cyrilzakka/clinical-trials huggingface dataset:
Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.

The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.

The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting for primary unilateral hip or knee arthroplasty
2. \> 18 years of age
3. Preoperative hemoglobin on day of surgery \> 10mg/dL

Exclusion Criteria:

1. Patients with a preoperative Hgb \< 10mg/dL
2. Patients who are unwilling to consent to blood transfusions
3. Patients with a history of bleeding disorder
4. Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
5. Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
6. Patients with platelet counts \< 100,000
7. Patients with kidney disease (Serum Cr \> 1.2)
8. Patients with end stage renal disease or on hemodialysis
9. Patients with renal transplant
10. Patients presenting for bilateral total hip or knee arthroplasty
11. Patients presenting for conversion or revision total hip or knee procedures
12. Patients donating pre-autologous blood
13. Patients with primary hematologic disease or malignancy
14. Patients with allergy to Tranexamic Acid
15. Patients with hepatic disease
16. Patients not discontinuing steroid use prior to surgery
17. Patients with religious beliefs/practices prohibiting blood transfusions
18. Patients with cognitive impairment
19. Patients who are terminally ill
Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection

The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera.

In both groups, the schedule treatment will consist of daily medication changes.

Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female ≥ 18 years
* Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
* Non infected
* Wound Bed Score ≥4 and \<13
* Wound area ≤ 100 cm2
* Patient having one or more factors associated with increased risk of wound infection (IWII, 2016)
* Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing, able and ensuring to comply with the study requirements for the whole study period.

Exclusion Criteria:

* Absence of factors associated with increased risk of wound infection
* Infected wounds - where infection is defined by:

For chronic wounds:

A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);

For acute wounds:

Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour

* Non-vital tissue greater than 25% of the total wound area
* Heavily exuding wounds
* Presence of fistula
* History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
* Active malignant disease
* Active sickle cell disease
* radiation therapy
* Known allergy to any of the devices' constituents
* Pregnant and breastfeeding women
* Subjects unable to understand informed consent or having a high probability of non- compliance with the study procedures and or non-completion of the study according to investigator's judgement.
Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy

The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical process of patients suffered sellar lesions. Moreover, if the patients are undergone the surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and hyper-natremia is the most common electrolyte disorder, which is directly correlated to the patients' outcome. However, in clinical works, different sellar diseases cause variant features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and hypernatremia always happen alternatively even without any precursor manifestation. Under this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will cause poor outcome, even death. So it is necessary to systematically collect and review the clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar diseases, more precise strategy for clinical fluid replacement will be proposed.


Eligibility Criteria:
Inclusion Criteria:

* 1. Suffered with sellar disease
* 2. Udergone surgery
* 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results)

Exclusion Criteria:

* 1. Without sufficitent clincal data
* 2. No surgery
Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

The goal of this clinical trial is to determine the effectiveness of a novel mobile health-based habit formation intervention for increasing and maintaining adherence to anti-hypertensive (AH) medication among people living with hypertension and indicate medication nonadherence. The main questions it aims to answer are:

* Can daily incentives for AH pill taking increase and maintain AH medication adherence, control blood pressure, and reduce healthcare utilization and costs?
* Can daily incentives for AH pill taking, combined with action planning (e.g., "After I drink my morning coffee, I will take my medication.") increase and maintain medication adherence, control blood pressure, and reduce healthcare utilization and costs?
* What aspects of daily incentives and/or action planning do participants find most helpful or effective for AH medication adherence?
* What barriers exist for participants who receive daily incentives and/or action planning?

Researchers will compare three study groups: those who only receive daily incentives for the AH pill taking, those who receive daily incentives for AH pill taking combined with action planning, and a control group (who do not receive daily incentives for AH pill taking or action planning). By comparing these three groups, the researchers will be able to determine the effectiveness of the daily incentives with or without action planning for promoting long-term AH medication adherence, reduce healthcare costs, and improve blood pressure.

