cyrilzakka/clinical-trials huggingface dataset:
Message 2: The Effect of Message Content and Clinical Outcome on Patient's Perception of Physician Compassion

The goal of this research study is to learn how patients view their doctor's compassion about supportive care and treatment options for advanced cancer patients.

If you agree to take part in this study, during an already scheduled office visit, you will complete the following:

* Basic information about you will be collected from your medical record (such as your date of birth, date of diagnosis, sex, and religion).
* You will complete 4 questionnaires about any symptoms you may be having, how hopeful you are in general, how you are dealing with the disease, your trust in the medical profession, and your strength of religious faith. It should take about 10 minutes total to complete all questionnaires.

You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Each group will watch a short video that shows actors playing a doctor and patient having a conversation about different cancer treatment options. Each video is about 4 minutes long and will discuss the same material, but the message shown in the videos will be different for each group.

After you watch the video, you will complete 3 questionnaires that will ask about your impression of the doctor in the video, how hopeful you think the doctor was, if you think the doctor was professional, and how you would rate the doctor overall. It should take about 8 minutes total to complete all questionnaires.

You will then read a small story about the patient in the video. Afterwards, you will complete the same 3 questionnaires that you filled out after you watched the video. You will also complete an additional questionnaire about your impression of the doctor's compassion and trustworthiness. This should take less than 10 minutes to complete.

Length of Study:

It should take about 25 minutes total to watch the video and to complete all questionnaires. Your active participation on this study will be over after you have completed the last questionnaire.

Other Information:

You are taking part in this study alone. Your family members will not be in the room with you. If you request, your family may be able remain in the room, but the investigators ask that they remain silent.

This is an investigational study.

Up to 128 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
2. Follow up patients seen in the outpatient Supportive Care Center.
3. Age \>/= 18 years-old
4. English speaking

Exclusion Criteria:

1. Altered cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
2. Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the Principal Investigator or by the attending palliative care physician.
Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe traumatic brain injury with less than 24 hours.

Exclusion Criteria:

* Primary decompressive craniectomy
* Brain death signs at admission
* Severe hemodynamic instability
Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.

OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.

PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.

Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.

Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events


Eligibility Criteria:
Inclusion Criteria:

* Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
* Informed consent signed by the mother or legal representative in his absence.

Exclusion Criteria:

* Fetal anomalies
* Severe hypertension
* Allergy to drug used in the test
* Amniotic fluid index ≥ 5 cm
* Contraindication for vaginal delivery
* Uterine abnormality and impaired coagulation
* Placenta previa
* Rh sensitization
* Multiple gestation
* Ruptured membranes
* Premature detachment of normally inserted placenta
* The mother greater weight to 85kg
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC

Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.


Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \&gt; 20%;
* IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
* At least one measurable lesion according to RECIST 1.1;
* Available core needle biopsy samples for PD-L1 status testing;
* ECOG 0 or 1 within 10 days prior to initiation of treatment;
* Not currently pregnant or breastfeeding, agree to strict contraception during treatment and at least 6 months after last dose;
* Intact hematologic, liver, renal and heart functions;
* Signed written informed consent.

Exclusion Criteria:

* Bilateral invasive breast cancer or Stage IV breast cancer;
* Severe heart disease;
* Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment;
* Had active autoimmune diseases requiring systemic therapy within the past 2 years;
* Severe systemic infections or other serious medical conditions;
* Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
* History of HIV infection;
* Active HBV or HCV infection;
* Known allergies or intolerance to the therapeutic drug or its excipients;
* History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors;
* Judged by the investigator to be unsuitable to participate in this study.
Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults

The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given twice daily for seven days in the treatment of adult patients with microbiologically confirmed uncomplicated urinary tract infection.

Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant women and men aged above 18 years old
* presence of ≥ 2 signs or symptoms suggestive of a UTI (dysuria, urinary frequency, urgency, suprapubic pain) with onset 10 days before enrollment
* asymptomatic patients with available positive urine culture
* pyuria defined as positive leucocyte esterase (LE) test with any color change after two minutes
* collection of clean-voided midstream urine sample for culture and susceptibility testing to confirm bacteriuria
* normal renal function (defined as blood creatinine \< 1.4 mg/100 ml)
* able to take oral medication on an outpatient basis
* written informed consent before enrollment

Exclusion Criteria:

* suspicion of complicated UTI (presence of fever above 38°C, flank pain, known urologic structural abnormality) or prostatitis
* negative urine dipslide results (uropathogen \< 100000 CFU (colony-forming units)/mL) or presence of nitrofurantoin resistant isolate uropathogens or mixed cultures of more than two isolates
* symptoms of UTI within the past 4 weeks
* evidence of predisposing factor to UTI (e.g. calculi, stricture, primary renal disease like polycystic renal diseases and neurogenic bladder)
* medical history of anaemia, complicated diabetes mellitus, peripheral neuropathy, vitamin B deficiency, renal insufficiency, other significant renal, hepatic or lung diseases
* medical history of glucose-6-phosphate dehydrogenase deficiency (G6PD)
* electrolytes disorders
* pregnant, breast-feeding women or not using medically accepted, effective method of birth control
* history of nitrofurantoin hypersensitivity
* use of systemic bacteriological agent within 48 hours before enrollment
Clinical Disease Activity With Long Term Natalizumab Treatment

The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.

Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of RRMS.
* Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
* ≥1 MRI scan of sufficient quality for reliable measurement.
* Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
* ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
* EDSS ≤ 6.5.

Key Exclusion Criteria:

* Anti-natalizumab antibody detection.
* Prior treatment with alemtuzumab.
* Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia

Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.

Clinical evaluation tools will be performed before and after the treatment for all patients

* K-Western Aphasia Battery for aphasia assessment tools
* Cerebral blood flow changes with near-infrared spectroscopy

During the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. In addition, the K-Western Aphasia Battery for aphasia assessment tools(K-WAB) and Cerebral blood flow changes with near-infrared spectroscopy will be performed. All participants will be assigned to a test group or control group. In addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment.

After treatment is completed, the K-WAB test and near-infrared spectroscopy will be performed again.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 19 years old
* Those with speech disorders that occurred after a stroke was diagnosed
* Those who can follow the clinical study procedures
* Those who voluntarily signed the consent form

Exclusion Criteria:

* Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline
Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer

The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).

* Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
* Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
* After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented prostate cancer
* Planned radical prostatectomy
* \> 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
* Older than 18 years of age

Exclusion Criteria:

* Inability to lay on a scanner for 60 minutes
TB Immunotherapy Trial With Heat-killed M. Vaccae

The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.

Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of TB
* sputum smear positive

Exclusion Criteria:

* pregnant
* likely to be non-compliant due to drug and/or alcohol abuse
* mentally unfit to comply with treatment
Nursing Education Intervention for Maternal Breastfeeding

An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications.

A randomized controlled clinical trial of an educational intervention was undertaken at a public hospital. the investigators compared a health education based on techniques to prevent complications and increase information about the benefits of breastfeeding with the usual practice. A group of nurses delivered the educational intervention. The trial involved randomization of 314 primiparous women. The analysis was by 'intention-to-treat'.

Eligibility Criteria:
Inclusion Criteria:

* primiparous women,
* no contraindications to breastfeeding,
* no skin disorders,
* no breast surgery,
* voluntary provision of data to enable their later localization.

Exclusion Criteria:

* women who planned to deliver their babies in other hospitals,
* twin pregnancy
Procoagulant Activity in Patients With Community Acquired Pneumonia, Pleural Effusion and Empyema

Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis.

The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.

Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. (2) The increased vascular permeability, mediated by several cytokines, such as IL-1, IL-6, IL-8, tumor necrosis factor (TNF), and platelet activator factor, allows migration of inflammatory cells, an increased fluid accumulation and bacterial invasion into pleural space. (3) At this stage, activation of the coagulation cascade leads to procoagulant activity and decreased fibrinolysis with deposition of fibrin in the pleural space. The activation of the fibrinolytic system produce the D-dimer and follow by increased other procoagulant markers like thrombin anti thrombin, fragment 1.2 (4-5) Several studies showed that the plasma D-dimer levels were increased even in community-acquired pneumonia patients. Moreover, others reported that Serum levels of AT-III, D-D and CRP at admission appear to be useful biomarkers for assessing the severity of CAP. However, no data exists about the fibrinolytic profile in patients with CAP alone in compare to CAP with parapneumonic effusion with and without empyema.

Aim:

To study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.

Eligibility Criteria:
Inclusion Criteria:

* All patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study.

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with anticoagulant treatment, primary coagulopathy, nephrotic syndrome, surgery, other infection in the month preceding the study, an abnormal liver or renal function test(s), a history of deep vein thrombosis in the last year or patients with acute coronary syndrome.
Sirolimus DEB in Coronary Bifurcation Lesions

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.

This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.

This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants with would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female that ages 18-85 year old;
2. Having evidence of myocardial ischemia;
3. Voluntarily participates in this study and signs the informed consent form (ICF);
4. Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;
5. Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
6. Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;
7. Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
8. The target vessel diameter was 2.0mm-4.0mm.

Exclusion Criteria:

1. Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
2. Cardiogenic shock patients;
3. With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;
4. ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
5. With severe congestive heart failure or NYHA class Ⅳ heart failure;
6. With severe valvuar heart disease;
7. Heart transplant patients;
8. With renal insufficiency (creatinine \> 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
9. With a life expectancy less than 1 year;
10. With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;
11. With known allergies to paclitaxel, sirolimus, contrast agents, etc.;
12. Participating in clinical trials of other drugs or devices and has not met the primary endpoint;
13. Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;
14. Intra-stent restenosis;
15. High-risk left main disease;
16. Other patients considered by the investigator to be unsuitable for inclusion.