cyrilzakka/clinical-trials huggingface dataset:
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Primary outcomes:

* the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy

  - compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
* the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia

  * does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR)
  * the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?

Secondary outcomes:

* sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard)
* the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (\< 3 cm and \> 3cm)

Eligibility Criteria:
Inclusion Criteria:

* outpatients with \> 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

Exclusion Criteria:

* Allergy or prior reaction to the fluorescent contrast agent proflavine
* Patients who are unable to give informed consent.
* Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion \> 2 cm in size not amenable to EMR
* Patients with a history of a severe allergic reaction (anaphylaxis)
* Patients unable to undergo routine endoscopy with biopsy :
* Women who are pregnant or breastfeeding
* Prothrombin Time \> 50% of control; PTT \> 50 sec, or INR \> 2.0)
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
* Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
* Patients with known severe esophagitis
* Patients with suspected but no biopsy confirmed BE
NearWave Optical Molecular Monitoring

The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study.

Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Patients who:

   1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
   2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
   3. are planned to receive neoadjuvant chemotherapy followed by surgery
   4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
   5. Have a palpable breast mass as determined by a treating physician

Exclusion Criteria:

1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
2. Inflammatory breast cancer
3. Prior breast cancer requiring surgery or radiation in either breast
4. Pregnant or nursing due to changes in breast architecture
5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\<3 cm from the skin surface), based on diagnostic scan measurements
6. Patients with any tattoos on their breasts
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.


Eligibility Criteria:
Inclusion Criteria:

* Children must be healthy and have a birth weight \> 2000 g to participate

Exclusion Criteria:

* confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
* Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
* Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
* Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination.
* Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
* New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: a Randomized Double -Blind Controlled Study

Laparoscopic cholecystectomy (LC) is one of the commonly performed surgical procedures associated with a moderate degree of postoperative pain especially on the 1st postoperative day. Adequate postoperative analgesia allows early patient ambulation, decreases analgesic requirements, and hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative analgesia is needed.

the aim of the study is To compare the analgesic effect of magnesium sulfate combined with bupivacaine versus bupivacaine combined dexmedetomidine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.

Transversus abdominis plane (TAP) block is a recent analgesic technique with efficacy in perioperative pain therapy for LC. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1. There weren't enough studies in the literature evaluating the OSCTAP block for pain management after LC.

Rafi et al and McDonnell et al were first to describe this novel abdominal field block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.

The OSCTAB block provides more effective analgesia than other TAP blocks. Numerous regional anesthetic adjuvants.

such as dexmedetomidine, clonidine, epinephrine, dexamethasone, and magnesium sulphate (MgSO4) are usually combined with enhancement of analgesic efficacy.

Recently, these adjuvants added to LA solution for prolonging the effect of TAP block with promising results.

Eligibility Criteria:
Inclusion Criteria:

* • Patients programmed for elective LC.

  * American society of anesthesiologists (ASA) physical state I or II.
  * Age over 18 years and less than 60 years old.
  * Patients of both sex are included in the study.

Exclusion Criteria:

* •Patient refusal

  * Known hypersensitivity to the study drugs.
  * Body Mass Index \> 40 kg/m2.
  * Inability to accurately describe postoperative pain to investigators.
  * Opioid tolerance or dependence.
  * Preexisting history of chronic pain.
  * History of renal, liver, cardiac, neuropsychiatric disorder problems.
  * Bleeding or coagulation abnormality.
EPICS-8: Reasons for Emergency Department Utilization by Patients With Non-urgent Conditions

EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:

Emergency Departments (EDs) are an important interface between primary and secondary health care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be investigated in this project.

EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:

Emergency Departments (EDs) are an important interface between primary and the secondary health care system in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be explored in this project.

EPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with data of the primary health care sector. Data linkage will be conducted for patients with the Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8 study is to develop a valid questionnaire for the assessment of reasons for ED utilization by non-urgent patients.

Primary objective:

Establishing of a research structure for the linkage of inhospital-data with data from the primary health care System. Records of 5,000 patients who attended one of the two EDs at the Charité University Medicine Berlin will be linked to Primary health care data.

Secondary objectives:

1. Development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100)
2. Characterization and quantification of non-urgent emergencies
3. Explorative analysis of patient pathways and influencing factors for ED-visits with non-urgent conditions.

Eligibility Criteria:
Eligibility criteria for record linkage:

* Age\>= 18 years
* Outpatients
* MTS-Triage category blue, green or yellow
* Treatment in one of the two participating EDs

Eligibility criteria for questionnaire pretest:

Inclusion Criteria:

* Age\>= 18 years
* Outpatients
* MTS-Triage category blue, green or yellow
* Treatment in one of the two participating EDs
* Eligibility to understand the study purposes and give written informed consent

Exclusion Criteria:

* Dementia
* no sufficient German language skills
* patients with legal representatives
Accuracy of Pulse Oximeters With Profound Hypoxia

This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).

