Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the use of episodic, intensive blood glucose monitoring in persons with non-insulin treated type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the accu-chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the accu-chek 360 view blood glucose analysis system. the effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline hba1c values at 12 months. the anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>= 25 years of age * type 2 diabetes for \>= 1 year * hemoglobin a1c \>= 7.5% and \<=11% * diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic exclusion criteria: * type 1 diabetes * on any type of insulin therapy at start of study
docetaxel, radiation therapy, and hormone therapy in treating patients with locally advanced prostate cancer

Conditions: Prostate Cancer

Summary: this phase i trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high energy x-rays to kill tumor cells. docetaxel may also make tumor cells more sensitive to radiation therapy. androgens can cause the growth of prostate cancer cells. drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. no pelvic lymph node disease that would necessitate pelvic radiotherapy. no radiologic evidence of metastatic disease on bone scan or on ct scan or mri of the abdomen or pelvis 2. no prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. greater than 4 weeks since any major surgery. 3. performance status 0-2 4. must meet criteria for acceptable lab values as outlined in the protocol. 5. peripheral neuropathy must be greater than or equal to 1 6. men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. exclusion criteria: 1. no history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer
st. petersburg pain and alcohol intervention with naltrexone and nalmefene

Conditions: HIV Infection; Alcohol Use; Pain

Summary: this study is a randomized controlled trial (rct) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among hiv-infected persons with heavy alcohol use and chronic pain.

pain is a common co-morbidity for hiv-infected patients. prevalence studies suggest that, on average, half of all hiv-infected persons suffer pain. chronic pain can lead to heavy alcohol use among hiv-infected persons, which may in turn be a barrier to treatment/control of hiv and contribute to spread of hiv. thus there is an urgent need to address pain among persons with hiv. opioid receptor antagonists such as naltrexone and nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and safe treatments for chronic pain among persons with hiv. this study will pilot test novel pharmacotherapies (opioid receptor antagonists) to improve chronic pain among hiv-infected heavy drinkers. the specific aims of the research is to assess the feasibility, tolerability and safety of using opioid receptor antagonists (low-dose naltrexone and nalmefene) to treat pain among hiv-infected persons with heavy alcohol use and chronic pain.

Eligibility criteria:
inclusion criteria: * 18 years or older * hiv-positive * chronic pain (present ≥3 mo) of moderate to severe intensity * heavy drinking past year (based on niaaa criteria: \> 14 standard drinks per week/ \> 4 drinks in a day for men; \> 7 drinks in the past week/ \> 3 drinks in a day for women) * if female, negative pregnancy test and willing to use adequate birth control * provision of contact information for 2 contacts to assist with follow-up * stable address within 100 kilometers of st. petersburg * possession of a telephone (home or cell) * able and willing to comply with all study protocols and procedures exclusion criteria: * not fluent in russian * cognitive impairment resulting in inability to provide informed consent based on research assessor (ra) assessment * known active tb or current febrile illness * breastfeeding * uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ed or hospital) * history of hypersensitivity to naltrexone, nalmefene, or naloxone * current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test * unwilling to abstain from opiates during the treatment period * current use of neuroleptics * history of seizure disorder * known liver failure * alt/ast levels \>5x normal * history of raynaud's disease * planned surgeries in the next three months * enrolled in another hiv and/or substance use medication intervention study * taking naltrexone in the past 30 days * taking nalmefene in the past 30 days

Keywords: alcohol use pain hiv low-dose naltrexone nalmefene
metabolic effects of short term sugarcane bagasse supplementation

Conditions: Insulin Resistance

Summary: the purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.

the investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. the intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. caloric value will be constant with all three delivery systems. subjects will have blood testing and body composition analysis before and after the intervention.

