Kornimate/medical-research-clean huggingface dataset:
central sensitization in knee osteoarthritis

Conditions: Osteo Arthritis Knee; Central Sensitisation

Summary: the stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. therefore, central sensitization should be considered and treated in patients with osteoarthritis. although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. the aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * being diagnosed with primary knee osteoarthritis according to american college of rheumatology criteria, * to be stage 2-3-4 knee osteoarthritis according to kellgren lawrence radiological staging, * to be with a central sensitization score of over 40 according to the csi, * to be able to fill the scales and accept to participate in the study. exclusion criteria: * being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease, * having cognitive impairment, * to have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months * having various diseases that may adversely affect performing balance exercises,

Keywords: central sensitisation osteoarthritis balance exercises
selection of patients with chronic inflammatory rheumatism requiring management during the covid-19 pandemia

Conditions: Covid19; Inflammatory Rheumatism; Rheumatoid Arthritis; Spondyloarthritis; Inflammatory Arthritis

Summary: the project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the covid-19 pandemia. this selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. the other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

the covid-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the rheumatology department of the limoges university hospital. the department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (cir) during this period, which allowed maintaining contact with patients in the patient database. during this telephone call, an cir-covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management. the strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. these students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. they had an interview with a senior rheumatologist from the department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the covid-19 infection and recommendations of the french rheumatology society for cir patients. the students were trained with quizzes on practical situations, with feedback on the answers. the information's collected in the questionnaire were based on the patients' feelings. telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination. the opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. at any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties. 943 patients were thus contacted between 14/04/2020 and 28/04/2020. they were able to benefit from an optimized management according to the context of the covid19 pandemic. these questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of covid19 on this population.

Eligibility criteria:
inclusion criteria: * patients with chronic inflammatory rheumatism who answered the ric-covid19 survey during the telephone call set up by the rheumatology department of the limoges university hospital during the confinement. exclusion criteria: * patients objecting to the use of their data

Keywords: chronic inflammatory rheumatism - covid-19
lipid profile and weight after pregnancy

Conditions: Cardiovascular Risk Factor; Body Weight

Summary: a randomized controlled trial aiming to investigate the effects of diet behavior intervention postpartum on body weight and lipid and metabolite profile in overweight and obese women in oslo, norway


Eligibility criteria:
inclusion criteria: * women admitted to adipol, oslo university hospital, norway (outpatient clinic for women with overweight or obesity during pregnancy) exclusion criteria: * twin birth, * non-norwegian speaking
radical resection and hipec for recurrent retroperitoneal sarcoma

Conditions: Retroperitoneal Sarcoma

Summary: retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. in approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. one of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence. at present, there are no options to prevent recurrence after surgery. in recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (hipec). radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. this is in combination with the use of hipec. hipec is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree celsius. surgery coupled with hipec has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. we hypothesize that hipec when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. we hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve survival.


Eligibility criteria:
inclusion criteria: 1. disease characteristics 1. histologically proven soft tissue sarcoma of one of following high-risk groups: * tumours with grade 2 or 3 histology * size more than or equal to 5cm * extracompartmental and deep extension 2. local recurrence of primary tumour 3. inadequate surgical excision of previously operated on tumour 4. proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy 2. patient characteristics 1. age: ≥21 years old 2. performance status: ecog 0-1 3. normal haematological, hepatic, coagulation, renal and electrolyte profiles 4. normal left ventricular ejection fraction 5. not pregnant or nursing exclusion criteria: 1. patient is medically unfit for surgery due to concurrent medical comorbidities. 2. any medical or psychiatric condition(s) which would preclude informed consent. 3. patient is pregnant or nursing.
cd19 targeted universal chimeric antigen receptor t cells injection for cd19+ refractory/relapsed b-cell malignancies

Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia; Relapsed or Refractory B-cell Non-hodgkin Lymphoma

Summary: it is a single-arm, open-label clinical study to assess the safety and efficacy of the anti-cd19 universal car-t cells injection for patients with cd19+ refractory/relapsed b cell acute lymphoblastic leukemia and b cell non-hodgkin lymphoma.

the study consists of the following periods: screening, lymphodepletion, car-t cell infusion, safety follow up, and long term follow-up.

