cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney

Daptomycin ，is the ﬁrst approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains，disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. Because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. Daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys.

There is still a lot of controversy about the application of daptomycin in patients with severe illness. Although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. In addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (AKI), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of Daptomycin.

By exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin PK/PD, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe bloodstream infections eligible for daptomycin indications
2. Treatment in the ICU
3. Patients aged 18 to 65

Exclusion Criteria:

1. Pregnant and lactating women
2. The patient or his agent refused to participate in the trial
3. Incomplete clinical medical information
4. Patient participates in another clinical trial at the same time
5. Previous history of myopathy or current CPK increase more than 2 times than normal
6. Patients need to use warfarin anticoagulation
7. Patients use tobramycin for anti-infection
8. Patients use drugs such as cyclosporine and fibrates that can cause adverse reactions to muscle disease
9. Patients with Gram-negative bacterial infections caused by abdominal and respiratory infections
10. Patients with heart failure, respiratory failure, Glasgow coma index (GCS) ≤ 8 points, liver function CHILD PUGH score C that are not related to the infection
Duloxetine Versus Placebo for Osteoarthritis Knee Pain

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

* Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
Comparison of Kinesio Taping and Cervical Thrust Manipulation in Neck Pain

To compare the effects of kinesio taping, cervical thrust manipulation and conventional therapy on neck pain, functional status and range of motion

Neck pain is most prevalent condition affecting globally, which also create threats to the individuals. Mechanical neck pain affects mainly two third of population at some time in life possibly in middle age, some people may be acute mechanical neck pain while some leading to chronic stage. Mechanical neck disorders usually associated with pain, decreased cervical mobility, spasm. Often neck pain is mechanical in nature, according to literature mechanical neck pain is defined as, that pain originating from cervical spine which may be aggravated with cervical motion, prolonged posture, muscular stiffness. Due to widespread occurrence of mechanical neck pain mainly in modern society, proper interventional strategies of this problem is needed to facilitate that problem. Incidence of neck pain may range from 10.4-23.3%in one year, while according to previous literature prevalence of neck pain was 0.4 to 86.8%, with high proportion in office workers, computer users, and females especially 35 to 55 years. Pain, stiffness, tenderness and restricted mobility is most common symptoms associated with neck pain, manual therapy techniques, exercises, mobilization, manipulations, kinesio taping are treatment strategies used for this problem may improve neck pain.

The main purpose of my study is to improve neck pain, discomfort and functional status in patients with mechanical neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having mechanical neck pain.
* participants having neck pain more than 1 month.

Exclusion Criteria:

* History of serious pathology (Malignancy, inflammatory disorders).
* Cervical spinal surgery.
* History of trauma or fracture.
* Vascular syndromes.
* Neurological and cardiac pathologies.
Discrimination of DILI and AIH by Artificial Intelligence

A retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate Drug-induced liver injury and Autoimmune hepatitis.

A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis

Research Objectives:

1. To develop a machine learning-based model from retrospective data.
2. To validate the machine learning-based model from internal dataset and external datasets nationwide.
3. To setup a website or application based on the above model to discriminate Drug-induced liver injury and Autoimmune hepatitis.

Eligibility Criteria:
Inclusion Criteria:

* Drug-induced liver injury

  1. RUCAM ≥6 and met one of the following biochemical conditions: a.) ALT≥5 ULN, b.) or ALP ≥2 ULN, iii) or ALT≥3 ULN and TBil≥2 ULN.
  2. RUCAM was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility.
* Autoimmune hepatitis

  1. The revised International Autoimmune Hepatitis Group (IAIHG) diagnostic score≥6 points.
  2. Liver biopsy available, which is compatible with typical features of AIH.
  3. If liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy.

Exclusion Criteria:

* Drug-induced liver injury

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Autoimmune hepatitis.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.
* Autoimmune hepatitis

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Drug-induced liver injury.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.
Observational Study to Evaluate the Safety While Using Levemir®

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.


Eligibility Criteria:
Inclusion Criteria:

* After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
* Subjects currently being treated with insulin detemir;
* Subjects who previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)
Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lateral ankle instability
* Beighton score ≥4
* Age with 18 to 60 years

Exclusion Criteria:

* Patients with an acute or subacute ankle injury
* Injury of the deltoid ligament
* Alignment of lower extremity greater than 5 degrees
* Fractures of the lower extremity
* Stage III or IV osteoarthritis
* Patients who refused to participate in the study
Explore Effects of Dietary Fish Oil in Human Skin

The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age.
* Good general health.
* No disease states or physical conditions, which would impair evaluation of the biopsy sites.
* Signed, written and witnessed, Informed Consent Form
* BMI is between 18 to 36 kg/m2

Exclusion Criteria:

* Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol. A pregnant test will not be given to women who are capable to pregnant.
* Lovaza™ (prescription fish oil) and not willing to go off Lovaza for 3 weeks prior to enrollment to end of study.
* Frequent NSAID use (not including low dose aspirin) and not willing to go off NSAIDS for 3 weeks prior to enrollment and to end of study.
* Steroids (except inhaled steroids for asthma) and not willing to go off steroids for 3 weeks prior to enrollment to end of study.
* Other medications that may affect the biomarkers of interest.
* Any supplement use (i.e. fish oils, flax seed oils and other oils) that can affect the biomarkers of interest.
* Diet with frequent (1-2 days per week) oily fish (mackerel, salmon, sardines, cold water fish, et al).
* History of photosensitive conditions (connective tissue diseases, polymorphous light eruption, porphyrias etc).
* Received an experimental drug or used experimental device in the 30 days prior to admission to the study.
* History of keloids or any other condition that would complicate wound healing.
* Allergic to soybean, soybean oil, peanuts or seafood.
* History of allergic reactions to local anesthetics.
Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Eligibility Criteria:
Inclusion Criteria:

* All patients who candidate for open rhinoplasty

Exclusion Criteria:

* Revision cases
* History of scar
* Systemic diseases
Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis

Evaluating the efficacy and safety of the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy

Hepatic Encephalopathy (HE) is a central nervous system dysfunction caused by liver insufficiency and/or portosystemic shunting, manifesting as a wide spectrum of neurological or psychiatric abnormalities characterized by alteration of cognitive and motor function.