Eligibility criteria:
inclusion criteria: * males and females age 18-50 years * body mass index ≥ 30 kg/m2 (a ratio of weight to height) * fasting insulin level \>5 µiu/ml, as determined by tests performed during screening exclusion criteria: * women who are pregnant * past medical history of diabetes * history of intestinal surgery such as removal of bowel * history of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome * taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc. * any food allergies

Keywords: sugarcane bagasse, glucose tolerance, insulin resistance
the stage study for bipolar disorder

Conditions: Bipolar Disorder

Summary: when the investigators are caught up in emotions, it is by stepping back (or decentering) that the investigators are able to see the situation from another perspective. individuals with emotional disorders, however, can have difficulties in being able to do this. research has shown that improving an individual's ability to step back from their emotions and take perspective is possible and can have beneficial effects on depressive symptomatology (self distancing and perspective broadening \[sdpb\] training). the sdpb training package involves two techniques: 1) stepping back from situations using mental imagery (building a mental picture of the situation and changing the distance to it) and, 2) reframing situations using perspective broadening reappraisals (giving new meanings to situations). the training package trains these sdpb techniques using an individual's memories and every day events. the fortnightly training comprises of two one to one sessions and daily homework for a week in between.the sdpb training package is aimed at improving an individual's ability to step back from, and put a new meaning to emotional events that take place in their lives. the prospective pilot study aims to investigate whether the sdpb training package reduces symptomatology and improves these abilities in individuals who experience both depressive and manic episodes (bipolar disorder \[bd\]). bd has a cumulative lifetime prevalence ranging from 1.52% across europe and is treated with moderate success using cognitive behavioural therapy (cbt). however, 'moderate success' is considerably low compared to other mental health problems and cbt can be time time consuming, expensive, and cognitively demanding (requiring a high level of functioning of one or more cognitive functions). accordingly, bd may be one of the emotional disorders in greatest need of novel and evidence based treatments.


Eligibility criteria:
inclusion criteria include: - individuals with a diagnosis of bipolar disorder whom are at the time of testing in a euthymic state (not in an episode of depression or mania). exclusion criteria include: * current substance dependence or abuse * current cbt treatment * individuals who are not fluent in english * organic brain injury * active psychotic and manic symptoms requiring hospitalisation * active suicidal risk.
safety and efficacy of intravenous (iv) dexmedetomidine during flexible bronchoscopy and endobronchial ultrasound

Conditions: Pain

Summary: to achieve safe,consistent, continuous sedation using dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.

dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. this study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy

Eligibility criteria:
inclusion criteria: * adults between the age of 18 and 85 * adults scheduled for flexible brochoscopy using eubs (endobronchial ultrasound) exclusion criteria: * sever bradycardia (rate \< 50) and / or related bradydysrhymias (e.g. advanced heart block) * impaired ventricular functions (ef \<30%) * hypovolemia or hypotension (sbp \<90 or map \<a55) * have gfr less than 15ml/min 1.73m2 or undergoing hemodialysis * endstage liver disease.

Keywords: sedation
early de-escalation of empirical antibiotics treatment for neutropenic fever

Conditions: Safety Issues

Summary: this is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (hsct). in case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. in the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. in the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.

this is a randomized study to evaluate the safety and feasibility of early de-escalation treatment of empyrical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (hsct). all patients undergoing hsct will receive levofloxacin as regular prophylaxis. after patients develop neutropenia fever, the empirical antibiotics protocol will be impenem. in case of persistent for 48 hours, vancomycin will be added. if afebrile is achieved for 72 hours, all patients will randomized into early de-escalating group or control group. in de-escalating group, the empirical antibiotics treatment will be stopped and then levofloxacin prophylaxis will be resumed. in the control group, the empirical antibiotics treatment will be continue until recovery of neutropenia or at least 7 days.

Eligibility criteria:
inclusion criteria: * age ≥18，patients undergo hematopoietic stem cells * patients with neutropenic fever: t≥38.5°c once or t≥38°c twice a day with anc \<0.5x109/l or predicted to be \<0.5x109/l in 24 \~48 hours； * patients achieved afebrile （t\<37.5°c）for at least 72 hours； * inform consent given exclusion criteria: * patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection. * patients with septic shock * levofloaxin allergy or contra-indication

Keywords: neutropenic fever, empiric, antibiotics
comparison of n&h sandwich technique and cesarean hysterectomy in management of placenta accreta spectrum

Conditions: Cesarean Section Complications

Summary: the placenta accreta spectrum (pas)is one of the most common reasons for cesarean hysterectomy which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. and, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility. conservative management of pas defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences. the main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the triple-p procedure. these methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.

patients were allocated to one of two groups. group (i): patients will be received n\&h technique group (ii): patients will be received cesarean hysterectomy. in the n\&h group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated foley's catheter balloon tamponade was performed as follow: (i) 100-cm vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened. (ii) the needle transfixed the right side of the uterine wall from anterior to posterior, about5 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision. (iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm. (iv) at the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 fr foley's catheter with a 30-50-ml balloon (medical industries, 10th of ramadan city, egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . only one catheter was used for tamponade. (v) lastly ties the sutures.

