Kornimate/medical-research-clean huggingface dataset:
postoperative chemoradiation in patients with node-positive esophageal squamous cell carcinoma

Conditions: Esophageal Neoplasms

Summary: this is a unicentered phase i/ii study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.

although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients with pathologically positive lymph nodes who have been treated with resection alone. the investigators have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. for patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence occurred 34.6% in mediastinal lymph nodes，13.3% in supraclavicular lymph nodes，10% in abdominal lymph nodes. distant metastases occurred in 21% patients. adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). however distant metastases rate increased to 30.7%. chemotherapy may be vital for these patients. chen reported that the 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (p=0.03). based on the investigators' studies, treatment failure occurred in 8% patients because of celiac metastases. small radiation field by omitting celiac axis lymph node basin may ensure 5-6 cycles of concurrent chemotherapy for lower toxicity.

Eligibility criteria:
inclusion criteria: 1. kps≥70 2. diagnosis of pathologically positive lymph node thoracic esophageal cancer 3. complete resection 4. adequate organ function: hematopoietic absolute granulocyte count at least 1,500/mm\^3 platelet count at least 150,000/mm\^3 hemoglobin at least 10 g/dl hepatic not specified renal creatinine no greater than 1.5 mg/dl and/or creatinine clearance at least 65 ml/min calcium no greater than 11 mg/dl cardiovascular no uncontrolled heart disease no uncontrolled hypertension exclusion criteria: 1. uncontrolled diabetes 2. interval between surgery and adjuvant therapy more than 3 months 3. sign of recurrence on ct scan or ultrasound or pet-ct no palpable supraclavicular lymph nodes or involvement after cytology needle aspiration no lymph nodes greater than 1 cm on ct scan 4. with weight loss greater than 10% from baseline 5. with other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix 6. be pregnant

Keywords: chemoradiation dose escalation
a pilot study for pharmacokinetic/pharmacodynamic (pk/pd) parameter of allopurinol and its metabolite-oxypurinol after once-daily allopurinol in chronic kidney disease patient

Conditions: Chronic Kidney Disease

Summary: to know the blood level of allopurinol in chronic kidney disease (ckd) patient.

after the result of this pilot study, we can prescribe the optimal dose of allopurinol in ckd patient.

Eligibility criteria:
inclusion criteria: * from 18yrs to 80yrs , man and women * the patient who are taking allopurinol * on screening, the patient shows that the level of protein/creatinine ratio is over 3.0 * on screening, the patient shows that mdrd gfr \>= 30 ml/min and \<= 60 ml/min * the patient sign on the concent form exclusion criteria: * the patient have experience to take medication that have an effect on renal function * the patient have experience to take cyclosporin within 3month * at least, the average level of two separate blood pressure ( 2min interval ) shows that sbp \ =160 mmhg and dbp \ =100 mmhg, or heart rate \ 90 beats/min * uncontrolled hypertension * pregnancy or anticipate pregnancy with 6 month * hypersensitivity to allopurinol * acute hepatitis or the level of ast or alt is over 2times of normal range or the level of bilirubin is over 2.0 mg/dl * serum albumin \ 5mg/dl * urinary retension, prostatic hyperplasia * the patient show gout attack on taking allopurinol * the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine. * the patient who should take azathioprine, mercaptopurine, cyclophosphamide, losartan, benzbromarone,fenofibrate,furosemide ,probenecid * the patient who had taken part in the other study within 3months * the patient who had gotten blood transfusion * pregnant, breast feeding

Keywords: allopurinol chronic kidney diseae
safety study of eco conversion system for red blood cells.

Conditions: Anemia

Summary: the purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make a-eco red blood cells, can be safely re-infused, repeatedly. each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. additional samples of blood will be drawn for testing and evaluation.

this study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of a-eco cells. all participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create a-eco cells (test group); or 2) washed with saline (control group). the test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.

