Kornimate/medical-research-clean huggingface dataset:
auto-adjustable mobiderm autofit armsleeve in the management of upper limb lymphedema.

Conditions: Lymphedema of Upper Limb

Summary: this study aims to assess auto-adjustable mobiderm® autofit armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema

the overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. for all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages. the day-time elastic compressive armsleeves are proposed as an alternative to bandages. however, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan. in order to optimize treatment of lymphedema efficacy, thuasne developed the standard auto-adjustable armsleeve using the mobiderm technology.

Eligibility criteria:
inclusion criteria: * unilateral secondary upper limb lymphedema of stage ii or iii according to the criteria defined by the international society of lymphology, following breast cancer * volume difference between affected and healthy arm ≥ 10% * affected arm that fits with one of the 6 standard sizes of the auto- adjustable mobiderm autofit armsleeve provided. * signed informed consent prior to any study-mandated procedure. exclusion criteria: * stage i lymphedema or located in several places. * patients for whom compression is contraindicated. * lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis. * motor and sensitive neurological deficiency / psychiatric or addictive disorders * pregnant or breastfeeding patient * patient intolerant to mobiderm autofit or known allergies to the components used. * participation to any other clinical study which has an impact on the different endpoints * vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.

Keywords: lymphedema of upper limb compression garments lymphedema management
a cohort study of musculoskeletal health in patients with breast cancer during aromatase inhibitors therapy

Conditions: Musculoskeletal Health

Summary: postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors with 5 years or longer durations of therapy as recommended by clinical guidelines, which contributes to reducing breast cancer recurrence. however, aromatase inhibitors treatment is associated with a high incidence of musculoskeletal symptoms (mss), often described as symmetrical pain, soreness in the joints, musculoskeletal pain, and joint stiffness, which even leads to bone loss, osteoporosis, and fractures. mss reduces patients' quality of life and compliance with aromatase inhibitors therapy in up to one-half of women undergoing adjuvant aromatase inhibitors therapy, potentially compromising breast cancer outcomes. therefore, this study aimed to monitor the musculoskeletal health of breast cancer patients during endocrine therapy to provide references for clinical practice.


Eligibility criteria:
inclusion criteria: 1. postoperative early breast cancer； 2. hormone receptor-positive breast cancer diagnosed by pathology； 3. aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) was initiated within 3 months; 4. postmenopausal women, or premenopausal or perimenopausal women taking ovarian function inhibitors; 5. informed consent and voluntary participation in the study. exclusion criteria: 1. breast cancer recurrence or distant metastasis; 2. with other malignant tumors; 3. with cognitive or psychiatric disorders.
heat shock protein inhibitor- mpt0b640 for covid-19 infection

Conditions: Covid19

Summary: indication : treatment of subject with covid-19 infection phase : phase i duration of study : 12 day sample size : at least 15 subjects methodology : classical 3+3 design investigational product : mpt0b640, 15, 30, 60, 80 and 100mg, oral suspension study objective 1. primary objective to determine the maximum tolerated dose (mtd) or maximum feasible dose (mfd) of mpt0b640 2. secondary objectives to evaluate the safety and tolerability of mpt0b640 during entire study period to assess the efficacy of mpt0b640 to characterize the 48 hours pk of mpt0b640


Eligibility criteria:
inclusion criteria: subjects must meet all inclusion criteria as listed below: 1. age ≥18 years at time of signing informed consent form 2. laboratory (quantitative polymerase chain reaction, qpcr) confirmed infection with 2019-ncov. 3. lung involvement confirmed with chest imaging 4. hospitalized with a sao2/spo2≤94% on room air or pao2/fio2 ratio \<300mghg 5. ≤7 days since illness onset 6. must agree not to enroll in another study of an investigational agent prior to completion of day 12 of study. exclusion criteria: 1. physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. 2. severe liver disease (e.g. child pugh score ≥ c, ast\>5 times upper limit) 3. pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 4. patients with known severe renal impairment (estimated glomerular filtration rate ≤30 ml/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis 5. will be transferred to another hospital which is not the study site within 72 hours. 6. receipt of any experimental treatment for 2019-ncov (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
prospective clinical 5-year follow-up of the link® endo-model® sl®

Conditions: Bone Necrosis; Arthritis/Arthrosis; Failure of Prosthetic Joint Implant

Summary: the objective of this study is to collect outcome information on patients requiring total knee replacement (tkr) in primary or revision cases and therefore receiving the link® endo-model® sl® under routine conditions.

post market clinical follow-ups (pmcf) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. against this background a prospective multi-center study with the link® endo-model® sl® will be conducted.

