Kornimate/medical-research-clean huggingface dataset:
to assess the prevalence of spasticity and the impact on the quality of life in multiple sclerosis patients

Conditions: Multiple Sclerosis, Relapsing Remitting

Summary: this study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. as part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (qol). the purpose of this observational study is to assess the incidence of spasticity in a group of subjects with relapsing remitting multiple sclerosis (rrms) in argentina and the way it affects the qol of these subjects.

one of most frequently observed symptoms in subjects with ms is spasticity. spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. it is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability. the spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. it is a frequent cause for consultation among subjects with ms and, consequently, has a significant impact on the qol. men and those subjects with ms of longer duration are the most affected by spasticity. the aim of this study is to assess the impact that spasticity has on the qol of subjects with ms. the total duration of the study is 24 months. the recruiting period will be 12 months. once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

Eligibility criteria:
inclusion criteria: * subjects aged from 21 60 years of age * subjects with established diagnosis of rrms according to the revised mcdonald criteria - 2005 * subjects with a diagnosis of rrms for more than one year * the subject who have signed the informed consent exclusion criteria: * subjects with other causes of spasticity * subjects with other clinical forms of ms (different from relapsing-remitting)

Keywords: multiple sclerosis, relapsing remitting quality of life
retrospective analysis of real-world data from medical records on the use of menopur for infertility treatment

Conditions: Infertility, Female

Summary: the purpose of this retrospective observational study is to describe the treatment patterns with menopur and to understand the clinical impact for patients that underwent infertility treatment under real-world setting. the primary objective is to describe the treatment patterns for the general population and for selected patient profiles.


Eligibility criteria:
inclusion criteria: * consecutive adult females who underwent art treatment with menopur for ovarian stimulation in 2018 exclusion criteria: * none

Keywords: menopur
the study of the natural way of development of external pancreatic fistulas in children with necrotizing pancreatitis

Conditions: Children; Pancreatic Fistula; Pancreatitis,Acute Necrotizing; Pancreatitis, Acute

Summary: the external pancreatic fistula (epf) is characterized by the leakage of pancreatic juice outward through an area of skinor through a drainage tube. the leakage of pancreatic juice occurs due to the rupture of the pancreatic duct (pd) caused by the destruction of pancreatic tissue. epf can cause deterioration in the patient's condition due to the leakage of protein-rich pancreatic juice outward, as well as the increased risk of skin irritation and infection.

the treatment of epf has traditionally been conservative, including the nutritional support in an attempt to reduce pancreatic secretion, or total parenteral nutrition with antisecretory therapy (octreotide). in cases where the conservative therapy has proved to be ineffective, there has been performed the surgical treatment. the cases of successful treatment of epf by endoscopic transpapillary drainage have been reported in the literature as an effective and minimally invasive therapeutic alternative to the surgery for the treatment of epf. however, the endoscopic transpapillary drainage is usually ineffective in patients with the complete pd failure. the complete pd failure in the presence of the functional pancreas above the failure results in the disconnected pancreatic duct syndrome. sepsis, infection, electrolyte disturbances, malnutrition, and infections are commonly seen in patients with high-output epf. in addition, there has occasionally been reported the spontaneous closure of low-output epf. however, there are no data on the natural history of epf. the aim of this study is to evaluate the natural clinical history of epf in children with necrotizing pancreatitis by examining the outcomes and the complications of the conservative treatment.

Eligibility criteria:
inclusion criteria: * patient or legal representative consent * external pancreatic fistula * age from 0-18 years * moderate severe (msap) or severe acute pancreatitis (sap) according to atlanta criteria revisited in 2012 * acute pancreatitis was defined in case of the presence of at least two of the three criteria according to the classification developed by the insppire (international study group of pediatric pancreatitis: in search for a cure) group: abdominal pain consistent with the diagnostic hypothesis; serum amylase and/or lipase increased by ≥3 times; imaging results typical of ap: abdominal ultrasound and/or contrast-enhanced ct. exclusion criteria: * mild acute pancreatitis * chronic pancreatitis * no consent from patient or legal representative

