Kornimate/medical-research-clean huggingface dataset:
impact of intensive exercise training on coronary collateral circulation in patients with stable cad

Conditions: Stable Coronary Artery Disease

Summary: exercise training in patients with coronary artery disease is able to correct several risk factors. furthermore endothelial function can be improved. there are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. this might be due to technique of collateral measurement. therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.


Eligibility criteria:
inclusion criteria: * stable cad * min.1 coronary artery stenosis \>50% * patient is symptomatic ( ccs 1-3)or has documented myocardial ischemia during stress test * angina threshold \>75 watt * informed consent exclusion criteria: * age \ 75 * akut coronary syndrome within 2 weeks * lv-ef \< 40 % * significant valve diseases * reduced patient compliance * muscular disorder * bronchial asthma or cold stadium iii and iv

Keywords: stable coronary artery disease significant coronary stenosis
cohort trial in clinical pelivc lymph node metastatic prostate cancer

Conditions: Prostate Neoplasm

Summary: in local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. for these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. recently, the reports from nccb and seer data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone. this randomized phase iii trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * pathologically confirmed prostate cancer within 6 months for study enrollment * clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (ct, mri, pet-ct) at diagnosis and partial response or complete remission of enlarged lymph nodes according to recist v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4. ecog performance status 0-1 5. optimal hematologic profiles within 6 months for study enrollment * absolute neutrophil count (anc) ≥ 1500 cells/mm3 * platelets ≥ 50,000 cells/mm3 * hemoglobin ≥ 8.0 g/dl 6. optimal kidney function within 6 months for study enrollment * creatinine \< 2.0 ng/dl 7. optimal liver functions within 6 months for study enrollment * total bilirubin \< 1.5 x maximum normal value * alanine aminotransferase or aspartate aminotransferase \< 2.5 x maximum normal value exclusion criteria: 1. combined with distant metastasis (retroperitoneal lymph node, bone,...) 2. previous history of antiandrogen therapy within 6 months of study enrollment 3. previous history of definitive prostate cancer treatment such as prostatectomy 4. previous history of pelvic radiotherapy 5. previous history of other cancer treatment except for skin cancer and theroid cancer
be-prox. an effectiveness study of bullying intervention in norwegian kindergartens.

Conditions: Bullying of Child

Summary: with an overall aim to ensure a safe and sound kindergarten environment for all norwegian children in accordance with the kindergarten act §§41-43, the objectives of the current project are: to evaluate the effectiveness of be-prox norway to prevent and handle negative behavior and bullying among peers in norwegian kindergartens. to examine implementation factors that promote and inhibit the effectiveness of be-prox norway in norwegian kindergartens. to describe the cost-effectiveness of the be-prox norway intervention in norwegian kindergartens. to generate knowledge on how the be-prox norway intervention can be aligned and implemented in norwegian kindergartens.

january 1st, 2021, new additions to the kindergarten act came into force in norway introducing the right for all children to a safe and sound kindergarten environment. according to this act, norwegian kindergartens shall systematically work to preventing bullying and social exclusion, including adopting a zero-tolerance for violations such as exclusion, bullying, violence, discrimination, and harassment. while relatively little is known about bullying at this age, a growing body of research suggests that bullying occurs also between kindergarten peers and that experiencing bullying at early age is associated with negative consequences. currently there are few evidence-based interventions directly targeting bullying among kindergarten peers. be-prox, developed for swiss kindergartens to prevent, uncover and handle negative behavior and bullying in kindergartens have been translated and adjusted to a norwegian context in a previous pilot study. the current project is a close collaboration between two norwegian municipalities, regional centres for child and youth mental health and welfare, and research and educational institutions. the project aims to evaluate the effectiveness of the be-prox norway in a cluster randomized controlled trial, including process and implementation evaluation and cost-effectiveness analyses. hence the project complies with the current call through introducing research on tools, systems and models that promote evidence-based practices in norwegian kindergartens in general, and to prevent negative acts and bullying between kindergarten peers in particular. if proven effective, be-prox norway can be offered to kindergartens nationwide as evidence-based practice to prevent, uncover and handle negative behavior and bullying among norwegian kindergarten peers.

