Kornimate/medical-research-clean huggingface dataset:
evaluation of therapeutic effects of melatonin by inhibition of nlrp3 inflammasome in covid19 patients

Conditions: COVID-19

Summary: the leading cause of death in patients with covid19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. but it can be said that treatments are the main source of inflammation. inflammasome nlrp3 is one of the mechanisms involved in many severe inflammatory disorders. inflammatory activation has already been demonstrated by many viruses. melatonin, on the other hand, is a hormone in the body that can inhibit inflammation nlrp3 in addition to various anti-inflammatory effects, especially after severe inflammation. older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. in the present study, while measuring melatonin in patients with covid19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 based on either ground glass appearance in chest ct scan or positive rt-pcr test for covid-19 * oxygen saturation drop below 93% * systolic blood pressure drop below 100 or blood pressure drop of 30 mm hg from the patient's previous normal systolic blood pressure * fever * dry cough * positive pcr for covid-19 * laboratory indices include crp and esr indicating covid-19 exclusion criteria: * patient dissatisfaction * existence of drug interactions * lack of proper conditions for receiving medication
web-administered stair for patients on behavioral health waitlists

Conditions: Post Traumatic Stress Disorder

Summary: posttraumatic stress disorder (ptsd) is a significant public health challenge with population prevalence rates in the us between 6.1 to 9.2%. there are large racial and socioeconomic inequities in access to ptsd treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for ptsd, yet only 13% receive any behavioral health treatment. workforce shortages are one major barrier to accessing care. additional barriers to care can include heightened mental health stigma and mistrust of health services. digital mental health interventions (dmhis) may be suitable within the continuum of care for ptsd in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of dmhi among individuals with high stigma and social needs. among the available dmhis for ptsd, the investigators have selected web-administered skills training in affective and interpersonal regulation (webstair), based on emerging scientific evidence and a close collaboration with boston medical center (bmc) users (patients and providers) in a previous pilot study in primary care. the aim of this randomized study is to implement webstair at bmc in the recovery from stress and trauma through outpatient care, research, and education (restore) center's subspecialty clinic.


Eligibility criteria:
inclusion criteria: * client on the restore center waitlist at boston medical center * over 18 years of age * able to receive therapy in english or spanish (per participant report) * exposure to trauma (as indicated by the life events checklist for the dsm-5 \[lec-5\]) * probable ptsd (as indicated by the ptsd checklist for the dsm-5 \[pcl-5\] based on pcl score of 33+). * reasonable to access to technology (e.g., phone, computer, internet access). exclusion criteria: * patient declines to be in the study.

Keywords: digital mental health intervention (dmhi) community health worker (chw) web-administered skills training in affective and interpersonal regulation (webstair) stepped care
medication-assisted treatment implementation in community correctional environments (maticce)

Conditions: Opioid-Related Disorders; Alcohol-Related Disorders

Summary: the goal of this study is to see whether or not a strategic planning process is able to introduce and sustain improvements in the working relationship between probation/parole departments and community-based addiction treatment agencies that provide medication assisted therapy (mat) for individuals with opioid or alcohol dependence. in addition, this study seeks to improve probation/parole agency personnel's knowledge and perceptions about mat, and increase the number of appropriate referrals to community treatment agencies that provide mat. there are three phases to this study. phase 1 includes a pilot study to determine the quality and availability of client level records and the collection of baseline data (the pilot study protocol was previously submitted to tmh irb). phase 2 will consist of a knowledge, perceptions and information (kpi) intervention during which probation/parole agencies will undergo training to increase knowledge about the effectiveness of mat, and complete a post training assessment to evaluate the effectiveness of the kpi intervention. during phase 3, probation/parole agencies will be randomly assigned to a 12-month organizational linkage intervention (oli) condition or to control (no further intervention). agencies assigned to the oli will establish a pharmacotherapy exchange council (pec) that consists of staff from both the probation/parole and community treatment agencies. the pec will undergo a strategic planning process to increase the availability of mat for opiate and/or alcohol dependent individuals who are on probation/parole.


