Kornimate/medical-research-clean huggingface dataset:
effect of dexmedetomidine on microcirculation in patients undergoing extracorporeal shock wave lithotripsy

Conditions: Microcirculation

Summary: dexmedetomidine administration for minor procedure, such as extracorporeal shock wave lithotripsy, provides good quality of sedation and analgesia. dexmedetomidine is a highly selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. extracorporeal shock wave lithotripsy may cause pain and result in tachycardia and vasoconstriction-related hypertension. surgical or procedural stress may induce inflammation and it may cause further microthrombosis. both vasoconstriction and microthrombosis will alter the microcirculatory status. dysfunction of microcirculation may impair tissue perfusion and result in organ dysfunction. dexmedetomidine may induce vasodilation by slow intravenous infusion for sedation. dexmedetomidine may also reduce inflammation. after reviewing the literature, the investigators found that the effect of dexmedetomidine on microcirculation was not well investigated. by application of the non-invasive technique of sidestream dark field imaging, the investigators can investigate the vessel density, percentage of perfused vessels, and microvascular flow index on sublingual vessels. the goal of this study is to identify the effect of dexmedetomidine on sublingual microcirculation in patient undergoing extracorporeal shock wave lithotripsy.


Eligibility criteria:
inclusion criteria: * patient who is older than 18 years old and less than 75 years old * patient who receive extraproporeal shock wave lithotripsy with asa class i or ii * patient who has understood the inform consent and agree to participate this study exclusion criteria: * patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock * patient who has a past history of allergy to s dexmedetomidine * patient who has history of cardiovascular, renal or hepatic dysfunction * patient who has participated in any other investigational study of other drugs currently * female patient who is pregnant or considers breast feeding currently * patient who has suspected full stomach
doxycycline and airway inflammation in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Inflammation; Pulmonary Emphysema

Summary: copd is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. the inflammation is associated with tissue loss and remodelling. the investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with copd. therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.

rationale: copd is a disease characterized by chronic inflammation and irreversible airway obstruction. chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis. objective: to assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable gold ii and iii copd patients. study population: thirty patients with stable gold ii copd. intervention: placebo versus doxycycline in randomised design.

Eligibility criteria:
inclusion criteria: * gold ii or iii copd (gold ii: fev1/fvc \< 70%; 50% \< fev1 \< 80% predicted, gold iii: fev1/fvc \< 70%; 30% \< fev1 \< 50% predicted ). * stable disease (no exacerbations in the last 3 months). * age \> 40 yrs. * written informed consent. exclusion criteria: * infections and/or use of antibiotics in the last month. * bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (bal). * allergy for tetracyclines or a history of substantial side-effects. * active respiratory diseases other than copd (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis). * acute exacerbation of copd as defined by anthonisen et al. \[10\]. * signs and/or symptoms of a current respiratory or non-respiratory infection. * use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.

Keywords: copd inflammation neutrophilic myeloperoxidase doxycycline
the transitions project: supporting adults during the shift from cancer treatment to surveillance

Conditions: Non Small Cell Lung Cancer; Small-cell Lung Cancer; Mesothelioma; Cognitive Behavioral Therapy

Summary: this research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.

the aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance. the research study procedures include screening for eligibility. this study consists of 2 parts. it is expected that about 45 people will take part in this research study. * in the first part of this study, about 5 participants will complete survey questions and receive a 5-session program. * in the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control). * these sessions will focus on providing targeted support related to life after cancer treatment. the sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.

Eligibility criteria:
inclusion criteria: * age 21 or older * diagnosis of non-small cell (nsclc) or small cell (sclc) lung cancer or mesothelioma * documented treatment plan with curative intent * ability to read and respond in english * treatment completion eligibility: run-in: has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at massachusetts general hospital. rct: has completed treatment including systemic treatments +/- radiation and +/- surgery. 1. if final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete. 2. if final treatment is surgery: within three weeks after hospital discharge following surgery. exclusion criteria: * comorbid health condition that would interfere with study participation * current participation in cognitive behavioral therapy treatment

Keywords: non small cell lung cancer small-cell lung cancer mesothelioma cognitive behavioral therapy
a study of second-line treatment with apatinib in patients with advanced intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma; Second-line Treatment

Summary: the purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. the primary endpoint of this study is objective response rate (orr), disease control rate (dcr) and progression-free survival (pfs).