Eligibility criteria:
inclusion criteria: * healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders * blood group a * available for follow up periodically at varying intervals for twelve weeks * have a clinical presumption of a stable blood volume * between 18 and 65 years of age * able to provide informed consent * practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age). exclusion criteria: * women that are pregnant * persons with documented immune deficiencies * persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen * persons with a history of idiopathic thrombocytopenic purpura * persons who are bleeding or undergoing an active hemolytic process * persons who have any history of hemorrhagic tendency * persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing * persons who test positive for von willebrand's disease * persons taking investigational drugs or using an investigational device * persons with a family history of a bleeding disorder * persons with a history of vasculitis * persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator * persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator * persons with unexplained bruising * persons with abnormal laboratory screening tests

Keywords: transfusion; red blood cells
comparison between conventional and modified smead jones method for mass closure in emergency midline laparotomy

Conditions: Midline Laparotomy

Summary: the occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation. many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough. wound dehiscence may be related to the technique of closure of abdomen and the sutures used. numerous studies have been conducted evaluating many closure techniques and suture materials. there is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. in developing countries such as india, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition. the current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . tension is distributed evenly along the length of the wound. the standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (pds) are also widely used . in smead-jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. originally described method was interrupted. continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. we proposed modification of original smead-jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.


Eligibility criteria:
inclusion criteria: * any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision . exclusion criteria: * patients who had previous laparotomy. * patients who underwent laparotomy through incisions other than midline incisions.
extension of the mime robotic system for stroke rehabilitation

Conditions: Stroke; Impaired Upper Extremity Function

Summary: the goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. our previous work has shown that the mime robot is safe and effective for improving reach in stroke subjects. but adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. in a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.

research design: we hypothesize that: 1) gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy. methodology: in the first year of the study, we will develop a robotic system with the ability to assist hand movement. since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. this exoskeleton will be integrated with the armin iii arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. in the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. outcome measures will be taken before training and immediately after training.

Eligibility criteria:
inclusion criteria: * an ischemic or hemorrhagic stroke more than 6 months prior to entry into the study; * trace ability to move the wrist and fingers in extension; * voluntary shoulder elevation to approximately 45 deg; * be between the ages of 21 and 90. exclusion criteria: * have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the folstein mini - mental state examination (bleeker, 1988); * have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; * have an upper extremity injury or conditions prior to stroke that could limit participation; * have severe hemispatial neglect. * have a full score of 24 on the distal section of the fugl-myer test (fm) (fugl-meyer 1975); and * have severe sensory loss.

Keywords: stroke function arm hand robotic therapy motor movement treatment
reducing the overall risk level in patients suffering from metabolic syndrome

Conditions: Hypertension, Dyslypidaemia

Summary: this study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * age between 40 - 65 years * diagnosed metabolic syndrome * risk of cardiovascular death ≥ 5% (according to score) * written informed consent exclusion criteria: * women not in menopause or not using efficient contraception * known hypersensitivity to study drugs * history of ischemic heart disease

Keywords: hypertension, dyslipidemia
effects of contralateral strength training on postoperative strength deficits in the immobilized lower extremity

Conditions: Meniscus; Detachment, Current Injury

Summary: this is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. the objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity. after the completion of surgery, patients will be randomized to either the experimental treatment (group 1) or control group (group ii)for postoperative rehabilitation.

group i will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. the experimental strength training will be performed with moderate resistance and will require moderate effort. exercises will include unilateral leg presses, lunges, step ups, and step downs. these exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. in the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.

Eligibility criteria:
inclusion criteria: * patient is indicated for meniscal root repair * patient is indicated for meniscus transplant * patient is at least 18 years of age * patient is expected to survive at least 1 year beyond surgery * patient has intact lower extremities bilaterally * patient is willing to participate by complying with pre-and post-operative visit requirements * patient is willing and able to review and sign a study informed consent form exclusion criteria: * lower extremity musculoskeletal defects * systemic neuromuscular disorders * failure to complete pre-operative bidoex strength assessment * failure to complete pre-operative self-assessment score intake forms

Keywords: meniscus root tear
targeting sleep homeostasis to improve alcohol use disorder treatment outcomes (m-star study)

Conditions: Insomnia; Alcohol Use Disorder

Summary: insomnia is common in people who are in treatment for alcohol use disorder. it can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. this study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.


