Kornimate/medical-research-clean huggingface dataset:
study to improve quality of care and patient health in the field of cardiovascular risk factors in general practice

Conditions: High Risk Hypertensive Patients

Summary: observational studies performed in france and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. in primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach. objectives principal. to demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention. method pragmatic, cluster-randomised controlled trial. at least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. the regional teaching colleges will be randomised to avoid a contamination bias. the study will be coordinated by local coordinators at the college level. intervention in the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. the training will concern the targets to be reached, therapeutic strategies recommended by the afssaps/has, and scientific data. the investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance. in the control group, investigators will care for their patients as usual. end points main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (t2d), and in the sub-group with hypertension and dt2. secondary: number of targets reached by the patients, changes in level of blood pressure, ldl-cholesterol, hba1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

cluster randomised pragmatic controlled trial in general practice

Eligibility criteria:
inclusion criteria: * treated high blood pressure patients with at least two other cardiovascular risks exclusion criteria: * secondary prevention

Keywords: high blood pressure high cardiovascular risk type 2 diabetes reaching goals
be.amycon registry uz leuven

Conditions: Amyloidosis

Summary: the goal of this observational study is to establish database with (limited) personal and health data of patients diagnosed with amyloidosis (any subtype) in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.

with the support of vib grand challenges program, this project aims to establish the belgian amyloidosis consortium (be.amycon) by joining forces of vib researchers, a state-of-the-art diagnostic platform, and clinicians from various disciplines and different institutes. such a consortium will address patient needs and improve outcomes on many levels. in this context, a registry of clinical data is a requirement for both improvement of diagnostics as well as fundamental research purposes.

Eligibility criteria:
inclusion criteria: * age 18 years or older * provide consent and sign informed consent form * confirmed diagnosis of amyloidosis (any subtype), systemic and/or localised * newly diagnosed or in follow-up during the study time-frame (1 jun 2025 until 31 dec 2027) exclusion criteria: * not able to provide informed consent * not willing to sign informed consent
neuro-music-therapy for patients with chronic tinnitus - a controlled clinical trial

Conditions: Tinnitus

Summary: background: tinnitus is a nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. despite a variety of treatments, many patients with chronic tinnitus ask for more active ways in coping with their tinnitus. gold standard treatment in chronic tinnitus is a comprehensive directive counseling explaining the underlying mechanisms leading to the tinnitus percept. therefore a neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and compared to a counselling-only control group. intervention: two standardized protocols for tinnitus therapy were defined ("neuro-music therapy" vs. "counselling")


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic tinnitus persisting for a minimum of 6 month * adults, aged 18 or over * patients are able to understand, read and speak german fluently * patients are able to give written informed consent * tinnitus with determinable centre frequency exclusion criteria: * tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to cochlear implantation * tinnitus is concomitant symptom of a known systemic disease (such as menière's disease, vestibular schwannoma, endolymphatic hydrops) * status following craniocerebral trauma, cervicogenic or stomatognathic tinnitus * tinnitus is neither noisiform nor tonal (cricking, clacking, rumbling) or has different sound components or is pulsatile, intermittent or non-persistent * severe hearing impairment (greater than 50 decibel hearing loss (db hl) in the region of the centre tinnitus frequency) * severe hyperacusis * one or two sided deafness * clinical diagnosis of severe mental disorder or psychiatric or neurological disease (psychosis, epilepsy, parkinsons's disease, dementia, alcohol or drug abuse) * history of severe ischemic disorder (previous stoke, previous heart attack, peripheral arterial occlusion disease) * inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine, aminoglycosides) or psychotropic medication prior to entry into the study * patients are not able to understand, read and speak german fluently * patients are not able to give written informed consent

Keywords: tinnitus music therapy directive counselling acoustic stimulation group comparison subjective evaluation pitch
a study of aflibercept versus placebo in patients with second-line docetaxel for locally advanced or metastatic non-small-cell lung cancer

Conditions: Carcinoma; Non Small Cell Lung

Summary: the primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (nsclc). the secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (iv) aflibercept in this participant population and to determine immunogenicity of iv aflibercept in all participants.

the study included: * a screening visit of up to 21 days prior to randomization * randomization at baseline (treatment was initiated with 3 days of randomization) * a treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment * a post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Eligibility criteria:
inclusion criteria: * histological/cytological proven locally advanced or metastatic non-small cell lung cancer * disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * adequate renal, liver and bone marrow functions exclusion criteria: * squamous histology/cytology * less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization * prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow * prior docetaxel treatment * uncontrolled hypertension the above information was not intended to contain all considerations relevant to participation in a clinical trial.

