cyrilzakka/clinical-trials huggingface dataset:
Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.

Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in good health (ASA Class I, II).
2. Age between 18-60 years old.
3. Males or females.
4. Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
5. Patients who can understand NRS scale and sign the informed consent.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
2. Pregnant or nursing females.
3. Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.
Nutrition in Gastrointestinal Tumors

Malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and can negatively effect therapy outcome. Especially patients with cancer of the gastrointestinal tract are often affected by malnutrition. Therefore, this study aims to examine changes in nutritional status of patients with cancer of the gastrointestinal tract during chemotherapy. Findings of this study will help to improve nutritional treatment of patients undergoing chemotherapy.

Malnutrition and sarcopenia are common complications in patients with malignant diseases of the gastrointestinal tract. During chemotherapy there is a high risk of further impairment of nutritional status due to anorexia, nausea, emesis and other gastrointestinal conditions that adversely impact food assimilation or absorption. Findings on changes of nutritional status during chemotherapy are scarce but of paramount importance for adequate nutrition therapy. Therefore, this study aims to provide a detailed description of changes in nutritional status of patients with a malignant condition of the gastrointestinal tract during chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.
* ongoing cytostatic treatment of a known malignant condition of the gastrointestinal tract

Exclusion Criteria:

* pregnancy
* history of any other malignant tumor disease
* inability to provide consent
RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada

In the RELEVANCE study, we will develop a scalable electronic medical report data capture platform to collect and analyse real-world data in the stage III NSCLC population in Canada across several Canadian cancer centres. Subsequent analyses will examine treatment patterns and clinical outcomes, including overall survival, for these patients, stratified by durvalumab regimen or non-durvalumab regimen during the time of the PACIFIC Patient Support Program.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent (stage III) disease between November 1, 2017 and December 31, 2019 at the centre (Note: durvalumab uptake rate requires a secondary index date, such as initiation of CRT before availability of durvalumab in May 2018)

Exclusion Criteria:

* Patients treated with durvalumab in clinical studies prior to the start date
* Clinical trial patients where treatments received are blinded in the patient medical records
Personalized Models for Cancer Research

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology.

Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute will establish a living biobank of tumor/organoids and stem cells representing individual patients diagnosed with cancer. Samples from healthy individuals (non-cancer diagnosis) or from non-disease tissue will also be collected to be used as controls in this study.

Information and biospecimens may be transferred to NYSCF by external institution or NYSCF research personnel may prospectively enroll participants to have portions of samples or cells that were (or will be) collected for reasons other than this study transferred into the biobank.

NYSCF's researchers hypothesize that the development of patient-specific models that can expand in vitro while capturing tumor complexity at the genotypic and phenotypic levels will enable accelerated discovery of more efficient treatments for patients and improve outcomes.

This study is not a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 and older with a solid tumor cancer diagnosis.
* Adults ages 18 and older serving as healthy controls.

Exclusion Criteria:

* Human fetuses.
* Neonates.
* Children.
* Wards of the state.
* Prisoners.
Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw

Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

1. Controlled group : spinal anesthesia alone
2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
3. Spinal anesthesia plus 0.1 mg morphine intrathecally
4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

1. Demographic data
2. Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)
3. Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative
4. The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* good consciousness, well co-operated, can use PCA machine
* ASA class 1-3
* no contraindication of spinal anesthesia
* accept for spinal anesthesia
* body weight \> 30 kg
* BMI 20-35 kg/m2
* no history of research-drug allergy

Exclusion Criteria:

* previous history of hip surgery (the same side)
* pathological fractured such as severe infection, bone cancer
Automatic Adaptive System Dialysis (AASD)

AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).


