Kornimate/medical-research-clean huggingface dataset:
the effect of emotional freedom techniques on pelvic pain

Conditions: Woman; Pelvic Pain

Summary: pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life. eft is a method that can be preferred in pelvic pain due to its ease of use and low cost. raising women's awareness for eft

pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life. eft has become widely used in medical and psychological treatment settings in recent years.it is also used as a self-help technique by millions of people every year.eft is a method that can be preferred in pelvic pain due to its ease of use and low cost.

Eligibility criteria:
inclusion criteria: 1. being diagnosed with endometriosis 2. experiencing pelvic pain 3. being between the ages of 18-49 4. those whose symptom complaints are 5 or above on the visual analogue scale exclusion criteria: 1. patients with known systemic diseases (e.g. hypertension, diabetes, coronary, kidney and liver diseases); 2. patients with known malignancy; 3. women in menopause; 4. having any obstacle to communication

Keywords: pelvic pain woman quality of life
a study to establish the safety and tolerability of zimura™ (anti-c5 aptamer) in combination with anti-vegf therapy in subjects with idiopathic polypoidal choroidal vasculopathy (ipcv)

Conditions: Idiopathic Polypoidal Choroidal Vasculopathy

Summary: the objectives of this study are to evaluate the safety and tolerability of zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (vegf) therapy in subjects with idiopathic polypoidal choroidal vasculopathy (ipcv).

treatment experienced (prior treatment with anti-vegf monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of ipcv, will receive 3 monthly (q4w) intravitreal injections of zimura™ (1 mg/eye) in combination with anti-vegf therapy (avastin® 1.25 mg/eye or lucentis® 0.5 mg/eye or eylea® 2 mg/eye). safety endpoints include visual acuity loss (proportion of subjects with \>15 letter loss at month 3), ophthalmic adverse events (aes), systemic adverse events (aes), change in total retinal thickness (sd-oct) at month 3, regression and/or elimination of polyps at month 3 compared to screening as measured by indocyanine green angiography (icga), and laboratory values.

Eligibility criteria:
inclusion criteria: * subjects of either gender aged ≥ 50 years * diagnosis of ipcv * treatment-experienced defined as prior treatment with anti-vegf mono therapy of ≥ 8 injections in the previous twelve (12) months exclusion criteria: * any intraocular surgery or thermal laser within three (3) months of trial entry * any prior thermal laser in the macular region, regardless of indication * any ocular or periocular infection in the twelve (12) weeks prior to entry * history of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant * previous therapeutic radiation in the region of the study eye * a diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)

Keywords: idiopathic polypoidal choroidal vasculopathy ipcv zimura™ (previous name) avastin® eylea® lucentis®
comprehensive geriatric assessment in the elderly subjects (promising)

Conditions: Ageing; Frailty

Summary: the primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.

the primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. short- to medium-term outcomes will also be evaluated through follow-up.

Eligibility criteria:
inclusion criteria: * subjects with 65 years or older exclusion criteria: * no informed consent

Keywords: ageing comprehensive geriatric assessment polypharmacy
effects of administration of fostamatinib on blood concentrations of pioglitazone in healthy subjects

Conditions: Rheumatoid Arthritis; Healthy Volunteers; Pharmacokinetics; Pioglitazone; Drug-drug Interaction; Amount of Pioglitazone in Blood

Summary: the purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * males or females (of non-child bearing potential) aged 18 to 55 years (inclusive) * minimum weight of 50 kg and a body mass index (bmi) of 18 to 35 kg/m2 (inclusive) * males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy) * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product * subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day * absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/l * any previous treatment with fostamatinib or pioglitazone

Keywords: phase 1 healthy volunteers pharmacokinetics rheumatoid arthritis ra fostamatinib pioglitazone drug-drug interaction
a clinical investigation of the vanguard™ complete knee system

Conditions: Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Lower Limb Deformity; Complications, Arthroplasty

Summary: the purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the vanguard™ complete knee system.

this is a 10-year prospective observational data collection on the vanguard total knee system. patients are asked to come in for a preop, operative, immediate post-operative, 6 month, 1 year, 3 year,5 year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device. the vanguard knee is an fda cleared device, and has been on the market since 2004.