Eligibility criteria:
inclusion criteria: * children born 2018-2020 in kindergartens enrolled to the be-prox project and with parental consent to participate. * personnel i norwegian kindergartens enrolled in the be-prox project and who consent to participate. * parents of children in kindergartens enrolled to the be-prox project exclusion criteria: * children born 2021-2023 * children with no parental consent to participate

Keywords: early childhood and educational care norway bullying intervention randomized controlled trial
spo2 difference between fingers of the hand during sequential desaturation and step resaturation

Conditions: Hypoxia; Pulse Oximetry; SpO2

Summary: the aim of the project is to experimentally compare the fingers of the hand in terms of measured concentrations of peripheral blood oxygen saturation (spo2) in healthy humans during gradual desaturation in the range of 60-100% spo2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

the finger sensors of pulse oximeters are most often placed on the middle two fingers of the hand. although there have been many studies looking at the accuracy of different pulse oximeters or comparing fingers in terms of spo2. there is no study comparing fingers in terms of spo2 under hypoxic condition with simultaneous randomization of finger probe placement. at the same time, there is no study that compares spo2 changes between fingers during a step change in blood oxygen saturation. the data obtained could help to improve the reliability of monitoring physiological parameters with pulse oximeters.

Eligibility criteria:
inclusion criteria: * passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation exclusion criteria: * post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers. * pneumothorax or a condition after cardiovascular surgery. * anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.
impact of an enhanced patient reported outcome measurement (prom) strategy on prom completion rates

Conditions: PROM

Summary: in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time. patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and visualized with the patient. the questions may seem impersonal (e.g. too general and not directly assessing their individual goals, motivations, aspirations), irrelevant (e.g., asking about symptoms of depression when a person is seeking musculoskeletal specialty care) and insensitive (e.g., asking about sensitive subjects at the outset thereby disengaging the individual), and redundant or awkward (e.g., presenting questions that seem very similar or administered in strange orders). finally, proms may also confer some burden (e.g., long prom questionnaires often used for research may be unnecessarily burdensome for patient care), and provide logistical challenges (e.g., difficulties in administering the tools at the right time points), adding to a poor patient experience.

the investigator sought to assess the impact of an enhanced and more personalized prom strategy to overcome these barriers by providing i) a primer ahead of proms administration, ii) simple 3-part survey capturing capability, comfort, and calm, iii) a short distress and misconception survey, iv) goal setting question, v) summary sheet of pro scores, and vi) a commitment intervention. patients will subsequently be requested to complete the collaborate survey, jsppe survey, and questions about their experience in relation to the new format of surveys (only if they were in the intervention group) before receiving a text message reminder around 6-weeks followed by a set of deprioritization questions and the 3-part capability, comfort, and calm survey.

Eligibility criteria:
inclusion criteria: all new patients english and spanish speakers exclusion criteria: cognitive deficiency precluding prom completion language other than english or spanish
quantitative characterization of safe irrigation for ventricular shunt catheters

Conditions: Hydrocephaly

Summary: the objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery. this maneuver involves injecting saline with a syringe to clear plugged shunt catheters. based on data obtained in stage i of the study, a device has been fabricated which provides the same small-volume pulse of fluid used by surgeons. in stage ii of the study, pressure and flow rate measurements generated by this specialized flusher device will be collected and measured.

primary objective: to collect pressure and flow rate measurements during shunt revision surgeries in human patients. pressure recordings of the injected fluid will be obtained using disposable off-the-shelf sterile pressure transducers (which are typically used for intracranial and arterial pressures monitoring) readily available in the operating room. first, the surgeon will attempt to flush the catheter using the alcyone in-line flusher device. if this fails, the surgeon may elect to attempt to flush using a standard syringe attached to the catheter. the flow rates will be measured by video, recording the syringe during the flushing maneuver, and then extracting plunger motion information by applying image processing on the acquired videos. in the event the recording equipment is not available (in that these operations are usually unscheduled and sometimes urgent), the same irrigation techniques may be used without the pressure recordings. secondary objective: to analyze the collected data and establish maximal allowable injection pressure and flow rate. the collected data segments for each patient will be analyzed and maximal values for pressure and the saline injection rate will be recorded in a spreadsheet. inter-patient variation in the results, presumably due to different degrees of occlusion, will be statistically evaluated. we will also determine if any of the catheters which appear occluded in the operating room resume flow with the flushing maneuvers.

