Kornimate/medical-research-clean huggingface dataset:
a trial of percutaneous lumbar discectomy combined with ozone for treatment of ldh

Conditions: Lumbar Disc Herniation

Summary: lumbar disc herniation (ldh) is a common pathological process leading to spinal surgery. open discectomy used to be a widespread procedure for surgical treatment for symptomatic ldh. currently, several minimal invasive surgeries have been uesd widely. percutaneous lumbar discectomy(pld) and ozone therapy are two widely used minimal invasive treatment, and ozone therapy combined other minimally invasive treatment could improve other minimally invasive treatment's clinical effectiveness. the effectiveness of which has been proved to be comparable to conventional open discectomy. in this study, a single-blind randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic ldh. two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing pld combined with ozone, and 2) patients diagnosed with lumbar disc herniation undergoing pld. the primary endpoints of the study will be changes in in pain and functional status by the visual analog scale (vas) and functional status as measured by oswestry low back disability questionnaire (oswestry disability index,odi) and japanese orthopaedic association (joa) as measured at pre- and post-operation, 1 month, 3 months, 6 months. secondary outcomes include response evaluation by macnab response evaluation criteria as measured at pre- and post-operation, 1 month, 3 months, 6 months. treatment effect is defined as the difference in the mean change from baseline between the two groups. for the first time,the results of this trial will provide scientific evidence as to the relative effectiveness of pld combined with ozone versus pld for minimal invasive surgical treatment for symptomatic lumbar disc herniation.


Eligibility criteria:
inclusion criteria: * age older than 18 years. * 4 or more weeks low back pain and/or lower-limb radiation pain. * mri and/or ct test confirm diagnosis lumbar disc herniation and level(s). * invalid after non-steroidal anti-inflammatory medical therapy and physical therapy. * pain level（visual analog scale）≥5. exclusion criteria: * spinal tumors. * spine infections, fractures, slippage(more than i °) and other deformities. * combining with spinal stenosis, lateral recess stenosis, yellow ligament hypertrophy. * nucleus pulposus herniated too much, dural sac compressed more than 50%; * psychological, cognitive disorders which may affect the reliability of the outcome; * previous lumbar disc surgery; * bleeding tendency or severe cardiovascular disease can not tolerate surgery; * don't accept the trial's informed consent; * possible pregnancy.

Keywords: herniation discectomy ozone
'smart reminder': a feasibility pilot study on the effects of a wearable device treatment

Conditions: Stroke

Summary: this pilot study examines the feasibility and potential effects on upper limb (ul) motor function using a wearable device integrated with a telerehabilitation function in the home setting with chronic stroke survivors. the study seeks to address the question: - is wearable device intervention more effective in promoting arm recovery in stroke survivors than conventional therapy for home-based training? we hypothesize that using a multimodal feedback system in the wearable device can provide more effective training to improve the hemiplegic ul function of chronic stroke survivors than conventional therapy. this is a single-blinded randomized crossover pilot trial. twelve participants will be randomly assigned into two groups: the experimental (wristwatch) and the control (conventional therapy) groups. participants in the experimental group will undergo a 4-week wearable device treatment followed by a 4-week conventional training. participants in the control group will complete conventional therapy and then wearable device treatment. there will be a 3-week washout period between treatments. upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, after a 3-week washout period for pre-intervention, and post-intervention after crossover by research assistants blinded to group allocation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * unilateral hemispherical involvement * diagnosis of stroke with onset ≥ three months * hemiplegic upper limb with functional test for hemiplegic upper extremity-hong kong version (fthue-hk) ≥ score of 3 (maximum of 7) (fong et al., 2004). * no complaint of excessive pain and swelling over the hemiplegic arm * able to provide informed consent to participate. exclusion criteria: * participating in another similar form of experimental study during the same period * having a history of botulinum toxin injection in the past three months * having other significant upper limb impairment, i.e. fixed contractures, frozen shoulder, and severe arthritis * having a diagnosis which would interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment.

