cyrilzakka/clinical-trials huggingface dataset:
Tranexamic Acid Use in Acute Hip Fractures

BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion.

STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty.

METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.

This is a prospective randomized control trial. Patients scheduled for either intramedullary nailing for intertrochanteric fractures or for hemiarthroplasty will be selected for the study population.

The proposed research is needed to bridge the gap between the efficacy of TXA in elective, non-emergency procedures (such as total knee arthoplasty and total hip arthroplasty) and its efficacy in emergent acute hip fracture interventions. This study will use intravenous TXA (1g pre-op and 1g post-op) to study its effect on both the reduction of blood loss during intramedullary nail for intertrochanteric fractures and hemiarthroplasty procedures, and the subsequent reduction in the rate of blood transfusion in this patient population.

Both study and control groups will have standard post-operative care and laboratory testing and will be followed for one year post-operatively to record adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture

Exclusion Criteria:

* Prothrombotic state
* Cardiac stent within the past year with corresponding antiplatelet therapy
* Mechanical heart valves
* Deep vein thrombosis history
* Aortic stenosis
* Currently on Coumadin
* Malignancy
* Kidney dialysis
* Non-English speaking patients
* Medications contraindicated with tranexamic acid.
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential \[INOCBP\]) participants.


Eligibility Criteria:
Inclusion Criteria

* Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee.
* Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee.
* Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.

Exclusion Criteria

* History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee.
* History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable.
* Gilbert's syndrome.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Virtual Management of Lung Nodules

This is a study to determine how a virtual model for the management of lung nodules compares to a face-to-face clinic for patient satisfaction, quality of life and cost.

Initial Steps:

1. Individuals that have been referred to the Respiratory Outpatient Department of Flinders Medical Centre for management of a lung nodule will have their referral data screened by a doctor to determine that the referral meets criteria for management in the outpatient department and which category of follow-up is required (triaging process).
2. Eligible referrals will be provided to the study's research assistant who will contact the individual to discuss the study in detail and obtain consent to participate.
3. Individuals that have consented to participate are randomly assigned to either the 'virtual model' of lung nodule management (a), or the 'face-to-face model' of lung nodule management (b). Each participant has a 50% chance (1 in 2) of being assigned to either group.

   1. The 'virtual model' involves participants' CT scan(s) being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse these scans and make a recommendation for any follow-up scans, procedures or appointments that may be required. The team will contact each participant with a phone-call. Participants primary care providers will also receive a letter describing the review and plan. Participants are not required to physically attend the hospital or outpatient department for this review to occur.
   2. The 'face-to-face model' involves a face-to-face appointment in the Respiratory outpatient clinic at Flinders Medical Centre, where a doctor will review participants' CT scan(s) and make a plan for any follow-up scans, procedures or appointments that may be required. Primary care providers will be informed of the outcome of this visit. Participants are required to physically attend the clinic appointment for this review.

All participants in this research study will be asked to complete an initial set of two questionnaires. The questionnaires include:

* Participant information questionnaire - collects personal information and contact details, as well as specific health-related, occupational and lifestyle information.
* Hospital Anxiety and Depression Scale (HADS)

Once participants have had their face-to-face appointment or virtual review, they will be asked to complete four questionnaires at a 1-month and 3-month interval. The questionnaires include:

* Hospital Anxiety and Depression Scale (HADS)
* Patient experience questionnaire
* Patient economic impact questionnaire
* Modified Visit-specific satisfaction instrument (VSQ-9)

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* At least 1 IPN identified on CT imaging measuring 4-30 mm in maximal diameter
* CT slice thickness of 3 mm or less

Exclusion Criteria:

* Previous diagnosis of lung cancer
* History of haemoptysis
* Unexplained weight loss \> 7 kg in the preceding 12 months
* Past history of malignancy within 5 years (excluding non-melanoma skin cancer)
Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's Disease

Patients with Crohns' disease (CD) are always complicated with malnutrition. Exclusive enteral nutrition (EEN) is an effective treatment to improve nutritional status and induce remission in patients with CD however a reduction in microbiota diversity was the most frequently reported effect of EEN. There was a raised critical question that whether EEN combining microbiota transplantation can bring much more benefits to those CD patients with malnutrition.

Fecal microbiota transplantation (FMT) is an effective way of remodeling microbiota. The improved methodology of FMT in our group since 2014 was different from the traditional manual FMT and was recently coined as washed microbiota transplantation (WMT), which is dependent on the automatic facilities and washing process in a laboratory room with biosafety level 3.