Eligibility criteria:
inclusion criteria * implantation of the link® endo-model® sl®. * between 18 and 78 years of age. * patient has signed the informed consent. the indications and contraindications for the implantation of the link® endo-model® sl® listed in the product catalogue and chapter 2.5 and 2.6 \[of the protocol\] are applicable and have to be considered / fulfilled exclusion criteria * body mass index (bmi) \> 40 kg/m2 * poor general state of health with a foreseeable life expectancy of less than 5 years * knee replacement on the contralateral side within the last year and with a kss fuctional score \< 70 points * comorbidities and known medical circumstances which forseeable affect the clinical functional results after implantation (e.g. neurological or musculoskeletal impairments) * revision in floride septic environment * female patient who is pregnant * prisoner * patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule

Keywords: revision knee joint pmcf endo-modell sl
a study of sweat testing using a quantitative patch

Conditions: Cystic Fibrosis

Summary: the primary aim of the study is to determine if the cf quantum sweat test provides sweat chloride results that are equivalent to the results from traditional sweat testing. the secondary aim of the study is to assess the quantity not sufficient rate of the cf quantum sweat test compared to traditional sweat testing.

all 50 states and the district of columbia are performing newborn screening for cystic fibrosis (cf). infants who have a positive newborn screen require follow-up with a sweat test. gibson-cooke quantitative pilocarpine iontophoresis (gcqpit) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. this test has many difficulties including specimens that are quantity not sufficient (qns), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. the only manufacturer of a chloridometer has ceased production of this instrument. the cf quantum® sweat test system (cfqt) overcomes all of the difficulties of gcqpit. this pilot study will determine if the cfqt provides results that are equivalent to gcqpit.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystic fibrosis * patients who require a sweat test exclusion criteria: * infants less than 48 hours of age * patient is receiving oxygen by open delivery * collection site has diffuse inflammation or rash
propranolol administration in pediatric patients with recurrent respiratory papillomatosis

Conditions: Recurrent Respiratory Papillomatosis

Summary: juvenile onset recurrent respiratory papillomatosis (jorrp) is a rare, difficult to treat, benign tumor of the pediatric airway. current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. although multiple adjuvant medical therapies have been tried, success has been limited. we have seen some success in a limited amount of patients using orally administered propranolol. our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for jorrp.


Eligibility criteria:
inclusion criteria: * 1. biopsy proven with appropriate human papilloma virus typing recurrent respiratory papilloma * 2. child under age 10 * 3. informed consent and where appropriate informed assent * 4. children who have undergone at least 4 documented surgical interventions in the past year. exclusion criteria: * parental or child refusal to participate * heart failure * atrio-ventricular heart block * cardiac anomalies * low resting heart rate * low resting blood pressure * wolff-parkinson white syndrome * unexplained syncope * asthma or reactive airway disease * renal or liver failure * expected long fasting periods, \>12 hours * diabetes mellitus * hypersensitivity to propranolol

Keywords: respiratory, papilloma, pediatric, juvenile
the effect of packing in post operative management of fess

Conditions: Epistaxis; Nasal Obstruction; Pain

Summary: chronic sinusitis is a very common problem. the functional endoscopic sinus surgery is a prevalent option to treat this disease.during usage of different techniques of surgery, the need for packing after surgery is debatable problem. so to solve this problem this research has been designed.

chronic sinusitis is a very common problem. the functional endoscopic sinus surgery is a prevalent option to treat this disease.during usage of different techniques of surgery, the need for packing after surgery is debatable problem. someone claimed packing is unnecessary and other one propose different material to packing after surgery. so to solve this problem this research has been designed.

Eligibility criteria:
inclusion criteria: * all patients with chronic sinusitis who candid of fess exclusion criteria: * systemic disease * corticosteroid usage counterindication * immune suppresive usage * choncha bollusa resection-

Keywords: chronic sinusitis fess packing
the substance abuse treatment to hiv care ii (sat2hiv-ii) project

Conditions: Substance Use

Summary: an experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.

a cluster-randomized type 3 hybrid trial with hiv service organizations across the united states. the primary aims is to test the effectiveness of an innovative pay-for-performance (p4p) strategy for improving the implementation of a motivational interviewing-based brief intervention for substance use.

Eligibility criteria:
inclusion criteria: * inclusion criteria for staff participants: * 18+ years of age inclusion criteria for client participants: * 18+ years of age * diagnosed with hiv exclusion criteria: * exclusion criteria for staff participants: * none exclusion criteria for client participants: \* none
the prevail study

Conditions: In-stent Restenosis; Ischemic Heart Disease; Coronary Artery Disease

Summary: to evaluate the clinical safety and efficacy of a new medtronic coronary drug-coated balloon catheter in the treatment of de novo lesions, small vessel disease or in-stent restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

this study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the medtronic coronary drug-coated balloon catheter. patients with de novo lesions, in-stent restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study. each subject is expected to be followed in the study for 12 months. procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.

Eligibility criteria:
key inclusion criteria * subject with documented stable or unstable angina, and/or clinical evidence of ischemia * subject is an acceptable candidate for treatment with a coronary drug- coated balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's instructions for use and the declaration of helsinki. key exclusion criteria * acute myocardial infarction within the previous 72 hours * planned treatment involves a bifurcation * three vessel disease
safety and efficacy of bhv-3000 (rimegepant) orally disintegrating tablet for acute treatment of temporomandibular disorders

Conditions: Temporomandibular Disorders (TMD)

Summary: the purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of temporomandibular disorders (tmd), which are medical conditions involving the temporomandibular joint (the joint connecting the jawbone to the skull) and surrounding muscles and tissues.