Eligibility criteria:
inclusion criteria: 1. subjects must be 30 days to 35 years of age, of any race or gender. 2. subjects must be scheduled to undergo a neurosurgical procedure potentially requiring a revision of neurosurgical catheters. 3. subjects aged \>18 years of age must be willing and able to provide written informed consent. parental consent will be required for minors. exclusion criteria: 1. inability or unwillingness of subject or parent/guardian to give informed consent/assent. 2. judgment of the investigator, surgeon, or any member of the care team (including anesthesiology or operating room nursing staff) that participation in the study will interfere with, or be detrimental to, administration of optimal healthcare of the subject. 3. inability or unwillingness of subject to endure the test or any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
evaluation of drainless thyroidectomy for benign thyroid diseases regarding surgical site complications

Conditions: Benign Thyroid Diseases

Summary: in all thyroid surgeries, many surgeons utilize drains on a regular basis and have done so for years according to recommendations. due to the thyroid's high vascularization throughout its endocrine function, any haemorrhage inside the closed paratracheal space has the potential to impede venous and lymphatic drainage, which might result in airway blockage and laryngopharyngeal oedema. surgeons routinely perform post-operative thyroid gland draining in the modern surgical field. the goal is to stop fluid from accumulating in the surgical wound site, which could constrict the patient's trachea and jeopardize their life. thyroid storm, hypocalcemia, hematoma/haemorrhage impairing airway, recurrent or superior laryngeal nerve damage, and wound problems such as wound infection are among the main post-operative consequences of thyroid surgery. some reports indicate the use of drains following thyroid surgery is not very beneficial. some researchers have been prompted by this to consider whether drains should be inserted during thyroid surgery in which several research papers and meta-analyses have also failed to demonstrate the benefit of drainage in thyroid surgery. blood clots in the drains could cause severe post-operative bleeding, preventing the surgeon from being notified. difficult thyroidectomy cases might be predicted by factors linked to the patient, the thyroid, or the surgeon. when thyroidectomies are performed under ideal conditions-that is, in a setting where good anatomical and physiological expertise is matched with meticulous surgical skills-complications are rare. the ability of the surgeon to do a thyroid surgery without difficulties is crucial. it is not possible to see routine drain use as a substitute for these components. percutaneous drains are frequently used in head and neck surgery cases. however, although effective at preventing post-operative haematoma formation, their use can also be associated with significant complications, including infection, fistulae, pain, psychosocial implications and most notably, prolongation of hospital stay. accordingly, some researchers that reject the use of intraoperative drains, there isn't a very high rate of wound hemorrhages following thyroid surgery. additionally, other research indicates that there is no difference in the two groups' incidence of post-operative problems with and without drainage. nearly all surgeons utilize a closed vacuum drain after the intervention to avoid the deadliest complication, a smothering haemorrhage, which several studies suggest may not be essential


Eligibility criteria:
inclusion criteria: * age 18-60 years. * both sexes. * unilateral \\ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy. exclusion criteria: * surgical contraindications such as coagulation dysfunction. * retrosternal goiter. * a history of cervical surgery. * sever co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease). * malignancy.
hypoxia-positron emission tomography (pet) and intensity modulated proton therapy (impt) dose painting in patients with chordomas

Conditions: Chordoma

Summary: before radiation treatment is given to treat chordomas, ct and mri scans are used to create a three dimensional picture of the tumor using x-rays. the ct and mri scans are used to determine the size and location of the area that will receive radiation treatment. the purpose of this research study is to see if combining the images from the fmiso-pet scan and the ct and mri scans in radiation treatment planning changes the size and location of the area that will receive radiation treatment when compared to planning the radiation treatment with ct and mri scans alone.

* in this research study we are determining whether the positron emission tomography (pet) investigation performed with the investigational radioactive substance fmiso can show areas of tumor with lower oxygen levels. there is evidence that tumor with low oxygen levels are more resistant to radiation therapy. ct and mri scans are not able to detect these oxygen levels in tumors. * participants will be asked to have the fmiso-pet/ct scan at 2 different times. it will be performed 2 weeks before and 3 weeks after the participants first proton radiation treatment.

