cyrilzakka/clinical-trials huggingface dataset:
Use of Tranexamic Acid in the Total Knee Arthroplasty.

Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate without significant complications. In addition, many meta-analyses have confirmed these results. This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.

Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO) bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. The study is a prospective, randomized, triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months.

The study was done in Damascus, Syria. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. Participants who went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium chloride), formed the control group. In contrast, the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary knee osteoarthrosis who underwent unilateral primary TKA

Exclusion Criteria:

* Known allergic reaction to tranexamic acid
* Secondary arthritis (ex., Rheumatic arthritis, traumatic arthritis, septic arthritis)
* BMI less than 20 and more than 40.
* Patients having vascular or hematologic disease.
* Patients who were taking anti-coagulant medicine and couldn't stop it.
* Patients having acute or chronic renal failure.
* Patients classified as the AAA as grade four or five.
* Patients with intra-operative complications such as intra-operative fractures or vascular injuries.
* Post-traumatic and secondary knee arthritis patients.
* Revisions and complex primary cases.
* Patients with an active infection or a history of lower limp infection.
Advanced Ultrasound in Pleural Infection

Pleural infection is a potentially serious infection of the fluid normally found around the lung and current evidence suggests its incidence is increasing in both adult and paediatric populations.

Identification of bacterial pathogens causing pleural infection is of paramount importance in the clinical care of patients are currently, only 40% of patients have a laboratory confirmed microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to various reasons such as a small sample volume therefore the aim of the AUDIO study is to ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural infection.

Currently, there are no well validated methods for identifying patients presenting with pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical outcomes of patients with pleural infection.

The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise and these patients will be followed up over a 12 month period. Investigators hope that through the information gathered from ultrasound imaging and pleural biopsies, it will aid physicians' clinical and therapeutic decision making when treating patients with pleural infection.


Eligibility Criteria:
Inclusion Criteria:

* A clinical presentation compatible with pleural infection
* A pleural fluid collection that may or (rarely according to clinical judgement) may not require drainage that meets at least one or more of the following criteria:
* Purulent
* Gram stain positive for bacteria
* Bacterial culture positive
* Acidic with a pH \<7.2
* Low pleural fluid glucose \<3mmol/L (\<55mg/dL)
* CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT)

Exclusion Criteria:

* Age \<18 years
* No pleural fluid available for analysis
* Previous pneumonectomy on the side of pleural infection
* Expected survival \<3 months due to co-morbid disease
* Inability to give informed consent.
Comfort and Quality of Life of Patients at the End of Life

A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.

Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.

Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.


Eligibility Criteria:
Inclusion Criteria:

* between 25-70 years old,
* communicable,
* at least primary school graduates,
* hospitalized in the unit for at least 2 weeks, and who agreed to participate in the study were included in the study.

Exclusion Criteria:

* All patients who did not meet the inclusion criteria and patients who were included in the study but died within 2 weeks were excluded from the study.
Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.


Eligibility Criteria:
Key Inclusion Criteria:

* Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit
* Evidence of a personally signed informed consent

Key Exclusion Criteria:

* Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib
* Toxicities that would preclude initiating therapy with idelalisib prior to enrollment
* Concurrent participation in another therapeutic clinical trial
* Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Low-level Laser Therapy in Patients With Chronic Fibromyalgia

The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its effects on pain, fatigue, and physical function in individuals with fibromyalgia.

Fifty consenting participants with long-standing fibromyalgia (\> 3 mo duration) will be randomized to one of two treatment groups (n=25 per group) according to a computer generated randomization table. Group 1 will be the 'sham' control group and Group 2 will be the 'active' laser treatment group. The study will be conducted in a double-blind fashion using a standard 42 watt Class IV laser which has a switch at the back of the device which allows the laser to operate in the 'inactive' mode despite giving the operator and patients the appearance of being active (e.g., generates skin warmth and a red beam of light). Treatment will be administered three times/week for three weeks. Data will be collected across the 3-week intervention and one week after completion of the intervention. Data will be analyzed with appropriate statistical methods.

The following outcome measures will be collected at baseline: (1)Standardized SF-36 questionnaire; (2) Symptom Impact Questionnaire; (3) current analgesic medication usage; (4) pressure-pain threshold testing over tender points; and (5) spinal range of motion with an inclinometer and accelerometer. Outcome measures (2) and (3) will be re-assessed during the treatment phase at the end of weeks 1, 2 and 3. At 1 week and 1 month after the last laser/sham treatment session, all baseline assessments will be repeated, in addition to a global rating of change scale. Any patient who reports any harm from the laser/sham treatments on the helpfulness scale will be queried for specific harm details.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. Pre-existing medical conditions are under stable control
3. Diagnosis of fibromyalgia by Widespread Pain Index and Symptom Severity Score
4. Able to wear laser protective eyewear during the treatment session
5. Ability to speak English and complete testing

Exclusion Criteria:

1. Presence of another pain syndrome that has anatomical overlapping with fibromyalgia pain
2. Unstable psychiatric disorders or cognitive dysfunction or serious memory impairment
3. Previous treatment with low level laser therapy
4. Contraindication to receiving laser treatments
5. Current use of photosensitive medication (has been instructed to minimize sun exposure)
6. Active metastasis
7. Active infection
8. Impaired sensation
Cardiac Positioning System in Peripheral Angioplasty Procedure.