Eligibility criteria:
inclusion criteria: \* subject has a minimum 3-month to a maximum 5-year history of temporomandibular disorder diagnosed by a healthcare provider. * at least one instance of pain ≥ 6 on a numeric rating scale (nrs) (0-10) in the jaw and/or temple area on either side in the past 30 days prior to the screening visit. * subject agrees to study-required restrictions of new pain medication, injection therapy, oral devices, occlusal splint therapy or any other pain management techniques during the course of the study. * subject agrees to study-required birth control methods during the course of the study and female subjects must not be breastfeeding. * no clinically significant abnormality identified on the medical or laboratory evaluation. exclusion criteria: \* subject has an exclusionary headache, joint, pain, connective tissue, or developmental disorder. * subject has an exclusionary history of trauma, surgery, or radiation treatment to the head and neck. * body mass index ≥ 33kg/m2. * subject history of exclusionary medical conditions such as hiv disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions. * subjects taking/using excluded therapies. * participation in clinical trial with non-biological investigational agents or investigational interventional treatments. * subjects who have previously participated in any bhv-3000/ bms-927711/ rimegepant study. * planned participation in any other investigational clinical trial while participating in this clinical trial.

Keywords: temporomandibular disorders tmd temporomandibular joint tmj
abdominal aortic junction tourniquet (aajt-s) for non-compressible torso haemorrhage

Conditions: Exanguination; NCTH; Polytrauma

Summary: this study seeks to evaluate the feasibility of a abdominal aortic balloon occlusion of the aorta (aajt-s) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.

the study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. however, the device has already been used in the emergency room and aajt-s application is no study specific intervention.

Eligibility criteria:
inclusion criteria: * aged, or believed to be aged, 18 years or above, * confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss) * is thought to benefit from trauma resuscitation with aajt-s or reboa zone iii exclusion criteria: * suspected additional bleeding source proximal to the umbilicus, or * known or suspected pregnancy at presentation, or * known abdominal aortic aneurysm

Keywords: ncth aortic occlusion exanguniation
feasibility of remote activity assessment and pro collection among transgender cancer survivors

Conditions: Neoplasms; Chronic Disease

Summary: prospective observational feasibility study to evaluate the role of wearable activity monitors to determine the feasibility and acceptability of remote monitoring using wearable technology and pros to monitor fatigue and physical function in transgender cancer patients and survivors.

transgender cancer survivors are a diverse population who currently suffer from cancer-related disparities. enrolled subjects will receive wearable activity devices to help understand how their daily activity (e.g., daily step counts, stairs climbed) and sleep levels are affected by their symptoms and treatment side-effects, including fatigue, physical functioning, emotional well-being, sleep quality, and quality of life over the 2-week course of the study. qualitative interviews will be conducted to gain a deeper understanding of barriers to physical activity and their perceived relationships with their cancer history, treatment symptoms and gender affirming hormone therapy.

Eligibility criteria:
inclusion criteria: * self-identifies as transgender person with a history of cancer or receiving treatment for cancer in the last five years from screening for the current study (case) or self-identifies as transgender person without a history of cancer (control) * 18 years or older * ambulatory (use of walking aids, such as cane and rollator, is acceptable) * access to a device (e.g., smartphone, tablet, iphone) that has the capability to sync to the fitbit * have an understanding, ability, and willingness to fully comply with study procedures and restrictions * can read and understand english, spanish, or tagalog (for participant surveys and interviews) * informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: * any person that does not meet the listed criteria above * using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment\*. however, removable hearing aids are permitted.
trial of montelukast for treatment of acute bronchiolitis

Conditions: Bronchiolitis

Summary: the primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.


Eligibility criteria:
inclusion criteria: * male or female infants aged 3 to 12 months of age * diagnosis by emergency physician of bronchiolitis exclusion criteria: * any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma * any history of previous bronchodilator use prior to this illness * treatment with corticosteroids in the 14 days prior to the current illness * immunosuppression * immunodeficiency * caregiver does not speak english * diagnosis by the treating ed physician of croup * diagnosis by the treating ed physician of pneumonia * caregiver does not have access to a telephone

Keywords: bronchiolitis montelukast leukotriene inhibitor
survivorship and outcomes of robotic-arm assisted medial unicompartmental knee arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of the study is to determine the survivorship of robotic-arm assisted mck medial onlay unicompartmental knee arthroplasty implants at two, five and tem year follow up.

the purpose of the study is to determine the survivorship of robotic-arm assisted mck medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted unicompartmental arthroplasty.

Eligibility criteria:
inclusion criteria: * all patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial mck onlay implant and are at least 24 months post-operative. * patient has signed an irb approved informed consent form or with irb approved waiver of written consent, patient has verbally consented to study participations. * patient willing to comply with follow up. exclusion criteria: * patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms. * patient had active infection * medial mck onlay implants were implanted without bone cement * patients did not have sufficient bone stock to allow for insertion and fixation of components * patient did not have sufficient soft tissue integrity to allow for stability * patient had a neurological or muscular deformity that did not allow for control of the knee.

Keywords: osteoarthritis medial unicompartmental