Kornimate/medical-research-clean huggingface dataset:
preventing chemotherapy induced neuropathy (prechin)

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Summary: the project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (cipn). as a pilot study, safety, tolerability and early clinical activity will be studied. the study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.

localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (cipn). there are no reliable methods for the prevention or the treatment of cipn. on the basis of the dose-related pathophysiology of cipn, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of cipn. the proposed potential treatment method would aim to reduce the development of cipn. this project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of cipn in cancer subjects undergoing taxane-based chemotherapy.

Eligibility criteria:
the inclusion criterion for the healthy subjects * age 21-80 years * signed informed consent from patient * no history of neuropathy * ecog 0 * no history of hospitalization in the past 6 months the inclusion criteria for the cancer patients undergoing taxane-based chemotherapy * age 21- 80 years. * signed informed consent from patient or legal representative. * scheduled to receive taxane-based chemotherapy the exclusion criteria for both healthy subjects and cancer patients * open skin wound or ulcers of the limbs * a score of more than 5 in the total neuropathy score (tns) at baseline (not applicable for healthy subjects) * history of raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes

Keywords: paclitaxel neuropathy hypothermia cryocompression
study of pasireotide long acting release (lar) injection in patients with acromegaly and patients with carcinoid disease

Conditions: Carcinoid Tumor; Acromegaly

Summary: this study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide lar intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease


Eligibility criteria:
inclusion criteria for patients with acromegaly: * male or female patients between 18 and 80 years * patients with acromegaly due to a pituitary adenoma with elevated gh and igf-1 concentrations exclusion criteria for patients with acromegaly: * patients with compression of the optic chiasm causing any visual field defect * specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start * female patients who are pregnant or lactating inclusion criteria for patients with carcinoid disease: * male or female patients aged ≥18 years * patients with histologically confirmed, metastatic carcinoid tumors of the digestive system * patients with elevation of chromogranin-a (cga) and/or serotonin * patients who are not adequately controlled by somatostatin analogues exclusion criteria for patients with carcinoid disease: * specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start * female patients who are pregnant or lactating other protocol-defined in- and exclusion criteria may apply.

Keywords: refractory/ resistant carcinoid disease acromegaly adults pasireotide lar somatostatin analogue som230 pharmacokinetics refractory or resistant carcinoid disease and acromegaly
a safety study of ly3462817 and ly3509754 in participants with psoriasis

Conditions: Psoriasis

Summary: this study is being conducted to determine how safe and how well tolerated ly3462817 is when given to participants with psoriasis. blood tests will be done to check how much ly3462817 is in the bloodstream and how long the body takes to get rid of it. the study will last up to one year and one month for each participant. as part of protocol addendum, this study is additionally evaluating the safety and tolerability of ly3509754 in participants with psoriasis. blood tests will be done to check how much ly3509754 is in the bloodstream and how long the body takes to get rid of it. the addendum will last up to 12 weeks for each participant.


Eligibility criteria:
inclusion criteria: * participants must have been diagnosed with psoriasis for at least 6 months * participants must have active psoriasis plaques * participants must be willing and able to have skin biopsies (small samples of skin removed for testing) exclusion criteria: * participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (day 1) * participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline
assessmet of patients with pah right ventricular volume

Conditions: Pulmonary Arterial Hypertension

Summary: the primary endpoint of this study is the percent difference between the ventripoint medical system (vms) and cmri for estimating the end diastolic and end systolic right ventricular volumes (rvedv and rvesv) in subjects with pulmonary arterial hypertension (pah). the trial will be defined as positive if the mean vms-cmri percent difference is \ -10% at a 1-sided 0.025 statistical significance level for rvedv and for rvesv, with no safety concerns for the vms procedure.

the objective of this study is: the comparison of the vms and mri values for edv, esv, and ef using 75 subjects. secondary objectives are: the determination of vms inter-observer and intra-observer variability of these quantities using 30 subjects.

Eligibility criteria:
inclusion criteria: * patients with group 1 pulmonary arterial hypertension * ipah * hpah * apah-ctd * apah-hiv * apah-poph * apah-drugs/toxins * apah-chd repaired simple systemic to pulmonary shunts, i.e. asd, vsd and/or pda * apah-chd unrepaired simple systemic to pulmonary shunts, i.e. asd, vsd and/or pda patients who can be expected to lie motionless during imagine males and females 12 years of age and older exclusion criteria: * lack of informed consent (and assent as appropriate) * other forms of ph not included in inclusion criteria * left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, lv systolic dysfunction, i.e. lvef \<40% or lvsf \<22%, and/or clinically significant lvdd * known/detected arrhythmia that interferes with image acquisition * implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials * pregnant or breast-feeding females * contraindications for mri (for those patient that undergo mri) * clinically significant obstructive or restrictive lung disease * subjects with known hiv infection who have any clinical or laboratory evidence of any opportunistic pulmonary disease (e.g., tuberculosis, pneumocystis carinii pneumonia, or other pneumonias) * pah associated with thyroid disorders, glycogen storage disease, gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy * any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria * pah associated with significant venous or capillary involvement (pcwp ˃ 15 mmhg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis * clinically significant cardiac ischemic disease * systemic hypertension defined as sbp ˃ 160 mmhg and/or dbp ˃ 95 mmhg (treated or untreated) * moderate or severe hepatic impairment, i.e., child-pugh class b or c * any subject with obstructive sleep apnea or who requires the use of cpap or bipap device

