Kornimate/medical-research-clean huggingface dataset:
lifestyle advises sent via email in attempt of improving a1c in dm2 patients

Conditions: Diabetes Mellitus, Type 2

Summary: diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes. this trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in hemoglobin a1c)

the study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with dm2 and unbalanced in their glycemic values (hba1c above 7%). the patient were sent via email , once every other week, a link to web-based pages which provides information on changing dm2 related such as general dm2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more. furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to. each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages. during the course of the study, information regarding the patients' glycemic control (in the form of hga1c levels) was collected. additional variables (age, sex, bmi, time passed since diagnosed with dm2) were collected and used for statistical comparison.

Eligibility criteria:
inclusion criteria: 1. previous diabetes specialist follow 2. age over 18. 3. diagnosis of diabetes type 2. 4. hba1c over 7% 5. self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase. 6. able to read hebrew 7. uses email account that is actively read at least twice weekly. exclusion criteria: * patients who did not the inclusion criteria

Keywords: : type 2 diabetes mellitus web-based intervention medication adherence lifestyle changes
thalidomide for multiple myeloma

Conditions: Multiple Myeloma

Summary: the objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma.

this study attempts to examine the potential efficacy of thalidomide in the treatment of patients with previously untreated multiple myeloma. the trial focuses on patients with asymptomatic and indolent disease who do not require immediate chemotherapy. we intend to treat asymptomatic patients with an initial dose of 200 mg each evening, increasing to a maximum of 800 mg. thalidomide is supplied as 50 mg capsules to be taken by mouth. the initial dose will be 200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion) daily provided there are no side effects. patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days. once a maximum tolerated dose has been reached free of side effects, that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance. only patients who have received at least 200 mg/d for at least 2 months will be considered evaluable for response. for patients in remission, treatment will be continued at the maximum dose free of side effects until relapse. selected patients \<55 years of age who achieve remission may be eligible for stem cell transplant (sct) in which case thalidomide will be discontinued prior to sct. patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

Eligibility criteria:
* previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). all asymptomatic patients with low or intermediate tumor mass will qualify. * patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium \>11.5 mg%), anemia (hgb \ 2.0 mg/dl), high serum lactate dehydrogenase (\>300 u/l) or plasma cell leukemia (\>1000/ul) are ineligible. * overt infections or unexplained fever should be resolved before treatment. adequate liver function (including sgpt, bilirubin and ldh) is required. * patients must have zubrod performance of 1 or less. * patients must provide written informed consent indicating that they are aware of the investigational nature of this study. * life expectancy should exceed 1 year. * patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. patients whose only prior therapy has been with local radiotherapy, alpha-ifn, or atra are eligible. patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.

Keywords: myeloma
hip fracture and patent foramen ovale

Conditions: Hip Fractures

Summary: ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin. a patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain. the hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.


Eligibility criteria:
inclusion criteria: * hip fracture requiring a surgical procedure exclusion criteria: * simultaneous other traumatic lesion
safety and efficacy of ez-ject injector a pain-free subcutaneous automatic injection in healthy volunteers

Conditions: Healthy

Summary: subcutaneous injections are a widely used method for drug delivery. one of its major drawbacks is the pain inflicted during the process. sindolor has developed the chemical-free ez-ject injector device, based on employing cutaneous local anesthesia on the injection site by an electronic anesthetic system. the purpose of this study is to determine the safety and efficacy of the ez-ject for subcutaneous injections.


Eligibility criteria:
inclusion criteria: * healthy caucasian males and females between 18 and 50 years of age. * colour of skin that will enable to clearly observe dermal effects. * non-pregnant, non-lactating female subjects whose urine screening pregnancy test is negative. * subjects must be available to complete the study. * subjects must satisfy a medical examiner about their fitness to participate in the study. * subjects must provide written informed consent to participate in the study. exclusion criteria: * persons with a large amount of hair on the injection sites * presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions that could interfere with the observation of the injection sites. * history of skin allergy or hypersensitivity * history of severe skin infection in the past 1 year. * history of easy bruising. * current or previous history of neurological disorders (particularly neuropathies), low back pain with neurological involvement. * any psychological condition that could influence the conduct of the study or interpretation of results. * a history of drug or alcohol abuse * use of alcohol or medications within 48 hours prior to and during study participation * any condition, which in the opinion of the principal investigator or the study physician would place the subject at risk or influence the conduct of the study or interpretation of results. * inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function). * pregnancy