Eligibility criteria:
probation/parole or community treatment agency staff.
medroxyprogesterone +/- cyclophosphamide & methotrexate in hormone receptor-negative recurrent/metastatic breast cancer

Conditions: Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Summary: the purpose of this study is to evaluate the impact of mpa alone and in combination with low dose oral chemotherapy in patients with er- and pr- advanced breast cancer.

primary objectives: i. to determine the clinical benefit rate (complete response \[cr\] + partial response \[pr\] + stable disease \[sd\] \>= 6 months) of medroxyprogesterone acetate (mpa) monotherapy and mpa + low dose oral cyclophosphamide and methotrexate (ldocm) in patients with refractory hormone receptor negative metastatic breast cancer. secondary objectives: i. to evaluate the toxicity of mpa and mpa + ldocm in this patient population. ii. to explore the relationship between mpa trough level and clinical benefit. iii. to explore genetic determinants of mpa bioavailability and trough concentration. iv. to explore potential surrogates of biologic activity including nm-23 expression in primary tumor, change in nm-23 expression in skin, change in plasma thrombospondin (tsp)-1, change in plasma plasminogen activator inhibitor (pai)-1 antigen and activity. outline: patients are assigned to 1 of 2 treatment arms. cohort i: patients receive mpa orally (po) once daily (qd). cohort ii: patients receive mpa as in cohort i, cyclophosphamide po qd, and methotrexate po twice daily (bid) on days 1 and 2 of every week. in both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease * primary tumor must be er negative and pr negative * patients must be post-menopausal * patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease * adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol * patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required exclusion criteria: * patients must not have extensive pleural effusion or ascites * patients must not have history of dvt or pulmonary embolism w/in past 12 mo * patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry * patients must not have had radiation therapy within 1 week of study entry.

Keywords: medroxyprogesterone progesterone acetate (mpa) cyclophosphamide plus methotrexate
effect of vitamin d on cognitive decline of patients with memory complaint

Conditions: Memory Disorders; Age-Related Cognitive Decline

Summary: as recommended allowance of oral vitamine d are unable to ensure the recommended serum concentration of vitamine d, the purpose of this study is to show that a dose of vitamin d3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.


Eligibility criteria:
pre-inclusion criteria : * patients aged 60 years or older, * who report to a memory centre with symptoms of memory complaint, * having a mini-mental state examination (mmse) score strictly \> the 5th percentile for sociocultural level of the patient (greco standards for elderly patients), * having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests, * who accept participation in the study and are able to sign the informed consent of the - affiliated to the french social security system. inclusion criteria: * insufficient 25 oh d serum level : 25 oh d \< 50 nmol/l (20 ng/ml), * normal corrected plasma calcium concentration, * normal kidney function (cockcroft \> 30 ml/mn) exclusion criteria: * alzheimer's disease or other dementia, * parkinson's disease treated, * epilepsy treated, * huntington's disease, * brain tumor, * history of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmhg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery), * antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition, * severe depression : score montgomery asberg depression rating scale (madrs) \> 18, * psychotropic drug therapy (at the discretion of the clinician), * hypercalcaemia or treatment for a hypercalcaemia, * known hypersensitivity to the vitamin d, * granulomatous disease, * treatment of vit d at doses higher than the current recommendations, * history of calcium urinary lithiasis of less than 1 year, * nonsteroidal antiinflammatory drug (nsaid) chronic treatment, * severe medical or surgical affection of less than 3 months, * unstable health, severe hepatic or renal deficiency, * deprivation of liberty, under judicial protection, * institutionalization (ehpad), * illiteracy, * participation in another biomedical research. a diagnosis of mci (mild cognitive impairment) of less than 6 months is not a criterion of non-inclusion.

