Kornimate/medical-research-clean huggingface dataset:
multi-centre, open-label, first-in-man study with mucopad ha

Conditions: Oral Mucositis

Summary: the device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.to prove safety of the device in terms of clinical results.

this is an multi-centre, open-label, first-in-man prospective study. up to 60 patients in total will be involved in the open-label trial of new medical device - mucopad ha. eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. it is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. mucositis will be assessed as a who scale. quality of life will be assessed by oral mucositis daily questionnaire (omdq) provided by facit. the facit and all related works are owned and copyrighted by, and the intellectual property of david cella, ph.d. permission for use of the omdq questionnaire is obtained by contacting dr. cella at information@facit.org. list of investigational sites is in appendix 7.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * oral mucositis after radiotherapy of grade i - iv according to who * patient willing and able to provide the written consent * ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study exclusion criteria: * age \< 18 years * pregnant or lactating women * patients in terminal stage of living * patients with known hypersensitivity or allergy to any of the substances contained in medical device * alcohol or drug abuse
peri-procedural management of direct oral anticoagulants for central venous catheters in cancer patients with venous thromboembolism or atrial fibrillation pilot study

Conditions: Anticoagulant-induced Bleeding; Direct Oral Anticoagulant; Cancer; Central Venous Catheter; Periprocedural Complication

Summary: the peri-procedural management of direct oral anticoagulants (doacs) in persons with cancer (pwc) undergoing tunneled or port central venous catheter (cvc) insertion is a common but understudied clinical problem, with conflicting management advice from guidelines and resultant uncertainty for best practices. data from prospective studies assessing peri-procedural doac management exist; however, these data pertain to procedures in the general population. these management strategies may not be applicable to pwc because (1) although cvc insertion is a low risk, image-guided specialized procedure, (2) pwc are at considerably higher risk of peri-procedural bleeding and thrombosis than non-pwc. it is not surprising, therefore, that guideline recommendations and current practices vary widely. to resolve management uncertainty and establish a standard-of-care, the venocat pilot randomized controlled trial (rct) is a first step that will assess the feasibility of a definitive trial comparing continued vs. interrupted doac management in pwc undergoing tunneled or port cvc insertion. evidence is needed to standardize clinical practice and reduce the risk of bleeding and thrombotic complications.


Eligibility criteria:
inclusion criteria: 1. adult patients with vte or non-valvular af on prophylactic or therapeutic dose doac 2. active cancer, defined as diagnosed within the past 6 months; or recurrent, regionally advanced, or metastatic cancer; or for which treatment had been administered within 6 months of port or tunneled cvc insertion; or hematologic cancer not in complete remission 3. pending elective radiologically guided insertion of tunneled or port cvc 4. able and willing to adhere to peri-procedural doac management plan and follow-up exclusion criteria: 1. creatinine clearance (cockcroft-gault equation) \<30 ml/min for dabigatran, rivaroxaban, or edoxaban, and \<25ml/min for apixaban 2. diagnosis of vte within 21 days 3. platelet count \< 50 x 10\^9/l at time of study entry 4. concomitant strong inhibitors or inducers to p-glycoprotein and/or cyp-3a4
health-related quality of life (qol), physical and respiratory function in patients with myeloma affecting the spine

Conditions: Multiple Myeloma

Summary: the purpose of this study is to create a prospective database of patients with myeloma affecting the spine. this database will define changes in health-related quality of life over time, and the effect of incident fractures and their treatment on specific measures of pain, physical function, pulmonary function, and future fractures. in 2008, the ucsf myeloma service was actively caring for 347 patients with myeloma, of which 150 patients had lytic lesions on radiographs, and 100 had a known vertebral fracture. this population, as well as any new myeloma patients, will serve as the source of the study population.

the ucsf adult hematology program maintains a data base of all patients with a diagnosis of multiple myeloma seen in the clinic. as patients are treated, relapse, receive new treatment, are transplanted, or pass away, these data are entered into this multiple myeloma data base (mmdb). the mmdb will be expanded to include parameters to identify those patients with myeloma affecting the spine. a recruitment letter will be sent to all patients in the mmdb identified as having myeloma affecting the spine asking if they would be interested in participating in this study. patients who agree to participate in the study will be given an appointment to meet with dr. wolf or dr. martin to discuss the study and if willing, to sign the informed consent document. they will have an exam and history taken that includes fracture history. patients who have signed consent will be sent for thoracic-lumbar spine films (unless they had prior spine films taken within the last 3 months). those with normal films will not be eligible to be enrolled to the study. those with abnormal spinal films will then be sent for mri of the spine, pulmonary function testing, and meeting with dr. r. yonge who will administer the various qol tests described below. all eligible established and new patients will be invited to participate in the prospective study. patients who sign the informed consent will be included in the prospective study. a minimum of 25 patients with vertebral fractures and 25 patients without fractures, will be observed to measure the impact of fractures on health-related quality of life. study enrollment will be complete when 25 patients without a new fracture and 25 patients with a new fracture treated by balloon kyphoplasty have been enrolled.

