cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty

The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.

In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed.

The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.

Theoretically, the greater porous surface of mid-coated implants should:

* Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
* Improve anchorage of the implant due to the higher friction coefficient
* Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores

The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary arthritis in the hip.
* Patients with sufficient bone density to allow uncemented implantation of a femoral component.
* Informed patient consent in writing.

Exclusion Criteria:

* Patients with neuromuscular or vascular disease in the affected leg.
* Patients found upon operation to be unsuited for uncemented acetabulum component.
* Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
* Patients with fracture sequelae.
* Female patients of childbearing capacity.
* Hip joint dysplasia.
* Sequelae to previous hip joint disorder in childhood.
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

Exclusion Criteria:

* Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
* Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.
Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.

OBJECTIVES:

* To evaluate the biochemical progression-free survival (PFS), overall survival, clinical PFS, and disease-free survival of patients with previously untreated intermediate-risk prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH agonist therapy.
* To determine the non-adaptive interval to salvage therapy in patients treated with these regimens.
* To determine the safety of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy for up to 3 months and undergo permanent iodine I 125 implantation. Patients then receive adjuvant LHRH agonist therapy for up to 9 months.
* Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine I 125 implantation as in arm I.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed prostate cancer

  * Previously untreated disease
* Intermediate-risk disease, as defined by the following:

  * Clinical stage \< T2c
  * Prostate-specific antigen (PSA) ≤ 20 ng/mL
  * Gleason score \< 8

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Leukocyte count ≥ 3,000/uL
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/uL
* Serum creatinine ≤ 2.0 mg/dL
* ALT and AST ≤ 100 IU/L
* No other cancer requiring treatment
* No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
* No severe psychiatric disorders, including schizophrenia or dementia
* No poorly controlled diabetes
* Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

* No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
* No prior surgery for prostate cancer
* No concurrent steroid drugs (except for ointment)
* No other concurrent antiandrogen therapy
Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery

The etiology of tourniquet pain is complex, and the study team hypothesizes that blocking with Interscalene brachial plexus block (ISBPB) is more efficient in decreasing the incidence of tourniquet pain in comparison with other techniques.

As there is a paucity of studies that evaluate the effect of intercostobrachial nerve (ICBN) block and ISBPB and Patient-Controlled Analgesia (PCA) with a supraclavicular brachial plexus block (SCBPB) on tourniquet pain in forearm surgery, Therefore, we established this randomized study to compare ISBPB and ICBN and PCA with fentanyl with SCBPB in terms of the incidence and severity of tourniquet pain in patients undergoing forearm surgery.


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years,
* ASAI-III patients
* scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min.
* desiring regional anesthesia as the primary anesthetic.

Exclusion Criteria:

* Contraindication to regional anesthesia.
* Allergy to local anesthetics.
* Primary block failure.
* If patients desired deep intraoperative sedation.
* Clinically significant cognitive impairment.
The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods

This is a case-control study that aims to build a predictive model for MAFLD based on machine learning.

Metabolic dysfunction-associated fatty liver disease (MAFLD) also known as non-alcoholic fatty liver disease (NAFLD), is one of the most prevalent liver diseases worldwide with high prevalence and economic burden, which affects 25% of global adult population. Despite extensive research on understanding the inner pathophysiology of MAFLD, it still keep growing with no approval therapy. Therefore, preventive measures are particularly important in diagnosing MAFLD. So far the liver biopsy is still the gold standard for diagnosis of MAFLD, however considering the invasive process and potential risks, it still has low acceptance for asymptomatic patients, thus non-invasive methods are necessary for this reason.

The purpose of this study is to establish a prediction model to identify MAFLD patients, which can accurately predict whether the participants have MAFLD according to the relevant metabolic indicators of the participants, without the need for invasive examinations such as tissue biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 75 years;
2. meeting the diagnostic criteria of MAFLD;
3. no other organic lesions were found in imaging examination;
4. willing and able to sign informed consent.

