cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.

In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.

Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Eligibility Criteria:
Inclusion Criteria

* All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

Exclusion Criteria for IV TXA administration

* Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
* If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
* Renal impairment defined as serum Cr \> 1.5 or Cr Clearance \< 50 mL/min
* Severe ischemic heart disease
* Color blindness or problems with color vision

Criteria for Use of Topical TXA

* Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA

Absolute Exclusion Criteria

* History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Known congenital thrombophilia
* History of thromboembolic or vascular disease
* Disseminated intravascular coagulation (DIC)
* History of seizures
The Comparison Between Ringer Lactate Solution and Normal Saline with Dextrose Water in Post-Operative Period of Kidney Transplantation

This is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of Ringer lactate solution (RLS) and normal saline solution (NSS) with dextrose water (D5W) on the electrolyte abnormality of kidney transplant recipients (KTR) during the first post-operative week. The problem with using NSS with or without D5W as a standard replacement fluid is the hyperchloremic metabolic acidosis which might compromise the kidney allograft function. A total 60 KTR will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.


Eligibility Criteria:
Inclusion Criteria:

* A kidney transplant recipient who receives transplant at King Chulalongkorn Memorial Hospital.
* Age \>=18 years
* Both deceased donor and living donor kidney transplantation will be included

Exclusion Criteria:

* multiorgan transplantation
* Known allergy to RLS or NSS
Evaluation of Oral Hygiene Products in an In Situ Caries Model

The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR).

This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 85 years inclusive
2. Understands and is willing, able and likely to comply with all study procedures and restrictions
3. Good general and mental health with, in the opinion of the investigator or medically qualified designee:

   * No clinically significant and relevant abnormalities in medical history or upon oral examination.
   * Absence of any condition that could affect the participant's safety or well-being or their ability to understand and follow study procedures and requirements
4. Currently living in the Indianapolis, Indiana area and has not had a professional fluoride treatment within 14 days of the first treatment visit
5. Currently wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange areas to accommodate two enamel specimens
6. Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
7. Have a salivary flow rate in the range of normal values (un-stimulated whole saliva flow rate ≥ 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).

Exclusion Criteria:

1. Pregnant or breast feeding women
2. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
4. Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
5. Participation in another GSKCH investigational dental product study within seven days of first study treatment.
6. Previous participation in this study.
7. Recent history (within the last year) of alcohol or other substance abuse.
Early Rehabilitation of COPD Patients in ICU

Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years of age
* Chronic obstructive pulmonary disease
* Intubated with mechanical ventilation
* Patients without sedation or catecholamine
* 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful
* Conscious and cooperative state
* Ability for the patient to sit in a armchair

Exclusion Criteria:

* Non chronic obstructive pulmonary disease
* Lack of patient involvement
* Minor Patients
* Patients under guardianship
* Unconscious and non cooperative state
* Patients unable to ride in a wheelchair
* Patients not affiliated with a Social Security System
* Patients under justice safeguard
* Patients under curator ship
Treatment of Globus Sensations With Psychotherapy

The purpose of this study is to determine whether psychotherapy (based on exposure techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform Disorders (as exemplified here in subjects with globus sensations in the throat).

Functional somatic symptoms (FSS) and somatoform disorders are characterized by the presence of medically unexplained symptoms. They are among the most prevalent disorders in the general medical setting, leading to individual suffering and having huge impact on public health alike. Unfortunately, many patients still remain untreated and not all patients get better, even when receiving currently proposed treatments. The aim of the present project is twofold: First, we want to improve the understanding of risk factors and psychobiological processes leading to the development of FSS. Second, we will explore and evaluate new ways of treating subjects with FSS. Within the project, we will examine subjects with globus sensations in the throat, a very common und impairing form of FSS. The proposed study i) may provide insight into the development of FSS, thereby improving our way by which we recognize and diagnose subjects with FSS, and ii) may help fostering our understanding of how to better treat subjects suffering from FSS.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient spoken and written knowledge of German
* Presence of globus sensations and somatoform disorder
* Clinically significant impairment

Exclusion Criteria:

* Current (past 12 months) severe chronic physical illnesses, especially neurological, endocrine or metabolic diseases
* Current (past 12 months) substance dependence or eating disorder
* Lifetime history of psychotic disorder or bipolar disorder
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).

Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.