Keywords: ipah hpah apah ctd apah hiv apah poph apah drugs/toxins apah chd repaired apah chd unrepaired
immune intervention with rituximab to preserve beta cell function in early onset type 1 diabetes

Conditions: Type 1 Diabetes

Summary: transient elimination of b lymphocytes with anti-cd20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of beta-cell destruction in type 1 diabetes is typically associated with t-lymphocyte autoimmunity. many t-lymphocyte-mediated diseases include a b-lymphocyte component. b lymphocytes can play a crucial role as antigen-presenting cells, expressing high levels of class ii major-histocompatibility-complex antigens and generating cryptic peptides to which t lymphocytes are not tolerant. b lymphocytes can be selectively depleted with the anti-cd20 monoclonal antibody. we will test the hypothesis that transient elimination of b lymphocytes with anti-cd20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type 1 diabetes * the age of subjects between 8 and 70 years old * course of disease within 12 months * presence of at least one type of detectable islet autoantibody \[zinc transporter 8 antibody(znt8a),glutamic acid decarboxylase antibody(gada),protein tyrosine phosphatase-2 antibody(ia-2a),insulin autoantibody(iaa)\] * fasting c-peptide levels of at least 0.2 pmol/ml exclusion criteria: * confirmed diagnosis of type 2 diabetes * severe chronic or acute complications of diabetes * severe infection or damage to the immune response * presence of chronic latent infection in vivo * viral hepatitis b patients whose hepatitis b virus(hbv)dna \> log10\^5 * liver and kidney dysfunction, alanine aminotransferase(alt), aspartate aminotransferase(ast), and creatinine more than 2 times the upper limit of normal * hypotension, systolic blood pressure(sbp) ≤ 90mmhg, diastolic blood pressure(dbp) ≤ 60mmhg * patients with rheumatoid arthritis * allergic to any component of this drug * pregnancy, breast-feeding women * use of other immunosuppressive agents 3 months before selected

Keywords: type 1 diabetes age course of disease autoantibodies c-peptide levels
assessment of eyelid topology and kinetics based on deep learning method

Conditions: Eyelid Diseases

Summary: this study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.


Eligibility criteria:
inclusion criteria: 1. normal volunteers without eyelid diseases 2. patients with blepharoptosis 3. patients with blepharospasm 4. patients with dry eye disease 5. patients with graves' disease exclusion criteria: variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
peer support in dialysis

Conditions: End Stage Renal Disease

Summary: peer mentoring is an approach used to support patients through their experience. in the end stage kidney disease community many patients find out about their kidney failure without warning. this study is designed to test the feasibility of a structured peer support program, specifically, patient uptake, engagement and patient and staff perspectives.


Eligibility criteria:
mentor patient participants inclusion criteria: * patients living with dialysis or kidney transplant, who volunteer to support other patients. * mentor participants agree to complete the cms end stage renal disease network peer mentoring training program (https://www.kidneylearninghub.com/patients-peer-mentoring-program/ ) and follow the guidelines for participation in the program. mentor patient participants exclusion criteria: * age \<18 years. * patient cannot communicate in english. * concerns raised by the clinical team that may expose the mentor, mentee, staff, or the program to risks, as identified by the clinical team and discussed with the principal investigator. mentee patient participants inclusion criteria: * all incident (new) dialysis patients or their care partners, within the first three months of dialysis. or * prevalent dialysis patients or their care partners identified by the clinical team to need peer support. mentee patient participants exclusion criteria: * age \< 18 years. * significant physical or psychological health conditions (including cognitive impairment) that would limit the patient's ability to interact with the mentor, and care partner not available or reachable to join the program. * this criteria will be subjectively evaluated by the clinical team. clinical and administrative staff supporting the program inclusion criteria * referring physicians, the medical director of the center, social workers, nurses, patient care technicians (pct), certified clinical hemodialysis technicians (ccht), and administrative staff. * support staff are those who interact with mentors or mentees as part of their routine work. * formally participate in supporting the program by identifying candidates, introducing them to the program, or providing them with support.
fluid restriction and quality of life on dialysis

Conditions: End Stage Renal Disease

Summary: almost 30,000 people in the uk receive dialysis due to end stage renal disease (esrd). although dialysis prolongs life, people receiving dialysis are still typically bothered by a range of physical symptoms and need to make substantial adjustments in order to accommodate esrd and its treatment. one adjustment that is often required is a dramatic reduction in fluid intake. although sticking to fluid intake restrictions improves the efficiency of dialysis, monitoring fluid intake is complicated. the restrictions also leave people feeling very thirsty so restrictions can be hard to stick to. this project will develop and test a brief psychological intervention for people who struggle to adhere to fluid intake restrictions and will aim to increase quality of life whilst on dialysis. the intervention will be developed with input from people with lived experience of esrd. it will then be offered to 12 people, recruited from clinics, who will complete questionnaires to monitor experiences and symptoms before, during and after the intervention. participants' data will be analysed to find out whether the intervention has been helpful in reducing fluid intake and improving quality of life. if the findings are promising, this would suggest that the intervention could be tested in a larger clinical study in the future.

please note: this study adopts a between-subjects concurrent multiple baseline single case abc experimental design. participant change within and across phases a (baseline, variable with participants randomised to a 6, 8, or 10 week baseline), b (4 week intervention phase) and c (4 week follow-up) will be explored.

