* Able to speak and understand Turkish,
* Women diagnosed with pregnancy by USG,
* Singleton pregnancy,
* Agreeing to participate in the study voluntarily.

Exclusion Criteria (Pregnancy women):

* Those with any systemic disease concerning the musculoskeletal system,
* Women with any type of disability,
* Having communication problems,
* Multiple pregnancy,
* Refusing to participate in the study.

Inclusion Criteria (Non-Pregnancy women):

* Being between the ages of 18-45,
* At least primary school graduate,
* Able to speak and understand Turkish,
* Agreeing to participate in the study voluntarily.

Exclusion Criteria (Non-Pregnancy women):

* Those with any systemic disease concerning the musculoskeletal system,
* Women with any type of disability,
* Having communication problems,
* Refusing to participate in the study.
Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age,
* ED 6 months or longer
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics
Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding

* To study the association between non-variceal UGIB and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy.
* To compare the severity of bleeding related to specified drugs.
* To determine risk factors associated with non-variceal UGIB.

Upper gastrointestinal bleeding (UGIB) carries a high mortality, especially in elderly patients having co-morbidities, and the incidence of non-variceal and variceal bleeding is reported to be 3.5% and 15%, respectively.

Atrial fibrillation, deep vein thrombosis, pulmonary embolism, and other conditions require anticoagulation, non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet therapy putting the patients at high risk of hemorrhage.

The latest American Heart Association (AHA) report on cardiovascular diseases suggests a doubling of the prevalence of atrial fibrillation by 2030 compared to 2010. The need to institute anticoagulation for this condition, both as primary and secondary prevention, will automatically increase the number of UGIB cases. An improvement in this regard has occurred with the advent of direct oral anticoagulants (DOACs) which have been shown to be non-inferior to vitamin K antagonists (VKAs).

In the event of UGIB, the Rockall score is a valid prediction score, repeatedly confirmed to assess the risk of patients with non-variceal bleeding. The management of UGIB is commonly adapted according to this score. Identifying high-risk patients who may benefit from longer hospitalization is crucial.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and/or melena)

Exclusion Criteria:

* Variceal bleeding
* Age below 18 years
* Pregnant women
* Consent refusal
Scooping Mobilization With and Without Scapulothoracic Mobilization in Patients of Lateral Epicondylalgia

Lateral epicondylalgia is well known musculoskeletal disorder now a day. Lateral epicondylalgia is a disorder in which pain and tenderness at lateral part of elbow. This study is targeting the scapulothoracic mobilization and scooping mobilization at lateral epicondylalgia. This study is single-blinded Randomized Clinical Trial will be conducted in Fatima memorial Hospital and Bajwa hospital Lahore. Non-probability convenience sampling will be used with 38 Participants involved in this study is with age of 18 to 45 with presence of pain and tenderness around lateral epicondyle, positive Cozens test and maudsley test, scapular dyskinesia, pain on resisted elbow extension, wrist extension and gripping activities. In this study, one group is treated with scooping mobilization with scapulothoracic mobilization. Second group is treated with scooping mobilization alone. The participants will be randomized into two Groups by computer generated randomization software. Outcomes measures which are used in this study is Numeric pain rating scale for pain, goniometer for range of motion and patient related tennis elbow evaluation for activities of daily livings for patients of lateral epicondylalgia.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years
* Pain and tenderness around lateral epicondyle
* Pain on resisted elbow extension ,wrist extension and gripping activities
* Gender both male and female.
* Scapular Dyskinesia.
* Positive Cozen test and maudsley test for lateral epicondylalgia.
* With moderate pain intensity on Numeric Pain Rating Scale (NPRS) with a score of 3 or higher

Exclusion Criteria:

* Any injury or disease around the shoulder, elbow and wrist on affected side
* Cervical radiculopathy.
* Local steroid injection
* History of fracture of humerus, radius, ulna which is affected upper extremity
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line

Background: Peripheral Intravenous catheter (PIVC) is a frequently used device for intravascular access. It is usually indicated to administer intravenous fluid and medications. However, the investigators could possibly utilize this line for blood sampling even after using it as a fluid port.

Aims: To investigate the quality of previously flushed PIVC sample and the effectiveness of the withdrawal technique.

Methodology: Study will be held in King Fahad University Hospital during a year after obtaining the IRB approval. Selection of study participants will be depending on their health status and the investigators will exclude pediatric participants. Two blood samples will be collected from participants. First one is after the insertion of the intravenous peripheral line. The second is after fluid infusion through the same line. Samples will be sent to the laboratory then. Results will be collected and analyzed.

The importance of the research: If this type of sampling can be standardized , this means there will be less insertions to the patients, less adverse effects in relation to the number of insertions, fast and preexisted intravascular access for sampling so the time can be saved in critical conditions.

Eligibility Criteria:
Inclusion Criteria:

* It will include healthy adult volunteers.

Exclusion Criteria:

* Pediatric patients and critically ill patients will be excluded from the study
Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.

The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age : \>18 years old
* adult patients referred to the imaging department for intracranial hypertension assessment
* adult control subjects without history of cerebral or vascular pathology

Exclusion Criteria:

* history of cerebral or vascular pathology for the control subjects
* pregnant woman
* claustrophobia
* major obesity
* any contraindication to MRI exam
A Clinical Study on TILs for the Treatment of Advanced Solid Tumors

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The expected survival time is not less than 3 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (\>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.
5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment

Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.

The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. Most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. The authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.However, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). This study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the Service of the researcher, Orthopedic Hospital of Passo Fundo, with minimum follow-up of 24 months fracture.

Exclusion Criteria:

* Patients with neurological deficit or who have left before 24 months the follow-up.
Evaluation of Local Mechanisms for Staff Motivation to Reduce Hospital Mortality

We observed in a randomised intervention trial in Bissau that mortality due to malaria could be reduced by half by adding a small monetary incentive to the staff and strict follow-up of a standard protocol for available drugs. The Government and donors are not able to sustain such incentives. We intend to evaluate whether strict organisation of a cost recovery system and the use of part of the funds for staff incentives would improve performance of the staff and contribute to reduction of hospital and post-discharge mortality.

A committee will organise collection and use of the money, and decide on incentives to be paid to the staff based on performance indicators. All children \< 5 years of age admitted to the ward will be registered and followed-up until two months after the consultation. Data on the level of mortality before and after the study period will be collected. Furthermore, interviews on quality perception of the parents will be carried out before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Children under five years of age admitted to the ward
* Parents of these children