cyrilzakka/clinical-trials huggingface dataset:
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy

Combined treatment of soft tissue sarcoma includes 3 steps:

1. step - preoperative stereotactic radiation therapy in hypofractionation mode
2. step - operation
3. step - postoperative conformal radiation therapy in normofractionation mode

Combined treatment of soft tissue sarcoma includes 3 steps:

1. At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.

   At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.

   GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
2. Second step is surgery in 14-21 days.
3. In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.

PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.

Eligibility Criteria:
Inclusion Criteria:

* morphologically verified diagnosis of soft tissue sarcoma
* first diagnosed tumor process
* ability to perform radical surgery
* signed informed consent
* indications for stereotactic and conformal radiation therapy
* no contraindications for radiation and surgical treatment

Exclusion Criteria:

* previous radiation treatment
* acute infection
* pregnancy, lactation
* recurrent tumor
* refuse to sign informed consent
* conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)
* tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice

The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice.

In addition, this study will describe patient demographics and reason for switching


Eligibility Criteria:
Inclusion Criteria:

- Female and male adult patients diagnosed with PAH or inoperable/recurrent/persistent CTEPH who have been switched from a PH treatment (i.e. Endothelin Receptor Antagonist(ERAs), Phosphodiesterase-5 inhibitor(PDE5i) or Prostacyclin Analog (PCA) to Adempas

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients who have not switched their therapy from an Endothelin Receptor Antagonist (ERA) or Prostacyclin Analog (PCA) but received Adempas purely as an add-on therapy
Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a completed randomized clinical trial in 25,875 U.S. men and women which investigated whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduced the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Observational follow-up of participants is currently ongoing. The current study is being conducted among participants in VITAL who experience a stroke event during follow-up and will examine whether vitamin D or omega-3 fatty acid supplementation impact post-stroke outcomes.

Stroke is a leading cause of disability and death worldwide and is expected to become an even more prevalent cause of disability in the future as the population ages. Understanding risk factors which may prospectively influence stroke outcomes may help to reduce the morbidity burden of stroke.

The VITamin D and OmegA-3 TriaL (VITAL) examined the impact of vitamin D3 (2,000 IU/day cholecalciferol) and omega-3 fatty acids (840 mg eicosapentaenoic acid \[EPA\] + docosahexaenoic acid \[DHA\]) on stroke incidence. However, the parent trial did not examine the impact of these supplements on stroke outcomes. Even if they do not significantly reduce stroke incidence, these supplements may still reduce stroke severity and improve outcomes post-stroke. Given the high morbidity burden of stroke, the impact of these supplements on stroke outcomes is of substantial scientific and public health importance.

The first aim of this study is to test whether vitamin D3 or omega-3 fatty acid supplementation reduces the risk of poor functional outcomes as measured at hospital discharge and 6- and 12-months post-stroke. The second aim is to determine whether chronic cerebrovascular changes (white matter hyperintensity volume and cerebral microbleeds) mediate the effect of vitamin D3 or omega-3 fatty acid supplementation on stroke outcomes.

Individuals enrolled in VITAL who experience a non-fatal stroke event will be mailed additional questionnaires assessing functional limitations, physical disability, and social disability. Responses from these questionnaires will be used to determine the effect of vitamin D3 or omega-3 fatty acid supplementation on post-stroke outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who experience a stroke during follow-up.

Exclusion Criteria:

* Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who do not experience a stroke during follow-up.
Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens

Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes.

Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
2. Subject without any metastasis present.
3. Subjects who have peripheral lung nodule location
4. Subjects must be 18 years of age or older.

Exclusion Criteria:

1. Subjects who received preoperative chemotherapy or radiotherapy.
2. Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.
Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies

Collagens are proteins present in all tissues. Besides their structural role, recent data showed that they were able to regulate many cellular functions. Many interactions occur between extracellular matrix macromolecules, especially collagen, and various cell types. These interactions can be controlled by peptides derived extracellular matrix macromolecules, called matrikines. Previous work from the investigators laboratory and others have shown that several C-terminal domain (NC1 domains) from basement membrane-associated collagens could regulate many cellular activities.