Eligibility criteria:
inclusion criteria: * currently receiving haemodialysis for end-stage kidney disease * aged 18+ * adequate fluency in written and spoken english to undertake the intervention and complete measures (assessed by research psychologist during discussion of study commitment) * willing and able to participate in face-to-face and/or digital delivery of a psychological intervention (e.g. if digital delivery is requested or/or necessitated by covid 19 restrictions patient has access to a computer, tablet or phone). * identified by clinical staff as having difficulty with adherence to fluid intake recommendations. * consents to participation, including recording of video sessions for fidelity/adherence rating and supervision. exclusion criteria: * • lack of capacity to consent * poorly controlled diabetes resulting in recent hospital admissions for hypo/hyperglycaemic episode(s) * intellectual disability that prevents self-management of fluid intake
angiogenic factor expression during fractionated irradiation

Conditions: Primary Esophageal Carcinoma

Summary: the main question of this study is if and when vegf (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor. * therefore the first aim of this study is to identify the time point of induction of vegf in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation). * if we identify increased expression of vegf at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.


Eligibility criteria:
inclusion criteria: * patients that will receive chemoradiation following cross-schedule before surgery for esophageal carcinoma * ability to give informed consent * age 18 years or older exclusion criteria: * pregnancy * evidence of bleeding diathesis, coagulopathy * inflammation of the gi-tract * brain metastases * diastolic/ systolic hypertension, not responding to treatment * arterial thromboembolism in medical history * surgery within the month prior to start of bevacizumab treatment

Keywords: radiotherapy vegf esophagus carcinoma bevacizumab
liposomal bupivacaine vs adductor canal block in total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: this study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. the goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female between the ages of 18-65 * patients willing and able to sign the informed consent * patients able to comply with follow-up requirements including self-evaluations * patients requiring a primary total knee replacement * patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis exclusion criteria: * revision total knee arthroplasty * bilateral total knee arthroplasty * patients with inflammatory arthritis * patients with a body mass index (bmi) \> 40 * allergy to ropivacaine, bupivacaine, or other local anesthetic agents * current use of opioid drugs * patients with a history of total or unicompartmental reconstruction of the affected joint * patients that have had a high tibial osteotomy or femoral osteotomy * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels * patients with a systemic or metabolic disorder leading to progressive bone deterioration * patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers * patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis * patients with knee fusion to the affected joint * patients with an active or suspected latent infection in or about the knee joint * patients that are prisoners

Keywords: bupivacaine osteoarthritis arthritis joint diseases ropivacaine anesthetics, local anesthetics
study to gather information on the safety and use of aflibercept injections into the eye for the treatment of eye disorders in mexican routine clinical practice

Conditions: Retinal Disease

Summary: the study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. data will be collected from patients who are being treated for such eye disorders in mexican routine clinical practice.

the primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wamd), myopic choroidal neovascularization (mcnv), diabetic macular edema (dme), macular edema secondary to central retinal vein occlusion (crvo) or macular edema secondary to branch retinal vein occlusion (brvo). secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on crvo, brvo and mcnv indications.

Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of a wet age-related macular degeneration (wamd), diffuse diabetic macular edema (dme), macular edema secondary to central retinal vein occlusion (crvo), macular edema secondary to branch retinal vein occlusion (brvo) or myopic choroidal neovascularization (mcnv); * decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion; * treatment naïve or pre-treated for macular diseases (to anti-vegf and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation; * if of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept exclusion criteria: * patient diagnosed with two or more of the studied indications in the same eye (wamd, dme, crvo, brvo and mcnv); * patients that were already treated with anti-vegf or steroids are allowed to be enrolled only if they received the last dose of anti-vegf 3 or more months ago and in the case of a steroid implant 6 months after the last dose; * current treatment with other intravitreal therapies * contra-indications according to eylea's / wetlia's local marketing authorization: * ocular or periocular infection * active intraocular inflammation * known hypersensitivity to aflibercept or to any of its excipients * pregnant or lactating women. * participation in an interventional study

Keywords: aflibercept intravitreal injection ocular disease wet age-related macular degeneration (wamd) diabetic macular edema (dme) macular edema secondary to central retinal vein occlusion (crvo) macular edema secondary to branch retinal vein occlusion (brvo) myopic choroidal neovascularization (mcnv) mexico