cyrilzakka/clinical-trials huggingface dataset:
Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.

Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients over age eighteen
* Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

Exclusion Criteria:

* patient history of venous thromboembolic disease or coagulopathy
* use of anticoagulant medications within 7 days of surgery
* history of arterial embolic disease
* history of Class III or IV heart failure
* renal failure
* intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

This is an open-label extension study following the double blind 905-CL-055 study

Eligibility Criteria:
Inclusion Criteria:

* Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion Criteria:

* Any significant PVR volume (\>150 mL)
The New Silicone N99 Half-Piece Respirator

Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The N95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more than 95%. It is tightly fit and had high filtration capacity. The widespread pandemic of COVID-19 leads to greater requirement of FFR. A rising in demand would greatly exceed current productive capabilities and stockpiles and would almost certainly result in a robust shortage.

In order to solve these problems, our team had invented a new type of half-piece respirator made from silicone and assembled with hepa or elastostatic filter . A variety of methods have been used to evaluate this new device, including qualitative fit test with Bitrex® test kit and filtration test.

As required by Occupational Safety and Health Administration OSHA)\[7\], the halfpiece respirators need to pass the fittestto identify those individuals who do not achieve the good fit necessary for adequate protection. The performance of this respirator was also determined by measuring percent leakage under constant airflow\[8\]. The purposes of this study was to evaluate the fitting characteristicof our newly invented silicone N99 respirator and the performance against 30 µm particles using NaCL aerosols. The study was conducted to achieve two specific research objectives

1. To investigate the fit characteristic of the novel silicone mask and whether the strap adjustment can help reduce the face-seal leakage
2. To determine the level of performance by measure the inward leakage of the generated aerosolswith the new filter and used filter for up to 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers

Exclusion Criteria:

* Intolerance to exercise
* cannot taste bitter sensation
Translation of Stroke Specific Quality of Life Questionnaire Into Local Languages of Pakistan

The aim of the present study is to translate the Stroke Specific Quality of Life Questionnaire into local languages of Pakistan along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from a stroke. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

The stroke-Specific Quality of Life Scale is regarded as one of the most extensive and more commonly utilized patient-centred and self-reported measure of outcomes in the stroke population. The SS-QoL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. It covers a more extensive inclusion of capacities ordinarily influenced by stroke.

The Stroke Specific Quality of Life questionnaire, originally developed in English, has been translated into many languages to assess for its validity and reliability ever since, but not any of the Pakistani native versions are made or tested. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and have an insight into patient's health-related concerns post-stroke. Thus, it is imperative to translate this questionnaire into psychometrically sound versions of indigenous Pakistani languages such as Urdu, Punjabi, Sindhi, Balochi and Pashto. This may promote an easy understanding of the local population in Pakistan where the languages are spoken and will provide a valid measure of stroke-specific health outcomes to be clinically utilized by practitioners and researchers across the country.

Eligibility Criteria:
Inclusion Criteria:

* Patients post-stroke (sub-acute/chronic stage)
* Participants belonging to Urdu, Punjabi, Sindhi, Balochi and Pashto speaking class
* Patients should be capable to complete the questionnaire without any help.

Exclusion Criteria:

* Healthy population
* Patients at the acute stage of stroke/ TIA.
* Individuals diagnosed with conditions other than stroke.
* Individuals with language/ memory problems.
* Individuals with disability due to any structural/congenital cause.
Effect of Chemotherapy on PD-L1 in NSCLC

PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
* Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient can not comply with research program requirements or follow-up;
* Patient will receive immunotherapy;
Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)

Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)


Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Age ≤ 18 years
* Refuse to participate in this study
* prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death
In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. For each treatment period, subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site until 24 h post-dose. Following Period 2, there will be an interim analysis and review of safety and scintigraphy data from dosed regimens in order to determine which formulations will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days post-final dose to ensure the ongoing wellbeing of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 30 to 65 years
* Body mass index 18.0 to 32.0 kg/m2

Exclusion Criteria:

* None
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria:

* Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
* Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin \>8.0%)
* Patients had evidence of hepatic disease or renal impairment
* Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
* Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.
Utilizing a 3D Printed Model of the Mediastinum to Teach Thoracic Anatomy to Medical Trainees

Three-dimensional (3D) printed anatomic models are increasingly being developed for medical education. The investigators sought to compare the efficacy of a 3D printed model of the mediastinum as a study tool with standard textbooks for teaching medical trainees thoracic anatomy.

