cyrilzakka/clinical-trials huggingface dataset:
Naloxone Nasal Spray Pharmacokinetic Study

This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).

Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-60 50 years of age
* Provide written informed consent prior to completing any study specific procedure.
* Body Mass Index (BMI) range 18.5-30 kg/m2
* Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
* Using reliable contraception

Exclusion Criteria:

* Intranasal problems
* Taking prescribed or over the counter medications
* Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)

Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty

Exclusion Criteria:

* Previous complex surgery of the affected knee
* Metalic implant in the affected lower limb
* Patients who unable or contraindicated to perform MRI
* Extra-articular deformities of the affected lower limb
* Extensive bone loss of distal femur or/and proximal tibia
* More than 30 degrees of knee flexion contracture
* Unable to perform TKA within 12 weeks after MRI
Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment

Post-dural puncture headache (PDPH) is one of the most important complications of neuraxial blocks and lumbar interventions for cerebrospinal fluid (CSF) examination. It occurs due to tear in the dura mater and loss of cerebrospinal fluid (CSF) after intrathecal or epidural interventions.The incidence of PDPH depends on the thickness of the needle used and the type of tip. Headaches are more common with thick needles than with thin needles.In our study, postdural puncture headache in patients whose surgery was planned and spinal anesthesia was applied at Süleyman Demirel University faculty of medicine;frequency, predisposing factors, treatment intended to examine.

Different anesthesia techniques are applied to patients undergoing surgery. These are general anesthesia and regional (Spinal, Epidural, peripheral nerve blocks, etc.) anesthesia applications. Today, regional anesthesia is the most frequently preferred anesthesia method by anesthesiologists due to its low side effects. Spinal anesthesia is the temporary stopping of nerve conduction with a local anesthetic solution injected into the cerebrospinal fluid. It is one of the most commonly used regional anesthesia techniques today.Important advantages of regional anesthesia include the patient's continued spontaneous breathing, preservation of oropharyngeal reflexes, continuation of analgesia in the postoperative period, early mobilization, and short hospital stay.Post-dural puncture headache (PDPH) is one of the most important complications of neuraxial blocks and lumbar interventions for cerebrospinal fluid (CSF) examination. The incidence of PDPH is significantly higher in young people than in the elderly, in women compared to men, and in pregnant women compared to the normal population.In our study, spinal anesthesia cases will be examined. Patients with headache will be identified. Patients' demographic data (age, height, body weight, gender, comorbidities), ASA (American Society of Anesthesiologists) score, operation type, presence of headache etiology, needle type and diameter used, number of interventions and procedures. level, amount of local anesthetic given, adjuvant drugs added, experience of the practitioner, amount of fluid given, date and time of headache onset, treatment and procedure complications will be monitored and recorded in the form.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* ASA physical status class I, II and III
* BMI \<40 kg/m²
* Patients undergoing spinal anesthesia

Exclusion Criteria:

* ASA physical status class \> III
* Severe cardiac, respiratory, hepatic, and renal disease
* Refusing spinal anesthesia
* History of local anesthetic allergy
* Localized infection at the injection site
* Coagulopathy
* Anticoagulant drugs usage
* History of chronic pain (migraine, sinusitis, etc.)
* Alcohol and opioid addiction
* Psychiatric diseases
* Communication difficulties
* Vertebral or chest wall abnormalities
* BMI \> 40 kg/m²
Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
* Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.
* Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
* Hemoglobin ≥ 9 gm/dL
* White blood cell count \> 3000/mm3
* Platelet count ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
* History of infusion reactions to monoclonal antibody therapies.
* Pregnant or breastfeeding.
* Magnesium or potassium lower than the normal institutional values.
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
* Severe renal disease or anuria.
Fusobacterium Nucleatum at Colorectal Cancer Sites

Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of colorectal cancer
Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19

Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset

Exclusion Criteria:

* Pregnancy
* Sepsis
* Malignancy
* Patients on immunosuppressant therapy
* Chronic inflammatory conditions
* Cases lost to follow up
The Application of Artificial Intelligence in Dental Education

Clinical procedural skills training is a cornerstone of preclinical education for dental students. While technological aids such as virtual reality and simulators are increasingly integrated into training, direct instructor guidance remains fundamental to skill development. Artificial intelligence（AI）， as an emerging technology, is now gradually being adopted in medical education. This medical education trial, aimed at evaluating the potential of artificial intelligence in dental education, seeks to address two key questions: 1) Can AI assistance enhance the skill performance of dental students? 2) How can AI be effectively integrated into modern medical education? Researchers will compare the effects of AI and video-based instruction on skill acquisition, assessing differences in skill performance outcomes. Participants will engage in skill acquisition using either AI or video-based instruction over a one-week period.


Eligibility Criteria:
Inclusion Criteria:

* They must have completed courses in endodontics, periodontology, prosthodontics, and oral and maxillofacial surgery; participants should have little to no prior training in the skills related to the experiment; and they must voluntarily agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

* Participants will be excluded if they meet any of the following criteria: failure in final exams of the four courses (endodontics, periodontology, prosthodontics, and oral and maxillofacial surgery); transfer to another major, suspension, or withdrawal from the current academic year; refusal to join the study or withdrawal midway; failure to meet the calibration standards in the 9-point eye-tracking calibration; use of OpenAI-related software or applications in the control group; or failure to complete the skill test.
Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China

Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.

