Kornimate/medical-research-clean huggingface dataset:
effect of melatonin and metformin on glycemic control genotoxicity and cytotoxicity markers in patients with prediabetes

Conditions: PreDiabetes

Summary: melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate dna modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. the administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.

a randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the american diabetes association criteria. the patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. the intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, a1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.

Eligibility criteria:
inclusion criteria: * age beween 30 to 60 years old. * diagnosis of prediabetes state according to the american diabetes association criteria. * without pharmacological treatment. * body mass index between 25 to 34.9 kg/m2 * sign informed consent exclusion criteria: * patients with pharmacological treatment. * pregnant woman * patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment * workers on night or changing shifts. * subjects that have been exposed to radiation * dyslipidemia: total cholesterol \>250mg/dl, triglycerides \>500 mg/dl. * subjects that have travel to other place with a different time zone. * patients with diagnosis of insomnia * patients with a glomerular filtration \<60 ml/min using the cockroft-gault formula.

Keywords: melatonin metformin pre diabetes prediabetes micronuclei genotoxicity markers cytotoxicity markers
anatomic and clinical long-term follow-up of conservatively treated rotator cuff tears

Conditions: Full-thickness Rotator Cuff Tears

Summary: study population: patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005. study method: at the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by mri. some patients also completed a shoulder score. all study patients will now be reexamined, 8 to 10 years after they were diagnosed. reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), sonography and mri. findings of interest are * the number of relapses during follow-up, * the need for surgical treatment during follow-up, * the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up * the actual clinical shoulder condition (as given by shoulder scores) at reexamination. study purpose: we want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. we want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.


Eligibility criteria:
inclusion criteria: * full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and mri. at the time of diagnosis (2002 to 2005): * typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (neer or hawkins) * potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to thomazeau, fatty degeneration not exceeding grade 1 according to goutallier). * treated by physiotherapy for at least 3 months exclusion criteria: at the time of diagnosis (2002 to 2005): * full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons * other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis * earlier treated with rotator cuff repair in the study shoulder
conservative endometrioma surgery

Conditions: Endometriosis Ovary; Endometrioma

Summary: to study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. the 2 conservatives techniques used are: 1. the combined technique 2. co2 laser vaporization only ovarian reserve will be assessed by consecutive measurements of amh serum levels before and after surgery.


Eligibility criteria:
population: patients planned for laparoscopic co2 laser surgery for endometriotic cysts. inclusion criteria: * age: 18 - 40 years (both inclusive) * unilateral endometriotic cysts with a mean diameter of \>=2.5cm and ≤8 cm, measured in 3 dimensions. * presence of a contralateral endometrioma of ≤ 2cm is allowed * complaining of infertility and/or pain * bmi ≤35 * use of contraception (combined or progesteron only) for at least 4 weeks before surgery exclusion criteria: * incomplete surgery for the pelvis * contra-indication for the use of contraception (combined or progesteron only) * use of gnrh analogues preoperatively and in the first 3 months postoperatively * (history of) hysterectomy * prior unilateral oophorectomy * pituitary/hypothalamic disorders * suspected malignancy * contralateral endometrioma of \>2 cm * amh \<0.7 preoperatively * pregnancy
study of xeloda and gleevec in patients with advanced solid tumors

Conditions: Colon Cancer; Colorectal Cancer

Summary: this study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. the purpose of this research is to evaluate the side effects of xeloda (also called capecitabine) in combination with a new anticancer agent called gleevec (also called imatinib mesylate). xeloda is an anticancer drug, and can be taken by mouth. the active ingredient is a well-studied cancer drug called 5-fu. xeloda is approved by the fda for the treatment of colon cancer. gleevec is approved in the us for the treatment of patients with a leukemia called cml (increase of white blood cells) after failure of standard therapy. it is also approved by the fda for patients with gastrointestinal stromal tumors (a rare tumor in the digestive tract). this study will test how much gleevec we can safely give with xeloda. xeloda will be given at the recommended dose for colorectal cancer and gleevec will be given in increasing amounts.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective. * swog performance status 0-2. * anc greater than 1500, platelets greater than 100,000. * total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. transaminase (ast and/or alt) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis. * serum creatinine less than 1.25 x institutional upper limit of normal. * female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. exclusion criteria: * patient has received any other investigational agent- within 28 days of first day of study drug dosing. * patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention. * patient has another severe and/or life-threatening medical disease. * patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis). * patient has a known diagnosis of human immunodeficiency virus (hiv) infection. * patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-c or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by novartis. * patient had a major surgery within 2 weeks prior to study entry. * patients with symptomatic brain metastasis. * patient with grade iii/iv cardiac problems as defined by the new york heart association criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study) * medical, social or psychological factors interfering with compliance. * patients under therapeutic coumadin therapy. * patients under routine systemic corticosteroid therapy.

