cyrilzakka/clinical-trials huggingface dataset:
Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy

The study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.

This is a prospective study lasting 36 months.

Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability.

This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven gastric cancer(early or advanced).
2. Age:older than 18 years old,younger than 80 years old.
3. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition
4. No obvious surgical contraindications.
5. American Society of Anesthesiology (ASA) score class I, II, or III
6. Written informed consent.

Exclusion Criteria:

1. Severe mental disorder
2. Pregnancy
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
5. History of unstable angina or myocardial infarction within past six months
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of other malignant disease within past 5 years.
8. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
9. Any accompanying surgical condition needed to be performed in the same time
Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia

The aim of our study is to evaluate the viscoelastic properties of lower extremity muscles in patients with hemophilia A and hemophilia B secondarily to compare them with their healthy peers.

Hemophilia is a rare inherited coagulation disorder that develops as a result of factor VIII (hemophilia A) or factor IX (hemophilia B) deficiency, and is a chronic group of diseases that mainly manifests with intra-articular (hemarthrosis) and intramuscular (hematoma) bleeding, affecting quality of life. The presence of easy ecchymosis formation in early childhood, especially intra-articular and intramuscular spontaneous bleeding, interventions and a history of bleeding that lasted longer than expected after trauma should suggest hemophilia. The severity of bleeding findings is directly related to the degree of deficiency of hemophilia A and B. Hemarthroses due to bleeding in the joint (80%) and hematomas due to intramuscular bleeding (20%) cause joint degeneration and muscle atrophy. The joint in which hemarthrosis is most common is the knee joint, however, bleeding into the lower extremity muscles seriously affects the activities of daily living and lower extremity functionality. For this reason, the researchers aimed to evaluate the viscoelastic properties of lower extremity muscles in hemophilia patients and, secondarily, to compare them with their healthy peers.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-17 years
* Those who have been diagnosed with Hemophilia A and Hemophilia B by a physician
* No history of acute bleeding
* Children who have family consent and volunteer to participate in the study

Exclusion Criteria:

* Those with a history of lower extremity surgery
* Those with neurological disease
* Those with a history of lower extremity hemarthrosis or hematoma in the last 1 month
* Patients with inhibitor positive
Pilot - Peri-operative Beta Blockade

Perioperative cardiac adverse events \[heart injuries caused by general anesthesia and surgical procedures\] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* American Society of Anesthesiologists (ASA) risk status III-IV
* Revised Cardiac Risk Index ≥2
* β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
* Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
* History of peripheral vascular disease, or
* Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
* Chronic renal failure (eGFR \<30 m/min)
* Major non-cardiac surgery under general anesthesia

Exclusion Criteria:

* History of stroke
* Heart rate \<55bpm
* Heart failure
* Second or third degree AV block without pacemaker
* Active asthma or COPD
* Anemia \[Hb\<9g/dL\]
* Allergy to beta-blockade drugs
* Hemodynamic instability
* Uncontrolled hemorrhage
* Unwilling or unable to give consent for participation
Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use

This study is being conducted to assess the acceptability and feasibility of a randomized trial of a 10 week virtual intervention to reduce fall risk in people with HIV who consume alcohol. The hypothesis is that this randomized trial of the fall prevention intervention will be found to be feasible and acceptable in this pilot stage.

Standardized assessments will be administered in-person at Boston University Medical Campus to assess various domains including fall risk, fear of falling, physical performance measures (such as grip strength, balance, and gait speed), substance use, and other related measures. The intervention has 3 main components: home exercises, virtual group sessions and weekly phone check-ins. Home exercise will be customized to match the current fitness level of participants. Participants will be asked to complete assigned exercises 3 times per week. Additionally, there will be a weekly virtual group session led by an Occupational Therapist trained in group facilitation via Zoom. The virtual group sessions will be used to help answer any questions and lead a discussion around challenges related to falls. Finally, a member of the research team will check-in with participants once per week to answer any remaining questions that participants have, provide individual feedback on exercises, and set up reminders for the upcoming week. Reminders will be tailored to the individual participant's needs to remind the participant to complete the intervention's components.


Eligibility Criteria:
Inclusion Criteria:

* Prior or current participant in the Boston ARCH 4F Cohort
* Any alcohol consumption in the last 30 days using Addiction Severity Index
* Deemed a Fall Risk using the CDC STEADI Fall Risk Assessment Form
* Has reliable access to a phone or computer with internet connection

Exclusion Criteria:

* Requires wheelchair for mobility
Breast Cancer Proteomics and Molecular Heterogeneity

Primary objective:

The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes

Secondary objective:

* To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.
* To relate proteomic findings to survival data
* To identify potential serum markers of breast cancer progression

This is a translational study. Patient will undergo standard treatment and tissue and blood samples will be taken at various time points:

Tissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue.

