cyrilzakka/clinical-trials huggingface dataset:
Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer

Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.

Objectives of the study:

Primary objective

1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy.

Secondary objectives

1. Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.

Number of patients:

N = 300

Population:

Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.

Study duration:

From February 2009 to February 2012 - 3 years


Eligibility Criteria:
Conditions for patient eligibility

Inclusion criteria:

* Patients must be female.
* Patients must be 18 years of age or older.
* Patients with stage IIA, IIB, IIIA (T1-3 and N1-2) breast cancer. Clinical N0 accepted if biopsy proven node disease.
* Patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
* Patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
* Patients with bilateral breast cancer are eligible. Sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
* Patients that understand, accept and have signed the approved consent form.

Exclusion Criteria:

* Patients with inflammatory breast cancer.
* Patient with stage IIIB, IIIC or IV breast cancer (T4 and N3) Patients with clinical N3 disease are excluded.
* Patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
* Patients that have had previous radiotherapy to the axillary nodes
* Patients that have had mammary reduction
* Patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
* If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, Patent blue or methylene blue or radiocolloid dye are ineligible.
* Patients who are pregnant or breast feeding .
* Psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.
ICBTG in Routine Care

Problem gambling (PG) is a major public health concern worldwide. As awareness of PG has risen, treatment demand is increasing, and internet interventions is a promising alternative for providing fast, evidence-based treatment at scale, to a low cost. This article presents the protocol of an open label, uncontrolled pilot and feasibility trial of a novel internet-delivered cognitive behavioral treatment, conducted in regular addiction care with adult treatment-seeking patients (max N=25) with problematic gambling. Weekly measures of gambling symptoms and gambling will serve as outcome measures. Study results will further guide the development of the intervention and its implementation into regular addiction care.


Eligibility Criteria:
Inclusion criteria:

* being at least 18 years old
* living in Sweden
* being able to read and write Swedish.
* having a total score of \>= 3 on the Problem Gambling Severity Index (PGSI; Ferris \& Wynne, 2001)
* having the ability to work with online treatment material by themselves (with support from a therapist)

Exclusion criteria:

* fulfilling criteria for ongoing manic episode
* currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.
The Link Between Human Cytomegalovirus (HCMV) and Hypertension

It has been reported that mouse cytomegalovirus infection alone can elevate the blood pressure in mice. Since HCMV has uniquely evolved with its human host, with little genetic similarity to the animal CMV counterparts, and it only replicates in human, an epidemiological study is required to define the relevance of HCMV infection and expression of hcmv-miRNA-UL112 to the pathogenesis of essential hypertension.

The investigators found that hcmv-miR-UL112, a human cytomegalovirus (HCMV)-encoded miRNA, was highly expressed in the hypertensive patients. Among the top miRNA target predictions, the investigators demonstrate that IRF-1 is a direct target gene of hcmv-miR-UL112, along with MICB that has been previously reported. Both IRF-1 and MICB play critical roles in immuno/inflammatory and anti-infection response. Thus, the investigators speculated that IRF-1 and MICB repression by hcmv-miR-UL112 could be considered a unifying mechanism that evades the host response at several levels: antiviral, inflammatory, and immune. In addition, there is an increasing evidence that IRF-1 may be important in apoptosis, angiogenesis, neointima formation and the pathogenesis of vascular diseases. IRF-1 can up-regulate angiotensin II type 2 receptor (AGTR2) that exerts antiproliferative and proapoptotic actions and affects regulation of blood pressure. It has been reported that the targeted disruption of the mouse AGTR2 gene resulted in a significant increase in blood pressure and increased sensitivity to angiotensin II. The nitric oxide synthase expression and NO synthesis in macrophages and distinct cardiomyocytes are induced and controlled by IRF-1 in response to inflammation, important steps in vascular biology that may improve endothelial function and inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension. Collectively, these reports support a strong relationship between IRF-1 regulation and hypertension, indicating a potential role of hcmv-miR-UL112 and HCMV infection in the pathogenesis of hypertension.Thus, the investigators want to investigate the potential link between HCMV infection and essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension are assessed for potential secondary causes, for the severity of hypertension, other risk factors and for end-organ damage
* Aged between 30 to 60 years
* Untreated (whole day average \> 140/90 mmHg) or treated hypertension whole-day average \< 140/85), as determined by 24-hour blood pressure monitoring.