Keywords: phase 1 phase i phase one colon cancer colorectal cancer
trial on the efficacy of hypertonic saline on non-cf csld.

Conditions: Bronchiectasis

Summary: to determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-cf csld. secondary aims: to determine the: 1. efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. 2. efficacy of nebulized 5% hypertonic saline on lung function 3. adverse effects of nebulized 5% hypertonic saline in children

primary aim: to determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-cf csld. here the investigators will be using validated pediatric cough questionnaires to asses this. patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) secondary aims: to determine the: 1. efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. furthermore, nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% hs. 2. efficacy of nebulized 5% hypertonic saline on lung function. here is investigators will be doing portable spirometry ( pre and post bronchodilator). patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) 3. adverse effects of nebulized 5% hypertonic saline in children hs has been associated with side-effects. the investigators will monitor this. we will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.

Eligibility criteria:
inclusion criteria: * patients \< 18 years old * followed up in the paediatric respiratory clinic of ummc with a diagnosis of csld exclusion criteria: * incomplete data or refusal to participate * unwell and/or unable to stop hs and/or antibiotics of any preparation other than azithromycin ( eod * on supplementary oxygen/home ventilation * poorly controlled asthma (as in the gina guidelines) or bronchoconstriction that precedes the use of hypertonic saline. * oral antibiotics for less than 4 weeks before randomization for medication. * fall in pefr \> 20% post 5% hs challenge test or a positive hs challenge test in young children, as mentioned below.

Keywords: csld child nebuliser hypertonic saline outcome chronic cough
skin biopsies in chemotherapy-induced neuropathy

Conditions: Multiple Myeloma; Peripheral Neuropathy

Summary: neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. the neuropathy induced by these drugs is often preferentially small fiber. small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. determining intra-epidermal nerve fiber density (ienfd) in skin biopsies from diabetes and aids patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. in this study the investigators aim to establish the sensitivity of ienfd measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma receiving bortezomib exclusion criteria: * patients not able to provide informed consent * patients with coagulation disturbances or immunocompromised patients

Keywords: cancer peripheral neuropathy bortezomib
a study of shr-a1811 in subjects with advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer

Summary: this is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of shr-a1811 for injection in subjects with advanced non-small cell lung cancer who have her2 expression , amplification, or mutation


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 3. advanced non-small cell lung cancer with her2 expression , amplification, or mutation 4. has previously received platinum-based chemotherapy for advanced or metastatic nsclc, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy. 5. there is at least one measurable lesion according to recist v1.1 criteria exclusion criteria: 1. has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to nci-ctcae version 5.0 grade ≤ 1. 2. has received her2 antibody drug conjugates, 3. central nervous system metastasis or meningeal metastasis with clinical symptoms 4. has active infection requiring systemic treatment.
hmpl-523 (sovleplenib) in the treatment of warm antibody autoimmune hemolytic anemia

Conditions: Warm Antibody Autoimmune Hemolytic Anemia

Summary: phase ii study: to evaluate the safety and preliminary efficacy of hmpl-523 in adult patients with waiha phase iii studies: confirmation of efficacy safety and of hmpl-523 in adult patients with waiha

phase ii study: the proportion of patients with overall hb response by week 24 phase iii study: the proportion of patients who achieve a durable response by week 24

Eligibility criteria:
inclusion criteria: 1. voluntarily signed the informed consent form (icf); 2. males or females aged 18 to 75 years; 3. patients diagnosed with primary waiha or secondary waiha whose underlying diseases are stable; 4. organs in good function. exclusion criteria: 1. patients with other types of aiha other than waiha; 2. patients with secondary waiha with unstable underlying disease; 3. patients with drug-induced secondary waiha; 4. patients with infections requiring systemic treatment; 5. patients previously treated with syk inhibitors (e.g., fostamatinib); 6. patients with known allergy to the active ingredients or excipients of the study drug; 7. patients with serious psychological or mental disorder; 8. alcoholic or drug abuser; 9. female patients who are pregnant and lactating.
a case control observational study to assess cydar automated overlay guidance during evar