Eligibility criteria:
inclusion criteria: * adults with a diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures. exclusion criteria: * myeloma patients without evidence of bony lesions in the spine.

Keywords: multiple myeloma spinal disease
the complete® se sfa study for the treatment of sfa/ppa lesions

Conditions: Peripheral Vascular Disease

Summary: to evaluate the safety and efficacy of the complete se sfa stent system in the treatment of de novo and/or restenotic lesions or occlusions in the superficial femoral artery (sfa) and/or proximal popliteal artery (ppa) in subjects with symptomatic peripheral artery disease (pad).

the complete self-expanding (se) sfa stent is designed to be a permanent implant. it is cut from a nickel titanium alloy (nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. each segment consists of two struts and a crown (figure 1). it is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.

Eligibility criteria:
inclusion criteria: 1. rutherford 2-4, with an occlusion or de novo and/or restenotic sfa/ppa lesion ≥50% and ankle-brachial index/toe-brachial index (abi/tbi) \<0.90/0.80. 2. target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur; 3. target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate); 4. target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate); 5. adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel \<50% stenosed; 6. life expectancy \>12 months. exclusion criteria: 7. women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment; 8. any condition that precludes safe access with percutaneous transluminal angioplasty (pta) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified; 9. lesions in contralateral sfa/ppa that require intervention during the index procedure, or within 30 days before or after the index procedure; 10. previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion; 11. target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion; 12. target lesion requires treatment other than standard pta prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure); 13. history of bleeding diatheses or coagulopathy or will refuse blood transfusions; 14. known impaired renal function, defined as creatinine \>2.5 mg/dl; 15. known platelet count \ 700,000 cells/mm3; 16. known white blood cell (wbc) of \<3,000 cells/mm3; 17. participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the complete se sfa study endpoints, or previously enrolled in the complete se sfa study.

Keywords: pad peripheral arterial disease stent sfa ppa
investigating the effect of topical imiquimod on sebaceous hyperplasia

Conditions: Sebaceous Hyperplasia

Summary: this study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.


Eligibility criteria:
inclusion criteria: * patient has sebaceous hyperplasia lesions on both sides of the face. at least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size. * if of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. for women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical. * ability to understand and willingness to sign a written informed consent exclusion criteria: * current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks. * prior use of imiquimod on the treated area. * concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks. * concurrent facial peels or cosmetic laser therapy on the treated areas. * nursing, pregnant or planning to become pregnant. * immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine). * current participation in other investigational trials. * known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies. * known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications. * received radiation therapy and/or anti-neoplastic agents within 3 months prior to study entry.

Keywords: lesions on both sides of the face topical imiquimod
the effects of lifebloom one on physical activity after acquired brain injury

Conditions: Stroke; Brain Injuries, Traumatic

Summary: the goal of this clinical trial is to evaluate the effects of lifebloom one in people who have suffered a stroke or a traumatic brain injury. the main questions to be answered are: * does lifebloom one allow users to spend more time standing each day? * does lifebloom one allow users to improve their balance and gait? participants will use lifebloom one during 8 weeks. for each participant, gait and balance are compared either with and without oxilio or before and after lifebloom one intervention.


Eligibility criteria:
inclusion criteria: * stroke or traumatic brain injury more than 2 months old * unable to walk without assistance * expected length of stay equal to or greater than 4 months exclusion criteria: * anthropometric incompatibility with oxilio * unable to walk prior to brain injury * no functional upper limb * complete sensory deficit in the lower limb(s) * degenerative impairment (tumor, neurodegenerative disease, etc.)
effectiveness of intensive rehabilitation in advanced stages of parkinson's disease.

Conditions: Parkinson Disease

Summary: this study is aimed to evaluate the effectiveness of an multidisciplinary intensive rehabilitation treatment in advanced stages of parkinson's disease. in the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease. hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease

parkinson's disease (pd) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms. dopamine replacement therapy (drt) is the standard treatment for the motor symptom of pd, however drt does not reduce axial pd symptoms such as freezing of gait, postural instability and balance disturbances. further, long-term drt could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease. the investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease in according with hoehn and yahr scale (h\&y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5. clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. all evaluations were performed in the morning, one hour after taking drugs. the assessment included: unified parkinson's disease rating scale (updrs), for clinical evaluation, berg balance scale (bbs), timed up and go test (tug), six minutes walking test (6mwt), freezing of gait questionnaire (fogq) and abnormal involuntary movements scale (aims) for motor symptoms evaluation and, finally, parkinson's disease disability scale (pdds), for evaluation of the functional impact of the disease. since in the advanced stages of pd one of the most troublesome complication includes cognitive disorders, a neuropsychologist performed a cognitive assessment at the admission. the neuropsychological profile was explored using the mini mental state examination (mmse), a tool for screening of cognitive impairment, and the frontal assessment battery (fab) for the evaluation of frontal lobe dysfunctions.