Keywords: vitamin d cholecalciferol 25-hydroxyvitamin d memory complaint subjective memory complaint mild cognitive impairment preventive therapy cognitive disorders
periodontal treatment in non-controlled type 2 diabetes mellitus patients. clinical trial

Conditions: Diabetes Mellitus.; Chronic Periodontitis

Summary: periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. type 2 diabetes mellitus (dm2) is a risk factor for periodontitis.patients with dm2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. it has been reported an average decrease of 0.4% in glycosylated hemoglobin levels (hba1c) in patients periodontally treated versus untreated. it is not has been established that periodontal treatment type in spaced sessions (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours), has a greater impact on glycemic control in type 2 diabetes patients. objective: to evaluate the effectiveness of intensive periodontal treatment modality as compared with conventional on hba1c level in periodontitis and dm2 decompensated patients.

it is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor glycemic control defined as a glycated hemoglobin (hba1c) ≥ 7% at last check, with randomization stratified by referral center, with two parallel groups (1: 1). diabetic patients are in treatment and control in diabetes polyclinic medical specialty center of the university of the andes or the medical polyclinic joan alsina in san bernardo . all decompensated dm2 patients diagnosed with chronic periodontitis will receive periodontal treatment based on 2 different periodontal treatment modalities: the first and most traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). the second form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24 hours. all patients will be given an initial periodontal examination with manual north carolina periodontal probe, performed by a single operator previously calibrated. periodontal status will be determine according to the classification of page and eke (2007) and periodontal wound size (pisa) will be also determine. also, will be measured inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (gcf) by elisa test. the data were entered into a medical record designed specifically for this study and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.

Eligibility criteria:
inclusion criteria: * decompensated type 2 diabetic patients (hba1c ≥ 7% at last check). * minimum 12 teeth in the mouth. * no history of surgical or nonsurgical periodontal treatment in the six months prior to baseline. * not be involved in another clinical trial. exclusion criteria: * patients with renal failure * patients with rheumatoid arthritis, * patients with heart disease. * patients with history of stroke or acute cardiovascular event in the 12 months prior to the start of the study. * patients with liver dysfunction * patients in state of pregnancy or planning pregnancy. * patients on medical treatment with systemic antibiotics in the past 3 months.

Keywords: diabetes mellitus. periodontitis periodontal treatment.
whole soy replacement diet on metabolic features

Conditions: Metabolic Syndrome

Summary: project title: a randomized controlled trial of whole soy diet in place of red/processed meat and high fat dairy products on metabolic features in postmenopausal women objectives: metabolic syndrome (mets) is an escalating public health problem especially in postmenopausal women. traditional whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that could benefit on mets. the aim of the study is to examine the effect of whole soy replacement diet on the features of mets among postmenopausal women. hypothesis to be tested: whole soy diet in place of red or processed meat and high fat dairy products will significantly improve metabolic features. design and subjects: this will be a 12-month randomized, single-blind, controlled trial among 208 postmenopausal women with high risk of mets or early mets. study instruments: after 4 weeks' run-in, participants will be randomly allocated to either of two intervention groups, whole soy replacement group or control group, each for 6 months. interventions: subjects in whole soy group will be required to include 4 servings of whole soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or processed meat and high fat dairy products. subjects in the control group will remain an usual diet. main outcome measures: the outcome measures will include the indices of metabolic features as well as a 10-year risk for ischemic cardiovascular disease. data analysis: the changes and %change of the metabolic features at 6- and 12-month will be compared among the two groups. expected results: whole soy diet substitution of high saturated fat and cholesterol rich animal products will notably decrease the risk of mets.


