Kornimate/medical-research-clean huggingface dataset:
medtronic hugo™ robotic assisted surgery (ras) system in urologic surgery (expand uro)

Conditions: Bladder Cancer; Prostate Cancer; Kidney Cancer; Pelvic Tumor; Interstitial Cystitis; Congenital Abnormalities; End Stage Renal Disease; Renal Tumor; Kidney Injury

Summary: this study will evaluate the safety and performance of the medtronic hugo™ ras system when used for urologic ras procedures.

a prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic ras procedure using the medtronic hugo™ ras system. subjects without an oncologic indication will be followed for 30 days post-procedure. oncologic subjects will be followed annually through 5 years. the study will be conducted in up to 6 investigative sites in the united states of america (usa).

Eligibility criteria:
inclusion criteria: 1. adult subjects (age ≥ 22 years) as required by local law 2. subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure 3. subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure 4. the subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form exclusion criteria: 1. subjects for which minimally invasive surgery is contraindicated as determined by the investigator 2. subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the investigator 3. subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care 4. non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy. 5. female subjects pregnant at the time of the surgical procedure. 6. subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity) 7. subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 8. subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
meaning-centered intervention for muslim patients who are being treated for advanced cancer

Conditions: Advanced Cancer

Summary: this study will compare the effectiveness of the masterful supportive care intervention with that of the non-faith-based active control supportive care intervention, which uses the american cancer society's patient education materials, for muslim patients who have advanced cancers. all 3 sessions may occur within one week or over multiple weeks (nonconsecutively), depending on the participants preference. the participant will have up to 12 weeks from recruitment to complete all sessions and follow up surveys.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * identify, either as self-report or on the mskcc emr, as muslim * are in treatment including surveillance, for a confirmed diagnosis of stage iii or iv cancer (solid or liquid) as per clinician or pathology report * have an estimated life expectancy of at least 6 months, as determined by their primary oncologist * are cognitively intact (oncologist's clinical impression or judgement of study staff) * able to speak and read english or arabic (self-reported preference or on the mskcc emr system). * to assess english proficiency, participants will be asked two questions: (1) the census limited english proficient item "how well do you speak english?" with response options "not at all, not well, well, or very well" and (2) "what is your preferred language for healthcare?" * participants who are eligible for the study and are fluent in english will be identified by the response "very well" to the 1st question and a response indicating english as the preferred language for healthcare. exclusion criteria: * major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation * patients diagnosed with primary brain tumors as per clinician report, as they may have difficulty completing the intervention and answering the questionnaires * undergoing hematopoietic stem cell transplantation (hsct) as per clinican report or the emr * currently in psychotherapeutic treatment. symptoms of anxiety and depression are common among patients with stage iii or iv cancer. antidepressants, anxiolytics, and other psychotropic medications do not diminish the effects of psychotherapy; thus we will not exclude patients who are being treated with these medications, as long as they are not in psychotherapy.

Keywords: meaning-centered intervention masterful intervention 20-018
stellarex dcb versus standard balloon angioplasty for treatment of below-the-knee (btk) arteries

Conditions: Critical Limb Ischemia

Summary: the purpose is to demonstrate the safety and effectiveness of the stellarex dcb for the treatment of stenosis or occlusions of below-the-knee arteries.


Eligibility criteria:
inclusion criteria: * rutherford clinical category 4-5 * life expectancy \> 1 year * significant stenosis ≥70% * patent inflow artery * target vessel(s) diameter between 2 and 4 mm * target vessel(s) reconstitute(s) at the ankle exclusion criteria: * pregnant or planning to become pregnant * history of stroke within 3 months * planned major amputation * egfr \<30 * acute limb ischemia * prior stent placement in target lesion
a multicenter study to evaluate functional outcome after knee replacement

Conditions: Osteoarthritis

Summary: patients will be consecutively enrolled by implant. implant groups will be those who have undergone surgery with either a conformis itotal® cr tka or an off-the- shelf (ots) system. the patient will conduct functional testing and answer questionnaires. the results will compare the conformis itotal with an off the shelf knee replacement.

to compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a conformis itotal® cr tka or an off-the- shelf (ots) system.the person conducting the functional testing will be blinded to the device implanted. sites will perform the off-the-shelf total knees conventional instrumentation.