Keywords: painless injections subcutaneous injections subcutaneous injections to healthy volunteers
the acute effects of meals rich in saturated or unsaturated fatty acids on postprandial lipaemia in healthy men

Conditions: Cardiovascular Risk Factor

Summary: current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than butter. to date, only limited studies have determined the acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent. therefore, further studies are needed to address this knowledge gap and compare the postprandial effects of test meals rich in coconut oil with other sources of saturated fatty acids such as butter and unsaturated fatty acids (vegetable oils). a cross-over, double-blind, randomised acute postprandial study will be conducted in 15 healthy men. participants will be assigned to consume the test meals rich in saturated or unsaturated fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit. participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and lunch (toast with jam and milkshake, 30g fat). the anthropometric, blood pressure, arterial stiffness, and breath samples will be taken for each study visit. blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, whole blood culture as well as blood clotting. breath samples are collected for the measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm visual analogue scale) completed throughout the day. the findings from this study will contribute to the evidence base on how consuming meals rich in coconut oil influence the level of blood lipids as well as other biomarkers for cardiovascular disease.


Eligibility criteria:
inclusion criteria: * healthy men * aged between 30 to 70 years * serum triacylglycerol \< 2.3 mmol/l * body mass index between 19-32 kg/m2 * total cholesterol \< 7.5 mmol/l exclusion criteria: * females * smokers * medical history of myocardial infarction or stroke in the past 12 months * diabetes (defined as fasting glucose \> 7.0 mmol/l) or other endocrine disorders * kidney, liver, pancreas or gastrointestinal disorder * hypertension (blood pressure \> 140/90 mmhg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation * anaemia (\<130 g/l haemoglobin) * taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics) * drinking in excess of 14 units of alcohol per week * planning on a weight-reducing regime * parallel participation in another dietary intervention study * any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study

Keywords: coconut oil postprandial lipaemia platelet function gastric emptying appetite
efficacy, safety, and pk of lx9211 in patients with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathy; Diabetes

Summary: evaluation of the efficacy of a low and high dose of lx9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.


Eligibility criteria:
inclusion criteria: * patient has given written informed consent to participate in the study in accordance with local regulations * adult male and female patients ≥18 years of age at the time of screening * body mass index ≥18.0 to ≤40.0 kg/m2 at screening * diagnosis of dpnp at screening * pain from dpn present for at least 6 months * a1c ≤11% at screening * stable regimen for the treatment of t1dm or t2dm for ≥1 month prior to screening exclusion criteria: * presence of other painful conditions that may confound assessment or self-evaluation of dpnp * history of major depressive episode, active, significant psychiatric disorders * history of clinically significant drug or alcohol use disorder * history of neurolytic or neurosurgical therapy for dpnp * use of opioid medications for management of dpnp within the 2 months prior to screening visit * use of nsaids less than 2 weeks prior to the screening visit
epidermal cells delivery and acute burns

Conditions: Burn

Summary: the aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns. determine if the costs of the innovating treatment recell®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy. give an information about efficiency improvement of recell® with additional costs

Eligibility criteria:
inclusion criteria: * thermal burns requiring surgical debridement * area involved \< 1260cm² exclusion criteria: * local or systemic infection * conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids) * hypersensitivity to trypsin

Keywords: keratinocytes cell spray deep partial thickness burns full thickness burns
trial of db289 for the treatment of stage i african trypanosomiasis

Conditions: African Trypanosomiasis

Summary: human african trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. treatment of the disease remains unsatisfactory. all currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. there are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control. this study aims to compare the safety and efficacy of db289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. the project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the democratic republic of congo ministries of health.


Eligibility criteria:
inclusion criteria: 1. the patient has early stage t. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 wbc mm-3 detected in the csf by microscopic examination 2. patient is 15 to 50 years old 3. patient has a minimal weight of 35 kilograms 4. if the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy): 1. she is not lactating, 2. she had a negative urine pregnancy test result within 24 hours prior to db289 treatment and 3. she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7). 5. patient has understood and signed the informed consent. if the patient is minor, a legal guardian has signed the informed consent exclusion criteria: 1. the patient has late stage t.b. gambiense infection i.e. presence of parasite in the csf upon microscopic examination or a wbc count of \> 5mm-1 2. active clinically relevant medical conditions that in the investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known hiv infection, cns trauma or seizure disorders (a list of typical signs and symptoms is provided for guidance of the investigator in attachment 1) 3. coma score of less than 9 on the glasgow coma scale (appendix 8) 4. withdrawal of consent at any time during the study 5. any condition which compromises ability to communicate with the investigator as required for the completion of this study. 6. the subject has been previously treated for african trypanosomiasis. 7. the subject has been previously enrolled in the study. -