Importantly, the worse nutritional status might decrease the efficacy of FMT. Therefore, there was a raised critical question that when is the proper time to combine WMT for those CD patients requiring EEN. This trial aimed to explore the timing of WMT in CD patients with malnutrition and assess the efficacy and safety of the strategy using WMT combined with EEN in CD patients.


Eligibility Criteria:
Inclusion Criteria:

1. patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score \>4;
2. patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4;
3. patients with high compliance.

Exclusion Criteria:

1. accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock;
2. severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases;
3. parenteral infection such as urinary infection, pneumonia, etc;
4. steroids or biologicals use within 6 week;
5. intestinal fibrotic stenosis;
6. patients who are pregnant or going to be pregnant;
7. patients with mental disorders.
The Absorption Rate of Subcutaneous Infused Fluid

The purpose of the study is to examine the rate of absorption of subcutaneous infused fluid in older adults when acutely ill compared to when they are not acutely ill.

Dehydration is a common condition in older adults. When oral hydration is insufficient there is a need for parenteral hydration. Subcutaneous infused fluid or hypodermoclysis is a method for parenteral hydration. This method is used to treat older adults with mild to moderate dehydration or at risk of dehydration. Despite that, this method is used in older adults who are acutely ill we have a very limited understanding of the absorption time and thereby when the infused fluid is available in the circulatory system. This study aims to compare the absorption time in older adults who are acutely ill with when they are not acutely ill. Furthermore, this study aims to describe how fast the subcutaneous infused fluid is absorbed from the subcutaneous space and subsequently when it is available in the circulatory system where it has its effect.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Hospitalized for an acute illness

Exclusion Criteria:

* Severe limitation on fluids
* Risk of acute deterioration of illness
* Requiring constant care
* Short life expectancy
Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors

Subjects treated with Canagliflozin, Dapagliflozin and Empagliflozin obtained improvement on blood pressure values, body weight and cardiovascular mortality but pathophysiological explanations of these effects are not yet known.

The pathophysiological explanations of the cardiovascular improvement of patients treated with SGLT2i are not yet known: osmotic diuresis and natriuresis, direct effects of weight reduction, increased in nitric oxide release, oxidative stress reduction, local renin-angiotensin-aldosterone system (RAAS) inhibition are the supposed mechanism. In the Literature the diuretic effect of SGLT2i therapy seems to be even stronger than thiazide or thiazide-like drugs. However, it is not defined the role of SGLT2i on antidiuretic function (RAAS, brain natriuretic peptide-BNP and antidiuretic hormone-ADH). Defining this relation could be important for:

* knowing effect of SGLT2i on RAAS (drugs interferences are important particularly during case detection of primary aldosteronism);
* discovering antidiuretic response to SGLT2i treatment and interactions between RAAS, BNP and ADH on the volume improvement induced by this new antidiabetic drugs.

In addition the aim of the study is to define effect of treatment on blood pressure and body composition.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients;
* clinical indication to SGLT2i therapy.

Exclusion Criteria:

* signs and symptoms of poor glycemic control (polydipsia, polyuria and weight loss);
* HbA1c \>10% or 86 mmol/mol;
* Body Mass Index (BMI) \> 40 Kg/m2;
* personal history of primary and secondary aldosteronism;
* personal history of heart failure;
* personal history of acute kidney injury;
* personal history of chronic kidney disease;
* personal history of liver cirrhosis;
* personal history of protein-wasting syndrome;
* personal history of renin secreting tumor;
* personal history of diabetes insipidus;
* personal history of syndrome of inappropriate antidiuresis (SIAD);
* personal history of hypocortisolism and hypercortisolism;
* therapy with Angiotensin Converting Enzyme inhibitors;
* therapy with Angiotensin Receptor Blockers;
* therapy with renin inhibitors;
* therapy with beta-blockers;
* therapy with alfa2-receptors agonists;
* therapy with Calcium Channel Blockers;
* therapy with diuretics;
* therapy with mineralocorticoid receptor antagonists;
* therapy with non steroidal and steroidal anti-inflammatory drugs.
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.


Eligibility Criteria:
* Confirmed diagnosis of malignant melanoma
* Measurable disease
* Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN
* No prior treatment with other camptothecin drug.
* ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C
* ECOG Performance Status 0-1
* Negative pregnancy test for female patients
A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers

The study consists of an eligibility screening period, two study periods involving single doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The total duration of the study is up to 16 weeks from screening to follow-up. After screening, eligible participants will be randomly assigned to one of the two possible treatment sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper arm). All participant groups will receive a total of two TCZ administrations each.