Blood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid (EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no biopsy/surgery required then study bloods will be taken prior to starting treatment).

Additional blood samples will be taken annually at follow-up visits for 5 years from primary cases and for up to 2 years from recurrent/metastatic cases.

Non-heparinised blood will be processed to serum. Clinical data will be collected at all times of biological sampling.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue

   Or

   -Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour tissue

   Or

   -Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage 4 breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue
2. Patients receiving neoadjuvant treatment are also eligible (if applicable)
3. Patients have to be ≥ 18 years of age
4. Patients must be able to give informed consent
CINC424A2X01B Rollover Protocol

This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.

Eligibility Criteria:
Key Inclusion criteria:

1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat

Key Exclusion criteria:

1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.
2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
3. Pregnant or nursing (lactating) women.
4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.

Other protocol-defined Inclusion / Exclusion criteria may apply.
Validity of an Actigraph Accelerometer Following Critical Illness

This study will determine whether an Actigraph GT3X accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

Ward based patients recovering from critical illness who satisfy the inclusion criteria will have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant leg. These will be used as an objective method of identifying adoption of lying, sitting and standing postures and quantification of step count. Both placement sites will be investigated in isolation. A further analysis will be undertaken to determine whether combining data from both placement sites (ankle and thigh) is superior in identification of lying, sitting and standing postures compared to an isolated single site. Accelerometer data will be compared against direct observation as the criterion measure.

Patients will undertake a semi-structured movement protocol consisting of typical activities undertaken by this population. These include lying in bed, transferring over the side of the bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking. Observation periods will not exceed 3 hours. During this time all aspects of the movement protocol will be completed.

The data from this study will be analysed to determine the validity of the Actigraph GT3X in identification of body position and quantification of step count using the placement sites described above.

Eligibility Criteria:
Inclusion Criteria:

1 18 years of age or above.

2. Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).

3. Currently resident on a hospital ward (secondary care) following step down from ICU

4. Able to undertake all postural transfers independently or with minimal assistance (one person only).

5. Able to mobilise short distances, either independently or with assistance from a walking aid or one person.

6. Willing to permit application of two Actigraph GT3X accelerometers Each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm.

7. Willing to consent to a period of direct observation for a length of time not exceeding three hours.

Exclusion Criteria:

1. Unable to provide informed written consent themselves
2. Unwilling to consent to a period of observation not exceeding three hours.
3. Unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions
4. Significant neurological or coordination impairment
5. Unable to speak or understand English.
6. Clostridium Difficile/ similar infection or unmanaged urinary incontinence.
7. Evidence/ diagnosis of peripheral vascular disease.
8. Lower limb amputation
9. Polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers
Effect of Influenza Vaccination on IVF Outcomes - IVF

In this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization.

Since 2004 flu vaccination has been recommended by American College of Obstetricians and Gynecologists (ACOG) Advisory Committee on Immunization Practices (ACIP) for all pregnant women during flu season, regardless of the trimester of pregnancy. Many studies have examined the safety of influenza vaccination and found benefits beyond the simple prevention of maternal infection including the reduction of still birth. Recently evidence has emerged that women who have received a flu vaccination were less likely to experience premature labor. The investigators hypothesize that some of the maternal benefits of influenza vaccination might be based on other than prevention of the flu, possibly secondary to the induction of immune system pathways that favor immunological tolerance. Induction of immune system pathways that favor immunological tolerance has long been considered a possible path to improved embryo implantation and reduce miscarriages, though the topic is still somewhat controversial.

Patients undergoing IVF will be randomized in two strata:

1. History of recurrent miscarriage or implantation failure
2. No history of recurrent miscarriage of implantation failure

Consenting patients will be randomized to receive either influenza vaccine or a saline placebo. Vaccination will occur 10 days before initiating anticipated menses or fertility treatment cycle start.

All patients will be receiving an offered a second injection at the time of negative pregnancy test or at the time of sign-out with a clinical pregnancy. The second injection will either be placebo or influenza vaccination depending on the original randomization. Patients and clinical staff will remain blinded to the original treatment assignment, except for the study coordinator and the single staff member assigned to administer the injection.