Keywords: children acute necrotizing pancreatitis pancreatic fistula
targeted group-based psychotherapy to address emotional stress in at risk icu survivors

Conditions: Post Intensive Care Syndrome; Anxiety; Traumatic Stress; Depression

Summary: this study is a pilot clinical trial to assess the feasibility of implementing a group-psychotherapy intervention to modify emotional stress (e.g., anxiety, depression, post-traumatic stress) following icu hospitalization

psychological symptoms and emotional distress, including anxiety, depression, and posttraumatic stress, are common problems among patients discharged from the intensive care unit (icu). the presence of psychological distress is associated with poor medical adherence, slower recovery, and reduced quality of life in this patient population. there is a lack of research on evidence-based interventions to address mental health symptoms in icu patients post-hospitalization. researchers have recently highlighted the potential utility of peer support/group interventions in the post-icu recovery process; however, they have yet to be widely tested in interventional trials, and their feasibility and acceptability in the post-icu population have yet to be demonstrated in a research study. thus, the purpose of this study is to adapt and deliver a 6-session group-based psychological intervention for post-icu patients in a single-arm, non-randomized interventional study. patients' symptoms will be assessed at baseline, post-intervention, and 3-month follow-up. the primary aim of the study is to assess the feasibility and acceptability of the group intervention in the post-icu patient population. secondarily, changes in patients' emotional distress will be examined to assess for the impact of the intervention on patients' symptoms.

Eligibility criteria:
inclusion criteria: * aged at least 18 years * icu stay of at least 3 days * access to a smartphone, laptop, or computer and able to participate in a meeting via a virtual platform * montreal cognitive assessment (moca)-blind score of at least 18 * english fluency * screening questionnaires consistent with clinically significant depression or anxiety (hospital anxiety and depression scale-depression \[hads-d\] or hads-anxiety \[hads- a\] score of \>7) or post-traumatic stress (ptsd checklist-civilian version \[pcl-c\] score of ≥ 30) * resides in the state of massachusetts. exclusion criteria: * unable or unwilling to participate in 6 weekly sessions of group therapy * permanent or severe cognitive impairment severe enough to impede participation (as assessed via the mmse).
immuno-based profiling of knee oa patients to predict response to regenerative treatment

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis (oa) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. platelet-rich-plasma (prp) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. we will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. we will focus on inflammatory (wnt system, il1 pathway, ptx3) and antioxidant (primarily, dpp3/keap1/nrf2) pathways. we foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee oa thus maximising the effectiveness of the healthcare allocation.


Eligibility criteria:
inclusion criteria: * men/women, aged \>40 - \ 1.75 -\ 1 conservative therapy failed. diagnosis of knee oa according to the american college of rheumatology (acr) classification criteria (altman, 1986) . * ability to give informed consent. exclusion criteria: * presence of active infection or abnormal knee effusion on day 1 at pre-injection of prp * diagnosis of chronic inflammatory disease (i.e. rheumatoid arthritis, reactive arthritis, psoriatic arthritis, chondromalacia, arthritis secondary to other inflammatory diseases) * untreated acute traumatic injury, presence of a symptomatic meniscal tear, valgus/varus deformity judged by the investigator to be clinically significant, in the index knee * recent (within 3-6 months) arthroscopy, open surgery, intra-articular steroid injections, intra-articular hyaluronic acid (ha) injections, systemic steroid treatment, malignancy * any serious, non-malignant, significant, acute, or chronic medical condition or active psychiatric illness that, in the investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study. * recent (within 30 days) use of any investigational drug or device prior to screening
sterile water injections for relieving ureterolithiasis pain

Conditions: Ureterolithiasis; Pain

Summary: ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. it would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.