Lung is an organ particularly abundant in basement membranes. It is likely that various lung diseases may affect metabolism of basement membrane associated collagens. To the investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in various pathophysiological situations.

The aim of this study are to:

* Study the presence of collagen IV and XIX (or fragments) in different types of sampling such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies
* Evaluate quantitative variations of expression of these collagen in different pulmonary diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia, pneumonitis or lung cancer.

Experimental Design: Cross-sectional study, with prospective inclusions, single center.

Investigations:

* Realization of bronchoscopy according to the indications (with or without bronchoalveolar lavage with or without bronchial biopsy, participation in research that do not modify patient's care)
* samples are sent to the laboratory, centrifuged and stored at -80°C until they were assessed.
* samples were used to specific analysis in this study:
* Study of qualitative expression of collagen IV and XIX by Reverse transcription polymerase chain reaction (RT-PCR) and Western Blot
* Study of quantitative variations of these collagens by ELISA

Statistical analysis planification:

* description of the data (mean and standard deviation),
* comparison of different groups (non-pathological vs pulmonary disease) by Student's t test, Wilcoxon, Chi2 or Fisher test.

Expected results and prospects:

The investigators should be able to demonstrate the presence of collagen IV and/or collagen XIX or different fragments in biological samples. The investigators would then be able to show variation in expression of these collagens according to different pathological situations. In the longer term, the objective is to validate these collagens as a markers of pulmonary pathologies or as therapeutic agents.

Eligibility Criteria:
Inclusion Criteria:

* Patient from the division of pulmonary medicine of the Reims University Hospital
* Patient that must undergo a bronchoscopy with bronchoalveolar lavage
* Male or female
* Informed of the study (written information) and not objecting to it (oral agreement)

Exclusion Criteria

- Aged bellow 18 years
The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People

In hospitals, older people can fall and hurt themselves. The investigators want to see if a new type of flooring can help stop people hurting themselves as badly, if they accidentally fall.

We will carry out the study in eight elderly care wards across England. We will first study the wards for up to 6 months. Then, half of the wards will have the new floor laid. Wards will be chosen to receive the new floor, or remain with a standard floor, by chance. The new floor has 'shock-absorbent' properties. We will study all the wards for another 12 months. This will allow us to compare the new flooring with the normal flooring.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the study area on a participating elderly care ward

Exclusion Criteria:

* none.
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.


Eligibility Criteria:
Inclusion Criteria:

* Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement
* Conscious
* Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment

Exclusion Criteria:

* Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida)
* Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<70%)
* Poor nutritional status (PG-SGA grade C)
Role of EUS in High Risk of Choledocholithiasis

The aim of this study is to demonstrate that patients with high risk of choledocholithiasis who undergo ERCP only for patients with choledocholith in the EUS examination\[EUS-ERCP group\] have less negative outcomes (including false-negative results and procedure-related complications) than patients who undergo ERCP in all patients with high risk of choledocholithiasis\[ERCP group\]. The primary outcome is the incidence of negative outcomes (including false-negative results and procedure-related complications) in both groups. The secondary outcomes included days of hospitalization and the rate of diagnostic ERC.

Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in patients with intermediate-risk choledocholithiasis. In other words, this results obtained by not performing ERCP in patients without choledocholith in the EUS examination. However, to the best of our knowledge, no prospective study has been conducted on the role of EUS in patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS screening in patients with high risk of choledocholithiasis. We compare the negative outcomes (including false negative and procedure-related complications of EUS and ERCP) of the 'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the 'ERCP group' in which ERCP is performed in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal CT or US showed a common bile duct diameter \> 6mm (\>8mm in patients with previous cholecystectomy) and elevated total bilirubin from 1.8mg/dL to less than 4.0mg/dL

Exclusion Criteria:

* Severe mental illness
* Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
* Pregnancy
* Pancreatic cancer or suspected malignant tumor of the biliary tract
* Acute pancreatitis
* Patient who has confirmed biliary stones in abdominal ultrasonography or CT
* Severe cholangitis according to TG 18 guideline
* Total bilirubin \> 4mg/dL
* Patients who have difficulty with EUS or ERCP due to previous gastric surgery (Billroth II or TG with R-en-Y)
Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy male subjects

Exclusion Criteria:

* Women
Examining Cortisol and Alpha Amylase in a Healthy Sample of Youth and Adults

The purpose of this study is to investigate how healthy youth and adults' cortisol levels and other hormone levels relate to anxiety levels while they participate in a behavioral task called the Trier Social Stress Task.

Data from these healthy participants will also be compared to those of anxious youth and adults collected as part of the in the Principal Investigator's ongoing study titled, "Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687)."

The aim of this study is to investigate the independent and interactive associations linking salivary cortisol (a marker of hypothalamic-pituitary-adrenal activity or HPA activity) and alpha amylase (a marker of autonomic nervous system activity or ANS activity) in a sample of healthy controls. Data from these healthy controls will be compared in the future to clinically anxious youth. In this study, participants are asked to complete a one-time assessment consisting of interviews, questionnaires, and a behavioral task (called the Trier Social Stress Task) involving a short public speaking task and an arithmetic task in front of study staff. Throughout the behavioral task, study staff will collect four, small saliva samples using a straw-like tube from each participant. The assessment will take approximately 3 hours. Participants will be fully debriefed regarding the purposes of the stress procedure and assessed for any signs of residual distress. Since there is no treatment or randomization, blinding of study staff is not applicable. Participation in this study will not affect any current or future medical or psychiatric treatment.

AIMS: To examine whether a) salivary cortisol and alpha amylase response and recovery to the Trier Social Stress Task is associated with anxiety in non-psychiatrically ill participants.

Eligibility Criteria:
Inclusion Criteria:

* Participant has no current psychiatric disorder
* Participant has no past psychiatric disorder
* Participant has no major medical disorder
* Participant is not currently receiving psychological or psychopharmacological treatment (medication) for any psychological disorder
* Participant is between the ages 11 and 34

Exclusion Criteria:

* Participant has or has had psychiatric disorder or medical condition contraindicating study participation
* Participant is pregnant
* Participant is not an English speaker
* Participant has a visual, motor, or hearing problem that would affect participation
Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.

Many studies show that patients with epilepsy frequently have disrupted sleep, as well as a high level of daytime sleepiness. This may be due to a sleep disorder, nighttime seizures that lead to disrupted sleep, and other abnormalities. Sleep complaints are widely reported among patients with various epilepsy syndromes.

Anti-seizure treatments may affect sleep. Effects vary by type of medication and other health issues. Generally, with improvement of seizure control, the sleep cycle improves and becomes more regular. However, some anti-seizure medications have been associated with insomnia. There have been studies that looked at sleep in relation to some anti-seizure medications. However, there are no currently available published reports on the effect of Clobazam (Onfi) on sleep.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 years or older
* diagnosis of epilepsy who are being considered for treatment with Clobazam

Exclusion Criteria:

* known untreated moderate or severe sleep apnea
* major circadian rhythm disorders
Liver Regeneration After Liver Resection

The aim of this study is to characterize Kupffer cell activity and activation of the innate immune response in the early phase of liver regeneration after right hepatectomy. The investigators hypothesise that liver regeneration after right hepatectomy in humans is associated with Kupffer cell activation and initiation of the innate immune response and that impaired liver regeneration, liver failure and sepsis following liver resection are associated with Kupffer cell dysfunction and an impaired innate immune response. The objectives for this study are to characterise Kupffer cell activity and the innate immune response in human liver before and after right hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring right hepatectomy for colorectal liver metastases

Exclusion Criteria:

* Age \>75, neoadjuvant chemotherapy, recurrent disease