Kornimate/medical-research-clean huggingface dataset:
rapid antidepressant effects of atp and phosphocreatine

Conditions: Major Depressive Disorder

Summary: this is a preliminary, double-blind clinical trail aimed to investigate whether the combination of fluoxetine with atp or phosphocreatine has a rapid antidepressant effect. 42 patients with major depressive disorder (hamilton depression rating scale (hamd) score \>= 20) will be recruited and divided into 3 groups randomly. this study involves two periods. in the first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and atp, and one with fluoxetine and phosphocreatine for 2 weeks. placebo, atp and phosphocreatine will be given intravenously, and fluoxetine orally. in the second period, each patient will be only given fluoxetine for 4 weeks.


Eligibility criteria:
inclusion criteria: * 18-65 year-old male or female * major depressive disorder diagnosed by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * hamilton depression rating scale score \>= 20 at screening * written informed consent exclusion criteria: * participants of other clinical trials in recent 4 weeks * suicidal idea or action that requires hospitalization * post traumatic stress syndrome in recent 6 months * secondary depression, or have a direct familial history of schizophrenia * diseases that prevent from appropriate expression of depressive emotion * psychiatric disorders including bipolar disorder and schizophrenia * severe heart, kidney, lung or liver diseases that require hospitalization * diabetes * neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor) * inflammatory disease including autoimmune disease * taking anti-inflammatory medication * taking antiarrhythmic drugs, antidiabetic agents or tryptophan * substance abuse or dependence history in recent 6 months * pregnant or having plan to be pregnant
novel methods for management of complicated wounds

Conditions: Complications Wounds

Summary: difficult to heal wounds are a common and complex medical problem, causing suffer to the patients and challenging medical, social and economic burden on the health system. based on data from the western world, it is estimated that in israel, at any given time, 30 to 60 thousand patients with difficult to heal wounds. among diabetics patients, it is estimated that 15% to 25% will develop a difficult to heal foot wounds during their live time. the medical definition of a difficult to heal wounds is: a wound showing no signs of recovery after 4-6 weeks of treatment. most of these wounds are caused by anaerobic bacteria inventions. one of the methods for the treatment of difficult to heal wounds is - roi-rnpt (regulated oxygen -enriched \& irrigation negative pressure -assisted wound therapy). this method creates in the wound a negative pressure in the presence of oxygen and irrigation applied directly into the wound bed. as part of the wound closure process the investigators will use the "external tissue expansion". this method under clinical use is exercised by the - "top closure" "tension relief system" (trs). in this study, the investigators intend to investigate whether roi-npt system combined with topclosure, is effective for the treatment of difficult to heal wounds, compared with methods currently in use.

1. the investigators will debride the wound if necessary. wound biopsies will be taken to determine the existing pathogens and direct the antibiotic treatment. 2. wound measurements will be taken (width, length and depth). 3. afterwards the wound will be closed with the topclosure device and the patient will be connected to a negative wound pressure device vcare alpha. 4. the investigators will change dressings according to schedule. if the wound is clean the investigators will change dressings every 3-5 days. if the wound is infected the investigators will change dressings every 2-4 days. if the investigators encounter a severe infected wound with a lot of pus the investigators will change dressings every 1-3 days. 5. the investigators will determine the time to heal when the wound is clean and there is no further need for negative pressure wound treatment (roi-npr) up to 10 weeks.

Eligibility criteria:
inclusion criteria: 1.a patient in our in-patient rehabilitation ward that is willing to participate in our study and is willing to be constrained to his bed for the time of the study. exclusion criteria: 1. patient with cognitive impairments interfering with his or her ability to understand the instructions by our team. 2. patient that is not willing to be constrained to his bed for the time of the study.
salivary gland autotransplantation for treatment of xrt induced xerostomia