Eligibility criteria:
inclusion criteria: * ureterolithiasis pain, acute onset, * requires pain relief, * standard treatment prescribed, * age 18-60, * ability to understand and follow instructions exclusion criteria: * other administration of nsaid for analgesia 12 hours prior to intervention, * pregnancy with obstructed flow of urine

Keywords: ureterolithiasis pain complementary rct
sequenced treatment alternatives to relieve adolescent depression (star-ad)

Conditions: Depression; Sequestra

Summary: this project aims to investigate the effectiveness of existing common antidepressants and to provide new evidence for depressed children and adolescents who are not responding to their first treatment.

this is an open-label sequential multiple assignment randomized trial (smart) of 16 weeks duration with two levels, each stage 8 weeks. in phase 1, adolescents with mdd will be selected into fluoxetine or fluoxetine combination cbt therapy groups and the choice of treatment will be at the discretion of the patient. subjects who fail to respond will enter phase 2 randomization， where patients will be randomly assigned to oral sertraline, votioxetine, duloxetine or adding one of aripiprazole, lithium carbonate, and olanzapine to fluoxetine. the primary outcome of the treatment phase is the treatment remission rate and response rate. secondary outcomes included: symptom scale; quality of life; sleep therapy; symptoms of anxiety; rumination and safety assessment.

Eligibility criteria:
inclusion criteria: 1. age 13 - 18 2. as assessed by k-sads-pl, it meets the dsm-v criteria for mdd with non-psychotic symptoms 3. score≥40 on the cdrs-r 4. participants with suicidal ideation are eligible, as long as clinicians consider outpatient treatment to be safe 5. sufficient audio-visual level to complete this study 6. written informed consent was obtained from patients and at least one of their parents exclusion criteria: 1. history of bipolar disorder, schizophrenia, autism, eating disorders, primary obsessive compulsive disorder, pervasive developmental disorder, or psychosis not otherwise specified 2. history of serious physical illnesses 3. substance abuse or dependence 4. current depressive episode with clear suicidal plans or suicidal behavior 5. requires inpatient treatment for psychiatric disorders 6. severe mental disorders requiring 7. 2 or more failed trials of antidepressant drugs: each trial for at least 8 weeks, with the last 4 weeks at full dose (e.g. fluoxetine 40mg/d, citalopram 40mg/d, escitalopram 20mg/d, sertraline 150mg/d ) 8. history of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option 9. taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment 10. taking or administering antidepressants within 5 half-lives 11. received modified electroconvulsive therapy within 12 months 12. if female, is pregnant
efficacy and safety of ivig-l in itp patients

Conditions: Purpura, Thrombocytopenic, Idiopathic

Summary: the efficacy and safety of a liquid intravenous immunoglobulin product, ivig-l, in patients with itp will be assessed and compared with data obtained from literature.

sanquin has developed, in cooperation with the finnish red cross blood transfusion service (frcbts), a liquid intravenous immunoglobulin product, ivig-l. the liquid formulation of intravenous immunoglobulin simplifies infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage. in addition to donor selection and screening, several procedures have been included in the production process to improve viral safety. in this clinical trial, the efficacy and safety of ivig-l in patients with itp will be assessed and compared with data obtained from literature. ivig-l will also be studied in patients with hypogammaglobulinemia.the results from both studies will be used for an application for marketing authorisation of ivig-l in finland and the netherlands.

Eligibility criteria:
inclusion criteria: * patients with chronic itp with a platelet count of about 20x109/l and at high risk of bleeding * patients with chronic itp with a platelet count of about 20x109/l, who have to undergo surgery * a stable clinical situation (no activity of any other disease) * age at least 18 yrs * the patient/legally acceptable representative has signed the consent form exclusion criteria: * the presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (sle), rheumatoid arthritis (ra) or nephritis * patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, hepatitis, epstein-barr virus, toxoplasma, hiv) * massive splenomegaly * treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study * having an ongoing progressive terminal disease, including hiv infection * known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin * presence of conditions predisposing for bleeding: anaemia (hemoglobin \ 110 mm hg). * use of corticosteroids for an acute situation within 7 days before study entry. patients using corticosteroids prophylactically can be included * splenectomy in the previous two weeks * renal insufficiency (plasma creatinine \> 115µmol/l) * pregnancy or lactation * known with insufficiency of coronary or cerebral circulation * iga deficiency and anti-iga antibodies