Eligibility criteria:
key inclusion criteria: 1. eastern cooperative oncology group performance status of 0 or 1； 2. expected survival time ≥12 weeks; 3. adequate hematological, renal and liver function; 4. subjects understand and voluntarily sign the informed consent form. key exclusion criteria: 1. positive for any of the following etiological tests: hiv, hbv, hcv, tppa ; 2. cyclophosphamide or fludarabine is contraindicated for subjects ; 3. active central nervous system (cns) involvement by malignancy； 4. active infection.
cardiac rehabilitation to improve breast cancer outcomes

Conditions: Breast Cancer; Cardiovascular Diseases

Summary: to develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. considering this program is secondary to the michigan medicine cardiac rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.


Eligibility criteria:
inclusion criteria: * breast cancer diagnosis stage i-iii * within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy) * age 18 years or older * at increased risk for cardiovascular disease based on one of the following; a.treatment with either anthracycline-based or anti-her2 therapy-based treatment regimen plus the presence of: \>2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), or age (\>60 years) at cancer treatment, or left ventricular ejection fraction \<50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.treatment with anthracycline followed by trastuzumab * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * planned surgery during the study period. * under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction \<35%) * metastatic cancer * unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise) * adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.
a study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with hbeag(+) chronic hepatitis b or clevudine and peg-interferon sequential treatment in patients with chronic hepatitis b who have hbeag(+)

Conditions: HBeAg(+) Chronic Hepatitis B

Summary: a study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with hbeag(+) chronic hepatitis b or clevudine and peg-interferon sequential treatment in patients with chronic hepatitis b who have hbeag(+)


Eligibility criteria:
inclusion criteria: 1. patient is between 18\~60 years 2. patient is hbv dna positive with dna levels ≥ 5 x 10\^5 copies/ml within 30 days of baseline. 3. patient is documented to be hbsag positive for \> 6 months and patient is hbeag positive. 4. patient has alt levels \>=80iu/l, prothrombin time(inr)\<1.7 and a serum albumin level of at least 3.5 g/dl. 5. patient has hemoglobin levels \>=11.5g/dl(if woman) or \>=12.5g/dl(if man) 6. women of childbearing potential must have a negative urine pregnancy test(β-hcg) taken within 14 days of starting therapy. 7. patient is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection. 3. patient is coinfected with hcv or hiv. 4. patient with clinical evidence of decompensated liver disease or hcc 5. patient has wbc levels \< 3.0x10\^9/l 6. patient has platelets levels \< 90x10\^9/l 7. patient has alpha fetoprotein levels \> 100ng/ml 8. patient has a history of thyroid disease. 9. patient has a history of autoimmune hepatitis. 10. patient is pregnant or breast-feeding. 11. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. 12. patient has a clinically relevant history of abuse of alcohol or drugs. 13. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 14. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
accuracy, yield and clinical impact of a low-cost hrme in the early diagnosis of esophageal adenocarcinoma

Conditions: Barrett's Esophagus

Summary: the overall goal of the study is to determine whether imaging with the low-cost high resolution microendoscope(hrme) will increase the efficiency and yield of the current standard of endoscopic surveillance of barrett's esophagus. we believe the hrme will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, emr).

primary outcomes: * the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of hrme with directed biopsy - compared to standard white-light endoscopy with 4-quadrant random biopsy (wl) for the diagnosis of be-associated neoplasia in flat mucosa as well as mucosal lesions * the clinical impact of hrme on the diagnosis and endoscopic surveillance of be- associated neoplasia * does hrme alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (emr) * the total number of total mucosal biopsies taken per procedure; does hrme alter the number of biopsies necessary? secondary outcomes: * sensitivity, specificity, positive predictive value, and negative predictive value of hrme for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with be (using histopathologic diagnosis of mucosal biopsies as the reference standard) * the total procedure time for imaging and mucosal biopsy acquisition of hrme - compared with wl, stratified by length of be (\ 3cm)

Eligibility criteria:
inclusion criteria: * outpatients with \> 1 cm biopsy-proven barrett's esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia. exclusion criteria: * allergy or prior reaction to the fluorescent contrast agent proflavine * patients who are unable to give informed consent. * known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion \> 2 cm in size not amenable to emr * patients with a history of a severe allergic reaction (anaphylaxis) * patients unable to undergo routine endoscopy with biopsy : * women who are pregnant or breastfeeding * prothrombin time \> 50% of control; ptt \> 50 sec, or inr \> 2.0) * inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other * patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope * patients with known severe esophagitis * patients with suspected but no biopsy confirmed be