Conditions: Xerostomia; Head and Neck Cancer

Summary: xerostomia, or dry mouth, is a common side effect of head neck radiation. current treatment options for radiation-induced xerostomia are generally supportive in nature. most of these supportive interventions do not reverse xerostomia and are palliative in intent. the investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (mscs) in salivary glands post-rt or post-chemoradiation therapy (crt) may provide an innovative remedy to treat xerostomia and restore quality of life. participants can expect to be on study for up to 6 months.

this feasibility study will analyze the salivary composition, salivary viscoelasticity, salivary gland us, and qol surveys of participants without head and neck cancer (hnc) to determine standard values. the investigators will then compare this to the salivary composition and viscoelasticity of participants with treated hnc. additionally, the investigators will examine the paracrine factors of marrow mscs in order to prove a hypothesis that paracine factors constitutively expressed by marrow mscs \[wnts, fibroblast growth factors (fgfs), gdnf and others\] will directly influence the biology of dormant salivary gland stem cells following intraglandular transplantation and allow for functional recovery following rt. primary objective * to determine the feasibility of in vitro expansion of marrow-derived mscs from hnc patients to \>50 million cells. secondary objectives * to assess the stability of salivary function in hnc patients using quality-of-life (qol) questionnaires and salivary composition analysis. * to assess the stability of salivary gland size as measured by ultrasound. correlative objectives * to compare assess the secretome profile of mscs from hnc patients treated with radiation or, chemoradiation, or previously untreated. * to compare the salivary composition, viscoelasticity, salivary gland ultrasound, and qol of hnc patients to non-hnc patients

Eligibility criteria:
inclusion criteria: * participants ≥2 years from completion of chemoradiation therapy or radiation therapy (n=6) with subjective complaint of xerostomia or with no diagnosis of hnc (n=5) * karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia * not pregnant * willing and able to give informed consent * non-hnc participants only need to meet the following applicable inclusion criteria * no history of radiation to the salivary glands * willing and able to give informed consent exclusion criteria: * salivary gland disease (e.g., sialolithiasis)

Keywords: dry mouth msc mesenchymal stem cells adult stem cells head and neck cancer salivary gland radiation hnc
pre-operative 5% dextrose infusion & ponv

Conditions: Nausea, Postoperative

Summary: with this study, we aim to compare the efficacy of pre-operative dextrose-containing fluid infusion with other fluid for the prevention of ponv in middle ear surgeries.

we hypothesized that maintenance of stable level of blood glucose in addition to adequate hydration through preoperative intravenous dextrose 5% infusion will have a rule in decreasing the incidence and severity of ponv; as it reduces insulin resistance and decreases gastric acid secretion; which may contribute to ponv.

Eligibility criteria:
inclusion criteria: * asa physical status i and ll. * patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty exclusion criteria: * history of dependence or use of antiemetics * history of motion sickness * presence of psychiatric illness * pregnant and lactating women * cardiovascular disorders (ischemic heart diseases, congestive heart failure and valvular diseases) * diabetic patients
the renin-angiotensin-aldosterone system and parathyroid hormone control: the raas-parc study

Conditions: Hyperparathyroidism

Summary: this study will evaluate whether commonly used blood pressure medications called "ace inhibitors" can lower parathyroid hormone.

the raas-parc study will evaluate whether angiotensin-converting enzyme inhibitors (acei) can lower parathyroid hormone (pth) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism. emerging data has implicated the renin-angiotensin-aldosterone system (raas) activity with increased pth. the principal investigator, and other investigators, have previously shown that inhibiting the raas may lower pth. the current study will focus on: 1. normal physiology: does an acei (which lowers angiotensin ii and aldosterone) reduce pth in normal individuals? 2. pathophysiology: does an acei reduce pth in individuals with primary hyperparathyroidism? the results of this study may have important implications for cardiovascular and skeletal health, as both the raas and pth have been implicated as mediators of these conditions.