Keywords: stroke telerehabilitation wearable device upper limb
intervention study of mind-body physical activity in frail institutionalized elderly

Conditions: Aging; Frailty

Summary: few previous studies have explored the effects of mind body approaches on health-related quality of life (hrqol) in frail elderly. cognition and action are an inseparable whole while functioning. a new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." the investigators aimed to explore the effects of two different mind-body exercise types on (hrqol) in frail institutionalized elderly. the investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve hrqol.


Eligibility criteria:
inclusion criteria: * aged 65 and older * institutionalized * ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands * have given a signed consent exclusion criteria: * terminally ill and bedridden patients * unable or unwilling to sign the consent * have participated in a study in the past 3 month

Keywords: tertiary prevention of disability
radiolabeled monoclonal antibody therapy in treating patients with gastrointestinal cancer

Conditions: Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer

Summary: rationale: radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. this may be an effective treatment for gastrointestinal cancer. purpose: phase i trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer.

objectives: i. determine the biodistribution and biokinetics of iodine i 131-labeled monoclonal antibody cc49-delta ch2 in patients with gastrointestinal adenocarcinoma. ii. determine the human anti-human monoclonal antibody response in patients treated with this drug. outline: patients receive iodine i 131-labeled monoclonal antibody cc49-delta ch2 (131i moab cc49-delta ch2) iv over 5-10 minutes on day 0. patients also receive unlabeled monoclonal antibody cc49-delta ch2 iv over 5 minutes followed by 131i moab cc49-delta ch2 iv over 5-10 minutes on day 28. patients are followed weekly for 4 months and then every 3 months for 1 year. projected accrual: a total of 25 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: histologically confirmed adenocarcinoma of the esophagus, stomach, pancreas, colon, or rectum more than 30% positively immunoreactive to monoclonal antibody cc49 in the metastatic or primary lesion or tag-72 antigen serum level greater than 15 measurable or evaluable unresectable or metastatic disease by ct scan patient characteristics: age: 19 and over performance status: ecog 0-2 life expectancy: at least 3 months hematopoietic: wbc greater than 3,500/mm3 platelet count greater than 150,000/mm3 hemoglobin greater than 10 g/dl hepatic: bilirubin less than 2.0 mg/dl alt and ast less than 3 times upper limit of normal (uln) (5 times uln if liver metastases present) ptt less than 37.0 seconds inr less than 2.0 renal: creatinine less than 2.0 mg/dl other: no known allergy to murine immunoglobulin no iodine allergy no concurrent illness that would preclude study not pregnant or nursing negative pregnancy test fertile patients must use effective contraception must be ambulatory and able to comply with study schedule prior concurrent therapy: biologic therapy: no prior murine immunoglobulin chemotherapy: prior or concurrent chemotherapy allowed endocrine therapy: not specified radiotherapy: prior radiotherapy allowed surgery: see disease characteristics

Keywords: stage iii colon cancer stage iv colon cancer stage iii gastric cancer stage iv gastric cancer recurrent gastric cancer stage iii pancreatic cancer recurrent pancreatic cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer stage iii esophageal cancer stage iv esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus adenocarcinoma of the colon adenocarcinoma of the rectum adenocarcinoma of the pancreas stage iv pancreatic cancer
lumateperone for the prevention of relapse in patients with schizophrenia

Conditions: Schizophrenia

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the diagnostic and statistical manual of mental disorders, fifth edition, (dsm-5).

the study will be conducted in the following 5 phases: * a no-drug screening phase up to 7 days in duration during which patient eligibility will be assessed; * a 6-week, open-label run-in phase (rip) during which all patients will receive oral lumateperone 42 mg/day; * a 12-week, open-label stabilization phase (sp) during which all patients will receive oral lumateperone 42 mg/day; * a double-blind treatment phase (dbtp) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio); * a 2-week safety follow-up (sfu) phase.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 60 years of age, inclusive. * current diagnosis of schizophrenia according to dsm-5 criteria as determined by the modified structured clinical interview for dsm-5 (modified scid-5). * diagnosis of schizophrenia for a minimum of 1 year before visit 1. * current psychotic episode \< 4 weeks duration at visit 1. * panss total score ≥ 70 and ≤ 120 at visit 1 and visit 2. * rating of at least 4 (moderate) on at least two of the following four panss positive symptoms: delusions (p1), hallucinatory behavior (p3), conceptual disorganization (p2), suspiciousness/persecution (p6) at visit 1 and visit 2. * patient must identify a caregiver who provides consents to participate in the study. * in the opinion of the investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study. exclusion criteria: * currently meeting dsm-5 criteria for any of the following: schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; bipolar i or bipolar ii disorder; intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; known or suspected borderline or antisocial personality disorder or other dsm 5 personality disorder of sufficient severity to interfere with participation in this study; substance use disorder (other than nicotine) within the 3 months prior to visit 1 of this study. * patients in their first episode of psychosis. * treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).

