Kornimate/medical-research-clean huggingface dataset:
high-intensity focused ultrasound in treatment of uterine adenomyosis

Conditions: Adenomyosis

Summary: uterine adenomyosis is a common uterine benign condition. they can cause abnormal menstrual bleeding, and menstrual pain. although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. high-intensity focused ultrasound (hifu) therapy is receiving increasing interest in the management of uterine adenomyosis by inducing focal thermocoagulation of the fibroids. results obtained by various research groups have shown that hifu treatment is safe, effective and is highly acceptable to patients. the main objective of this study is to evaluate the therapeutic efficacy of hifu in the treatment of uterine adenomyosis. in this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the study inclusion criteria will be invited to participate in the study which involves the use of hifu in the management of the adenomyosis. background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. subjects will also be asked to complete an eight-item section of a uterine fibroid symptom and quality of life questionnaire (ufs-qol) and menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of women.


Eligibility criteria:
inclusion criteria: * age \>40 years old, with no future childbearing plans * age \>30 years old, who has tubal sterilization * significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery. * clinical uterine size less than 20 weeks gestation * localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast mri, involving only anterior or posterior uterine wall and not both. * no laparotomy scars. * women should be able to give consent. exclusion criteria: * other pelvic or uncontrolled systemic diseases * confirmed or suspected pregnancy * patients who are unable to communicate with researchers during the treatment * patients who are contraindicated for mri examination * patients with thick abdominal wall (\>5 cm, as measured by mri) * presence or history of acute pelvic inflammatory disease or any pelvic malignancy * history of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion * presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures

Keywords: uterine adenomyosis
non-interventional retrospective correlation of tumor mutational status to clinical benefit of gist patients treated with sunitinib

Conditions: GIST

Summary: retrospective correlation of clinical outcomes data with mutational status in gist subjects treated with sunitinib.

this is a non-interventional trial. no active patients will participate in this study. only data generated from the a6181036 study will be utilized for correlational purposes. the a6181036 study data in addition to mutational status data previously analyzed but not collected as part of the a6181036 study in the same patient population

Eligibility criteria:
inclusion criteria: * gist subjects that participated in the a6181036 study that had mutational status data analyzed. exclusion criteria: * subjects not participating in the a6181036 study

Keywords: retrospective gist sunitinib mutational
intravenous dexamethasone to increase the analgesic duration of interscalene block

Conditions: Pain

Summary: interscalene brachial plexus block provides excellent but time limited analgesia. intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. we want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

75 patients will be randomly assigned to three groups: * d10: dexamethasone 10 mg i.v. diluted in normal saline 20cc, immediately after inter scalene block * d4: dexamethasone 4 mg i.v. diluted in normal saline 20cc, immediately after inter scalene block * c: control: normal saline 20cc i.v., immediately after inter scalene block. these patient will be recruited from 3 hospitals, with two surgeons performing the surgeries. all patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc. in the postoperative period, patients will be given analgesic medication on an as needed basis. they will be instructed to take the first analgesic medication once postoperative shoulder pain has reached \>3/10. they will note the time and day at which this outcome occurs.

Eligibility criteria:
inclusion criteria: * elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression) * asa i-iii * age 18-80 years old exclusion criteria: * any contraindication to interscalene brachial plexus block anesthesia * interscalene brachial plexus block failure * known local anesthetics allergy * dexamethasone allergy or intolerance * any contraindication to acetaminophen * any contraindication to morphine or hydromorphone * brachial plexus neuropathies * chronic pain syndrome other than shoulder pain * routine use of opioid medication * routine use of systemic corticosteroid * pregnancy * weight below 50 kilograms * incapability to understand a numeric verbal pain scale * incapability to consent * patient refusal
5fu/vl vs lv5fu2 + cpt11 in stage ii-iii resected rectal cancer

Conditions: Cancer of the Rectum

Summary: the main objective of this randomized trial is to compare 5fu/lv (mayo-clinic regimen or lv5fu2) to lv5fu2 + irinotécan in patients with resected b2 and c rectal cancer. preoperative radiotherapy is recommended but not mandatory. main endpoint is disease free survival. secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. a total of 600 patients will be included in the trial.