Eligibility criteria:
inclusion criteria: * all pregnant women with a full-term pregnancy with placenta accreta spectrum exclusion criteria: * patients with a cardiac, hepatic, renal or thromboembolic disease. * patients with pelvic endometriosis and adnexal mass. * those presented with severe antepartum hemorrhage will be excluded * known coagulopathy * twin pregnancy

Keywords: cesarean section placenta accreta spectrum n&h sandwich technique
study of zio-201 in advanced sarcoma

Conditions: Advanced Sarcoma

Summary: the study of safety of isophosphoramide mustard (ipm) in the treatment of advanced sarcoma.


Eligibility criteria:
metastatic and /or unresectable disease state after previous standard chemotherapy
a phase iii randomized, double blind, placebo controlled multi-center study of panobinostat for maintenance of response in patients with hodgkin's lymphoma (hl)

Conditions: Hodgkin's Lymphoma

Summary: the primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with hl after achieving a complete response following autologous hematopoietic stem cell transplant (ahsct) with high dose chemotherapy (hdt). primary objective as stated above reflects a change from the original protocol as of an amendment. the original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. an amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). therefore, the study was completed as per this amendment. no secondary objectives were included for this trial from the amendment; this was a change from the original protocol.


Eligibility criteria:
inclusion criteria: 1. patient age is greater than or equal to 18 years 2. patient has a history of histologically confirmed classical hl (i.e. nodular sclerosing (nshl), mixed-cellularity (mchl), lymphocyte-rich (lrhl), lymphocyte depleted (ldhl)) 3. patient has achieved a complete response by ct/mri scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (ahsct) following hdt. complete response is defined as: normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. any residual abnormal masses on the post transplant ct/mri must be metabolically inactive on a pet scan. 4. patient has at least one of the following factors that places them at risk for relapse: * primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment) * first relapse \>3 but \<12 months from last dose of 1st line treatment * multiple relapses (prior to transplant) * stage iii/iv disease (at relapse, prior to transplant) * hemoglobin \<10.5 gm/dl (at relapse, prior to transplant) exclusion criteria: patient has been treated with allogeneic transplant 2. patient has received any anti-lymphoma therapy after ahsct including but not limited to: * chemotherapy prior to start of study * biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study * radiation therapy 3. patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or grade ≤1) except for hematological laboratory parameters note: patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. patient has received prior treatment with dac inhibitors including panobinostat

Keywords: phase iii randomized double blind placebo controlled multi-center study panobinostat hodgkin's lymphoma at risk for relapse autologous stem cell transplant
therapeutic cocaine vaccine: human laboratory study

Conditions: Cocaine Dependence

Summary: clinical data demonstrate that a cocaine vaccine (ta-cd: celtic pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. the objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects. cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. vaccinations occur at weeks 1, 3, 5 and 9.

i do not desire to provide a more extensive description.

Eligibility criteria:
inclusion criteria: 1. meets dsm-iv criteria for current cocaine dependence. the volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine). 2. primary route of cocaine administration is smoking. 3. age 21-45. 4. females must be surgically sterilized or post- menopausal 5. able to give informed consent, and comply with study procedures. exclusion criteria: 1. dependence on substances other than cocaine or nicotine. 2. judged to be noncompliant with study protocol. 3. history of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. an hiv test must be negative. 4. currently uses drugs intravenously 5. currently taking any psychotropic medication 6. laboratory tests that are clinically unacceptable to the study physician (bp \> 140/90; bun, creatinine, lfts \> 1.5 uln; hematocrit \< 34 for women, \< 36 for men) 7. blood or blood products given in the three months prior to vaccination 8. other vaccines, including flu vaccine, given within 30 days of screening. 9. ongoing active infection 10. currently taking immunosuppressives -

Keywords: cocaine immunotherapy vaccination antibody addiction dependence