Kornimate/medical-research-clean huggingface dataset:
avareg study: an observational study of avastin (bevacizumab) in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: this multicenter, single-arm observational study will evaluate the clinical benefits of avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. patients with metastatic breast cancer who have started avastin treatment within 6 months prior to study start will also be eligible. data will be collected from patients for up to 5 years.


Eligibility criteria:
inclusion criteria: * patients with metastatic breast cancer initiated on first-line treatment with avastin in combination with paclitaxel according to the current hungarian summary of product characteristics * patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with avastin according to the current hungarian summary of product characteristics exclusion criteria: contraindications for avastin according to the current hungarian summary of product characteristics: * hypersensitivity to active ingredient of avastin or to any excipients * hypersensitivity to products produced in chinese hamster cells or to other recombinant or humanized antibodies * pregnancy * untreated central nervous system metastases
effects of two techniques of mobilization in the dorsiflexion on patients with chronic ankle instability

Conditions: Chronic Instability of Joint

Summary: restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (cai). in fact, this is one factor that can contribute to the recurrence of such injuries. passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. however, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability. the aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.


Eligibility criteria:
inclusion criteria: * subjects with chronic ankle instability exclusion criteria: * acute or subacute ankle sprain. * recent lesions in lower extremities.
role of percutaneous vertebroplasty in treatment of vertebral tumors

Conditions: Bone Tumor

Summary: percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain for patients with vertebral tumors

destructive vertebral lesions are a common in metastatic disease, multiple myeloma and lymphoma. symptoms are caused by pathologic fracture consequences secondary to vertebral destruction, development of spinal instability and compression of adjacent neurological elements. nonoperative treatments include radiotherapy, hormone therapy, cytotoxic drugs which are effective to halt the osteolytic process and reverse the neurological compromise, however; they cannot provide stability or relieve pain or cord compression. surgical management options including vertebrectomy, reconstruction with a cage or pmma bone cement, and stabilization with pedicle screws can restore spinal canal support and neurological functions also control pain, however; usually associated with high postoperative morbidity and mortality. also not advisable for multifocal spinal disease. percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain. it is percutaneous, minimally invasive, image-guided procedure that involves injection of radio-opaque bone cement into a partially collapsed vertebral body, in an effort to provide stability and pain relief. the exact mechanism of pain relief remains unclear. proposed theories include more favourable biomechanics after cement strengthening, chemical toxicity and exothermic effect of cement polymerization on nerve endings.

Eligibility criteria:
inclusion criteria: * spinal instability * pain with movement * multiple level involvement * expected survival 3-6 months exclusion criteria: * absolute * asymptomatic * improving on medical treatment without worsening of the collapse. * infection local or systemic * uncorrectable coagulopathy * allergy to bone cement or contrast media * relative * radicular pain * tumor extension inside the vertebral canal or cord compression * fracture of the posterior column * sclerotic metastasis * diffuse metastases

Keywords: pvp bone tumor
baduanjin with resistance training program

Conditions: Osteoporosis; Lumbar Disc Herniation

Summary: the purpose of this study is to improve symptoms of lumbar disc herniation (ldh) and osteoporosis (op) by implementing an evidence-based baduanjin exercise to reduce pain and increase muscle strength and quality of life in chinese patients. this study will provide new sights of exercise of elderly patients with ldh and op for elderly patients.

participants in the control group will continue with their conventional post surgery treatment as follows: comprehensive post-operative care and educational handouts that include guidelines for lumbar and back exercises to improve recovery and promote spinal health. in addition, participants will receive three interactive q\&a sessions before discharge (pre-operation, post-operation, and on the day of discharge). during these sessions, patients can discuss their concerns and ask questions about their recovery. participants in the experimental group will continue to receive their conventional post surgery treatment in addition to bdj as follows: individual session training (admission to week 1 post-surgery), no training week 2, group session i (week 3 and 4), group session 2 (week 5-12) and perform independent exercises during which participants will have to keep an exercise diary (week 13-24). data collection will be conducted through in-person visits at baseline and week 1, followed by phone calls at week 12 and week 24.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ldh and op based on the chart and clinical diagnostic criteria. * age of female patients ≥ 45 years，age of male patients ≥ 50 years. * visual analogue scale (vas) ≥ 3 points. * surgical operation will be performed during the 7-day admission period. * mandarin speakers. exclusion criteria: * severe primary diseases: ulcerative colitis, gastrointestinal bleeding, pancreatitis, lung cancer, pneumonia, acute respiratory distress syndrome or psychosis, depression, anxiety or substance abuse, identified by diagnosis and interview. * current engagement in regular physical activity routines over the past 3 months: aerobic exercises for at least 30 minutes, at least 3 times per week. * taken drugs within 3 months before enrollment: bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin, etc.
evaluation of alternative exercise treatments on weight loss in overweight women.