Eligibility criteria:
inclusion criteria: * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus, or posttraumatic deformity * correction or revision of unsuccessful osteotomy, or arthrodesis patient selection factors to be considered include: * need to obtain pain relief and improve function * ability and willingness of the patient to follow instructions * including control of weight and activity level * good nutritional state of the patient * patient must have reached full skeletal maturity exclusion criteria: absolute contraindications include: * infection * sepsis * osteomyelitis * failure of a previous joint replacement relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, neuromuscular disease * incomplete or deficient soft tissue surrounding the knee additional exclusion criteria includes: failure of a previous joint replacement

Keywords: total knee arthroplasty total knee replacement knee arthritis
a pragmatic observational study of congestion profiles in patients with acute heart failure

Conditions: Acute Heart Failure

Summary: the goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. the main question\[s\] it aims to answer \[is/are\]: * primary objective: to study the prevalence of distinct congestion phenotypes * other objectives (including): * response to therapy as assessed by * natriuresis after 24 hours * rehospitalization and/or deats after 6 months * length of hospital stay * congestion at discharge * changes in filling pressures over time * relationship between liver stiffness, as assessed with fibroscan and congestion * substudy: glycosaminoglycan netword and endothial glycocalyx participants will undergo several extra study related measurements: * assessment of filling pressures with ultrasound * ultrasound investigation of the lungs and kidneys * fibroscan of the liver * sidestream darkfield imaging sublingual * as part of substudy glyco-ahf: skin biopsy to determine glycocalyx, as well as salt and water content. * as part of substudy preach-ahf: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins

objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients. study design: observational, prospective study study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics. main study parameters/endpoints: to identify distinct congestion phenotypes and study their association with response to therapy and outcomes secondary outcomes: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months exploratory outcomes include: length of hospital stay, congestion at discharge and changes in filling pressures over time. furthermore, as part of the glyco-ahf substudy: the expression of glycosaminoglycans and, as part of the preach-ahf substudy: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins.

Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent * age ≥ 18 years * male or female * primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. diagnosis is based on the criteria in the esc hf guidelines (1) * requirement of intravenous loop diuretics exclusion criteria: * patients with severe kidney dysfunction (in need for ultrafiltration or dialysis) * previous participation in this study * inability to follow instructions * dyspnoea or oedema primarily due to non-cardiac causes
internal radiation therapy after lumpectomy in treating women with ductal carcinoma in situ

Conditions: Breast Cancer

Summary: rationale: internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery. purpose: this phase ii trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

objectives: primary * determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the mammosite\^® radiation therapy system. secondary * determine the early and late complication rates and cosmetic outcome in these patients after treatment. outline: patients undergo lumpectomy. patients with negative tumor margins\* (no ink on tumor) undergo placement of the mammosite\^® radiation therapy system at the time of lumpectomy or within 4 weeks after surgery. note: \*if positive margins are present, the surgeon may elect to resect the positive margins and then insert a new mammosite® device if all other eligibility criteria are met. beginning 2-5 days after placement of the mammosite\^®, patients undergo brachytherapy through the mammosite\^® twice daily for 5 days (a total of 10 fractions). after completion of study treatment, patients are followed periodically for ≥ 5 years.

Eligibility criteria:
inclusion criteria: * ductal carcinoma in situ (dcis) confirmed by excisional or needle biopsy * size: \< 3 cm on mammogram * unicentric disease * ability to place mammosite device at time of lumpectomy or within 4 weeks of lumpectomy * patient age: ≥ 18 years, no upper limit * life expectancy \> 5 years exclusion criteria: * prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix * pregnant or breast feeding * multicentric disease * diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis

Keywords: ductal breast carcinoma in situ breast cancer in situ
study of the sars-cov2 neuroinvasiveness - covid19

Conditions: COVID19

Summary: sars-cov2 (covid-19) may invade the cns inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. management of severe neurological complications in covid-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. during surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. in this study, covid-19 patients will be evaluated first, for the presence of sars-cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of sars-cov2 neuroinfection in terms of inflammatory and immune responses.


Eligibility criteria:
inclusion criteria: * covid-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery exclusion criteria: * pregnant or lactating women

Keywords: sars-cov2 neuroinvasiveness covid-19 rt-pcr test
auricular neurostimulation for chemotherapy induced nausea and vomiting

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: this study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy induced nausea and vomiting.

chemotherapy induced nausea and vomiting (cinv) is a difficult to treat and potentially debilitating complication of chemotherapy. nausea and vomiting are one of the most prevalent and problematic side effects associated with chemotherapy treatment, effecting numerous patients. autonomic nervous system (ans) and the vagus nerve are important modulators of nausea and vomiting and are responsible for conveying visceral sensory information to the central nervous system responsible for nausea and vomiting. the aim of the study is to determine if stimulating a branch of the vagus nerve in the outer ear would reduce the frequency and severity of nausea and vomiting for patients undergoing chemotherapy treatment. subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy which would be applied for maximum of 5 days at the onset of inpatient admission for moderate to severe emetogenic chemotherapy cycle. they will then cross over to the other group (active vs sham) during the admission of the following identical chemotherapy cycle. nausea, vomiting, the need for additional antiemetic support and potential side effects will be monitored during the entire study.