Eligibility Criteria:
Inclusion Criteria:

1. All women preparing to undergo an IVF cycle
2. Women will only be allowed to participate in one treatment cycle
3. Willingness to have an influenza vaccination
4. Signed informed consent

Exclusion Criteria:

1. Any contraindication for flu vaccination
2. Unwillingness to have a flu vaccination
3. Unwillingness to sign informed consent
4. Previous diagnosis of unfavorable endometrial development
5. Unresolved uterine condition that significantly compromises the endometrial cavity
Informed Implementation of Breast Density Reporting

1. To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers.
2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening \[i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer\], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* undergoing screening mammography at participating hospital facility
* normal mammogram result
* no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer
* must have email account

Exclusion Criteria:

* non-English speaking
* prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer
* no email
Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation

Lung cancer \[LC\] is the leading cause of cancer death worldwide. The standard treatment of locally advanced lung cancer unresectable or marginally resectable is combination therapy with radical or preoperative chemoradiation. The local control rates and survival with this treatment modality have increased by more than 30%. Radiotherapy \[RT\] with technical molded 3D \[3D-CRT, Three-Dimensional Conformal Radiation Therapy\] or IMRT \[intensity-modulated radiation therapy\] has allowed that the total dose of radiation has increased which leads to a direct benefit on the results treatment.

Between 17-30% of patients are susceptible to pneumonitis due to radiation \[NR\]. This complication may appear at the end of the RT or up to 6 months after the treatment. In severe cases, mortality can reach 50%.

It's well known that in various diseases, functional abnormalities precede the clinical manifestations. The degree of pulmonary failure secondary to RT is measured following the standards of the Radiation Therapy Oncology Group who ranks in degrees \[0 to 4\].

Not precisely known factors that influence the development of NR.

Objectives:

To evaluate the effect of chemotherapy and thoracic radiotherapy on pulmonary function and identify predictors of radiation pneumonitis in locally advanced lung cancer \[stages IIIA and IIIB\].

Hypothesis:

Respiratory function tests may predict the development of radiation pneumonitis in patients with locally advanced lung cancer who receive radical treatment with chemoradiation.

Methods Prospective cohort study with patients with locally advanced lung cancer of the Lung Cancer Clinic of the National Cancer Institute \[INCAN\]. Patients will receive weekly paclitaxel 50 mg and carboplatin AUC 2 with concomitant radiotherapy 44-63 Gy (22-33 fractions). Followup of lung function tests at baseline, during treatment with radiotherapy and will be carried out on 4 more occasions.

Eligibility Criteria:
Inclusion Criteria:

* Candidates must have understood and signed informed consent
* Histopathological diagnosis of locally advanced lung cancer \[IIIA-cT2N1-2, cT3N1-2, cT4N0, M0o IIIB: cT2N3, cT3N3, cT4N1-3, M0\]. They may also include patients with oligometastatic disease\[M1\] candidates for chemoradiation
* Any histology
* Medical tests: white blood cell count ≥ plasma 3,000 / mm3, platelets ≥ 100,000 / mm 3, hemoglobin ≥ 12 g / dl, serum creatinine ≤ 1.5 mg / dl, total bilirubin ≤ 1.5, transaminases \[ ≤ 2.5 times the upper limit of normal \[ULN\], alkaline phosphatase \<5 ULN.
* Age ≥ 18 years.
* General condition score according to ECOG 0 to 2 or a ≥ 60% Karnofsky.
* Estimated life expectancy with treatment of at least 24 weeks.

Exclusion criteria:

* Uncontrolled concurrent diseases.
* History of previous radiotherapy to the primary site.
* Pregnant or breast-feeding.
* Use of anticoagulants in therapeutic doses
* Intercurrent Malignancies, except dormant basal cell carcinoma in skin, carcinoma in situ of the cervix
* Invasive cancer unless the background was at least 5 years and the disease-free status.
A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade

The present study is an evaluation of school-based intervention. The intervention aims to strengthen students' well-being and increase their mental health through training in tools that increase self-efficacy and ability to understand themselves and others. The Danish Committee for Health Education is responsible for developing and implementing the intervention and for recruiting schools, while the the Danish National Institute of Public Health at University of Southern Denmark is responsible for the evaluation of the intervention, including data collection, analysis and reporting.


Eligibility Criteria:
Inclusion Criteria: Student classes in grade 7 to grade 10. This corresponds to students who are typically ages between 12 and 16 years old.

Exclusion Criteria: None