Conditions: Obesity; Weight Loss

Summary: the purpose is to examine the additional effect of either yoga or resistance exercise on weight loss weight combined with a standard behavioral weight loss intervention.


Eligibility criteria:
inclusion criteria: 1. female 2. 25-55 years of age 3. bmi = 25-35 kg/m2 4. ability to provide informed consent. 5. ability to provide consent from their personal physician to participate in this study. exclusion criteria: 1. participation in regular exercise (aerobic, yoga or resistance exercise) for \> 20 minutes per day on \> 2 days per week for the last 3 months. (this study is designed to recruit relatively sedentary adults.) 2. currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication. 3. diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 4. women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. however, pregnancy status will also be verified by the pregnancy test that is required for the baseline, 6 and 12 month dexa). 5. non-medicated resting systolic blood pressure \>160 mmhg or non-medicated resting diastolic blood pressure \>100 mmhg, or taking medication that would affect blood pressure. 6. taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). 7. arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. 8. history of myocardial infarction or valvular disease. 9. history of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
menstrual-phase-dependent differences in response to sleep loss

Conditions: Sleep Deprivation

Summary: this study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

during a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). subjects will be randomly assigned to each study arm. during their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.

Eligibility criteria:
inclusion criteria: * female * 18-35 years old * regular menstrual cycle between 26-35 days in duration * not using any form of hormonal contraception for at least the prior 3 months * regular sleep patterns (7-9 hours/night) * not taking any medications or supplements * weight \>110 lb * bmi between 18.5 and 29.5 kg/m2 exclusion criteria: * primary sleep disorder * history of shift work * transmeridian travel in the previous 3 months * presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders * current pregnancy, \< 6 months postpartum, and/or breastfeeding * blood donation in the past 8 weeks * extreme morning or evening chronotype

Keywords: sleep restriction women's health
perioperative collection of temperatures and hypothermia

Conditions: Hypothermia; Hypothermia; Anesthesia; Hypothermia, Accidental

Summary: accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. although preventive measures are widely used, it remains very frequent in france. this observation led a group of experts to draft, under the aegis of the société française d'anesthésie et de réanimation (sfar), several recommendations aimed at improving the prevention of perioperative accidental hypothermia. perioperative hypothermia is defined as a core body temperature below 36.0 ° celsius. this study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.


Eligibility criteria:
inclusion criteria: * \>= 18 years old * surgeries performed at the centre léon bérard exclusion criteria: * digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room) * patient who decline to participate in the study * active systemic infection * hyperthermic intraperitoneal chemotherapy (hipec) or intrathoracic chemotherapy (hitec) * deprivation of liberty * operation performed under local anesthesia only
treatment of constipation due to opioids being taken for persistent non-cancer pain

Conditions: Bowel Dysfunction; Constipation

Summary: adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (obd) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. the primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of obd. the primary efficacy endpoint is based on frequency of bowel movements. subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.


Eligibility criteria:
inclusion criteria: * has consented to participate in this study. * taking opioid therapy for persistent non-cancer pain. * has bowel dysfunction mainly due to opioids. * has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. * willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). * willing to report daily bowel symptoms. exclusion criteria: * pregnant, lactating, or planning to become pregnant. * not ambulatory. * participated in another trial with an investigational drug in the past 30 days. * taking opioids for the management of drug addiction or cancer-related pain. * severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. * gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (gi) obstruction, or contribute to bowel dysfunction. * hiv-infected, has active hepatitis, or has ever been infected with hepatitis c.

Keywords: bowel dysfunction constipation gastrointestinal opioids pain non-cancer pain opioid-induced
low dose exposure to oxidized r-limonene - a repeated open application test (roat) study

Conditions: Allergic Contact Dermatitis Due to Cosmetics

Summary: this study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized r-limonene. three groups of participants are included: 1) patients with a previous positive patch test to oxidized r-limonene, 2) patients with a previous doubtful patch test to oxidized r-limonene and 3) healthy controls with no contact allergy to oxidized r-limonene


Eligibility criteria:
inclusion criteria: * positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized r-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years. * aged 18 years or older * received written and verbal information on the study. * signed written consent form. exclusion criteria: * active eczema in test areas. * pregnancy or breast feeding. * treatment with topical corticosteroids or other immune-suppressants on/near test areas within two weeks prior to study start. * systemic immune-suppressant treatment within seven days prior to study start. * uv exposure of test areas within three weeks prior to study start. * unable to cooperate or communicate with the investigators.
aspirin and enoxaparin for vte in trauma

Conditions: Venous Thromboembolism; Thromboprophylaxis; Trauma

Summary: the purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (vte) in high-risk critically injured patients. the investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of vte after trauma.