Exclusion Criteria:

1. significant drinking history (weekly alcohol consumption ≥ 140g for male, or weekly alcohol consumption ≥ 70g for female);
2. presence of evidence for having hepatic steatosis, viral hepatitis, history of hepatic cancer, drug-induced liver injury, liver cirrhosis and other liver and biliary tract diseases;
3. major organ malfunction, severe systemic illnesses, mental health issues, or inability to complete examination;
4. pregnant or pregnancy planning female;
5. missing of important clinical data.
Exercise Capacity in Pediatric Sickle Cell Anemia

The purpose of this study is to use comprehensive exercise testing to examine causes of exercise limitation in children and young adults with sickle cell anemia.

Although the burden of sickle cell anemia (SCA) on affected individuals is significant, few studies have examined the influence of having SCA on such measures of physical function as exercise capacity. Moreover, the physiologic basis of poor physical functioning in children with SCA is unknown and has not been studied extensively. The purpose of this proposal is to use cardiopulmonary exercise testing (CPET) to gain a comprehensive understanding of exercise capacity, as a measure of physical function, in children and young adults with SCA. The specific aims of this project are to: 1) Measure peak oxygen consumption (VO2), the reference standard for exercise capacity, in children and young adults with SCA classified by primary pathophysiologic contributor to their decreased exercise capacity, and 2) Examine the acute inflammatory response, measured by an increase in soluble vascular cell adhesion molecule (sVCAM) activity, in subjects undergoing CPET. These aims will be performed in 60 subjects with SCA and 30 matched controls without SCA. In a secondary analysis, we will also study the impact of baseline exercise capacity and the inflammatory response to exercise on short and long-term disease related morbidity. This study is essential because it will address several areas of exercise capacity, including the physiologic contributors to exercise limitation that remain fundamental knowledge gaps in SCA.

Eligibility Criteria:
Inclusion Criteria:

1. age 10 to 21 years old; AND
2. Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis

Exclusion Criteria:

1. inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); OR
2. history of exercise-induced syncope or arrhythmias. Subjects will wait at least 2 weeks following any vaso-occlusive pain episode and 12 weeks following any disease-related complication requiring transfusion support. Individuals on hydroxyurea will be eligible. A total of 30 controls without SCA or sickle cell trait will be matched for age, sex and race and recruited from the siblings, friends or relatives of subjects enrolled on this study
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers

Study objectives

* To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
* To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Male volunteers in the age between 20 and 45 years old

   * BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
2. Subject with no history of any significant chronic disease
3. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
4. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

1. History of clinically significant allergies, including Bepotastine.
2. History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
3. History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
4. Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
5. Clinical laboratory test values are outside the accepted normal range

   * AST or ALT \>1.25 times to normal range
   * Total bilirubin \>1.5 times to normal range
6. Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min/1.73m2
7. Clinically significant vital sign

   * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
   * DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
8. History of drug abuse or positive urine screen for drugs
9. History of caffeine, alcohol, smoking abuse

   * caffeine \> 5 cups/day
   * alcohol \> 210g/week
   * smoking \> 10 cigarettes/day
10. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
11. Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
12. Participated in a previous clinical trial within 60 days prior to dosing
13. Donated blood within 60 days prior to dosing
14. Subjects considered as unsuitable based on medical judgement by investigators
Compare Two Anti-Scorpion Venom Serum In Children

The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.

On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).

We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).

Eligibility Criteria:
Inclusion Criteria:

1. Scorpion sting
2. Either sex
3. Age 1 to 15 years
4. Signing an informed consent (signed by parent or guardian)
5. Being residents of the state of Guanajuato

Exclusion Criteria:

1. Previous treatment with gamma globulin or immunoglobulin
2. Blood transfusion at any stage of life
3. Patients treated with drugs that interact with anti-scorpion serum
4. History or history of sensitivity or intolerance to anti-scorpion serum or horse products
5. Pregnancy
6. Any immunodeficiency
7. Patients who have participated in a research protocol in the previous month.
Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis

The COVID-19 pandemic widely affected delivery mode of healthcare services. While fewer number of patients were allowed to attend face-to-face rehabilitation sessions, some services were totally unavailable due to the safety measures. The COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs. While tests such as TUG, SLS, and 30CST are valid and reliable for clinical use in patients with knee OA, their psychometric properties are yet to be investigated when used as tele-assessment tests. Therefore, this study aimed to examine the intra- and inter-rater reliability of the TUG, SLS, and 30CST as remote tests in patients with knee OA.