Eligibility criteria:
inclusion criteria: * patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage iv; * have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment; * the previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment; * measurable disease according to response evaluation criteria in solid tumors (recist), version 1.1; * eastern cooperative oncology group performance score (ecog): 0-2; * life expectancy of at least 12 weeks; * subjects who understand and voluntarily signed a written informed consent form. exclusion criteria: * previous locoregional therapy within 4 weeks prior to enrollment. * diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma. * history of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma. * prepared for liver transplantation. * patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, iii-iv level cardiac insufficiency, severe liver and kidney dysfunction). * a previous history of interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence. * use of cyp3a4 inhibitor within 7 days or cyp3a4 inducer within 12 days prior to enrollment. * patients with central nervous system metastases or brain metastasis * previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia. * pregnant or lactating women. * patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
a follow-on trial to assess the long term safety and efficacy of spm 927 in painful distal diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (spm 927) in subjects with painful diabetic neuropathy. the safety and tolerability of the different doses of lacosamide will be investigated.

this phase 2/3 open-label trial is being conducted at approximately 100 sites in the us to assess the safety and tolerability of long-term treatment with lacosamide (spm 927) in subjects with painful diabetic neuropathy. approximately 525 subjects will be enrolled. to qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials sp665, sp742, or sp768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). the safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. in addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. subjects' quality of life will also be investigated.

Eligibility criteria:
inclusion criteria: * subjects who completed study sp665, sp742, or sp768 and, in the investigators opinion, might benefit from long-term administration of spm 927. exception: subjects who prematurely discontinued study sp742 or sp768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in study sp745, after consultation with the medical monitor. exclusion criteria: * subject has clinically relevant electrocardiogram (ecg) abnormalities, or qt-corrected (qtc) interval \>=500 milliseconds (ms), and/or a qtc interval increase of \>=60ms from the mean pre-dose qtc value at visit 2 of studies sp665, sp742 or sp768. * subject has aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>=3 times the upper limit of the normal range (uln) with total bilirubin \>=2 times uln or transaminases (ast and/or alt) \>=5 times uln. * subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.

Keywords: painful distal diabetic neuropathy
ralpps venus alpps for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: currently，the "alpps" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. however, the procedure has a high morbidity and mortality rate.using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage i will reduce the incidence of complications（bile leakage, abdominal infection,hemorrhage e.t.) the investigators named this technique as radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy （ralpps）.investigators hypothesized that the ralpps might result in lower morbidity and mortality rate than alpps in the treatment of hepatocellular carcinoma . this prospective randomized controlled trial is on the safety and efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * an insufficient future liver remnant(flr\<30% in normal hepatic function or flr\<40% with hepatic cirrhosis or after chemotherapy） * liver function of child-pugh class a or b. * liver reserve function：icg-r15≤10％ * no evidence of coagulopathy: platelet count \> 50 × 109/l and a prolonged prothrombin time of \< 5 seconds. exclusion criteria: * patients met the inclusion criteria but declined to participate. * patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites. * main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus. * extrahepatic or lymph node metastasis

Keywords: rfa alpps hepatectomy morbidity and mortality
trichuris suis ova (tso)in recurrent remittent multiple sclerosis and clinically isolated syndrome

Conditions: Multiple Sclerosis

Summary: trichuris suis ova (tso) is a probiotic treatment based on the hygiene hypothesis, that has proven safe and effective in autoimmune inflammatory bowel disease. clinical trails indicate that helminth infections have an immunomodulatory effect in multiple sclerosis as well. investigators hypothesize that tso® 2500 eggs given oral every 2 weeks for 12 months is - due to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple sclerosis and clinically isolated syndrome significantly more effective than an oral placebo treatment as assed by new t2 lesions in cerebral magnetic resonance imaging and clinical examination.

tso has an impact on the th1-th2 balance and effects il-10 producing b-cells, mechanisms that result in an antiinflammatory effect. a 12 month treatmet with tso is safe and well-tolerated

Eligibility criteria:
inclusion criteria: * active recurrent remittent multiple scleosis or clinically isolated syndrome * inefficacy or intolerance for a therapy with interferon-beta * age 18 - 65 * edss \<4 exclusion criteria: * secondary or primary chronic progressive multiple sclerosis * immunomodulatoric or immunosuppressive therapy

Keywords: multipe sclerosis, trichuris suis ova
a double-blind, placebo-controlled study of antidepressant augmentation with agomelatine

Conditions: Major Depressive Disorder

Summary: the purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (ssri) and serotonin-noradrenaline reuptake inhibitor (snri) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with mdd.