Eligibility criteria:
inclusion criteria: * age 18 years or older * blunt or penetrating trauma * requires vte thromboprophylaxis * high-risk for vte exclusion criteria: * presence of vte upon admission * pregnant or nursing * inability to give informed consent by patient or healthcare proxy * contraindication to enoxaparin * contraindication to aspirin * epidural or subdural hematoma * presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

Keywords: aspirin enoxaparin thromboprophylaxis trauma venous thromboembolism
lutathera injection general use result survey

Conditions: Somatostatin Receptor-positive Neuroendocrine Tumor

Summary: this study is a multicenter observational study with a central registration system and all-case surveillance system without a control group.

from the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart). for patients who discontinue treatment with this drug during the observation period, necessary variables will be examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (crf).

Eligibility criteria:
inclusion criteria: * all patients treated with this drug for the following indications during a certain post-marketing period * indication: somatostatin receptor-positive neuroendocrine tumor patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug. exclusion criteria: * not applicable

Keywords: lutathera
mmr/msi phenotypes in prediction of tumor vaccine benefit for gliomas

Conditions: Glioma

Summary: glioblastoma (gbm) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. tumor vaccines has been shown to improve survival of gbm, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. deletion of mismatch repair (mmr) protein and microsatellite instability (msi) state are important features in the biological evolution of gbm, and may be used as markers for tumor vaccine. therefore, this project will collect samples from gbm patients before and after vaccine treatment respectively, and evaluate the role of mmr/msi gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. moreover, mmr/msi phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.


Eligibility criteria:
inclusion criteria: the patients with glioma in the department of neurosurgery of huashan hospital affiliated to fudan university who meet the following three conditions can be enrolled 1. they were 18-80 years old, male and female; 2. the pathological results of frozen section during operation were gliomas (20 cases of who grade ii, ii and iv, respectively); 3. tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis; 4. sign informed consent. exclusion criteria: patients who meet any of the following criteria will not be included in this study: 1. participants in other clinical trials; 2. pregnant women.

Keywords: glioblastoma multiforme dc vaccine mismatch repair microsatellite instability biomarker
detraining in people living with hiv/aids

Conditions: Lipodystrophy Syndrome, HIV; Sarcopenia

Summary: the goal of this study was to evaluate the effect of detraining in the components of physical aptitude of people living with hiv/aids (pvha).

the study was experimental with a sample composed by an experimental group (eg) with 11 pvha, under antiretroviral therapy and a control group (cg) with 10 individuals without the infection; all which were under medical release and insufficiently active. the body composition was evaluated through the dxa, as well as the cardiorespiratory aptitude through the ergometer and the strength of the upper and lower limbs through dynamometry. both groups conducted interventions with concurrent training for 15 weeks and the interruption of exercise was evaluated after a period of 5 weeks.

Eligibility criteria:
inclusion criteria: * group experience to have a diagnosis of at least 2 years living with hiv / aids being in clinical follow-up in the specialized attention services in hiv / aids (sae), using art, tcd4 lymphocyte count equal to or greater than 500 copies / mm³, viral load undetectable (≤ 50 copies / mm³) * group control without any diagnosis of hiv / aids or any other pathology. both groups completed the exercise program with a minimum frequency of 75%. exclusion criteria: * both groups taking part in any physical exercise in time of detraining

Keywords: detraining physical aptitude hiv
effects of two anti-hiv drug regimens on quality of life and health care use among smart study participants

Conditions: HIV Infections

Summary: the purpose of this study is to compare the effects of two different anti-hiv drug regimens on quality of life and health care utilization among smart study participants.

advances in antiretroviral therapy (art) have dramatically reduced mortality and morbidity rates for hiv infected people. however, hiv infection is a costly disease to treat. with improvement in survival, quality of life and the long-term cost of hiv treatment have become increasingly important to the majority of individuals infected with hiv. different hiv treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. in the smart study, participants were randomly assigned to one of two treatment groups: * group 1 participants followed a drug conservation (dc) regimen in which art was stopped or deferred until cd4 cell count dropped below 250 cells/mm3, initiated until cd4 cell count was at least 350 cells/mm3, and then followed by episodic art based on cd4 cell count. * group 2 participants followed a viral suppression (vs) regimen in which art was continued to keep viral loads as low as possible, regardless of cd4 cell count. the purpose of this study is to compare how the dc and vs regimens affect quality of life, symptom severity, health care utilization, and resulting costs among smart study participants. at baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. body appearance and signs of hiv disease progression will also be assessed at this time. follow-up evaluations on quality of life and symptoms will be repeated at months 4, 8, and 12 and annually thereafter. follow-up evaluations of all other baseline measures will occur once a year.

Eligibility criteria:
inclusion criteria: * coenrollment in the smart study * parent or guardian willing to provide informed consent, if applicable

Keywords: treatment experienced