Eligibility criteria:
inclusion criteria: * healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30) * normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication. * age \>18 years and \<80 years * estimated gfr \> 60ml/min exclusion criteria: * chronic kidney disease or egfr\<60 * stage 2 or stage 3 hypertension or the use of more than 1 antihypertensive drug * type 2 diabetes mellitus that is not controlled by diet or metformin alone or with a hemoglobin a1c \>7.5% * history of liver failure * history of heart failure * the use of typical or atypical antipsychotic medications or lithium. * chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of nsaids or glucocorticoids * the use of prescribed doses of potassium supplements. * illness requiring overnight hospitalization in the past 6 months * active tobacco or recreational drug use * pregnancy or current breast feeding

Keywords: hyperparathyroidism renin-angiotensin-aldosterone system ace inhibitors
melanoma research lymph node prediction implementation national_001

Conditions: Melanoma

Summary: merlin_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (sn) status and to determine its prognostic value for more accurate staging of sn-negative melanoma patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with invasive malignant melanoma of the skin (ajcc 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation. * male or female, age ≥18 years. exclusion criteria: * full primary melanoma pathology report unavailable. * documented clinically apparent nodal metastases at diagnosis. * distant metastatic disease (m1a,b,c,d) clinically present at primary diagnosis * any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s). * documented history of another (prior or concurrent) primary invasive melanoma of t1b or greater at any site within the last 5 years. * previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma. * ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (meltump) or atypical spitz tumors.

Keywords: prospective study gene expression melanoma merlin assay
pk/pd study of shr-2017 injection in patients with bone metastases

Conditions: Patients With Bone Metastases

Summary: to evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of shr-2017 injection in patients with bone metastases, and to evaluate the efficacy of shr-2017 injection in the treatment of skeletal-related event and cancer pain.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. male or female, age ≥ 18 years; 3. solid tumors confirmed by histological or cytological examination; 4. at least 1 bone metastasis from a documented tertiary a hospital during the screening period; 5. worst pain score nrs ≥5 points when treated with a stable analgesic regimen during the baseline assessment period; 6. received a stable anti-tumor regimen within 28 days prior to the baseline assessment period 7. during the screening period, the physical status score of the eastern cooperative oncology group (ecog) was 0-2 points; 8. life expectancy judged by the investigator to be at least 6 months 9. good organ function during the screening period (repeated testing can be confirmed if necessary); 10. female subjects of childbearing potential with negative blood pregnancy test results within 7 days prior to the first dose of study drug and not lactating. exclusion criteria: 1. previous occurrence or concomitant osteomyelitis of the jaw or osteonecrosis of the jaw, dental disease or jaw disease that is active, requiring oral surgery, dental surgery or oral surgery wound that has not fully healed, or has planned invasive dental procedures during the study; 2. history of major joint trauma or surgery within 1 year prior to enrollment 3. cardiac dysfunction within 6 months before enrollment; 4. resting tachycardia or resting bradycardia on ecg at screening； 5. subjects who have evidence of orthostatic hypotension at screening； 6. hepatitis b surface antigen (hbsag), hepatitis c antibody (hcvab), human immune defect antivirus (hiv) antibody, syphilis antibody; 7. the pain of the subjects not predominantly related to a bone metastasis; 8. the subject with neurological diseases and/or mental illness and/or cognitive dysfunction ； 9. receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 1 month of the treatment period, and the subject who received the radiotherapy within one month before the first research drug administration 10. subject has a history of allergic or anaphylactic reaction to mammalian -based drugs, or allergies to supplements (calcium or vitamin d supplements), or have a history of allergens of opioids, or past history of treatment or diagnostic monoclonal antibody, or other allergies; 11. the subject participated in the treatment of other clinical trials within one month before receiving the experimental drug (except for participating in other clinical trial screening losers); 12. in the judgment of the investigator, would make the subject inappropriate for entry into this study;
using glucose sensors to prevent hypoglycemia

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: hypoglycemia is the most common complication of type 1 diabetes particularly in those who strive for good glycemic control. in some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. such a situation may carry risks that the patient may harm him or her self. medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (paradigm rt) that may be worn or left close by eg on a bedside table. the device may be programmed to alarm for a rapidly falling glucose or for low glucose levels. we propose to use this in 16 patients with severe hypoglycemia as evidenced by a high hypo score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better hypo score.

