Kornimate/medical-research-clean huggingface dataset:
quality of life in patients undergoing colorectal resection for deep infiltrating endometriosis

Conditions: Endometriosis

Summary: the aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow up visit

all patients fit for the study will be asked to complete a visual analogue scales (vas) for dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (cpp) patients will fill in the endometriosis qol questionnaire (ehp30), the gastrointestinal well-being questionnaires bristol stool chart, gscg (gastrointestinal symptom rating scale), stay (1 and 2), the psychological general well-being index (pgwbi), generalized self-efficacy, cd-risc - connor-davidson scale about their pre operative and actual status. surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis perioperative and post-operative complications will be collected using the extended clavien-dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset).

Eligibility criteria:
inclusion criteria: * women aged between 18 and 45 years * clinical diagnosis of deep endometriosis infiltrating the bowel * women undergoing surgical removal with colorectal resection with or without loop ileostomy creation exclusion criteria: * history of previous or ongoing neoplastic pathology * contraindications to surgical intervention * not complete eradicating surgery * psychiatric disorders * surgical, spontaneous or pharmacological menopause - intestinal surgery different from segmental bowel resection and colorectal anastomosis

Keywords: deep infiltrating endometriosis colorectal resection quality of life
human umbilical cord-mesenchymal stem cells for hepatic cirrhosis

Conditions: Hepatic Cirrhosis

Summary: the purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(huc-msc) for hepatic cirrhosis.

human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. there have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of hepatic cirrhosis. to investigate the effects of huc-msc treatment for hepatic cirrhosis, 20 patients with hepatic cirrhosis will be enrolled and receive 4 times of huc-msc transplantation.

Eligibility criteria:
inclusion criteria: * the patient who have signed the informed consent document; * clinical, radiological, or biochemical evidence of liver cirrhosis. exclusion criteria: * pregnant women or lactating mothers; * patients who have received any anti-inflammatory drugs including herb-drug within 14 days; * patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment; * patients with positive human immunodeficiency (hiv) at screening indicative of current of pass infection; * abnormal blood coagulation, combine other tumor or special condition; * patients who had participated in other clinical trials within three months prior to this study.

Keywords: stem cell human umbilical cord mesenchymal stem cell mesenchymal stem cell hepatic cirrhosis
drug therapy for alcohol dependence in alaska natives (naltrexone/sertraline)

Conditions: Alcoholism; Alcohol Dependence

Summary: this study will assess the ability of naltrexone (revia) to reduce the risk of relapse in alaska natives with alcohol dependence. the study will also examine whether a combination of naltrexone and sertraline (zoloft) yields better abstinence rates than naltrexone used alone. alaska native individuals will be recruited into a 16 week outpatient study.


Eligibility criteria:
inclusion criteria: * alaska native having biological alaska native ancestry. * meets criteria for alcohol dependence. * prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment. * stable residence to ensure that subjects can be located during the study. exclusion criteria: * currently meets criteria for abuse or dependence on substances other than alcohol or nicotine. * current use of disulfiram. * psychotic or otherwise severely psychiatrically disabled. * use of other psychotropic medications including antidepressants and anxiolytics. * medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease. * hepatocellular disease or elevated bilirubin levels. * females who are pregnant, nursing, or not using a reliable method of birth control. * probation or parole requirements that might interfere with participation in the study. * involvement in alcohol treatment other than provided by the study or aa. * use of monoamine oxidase inhibitors in the past month. * current use of type 1c antiarrhythmics propafenone and flecainide.

Keywords: alcoholism alcohol dependence
deep brain stimulation for refractory trigeminal neuralgia with a pontine lesion

Conditions: Trigeminal Neuralgia

Summary: the aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis. these patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief. hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.


Eligibility criteria:
inclusion criteria: * adults of at least 18 years old * refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy). * pontine lesion proved by mri in contact with trigeminal nerve tract exclusion criteria: * absolute contraindication to mri * medical contraindication to the procedure

Keywords: multiple sclerosis deep brain stimulation pontine lesion
promoting alcohol treatment engagement post-hospitalization

Conditions: Alcohol Use Disorder

Summary: this study is a 3-arm randomized clinical trial to evaluate the effectiveness of hospital-initiated alcohol use disorder treatment, involving a brief negotiated interview (with referral and telephone booster) alone, bni+facilitated provision of maud, bni+facilitated provision of maud+cbt4cbt on aud treatment engagement, alcohol use and healthcare utilization.

