Kornimate/medical-research-clean huggingface dataset:
study of gemcitabine/taxotere/xeloda (gtx) in combination with cisplatin and irinotecan in subjects with metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: this study will be looking at whether gemcitabine, taxotere, and xeloda (gtx) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.

the study is being done in 2 parts. the first part is the dose escalation (phase i) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin. after the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. 2. have measurable disease. 3. male or non-pregnant and non-lactating female of age \>18 years. 4. eastern cooperative oncology group (ecog) performance status of 0 to 1 . ecog 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ecog 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature 5. subjects must have adequate organ and marrow function. 6. must use acceptable form of birth control prior to study and and for the duration of study. 7. willing and able to comply with study procedures exclusion criteria: 1. patient who have had any prior chemotherapy within 5 years of enrollment. 2. patient who have had radiotherapy for pancreatic cancer. 3. age ≥ 76 years 4. patient who is receiving or have received any other investigational agents within 28 days prior to day 1 of treatment in this study. 5. patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to day 1 of treatment in this study. 6. patient who has known brain metastases. 7. patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan. 8. patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 9. patient who has serious medical risk factors involving any of the major organ systems. 10. patient who has known history of infection with hiv, hepatitis b, or hepatitis c. 11. pregnant or breast feeding. 12. patient is unwilling or unable to comply with study procedures 13. patient with clinically significant wound
physical therapy trial for pelvic pain

Conditions: Interstitial Cystitis; Painful Bladder Syndrome; Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Summary: the purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.

this is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. those receiving global therapeutic massage will have non-specific somatic treatment with full-body western massage.

Eligibility criteria:
inclusion criteria: * female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome * male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome exclusion criteria: * neurologic disorder affecting bladder * bladder cancer, prostate cancer, or urethral cancer

Keywords: interstitial cystitis painful bladder syndrome chronic prostatitis chronic pelvic pain syndrome
a study of cc-5013 in the treatment of complex regional pain syndrome (crps)

Conditions: Complex Regional Pain Syndrome (RSD)

Summary: this is a multicenter, open-label study in adult subjects with type 1 complex regional pain syndrome. subjects diagnosed with unilateral type 1 crps will be enrolled sequentially to receive cc-5013 10 mg/day orally. for each subject the study consists of two phases: pre-treatment phase(1 wk) and treatment phase (12 wks)

once the subject completes the 12 week treatment phase the subject is eligible to continue on the trial. subjects may continue until no further benefit is obtained.

Eligibility criteria:
inclusion criteria: * a diagnosis of type 1 crps as defined by modified international association for the study of pain criteria (app 1) for at least one year duration * unilateral involvement of a distal hand or foot with or without proximal speed must be present. the most severely affected limb will be designated the index limb. * crps pain severity score in the index limb of 4 or greater on an 11-point (0-10) nrs (appendix i). * opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants and antidepressant drugs may be continued provided that the subject was on stable doses for at least four weeks prior to the treatment phase. * understand and voluntarily sign an informed consent form * able to adhere to the study visit schedule and other protocol requirements * women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test within 7 days of starting study drug. * in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. * wcbp must agree to have pregnancy tests every 4 weeks while on study drug. * the average crps pain severity score in the index limb at the end of the pre-treatment phase i (must be 4 or greater) and 2 each of the daily scores over the week must be within +/- one point of this average. exclusion criteria: * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * prior treatment with cc-5013 * prior development of an allergic reaction/hypersensitivity while taking thalidomide. * prior development of a moderate or sever rash or any desquamation while taking thalidomide. * pregnant or lactating females. * active litigation, compensation or disability issues related to crps. * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * use of any other experimental drug or therapy within 28 days of the treatment phase.

Keywords: pain pain syndrome reflex sympathetic dystrophy cc-5013 cc5013 revlimid celgene crps
linking women to prep care

Conditions: Prevention

Summary: pre-exposure prophylaxis (prep) can be very effective at preventing hiv infection among women at high-risk for hiv but is underused in this population. periods of incarceration represent an opportunity to identify women at risk and link them to prep care as they leave jail or prison. this study aims to improve linkage to community-based prep care to reduce hiv acquisition in a high-need, underserved community.

incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for hiv. pre-exposure prophylaxis (prep) is an efficacious means of reducing hiv acquisition. there is a general lack of knowledge regarding prep among women at elevated risk, and only a small percentage of at-risk women are currently engaged in prep care. the period of incarceration represents an opportunity to identify at-risk women, initiate prep during incarceration, and establish linkage to community-based prep care upon release from incarceration. further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention. to date, very little research has been done to improve linkage to prep care among us women. the proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote prep initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based prep care upon release from incarceration. the long-term goal of this line of research is to disseminate an efficacious prep care linkage intervention for at-risk women post-release from incarceration. the present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (rct) of the intervention.