Eligibility criteria:
inclusion criteria: * meet probable diagnostic and statistical manual of mental disorders (dsm)-5 criteria for alcohol use disorder with ≤12 weeks of abstinence * planned enrollment into an abstinence-based treatment program * meet probable dsm-5 criteria for chronic insomnia, confirmed with sleep diary * ability to travel to ann arbor for sleep laboratory assessments * access to a video chat-capable device and reliable wi-fi network exclusion criteria: * diagnosis of, or high suspicion for, sleep disorders other than insomnia * meet probable dsm-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (ptsd) * terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia * self-reported pregnancy or intention to become pregnant during the study

Keywords: cognitive behavioral therapy sleep hygiene
global multicenter registry on transcatheter tricuspid valve replacement

Conditions: Tricuspid Regurgitation

Summary: the field of transcatheter tricuspid valve replacement (ttvr) is rapidly emerging and data on this topic are scarce. particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. on this background, the triplace registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic ttvr.

the primary aims of the registry will be: * to examine the safety, efficacy, and long-term outcomes of ttvr * to assess the incidence of procedural complications and their correlations with adverse clinical outcomes * to investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after ttvr * to explore the characteristics of patients deemed eligible for ttvr.

Eligibility criteria:
inclusion criteria: * patients undergoing transcatheter tricuspid valve replacement * native tricuspid valve disease * orthotopic tricuspid valve implantation exclusion criteria: * age under 18 years

Keywords: valvular heart disease tricuspid regurgitation transcatheter tricuspid valve replacement
the role of mechanical stress and muscle fatigue in strength gains

Conditions: Strength Training; Muscle Strength, Muscle Mass, Inflammatory Processes

Summary: the purpose of this study is to compare the impact of different levels of mechanical stress and muscle fatigue in strength training conditions on muscle strength, muscle mass and inflammatory processes.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * knee pathology * systematic training
rate of prolonged response after stopping thrombopoietin-receptor agonists treatment in itp

Conditions: Persistent or Chronic ITP

Summary: thrombopoietin-receptor agonists (tpo-ras) have profoundly changed the management of itp. however, today, there are no international recommendations concerning the long-term use of these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis in case of prolonged treatment. tpo-ras have been thought to play only a supporting role in itp management. but our center along with many other research centers, have reported unexpected cases of durable remission after tpo-ras discontinuation in adult chronic itp. in these retrospective studies, more than 20 % of patients were able to achieve prolonged remission. the purpose of this study is to demonstrate that a substantial proportion of itp patients may achieve a prolonged response after tpo-ra discontinuation. the investigators developed, in this study, a standardized procedure to discontinue eltrombopag and romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding. in case of relapse after tpo-ra discontinuation, the decision to start a new therapy will be based on the clinician's judgment.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. diagnosis of itp according to the standard definition 3. disease duration of more than 3 months at tpo-ra initiation 4. platelet count \> 100 x 109/l for more than 2 months on tpo-ra therapy, with at least 3 platelet counts \> 100 x 109/l 5. blood count lasting for less than 7 days 6. normal marrow aspirate for patients aged of 60 and over 7. informed signed consent 8. treatment with tpo-ra for at least 3 months exclusion criteria: 1) anticoagulation or anti-platelet treatment 2) recent treatment with corticosteroids ± intravenous immunoglobulins (less than 2 months) 3) rituximab or splenectomy within the 2 months preceding the tpo-ra initiation 4) rituximab or splenectomy after tpo-ra initiation/ra initiation 5) previous failure of tpo-ra discontinuation 6) pregnant or breastfeeding women 7) no affiliation to a social security scheme or other social protection scheme 8) inability or refusal to understand or refusal to sign the informed consent from study participation 9) patient deprived of freedom or under legal protection (guardianship, curatorship) 10) hypersensitivity to romiplostin or to any of the excipients or to e. coli derived proteins -

Keywords: itp tpo-ras thrombopoietin-receptor agonists