cyrilzakka/clinical-trials huggingface dataset:
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 to 18 years old must weigh \>60 kg
* Patients diagnosed with ABSSSI with at least one systemic sign of infection
* Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical)
* Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess
* Suspected or documented ABSSSI caused by a Gram-positive pathogen

Exclusion Criteria:

* Involving a chronic diabetic foot infection (diabetic foot ulcer)
* Involving burns
* Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely
* Documented bacteremia associated with the current ABSSSI
* Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
* Evidence of significant liver disease: ALT \>3x ULN, or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Dysfunctional Breathing, Exercise Capacity, and Balance in Hypertension

This prospective cross-sectional study aims to investigate the relationship between dysfunctional breathing (DB), exercise capacity, and balance in patients with arterial hypertension (HT). DB is characterized by abnormal breathing patterns and is associated with symptoms such as dyspnea and inefficient ventilation, regardless of the presence of organic respiratory disease. Hypertension may further exacerbate these symptoms and contribute to impaired exercise performance and postural balance. The study will assess DB using the Nijmegen Questionnaire, along with anthropometric measurements, balance tests, and functional exercise capacity evaluations. Findings may contribute to better understanding of respiratory dysfunctions in hypertensive individuals and their impact on physical performance.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years
* Diagnosed with hypertension and under follow-up for at least 6 months
* Willing to participate in the study voluntarily
* Nijmegen Questionnaire score of 23 or above

Exclusion Criteria:

* Medication change within the last month prior to study enrollment
* Presence of unstable metabolic disease
Clinical and Pathological Characteristics of Women With Ovarian Cancers in Syria

the goal of this observational study is to describe ovarian cancer epidemiology and characteristics in Syrian women, especially during the war to do more research in the future about the risk factors of ovarian cancer.

Ovarian cancer (OC) is the eighth most common cause of death worldwide, and current studies show that the death numbers caused by it will rise dramatically in the coming years. As the epidemiological features of the cancer may vary, studying these different characteristics can help us improve treatment outcomes and add preventive measures. In addition, giving special attention to these features in developing countries, or countries undergoing crisis, will help us understand the associated risk factors in these regions.

Eligibility Criteria:
Inclusion Criteria:

* female adult (age ≥18 years)
* primary ovarian malignancy

Exclusion Criteria:

* less than 18 years old
* women who have benign tumors or metastatic ovarian cancer.
Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes

Why Is This Research Study Being Conducted?

* The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.
* Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.
* By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS

What Is Involved in The Study?

* This study will follow patients with MDS over 6 months.
* Participants will come to the hospital for the first visit. Participants will learn about the study, sign papers to join the study, and share some basic health information. Participants will also give a blood sample of 10 milliliters after not eating overnight.
* After the first visit, participants will come back to the hospital once a week for 3 weeks to give more blood samples after fasting overnight.
* The study team will call participants the day before each scheduled blood draw to remind you of your appointment.
* Then participants will return to the hospital for another visits once a month for the next 5 months. Participants will talk about any changes in their health and give a blood sample at each visit.
* Participants won't get any treatment as part of this study, but their participation will help researchers learn how inflammation affects the health of people with MDS
* Researchers will collect a small amount of blood (6-10 mL) per visit
* These blood collections are a normal part of medical care and won't require participants to come in more often than usual. The frequency of visits will be part of the routine care for myelodysplastic syndrome at the cancer center. Extra blood will be collected during standard of care blood draws in the clinic.
* Sessions will take about 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms
* Eastern Cooperative Oncology Group (ECOG) performance status ≤3
* Expected survival of at least 6 months
* Ability to provide consent

Exclusion Criteria:

* Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis
* Hematopoietic stem cell transplantation expected within 6 months
Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty

The purpose of this study is to examine whether the effect of "hiking poles exercise" on lower extremity muscular strength, knee range of motion, and quality of life in elderly patients underwent total knee arthroplasty

This is a longitudinal-experimental study. The data collection and analysis are in a single-blind manner. The study will be undertaken in the Department Orthopaedics of En Chu Kong hospital (approximate 500-bed regional teaching hospital). All patients who meet the inclusion criteria are admitted for primary total knee arthroplasty and assigned to control group or intervention group randomly. The 44 patients in the control group received routine guidance of " Rehabilitation and precautions for artificial knee replacement ". In addition to the routine guidance, the 44 patients in the intervention group received educations of " hiking poles exercise " on the day before surgery and before discharge, as well as a follow-up call at least once a week after discharge.

