Kornimate/medical-research-clean huggingface dataset:
open-label study to evaluate safety of a single dose of sym-1219

Conditions: Bacterial Vaginosis

Summary: this is a phase 3, multi-center, prospective, open-label study to evaluate the safety of sym-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

approximately 325 patients will be enrolled. patients determined to be eligible for the study will receive sym-1219 granules containing 2 grams of secnidazole orally as a single dose. patients determined to be eligible at the baseline visit will receive a single dose of sym-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on day 1. patients will be contacted by telephone once between days 8 to 10 to inquire about possible adverse events. a final study visit will occur on day 21 to 30 to assess the patient for safety.

Eligibility criteria:
inclusion criteria: * are adult females or postmenarchal adolescent girls ≥ 12 years of age. * are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the investigator's opinion, may interfere with study participation. * have a negative urine pregnancy test result prior to study treatment initiation. in addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the investigator * agree to abstain from alcohol for 3 days following study treatment. * have a clinical diagnosis of bacterial vaginosis * agree not to use vaginal douches or similar products for the duration of the study. exclusion criteria: * are pregnant, lactating, or planning to become pregnant during the study. * are menstruating or have vaginal bleeding at the baseline visit (day 1). * are menopausal as determined by the investigator * are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae or herpes simplex * have active genital lesions, including active herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the investigator * have consumed any alcohol within 12 hours prior to treatment with study medication. * have a history of an abnormal pap smear which required cervical biopsy or cervical cauterization within 3 months of the baseline visit (day 1). * have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
lipoprotein a is an independent risk factor for overall survival in patients with pancreatic cancer: a propensity score matching analysis

Conditions: Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis

Summary: background: this study aims to assess the prognostic significance of serum lipoprotein (a) \[lp (a)\] levels on overall survival (os) and progression free survival (pfs) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (psm). methods: a retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the affiliated hospital of qingdao university from january 2019 to december 2022. the cut-off value for lp (a) was determined based on one-year survival rates after diagnosis. patients were then categorized into the high and low lp (a) groups. we applied psm analysis to minimize selection bias. the study compared os and pfs between two groups by kaplan-meier method and analyzed differences using the log-rank test. additionally, univariate and multivariate cox-regression analyses were performed to identify prognostic factors among patients.


Eligibility criteria:
inclusion criteria: * adult patients aged over 18 years; (2) patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) complete lipid profiles available within one week prior to diagnosis. exclusion criteria: * (1) presence of concurrent malignancies; (2) history of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) incomplete clinicopathological information.

Keywords: pancreatic carcinoma; lipoprotein a; overall survival; prognosis
implementation of a new strategy to identify hnpcc patients

Conditions: Colorectal Neoplasms; Hereditary Nonpolyposis Colorectal Cancer

Summary: the purpose of this study is to compare two different strategies to implement a new method to identify patients with hnpcc, which appeared cost-effective and feasible. the effectiveness, costs and feasibility of both of the implementation strategies will be assessed.

the radboud university nijmegen medical centre developed a new method to identify patients with hnpcc. this method appeared cost-effective and feasible. using this new method 70% of the hnpcc patients will be identified as compared to less than 30% when the current method is used. however, this new method does not implement itself; large gaps exists between best evidence and daily practice. this study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. the aim is to find the most cost-effective strategy to implement the new method to identify patients with hnpcc in the netherlands.

Eligibility criteria:
inclusion criteria: * colorectal cancer before the age of 50 years * second colorectal cancer at any age * colorectal cancer and other hnpcc associated extracolonic cancer irrespective of age at diagnosis * adenoma with high grade dysplasia diagnosed before the age of 40 years

Keywords: hereditary colorectal cancer microsatellite instability physician roles health care implementation intervention
comparison of tstvs nt along with conventional therapy for upper limb motor function among chronic stroke patients

Conditions: Stroke

Summary: comparison of task specific training vs neurodevelopmental training along with conventional therapy for upper limb motor function among chronic stroke patients

to compare task specific training versus neurodevelopmental training along with conventional therapy for upper limb motor function among chronic stroke patients.

Eligibility criteria:
inclusion criteria: * chronic ischemic stroke patients( after 3 months of stroke ).(41) * patients from both gender.(42) * patients of around age of 45-65.(43) * patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44) * patient with good cognitive function minimum 20 or more on mini mental state examination (mmse).(45) exclusion criteria: * patients with history of the recurrent stroke.(41) * patient with fracture or dislocation of upper limb.(46) * patient with any peripheral vascular disease (47) * patient with any comorbid neurological disease like parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21) * patient with skin discoloration, skin ulcers and skin allergy.(48)
pre-meal load of raw almonds and postprandial hyperglycemia

Conditions: Intervention

Summary: a few studies show the effect of almonds on postprandial hyperglycemia (pphg); high blood glucose after meals. in our previous study on intervention with almonds, we observed a significant decrease in hba1c and a small decrease in fasting blood glucose indicating a possible effect of almonds on pphg. studies have shown that a preload of a food article that is high in protein, mono-unsaturated fatty acids, fiber, and low in carbohydrates, such as almonds could be helpful in stimulating insulin secretion and help improve postprandial hyperglycemia. the proposed study shall be undertaken to assess the effect of almond supplementation on postprandial hyperglycemia in asian indians with prediabetes.