As the main cause of disability and loss of function in lower limb in middle-aged to elderly individuals , knee osteoarthritis (OA) is the most common OA worldwide and its prevalence increases with age and obesity . Among non-pharmacological methods, which are the first line of knee OA treatment , physical therapy is commonly prescribed to alleviate pain and improve physical function. However, not all patients with knee OA have access to face-to-face rehabilitation sessions under direct supervision of physicians or physiotherapists. Thanks to telemedicine, patients' access to real-time communication with health professionals has been considerably facilitated in recent years.

Detailed and comprehensive assessment is a fundamental factor for an effective rehabilitation program. Different assessment tools are available to assess the effectiveness of rehabilitation in patients with knee OA. To assess physical performance, practical tests, which are time- and space-effective, such as Timed Up and Go Test (TUG), Thirty Second Chair Stand Test (30CST), and Single Leg Stance Test (SLS) are commonly used in patients with knee OA .COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2 and 3 knee OA on the Kellgren and Lawrence (K/L) scale,
* radiologically confirmed
* pain in the knee,
* willingness to join the study

Exclusion Criteria:

* Grade 0, 1 and 4 knee OA on the K/L scale,
* central or peripheral nervous system involvement,
* previous knee surgery within the past six months,
* neurological or musculoskeletal disorders that would limit their performance on the tests,
* history of systemic arthritic conditions
Improving Mobility in Residential Aged Care

This study aims to test which of three exercise programs, previously demonstrated valuable for residential aged care adults, has the greatest benefit for walking speed and the spatiotemporal parameters that define it. The programs to be included are:

1. The GrACE program and
2. The GrACE plus Gait specific training.

This study will employ a non-randomised controlled design in which three different 24-week exercise programs and a non-exercising control group will be compared in the residential aged care (RAC) setting. The three programs are the GrACE and the GrACE plus a gait specific training program.

Data Collection

\~40 participants from two RAC facilities will be recruited into the study. This number of participants will provide 80% statistical power to identify moderate effect size between group differences on the primary outcome measures. The control group will be drawn from each of the RAC facility approached receiving exercise treatment. Participation will be informed by a discussion with the facilities Service Manager about the eligibility of participants and a medical history screen undertaken. All participants will provide informed written consent prior to participation.

Participants in the exercise group will perform twice weekly training for 24 weeks. Data will be collected at 0 weeks, 12 weeks and 24 weeks in the control and exercise groups.

Eligibility Criteria:
Inclusion Criteria:

* aged over 65 years
* residing in a RAC facility
* able to walk with a walker and/or walking stick or can self-ambulate for the test (including those who have had knee and hip replacements)
* can provide informed consent (Self- or by proxy).

Exclusion Criteria:

* end-stage terminal and/or life expectancy \<6-months (ethical reasons)
* two person transfer or unable to self-ambulate (increased falls risk)
* unable to communicate or follow instructions (personal needs beyond the scope of this project)
* dangerous behaviours (endanger the client or research staff).
Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)

The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).

This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients received XIENCE stents
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year.
* Patients with cardiogenic shock
Restricted or Liberal Antibiotics After Appendectomy - Denver Health

The purpose of this study is to see if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
* Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria:

* Unable to consent
* Pregnant Women
* Prisoners
* Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
* Heart failure
* Allergy to bupivacaine
* Unlikely to comply with treatment or follow-up
* Inpatient consultation for appendicitis
* Clinically suspected of sepsis based on Sepsis-3 definition
* Current use of antibiotics for other indications
* Uncontrolled hyperglycemia or Type 1 Diabetes
* Surgeon preference
* Patient preference
* Research team unavailable