Keywords: barrett's esophagus proflavine microscopic imaging
the application of rapid pth test paper in operation of hyperparathyroidism

Conditions: Hyperthyroidism; Thyroidectomy; PTH; Immunochromatographic

Summary: the half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid pth test paper in operation of hyperparathyroidism.pth test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of pth test paper in evaluating the miami principles with the linear relation of blood pth and the pth test paper method.

primary hyperparathyroidism is a clinically common disease. at present, the gold standard for determining whether the operation is successful is based on the miami principle. that means the pth hormone decreased to 30% of the baseline level after 15min after the tumor was removed. however, due to the differences in pth monitoring conditions in various hospitals, many hospitals cannot perform rapid pth monitoring in the operation. therefore many doctors choose rapid freezing pathology to confirm the lesion., this also led to the inability to evaluate pth in the presence of multiple lesions,and resulting in the need for reoperations.

Eligibility criteria:
inclusion criteria: * primary hyperthyroidism. * secondary hyperthyroidism * unilateral thyroidectomy. * total thyroidectomy and bilateral central compartment dissection exclusion criteria: * age older than 70 or younger than 18.

Keywords: hyperthyroidism thyroidectomy pth immunochromatographic assay
post-approval clinical study of asfotase alfa treatment for patients with hypophosphatasia (hpp) in japan

Conditions: Hypophosphatasia

Summary: this is a multicenter study in japan. eleven sites which have already participated in the investigator-initiated clinical study (early access program) will participate in this study.the objective of this study is to gain further information on the safety and efficacy of treatment with asfotase alfa.

the primary objective of this study was to collect data on the safety of repeated subcutaneous (sc) injections of asfotase alfa. there were no secondary objectives. exploratory objectives related to the efficacy of asfotase alfa are not being reported.

Eligibility criteria:
inclusion criteria: 1. patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. where appropriate and required by local regulations, patient assent for participation must also be obtained. 2. patient has completed the investigator-initiated clinical study (hppjeap-01) protocol for asfotase alfa exclusion criteria: 1. patient has a documented form of rickets caused by a condition other than hpp, including, but not limited to, rickets caused by 25(oh) vitamin d deficiency 2. patient has serum calcium and/or phosphorus levels below the normal range 3. patient is pregnant or lactating 4. patient received treatment with bisphosphonates within 2 years prior to the screening visit 5. patient has a documented sensitivity to any of the components of asfotase alfa 6. patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for hpp (eg, bone marrow transplantation) 7. patient has clinically significant other disease in the opinion of the investigator, defined as any other non hpp-related condition for which the patient is considered medically unstable.

Keywords: hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase rickets osteomalacia
comparisons of two types of armeo robot for upper extremities

Conditions: Stroke

Summary: comparison of two types of robot (armeo power vs armeo spring) for upper extremity rehabilitation on upper extremity function

the purpose of this study is to compare two types of robot. the robot used in this experiment was armeo power and armeo spring. armeo power could provide assistive force via motor, on the other hand, armeo spring could not provide any assist. thus the results from this study might suggest usefulness of motorized robot.

Eligibility criteria:
inclusion criteria: * hemiplegic patients secondary to first cerebrovascular accidents * onset ≥ 3 months * 26 ≤ fugl-meyer assessment score ≤ 50 * 3 ≤ shoulder or elbow mrc scale ≤ 4 * shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+ * cognitively intact enough to understand and follow the instructions from the investigator exclusion criteria: * history of surgery of affected upper limb * fracture of affected upper limb

Keywords: stroke upper extremity rehabilitation robot stroke rehabilitation
do single use negative pressure dressings reduce wound complications in obese women after cesarean delivery

Conditions: Obesity; Surgical Site Infections; Wound Complications; Complications; Cesarean Section

Summary: the investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (bmi \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.

subjects admitted to l+d for obstetric or medical indications at a tertiary medical center with a bmi \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. post operative care will not be altered. incisions will be evaluated prior to hospital discharge. subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.

Eligibility criteria:
inclusion criteria: * bmi \>40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at tufts medical center. exclusion criteria: * women less than age 18, women with an active infection in the location of pfannenstiel skin incision, women not willing to come to tufts medical center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a bmi \< 40 kg/m2 will be excluded from this study.

Keywords: negative pressure wound therapy cesarean delivery