Exclusion Criteria:

* Cancer
* Diabetes
* Smoking
* Renal failure
* Stroke
* Peripheral artery disease
Endothelial Function in Human Arteries

Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with L-arginine to assess changes in endothelial function.

We will assess doses of regional L-arginine supplementation in patients undergoing elective angiography for lower extremity PAD. Assessment of EDR and EIR with IVUS in patent arteries will be performed with one of 3 doses of catheter-directed L-arginine. We will obtain plasma samples from the peripheral arteries and assay amino acid levels and protein oxidation products using mass spectrometry. These experiments will determine the optimal L-arginine supplementation dose to be used in further studies. We expect to show that L-arginine supplementation will have a more significant effect on vessels less affected by atherosclerosis, but that this effect diminishes with greater atheroma accumulation as measured by IVUS virtual histology. Also, we expect L-arginine supplementation to be most effective in vessels with low baseline L-arginine levels. Lastly, we will compare local arterial factors obtained via catheter-directed arterial sampling (NOx, L-arginine, nitrotyrosine levels) to traditional serum risk factors (glucose, HbA1c, LDL, homocysteine and hs C-reactive protein).

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* symptoms of intermittent claudication, rest pain or minor tissue loss (Rutherford Category I-V)
* ABI of \<.90
* angiographic demonstration of a 100mm patent segment of superficial femoral artery containing at least one distal runoff vessel

Exclusion Criteria:

* acute limb ischemia,
* contraindication to angiography (creatinine \>2.5)
* concurrent oral anticoagulant therapy that cannot be safely withheld
* extensive tissue loss or gangrene
A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia

Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with community-acquired pneumonia
2. Inpatients from 2017 to 2019
3. Regardless of age and gender

Exclusion Criteria:

1. Patients diagnosed with hospital-acquired pneumonia
2. Patients who take two or more oral mucolytics
3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs
Aftercare in the Community Health Center

This is a trial to examine the effects of aftercare for mental health patients in community health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two groups: intervention group (community health center, primary care) or control group (Community mental health centers of District Psychiatric Service, specialist care).

The project's primary objective is to investigate the effect of community services on patients' functional capacity and user satisfaction after discharge. Secondly, the number of treatment days and readmissions to mental health care will be examined. The project will also compare costs of hospitalization, in psychiatric hospital and community health center respectively. Data will be collected from community health records, medical records and patient systems in psychiatric hospital, community mental health centers of District Psychiatric Service (DPS) and questionnaires filled out by patients.


Eligibility Criteria:
Inclusion Criteria:

* considered by the responsible manager to have given consent
* hospitalized, diagnosed and treated such as can be continued in a District Psychiatric Service or a health center.
* stable condition, but anxiety and disruptive behavior may occur to a lesser extent.
* considered to have a perceived need for complex services from specialist health and community for a long time after discharge.

Exclusion Criteria:

* not in a stable phase thus shielding required
Smoking Reduction or Cessation With Nicotine Replacement Therapy

The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.

To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Smoking \>/= 15 cigarettes/day
* Having smoked for 3 years or more
* CO \>/= 10ppm at inclusion
* Want to reduce smoking
* Prepared to adhere to the protocol
* Willing to provide signed informed consent
* Having made at least one serious attempt to quit smoking

Exclusion Criteria:

* Unstable angina pectoris, myocardial infarction within the last three months
* Use of other nicotine-containing products such as cigars, pipes, snuff
* Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
* Pregnancy/lactation or intended pregnancy
* Under psychiatric care or medication that might interfere with the trial
* Abuse of alcohol or any other drug
Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series

The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* VAS pain level ≥6
* Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)

Exclusion Criteria:

* Age \<18 years
* Local or systemic neurological disease
* Rheumatological disease
* Malignant disease
* Previous spinal surgery or spinal disease
* Coagulopathies
* Pregnancy
* VAS pain level \<6
* Recent (≤6 weeks) trauma to the coccyx
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?

Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited.

Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus.

Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.


Eligibility Criteria:
Inclusion Criteria:

* All women referred to elective outpatient cystoscopy.

Exclusion Criteria:

* Known urethral stricture.
* Known allergy to lubricant/anesthesia gel.
* Patients under the age of 18 (minors).
* Patients with current Urinary Tract Infections.
* Chronic pelvic pain (e.g Interstitial Cystitis/Bladder Pain Syndrome.
* Known neurlogical or other chronic pain syndrome requiring chronic analgesia medication.
* Mentally incapable for consensual agreement of participation.
Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes

Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)

We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.

The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women in Xiamen who registry in our database.

Exclusion Criteria:

* Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.
Evaluation of ST2 and IL-33 in Patients Presenting to the Emergency Department With Trouble Breathing

Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs), congestive heart failure (fluid build-up in the lungs because the heart is not pumping normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in your blood that physicians use to diagnose different diseases and to determine what the course of an illness will be. In preliminary research studies, ST2 and IL-33 have been elevated in patients with a wide variety of diseases where the lungs are the primary organs involved. This research study will further investigate the ability of ST2 and IL-33 to predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of various lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours
* Normal cardiac output as measured by noninvasive bioimpedance
* Greater than or equal to 18 years of age
* Patient or legal representative willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

* ECG changes diagnostic of acute myocardial ischemia/infarction
* Ischemic chest pain within the prior 24 hours by history
* Obvious chest trauma

Exclusion Criteria for Blood Draw:

* A history of congestive heart failure and a BNP \> 500pg/mL (or NTproBNP \> 900pg/mL) if obtained by the treating physician
* Treating physician suspects patient has new onset congestive heart failure
The Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia

The main purpose of this research study is to determine if exercise improve or worsen cachexia.

In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise may impact this process. The investigator would like to see whether a progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how exercise may affect different markers in the blood over time.

Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnosis of colorectal, esophageal, gastric, pancreatic or biliary tract cancer and plans to initiate systemic chemotherapy within the next 4 weeks after enrollment.
* Have been diagnosed as having an advanced unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
* Have an ECOG performance score of 0 or 1.
* Have a life expectancy of \>3 months as determined by their primary oncologist.
* Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. Patients who have 2 - 4.9% weight loss should also have one of the following metabolic changes: a hemoglobin level \<13, an albumin level \<3.5, and/or impaired glucose tolerance within the past year such as a new diagnosis of diabetes, an A1C level \>5.7, a random glucose level \>200 or a fasting glucose level \>100.
* Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
* Be able to read English (since the assessment materials are in printed format).
* Be able to give written informed consent.

Exclusion Criteria:

* Have any of the following limitations: unable to walk the 4 meters of the SPPB test, wheel-chair bound, unable to perform low-to-moderate intensity exercise regimen (patients unable to perform 6 minute walk or stair climb test will be allowed to participate, but will be held out of these measurements).
* Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
* Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
* Be enrolled on hospice at time of consent.
* Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (40).
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).

Eligibility Criteria:
Main Inclusion Criteria:

1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
2. Age 18 years or older
3. Body weight ≥ 35 kg
4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
5. Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study
6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
7. Life expectancy ≥ 12 weeks
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1

Main Exclusion Criteria:

1. Mixed small cell and non-small cell lung cancer histology
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
5. Subjects with a history of venous thrombosis within the past 3 months
6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
7. Congestive heart failure
8. Active or prior documented autoimmune or inflammatory disorders
9. History of active primary immunodeficiency
10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
11. History of allogenic organ transplantation
12. QTcF interval ≥ 470 ms
13. History of another primary malignancy
14. Concurrent enrollment in another clinical study \[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\]
15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Cpap at Delivery Room for Preterm Infants

The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.

A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs

Eligibility Criteria:
Inclusion Criteria:Inborn.

* Birth weight 1000g to 1500g
* No major malformations

Exclusion Criteria:

* Necessity of intubation
* Maternal decision