After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions

To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 and older
* Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes

Exclusion Criteria:

* Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
* Patients unwilling or unable to provide informed consent.
Prevalence and Characteristics of Pulmonary Embolism on COVID-19 Patients Presenting Respiratory Symptoms

Multicentric case-control study that is aims at:

* evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP)
* and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

In December 2019, China reported the first cluster of severe acute respiratory syndrome due to a new coronavirus (SARS-CoV-2). The disease rapidly spread into a global pandemic of public health emergency worldwide leading to more than 330.000 deaths (data from May 25th, 2020). We have, to date, no demonstration on the efficacy of any drug to cure or prevent severe evolution of the disease (COVID-19). The primary target of SARS-CoV-2 is the lung with frequent occurrence of acute respiratory distress syndrome (ARDS) justifying supportive care, including invasive mechanical ventilation (IMV). The characteristics of ARDS in COVID-19 patients appeared atypical due to the dissociation between initial well-conserved lung compliance and severe hypoxemia, attributed to pulmonary vasoregulation disruption and local thrombogenesis. Strikingly high D-dimers levels, caused by both inflammation storm and coagulation activation, have been early reported in COVID-19 patients and have been associated with increased mortality. A single observational study suggests that anticoagulation is associated with a decreased mortality in severe COVID-19 patients. These reports have led to several therapeutic propositions in terms of anticoagulant therapy from worldwide scientific societies (Khider et al JMV 2020). Publications recently reported thrombotic complications in series of severe COVID-19 patients admitted in ICU, but the frequency of pulmonary embolism (PE) in larger cohort of COVID-19 patients of any severity remains uncertain.

This cohort enrolled patients in whom PE is proven by CTPA and compared them into two subgroups of controls matched for age and sex in whom PE was either excluded or non suspected:

1. COVID-19 patients with a negative CTPA and
2. COVID-19 patients in whom only an unhenced CT was performed.

Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years,
* admitted for acute COVID-19 pneumonia and have recieved a chest CT scan during hospitalization,
* COVID-19 diagnosis confirmed by a positive result of a RT-PCR,
* CT findings of COVID-19 pneumonia.

Exclusion Criteria:

* Respiratory distress syndrome explained by other cause
* Patients who refuse to participate to the study.
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients

This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol. The patients are required to be hospitalised for the treatment and assessment defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis. The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit. At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for study participation, signed by the patient's legal guardian.
* Both at screening and at randomization (Day 1), had a YMRS total score of at least 20.

Exclusion Criteria:

* Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
* Known or suspected hypersensitivity to quetiapine or lithium.
Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)

This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

LMVOS is a prospective, real-world registry lasting for 22 years. A total of 8000 patients with large- or medium-vessel occlusion will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018).

Informed consent from the patient or surrogate.

Exclusion Criteria:

No additional exclusion criteria.
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.

Obtaining Tumor tissue or cytology samples are not always available in some patients with lung cancer. Recently, studies showed that circulating tumor DNA can be used as a suitable substitute for mutation analysis. The sensitivity of EGFR mutation tests using circulating tumor DNA was reported in the range of 65.7% (10) to 75% (11), with high specificity and positive predictive value. In this trial, treatment efficacy of afatinib will be assessed in patients with NSCLC harboring EGFR mutations which were detected from circulating tumor DNA.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis
2. Age\> 18 year-old
3. ECOG performance status 0\~2.
4. Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating DNA
5. Any one of the following criteria should be met

   * Unavailable or failed pathologic/cytologic diagnosis
   * Wild type or failed EGFR testing based on tumor tissue
   * No more tumor sample available for EGFR test
6. Measurable lesion by RECIST v1.1
7. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.
8. Male patients should be willing to use barrier contraception.
9. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
10. Adequate organ function, defined as all of the following:

    * Absolute neutrophil count (ANC) \>=1500/mm3
    * Platelet count \>= 75,000 /mm3
    * Serum creatinine \< 1.4 mg/dL
    * AST or ALT \< three times the upper limit of normal

Exclusion Criteria:

1. Prior exposure to EGFR-TKI. Prior chemotherapy will be permitted.
2. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
3. Severe or unstable medical conditions such as history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation.
4. Known pre-existing interstitial lung disease
5. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
6. Active hepatitis B infection (defined as presence of HepB sAg and Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.