Conditions: Aortic Aneurysm

Summary: this is an observational trial to determine if use of fusion imaging in infrarenal endovascular aneurysm repair will decrease the radiation dose and improve patient safety for this procedure.

the aorta is the main artery of the body. an aortic abdominal aneurysm (aaa) is defined as an abnormal dilatation of the aorta, based on a diameter of 3 cm or more, due to a weakness of the aortic wall that is prone to rupture, leading to a lifethreatening condition. once aaa diagnosed, a ctscan is required to assess the anatomy and if indicate an endovascular aneurysm repair (evar) is performed. this mini invasive procedure allows the exclusion of the aaa by positioning an endograft inside the aorta through a femoral access under live xrays (fluoroscopy) guidance. the xrays are good at showing bones and radioopaque endovascular tools, but they do not show soft tissues like the aorta, and they produce flat (2d) images that superimpose all the 3d anatomical features. in order to see the aorta, physicians have to inject iodinated contrast during high quality imaging recording. one way to improve clinicians' perception of peroperative 3d vascular anatomy is to accurately overlay selected information from the preoperative ct scan (a 3d vascular mask) onto the live xray image creating a '3d roadmap'. this advanced imaging application is currently available only in the latest expensive hybrid rooms. this trial will examine the clinical benefits of the first advanced imaging application allowing automated 3d overlay guidance during evar in any theatre. the software, combined with secure and certified cloud high performance computing, deduces the patient position from comparing the bony anatomy visible on the xray to that on the patient's ct scan, enabling it to produce and update accurate and reliable overlays of the diagnostic ct 3d vascular mask throughout the operation (www.cydar.co.uk). expected benefits include reducing the total xray exposure of the patients and staff, reduced use of iodinated contrast (a major cause of kidney failure) and shortening procedure duration.

Eligibility criteria:
inclusion criteria: 1. willing and able to give informed consent,and 2. aged 18 or older, and 3. been scheduled for endovascular repair of an infrarenal aortic aneurysm (evar), and 4. who have had a preoperative diagnostic ct scan, and 5. able (in the investigator's opinion) and willing to comply with the study requirements. exclusion criteria: 1. female participants who is pregnant or planning pregnancy during the course of the study. 2. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 3. any patient requiring an associated procedure (iliac branch device implantation, renal or mesenteric angioplasty) 4. ruptured aaa and emergency procedures
remifentanil in deep vs moderate neuromuscular blocks during surgical pleth index-guided anesthesia for laparoscopic herniorrhaphy

Conditions: Hernia Abdominal Wall

Summary: the primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.


Eligibility criteria:
inclusion criteria: * laparoscopic hernia repair exclusion criteria: * patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease
roma (reminiscence, reality orientation, music and art ) therapy, cognition, depression and behavioral problems in the population with dementia

Conditions: Dementia

Summary: this study aimed to conduct a randomized controlled trial to examine the effectiveness of roma therapy( reminiscence, reality orientation, music, and art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. the hypotheis of this study is that these patients with dementia receiving roma therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.

this study aimed to conduct a randomized controlled trial to examine the effectiveness of roma therapy( reminiscence, reality orientation, music, and art) on improving cognitive function, behavioral and psychological symptoms in demented population. a total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. the experimental group will undergo roma therapy with a 60 minute per week for eight weeks. the control group will receive three times roma therapy after completing outcome measurements. two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. the measurements comprises: short portable mental status questionnaire(spmsq), cornell scale for depression in dementia(csdd),and neuropsychiatric inventory-questionnaire(npi-q). by identifying the effectiveness of roma therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.

Eligibility criteria:
inclusion criteria: 1. been diagnosed as mild to moderate dementia and cdr score between 0.5\~2 2. can communicate in chinese or taiwanese 3. without visual or auditory impairment after equipping assist devices exclusion criteria: 1. severe dementia and clinical dementia rating (cdr) score more than 2 points 2. functional dependence 3. incapable of expressing their feelings