Eligibility criteria:
1. age between 18 and 60 years. 2. meeting the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) criteria for a current major depressive episode. 3. demonstrating an inadequate response to antidepressant treatment lasting at least 2 weeks, at the minimum effective dose for antidepressants. inadequate response is defined as a \< 20% change in the hamilton depression rating scale-17 (hamd-17) score or as per patients' self-report in the antidepressant treatment questionnaire. minimum effective doses for some commonly used classes of antidepressants include: * sertraline: \>50mg * fluoxetine: \>20 mg * citalopram: \>20 mg * escitalopram: \>10mg * venlafaxine: \>75 mg * duloxetine: \>50 mg 4. hamd-17≥17; clinical global impression-severity (cgi-s) score ≥4. 5. education level of at least 6 years, with the ability to independently complete all scales and assessments. 6. agreement from primary healthcare providers and patients to maintain current antidepressant treatment while adding agomelatine. \*\*exclusion criteria:\*\* 1. meeting criteria for other psychiatric disorders according to dsm-iv (except generalized anxiety disorder), such as schizophrenia, bipolar disorder, or mental disorders related to alcohol and drug dependence. 2. current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes. 3. current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.). 4. current serious suicidal ideation or suicide attempt. 5. pregnancy or lactation in women. 6. color blindness (which would hinder neurocognitive testing). 7. use of anticoagulants (e.g., heparin, warfarin), glucocorticoids, or treatment for thyroid diseases in the past 3 months. 8. having received any neurocognitive assessment similar to this study in the past 12 months. 9. positive urine drug screening results or abnormal thyroid function test. 10. liver function tests showing transaminase (alt and ast) levels 2 times above the upper limit of the normal range. 11. electrocardiogram examination revealing a qtc ≥ 430 ms in males or qtc ≥ 450 ms in females.

Keywords: agomelatine antidepressant augmentation major depressive disorder early-nonresponsive
acupuncture for functional constipation in older adults

Conditions: Constipation - Functional

Summary: through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging fu organs".

functional constipation is a common disease of old people. to date, there has not specific therapy on it. former research showed acupuncture may work for functional constipation. in the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. this rct is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.

Eligibility criteria:
inclusion criteria: * meet rome iv diagnostic criteria for constipation and tcm diagnostic criteria of constipation with yin deficiency syndrome; * no gender restriction, age 60-80; * fc that is classified as mild or moderate; * have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment); * have not participated in other medical clinical trials over the past one month; * those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment; * sign the informed consent. exclusion criteria: * irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs; * constipation caused by organic diseases; * patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases; * those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances; * patients with cognitive impairment or aphasia; * those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).
prophylactic laparoscopic suspension after mccall

Conditions: Prolapse Pelvic

Summary: there is prove of prolapse prevention in vaginal hysterectomy using the mccall suture. poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. the aim is to test the effectiveness of the laparoscopic mccall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.

182 patients will be enrolled in the study. we randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. the surgeon will open the envelope just before surgery. for randomization we apply a 1:1 allocation (standard vaginal cuff closure vs standard vaginal cuff closure with mccall sutures). the mccall suture is standardized: we apply a purse-string suture including both usl and the peritoneum. follow-up visits measuring pop-q are planned after 6 weeks and yearly until 5 years.

Eligibility criteria:
inclusion criteria * lsc simple hysterectomy, * neg. ss test if premenopausal * \>18j, * consent to participate in the study * understanding of the german language exclusion criteria * prolapse as indication for surgery * known or suspected non-compliance * additional incontinence procedures * patients with deep infiltrating endometriosis * irradiation pre- or postoperative * pregnancy and lactation. * transgender population * conversion from laparoscopy to laparotomy * inability to understand the study protocol
molecular imaging exploration of ocular angiogenic activity and evaluation of its interest in the therapeutic follow-up of patients with amd (age-related macular degeneration)

Conditions: Age Related Macular Degeneration

Summary: the main objective of this pilot study is to evaluate the ability of 68ga-nodaga-rgd pet imaging to demonstrate, in patients with unilateral amd, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

to date, no functional imaging modality has been validated to assess the level angiogenic activity of choroidal neovascularization in amd, while the therapeutic use of antiangiogenic agents is almost systematically in the form of intraocular injections. the therapeutic response is observed anatomically and functionally only after 6 months of treatment. several arguments in the literature suggest that the therapeutic response occurs earlier at the molecular level, as soon as the induction phase is complete (after 3 months of treatment). the main objective of this pilot study is to evaluate the ability of 68ga-nodaga-rgd pet imaging to demonstrate, in patients with unilateral amd, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Eligibility criteria:
inclusion criteria: * age ≥ 18, membership of a social security scheme. signature of informed consent, * subject presenting amd with unilateral involvement, involving at least 1 choroidal neovascularization objectified in oct, naive to any treatment antiangiogenic. * initial assessment including at least oct and measurement of visual acuity, dating from maximum 1 month at the time of pet 68ga-nodaga-rgd. exclusion criteria: * pregnant or breastfeeding women, as a result of radiation protection. * subjects under 18 years of age and / or not affiliated to a social security scheme. * subjects with amd with bilateral involvement. * subjects with amd without a focus of neovascularization objectified by the classic diagnostic battery. * subjects having already been treated with antiangiogenic therapy. * subjects with any other ophthalmological pathology. monophthalmic subjects