Keywords: lung cancer angiogenesis inhibitor chemotherapy
patients completing core protocol (camn107a2103), exhibiting stable disease (sd), partial response (pr) or complete response (cr) to nilotinib in combination with imatinib

Conditions: Gastrointestinal Stromal Tumors

Summary: to provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in gist


Eligibility criteria:
inclusion criteria: * documented complete response, partial response, or stable disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator. * normal organ and marrow function as defined in core protocol (camn107a2103). * extension protocol written informed consent. exclusion criteria: * inability to swallow the medication. * any unresolved adverse events related to participation in the core protocol (camn107a2103). * a history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits. other protocol defined inclusion/exclusion criteria may apply.

Keywords: oncology cancer imatinib-resistant gastrointestinal stromal tumors gist nilotinib imatinib-resistant gastrointestinal stromal tumors (gist)
an investigational immuno-therapy study of nivolumab combined with ipilimumab compared to nivolumab by itself after complete surgical removal of stage iiib/c/d or stage iv melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether an investigational immunotherapy nivolumab, when combined with ipilimumab, is more effective than nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage iiib/c/d or stage iv melanoma


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * completely surgically resected stage iiib/c/d or stage iv melanoma within 12 weeks of participation in study. * must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work * no prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (rt) after neurosurgical resection for central nervous system (cns) lesions) exclusion criteria: * history of uveal melanoma * patients with active, known or suspected autoimmune disease * prior treatment with interferon (if complete \< 6 months prior to participation in study), anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways other protocol defined inclusion/exclusion criteria could apply
the robot-lva study: robot-assisted microsurgical lymphaticovenous anastomosis in breast cancer-related lymphedema

Conditions: Lymphedema; Lymphedema Arm; Lymphedema of Upper Arm; Lymphedema of Upper Limb; Lymphedema; Surgical; Lymphedema, Secondary; Lymphedema of Limb; Lymphedema, Breast Cancer; Lymphedema, Non-Filarial

Summary: this study assesses the performance of robot-assisted microsurgery. lymphaticovenous anastomosis (lva) is the most difficult procedure in microsurgery at this moment. the lva technique is applied to treat for example breast cancer-related lymphedema (bcrl). therefore, this lva procedure is compared using a manual expert and the same expert applying robot-assisted lva.

microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world. it is a prospective study in maastricht university medical center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (lva) tot treat breast cancer-related lymphedema (bcrl). the primary outcome parameter is lva technique. secondary outcome measures include duration of surgery, technical errors during \& complications peri-operatively, surgeon's satisfaction with the lva procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.

Eligibility criteria:
inclusion criteria: * female gender; * treated for primary early stage breast cancer; * early stage lymphedema of the arm (stage 1 or 2 on isl classification); * elv \> 10%; * suffering from unilateral disease. exclusion criteria: * male gender; * stage 3 lymphedema of the arm; * receiving current breast cancer treatment; * distant breast cancer metastases; * current substance abuse; * history of marcaine or indocyanine green allergy; * non-viable lymphatic system as determined by near infrared imaging; * previous lva (\<10 years) in the arm with lymphedema.

Keywords: robot-assisted microsurgery microsurgery robot robotic-assisted robot-assisted lymphaticovenous anastomosis lymphatico-venular anastomosis lva
non-invasive, real-time technology for diagnosis of cervical tissue

Conditions: Cervix; Cancer

Summary: in general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance. determine how specific structural features contribute to light scattering. investigate light scattering differences in tumorigenic and nontumorigenic cells. develop and implement quantitative and sensitive methods for measuring morphological properties. clinical measurements.

patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.

Eligibility criteria:
inclusion criteria: * patients with abnormal pap smears who are referred for colposcopy. exclusion criteria include: * anyone of the male sex since this study focuses on cervical cell abnormalities * any woman who has had a hysterectomy, leep, or chemotherapy.