sixteen patients with type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and c-peptide negative), with a hypo score over the seventy-fifth percentile (\>423), will be approached and offered the study. the study will be conducted over a three month time-frame. the first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. these records will be used to calculate the baseline modified hypo score. patients will be screened during the first month for thyroid disease, celiac disease and addison's disease. during the second month they will meet with the study nurse for an intensive instruction period on the use of the paradigm rt sensor. they will spend this month practicing to use the sensor and confirming they can use it adequately. during the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified hypo score. the end point will be the change from the baseline modified hypo score to the final four week hypo score and this would be used to identify any improvement.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus confirmed by c-peptide \<0.10 nmol/l * age 18 - 70 yrs. * hypo score \>423 * normal tsh, serum cortisol and anti-transglutaminase (attg) exclusion criteria: * current diagnosis of cancer * planning a pregnancy * inability to give informed consent

Keywords: type 1 diabetes hypoglycemia glucose sensor
cohort study on the outcome and influencing factors of perinatal depression

Conditions: Perinatal Depression; Prognosis

Summary: 1. research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester; 2. factors affecting the outcome of the disease; 3. recurrence of pnd in pregnancy again; 4. the influence of different intervention methods on the course of the disease.

research objectives 1. research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester; 2. factors affecting the outcome of the disease; 3. recurrence of pnd in pregnancy again; 4. the influence of different intervention methods on the course of the disease. research process: 1. the pregnant women who were filed at xinhua hospital and tongji hospital and were receiving perinatal care from july 2019 to december 2019 were evaluated in the third trimester of pregnancy using the general situation questionnaire, ssrs, phq-9, and gad-7. those with phq-9 score ≥ 5 or gad ≥ 5 were classified as having symptoms of depression and anxiety, and those who were screened positive were included in the study cohort; 42 days postpartum, 3 months postpartum, 6 months postpartum, 12 months postpartum, 18 months postpartum , 24 months postpartum, use phq-9, gad-7 scale, 6 quality of life questionnaires, and ssrs to evaluate the cohort. if the phq-9 score is greater than or equal to 5 or the gad is greater than or equal to 5, the psychiatrist will perform a clinical examination based on dsm-iv to make a clinical diagnosis; the outcome of the cohort and the incidence and influencing factors; 2 . during the follow-up process, the cohort developed high-risk pregnant women with depression, anxiety symptoms and other perinatal depressive disorders during the follow-up process. based on the wechat platform, integrated general hospitals, psychological counseling centers, social families and other service resources were carried out throughout the prenatal and first delivery period. intervention methods such as community intervention for perinatal depression that focus on the comprehensive "physiology, psychology, and society" of the whole process after the first childbirth. pregnant women diagnosed with pnd will be evaluated by a psychiatrist to determine the treatment plan, and follow-up will continue.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -
a study to assess the efficacy, safety and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Summary: the purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (cidp).


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age with a minimum body weight of ≥42 kg at visit 1 (screening) * subject has a documented definite or probable diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (cidp) according to the european federation of neurological societies (efns)/ peripheral nerve society (pns) criteria 2010 * subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to screening and documented in medical history * subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (scig) or intravenous immunoglobulin (ivig) and a fixed interval for at least 4 months of either treatment * female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (imp) * male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of imp exclusion criteria: * previously received treatment in this study or subject has previously been exposed to rozanolixizumab * current diagnosis or has a history of type 1 or type 2 diabetes mellitus and/or hemoglobin a1c level \>6.0 % * known immunoglobulin m (igm)-mediated neuropathy * clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy * history of clinically relevant ongoing chronic infections * family history of primary immunodeficiency * received a live vaccination within 8 weeks prior to the baseline visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of imp * received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to baseline * prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the baseline visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to baseline and b cells are not within the normal range * female subject who is pregnant or lactating

Keywords: chronic inflammatory demyelinating polyradiculoneuropathy cidp ucb7665 rozanolixizumab