Eligibility criteria:
inclusion: * clinical condition included in the approved indications for use for the itotal cr * osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a tkr procedure. disease status is assessed by clinical and radiographic assessment * willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits * \> 18 years of age exclusion: * subject will require a simultaneous bilateral procedure * other lower extremity surgery within 1 year * severe (\> 15º) fixed valgus or varus deformity * severe (\> 15º) extension deficit * severe instability due to advanced loss of osteochondral structure * loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified * insufficient bone stock on the femoral or tibial surfaces * contralateral knee replacement surgery within the past 6 months * bmi \> 40 * active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years * poorly controlled diabetes (defined as hba1c \>7 or surgeon discretion) * immunocompromised * other physical disability affecting the hips, spine, or contralateral knee that limits function * disabling chronic pain with narcotic dependence * compromised pcl or collateral ligament * prior history of failed implant surgery of the joint to be treated, including unicompartmental knee arthroplasty (uka), or bicompartmental knee arthroplasty (bka) * prior history of failed high tibial osteotomy (hto) * participation in another clinical study which would confound results * inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Keywords: knee implant knee replacement total knee replacement
barbershop talk: reducing excessive alcohol consumption among black men

Conditions: Drinking Behavior; Drinking Excessive; Drinking

Summary: socially disadvantaged black men are at increased risk for unhealthy drinking habits that may, in turn, increase preventable chronic disease. this project seeks to test the effectiveness of a screening, brief intervention, and referral to treatment (sbirt) intervention for use within barbershop settings to reduce average drinking days and the number of unhealthy drinking days. data from this study will further our understanding of how to reduce the risk of alcohol-related morbidity and mortality among black men. data will also improve our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings; thus, extending the reach of evidence-based care to communities with the highest need.


Eligibility criteria:
inclusion criteria: * self-identify as black * aged 18 or older * low income as defined by any indicator (e.g., medicaid; earned income tax credit; children's health insurance plan; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; head start program). exclusion criteria: -
ibrutinib in combination with corticosteroids vs placebo in combination with corticosteroids in participants with new onset chronic graft versus host disease (cgvhd)

Conditions: Chronic Graft Versus Host Disease

Summary: to evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cgvhd.


Eligibility criteria:
key inclusion criteria: * new onset moderate or severe cgvhd as defined by the 2014 national institutes of health (nih) consensus development project criteria * need for systemic treatment with corticosteroids for cgvhd * no previous systemic treatment for cgvhd (including extracorporeal photopheresis \[ecp\]) * participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute gvhd but if the subject is receiving prednisone for prophylaxis or treatment of acute gvhd it must be at or below 0.5 mg/kg/d * age ≥12 years old * karnofsky or lansky (subjects \<16 years) performance status ≥60 key exclusion criteria: * received any previous systemic treatment for cgvhd with the exception of corticosteroids administered for cgvhd within the 72 hours prior to signing the informed consent form. * inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cgvhd * any uncontrolled infection or active infection requiring ongoing systemic treatment * progressive underlying malignant disease or any post-transplant lymphoproliferative disease * known bleeding disorders * active hepatitis c virus (hcv) or hepatitis b virus (hbv)

Keywords: chronic graft versus host disease pcyc1140 pcyc1140im 1140 ibrutinib gvhd steroid dependent refractory chronic pci32765 imbruvica pharmacyclics pcyc graft versus host disease immunology new onset graft versus host disease integrate corticosteroids prednisone
preliminary study of early, primary hiv infection in a high risk cohort

Conditions: HIV Infections

Summary: the study of early, acute hiv infection is critical to understanding subtype-specific pathophysiologic differences, since up to 50% of acute hiv infections may be incapacitating. this study will establish whether the patient population of the thai red cross anonymous clinic is suitable for the study of early, acute infection.

this study will utilize existing (collected after 1 january 2006) and prospectively collected hiv seronegative clinical specimens not used as part of any research protocol. the specimens in this study are discarded anonymous samples from the voluntary counseling and testing (vct) facilities at the thai red cross anonymous clinic in bangkok, thailand. the specimens cannot be linked to the tested subjects. the samples will be labeled using the anonymous clinic identification number which is a 7 digit number with the first 2 digits representing the year and the following 5 digits representing the sequence of which the client sought care in that calendar year. preliminary study of early, primary hiv infection in a high risk cohort.