* acute phase study: randomized controlled cross over study design number of arms: 2, almond and control, n=60 needed (30 in each arm) subjects randomized to almonds arm are given a preload of 20 g of almonds 30 minutes prior to ingestion of 75 g of glucose, while those in the control arm do not have any food/almonds before ogtt. blood samples are collected at (minutes): -30, 30, 0, 30, 60, 90 and 120. cross over of these subjects is done and ogtt repeated in a similar manner. assessment of blood glucose, serum insulin, glucagon, c-peptide, serum triglycerides, free fatty acids, dpp-iv, and glp1 levels are done at these time points. * sub-acute study: three-day almond preload study monitored with cgms, n=60 needed. all study participants undergoing ogtt are further studied with cgms for three days each and then crossed over. those in almonds arm continue to receive preload of almonds (20g almonds, 30 minutes before breakfast, lunch and dinner)for three days and then studied without almond preload after cross over. a washout period of 7 days separates cross-over period. o chronic phase study: ninety days almond preload study monitored with self-monitoring of blood glucose; n=60 needed. this is a randomized controlled parallel-arm study to evaluate the long-term effect of preload of almonds on hyperglycemia. subjects fulfilling the inclusion/exclusion criteria are randomized to either the control arm or the almond arm.

Eligibility criteria:
inclusion criteria: * age 18 to 60 years * prediabetes as diagnosed on oral glucose tolerance test (ogtt): fasting blood glucose ≥100mg/dl and \<126 mg/dl and 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 gram anhydrous oral glucose) or 2-h plasma glucose * 140mg/dl and \<200mg/dl alone. exclusion criteria: * acute infections and advanced end-organ damage * history of hepatitis or pancreatitis, abnormal liver and renal functions * recent (\<3 months) changes in weight (≥5%) and/or weight changing medications * any known allergy to nuts * uncontrolled hypertension or hypothyroidism * suffering from acute infection or any debilitating disease or with renal failure

Keywords: almonds asian indians prediabetes
the effect of physiotherapy treatment following gynaecological surgery

Conditions: Vaginal Hysterectomy; Pelvic Organ Prolapse Vaginal Surgery

Summary: optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. it is also known that problems in some of tehse areas can be a consequence of pelvic surgery. by addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. this study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. it is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.

optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of pelvic health. it is also known that problems in some of these areas can develop after pelvic surgery. by addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgical phase when tissue repair and scar formation are critical, it is proposed that there will be a reduction in the long-term prevalence of bladder and bowel dysfunction, and weak pelvic floor and abdominal muscles in post-surgical patients. there have been no previous studies investigating whether a physiotherapy intervention can assist pelvic function in this group of surgical patients. this study aims to investigate the effect of a physiotherapy treatment program on pelvic function following gynaecological surgery. comparisons: pre- and post-operative physiotherapy treatment vs no treatment following gynaecological surgery. outcome measures: pelvic floor muscle strength, urine leakage, quality of life, sexual functioning, general fitness, measured at 3, 6 and 12 months post-operatively

Eligibility criteria:
inclusion criteria: * undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair exclusion criteria: * surgery for malignancy * anti-incontinence surgery * laparotomy

Keywords: hysterectomy prolapse pelvic floor muscles bladder bowel
comparing aerobic to resistance training in recovery from cancer

Conditions: Neoplasms

Summary: the purpose of this study is to compare the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using thera-bands) in sedentary patients within 6 months of completing treatment for cancer.


Eligibility criteria:
inclusion criteria: * have a biopsy-proven cancer diagnosis * be within six months of having completed chemotherapy or radiation therapy for treatment for cancer as determined by the primary physician * be ambulatory but sedentary (i. e., has not followed an exercise regimen of a minimum of 3 times per week for at least 20 minutes each session over the previous six weeks) * have an eastern cooperative oncology group (ecog) performance status score of 0 asymptomatic) or 1 (symptomatic, fully ambulatory) * be at least 18 years old * be able to read and speak english * have a medical statement from either the patient's primary care provider or the primary oncologist indicating that participation in the program is not medically contraindicated exclusion criteria: * following an exercise regimen a minimum of 3 times per week for at least 20 minutes each session within the previous 6 weeks * bone or joint destruction that could be aggravated with exercise * severe cognitive impairment identified by either the patient's medical care provider or by the study team * neuropathy-sensory common toxicity criteria (ctc) grade 3 (sensory loss or paresthesia interfering with activities of daily living) or grade 4 (permanent sensory loss that interferes with function) peripheral neuropathy

Keywords: sleep fatigue exercise tolerance quality of life health status
long term study of pregabalin in idiopathic restless legs syndrome patients

Conditions: Idiopathic Restless Legs Syndrome

Summary: this purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic rls patients for up to 12 months.