Keywords: first stage trypanosoma brucei gambiense t. b. gambiense sleeping sickness first stage t. b. gambiense sleeping sickness
reusing needles for subcutaneous insulin injection in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a randomized clinical trial (rct) will be carried out to compare the reuse or not of needles in patients with type 2 diabetes (t2dm) that use insulin. two groups will be studied: a group that will not reuse the needles and a group that will reuse the needles five times. the aim of this study is to evaluate related outcomes such as bruises, infection, lipodystrophy, pain and glycemic control, whether or not to reuse insulin delivery needles in patients with t2dm who use insulin.

type 2 diabetes mellitus (t2dm) is a highly prevalent chronic disease with increasing incidence worldwide. it is well demonstrated in the literature that adequate glycemic control can reduce the incidence of chronic complications. the brazilian ministry of health must provide patients with diabetes with the necessary resources for optimal glycemic control. however, this supply is often not enough and the population ends up reusing needles and lancets. according to the brazilian national health surveillance agency (anvisa) and the manufacturers, it is recommended to use the needle for insulin application only once, but a report from the brazilian society of diabetes shows that half of the patients disregard this rule - some reuse each needle up to five times. studies show that patients do not like carrying extra needles when they are away from home, are reluctant to carry containers to dispose used needles, and decide that it is not worthwhile worth buying a new needle for each injection. others describe that injections from reused needles are not noticeably more painful as long as they do not reuse them excessively. finally, some patients believe that disposing of a needle after use is ecologically wasteful because metal and plastic must be incinerated. a randomized clinical trial will be carried out to compare the reuse or not of needles in patients with diabetes who use insulin. primary outcomes as skin complications, local pain, glycemic control will be evaluated at baseline and after 4, 8 and 12 weeks and secondary outcomes will also be evaluated as quality of life, insulin application technique, frequency of capillary blood glucose tests, adherence to treatment, quality of needles, microbiological contamination and cost-utility analysis of after needle reuse.

Eligibility criteria:
inclusion criteria: * patients with t2dm * over 18 years of age * reuses each syringe at least three times for insulin application. exclusion criteria: * use of insulin pens * pregnant women * patients undergoing chemotherapy * use of anticoagulants * clotting disorders, lesions or skin changes

Keywords: diabetes mellitus, type 2 reuse needle insulin administration
investigation of clofarabine in acute leukemias

Conditions: Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia

Summary: the goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (aml), acute lymphocytic leukemia (all), and chronic myelogenous leukemia (cml) in accelerated and blastic phases.

the specific aims of the project are (1) conduct the phase ii study of clofarabine and evaluate the antileukemic efficacy in aml, all, and cml-accelerated and blastic phases in terms of complete response (cr) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of dna synthesis, and clinical outcome. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
* patient is diagnosed with aml, all, myelodysplastic syndrome (mds), and cml in transformation (includes cml-blastic phase and cml-accelerated phase). * no prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician. * adequate liver function (bilirubin \</= 2 mg%) and renal function (creatinine \</= 2 mg%). * pregnant and lactating females not eligible. * zubrod performance status 0-2 * adequate cardiac status * no life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Keywords: clinical pharmacodynamics investigational drug clofarabine aml, all, cml-accelerated phase, cml-blastic phase chronic myelogenous leukemia - accelerated phase chronic myelogenous leukemia - blastic phase
desogestrel for the preoperative treatment of endometrioma compared with placebo

Conditions: Endometrioma

Summary: use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months the result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.

use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months in rajvithi hospital patient will randomized in 2 group : desogestrel and placebo after 1 months and 3 months the patient have to come to hospital to evaluate the result of study the result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.

Eligibility criteria:
inclusion criteria: * thai female and foreigner who can understand thai language * age 15-49 years * diagnose as endometrioma sized more than 3 cm * underwent to surgery in next 13 weeks exclusion criteria: * history of endometriosis * pregnancy woman * contraindication for desogestrel : history of thrombotic event, autoimmune disease,gestational trophoblastic disease * ovarian endometrioma with complications : ruptured, twisted * contraindications for nsaids : peptic ulcer, thrombocytopenia, liver disease * history of hormonal treatment for endometrioma : dmpa,ocp, gnrh agonist/antoginist