Eligibility criteria:
inclusion criteria: * all clients who access services included in the "health check up packages by age groups" at the thai red cross aids research centre. exclusion criteria: * none

Keywords: hiv seronegative acute infection
the hand functions in cerebral palsy

Conditions: Cerebral Palsy; Hand Functions

Summary: the hand motor functions are very important in the daily life activities, educational, and social participation of children. losing the hand motor functions limit these activities and participation. constraint-induced movement therapy (cimt) or virtual reality (vr) therapy has often been preferred to improve the hand's motor functions.

cimt and vr are used to improve the motor functions of the hand in cerebral palsy (cp). the aim of this study was to compare the effects of cimt-vr use and only cimt use on hand functions in children with hemiparetic cerebral palsy. hand function and performance were evaluated with the jebsen-taylor and moberg pick-up tests. all evaluations were made twice; before the first therapy and after six weeks. children with hemiparetic cp were divided into three groups randomly (traditional techniques (tt), tt+cimt, and tt+cimt+vr).

Eligibility criteria:
the inclusion criteria of the study were determined to be * aged 8 to 18 years, * diagnosed with hemiparetic cp, * being level 2 or 3 according to the gross motor function measurement scale and the manual ability classification system. the exclusion criteria of the study were, * severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping), * having pharmacologic medicine for spasticity, * having botulinum toxin a injections in the last 6 months, * having upper extremity surgery, * having visual and/or auditory problems which affect therapy or evaluation.

Keywords: hand functions virtual reality constraint-induced movement therapy cerebral palsy rehabilitation
additional hyperbaric oxygen after lower extremity amputation

Conditions: Diabetes Mellitus; Claudication, Intermittent; Critical Limb Ischemia; Osteomyelitis; Amputation; Lower Extremity Ulcer; Diabetic Angiopathy; Diabetic Neuropathies; Diabetic Foot

Summary: this study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. the patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.

hyperbaric oxygen therapy has been used to treat hard to heal wounds for decades. amputation, especially distal lower extremity amputations have the same problem with healing and patients often need to be re-amputated more proximally. in these patients oxygen levels are often the decisive factor. providing additional oxygen under hyperbaric conditions will increase tissue oxygen concentration sufficient for the amputation stump to heal. this will give the patients a more distal amputation with better condition for ambulation.

Eligibility criteria:
inclusion criteria: * lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis. * fit to receive hyperbaric oxygen therapy determined by an anesthesiologist/hyperbaric medicine physician. * able to cooperate and follow up appointments * included within 7 days after final surgery exclusion criteria: * not fulfilling inclusion criteria * pregnancy * dementia

Keywords: diabetic foot diabetes lower extremity amputation hyperbaric oxygen therapy hbot
study of obeldesivir in children and adolescents with covid-19

Conditions: COVID-19

Summary: the goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (odv) in children and adolescents with coronavirus disease 2019 (covid-19). the primary objectives are to evaluate the plasma pharmacokinetics (pk), safety and tolerability of odv in pediatric participants with covid-19.

pediatric participants will be enrolled as follows: * cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg * cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg * cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg * cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * cohort 5: ≥ 14 days to \< 28 days of age, gestational age (ga) ≥ 37 weeks and weight ≥ 2.5 kg * cohort 6: 0 days to \< 14 days of age, ga ≥ 37 weeks and birth weight ≥ 2.5 kg * cohort 7: 0 days to \< 56 days of age, ga \< 37 weeks and birth weight ≥ 1.5 kg