Eligibility criteria:
inclusion criteria: * female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets cdc indications for prep; likely to be incarcerated for less than 6 months; able to understand and speak english and to provide written and verbal informed consent

Keywords: prep women linkage to care
imaging characteristics of florbetapir 18f in patients with frontotemporal dementia, alzheimer's disease and normal controls.

Conditions: Alzheimer's Disease; Frontotemporal Dementia

Summary: study 18f-av-45-010 is designed to evaluate the cerebral uptake of florbetapir 18f as measured by pet imaging in frontotemporal disorder (ftd) in comparison to cognitively normal volunteers and subjects with alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: ad: * male or female \>= 50 years of age * meet national institute of neurological and communicative disorders and stroke (nincds) criteria for probable ad and have a mini mental state examination (mmse) score at screening between 10 and 24 inclusive * have a caregiver who can report on their mental status and activities of daily living (adl) * give informed consent or have a caregiver give consent with subject assent. ftd: * male or female \>= 45 years of age * meet consensus criteria for ftd and have mild to moderate disease severity. have a caregiver who can report on their mental status and adl * give informed consent or have a caregiver give consent with subject assent. cn: * male or female \>= 45 years of age * have and mmse \>= 29 * give informed consent exclusion criteria: * have a history or a current clinically significant neurologic disease (other than ad or ftd, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia * evidence from mri or other biomarkers that suggests an etiology of dementia other than ad or ftd, as applicable or in the case of cn subjects evidence indicating the presence of ad, ftd or other types of neurologic pathology * have current clinically significant cardiovascular disease, screening ecg abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease * have a recent history of alcohol or substance abuse or dependence * women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception. * require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days * have ever participated in a study with an amyloid targeting agent * have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol
study of the efficacy and safety of pegnano plus barivir (ribavirin) in treatment-naïve patients with chronic hepatitis c at kiengiang general hospital

Conditions: Chronic Hepatitis C

Summary: this study presents a clinical study on the efficacy and safety of pegnano combined with barivir (ribavirin) in treating treatment-naïve patients with chronic hepatitis c at kien giang general hospital. the study aims to provide affordable treatment options while evaluating the virological response and side effects associated with the therapy

this study evaluates the efficacy and safety of pegnano (peginterferon alfa-2a) combined with barivir (ribavirin) in treatment-naïve patients with chronic hepatitis c (hcv). conducted at kien giang general hospital from march 2011 to march 2013, this uncontrolled clinical trial enrolled 100 outpatients aged 18-65 with hcv rna \>80 iu/ml and compensated liver disease. patients received pegnano (180 mcg, subcutaneous, weekly) and barivir (15 mg/kg daily, oral) for 24 weeks (genotypes 2, 3) or 48 weeks (genotypes 1, 4, 5, 6), with possible extension to 72 weeks for genotype 1 with late virological response. the primary goal is to assess virological responses (rapid, early, end-of-treatment, and sustained at 24 weeks) by genotype and il28b rs12979860 polymorphism, alongside safety through adverse event monitoring. efficacy is measured via hcv rna levels using real-time pcr, while safety is evaluated through clinical and paraclinical assessments every 4 weeks. the study aims to provide evidence for affordable hcv treatment options in vietnam using locally produced drugs

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c. * age 18-65 years. * no previous treatment with interferon or peginterferon. * hcv rna serum baseline \>80 iu/ml. * compensated liver disease (total bilirubin \ 3.4 g/dl, no ascites or hepatic encephalopathy). * normal hematological and biochemical parameters (hemoglobin \>12 g/dl for males, \>11 g/dl for females; neutrophils \>1500 cells/µl; platelets \>75,000 cells/µl; serum creatinine \<1.5 mg/dl or \<132 µmol/l). exclusion criteria: * depression. * autoimmune hepatitis or other autoimmune diseases. * unstable hyperthyroidism or hypothyroidism. * severe medical conditions (e.g., hypertension, congestive heart failure, angina, uncontrolled diabetes, copd). * decompensated cirrhosis. * co-infection with hiv or hepatitis b. * pregnant women or those unwilling to use effective contraception.
naltrexone implants vs. mmt among inmates in the norwegian correctional services

Conditions: Opiate Addiction

Summary: the purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. the experimental group is compared with a control group that commences methadone maintenance treatment before release. the hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. the experimental group is going to have significant less days with opioid use compared to the mmt group. we hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.

the probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts. we attempt to prevent relapse to opiate abuse by two different means: methadone maintenance treatment (mmt) versus naltrexone implants, randomly allocated to two groups by sealed envelopes. all participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone. the total treatment period is 18 months, continuation with mmt is optional after study termination.