Participants were randomly assigned to either a lecture using a standard anatomy textbook or the same lecture along with a 3D printed model of the mediastinum. Participants took a timed pre-test and post-test, identifying 12 mediastinal structures on a prosected human cadaver. Independent and dependent t-tests were used to compare individual and group improvements respectively. A subjective assessment was also performed.


Eligibility Criteria:
Inclusion Criteria:

* Medical trainee

Exclusion Criteria:

* none
Clinical Study of the Tympanostomy Tube Delivery System

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
2. Either male or female

Exclusion Criteria:

1. History of sensitivity or reaction to anesthesia chosen for the procedure
2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Active acute otitis media
5. Otitis media pathology
6. Stenosed ear canal
Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of probable Alzheimer's disease;
* Have an MMSE score between 10 and 20;
* Must be able to swallow capsule/tablet;
* Must have a caregiver who is able to attend all study visits;

Exclusion Criteria:

* Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
* Have a current diagnosis of active, uncontrolled seizure disorder;
* Have a history within the past year or current diagnosis of cerebrovascular disease
* Have a current diagnosis of severe or unstable cardiovascular disease;
* Had a myocardial infarction (MI) within the last six months;
* Have specific respiratory, digestive, renal, or endocrine disorders;
* Have had previous treatment with rivastigmine or memantine;

Other protocol-defined inclusion/exclusion criteria may apply
Relationship of Mindfulness, Artistic Activities and Quality of Life

Methods: This study has the descriptive-correlational method and the statistical population was all artistic females of Bojnord city in 2018. In this study, 200 women of carpet weavers were selected by cluster random sampling. Participants filled out researcher-made questionnaires on how to do artistic activities, mindfulness, and quality of life. Data were analyzed using the Pearson correlation coefficient and hierarchical regression (moderator).


Eligibility Criteria:
Inclusion Criteria:

* be female, having 21 -60 years old, to work in workshops of weaving carpet, be literacy

Exclusion Criteria:

* be male, having under 21, upper 60, no work in workshops of weaving carpet , having psychotic disorders, be illiteracy
Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM)

The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Have been diagnosed with type 1 diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
3. Willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either Sensor site;
4. Willing to participate in an 8-hour in-clinic session on study Days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
5. Willing to take a minimum of 6 fingersticks per day during home use;
6. Willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
7. Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, x-ray, for the duration of the study;
8. Able to speak, read, and write English.

Exclusion Criteria:

1. Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Subjects who have a known allergy to medical-grade adhesives;
3. Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
4. Have a hematocrit that is less than 30%, or greater than 55%;
5. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
6. Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice.

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility Criteria:
Inclusion Criteria: Prostate cancer participants who meet all the following criteria:

1. Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
2. Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey )
3. Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit

Exclusion Criteria:

-
Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
* Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
* Interim analysis will be permitted as described in the statistical section 8.
* The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Overall study design

* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
* Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
* Interim analysis will be permitted as described in the statistical section 8.
* The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Number of subjects

• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.

Overall study duration

* The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
* The expected duration of the study is approximately 12 months.

Eligibility Criteria:
Donor Eligibility Criteria:

* Age 18-60
* A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
* At least 14 days from resolution of COVID-19-associated symptoms including fevers
* One negative nasopharyngeal swabs for COVID-19 RNA
* Covid-19 neutralizing antibody \>1:64
* Adequate venous access for apheresis
* Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)
* Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)

Recipient Eligibility Criteria:

Recipients age \>18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms \< 9 days.

Track 2:

* Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
* Symptoms may include fever, dyspnea, dehydration among others
* Hypoxemia may be present but is not a requirement

Track 3:

* Requiring mechanical ventilation for the care of COVID-19 infection
* Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal canula (HFNC).

Recipient exclusion criteria:

* History of severe transfusion reaction to plasma products
* Infusion of immune globulin within the previous 30 days
* AST or ALT \> 10 x upper limit of normal
* Requirement for vasopressors
* COVID-19-associated acute kidney injury requiring dialysis
* DNR status