Eligibility criteria:
inclusion criteria: * subjects who are scheduled to be admitted for chemotherapy administration and who will have at least one additional cycle of the same chemotherapy * chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy exclusion criteria: * significant developmental delays that would prohibit participation * infection or severe dermatological condition of ear * uncontrolled or severe infection * no implanted electrical device is permitted * pregnancy * severe cardiopulmonary disease * diagnosis of hemophilia or other bleeding disorders * diagnosis psoriasis vulgaris
a prospective study on sunitinib as first line therapy for advanced/metastatic renal cell carcinoma in asian population

Conditions: Renal Cell Carcinoma

Summary: this is a multi-national, phase ii, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for asian patients with advanced renal cell carcinoma.

sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (soc) for advanced renal cell carcinoma (rcc). however, asian patients in real world experienced grade iii/iv adverse events much more than expected. this multi-national, phase ii, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in asian people with advanced rcc.

Eligibility criteria:
inclusion criteria: * advanced renal cell carcinoma with histology confirmation * grade iii/iv aes happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest * ecog performance status 0 or 1 * appropriate vital organ functions exclusion criteria: * prior systemic treatment of mrcc * patients treated with any neoadjuvant or adjuvant systemic therapy * major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment. prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated * pregnant * allergic history to sunitinib

Keywords: sunitinib, 2/1 schedule, renal cell carcinoma
efficacy and safety of levocetirizine for treatment of recurrent cough associated with other allergic symptoms in children

Conditions: Cough

Summary: efficacy and safety of levocetirizine for treatment of recurrent cough associated with other allergic symptoms in children


Eligibility criteria:
inclusion criteria: * infants from 2 to 24 months both inclusive * suffering from recurrent cough associated with other allergic symptoms * hospitalized for respiratory or allergy related problems * laboratory results within normal ranges * height and weight between percentile 5 and 95 exclusion criteria: * having taken any of the disallowed medication * suffering form any disorder * history of sleep apnea * having concomitant chronic disease * known relevant renal, hepatic, cardiac or metabolism dysfunction * known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Keywords: levocetirizine dihydrochloride xyzal tablets
icareme global registry

Conditions: Type 2 Diabetes; Hypertension; Chronic Kidney Disease; Heart Failure

Summary: to provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, hypertension, heart failure and/or chronic kidney diseases

the registry intends to provide real world data on patient management and quality of care for patients with t2dm, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. to bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, hypertension, heart failure and chronic kidney disease. multinational, observational registry utilizing a cloud-based ecrf, for prospective and retrospective data collection, accessible to investigators and scientific committee. this registry will be open to all physicians managing t2dm, htn, hf or ckd across the world.

Eligibility criteria:
inclusion criteria: 1. being 18 years or older 2. having type 2 diabetes, hypertension, heart failure and/or chronic kidney disease 3. providing written informed consent to participate in the registry exclusion criteria: 1. having a life-threatening co-morbidity with life expectancy below 1 year 2. participating in an interventional trial requiring informed consent

Keywords: registry type 2 diabetes t2dm chronic kidney disease ckd hypertension htn adult population heart failure hf early cardiorenal complications
camp high 5: evaluation of the effect on upper limb function

Conditions: Neurological Injury; Hemiplegia

Summary: randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (cp) following a hybrid camp model of modified constraint induced movement therapy (mcimt) and hand-arm bimanual intensive training (habit).


Eligibility criteria:
inclusion criteria: * participants will range from 2 years to 11 years 11 months of age at time of enrollment. children under 5 years of age will attend a morning session and children 6 years and older will attend an -diagnosis: hemiplegia resulting from a neurological injury * manual ability classification system or mini manual ability classification system classification i-iii exclusion criteria: * botox injection within past 6 months or planned for within 6 months post camp * inability to follow commands * family unable to commit to daily sessions for 4 weeks * unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks
computed tomography-guided nasotracheal intubation procedure

Conditions: Computed Tomography-guided Nasotracheal Intubation; The Space Where the Tube Will be Passed in the Internal Nasal Valve Region

Summary: background: nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. the advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. the present study aimed to evaluate the effectiveness of computed tomography-guided nasotracheal intubation in predicting tube advancement difficulty and preventing epistaxis. material and methods: 60 maxillofacial surgery patients were included in the study. the space where the tube will be passed in the internal nasal valve region was measured horizontally (distance between inferior concha and septum) and vertically (distance between inferior concha and hard palate) by computed tomography. the patients were divided into two groups, 'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube through the nasal passage. roc analysis was performed, and cut-off values were determined to reveal the distance values at which difficulty may be experienced while advancing the tube. the cut-off values were 1.09 cm and 0.39 cm for the vertically and horizontally distances, respectively.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 who underwent bimaxillary orthognathic surgery * defined as asa (american society of anesthesiology) i or ii exclusion criteria: * the lack of preoperative ct scans * airways evaluated and considered difficult by the anesthesiologist * airways assessed and considered not appropriate for right angle endotracheal (rae) tube with7.0 mm internal diameter * history of sinusitis or head trauma * anticoagulant therapy

Keywords: computed tomography epistaxis maxillofacial orthognathic surgery intubation