Eligibility criteria:
inclusion criteria: * rectal adenocarcinoma * r0 surgery * t3, n0, m0 or t4, n0, m0 or n1,2, m0 * chemotherapy can be started within 8 weeks after surgery * age \> 18 * performance status ecog \< 3 * preoperative radiotherapy allowed * preoperative chemotherapy with 5fu +/- lv allowed * neutrophiles \> 1 500/mm3; pl. \> 100 000/mm3 * transaminases \< 2 x unl; alcalines phosphatases \< 2 x unl; bili \< 1.1 unl * creatininemia \ 60 ml/mn * written informed consent before inclusion exclusion criteria: * postoperative radiotherapy * distant metastases * contraindication to any drug contained in the chemotherapy regimens * any serious active disease or co-morbid medical condition including digestive inflammatory disease * gilbert disease * severe toxicity of radiotherapy * pregnancy or breast feeding * absence of contraception in non menopausal women * adult patient unable to give informed consent because of intellectual impairment * concomitant participation to another trial
real world study of mpm in china

Conditions: Malignant Pleural Mesothelioma; Diagnoses Disease; Treatments; Prognosis

Summary: malignant pleural mesothelioma (mpm) is a highly aggressive tumor with atypical clinical manifestations. most patients with mpm are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for mpm. in recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. targeted and immunotherapy may bring breakthroughs in mpm therapy. however, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of mpm patients in china. focusing on mpm, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. on this basis, we will estimate mpm incidence and mortality rates from 2014 to 2025 based on the data published by the national cancer registry. meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of mpm patients. also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.


Eligibility criteria:
inclusion criteria: * pathologically confirmed as malignant pleural mesothelioma * aged over 18 exclusion criteria: * follow-up less than 3 months

Keywords: mpm prognosis radiotherapy
study of gekotm interaction with cardiac pacemakers

Conditions: Stroke; Wound Heal; Edema Leg; Cardiac Pacemaker Electrical Interference

Summary: the gekotm device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. this contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers. there is evidence that some powered muscle stimulators and related devices can affect cardiac demand pacemakers. this study is to ascertain if there is any such interaction between the gekotm device and permanently implanted cardiac pacemakers.

cfr.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'powered muscle stimulators should not be used on patients with cardiac demand pacemakers'. further, iec 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'advice that a patient with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. however, no details on what criteria the specialist should apply. there is evidence that some powered muscle stimulators, and related devices can affect cardiac demand pacemakers(1,2). traditional powered muscle stimulators use pulse trains at a frequency of at least 30hz(3) to elicit muscle contractions. the electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso. the geko™ range of devices, however operate by delivering a single pulse at a frequency of 1hz with electrodes placed topically, close together, at the knee. the nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. however, there is no direct evidence to support this assumption. this trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.

Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years and able to provide written informed consent. * intact healthy skin at the site of geko™ device application. * patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent. * patient understands and is willing to participate in the study and is able to comply with study procedures and visits. exclusion criteria: * pregnancy or breast feeding. * use of any concurrent use of a neuro-modulation device. * any medication deemed by the investigator to potentially interfere with the study treatment (e.g. systemic steroids.) * participation in any other clinical study that may interfere with the outcome of either study
multilevel community-centered intervention to reduce pregnancy related and associated morbidity and mortality (pramm) disparities

Conditions: Provider Confidence; Provider Behavior

Summary: the goal of the study involving human subjects is to train providers to address patient-provider interactions. the study will survey providers to assess pre-post knowledge, understanding, and behavior changes.

provider/practice level intervention. the study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including chws and hv, for both clinical and community settings. trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal nhb/h women.

Eligibility criteria:
inclusion criteria: * providing care to pregnant and postpartum women in wayne, kent, and genesee counties in mi exclusion criteria: * none

Keywords: maternal mortality maternal morbidity
routine follow-up at 1 year after hip- and knee arthroplasty: wasting resources or appropriate healthcare?

Conditions: Hip Arthroplasty, Total; Knee Arthroplasty, Total

Summary: after undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an x-ray within 3 months and again at 1 year. follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. however, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. it is possible that a single follow-up within 3 months is sufficient. this could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. if patients or healthcare providers have concerns, they can always request an additional follow-up. the haka trial consists of three different work packages (wps). this trial (wp1) investigates the 1-year follow-up, wp2 examines the 10-year follow-up, and wp3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. the aim of the haka trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.


Eligibility criteria:
inclusion criteria: * painful and disabled hip or knee joint resulting from osteoarthritis * scheduled for primary tha or tka surgery * age 50 years or older at the time of tha or tka * capable and willing to complete questionnaires * proficient in dutch or english * willing to provide informed consent exclusion criteria: * other indication for surgery than osteoarthritis * scheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to tka or from hip hemiarthroplasty/resurfacing to tha * already participating in this study due to a previous hip or knee surgery

Keywords: total hip arthroplasty total knee arthroplasty follow-up promis physical function healthcare consumption
structural and functional changes in neuronal intranuclear inclusion disease(niid)