Keywords: schizophrenia relapse prevention maintenance design
effect of functional exercises on pain and quality of life in females with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.

primary dysmenorrhea and menstrual pain are significant health, social and economic problems. it involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women. women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. it compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours. non-steroidal anti-inflammatory drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness. so, there is a need for safe interventions with no side effects. therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: 1. their ages will be ranged from 18 to 25 years 2. they will be suffering from primary dysmenorrhea based on the menstrual distress questionnaire. 3. their bmi will be ranged from 20 to 25 kg/m2. 4. having regular menstrual cycles (one every 28-34 days). 5. they will be sedentary virgin females. 6. they are non-smokers. 7. they have not been in any exercise program for three months. exclusion criteria: 1. having secondary dysmenorrhea. 2. using regular medication or contraceptive pills. 3. having neuromuscular, metabolic, or cardiac diseases. 4. having a preexisting condition prevents them from engaging in an exercise program.

Keywords: primary dysmenorrhea functional exercises pain quality of life
observational study of pergolide mesylate and cardiac valvulopathy

Conditions: Parkinson Disease

Summary: the primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with parkinson's disease who are receiving pergolide as second-line therapy. the secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have parkinson's disease and are being considered for pergolide as second-line therapy.


Eligibility criteria:
inclusion criteria: * male or female, age 18 and older with a diagnosis of parkinson's disease * receiving pergolide as second-line therapy as prescribed by summary of product characteristics * willing to participate and sign a consent to release medical information * have had an echocardiogram within 3 months of initiation of pergolide therapy with no evidence of cardiac valvulopathy exclusion criteria: * there are no exclusion criteria for this study
national cohort study of effectiveness and safety of sars-cov-2/covid-19 vaccines (enforce)

Conditions: SARS-CoV Infection

Summary: national cohort study of effectiveness and safety of sars-cov-2 vaccines (enforce is an equivalence trial to evaluate the effectiveness and safety of multiple new sars-cov-2 vaccines approved for use in the eu, and which are being offered at participating units. the design is an open-labelled, non-randomised, parallel group, phase iv study with historical controls. a sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

first phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). if more vaccines become available additional 2,500 persons per vaccine will be included. subsequent phases with larger sections of the population included may be implemented. participants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. safety data will be collected at study visits until 3 months after the first vaccination. research samples will be collected at each study visit during the two year follow-up

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained before any trial related procedures are performed 2. male or female eligible for sars-cov-2 immunization (as defined by sst in the national vaccination plan) 3. the subject must be willing and able to comply with trial protocol (re-visits and biological samples) exclusion criteria: 1. male and female under the age of 18 2. any subgroup of individuals for which the vaccines are contraindicated 3. previous sars-cov-2 vaccination

Keywords: covid-19 vaccination
prevalence of abnormal postures in parkinson's disease

Conditions: Parkinson Disease

Summary: postural abnormalities represent disabling and painful complications in patients with parkinson's disease (pd). the stooped posture is a typical feature of pd but with advancing of disease more severe body abnormalities can affect people with pd. these deformities include pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and/or toes (striatal toes).

postural abnormalities represent disabling and painful complications in patients with parkinson's disease (pd). the first postural trunk deviation in pd was first described by james parkinson himself and recognized as stooped simian appearance, with flexion of the hips and knees, and rounding of the shoulders. although the stooped posture is a typical feature, more severe spinal misalignment (and deformities) can affect people with pd. these postural deformities include pisa syndrome (ps), camptocormia (cp), antecollis (ac), scoliosis (s) and striatal deformities related to hand (striatal hand) and/or toes (striatal toes). the prevalence of these postural deformities is variable because several diagnostic criteria have been used to characterize each deformity. recently, a consensus of diagnostic criteria has been reached in literature permitting us to better mapping the presence of these deformities in people with pd.