Eligibility criteria:
key inclusion criteria: * individual or legal guardian willing and able to provide written informed consent prior to performing study procedures. individuals will provide assent, if possible, in accordance with local requirements and investigator's discretion. * aged \< 18 years who meet one of the following weight criteria and gestational age (ga) criteria where applicable: * cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg * cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg * cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg * cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * cohort 5: ≥ 14 days to \< 28 days of age, ga ≥ 37 weeks and weight ≥ 2.5 kg * cohort 6: 0 days to \< 14 days of age, ga ≥ 37 weeks and birth weight ≥ 2.5 kg * cohort 7: 0 days to \< 56 days of age, ga \< 37 weeks and birth weight ≥ 1.5 kg * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) or an alternative molecular diagnostic assay ≤ 5 days before screening. * initial onset of coronavirus disease 2019 (covid-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening. * presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to covid-19 per protocol. key exclusion criteria: * anticipated access to and use of authorized or approved covid-19 therapies during the current covid-19 illness \< 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, intravenous remdesivir (rdv), monoclonal antibodies). * vaccination for sars-cov-2 or self-reported history of sars-cov-2 infection \< 4 months prior to screening. * received any approved, authorized, or investigational direct acting antiviral drug against sars-cov-2 for the treatment of covid-19 \< 28 days or \< 5 half-lives, whichever is longer, before enrollment. note: other protocol defined inclusion/exclusion criteria may apply.
a study to evaluate icp-022 in patients with r/r pcnsl and scnsl

Conditions: PCNSL; Secondary Central Nervous System Lymphoma

Summary: the phase ii clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of icp-022.

safety, tolerability evaluation, and anti-tumor effects of icp-022 in chinese patients with recurrent/refractory central nervous system lymphoma (pcnsl) and recurrent/refractory secondary central nervous system lymphoma (scnsl) will be evaluated in approximately 82 subjects. pharmacokinetics of icp-022 will be evaluated in approximately 20 subjects .

Eligibility criteria:
key inclusion criteria: 1. men and women ≥ 18, and ≤75 years of age 2. histologically documented pcnsl, or histologically documented systemic diffuse large b-cell lymphoma (dlbcl) for scnsl. 3. subjects with refractory or relapsed disease, one prior cns directed therapy, and ≤ 4 systemic treatments. 4. ecog performance status of 0-2 5. able to provide signed written informed consent key exclusion criteria: 1. patients with scnsl actively receiving treatment for extra-cns disease are excluded 2. t-cell lymphoma. 3. patient requires more than 8 mg of dexamethasone daily or the equivalent. 4. non-hematological toxicity must recover to ≤ grade 1 from prior anti-cancer therapy (except for alopecia) 5. known active infection with hbv, hcv or hiv. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: recurrent or refractory
esophageal motility disease screening in patient with suspicion or diagnosis of ibd

Conditions: Inflammatory Bowel Disease

Summary: aims: prospective evaluation of patients with a suspicion or diagnosis of inflammatory bowel disease (ibd) to evaluate osophageal motility before and during therapy material and methods: the investigators prospectively perform manometry in patients with or with symptoms consistent with ibd. the investigators evaluate esophageal motility with high resolution manometry before, during and after ibd therapy. clinical data are also collected to find possible correlations. the study do not modify the planned ibd therapy, but observe motility findings.

oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the ibd therapy and follow up. no other interventions are administered to participants during this study.

Eligibility criteria:
inclusion criteria: * inflammatory bowel disease * suspicion of inflammatory bowel disease exclusion criteria: * pregnancy

Keywords: inflammatory bowel disease manometry
identifying skin biopsy sites

Conditions: Identification of Skin Cancer Biopsy Sites

Summary: the primary objective of this study is to investigate the patient experience during skin biopsy.


Eligibility criteria:
inclusion criteria: * age 18 and over * the subjects are in good health. * the subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. * patients who have had one or multiple skin biopsies or board-certified dermatologists. exclusion criteria: * under 18 years of age. * subjects who are unable to understand the protocol or give informed consent.
impact of covid-19 on psoriasis practice

Conditions: Psoriasis; Covid19

Summary: covid-19 had a major impact on dermatology practice globally with special emphasis on chronic diseases e.g. psoriasis. the main objective of this work is to investigate the effect of covid-19 pandemic on psoriasis management. this work is designed as a cross-sectional survey based on a questionnaire directed to egyptian dermatologists.


Eligibility criteria:
inclusion criteria: * egyptian dermatologists

Keywords: psoriasis coronavirus sars-cov-2