The pathogenesis of hepatic encephalopathy is believed to be due to increased nitrogenous substances, primarily ammonia, in the blood. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status.

Treatment options include lactulose administered orally and non-absorbable antibiotics.

Lactulose is nonabsorbable disaccharides that is currently used as first line agents for the treatment of HE. Its action is thought to be due to Colonic metabolism of lactulose to lactic acid results in acidification of the gut lumen. This favors conversion of ammonium (NH4) to ammonia (NH3) and the passage of ammonia from tissues into the lumen. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Lactulose also works as a cathartic, reducing colonic bacterial load.

Nifuroxazide is an oral broad-spectrum nitrofuran antibiotic that is commonly used as an intestinal anti-infective agent. It is active against the majority of intestinal bacteria: Gram-positive (Staphylococcus family) and Gram-negative (Enterobacteriaceae family: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Yersinia) and is therefore expected to decrease ammonia production and to reverse the symptoms of HE.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from liver cirrhosis aging above 18 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade II or III) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with Model for End-Stage Liver Disease (MELD) score ≤ 25 and patients are able to swallow.

Exclusion Criteria:

* Patients with neurological or communication problems.
* Degenerative central nervous system (CNS) disease.
* Any significant psychiatric illness.
* Patients with previous intake of nifuroxazide and rifaximin within the last month.
* Presence of underlying renal impairment (serum creatinine ≥ 2 mg/dL).
* Alcohol consumption within prior 4 weeks.
* Non-hepatic metabolic encephalopathy.
* Anemia with hemoglobin level \< 7 g/dL.
Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation

During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.

This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.


Eligibility Criteria:
Inclusion Criteria:

* Lung resection
* Acute circulatory failure
* One-lung ventilation

Exclusion Criteria:

* Sinusal rhythm
Reliabılıty,Validity Of The Turkish Version Of The KNAP

This study, we performed the Turkish version validity and reliability of the KNAP

Chronic musculoskeletal pain is significantly affected by the attitudes and beliefs of healthcare professionals and affects patient management outcomes . Adopting a biopsychosocial approach rather than a solely biomedical approach is of great importance in order to comply with current pain management guidelines and reduce both pain levels and disability . Therefore, it is important to recognize healthcare professionals' knowledge, attitudes, and beliefs regarding pain . Pain science education is a powerful strategy to manage chronic musculoskeletal pain by addressing biopsychosocial factors . It improves the understanding of pain by integrating psychological and social aspects beyond anatomical factors and provides better rehabilitation outcomes. Healthcare professionals are crucial to providing effective treatment and patient pain education and require a solid understanding of pain science principles . Many validated surveys assess health care professionals' knowledge and attitudes regarding chronic pain, but they often lack elements of modern pain science and biopsychosocial treatment orientations . To address these limitations, the Knowledge and Attitudes to Pain (KNAP) questionnaire was developed to assess modern pain science and biopsychosocial attitudes toward pain. The KNAP questionnaire consists of 30 items divided into two domains. It is scored using a 6-point Likert scale and has been validated in Brazilian Portuguese, French, Spanish, and Japanese .Therefore, the aim of this study was to adapt the KNAP questionnaire for Turkish physiotherapists and to rigorously examine its psychometric properties among physiotherapy graduates and students in Turkey. The study aims to validate the questionnaire to accurately assess pain knowledge, attitudes, and beliefs by analyzing internal consistency, structural and construct validity, reliability, sensitivity, and interpretability.

Eligibility Criteria:
Inclusion Criteria: Physiotherapy and rehabilitation department students and physiotherapists who speak Turkish -

Exclusion Criteria: Physiotherapy and rehabilitation students and physiotherapists who do not speak Turkish.

-
Brain Substrates for Cardiovascular Stress Physiology

Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.

Physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. Disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. The aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.

Eligibility Criteria:
Inclusion Criteria:

18-30 years old

Exclusion Criteria:

History of a diagnosed chronic medical or neurological disorder Current pregnancy Current illness or infection (e.g., cold, flu) Any condition that would prohibit them from engaging in physical exercise
Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens

This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 38% color contact lens for vision correction.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must sign the informed consent form.
2. The subject must be at least 20 years of age as of the date of evaluation for the study.
3. The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
4. The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
5. The subject must have normal eyes, except ametropia.
6. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
7. The subject must appear able and willing to fill the daily card.

Exclusion Criteria:

1. The subjects who need to use ophthalmic medicine for therapy.
2. The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
3. The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
4. The subjects who have clinically significant tear secretion abnormal.
5. The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation

The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the cochleostomy location of an endaural approach (MINV) compared to the conventional posterior tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice a new surgical endaural approach to perform cochlear implantation. In the hands of an inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail for this technique. This is a prospective study of 24 human heads. Straight electrode arrays were implanted by an inexperienced surgeon: on one side using MPT and on the other side using MINV.


Eligibility Criteria:
Inclusion Criteria:

* cadaver heads
* person had provided written consent to give their entire body to science

Exclusion Criteria:

* none