The study will recruit 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. The 5000 participants in the intervention group will undergo a low-dose CT scan at baseline and one year later, and will be managed according to European volume-based protocol. The 5000 participants in the control group will undergo a low-dose CT scan according to the routine CT protocol and will be managed according to the clinical practice. Epidemiological data will be collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. The screening performance will be compared between volume-based and standard protocol for managing early-detected lung nodules. The effectiveness of quantitative measurement of CT imaging biomarkers for early detection of lung cancer, COPD and CVD will be evaluated.

The detected lung nodules in the intervention group will be classified into three groups depending on nodule volume: \< 100 mm3 (negative result), 100-300 mm3 (indeterminate result) and \> 300 mm3 (positive result). In case of a negative result, a CT scan after one year is recommended. In case of an indeterminate result, a 3-month follow up CT is recommended at which VDT will be assessed. For short VDT (\< 400 days), the screening result is positive. Long VDT (\> 400 days) is considered a negative screening result. In case of a positive result, referral to a multidisciplinary team is recommended for further investigation. The detected nodules in the control group will be managed according to the recommended cut-off values of diameter from NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening.

Eligibility Criteria:
Inclusion Criteria:

1. asymptomatic (without complaints of chest discomfort) residents registered in Shanghai city.
2. age between 40-74 years old
3. no history of lung cancer (self-reported).

Exclusion Criteria:

* Pregnant women will be excluded.
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube

in this study, it was aimed to examine the effect of the modular carrying system on the outcomes of care in the mobilization of patients with a chest tube. The population of the study consisted of patients followed in Yedikule Chest Diseases, and Thoracic Surgery Training and Research Hospital between October 2019 and January 2021, and the sample consisted of 83 patients who met the inclusion criteria. The study was performed with the intervention group (n=37) mobilized with the Modular medical equipment carrying vehicle and the control group (n=46) mobilized with the routine application.

Within the scope of the study, a Modular medical equipment carrying vehicle was developed by the researchers to ensure the safe and comfortable mobilization of patients with chest tube and additional medical equipment. This vehicle has been designed to maintain the level of the chest tube during mobilization and to prevent it from tipping over.Patients in the intervention group were mobilized with the help of this Modular medical equipment carrying vehicle for 20 minutes at least 6 times a day. Patients in the control group were mobilized at least 6 times a day for 20 minutes with clinical routine practice.

Eligibility Criteria:
Inclusion Criteria:

* chest tube inserted due to open surgery, hemodynamically stable, followed up in the clinic for at least 5 days, first mobilized after chest tube inserted

Exclusion Criteria:

* have a mental or psychological illness, hemodynamically unstable
Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

This study will evaluate the drug telbivudine (LdT) for treatment of hepatitis B virus (HBV) in HIV infected patients. Patients will take telbivudine alone for 24 weeks, add anti-HIV drugs for 24 weeks, then stop taking telbivudine while continuing their anti-HIV drug regimen. To enroll in this study, patients must not be taking any anti-HIV drugs and cannot have taken more than 31 days of treatment with lamivudine (3TC), protease inhibitors (PIs), or nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Studies indicate that 70% to 80% of HIV infected patients have or have had HBV infection and that 10% are HBV carriers. Lamivudine therapy for treatment of HBV in HIV infected patients has limited long-term efficacy due to the development of resistance mutations. Telbivudine is a thymidine analogue with excellent HBV inhibitory activity but no anti-HIV activity. The primary objective of this study is to evaluate the safety and anti-HBV activity of telbivudine alone and in combination with a lamivudine-based highly active antiretroviral therapy (HAART) regimen in patients coinfected with HBV and HIV.

Patients in this study will take telbivudine for 24 weeks. At Week 24, patients will add a HAART regimen containing lamivudine and efavirenz plus either didanosine or abacavir. Patients who are unable to add a HAART regimen at Week 24 due to lab abnormalities or other contraindications will be allowed to delay the initiation of HAART until Week 30. Patients may initiate HAART prior to Week 24 if deemed medically necessary by the primary HIV care provider. Patients will take both telbivudine and HAART for 24 weeks. At Week 48, patients will discontinue telbivudine and continue on the HAART regimen alone for an additional 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* No antiretroviral therapy within 6 months prior to study entry
* Less than 31 days cumulative therapy with lamivudine, a protease inhibitor, or a nonnucleoside reverse transcriptase inhibitor
* Willingness to delay HAART until at least Week 24 of study
* Ability to procure and initiate HAART regimen
* CD4+ cell count \>= 250 cells/mm3 within 60 days prior to study entry
* HIV-1 RNA \> 400 copies/ml within 60 days prior to study entry
* Serum HBV DNA \>= 1,000,000 copies/ml within 60 days prior to study entry
* Positive serum hepatitis B surface antigen (HbsAG)
* Acceptable methods of contraception

Exclusion Criteria:

* Pregnancy or breast-feeding
* Allergy, sensitivity, or intolerance to study drugs
* Alcohol consumption averaging more than 1 drink/day within past 30 days
* Decompensated cirrhosis
* HCV antibody positive or known HCV RNA positive
* HDV antibody positive
* Certain medical conditions
* Use of certain medications with anti-HBV activity within 90 days of study entry
* Use of systemic corticosteroids within 30 days of study entry
* Use of any systemic antineoplastic, immunomodulatory treatment, or radiation within 24 weeks of study entry
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia

This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to the SAIZEN® Product Information
* Aged between 2 and 18 years
* Appropriate Informed Consent/Assent provided

Exclusion Criteria:

* Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
* Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
* Use of an investigational drug or participation in another interventional clinical trial