Eligibility criteria:
inclusion criteria: * opiate addiction * living in greater oslo area exclusion criteria: * psychosis / major depression, currently not treated * pregnancy * liver enzymes: asat or alat \> threefold above upper boundary

Keywords: naltrexone implant methadone inmates randomized controlled trial
the effect of heating with electrical blanket after cesarean section on the postpartum

Conditions: Cesarean Section

Summary: it is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. one of the important problems after cesarean section is hypothermia. therefore, various methods are used to maintain normal body temperature. one of these methods is the use of electric blankets. this study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.

after cesarean section, mothers face more problems than mothers who give birth normally. post-cesarean pain, breastfeeding problems, anesthesia-related side effects, and postpartum complications are important reasons affecting maternal comfort. after a cesarean section, mothers may experience hypothermia due to the low temperature in the operating room, the incision, and the effects of spinal/general anesthesia. in mothers who develop hypothermia after cesarean section, undesirable results may occur in physiological parameters such as fever, pulse, blood pressure, pain, and intestinal motility. therefore, body temperature, blood pressure, pulse, saturation, pain, time to first flatus and defecation are the main factors that determine patient comfort after surgery. in the postoperative period, both pharmacological and non-pharmacological treatment methods are used to reduce pain, increase the amount of milk, and increase intestinal motility. it is stated in the literature that non-pharmacological methods such as early mobilization, chewing gum, early oral hydration (consumption of water, warm water, tea, coffee), and hot application are effective in increasing intestinal motility. using active and passive heating methods to prevent hypothermia after cesarean section are practices that affect postpartum comfort. with this study, it is expected that heating with an electric blanket will prevent hypothermia, increase postpartum comfort, reduce pain, and increase breastfeeding success by affecting the amount of milk.

Eligibility criteria:
inclusion criteria: * 18 years and over, * at least primary school graduate * the one who is married * primiparous women who gave birth at term, * having the baby with her after birth * those who agreed to participate in the study exclusion criteria: * those who gave birth at less than 37 weeks of gestation * mothers with babies weighing less than 2500 grams * the newborn has a congenital anomaly, * those with a history of high-risk pregnancy * those who received any food, including water, other than breast milk until the 10th day of follow-up * those with cardiovascular disease problems, those with a history of neurological diseases * mothers with nipple problems * diabetes mellitus, those diagnosed with gestational diabetes mellitus, * mothers who gave birth with general anesthesia

Keywords: caesarean section electric blanket nursing
exercise versus diet in the treatment of nonalcoholic fatty liver disease

Conditions: Non Alcoholic Fatty Liver Disease

Summary: the central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind nafld (non-alcoholic fatty liver disease) and nash (non alcoholic steatohepatitis). the investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing nafld parameters by improving hepatic mitochondrial content and function in human subjects. the investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have nafld or liver biopsy-confirmed nash

fatty liver disease) and nash (non alcoholic steatohepatitis). the investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing nafld parameters by improving hepatic mitochondrial content and function in human subjects. the investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have nafld or liver biopsy-confirmed nash

Eligibility criteria:
inclusion criteria: * sedentary individual between * age group 18-60 years old * elevated liver function tests (lft's) with fatty liver on ultrasound and biopsy proven nash exclusion criteria: * significant history of alcohol consumption \> 20 gm/day (\> 2 drinks / day) * evidence of other causes of hepatitis including positive screening b \& c, autoimmune hepatitis, hemochromatosis, celiac disease, wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis * subjects with planned exercise \> 30-60 minutes per week * bmi \ 44 kg/m2 * clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease * changes in last 3 months the dose of oral hypoglycemic medication and statin, * positive stress test * pregnant women * demented individuals who cannot give consent

Keywords: nafld nash weight loss exercise nas scores mitochondrial dysfunction