This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.

The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists.

Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method:

1. Fluoroscopy alone
2. Fluoroscopy + CPS combination.

The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age;
* Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
* Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.

Exclusion Criteria:

* Pregnant women or women planning to be pregnant during the study.
* Patients currently participating in another clinical study
* Patients with a thrombophilia
* Patients with critical limb ischemia
* Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.
Role of Senescence in the Development of Endometrial Cancer

Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).

A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.

Eligibility Criteria:
Inclusion Criteria:

* patient with endometrial hyperplasia or endometrial cancer
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery
Comparison of Pulse Hemoglobin and Pleth Variability Index

The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)\] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \>18 years old;
* must be having a major surgical procedure;
* The pre-operative estimation of blood loss must be at least 15% of the total blood volume

Exclusion Criteria:

* Does subject have hemoglobinopathy;
* cardiac arrhythmias producing irregular rhythms;
* severe pulmonary disease;
* procedures where loss of more that 10 to 15% of total blood volume is unlikely;
* subject refusal
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or kidney transplantation. This study will also observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.

Pediatric participants will be treated with a Modigraf (tacrolimus granules) based immunosuppressive regimen for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study.

Exclusion Criteria:

* Participant has previously received another organ transplant.
* Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score \> 50% in the previous 6 months (only applicable for kidney transplantation recipients).
* Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients).
* Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients).
* Participant receives an ABO incompatible donor organ.
* Participant has significant kidney impairment, defined as having serum creatinine ≥ 230 μmol/L (≥ 2.6 mg/dL) prior to transplantation (not applicable for kidney transplantation recipients).
* Participant has significant liver disease, defined as having elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBL) levels 3 times the upper value of the normal range prior to transplantation (not applicable for liver transplantation recipients).
* Participants with malignancies or a history of malignancy within the last 5 years.
* Participant has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer.
* Recipient or donor known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) positive.
* Participant requires systemic immunosuppressive medication for any indication other than transplantation.
* Participants taking or requiring to be treated with medication or substances prohibited by this protocol.
* Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.
* Participants with severe primary disease/complications/poor general condition which may be unsuitable for participating in this study.
* Participant is currently participating in another clinical trial and/or has been taking any other study drug within 1 month prior to screening.
* Participant is unlikely to comply with the visits scheduled in the protocol.
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)

This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).

This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.

In August 2016, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented Survival Motor Neuron1 (SMN1) homozygous gene deletion
* Clinical signs attributable to Spinal Muscular Atrophy (SMA)
* Able to complete all study procedures, measurements and visits and parent/participant has adequately supportive psychosocial circumstances, in the opinion of the investigator
* Estimated life expectancy \> 2 years from Screening
* Meets age-appropriate institutional criteria for use of anesthesia/sedation, if use is planned for study procedure

Key Exclusion Criteria:

* Respiratory insufficiency defined by the need for invasive or non-invasive ventilation during a 24 hour period
* Presence of a gastric feeding tube
* Previous scoliosis surgery or scoliosis surgery planned during the duration of the study that would interfere with the lumbar puncture (LP) injection procedure
* Hospitalization for surgery or pulmonary event within the last 2 months or planned during the study
* Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy
* History of brain or spinal cord disease that would interfere with LP procedures or cerebrospinal fluid (CSF) circulation
* Presence of an implanted shunt for the draining of CSF or an implanted Central Nervous System (CNS) catheter
* History of bacterial meningitis
* Clinically significant abnormalities in hematology or clinical chemistry parameters
* Treatment with another investigational drug, biological agent, or device within 1-month of Screening or 5 half-lives of study agent whichever is longer. Any history of gene therapy or cell transplantation
* Ongoing medical condition that would interfere with the conduct and assessments of the study. Examples are medical disability (e.g. wasting or cachexia, severe anemia, etc.) that would interfere with the assessment of safety or would compromised the ability of the participant to undergo study procedures

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Assessing the Surgical Skills of Trainees in Learning the LDG

Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However, there is no assessment system to measuring the surgical skill of surgical trainees. The novel surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed. This study describes assessing the development of surgical skill by JORS-LDG in the initial experience of LDG.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic distal gastrectomy to early gastric cancer
* D1 plus or D2 lymphadenectomy
* Provide signed informed consent

Exclusion Criteria:

* postoperative conditions affecting LDG
* pregnancy
* advanced gastric cancer
* D1 lymphadenectomy
* Total or subtotal gastrectomy
* unsuitable condition
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of IHD as defined by TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.

Eligibility Criteria:
Inclusion criteria

To be eligible, a patient must :

* Be male or female, between 18-65.
* Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV criteria
* Have TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina
* Be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone
* Be willing to change current antipsychotic medication to that chosen by the principal investigator
* Have a history of compliance with the above medication
* Be Medicaid eligible or maintain insurance covering requested lab procedures
* Be able to provide written informed consent.

Exclusion criteria

A patient will be considered ineligible if he/she:

* Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.
* Has a history of noncompliance with prescribed psychiatric medications
* Has a TG/HDL ratio \< 3.5 on current medication
* Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.
* Is unable to provide written informed consent.
* (Females only) Is pregnant, lactating or plans to become pregnant during study participation