Eligibility Criteria:
Minimum Age: 60 years Maximum Age: 85years Gender-Based: All Accepts Healthy Volunteers:No

Criteria:

Inclusion Criteria:

* Age between 60 and 85 years
* Informed consent
* Receipt of elective unilateral primary knee arthroplasty surgery.

Exclusion Criteria:

* Non-degenerative arthritis, including rheumatoid arthritis, or traumatic arthritis
* Patients receiving rehabilitation simultaneously
* Patients with other musculoskeletal or neurological problems, including fractures, Parkinsonism, cerebrovascular events, or patients with multiple comorbidities
* Cancer patients receive chemotherapy
* Patients with the peri-operative complication that has an adverse effect on outcomes,for example: intra-operative fractures, thromboembolism, peri-operative infections, or phlebitis
Effect of Two Exercise Programs on Obese Patients

The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.


Eligibility Criteria:
Inclusion Criteria:

* Anyone with a BMI of 25 and above

Exclusion Criteria:

* Those that cannot exercise
1% vs. 2 % Lignocaine for Flexible Bronchoscopy

Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lower concentrations (1%) versus a higher (2%) during bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during flexible bronchoscopy.

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to 1% lignocaine or 2% lignocaine group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation.

During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Eligibility Criteria:
Inclusion Criteria:

1. Indication for diagnostic or therapeutic flexible bronchoscopy
2. Age \> 18 years
3. Hemodynamic stability (defined as systolic BP \>100 mm Hg and, \<180 mm Hg).

Exclusion Criteria:

1. Refusal of consent
2. Known documented hypersensitivity to lignocaine
3. Procedure performed under general anaesthesia or sedation
4. Pregnancy
5. Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
6. Bronchoscopy done through endotracheal or tracheostomy tube
IlluminOss Hand Fracture International Clinical Feasibility Study

The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
* Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
* Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
* Fracture has occurred within past 3 weeks
* Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site

Exclusion Criteria:

* Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
* Patient has experienced a crush, mangling, or burn type injury
* Patient has probable history of infection or confirmed infection at baseline
* Patient has previous diagnosis of a significant bone disorder that may impair bone healing
* Patient has a life expectancy of \< 26 weeks
* Pathological fracture secondary to tumor
* Open fracture of Gustilo-Anderson Type II or III
Endothelial Dysfunction and Plaque Vulnerability

Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic and quantitative method to evaluate endothelial function. The investigators will investigate the association between endothelial function assessed by RH-PAT and plaque vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).

Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT before discharge.

Eligibility Criteria:
Inclusion Criteria:

* patients with angiographically proven ACS (luminal stenosis of at least 50%) who undergo both OCT examination before coronary stent implantation and RH-PAT examination before discharge.

Exclusion Criteria:

* none
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.

Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study

Eligibility Criteria:
Inclusion Criteria:

- Meet renal function criteria in one of four categories

Exclusion Criteria:

- Unstable or uncontrolled medical conditions
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

pharmacokinetic study

Eligibility Criteria:
Inclusion Criteria:

* Men and nonlactating and nonpregnant women greater than or equal to 18 years of age
* Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the asymptomatic or symptomatic phase of PBC.
* Otherwise healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results (other than those associated with PBC), vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Subjects with a recent increase in bilirubin, bilirubin \>15 mg/dL, presence of ascites, esophageal varices, or hepatic encephalopathy.
* Any major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
* Any malignancy including hepatocellular carcinoma.
Effect of Intravenous Lidocaine on Propofol Requirements

Lidocaine, an amide local anesthetic, has advantages of low price and easily obtaining. Intravenous lidocaine (IVL)initially has been used in the treatment of arrhythmia. It was demonstrated that IVL had analgesic effect, especially in colorectal surgery, but remained controversy in other types of surgeries. Other beneficial effects, such as prevention of hyperalgesia and propofol-induced injection pain, reduction of incidence of postoperative ileus and nausea and vomiting and anti-inflammatory also were proposed.