Eligibility criteria:
inclusion criteria: clinica diagnosis of parkinson disease exclusion criteria: comorbidity with other neurological conditions

Keywords: parkinson disease advanced stages rehabilitation
efficacy and safety of kochujang pills on blood lipids profiles in hyperlipidemia subjects

Conditions: Hyperlipidemia

Summary: the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of kochujang pills on improvement of blood lipids. the investigators measured improvement of blood lipids parameters , including total cholesterol, ldl-c, triglyceride and hdl-c, and monitored their blood pressure.


Eligibility criteria:
inclusion criteria: * males and females 19-55 years old * total cholesterol 200\~260 mg/dl or ldl-c 110\~190 mg/dl * able to give informed consent exclusion criteria: * allergic or hypersensitive to any of the ingredients in the test products * history of reaction to any of the test products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnant or lactating women etc.
trial in elderly with musculoskeletal problems due to underlying sarcopenia - faeces to unravel gut and inflammation translationally

Conditions: Sarcopenia

Summary: the overall aim of the tempus-fugit study is to assess gut microbiota composition in older persons without sarcopenia and to determine the relationship with and between intestinal and systemic inflammation and with sarcopenia-defining parameters (muscle mass, muscle strength and physical performance). the gut microbiota of older persons without sarcopenia (included in tempus-fugit) will be compared with the gut microbiota of older people with sarcopenia, participating in the exercise and nutrition for healthy ageing (enhance) study (nct03649698).


Eligibility criteria:
inclusion criteria: * male or female persons without probable, confirmed or severe sarcopenia according to the european working group on sarcopenia in older people (ewgsop2): no reduced muscle strength measured by chair stand test or hand grips strength * 65 years or older * community-dwelling elderly or assisted living * dutch speaking exclusion criteria: * impairments/diseases that affect performance of daily activities * persons who are systematically physically active (e.g. routine or organized sports activities) or who followed a physical activity training program (e.g., rehabilitation program) in the last 6 months (systematically = twice or more/week) * diagnosis of diabetes mellitus, measured by fasting glucose ≥126 mg/dl or hba1c ≥ 6.5% at screening or in recent (maximum 3 months old) lab report * use of antibiotics in the last 3 months * gastrointestinal cancer (active or treated in the last 5 years) * no freezer at home available after the screening visit, included persons will be invited for a test visit.

Keywords: gut microbiota gut-muscle axis healthy ageing intestinal inflammation systemic inflammation gut microbiome
pelvic floor rehabilitation study (beckenboden-rehabilitationsstudie - brest)

Conditions: Postpartum Urinary Incontinence

Summary: this study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.


Eligibility criteria:
inclusion criteria: * 18 years or older * gave birth within the 12 weeks prior to the postpartum visit * postpartum urinary incontinence * able to understand and give consent in german exclusion criteria: * treatment for postpartum urinary incontinence that started prior to inclusion * any neurologic disease that impairs bladder function
a study on the safety and effectiveness of rilpivirine hydrochloride (edurant) among adult filipino patients with human immunodeficiency virus type-i infection

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Summary: the purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (arv) medications for the treatment of arv-naive (patients who have not been exposed to arv) filipino patients with human immunodeficiency virus type 1 (hiv-1) infection.

this is an open-label (all people know the identity of the study medication), multi-center, observational (study in which the investigators/ physicians observe the patients and measure their outcomes) study. the total duration of the study will be 3 years, and approximately 60 patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. as this is an observational study, assessment of patients will be based on the accepted clinical practice in the philippines. patients will be monitored from baseline and throughout the 48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine hydrochloride.

Eligibility criteria:
inclusion criteria: * filipino patients * arv naive patients with hiv-1 infection who are assessed by the physician to be eligible for treatment with arvs * patients who voluntarily signed the informed consent form exclusion criteria: * patients receiving drugs known to prolong qtc intervals, medicinal products with a known risk of torsade de pointes and anticonvulsants, systemic dexamethasone, proton pump inhibitors * any previous treatment for hiv * previously documented hiv-2 infection * patients with viral load of \>100,000 hiv-1 ribo nucleic acid (rna) copies/ml * severely ill patients like those with acute acquired immune deficiency syndrome (aids)-defining illness or other major concomitant - disease prior to enrolment * patients with severe hepatic impairment * known hypersensitivity to rilpivirine hydrochloride * pregnant or breastfeeding females

Keywords: human immunodeficiency virus type 1 (hiv-1) infection hiv-1 anti-retroviral naive arv filipino patients rilpivirine hydrochloride edurant