the proposed 3-arm randomized clinical trial will initiate interventions during hospitalization and evaluate outcomes at 34- and 90-days following hospital discharge to compare the effectiveness of 1) bni, 2) bni+facilitated provision of maud, and 3) bni+facilitated provision of maud+cbt4cbt on aud treatment engagement, alcohol consumption, and healthcare utilization among 450 racially and ethnically diverse hospitalized individuals with aud. using a hybrid type 1 effectiveness-implementation design the investigators will also conduct an implementation- focused process evaluation to yield relevant data to inform future implementation, including process measures, clinician and staff (n=150) perspectives and cost effectiveness. this proposed study is directly informed by rigorous prior research by this group and others demonstrating: 1) a need for new strategies to engage patients, particularly black and hispanic individuals, with aud in treatment; 2) benefits of engaging patients in addiction treatment during acute care;3) benefits of maud and the potential to integrate its provision in general medical settings; and 4) benefits of cbt as an adjunct to maud with strong support for cbt4cbt across diverse populations

Eligibility criteria:
inclusion criteria: * hospitalized at yale new haven hospital (ynhh) * meet diagnostic and statistical manual (dsm-5) criteria for a moderate to severe aud (regardless of primary reason for hospitalization) consistent with clinical guidelines for maud initiation * \>1 heavy drinking day by tlfb in 30 days prior to hospitalization * willing to consider maud * willing and able to be contacted for follow-up * provide written informed consent exclusion criteria: * have been engaged in formal aud treatment in the past 30 days (i.e., excluding mutual help groups, such as alcoholics anonymous) * meet dsm-5 criteria for untreated moderate to severe opioid use disorder * self-reported or urine testing confirming pregnancy, nursing, or trying to conceive * life-threatening or unstable medical, surgical, or psychiatric condition that prohibits study participation * inability to provide \>1 collateral contact for a friend or family member * anticipate being unable to return for follow-up assessments for any reason, such as travel, incarceration, planned procedure * inability to understand english or spanish.

Keywords: cbt4cbt brief negotiated interview (bni) medication for alcohol use disorder (maud) phosphatidylethanol (peth)
the pulmonary protection trial

Conditions: Chronic Obstructive Lung Disease

Summary: the purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with tavi and the control-group with standard ecc (extra corporal circulation).


Eligibility criteria:
inclusion criteria: 1. planned and urgent surgery on legally competent patients over 18 years: * coronary artery bypass graft surgery * aortic valve replacement * coronary artery bypass graft surgery + aortic valve replacement * transcatheter aortic-valve implantation 2. spirometry fev1 measurement show less than or equal to 80% of the anticipated. we expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients. exclusion criteria: * previous surgery on the heart or lungs * previous thoracic irradiation * preoperative heart failure (ejection fraction below 20%). * surgical demanding mitral regurgitation * unstable patients (heart rate above 100 and systolic blood pressure below 100 mmhg) * intubated patients * patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia. * patients with renal insufficiency requiring hemodialysis * pregnant and lactating
effect of increased intake of low fat dairy products on weight loss and insulin resistance

Conditions: Impaired Glucose Tolerance; Type 2 Diabetes; Metabolic Syndrome

Summary: the purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.

obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. we know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. a promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. this study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. this information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.

Eligibility criteria:
inclusion criteria: * overweight and obese (bmi of 27 to 37 kg/m2) * impaired glucose tolerance (fasting blood glucose \>5.6 mmol/l) or * type 2 diabetes treated with diet and exercise alone (no medications) * one or more of the following criteria for metabolic syndrome: 1. hypertriglyceridemia (\> 1.70 mmol/l) 2. low high-density lipoprotein (hdl) cholesterol (\< 1.04 mmol/l in men and \< 1.30 mmol/l in women) 3. high blood pressure (\> 130/85 mm hg) 4. high waist circumference ( \> 94 cm in men, \> 80 cm in women) * weight stable and no changes in exercise in past 3 months exclusion criteria: * type 1 diabetes * type 2 diabetes treated with oral hypoglycemic agents or insulin * hba1c \> 8% * myocardial infarction or have undergone a cardiovascular intervention within the past three months * subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization * liver or pancreas disease * major gastrointestinal surgeries * pregnant or lactating * exhibit alcohol or drug dependence * taking drugs influencing appetite * have a milk allergy or lactose intolerance * following a diet or exercise regime designed for weight loss * have a body weight greater than 350 lb (weight limit for dexa instrument) * chronic use of bulk laxatives, antacids or calcium supplements

Keywords: prediabetes type 2 diabetes metabolic syndrome insulin resistance syndrome weight loss milk products calcium
study of durvalumab and tremelimumab as first-line treatment in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a randomized, open-label, multi-center, global, phase iii study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable hcc. the patients cannot be eligible for locoregional therapy

the study population includes patients 18 years of age or older with advanced hcc, barcelona clinic liver cancer stage b not eligible for locoregional therapy or stage c, and child-pugh a classification liver disease. patients must not have received any prior systemic therapy for unresectable hcc. patients in all treatment arms may continue receiving their originally assigned treatment, at the investigator's discretion, until progression patients in all arms with confirmed pd who, in the investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of pd may continue to receive their assigned treatment. if a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed pd and will be followed for survival