Participants will:

* Complete 5 online surveys over the course of 2 years (baseline, month 4, month 8, month 12, month 24).
* Submit blood pressure reading for 7 consecutive days after each survey timepoint.
* Submit photo evidence of their AH pill taking for 4 months (intervention groups only).

The highest- and lowest-performing participants in each intervention group will also be invited to complete a 30-minute interview to identify additional factors that contributed to either successful or unsuccessful completion of the intervention.


Eligibility Criteria:
Eligibility Criteria:

* Aged 18 years or older
* Currently diagnosed with hypertension (either stage I or stage II hypertension)
* Able to read/write/understand English
* Have daily access to a smartphone
* Engaged in hypertension care: Already been prescribed hypertension medication for a minimum of 12 months at the time of study enrollment
* Demonstrated AH medication nonadherence by having over 73 days without documented AH medication prescription coverage (observable in Arizona Health Care Cost Containment System (AHCCCS) prescription drugs claims) in the past 12 months (i.e. \<80% mean adherence)
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.

The effects of alcohol consumption during pregnancy have been known for decades. However, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. During pregnancy, standardized self-reports such as T-ACE would help identify early women with high-risk alcohol consumption. T-ACE appears to be one of the most used during pregnancy but its diagnostic value is not objectively known.

To evaluate the diagnostic value of T-ACE self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood.

Material and methods Multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of North of France. The self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. When they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. Made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of T-ACE. An alcohol consumption will be considered " at high risk " if blood phosphatidylethanol is ≥ 20 µg/L.

With a predictable 25% rejection rate and a positive 4% T-ACE frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of T-ACE with a satisfactory 95% confidence interval in this population.

The evidence of a link between positive T-ACE and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy.

The T-ACE within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the North of France is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. If T-ACE appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.


Eligibility Criteria:
Inclusion Criteria:

* pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care
* and having returned her self-report
* and having given her written consent
* no exclusion criteria

Exclusion Criteria:

* woman under 18 years old
* or not pregnant
* or not having returned her self-report
* or woman who refused to participate in the study (absence of written consent)
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).

This clinical research is a retrospective, feature comparison reader study with an enriched sample of 600 (100 per radiologist) breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations).

Six MQSA-qualified and board-certified mammographers representing various experience levels, will be shown DBT images of a breast with the modified processing side-by-side the same breast with the original processing on the ASPIRE Bellus II workstation.. One breast per subject (two views per breast; CC and MLO) will be evaluated by the readers. Readers will be blinded to the image reconstruction and presentation processing methods. Each reader will be given a different sample of cases to review. Approximately 600 total cases (100 cases per reader) will compose the sample. The order of the subjects and location (left or right review workstation high resolution monitor) of the images with modified processing will be randomized for each reader.

The primary objective is the readers' assessment for each of the 7 general mammographic features. The null hypothesis is that the pooled proportion of cases judged as non-inferior with modified image processing is \<0.50, versus the alternative hypothesis that the pooled proportion is \>0.50. If the 95% CI does not contain values \<0.50, then the null hypothesis will be rejected. These hypotheses will be evaluated for each of the 7 general mammographic features. If all 7 null hypotheses are rejected, then it will be concluded that the modified imaging features are non-inferior to the original imaging

Eligibility Criteria:
Inclusion Criteria:

* Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

* Female subjects that did not have known clinical status in FMSU2013-004A
Determination of Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children

In this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy Turkish children.

In this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy Turkish children.

The study was planned as a cross-sectional clinical study. All healthy children studying at Hamdi Akverdi Primary School and Halil Bedii Management Secondary School in the Bakırköy region of Istanbul will be included. The date of birth of the children will be learned. It will be determined in which city in Turkey the population is registered.

TANITA BIA analysis and hand grip strength (with jamar) measured in the dominant hand were planned for all children. In addition, the calf circumference of all children will be measured. Written consent forms will be obtained from the families of the children before the evaluation.