Eligibility criteria:
inclusion criteria: 1. postmenopausal women aged 45\~70y within 15 years after menopause; 2. participants who meet 2 or more of the following items: * waist circumference wc ≥80 cm; * triglyceride concentration ≥1.7 mmol/l; * hdl-c \<50 mg/dl (1.29 mmol/l); * sbp/dbp ≥130/85 mm hg; * fasting glucose ≥5.6 mmol/l. exclusion criteria: 1. on use of medications known to affect body weight, lipids and glucose within past 3-month; 2. medical history or presence of severe systemic or endocrine diseases; 3. present or history of breast, endometrial or ovarian cancer; 4. abnormal uterine bleeding after menopause; 5. on prescribed or vegetarian diet; 6. known soy allergy.
shoulder pacemaker for scapular dyskinesia

Conditions: Scapular Dyskinesis; Posterior Shoulder Instability

Summary: the investigators purpose of this study is to determine patients-reported outcomes (vas pain scores) in patients with scapular dyskinesis or posterior shoulder instability who undergo rehabilitation with a shoulder pacemaker.

the scapula plays a key role in nearly every aspect of normal shoulder function. shoulder dyskinesia or scapula winging effects patients as a result of nerve injury or muscle detachment or abnormal muscle recruitment. patients with abnormal muscle recruitment often are helped the most by therapy but restoring normal firing can be difficult. abnormal muscle recruitment is due to pain or weakness or instability of the glenohumeral joint and the muscles around the scapula attempt to compensate for the lack of normal firing patterns. in many patients, physical therapy and surgery have proven to be unsuccessful treatment options. the shoulder pacemaker is a device that specifically aims at resolving functional issues that surgery and physical therapy are unable. it's a wearable electro stimulator created for patients suffering from unbalanced muscle activation in the shoulder, such as scapular dyskinesis. the shoulder pacemaker delivers "smart stimulation" through a dynamic interaction between the patient and the device. the motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. this process helps to restore normal muscle activation patterns and equilibrium. the pacemaker will hopefully assist in restoring normal muscle recruitment.

Eligibility criteria:
inclusion criteria: * scapular dyskinesis * posterior shoulder instability exclusion criteria: * rotator cuff tearing * shoulder arthritis * patients with implantable electrical/electronic devices * if participants are using wearable electrical medical devices, such as glucose sensors or infusion pumps, these devices will be turned off or the participants will be excluded from the study.

Keywords: scapular dyskinesia posterior shoulder instability shoulder pacemaker treatment pain
safety and effectiveness of nxy-059 for the treatment of patients who have suffered from a stroke

Conditions: Cerebral Stroke; Stroke, Acute; Cerebrovascular Stroke; Ischemic Attack, Transient

Summary: this study will determine if nxy-059 will improve recovery from an acute stroke. the study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Eligibility criteria:
inclusion criteria: * males and females * acute ischemic stroke with limb weakness * onset of symptoms within 6 hours * full functional independence prior to the present stroke exclusion criteria: * unconsciousness * subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. * severe illness with life expectancy less than 6 months. * known severe kidney disorder. * current known alcohol or illicit drug abuse or dependence. * pregnant or breast-feeding. * treatment with acetazolamide and methotrexate is not permitted during the infusion * participation in a previous clinical study within 30 days. * meets all other exclusion criteria.

Keywords: stroke cerebral vascular accident cva ischemia hemorrhage tia transient ischemic attack brain attack cataplexy
assessment of the efficacy and safety of olaparib monotherapy versus physicians choice chemotherapy in the treatment of metastatic breast cancer patients with germline brca1/2 mutations.

Conditions: Breast Cancer Metastatic; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation

Summary: this open label, randomised, controlled, multi-centre phase iii study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gbrca 1/2 mutations.


Eligibility criteria:
inclusion criteria: * germline mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious. * histologically or cytologically confirmed breast cancer with evidence of metastatic disease. * prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting. * prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed. * er/pr breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. * ecog performance status 0-1. * adequate bone marrow, kidney and liver function. exclusion criteria: * prior treatment with parp inhibitor. * patients with her2 positive disease. * more than 2 prior lines of chemotherapy for metastatic breast cancer. * untreated and/or uncontrolled brain metastases. * prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, dcis or stage i grade 1 endometrial cancer allowed. * known hiv (human immunodeficiency virus) infection. * pregnant or breast-feeding women.

Keywords: breast cancer metastatic olaparib brca parp inhibitor her2 chemotherapy