cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients

Lung cancer is one of the most deadly types of cancer and the leading cause of death in cancer in Sweden. Five year survival is 10% in men and 15% in women. Approximately 3300 individuals in Sweden are diagnosed each year and the incidence of adenocarcinoma is increasing. Lung cancer patients are to a great extent currently being diagnosed by exfoliative cytology. However, new drugs leading to more personalized treatments will demand more specific classification of tumour types. Today EGFR mutation status is becoming an important factor when deciding treatment strategy for patients with Non-Small Cell Lung cancer.

Sufficient tumour material must be available if EGFR mutation status is to be tested. Core needle biopsy is one way to obtain the quantity of material needed when testing mutation status. The portion of patients having core needle biopsies is believed to vary greatly between hospitals in Sweden, a difference from 20% to 70 % have been assumed, but is not yet confirmed in studies. This study will investigate the current situation and procedures when patients are diagnosed with lung cancer. The results can be used to describe any possible adverse events connected to the procedure and possibly contribute to development of a better decision tool to be used when deciding if a core needle biopsy is to be performed or not.

More and more therapeutical targets having similar problems are likely to be developed in the future. An investigation of current quality and procedures when diagnosing lung cancer by biopsies will facilitate future diagnosing of lung cancer and ensure that personalized treatments can be offered to patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis code C34 (ICD-10).
* Inoperable lung cancer.
* Diagnosis of lung cancer made between 2010-05-31 and 2009-06-01.

Exclusion Criteria:

* Diagnosis code C34.9b.
* Diagnosis code C34.9h.
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-40 years of age between 24-35 weeks gestation
* Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts \> 50 cells/µL

Exclusion Criteria:

* Women who had CD4+ count ≤ 50 cells/µL
* Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
Detection of Neonatal Bradycardia

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test in clinical units and in real life a new method set for early detection of bradycardia in preterm infants.

Each preterm infant cardio-respiratory traces will be recorded during two 4-hours periods of time (the first one at the time of occurrence of apnea-bradycardias and the second one during the following week). During those periods, the alarms of the monitors usually used in the units will also be recorded through automatic detection and these alarms will be compared with the alarms generated by the algorithm tested, for false positive and precocity of the detection. A false positive alarm is a detection which is not associated with a bradycardia of less than 80 bpm. The system will be considered efficient if it allows an earlier detection of severe bradycardias without increasing the number of false positive detection.

Eligibility Criteria:
Inclusion Criteria:

* Parents informed consent
* Presenting with at least 2 significant apnea bradycardia (apnea + decrease in heart rate of more than 33% during at least 4 sec)

Exclusion Criteria:

* Postnatal age of less than 4 days
* Mechanical ventilation
* Severe neurological lesion
Educational Interventions for Surgeons During COVID-19 Pandemic: Cross-sectional, E-survey

The coronavirus disease 2019 (COVID-19) pandemic required a rapid surge of healthcare capacity to face a growing number of critically ill patients. For this reason, a support reserve of physicians, including surgeons, were required to be reassigned to offer support. Given the time shortage for trainers and trainees, time and cost-efficient programs to gain maximal benefit from short rotations for several physicians at one time are required 8. In case of pandemics, blending face-to-face education to e-learning seems sustainable, with online resources being scalable and more cost effective than other methods 9.

The aim of this study was to realize a survey on the educational programs (hospital based or web-based), during the COVID-19 pandemic, and their impact on behavior change, satisfaction and knowledge of the target population of surgeons.

Eligibility Criteria:
Inclusion Criteria:

* residents, fellows, consultants and physicians of any grade and affiliated to any surgical specialty

Exclusion Criteria:

* Mecical speciality
Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* TTR cardiac amyloidosis;
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test, cannot be breast feeding, and must be willing to use 2 highly effective methods of contraception;
* Male subjects agree to use appropriate contraception;
* Adequate blood counts, liver, renal and heart function;
* Adequate Karnofsky performance status;
* Adequate New York Heart Association (NYHA) Classification Score;
* Clinically stable on heart medications;
* Adequate 6-minute walk test;
* Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria:

* Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
* Subjects with a history of multiple drug allergies or intolerance to SC injection;
* Received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study;
* Uncontrolled hypertension, ischemic heart disease or cardiac arrhythmia;
* Untreated hypo- or hyperthyroidism;
* Prior major organ transplant;
* Considered unfit for the study by the Principal Investigator.
Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.

This study evaluates de efficacy of Theta Burst Transcranial Magnetic Stimulation (TMS) applied on the left dorsolateral prefrontal cortex in patients with Major Depressive disorder and tobacco consumption.

Major Depressive Disorder (MDD) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. Theta Burst Stimulation (TBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols.

Eligibility Criteria:
Inclusion Criteria:

* With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter.

Exclusion Criteria:

* History of head trauma with loss of consciousness, with intracranial metallic objects or metallic plates in the skull, patients with structured suicidal ideation or recent attempts, who suffer from uncontrolled chronic diseases at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases), patients with psychotic symptoms. subjects with alterations in electroencephalogram (epileptiform activity), patients with any type of uncontrolled chronic medical or neurological disease, pregnant women.
Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)

This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet.

Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.

It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid diet. However, tolerance is better with low fiber diet. There is no current evidence whether the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing quality.

This is the first controlled, randomized trial to compare bowel cleansing by using two different protocols: one day low fiber diet versus three day low fiber diet.

A researcher will offer to participate in the study to scheduled for outpatient colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. Thus, according to the allocation group, participants must comply with a low fiber diet the previous day of the examination or 3 days prior to the examination. In both cases, patients will take a liquid diet the night before.

Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with ascorbic acid 5 hours before the appointment for colonoscopy.

Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.

The hypothesis of the study is that in non-selected population, a 3-day low fiber diet before colonoscopy is superior to 1-day low fiber diet in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).

For the present study, a 10% improvement in the quality of colonic cleaning was hypothesized in the group of patients receiving 3 day low fiber diet regimen. Taking into account a power of 80%, alpha error of 5% and losses of 15% will require 202 patients per group.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Patients with previous colon surgery
* Last colonoscopy with poor bowel preparation
* Ileus, intestinal obstruction, megacolon
* Poorly controlled hypertension (HTAS\> 180 HTAD\> 100)
* Terminal renal failure (pre-dialysis or dialysis)
* Congestive heart failure (NYHA III-IV)
* Acute liver failure
* Severe psychiatric illness
* Dementia with difficulty in the intake of the preparation
* Pregnancy or breastfeeding
* Phenylketonuria
* Deficiency of glucose-6-phosphate dehydrogenase
* Refusal to participate in the study
* Inability to follow the instructions
Patient Preferences in Empathetic Communication by AI vs Human Authorship

This study aims to evaluate whether patients have different preference patterns for empathetic communication through AI vs human-being when knowledge of authorship is known vs blinded.

Hypothesis:

Patients will express increased preference for human-generated empathetic communication vs AI-generated empathetic communication when they are made aware of authorship vs when blinded to it.

Aims, purpose, or objectives:

Evaluate if patients have different preference patterns for empathetic communication through AI vs human-being when knowledge of authorship is known vs blinded

Background:

Artificial intelligence (AI) is rapidly gaining a foothold in the healthcare industry. AI's role in healthcare can largely be divided into two sets of tasks: Those which involve direct interaction with patients and those which do not. Many tasks which do not directly interact with patients, such as monitoring and resupplying medications, delivering goods across a hospital, and analyzing practice trends and outcomes are highly likely to benefit from the efficiency, cost-savings, and consistency AI can provide. Tasks involving direct patient interaction are considerably more controversial. Understanding of how patients will respond to AI communication remains quite limited which is concerning considering the rapid expansion of AI into the healthcare space. A logical first step to investigate is to see if patients react to AI communication when they are blinded to it vs when authorship is known. This concept has previously been tested in other industries such as business and the law, but patient communication preference in healthcare has been little studied, especially in palliative care. It is the aim of this study to investigate this.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 being seen in palliative care clinic who have already established care and with diagnosis of any malignancy

Exclusion Criteria:

* Inability to consent defined as: Acute mental status changes (delirium/encephalopathy), acute substance intoxication, intellectual disability, dementia, patient with active legal guardian
* Major psychiatric disorders including, but not limited to, bipolar disorder, psychotic disorders, active substance use disorder, and patients with active suicidal or homicidal thoughts.

  * NOTE: Patients with history of normal grieving reactions, major unipolar depressive disorder, posttraumatic stress disorder or generalized anxiety disorder would NOT be excluded.
* Inability to read in English
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

Maternal Criteria:

* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study
* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)
* Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose
* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning

Infant Criteria:

* Gestational age at delivery ≥35 weeks
* Birthweight \> 10th percentile
* Weight \> 10th percentile as reported by the mother at the time of enrollment

Exclusion Criteria:

Maternal Criteria:

* Any active infection or other condition that would prevent the individual from breastfeeding
* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
* History of mastectomy
* Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts
* Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones

Infant Criteria:

- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers

This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
* Participants with no ocular symptoms

Exclusion Criteria:

* History of ocular trauma, infection, or inflammation within the last 3 months
* Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation
* IOP \<10 mmHg or \>21 mmHg
Intra-arterial Magnesium Administration for Acute Stroke

Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to "at risk" tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique


Eligibility Criteria:
Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,
2. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
3. Age 21-95.

Exclusion Criteria:

1. Severe renal impairment with creatinine 3.0 or higher,
2. Myasthenia gravis,
3. Second or third degree heart block without a pacemaker in place,
4. Technical inability to navigate microcatheter to target clot,
5. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
Treatment of Acute Myeloblastic Leukemia in Younger Patients

study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.

The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age\< or =65 years.
* ECOG\<=3.
* AML of new diagnose.
* Consent for chemotherapy.
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
* BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
* Age greater than 75 years
* Family (maternal) history of fragility fracture
* Previous fragility fracture (self) after age 45
* Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.

Exclusion Criteria:

* Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency \[ less than 20 ng/mL\], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
* Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
* Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.