It was planned to include 1500 children in the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy children
* Children under 18
* Turkish children

Exclusion Criteria:

* Children with malignancy or known chronic disease
Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women


Eligibility Criteria:
Inclusion Criteria:

* adolescent and young nulliparous women requesting IUD insertion

Exclusion Criteria:

* multiparous women, contraindications to IUD insertion or to study drugs
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia

This study is ferformed to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in the management of Liver Cirrhosis Due to Biliary Atresia after Kasai's operation of 20 patients at Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam from January 2017 to December 2018

Eligibility Criteria:
Inclusion Criteria:

* Children were diagnosed with Liver Cirrhosis Due to biliary atresia after Kasai's operation
* From 5 months to 2 years old
* Weight ≥ 6 kg
* Patients with manifestation of cirrhosis after Kasai's operation: hepatomegaly, congestive splenomegaly, elevated liver enzymes, Esophageal Varices (based on Endoscopic Diagnosis), cirrhosis (based on liver biopsy)

Exclusion Criteria:

* Under 1 year old patients
* Epilepsy
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)

The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF. Secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected adults (\>17 y.o.)
2. Antiretroviral-naïve.
3. Be able to comply with protocol requirements and instructions.
4. Subject or the subject's representative capable of giving signed informed consent

Exclusion Criteria:

1. Women who are breastfeeding or plan to become pregnant during the study.
2. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
3. Patients with anticipated need to change the ART before study ending.
Health Effects of Consuming Olive Pomace Oil

Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or sunflower oil (SO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.

The intervention aimed at studying the potential health effects of olive pomace oil in comparison with sunflower oil.

After a 3-weeks run-in, 31 healthy (normocholesterolemic) and 37 hypercholesterolemic subjects were randomized to consume either OPO or SO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of corn oil. During all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats).

At the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. A complete batch of analysis were performed, including serum lipids, endothelial function (endothelial nitric oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules, E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (Total cholesterol \< 200 mg/dL; LDL-cholesterol \< 135 mg/dL)
* Hypercholesterolemic volunteers (Total cholesterol 200-300 mg/dL; LDL-cholesterol 135-175 mg/dL)

Exclusion Criteria:

* BMI \> 30 Kg/m2
* Smokers
* Vegetarians
* Pregnant women
* Medication/consumption of vitamins, dietary supplements
* On antibiotic treatment 3 months before starting the study
* Digestive disorders/pathologies (gastric ulcer, Chron's disease, inflammatory bowel syndrome, etc.)
* Food allergies/intolerances
Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.

Sedation-analgesia is an important therapy for patients in resuscitation. It requires a surveillance, in order to avoid excessive or insufficient dosages of sedative or nonmorphinics, sources of side effects. Yet, means of surveillance are limited in resuscitation care : variations of blood pressure and heart rate are not very sensitive criterias. Clinical scales to measure the sedation and analgesia level were proposed for patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold by pupillometry for patients in resuscitation receiving a sedation-analgesia.

The main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.

Secondary goals will be to bring this measures back to the pain score BPS and the pupillary diameter measured during a painful care (tracheal aspiration), as well as morphinics dosage.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and Mechanically Ventilated Patients receiving by continuous intravenous an hypnotic sedation (midazolam or propofol) associate with a morphine type drug (fentanyl, sufentanil, rémifentanil, or morphine) since at least 6 hours and for a predictable duration over 24 hours.
* Both gender
* Adult over 18 years

Exclusion Criteria:

* Neuromuscular pathology that does not allow the use of clinical scales in order to measure sedation-analgesia : tetraplegia, resuscitation neuromyopathy, curares.
* Intracranial hypertension (intracranial pressure over 20 mmHg) whatever the cause (traumatique, vasculaire, tumorale).
* Dysautonomia altering the pupillary dilatation's reflex (RDP) : old diabetes with diabetic retinopathy, multiple sclerosis, systemic amylose.
* Treatment in progress which may affect the pupillary dilatation's reflex (RDP) : antiemetic (droperidol, métoclopramide), alpha-2 agoniste (clonidine).
* Ocular pathology
* Opiate addiction
* Refusal by a patient
* Pregnant women