Eligibility criteria:
inclusion criteria * hcc based on histopathological confirmation * no prior systemic therapy for hcc * barcelona clinic liver cancer (bclc) stage b (that is not eligible for locoregional therapy) or stage c * child-pugh score class a * ecog performance status of 0 or 1 at enrollment exclusion criteria * hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy * clinically meaningful ascites * main portal vein tumor thrombosis * active or prior documented gi bleeding (eg, esophageal varices or ulcer bleeding) within 12 months * hbv and hvc co-infection, or hbv and hep d co-infection

Keywords: hepatocellular carcinoma non-resectable
safety and efficacy of insulin degludec/insulin aspart in patients with t1dm

Conditions: Type 1 Diabetes Mellitus With Diabetic Gastroparesis; HbA1c; Time in Range

Summary: in this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (idegasp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. this trial will enable assessment of the clinically relevant endpoint of a change in hba1c and time in range (tir).

the objective of the current study is to investigate the efficacy and safety of idegasp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. the primary endpoint in this study is the change from baseline in hba1c. patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. approximately 40 patients will be enrolled in the study. patients who qualify will be randomized to idegasp group or basal plus pre-prandial insulin group. duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 and ≤75 years with type 1 diabetes; * diagnosed as t1dm ≥ 12 months before enrollment in the study; * hba1c ≥ 7.0 to ≤10.0%; * receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study; * bmi ≤ 35kg / m2. exclusion criteria: * patients with any of the following conditions will be excluded: * pregnant or lactating women * severe hypoglycemia within one month; * myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent * receipt of sulfonylureas, meglitinides derivatives, thiazolidinediones, dpp-4 inhibitors or glp-1 agonists within 3 months prior to informed consent; * current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent * severe mental instability, or alcohol abuse, or drug abuse * cancer within 5 years prior to informed consent * pancreatitis of severe infectious diseases within 1 months prior to informed consent * known hypersensitivity or allergy to the insulin * renal impairment (ckd-epi egfr\<60ml/min) * impaired hepatic function, defined by serum levels of either alt (sgpt), ast (sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined * participation in another trial within 2 months prior to informed consent * patients that investigators believe may fail to complete the study

Keywords: type 1 diabetes insulin degludec/insulin aspart hba1c time in range
stellate ganglionic block versus stellate ganglionic block plus pecs ii block for mastectomy pain

Conditions: Post Mastectomy Pain Syndrome; After Breast Surgery

Summary: post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, a second version of the pectoral nerve block is described, called ''modified pecs block'' or pecs block type ii. this novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals iii-iv-v-vi and the long thoracic nerve. these nerves need to be blocked to provide complete analgesia during breast surgery

the aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs ii block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used. all patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. written informed consents will be obtained before the procedure. with each block, an intravenous cannula will be inserted and secured. all suitable resuscitation equipment and drugs will be available. vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. midazolam 0.02 ug/kg will be administered intravenously as premedication. brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status. all patients will be familiar with the use of 10-cm visual analogue scale score (vas) identifying 0 as no pain and 10 as worst imaginable pain.basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete quality of life questionnaire

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status iii or iv. * patients having irradiating pain of anterior chest wall and axilla after breast surgery. * patients having irradiating pain of ipsilateral arm after breast surgery * pain not responding to conservative treatment * pain persisting for more than 3 month exclusion criteria: * local skin infection * coagulation or blood disease * pregnancy * postpartum or lactating females * allergy to the study medications. * severely altered consciousness level. * psychiatric disorder * drug abuse * spine or chest wall deformities
comparison of four different recruitment maneuvers in patients after coronary surgery

Conditions: Hypoxemia; Recruitment

Summary: the risk of respiratory failure after cardiac surgery is high, and it may result in many complications. the maneuver of alveolar recruitment may improve the oxygen transport in the human organism. the investigators compare three different types of alveolar recruitment in patient after cardiac surgery, to reveal which one is better.

the study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 * off-pump coronary artery bypass grafting * possibility to discontinue respiratory support in the first day after intervention exclusion criteria: * signs of ards * copd in decompensation phase * requirement for inotropic support(epinephrine \>0,1 mcg/kg/hr) * bronchiectases * pregnancy * morbid obesity * aortic aneurism * ami in previous month

Keywords: recruitment coronary artery bypass grafting postoperative period