Keywords: nih non-invasive diagnosis of cervical tissue los alamos/nih
fungal prophylaxis with isavuconazole for patients undergoing allogeneic hematopoietic stem cell transplant (hct)

Conditions: Hematologic Malignancy; Myeloproliferative Disorder

Summary: the purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (hct).


Eligibility criteria:
inclusion criteria: * subjects of greater than or equal to 18 years of age of either sex and of any race. * have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder. exclusion criteria: * proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of isa. * history of allergy or intolerance to isa. * clinically significant elevation of liver function tests prior to the first day of dosing (fdd) that at the discretion of the treating physician would preclude the administration of an azole antifungal. * familial short qt syndrome.
head and neck maskless immobilization device in immobilizing patients with head and neck cancer or intracranial tumors undergoing radiation therapy

Conditions: Brain and Nervous System; Intracranial Neoplasm; Head and Neck Cancer

Summary: this pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.

primary objectives: i. to assess the setup accuracy and reproducibility of the maskless immobilization device (mid) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy secondary objectives: i. to assess the patient comfort and quality of life with the mid compared to the thermoplastic mask.

Eligibility criteria:
inclusion criteria: * patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time * age ≥ 18 years old * subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf * provide signed and dated informed consent form exclusion criteria * history of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the rt planning process * patient requires a neck brace for medical reasons * skull or bony defect in the area contacting the immobilization straps * rt delivered by clinical setup only (no ct simulation)
mk0954 versus placebo for treatment of mild to moderate hypertension

Conditions: Hypertension

Summary: the study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of losartan.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with mild to moderate hypertension * patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure exclusion criteria: * pregnant of lactating female patients * secondary hypertension or history of malignant hypertension * sitting systolic blood pressure \> 210 mmhg * history of stroke * history of myocardial infarction with in the past year * current of prior history of heart failure * known hypersensitivity to losartan * obesity * patients known to be hiv positive or known to be positive for hepatitis b * absence of one kidney * patient is abusing or previously abused alcohol or drugs with in past two years
lumbar epidural analgesia versus local anesthesia with dexmedetomidine infusion in endoscopic lumbar discectomy

Conditions: Lumbar Disc Herniation

Summary: to compare between local anesthesia combined with intravenous dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.

percutaneous transforaminal endoscopic discectomy. under la is recommended in consideration of safety. under la, patients keep conscious during the process of pted, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. due to its central sympatholytic action, dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs

Eligibility criteria:
inclusion criteria: 1. patients american society of anesthesiologists' physical status (asa) i to ii. 2. aged 18 to 50 years. 3. both sexes. exclusion criteria: * spinal malformation * recurrent ldh * multi segment ldh * patients younger than 18 years or older than 50 years * patients with hypersensitivity to one of the used drugs
extension of bps-mr-pah-203 in pulmonary arterial hypertension (pah) patients

Conditions: Pulmonary Arterial Hypertension

Summary: this is an open-label study for patients who participated in the bps-mr-pah-203 study and have volunteered to continue treatment for pah with beraprost sodium modified release (bps-mr) tablets.

eligible patients who participated in bps-mr-pah-203 and who elect to continue receiving study drug in an open-label extension.each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. patients will be called by study personnel to assess adverse events and concomitant medications at month 9, and at 3 month intervals following the annual visit. at the end of study visit, patients discontinuing study drug will be down-titrated off of bps-mr at the discretion of the investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. likewise, patients who withdraw early from the study will be down-titrated off of bps-mr in the same manner. upon completion of down-titration, patients will return to the clinic for a final closeout visit. currently enrolled patients may be invited to participate in an optional four times daily (qid) dosing substudy of bps-mr with total daily dose of bps-mr achieved previously in the main study. patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in bps-mr-pah-204 main study.

Eligibility criteria:
inclusion criteria: * patients who remained on study drug and completed all assessments during the treatment phase of study bps mr pah 203 are eligible for this study. * women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. if sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal. exclusion criteria: * patients who discontinued study drug during the previous study (bps mr pah 203) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study. * patients who are pregnant or lactating are excluded from participation in the open-label extension.