Eligibility criteria:
inclusion criteria: 1. participants will be considered enrolled after signing the consent form; 2. diagnosis of parkinson's disease; exclusion criteria: 1. concomitant neurologic diseases known to negatively affect posture; 2. a history of major spinal surgery or muscle and/or skeletal diseases; 3. treatment with drugs potentially able to induce abnormal postures; 4. clinical features consistent with a diagnosis of atypical parkinsonism;

Keywords: parkinson disease pisa syndrome camptocormia antecollis striatal deformities
treatment with abt-199 (venetoclax) and purine analogues in relapsed/refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory

Summary: non-commercial, open-label interventional phase ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory aml.

non-commercial, open-label interventional phase ib study. the aim of the study is to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory aml.

Eligibility criteria:
inclusion criteria: * relapsed or refractory aml * relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c/anthracyclin) or four cycles of hma (hypomethylating agents) * adult aml aged \>/= 18 years * who performance status: grade 0-2 at the time of enrollment * abt-199 (venetoclax) and pa-naïve. patient may be prior exposed but not refractory to venetoclax. in case of previous therapy with venetoclax inclusion is only possible after discussion with the pi. exclusion criteria: * participation in any other interventional clinical trial during the study period * active presence (or known history of) central nervous system disease * history or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for \>5 years or that is highly likely to be cured at the time of enrollment. * active hiv, hepatitis b or hepatitis c infection * use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. after the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the wbc-count to \<25 000/µl (e.g. hydroxyurea). * medical conditions requiring chronic therapy of moderate or strong cyp3a4 inducers without alternative * patients with known hypersensitivity to the active substance or to any of the excipients * pregnant or breastfeeding woman * active uncontrolled systemic infection
gonadotropin type in ovarian stimulation

Conditions: Infertility

Summary: a key challenge facing reproductive biologists is the integration of the knowledge about oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern folliculogenesis, cumulus cell function, and oocyte and embryo development. although key oocyte-secreted factors have been identified, understanding their modes of action is complicated by multiple interactions between maternal and oocyte signaling molecules, as well as the constantly changing state of physical interactions between the oocyte and its companion somatic cells during folliculogenesis. thus, the investigators study aimed to determine if there is any relationship between different gonadotropin preparations and oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the apoptotic rate in cumulus cells during controlled ovarian stimulation.

the follicular environment is primarily influenced by the type of gonadotropin the follicle is exposed to during the follicular phase. the role of gonadotropins has been especially important in improving the efficiency of in vitro fertilization. several studies comparing the use of human menopausal gonadotropin (hmg) with recombinant follicle-stimulating hormone (rfsh) have found significant differences in the endocrinological profile and the follicular dynamics. these differences have been related to the human chorionic gonadotropin (hcg)-driven luteinizing hormone (lh) activity added to hmg. moreover, differences in the proportion of acid residues in fsh molecules should be considered. on the other hand, the main physiological regulatory hormones of follicular survival are the gonadotropins. suppression of serum gonadotropins leads to massive apoptosis of granulosa cells in developing follicles resulting in atresia; whereas, gonadotropin treatment of early antral and pre-ovulatory follicles prevents this unplanned apoptosis. however, studies using cultured rat granulosa cells have shown that treatments with fsh or lh/hcg are ineffective in preventing spontaneous apoptosis, suggesting neighboring theca cells and local factors produced in the ovary are important for regulation of follicle growth and atresia.

Eligibility criteria:
inclusion criteria: * 18-35 years old * regular menstrual cycles * no hereditary or chromosomal diseases normal karyotype negative for sexually transmitted diseases * at least seven antral follicles per ovary exclusion criteria: * pco

Keywords: gdf-9 bmp-15 steroids apoptosis rate endocrinology