Eligibility Criteria:
Inclusion Criteria:Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months

* aged more than 18 years
* on chronic thrice-weekly HD
* symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week
* disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment
* dialysis session time: 4 hours (as much as possible)
* Signed inform consent form
* Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min)

Exclusion Criteria: Patients in a pregnant state

* Patients whose life expectancy is less than study period
* Patients with progressive acute pathology (neoplasia...)
* Patients included in an other protocol
* Psychiatric patients or patients unable to consent or unable to follow the study
Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study

1. Objective The purpose of this study is to evaluate whether there is a significant difference of early rebleeding rate (within the first 5 days after esophageal variceal ligation), late rebleeding rate (more than 5 days until 28 days after esophageal variceal ligation), and convenience level between cirrhotic patients in early diet group versus late diet group.
2. Method This study is a single blind randomised clinical trial. Subjects will be selected based on inclusion and exclusion criteria, then the subjects will be randomly divided into 2 groups, the early diet group (clear fluid diet is initiated 1 hour after esophageal variceal ligation) and the late diet group (clear fluid diet is initiated 6 hours after esophageal variceal ligation).

   The intervention arm is the early diet group, while the control arm is the late diet group. The primary outcome is the early rebleeding rate. The secondary outcomes are late rebleeding rate and patient's convenience level which will be measured using Visual Analogue Scale (VAS).
3. Expected result The expected result is there will be no difference in early bleeding rate, late bleeding rate, and convenience level between early diet group versus late diet group.

This study is a single blind randomised controlled trial (RCT) that will be conducted at gastrointestinal endoscopy center division of gastroenterology, integrated procedure room division of hepatobiliary, department of internal medicine, gastroenterology clinic, hepatobiliary clinic, internal medicine ward, high care unit (HCU) and intensive care unit (ICU) Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia from May 20, 2021-November 1, 2021. The proposed number of subjects are 130 patients.

Interventions will be given in the form of early clear fluid diet initiation compared to active comparator in the form of late clear fluid diet initiation in eligible liver cirrhosis patients who undergo esophageal variceal ligation (EVL) at Cipto Mangunkusumo Hospital. In early diet group diet, the 100 ml of clear fluid will be initiated at 1 hour after EVL followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. In late diet group, the 100 ml of clear fluid will be initiated at 6 hours after EVL, followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. Other routine and standardised drugs for liver cirrhosis patients will still be given. Statistical analysis will use Chi square test with alternative Fisher test for categorical dependent variables and independent T-test with alternative Mann-Whitney test for two group numerical dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis patients who underwent esophageal variceal ligation

Exclusion Criteria:

* Hemodynamic instability (shock)
* Possible perforation of the esophagus
* Esophageal diverticula
* Esophageal strictures
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer

This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following

This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:

1. understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
2. development of multidisciplinary comprehensive intervention
3. evaluation the effects of comprehensive intervention using cluster design

Eligibility Criteria:
Inclusion Criteria:

* lung cancer patients before surgery

Exclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status \<1
* Neoadjuvant therapy
* Multiple cancer
* Recurrent lung cancer.
Use of Cefiderocol in the Management of Gram-Negative Infections

The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections (GNIs) in participants treated through the Early Access Program (EAP) in Spain.

This is a multicenter, retrospective, chart review of existing medical records in participants who received cefiderocol for a GNI as part of the Shionogi EAP. Access to cefiderocol was granted as Medication not approved in Spain subject to RD 1015/2009, which dictates that each case is approved on an individual basis by the Spanish Agency of Medicines. This study will be conducted at Spanish sites where cefiderocol was supplied via the EAP, beginning in 2018.

Eligibility Criteria:
Inclusion Criteria:

* Have received first course of cefiderocol.
* Have received treatment for at least 72 hours (complete) with cefiderocol as a part of clinical compassionate management, requested in the EAP.

Exclusion Criteria:

* Enrolled in any clinical trial of an investigational product.
* Documented Acinetobacter spp infection.
* Incomplete medical records for the following essential data elements:
* Cefiderocol usage (dose, duration, frequency)
* Data to be able to determine clinical success (primary objective)
* Co-infection with a GNB resistant to cefiderocol in 28 days of the initial dose of cefiderocol.
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

Eligibility Criteria:
Inclusion Criteria:

1. To provide a signed and dated, written informed consent.
2. 80≥Age ≥ 18 years old
3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
5. Predicted life expectancy ≥ 12 weeks
6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
7. No previous systemic chemotherapy for advanced or metastatic disease.
8. Adequate organ system function:
9. Patient must have measurable disease according to RECIST 1.1.
10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled

Exclusion Criteria:

1. Spinal cord compression or meningeal metastasis
2. A history of malignant tumors within 2 years.
3. With known resistant mutations that have approved target therapy
4. Recover from AEs caused by previous treatment
5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
6. Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences

The purpose of this study is to prospectively evaluated the T2\* values of normal feti.A standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

The purpose of this study is to prospectively evaluate the T2\* values of normal feti. This study will be offered to mothers undergoing fetal MRI for any indication. Subjects will be required to sign an informed consent from. The addition of T2\* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. A standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. T2 and T2\* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . However, a standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Eligibility Criteria:
Inclusion Criteria:

* Any MRI study for fetus

Exclusion Criteria:

* Known iron deposition problem in the mother of fetus
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).

It was done in 40 subjects who were evaluated for a period of 6 months. the results were evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients age 20-55 years with intrabony defects and probing pocket depth of ≥5mm after initial therapy were included in the study.

Exclusion Criteria:

* Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers were excluded.
The Effect of Aromatherapy on Anxiety in Patients

Preoperative anxiety is considered a potential and preventable risk factor for postoperative complications.

Alot of patients face fear from intervention such as radiofrequency. The group of patients with chronic knee osteoarthritis already and mostly have some sore of psychological upset, radiofrequency itself , even in the presence of good periinterventional local anesthetic infiltration, the patients suffer pain and stress. It is well evidenced that aromatherapy specially with Lavender oil offers some sort of anxiety alleviation, pain alleviation and protection against postoperative nausea and vomiting

Eligibility Criteria:
Inclusion Criteria:

* adult patients with knee osteoarthritis
* scheduled for genicular nerve radiofrequency

Exclusion Criteria:

* Allergy to lavender
* psychological disorders
* upper respiratory tract illness
The Value of 68Ga-FAPI PET/CT in Preoperative Evaluation of Thyroid Cancer with Lymph Node Metastases

This study aims to investigate the value of 68Ga-FAPI in the preoperative evaluation of thyroid cancer of different pathologic types.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before surgery. The imaging response measurements will be compared with the histopathological results as gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological and clinical diagnosis of thyroid cancer with lymph node metastases.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 16-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction.
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person.
Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg

Exclusion Criteria:

* patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC
Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery

Weaning from mechanical ventilation represents 50% of the time spent under mechanical ventilation (1). The risk factors identified in the failure to wean from mechanical ventilation are:

* left heart dysfunction with LVEF \< 30%.
* an ineffective cough
* presence of resuscitation neuromyopathy
* mechanical ventilation time \>7 days
* presence of a delirium
* age \>65 years old
* abundant bronchial secretion
* presence of underlying lung pathology An ineffective cough is found in 40% of patients requiring reintubation. However, cough assessment is most often approximate, based on a subjective assessment of cough strength by asking the patient to cough spontaneously on his or her tube).

The objective evaluation of cough is based on the measurement of the peak expiratory flow rate at cough, commonly referred to as peak expiratory flow rate at cough (PEFD), the patient is asked to take a deep breath and then cough as hard as possible.

Subjective cough assessment does not predict the occurrence of ventilatory withdrawal failure. Conversely, all studies that objectively assessed the strength of cough before extubation by measuring the PEFD found a significant association with the outcome of extubation: a low PEFD increases the risk of extubation failure by a factor of 5 to 9.

The investigators hypothesize that the increase in parietal abdominal muscle contraction obtained by using a non-invasive ultrasound method indicates an effective cough. Conversely, an ineffective cough can be detected by this simple ultrasound criterion, which can be performed at the patient's bedside and extrapolated to all intensive care units equipped with an ultrasound scanner. This evaluation will be carried out before extubation: during the spontaneous ventilation test on a tube in a half-seated position (\>45°) and within 24 hours after extubation.


Eligibility Criteria:
Inclusion Criteria:

* Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.

Exclusion Criteria:

* Pregnant patient
* Recent history of stroke(\<6 months )
* Minor patient
* Neurological disorder (Alzheimer's disease, delirium, confusion)
* Emphysemal patient