cyrilzakka/clinical-trials huggingface dataset:
Neck Anatomy and Phrenic Nerve Palsy After BPB

The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery.

The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery. In addition, we want to identify risk factors for diaphragmatic paralysis after brachial plexus block. Through this study, we can find the basis for predicting the possibility of diaphragmatic paralysis after brachial plexus block according to the patient's anatomical characteristics and procedural factors.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia

Exclusion Criteria:

* Patients who refused to participate in the trial

  * Patients with respiratory diseases such as asthma and chronic obstructive pulmonary disease

    * Patients with neurological abnormalities of the upper limb

      * Patients with a history of surgery around the neck on the ipsilateral side of the surgery site, radiation treatment history, etc.

        * Patients with a history of allergy or hypersensitivity reactions to local anesthetics
Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study

postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.

postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.In this study, 100 patients were intubated to undergo general anaesthesia for shoulder arthroscopy and randomised into one of two groups. An endotracheal tube was soaked in 8mg of dexamethasone for the first group intubation, while 10% lidocaine was sprayed over the tube for the second group. Following extubation, the two groups examined the severity of sore throats

Eligibility Criteria:
Inclusion Criteria:

* •Patients belonging to ASA physical status I, II

  * Patients between age18 to 50 years
  * Patients belonging to both genders.
  * patients undergoing shoulder arthroscopic surgeries.
  * Patients with fasting blood glucose \&lt;100 mg/dl or random blood sugar \&lt;140 mg/dl.

Exclusion Criteria:

* Patients who are not willing to give consent for participation in the study

  * Patients with anticipated difficult airway
  * Patients who are allergic to steroids.
  * Patients with ASA physical status III, IV
  * Diabetic patients.
  * Patients on steroids
  * Patients requiring nasogastric tube or throat pack.
  * Patients posted for head and neck surgeries.
  * patient with GERD
  * Pregnant patients
  * preexisting upper respiratory tract infection.
Intraosseous Access

The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* paramedic
* more than 1 year experience in medicine

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases
Post Approval Study of the Eversense® Continuous Glucose Monitoring

A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System

The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.

The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PASstudy will provide safety and effectiveness data up to 27 months of repeated use.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has diabetes
2. Subject is greater than 18 years of age

Exclusion Criteria:

1. Subject is critically ill or hospitalized
2. Subject has a known contraindication to dexamethasone or dexamethasone acetate
3. Subjects requiring intravenous mannitol or mannitol irrigation solutions
4. Female subjects who are pregnant, planning on becoming pregnant or nursing
5. Subjects on hybrid closed loop systems or closed loop systems
6. Subjects on other CGM systems
A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm); a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus nivolumab arm (Belva + Cobi + Nivo arm) in a run-in phase followed by an expansion phase.

Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0 or 1
* Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressed disease at study entry
* Documentation of NRAS mutation-positive within 5 years prior to screening
* Tumor specimen availability
* Adequate hematologic and end-organ function
* Measurable disease per RECIST v1.1

Exclusion Criteria:

* Prior treatment with a pan-RAF inhibitor
* Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1
* Symptomatic, untreated, or actively progressing CNS metastases
* History or signs/symptoms of clinically significant cardiovascular disease
* Known clinically significant liver disease
* History of autoimmune disease or immune deficiency
* Prior treatment with a MEK inhibitor (cobimetinib arm)
* History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm)
* History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (nivolumab arm)
Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Stage D2 metastatic prostate cancer
* Progression after one prior chemotherapy
* ECOG Performance status equal / less than 2
* Life expectancy \> 3 months
* Surgical or medical castration
* Adequate bone marrow, hepatic and renal functions
* Informed consent

Exclusion Criteria:

* More than one prior chemotherapy
* Prior platinum containing compounds
* Prior malignancy
* Prior significant RT/radionuclide therapy
* Major GI surgery or GI disease affecting absorption
* Disease with contraindication to steroids
* Brain metastases
Step-down of Inhaled Corticosteroids (ICS) in Non-eosinophilic Asthmatics

There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled corticosteroids (ICS) than eosinophilic asthmatics.

As non-eosinophilic asthmatic patients are treated by ICS according to international guidelines for asthma, the investigators would like to investigate whether stepping-down of ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a progressive cessation of ICS is possible in some of these patients without any clinical worsening.

For patients whose asthma is not controlled at the beginning of the study, a step-up of the treatment is planned to the step 4 of Global Initiative for Asthma (GINA). This step-up will last for 3 months and will permit to ensure that these patients achieve the best possible level of asthma control. A progressive step-down of the inhaled corticosteroids (ICS) will then be achieved.

For patients whose asthma is controlled at the beginning of the study, a progressive step-down of the ICS will be directly achieved.

The progressive step-down of the ICS dose will be undertaken every 3 months according to the dose levels defined by GINA guidelines (from high to low daily dose) until a complete cessation of the ICS for 6 months. Other associated asthma treatment of asthma will be kept unchanged.