Conditions: Neuronal Intranuclear Inclusion Disease

Summary: to discover the microstructure, macrostructure and functional changes with 7t multi-modal magnetic resonance imaging of neuronal intranuclear inclusion disease, and to explore new biomarkers for evaluating the severity and the progression of neuronal intranuclear inclusion disease.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with niid 2. older than 18 years; 3. sign the informed consent form. exclusion criteria: 1. the informed consent is withdrawn by the subject; 2. contraindications or intolerance to mri: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.
perceptions and representations of vaccination against covid-19

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: sars cov2, the virus that causes covid-19, was first described in wuhan, china. for this pathology, which causes severe respiratory infections, preventing the transmission of the virus has become fundamental, that is why vaccines have been developed. in france, this vaccination campaign took place in a context where the lack of confidence in vaccination is high: according to a november 2020 ifop poll, only 41% of french respondents were willing to be vaccinated against covid-19. to our knowledge, there are still few qualitative studies on vaccination on the current issue of vaccination against covid-19.


Eligibility criteria:
inclusion criteria: * over 18 years of age * patient with a scheduled appointment in consultation or at the vaccination centre * not opposed to participation in the protocol exclusion criteria: * patient under guardianship or curatorship * patient unable to give free and informed consent * patient under court protection * patient without the cognitive capacity to ensure an interview

Keywords: vaccination perception
vegf imaging in renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the primary objective of the study is to evaluate the feasibility of 89zr-bevacizumab pet imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with rcc. 89zr-bevacizumab pet imaging will be regarded a promising biomarker if the target for treatment (vegf) can be visualised and if uptake changes after institution of treatment.

* to explore if 89zr-bevacizumab pet imaging can differentiate rcc patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon. * to explore relationships between vegf pathway related biomarkers and 89zr-bevacizumab pet response. * to explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89zr-bevacizumab pet response.

Eligibility criteria:
inclusion criteria: * locally advanced irresectable or metastatic renal cell cancer * no untreated brain metastases (ct or mri not necessary in the absence of symptoms) * no uncontrolled hypertension * no clinically significant cardiovascular events or disease during the last 12 months * no surgery in the last 4 weeks * no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months * no treatment with a tyrosine kinase inhibitor during the last 4 weeks * measurable disease with x-ray or ct scan, at least one site of disease must be unidimensionally measurable as follows: x-ray \> 20 mm, spiral ct scan \> 10 mm, non-spiral ct scan \> 20 mm * clear cell histology component * not pregnant or nursing * women of childbearing potential must use effective contraception * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * before patient randomization, written informed consent must be given according to gcp, and local regulations
effectiveness and tolerability of lidocaine 5% spray in treatment of lifelong premature ejaculation patients.

Conditions: Lidocaine Spray

Summary: this study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (pe). the current study has been designed as a randomized single-blind placebo-controlled clinical trial. it was done on 150 lifelong pe patients with normal erection. they were randomized evenly categorized into two treatment groups. group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.

this study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (pe). the current study has been designed as a randomized single-blind placebo-controlled clinical trial. it was done on 150 lifelong pe patients with normal erection. they were randomized evenly categorized into two treatment groups. group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. all medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. patients were evaluated with arabic index of premature ejaculation (aipe) scores, intravaginal ejaculatory latency times (ielts), and frequency of sexual intercourse before and after treatments.

Eligibility criteria:
inclusion criteria: clinical diagnosis of lifelong premature ejaculation exclusion criteria: 1. renal or liver diseases, 2. diabetes mellitus, 3. thyroid diseases, 4. chronic prostatitis, 5. neurological diseases 6. allergic reactions to local anesthetics or alcohols. 7. erectil dysfunction

Keywords: premature ejaculation
insulin resistance study

Conditions: Insulin Resistance; Metabolic Syndrome x

Summary: the purpose of this study is to evaluate how often patients with hepatitis c infection have abnormalities of sugar and fat utilization. additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.


Eligibility criteria:
inclusion criteria: * ability to give written consent * hcv rna pcr positive for 6 months * normal hgb, wbc,neutrophils * platelets of \>/= 65,000 * direct bili, within 20% uln * albumin \>3 * serum creatinine \<20% uln * tsh wnl * afp \</= 100 exclusion criteria: * women who are pregnant or breast-feeding * no thiazolidinedione, metformin,unless required for the treatment of type ii dm * hepatitis c of non-genotype 1,2,3 * any other cause for liver disease other than chronic hepatitis c * hemoglobinopathies * evidence of advanced liver disease * previous organ transplant * severe psychiatric disorder * significant cardiovascular dysfunction within the past 12 months * poorly controlled diabetes mellitus * immunologically mediated disease * any medical condition requiring chronic systemic administration of steroids * evidence of an active or suspected cancer * substance abuse at the time of the study * known hiv * irritability or unwillingness to provide informed consent