Eligibility criteria:
inclusion criteria: * skull base and spinal chordomas diagnosis based on pathology review by department of pathology at massachusetts general hospital * patient to be treated with proton or combined photon rt for primary cd or recurrent cd after surgery * 18 years of age or older * karnofsky score of 60% or greater * gross tumor mass larger than 1cm (maximal diameter on mri) exclusion criteria: * recurrences after rt * pregnancy * allergic reaction to fmiso injection

Keywords: fluoromisonidazole pet scan hypoxia-pet impt
bump2.0 feasibility study

Conditions: Weight Gain During Pregnancy

Summary: most women in the uk gain more weight than recommended during pregnancy, which puts them and their babies at risk of medical complications. studies which have interviewed women during pregnancy have shown that they recognise that controlling their weight is important, but this is rarely discussed with their clinical team. some women reported they expected to be weighed during pregnancy, and that regular weighing should be part of routine antenatal care, but it is not. trials which have trained midwives to regularly weigh women or to ask women to regularly weigh themselves, have not shown beneficial effects on gestational weight gain. however, these trials were either small, or reported low protocol adherence, or did not offer adequate feedback and advice in response to weight gain. a few programmes to manage weight during pregnancy have been effective, but were costly and burdensome for women. regular self-weighing has been shown to be an effective strategy for weight control outside of pregnancy, and if it can be enacted in pregnancy and help manage weight gain, it could improve health outcomes for women and their babies. the investigators have developed a mobile app to support women to weigh themselves regularly during pregnancy and track their weight gain, to provide feedback on whether weight gain is within, higher, or lower than recommended ranges, and to signpost to resources on weight management during pregnancy. the trial aims to test if it is possible to motivate participants to regularly weigh themselves during pregnancy and how well they engage with the app from early or mid-pregnancy until delivery. the investigators will also examine whether the processes of the study run as planned, whether there is an indication of an impact of the programme on gestational weight gain compared to a control group, and will explore participants' experiences of using the app through optional qualitative interviews. if feasible, after completion of this study, the next step will be a bigger trial to investigate whether this app-based programme is effective in helping women manage their weight gain and improve health outcomes during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant women at \<20 weeks' gestation * 18 years of age or above * singleton pregnancy * 18 years of age or above * able to access the internet with a smartphone and/or tablet * have access to weighing scales * able to communicate in english
rituximab (rituxan) for the prevention of ebv-lpd epstein barr virus (ebv) lymphoproliferative disorder post t cell depleted unrelated and hla mis-matched related hsct

Conditions: Hodgkin's Disease; Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to determine if we can prevent epstein barr virus lymphomas by the monthly administration of an (antibody) protein against b lymphocytes called rituximab. although this medicine has been approved by the food and drug administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with ebv lymphomas and other types of b-cell leukemias, it has not been approved to try and prevent ebv-lymphomas. use of rituximab to try to prevent ebv-lymphomas is therefore experimental.


Eligibility criteria:
inclusion criteria: * patient must be a recipient of at cell depleted unrelated or hla mis-matched related hsct for the treatment of a malignancy or immunodeficiency disease. * patients must have an anc \> or = to 1500 cells/ul on the day of first treatment. * patients with acute or chronic leukemia, or mds prior to transplant must be in remission defined as \<5% blasts in the bone marrow. * patient with must be in remission. * patient must be hepatitis b surface antigen negative pre transplant. * patients must have adequate cardiac function defined as a left ventricular ejection fraction at rest of \>50% documented pre-transplant. * patient may be of either gender and of any ethnic background. * patient may be of any age. there is no upper age restriction. * patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent. exclusion criteria: * karnofsky score \<70% * female patients who are pregnant or lactating. * evidence of ebv-lpd or circulating ebv copy number \>1000. * active uncontrolled bacterial or fungal infection. * prior history of hepatitis b infection or hepatitis b surface antigen positivity pre transplant. * hiv-1,2 sero-positive patients. * patients or guardians not signing informed consent. * patients with prior allergic reaction to rituximab or other murine monoclonal antibody. * patients taking other investigational agents under another protocol unless discussed and approved in advance by genentech and the idec therapeutic director.

Keywords: rituximab lymphoma
evaluating the effects of vqw-765 vs. placebo in performance anxiety

Conditions: Performance Anxiety

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of vqw-765 compared to placebo in male and female participants with performance anxiety.


Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent. * sufficiently fluent in english to participate in the trial. * male and female patients aged 18-70 years (inclusive). exclusion criteria: * lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder. * current or planned pregnancy or nursing during the trial period. * a positive test for substances of abuse.

Keywords: social phobia social anxiety disorder