Eligibility Criteria:
Inclusion Criteria:

* Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

* Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
* Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
* Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
* Patient has not previously attempted conservative treatment for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
* Patient has more than 2 episode of awakening to void during normal sleeping hours.
* Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course of the study.
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
* Patient refuses to provide written informed consent.
* Patient is not at least 18 years of age.
* Patient is not available for the follow-up evaluations as required by the protocol.
Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.

* Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
* Regular corneal astigmatism of 0.75D-2.50D
* Dilated pupil diameter of 7mm or greater

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
* History of corneal refractive and intraocular surgery.
* Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.


Eligibility Criteria:
Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick test
* History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days before the screening visit
* Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
* A known hypersensitivity to any corticosteroid
Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment.

In Base Study Phase IIa, participants were to receive blinded MK-8457 100 mg or matched placebo for up to 24 weeks. At Week 12 and 18 of Phase IIa, efficacy evaluation was conducted to assess eligibility for early escape, defined as \<20% reduction in both tender and swollen joint counts. The study plan included Base Study Phase IIb in which dose range finding or dose-response was to be evaluated, depending on the outcome of Phase IIa. Participants who completed Phase IIa or Phase IIb and those eligible for early escape could enroll in Period 3, a 2-year Safety Extension.

All participants must have been treated with MTX for at least 3 months prior to screening and have been receiving a stable dose of MTX for at least 4 weeks prior to screening.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis for at least 6 months prior to screening
* Active rheumatoid arthritis as defined by the presence of \>= 6 swollen joints (of 66 count) and \>= 6 tender joints (of 68 joint count)
* C-reactive protein blood level \>0.9 mg/dL
* Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening
* American College of Rheumatology Functional Class I, II, or III
* Received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening
* If using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone
* No history of either untreated, latent, or active tuberculosis prior to baseline
* Participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control

Exclusion Criteria:

* Presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
* Positive hepatitis B surface antigen or hepatitis C test result or the presence of Human immunodeficiency virus (HIV) infection
* HIV positive
* User of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence
* Females of childbearing potential who are pregnant, intend to become pregnant, or are lactating;
* Severe opportunistic infection within 6 months prior to study start.
The Development of Flat Foot After Ankle Fractures

In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.

Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.

Eligibility Criteria:
Inclusion Criteria:

Patients will be considered eligible if:

* They have sustained Weber type B or C ankle fractures and needed open reduction
* They are 18 years of age or older
* They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop

Exclusion Criteria:

* Patients will be excluded if they already have flat foot in their non-fractured foot.
* Patients with bilateral ankle fractures
* Patients who are not competent to sign a consent form
* A second fracture to the ankle
* Pathological fractures
* Patients with underlying cancer.
Association Between BMI and COVID-19

This study will involve collection of pseudonymized data from hospital-based data reporting at multiple international sites. Collating data from a large volume of patients with COVID-19 admitted in ICU across multiple international sites will enable investigation of whether obesity is a risk factor for complicated from of SARS-CoV-2 in adult patients and whether this association is independent of other cardiometabolic risk factors.

The COVID-19 pandemic is characterized by a high frequency of patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), who often require invasive mechanical ventilation (IMV). Body mass index (BMI) was however rarely mentioned in early clinical reports.

Disease severity gradually increased with body mass index (BMI) categories among patients admitted in intensive care unit (ICU) for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the need for invasive mechanical ventilation (IMV), reaching 85% in patients with class II or III obesity ( BMI \> 35 kg/m2).

In summary, there is an urgent need for more evidence on the specific role played by obesity in the development of COVID-19 complications, and more particularly of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

Eligibility Criteria:
Inclusion Criteria:

* Participant is aged 18 years or over
* Has been admitted to ICU with COVID-19 disease.
* COVID-19 disease has been confirmed by PCR for SARS-CoV-2
* Height and weight or BMI on admission has been recorded
* Data has been collected in an ethical manner as part of a national database or clinical auditing process approved by the local institution or collaboration

Exclusion Criteria:

-There are no exclusion criteria
Cervical Lidocaine-Prilocaine Cream vs Glyceryl Trinitrate Cream in Nulliparous Women With LNG-IUD Insertion

the aim of the present study is to compare safety and efficacy of cervical Lidocaine-Prilocaine cream versus glyceryl trinitrate cream on pain perception during levonorgestrel- intrauterine device insertion among nulliparous women: a randomized double-blind controlled trial


Eligibility Criteria:
Inclusion Criteria:

* young and adolescent women requesting LNG-IUD insertion

Exclusion Criteria:

* parous women and contraindications to LNG-IUD placement or to the study drugs.