At each quarterly visit, a clinical composite outcome will be measured, for each patient. This composite outcome includes the score of asthma control questionnaire (ACQ) and the number of exacerbations. This outcome will determine at each visit if patients continue the study (success criterion) or stop the study (failure criterion). The success criterion is defined in the section "Current Primary Outcome"

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Physician-diagnosed asthma based on the presence of typical symptoms (wheezing, breathlessness, chest tightness, cough)
* Asthma confirmed by:

  * Forced expiratory volume in 1 second (FEV1) increase of at least 12% and 200 mL after inhalation of 400 mcg salbutamol
  * And/or a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20M) less than 16 mg/ml
* Sputum eosinophils rate less than 3%
* Absolute blood eosinophils count less than 400 per mm3
* Treatment with a stable dose of inhaled corticosteroid (ICS) for the previous three months

Exclusion Criteria:

* High risk of asthma-related death, defined by:

  * Near-fatal asthma history, requiring a stay in an intensive care unit
  * Current using or recent discontinuation (four weeks) of oral corticosteroids (OCS)
* Treatment with omalizumab
* Pregnant women
A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to \<18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir \[PRS\]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
* Treatment naive or treatment experienced participants
* Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
* Participant and his/her legal representative voluntarily signs and dates an informed consent form
* Must not be participating or intending to participant in a concurrent interventional therapeutic trial

Exclusion Criteria:

None
The Acute Effect of Spices on Vascular Health

The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.

A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.

Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.

Eligibility Criteria:
Inclusion Criteria:

* male aged 40-65 years
* BMI 25-35kg/m2
* nonsmoking
* waist circumference =/\> 94cm and at least one other CVD risk factor (elevated LDL-C (\> 130 mg/dL), CRP (\> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (\< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
* low herb/spice consumers (consumption \<1/day)

Exclusion Criteria:

* Chronic disease risk factors that are diagnostic of diabetes (fasting glucose \> 126 mg/dL) or hypertension (SBP \>160 mm Hg or DBP \> 100 mm Hg).
* Prescription of anti-hypertensive or glucose lowering drugs.
* Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
* Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
* weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
* vegetarianism
The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill

To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism.


Eligibility Criteria:
Clinical diagnosis of climacteric syndrome
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.

To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
* Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
* ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.
* Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.

Exclusion Criteria:

Medical and surgical history:

* Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism.
* History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
* Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management)
* Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) \> Grade 2.
* Symptomatic metastatic brain or meningeal tumors unless the subject is \>3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
* Seizure disorder requiring therapy (such as steroids or anti-epileptics).
* History of organ allograft.
* Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment
A Trial of SHR0410 Injection in Postsurgical Pain Management

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent；
2. Subjects requiring elective general anesthesia orthopedic surgery；
3. Male or female；
4. Meet the body mass index standard；
5. Conform to the ASA Physical Status Classification；
6. Negative pregnancy test.

Exclusion Criteria:

1. Subjects with a history of myocardial infarction or unstable angina pectoris；
2. Subjects with atrioventricular block or cardiac insufficiency；
3. Subjects with a history of malignancy ；
4. Subjects with a history of stroke；
5. Subjects with a history of mental illness；
6. Subjects with a history of difficult airway；
7. Random blood glucose ≥11.1mmol/L；
8. Subjects with poor blood pressure control；
9. Abnormal values in liver or renal function；
10. Subject with a history of substance abuse and drug abuse；
11. Allergic to drugs that may be used during the study；
12. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
13. Participated in clinical trials of other drugs (received experimental drugs)；
14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.
OB-GYN Clinical Validation Study

This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.

Six healthcare professionals with training and experience in Obstetrics and Gynecology ultrasound qualitatively assessed the image quality of the Kosmos Diagnostic Ultrasound System compared to the benchmark Mindray M9 Ultrasound System. Five sonographers were required to complete each scanning cohort of at least three gravid and three non-gravid participants. A sixth sonographer was added to the study to accommodate a scheduling conflict and provided additional image quality data outside of the five completed cohorts.

The following views/structures were assessed for image quality:

Gynecology participants:

* Uterus
* Ovaries
* Endometrial cavity
* Cervix

  • Obstetrics participants in their 1st trimester:
* General image quality of the fetus
* Ability to visualize the crown rump length
* Visualization of gestational sac
* Visualization of yolk sac if present

  • Obstetrics and participants in their 2nd trimester:
* General image quality of the fetal structures
* Visualization of the amniotic fluid
* Visualization of the placenta
* Cardiac motion in 2D and M-mode with heart rate

Obstetrics and participants in their 3rd trimester:

* General image quality of the fetal structures
* Visualization of the amniotic fluid
* Visualization of the placenta
* Visualization of the maternal cervix
* Cardiac motion in 2D and M-mode with heart rate
* 3 vessel umbilical cord in 2D and Color Doppler The sonographers captured all views/structures on the Mindray M9 Ultrasound System, then switched over to the Kosmos Diagnostic Ultrasound System to capture the same views/structures. Once all views/structures were captured on both ultrasound systems, the healthcare professionals reviewed the images in parallel on each system, then provided a comparison score for Kosmos between 1 and 7.

Eligibility Criteria:
Inclusion Criteria:

1. Persons able to:

   1. Read and sign an English consent form.
   2. Read and complete an English demographic and general health survey.
   3. Give consent for participation.
   4. Able and willing to comply with study requirements.
2. Those aged 18 years through 40 years, healthy, particularly in respect to their pregnancy.
3. Pregnant individuals who have received a previous ultrasound exam by their physician.

Exclusion Criteria:

1. Children (minors) under 18 years old.
2. Adults over 40 years old.
3. Those who cannot or refuse to sign their consent.
4. Those who cannot provide informed consent.
5. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation.
6. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by parents, employer or monetary benefit.
7. Pregnant individuals who have not received a previous ultrasound exam by their physician.
8. Individuals who have had a hysterectomy, oophorectomy, and trachelectomy.