The most frequent drugs for procedural sedation and analgesia are propofol, benzodiazepines and opioids. However, these drugs may cause respiratory depression and circulatory instability. Combination will increase the risk of hypoxia and apnea.

In China, most anesthesia for hysteroscopy and gastroenteroscopy is procedural sedation and analgesia(PAS) provided by anesthetists. Foester et,al. have been tested that IVL could significantly reduce propofol requirements 、postoperative pain and fatigue scores in colonoscopy. Chen,et,al. find the same effect of IVL in elderly. However, there is no research reporting IVL used in hysteroscopy and diagnostic curettage. So, our main objective is to evaluate the effect of intravenous lidocaine on propofol requirements in patients undergoing hysteroscopy and diagnostic curettage.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent hysteroscopy and diagnostic curettage, American Society of Anesthesiologist' physical status 1-2, BMI 18.5-24.9 kg/m2,

Exclusion Criteria:

* Patients with known allergy to lidocaine or other local anesthetics, taken sedatives and analgesics within 1 week before surgery, mental and neurological diseases, hearing impairment, unwilling to sign informed consent or participate in the study, serious arrhythmia and organic heart disease.
Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)

In this survey study, researchers want to find out more about how physicians are treating patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood sugar level (type 2 diabetes); what physicians know about the different treatment options available; and how they use this knowledge to treat their patients successfully. Additionally, researchers want to gather information about patient's awareness of their disease and which criteria they consider important for their treatment of the disease.

The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for this study can be male or female and should be at least 18 years old. In addition, a total of 150 physicians will be surveyed. Physicians eligible for this study may be general practitioners, endocrinologist, or nephrologists.

The primary objective in this study is to assess the awareness, values and preferences of patients and physicians with respect to the risks, consequences and management of chronic kidney disease (CKD) in patients with type 2 diabetes.

Secondary objectives aim to assess awareness of available CKD treatments, referral tools and communication between patients and physicians.

Both patients and physicians will complete a survey that consists of various questions regarding the knowledge of disease, values and treatments, patient-physician interaction, physician referral tools and disease risk management.

Eligibility Criteria:
Inclusion Criteria:

* For patient cohort:

  * Diagnosis of type 2 diabetes
  * eGFR \< 60 ml/min per 1.73 m2 (measured within the last year) OR eGFR ≥ 60 ml/min per 1.73 m2 and uACR ≥ 2 (measured within the last year)
  * No documented non-diabetic etiology for renal disease
* For physician cohort:

  * Licensed general practitioner, endocrinologist or nephrologist
  * Currently providing care for patients with chronic kidney disease and type 2 diabetes

Exclusion Criteria:

* Patients with chronic kidney disease and type 2 diabetes who are physicians
* Physicians with chronic kidney disease and type 2 diabetes
A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, over the age of 18 years
* Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
* DAS28 \>3.2
* Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
* Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
* Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form obtained
* Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
* Pre-bronchodilator FEV1 of at least 65%
* Positive response to methacholine challenge test
* Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
* For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.

Exclusion Criteria:

* Clinically relevant and uncontrolled concomitant diseases
* Abnormal clinically relevant ECG
* Presence of aortic aneurism
* Uncontrolled hypertension
* Intake of non-permitted concomitant medications
* Participation in another clinical trials in the previous 8 weeks
* Seasonal variation in asthma
* Recent occurrence of asthma exacerbations
* Hypersensitivity to any product used in the trial, including excipients
* Heavy caffeine drinkers
* History of alcohol/drug abuse
* Smokers