Keywords: purpura, thrombocytopenic, idiopathic itp immunoglobulin, intravenous
pet-ct/mri in the radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: the trial is to explore new and effective techniques in the treatment of prostate cancer and evaluate the role of pet-ct / mri played in radiotherapy. intensity modulated radiation therapy(imrt) is adopted with all patients and the efficacy assessment for the prostate cancer will be examined with pet / ct or ct in three months after radiotherapy.

all participants judged to have prostate cancer with stage ⅲ-ⅳand considered able to conduct radiotherapy. 180 patients will be enrolled in the trial and randomly divided into three groups. three arms are respectively treated with ct、18f-fdg pet/ct、18f-fdg pet/mri. the images were passed in three-dimensional treatment planning system, using software manually fusion and reconstruction of pet and ct. all patients adopt imrt for the radiotherapy with 70gy-80gy. three months after radiotherapy, solid tumer size for the prostate cancer will be assesed with pet / ct or ct. early radiation reactions are evaluated by the united states rtog (rtog) acute response evaluation criteria, and late radiation reaction are evaluated with rtog and the european radiation therapy oncology organization (eortc). before and after radiotherapy treatment,the tumor-associated marker of psa will be monitored and the patients are regularly followed-up in the next three years.

Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed prostate cancer * staged with ⅲ-ⅳ prostate cancer * aged from 18 to 65 years old * quality of life score (karnofsky performance score) \> 70 * no distant metastasis * no serious internal diseases may affect the treatment plan * no previous history of prostate radiation therapy * patients must be able to understand and be willing to sign a written informed consent document. exclusion criteria: * distant metastasis * accompanied by other malignancies * previous history of prostate radiation therapy * pregnant or lactating women * history of allergic reaction to iodinated, non-iodinated, and/or gadolinium contrast agents * liver and kidney dysfunction * pacemaker or other metallic devices that would prevent mri imaging from being performed * patients quit during the treatment or violate of the study protocol caused by other factors * any reason that, in the option of the investigator, contraindicates that the patient participates in the study

Keywords: prostate cancer radiotherapy pet-ct/mri
interleukin-11 can prevent and treat of radioactive oral mucitis

Conditions: Nasopharyngeal Carcinoma

Summary: radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. this study is a prospective, multicenter, and exploratory study. the aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.

all nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. patients were randomly divided into two groups randomly. il-11 was used in experience group and control group, saline.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of nasopharyngeal carcinoma. 2. 8th version american joint committee on cancer (ajcc) stage i-ivb. 3. age must beetween 18-75. 4. performance status must be 0 or 1 according to eastern cooperative oncology group. 5. adequate bone marrow, renal, and hepatic function. exclusion criteria: 1. chemotherapy with fluorouracil drugs; allergies to recombinant human interleukin-11. 2. treatment with palliative intent.;previous malignancy. 3. pregnancy or lactation. 4. a history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes. 5. diabetes, oral mucositis and senile dry stomatitis. 6. any severe coexisting disease.

Keywords: nasopharyngeal carcinoma acute radiation oral mucositis recombinant human interleukin-11 oral microflora
epidural analgesia vs adductor canal block in bilateral tka

Conditions: Osteo Arthritis Knee

Summary: this study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. half of participants will be received continuous epidural analgesia, while other half of participants will be received single-shot bilateral adductor canal blocks.

continuous epidural analgesia is effective postoperative pain control but it has some limitations in patients with hypotension, concurrent anticoagulants, technical difficulty, urinary retention. adductor canal block is less invasive than continuous epidural analgesia. it provides effective analgesia for total knee arthroplasty and preserves quadriceps muscle strength.

Eligibility criteria:
inclusion criteria: * aged more than 18 years old undergoing bilateral total knee arthroplasty * american society of anesthesiologists physical status classification 1-3 exclusion criteria: * participants deny to enroll the study * allergy to bupivacaine * weight less than 50 kilograms * hepatic disease * contraincation for neuraxial block or adductor canal block * uncontrolled cardiovascular disease * creatinine clearance less than 50 ml/min

Keywords: continuous epidural analgesia bilateral single-shot adductor canal blocks