Eligibility Criteria:
Inclusion Criteria:

* Male participants and their partners of child-bearing potential must be willing to use two effective contraceptive methods
* Female participants must be either postmenopausal or surgically sterile
* Intact normal skin in the area for intended injection
* Body weight less than (\<) 150 kilograms (kg)
* Have no contraindications from the following: a detailed medical and surgical history, a complete physical examination, including vital signs, 12-lead electro cardio gram (ECG), hematology, blood chemistry, serology, and urinalysis

Exclusion Criteria:

* Participants with any known active current or history of recurrent Infectious disease
* Positive result on hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus-1 (HIV-1) and HIV-2 at screening
* A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
* Evidence of malignant disease, or malignancies diagnosed within the previous 5 years
* Use of or being dependent within the last 12 months on any substances of abuse, including a relevant past history of alcohol abuse
* Participants with a history of, or currently active primary or secondary immunodeficiency
* Participants who smoke more than 10 cigarettes per day or equivalent in tobacco
* Clinically relevant deviation from normal in the physical examination, including vital signs
* Clinically relevant ECG abnormalities on screening
* Evidence of atrial fibrillation, atrial flutter, right or left bundle branch block, Wolf-Parkinson-White syndrome, or cardiac pacemaker or any other significant cardiac abnormalities
* Known allergy to TCZ or any other ingredient in the subcutaneous (SC) formulation
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Known coagulopathy
* Clinically significant abnormalities in laboratory test results
* Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to study drug administration
Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.

This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.

Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o

Eligibility Criteria:
Inclusion Criteria:

1. Signing Informed Content Form;
2. Age \>= 20 (the age at the time of signing ICF; both gender);
3. hyperlipidemia patients who meet the following criteria:

   * 4.14 mmol/L (160mg/dL) =\< LDL-C (Serum low density lipoprotein-cholesterol) \< 6 mmol/L (232mg/dL)
   * TG (Serum triglycerides) \< 4.5 mmol/L (398mg/dL);
4. Framingham: Coronary Heart Disease 2-year risk probabilities \< 10%.

Exclusion Criteria:

1. Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
2. Subjects who receive Probucol within 6 months prior to the pre-screening period;
3. Coronary Heart Disease subjects;
4. Subjects being treated with cyclosporine;
5. Subjects with a history of hypersensitivity to Probucol;
6. QTc interval \> 450ms (male); QTc interval \> 470ms (female);
7. Subjects with impaired hepatic and renal function, who meet any of the following abnormal value:

   * AST \>= 100IU/L
   * ALT \>= 100IU/L
   * Serum creatinine \>= 1.5mg/dL
8. Female subjects who are pregnant, lactating, or who plan to conceive;
9. Subjects who are considered by the investigator to be inappropriate to participate in this trial.
Information and Acceptability of Biosimilars

Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment.

Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results).

Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient.

The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar.

The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms.

Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.


Eligibility Criteria:
Inclusion criteria:

* Age 18 and over (no upper age limit)
* All adult patients seen in rheumatology consultation at the Montpellier Hospital
* With inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis).
* Treated (or in the process of being treated at the end of the consultation) by etanercept or adalimumab
* In whom the biomedical treatment already used should in principle be renewed without modification (patient deemed good responder and well tolerant of the treatment)
* Or where biomedical initiation has just been indicated during the consultation
* Member of a social security scheme
* Informed and written consent

Exclusion criteria:

* Unable to understand information (not fluent in the French language, severe cognitive impairment, etc.)
* Known intolerance to one of the proposed biosimilar excipients
* Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
Amniotic Fluid Analysis

This is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. It will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.

Can amniotic fluid be serially aspirated via an Intrauterine pressure catheter (IUPC) and successfully analyzed in labor? Do abnormal amniotic fluid results collected serially predict which laboring patients will develop an intrapartum infection? Can the results predict infection sooner than the current clinical diagnostic criteria as outlined by the 2015 NICHD guidelines? How do the sensitivity, specificity, positive and negative predictive values compare to the 2015 NICHD diagnostic criteria?

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age ≥ 37 weeks
* Age of participant ≥ 18 years old

Exclusion Criteria:

* Multiple gestation
* Gestational age \< 37 weeks
* Intrauterine fetal demise
* Fetal anomalies
* Pre-gestational Diabetics / Gestational Diabetics
* Chronic immune suppression with steroids (defined as \> 1 month of consistent steroid use)
* Oligohydramnios
* Women with documented non-obstetric infections within 2 weeks of admission; including use of any antibiotics within 2 weeks of admission for non-documented/suspected infections
* Repeat temperature not performed within 45 minutes of index fever (100.4 F)
* Index fever (100.4 F) is \> 1 hour after delivery
* Expectantly managed premature rupture of membranes