Eligibility criteria:
inclusion criteria: * idiopathic rls with the presence of all four clinical manifestations of rls * rls symptoms occur predominantly in the evening * rls history at least 6 months * irls =\> 15 at the beginning and the end of placebo run-in * have =\>15 nights with rls symptoms in the month prior to screening exclusion criteria: * any secondary rls * current augmentation due to rls treatment * placebo responders identified during the placebo run-in

Keywords: rls
computer assisted symptom evaluation of complex patients

Conditions: Multiple Co-morbidities

Summary: patients who have advanced or multiple chronic illnesses present management difficulties for primary care providers. acute medical issues and limited time for patient evaluation can complicate complete assessment of physical symptoms that directly impact a patient's quality of life. the cook county health and hospitals system (cchhs) established an advanced illness management clinic to provide care for complex patients. patient entry into the advanced illness management clinic is by referral only, a passive process. after discharge, general medicine clinic patients who do not have a medical provider are given an appointment in the clinic. since the hospital is the source of many patients, this guarantees that these patients will have at least one illness advanced enough to require hospitalization, and most will have additional chronic illnesses. an outpatient palliative care clinic located in a specialty clinic setting was initiated in 2004. the goal of the clinic was to extend the benefits realized by hospital patients, for whom palliative care consultation has been available for many years, to patients cared for in the outpatient setting. the benefits provided include physical symptom management, spiritual counseling, and support for social issues. until recently, this outpatient palliative care model has mainly served patients with malignancy. with the addition of the advanced illness management clinic, palliative care clinicians now can provide care to patients with other chronic and serious illness in the primary care setting. hypothesis: complex patients will have improved quality of life and a reduced symptom burden if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a general medicine clinic.

outcome measures: 1. quality of life as measured by the national institutes of health (nih) patient reported outcomes measurement information system (promis) short form 2. physical symptom burden as measured by the memorial symptom assessment scale (msas), short form

Eligibility criteria:
inclusion criteria: * english or spanish speaker * must be a general medicine clinic patient * must have a physical symptom score on msas above threshold (i.e., 1.0 or higher) * must have a phone number for contact exclusion criteria: * visual or cognitive impairment

Keywords: medical informatics health services accessibility
sentry study: raman spectroscopy on ex vivo lungs

Conditions: Lung Cancer

Summary: in this proof-of-concept, ex vivo study, the study team will investigate whether raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

lung cancer is the most prevalent form of cancer worldwide and the leading cause of cancer-related deaths. despite recent advances in treatment, the five-year survival rate remains below 25% \[state of lung cancer report 2021,american lung association. this is largely due to the fact that most patients are diagnosed only at advanced stages of the disease when treatments are ineffective and the prognosis is poor. the national lung screening trial demonstrated the utility of lung cancer screening by low-dose computed tomography (ct) to improve early detection\\ and reduce lung cancer-related mortality by 20%. earlier detection of lung lesions in turn created an increased need for better early diagnosis modalities. reveal surgical is developing medical devices for tissue characterization based on raman spectroscopy technology. in this proof-of-concept, ex vivo study, the study team will investigate whether raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

Eligibility criteria:
inclusion criteria: * aged 18 or above, * with suspected or confirmed diagnosis of lung cancer, * scheduled for lobectomy surgery, * able to give informed consent. exclusion criteria: * suspected or confirmed diagnosis of mucinous adenocarcinoma of the lung * undergoing neoadjuvant therapy. (this exclusion criterion is intended to minimize confounding optical signals such as fluorescence or near-infrared raman signals that could arise from the presence of chromophores derived from neoadjuvant medication.) * previously diagnosed with cystic fibrosis or other lung disease, with the exception of chronic obstructive pulmonary disease (copd) and ild (interstitial lung disease), i.e., patients with copd or ild will not be excluded from the study. * tumor size below 1cm3 * resected lobe does not allow surgical pathology team to section two study specimens of minimal size 1.5cm × 1.5cm. in this case the patient will be found ineligible after consent.
antiretroviral treatment simplification study with efavirenz + abacavir + 3tc once daily

Conditions: HIV Infections

Summary: to evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3tc) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.

treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the hiv infection. the combination of abc+3tc+efv is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 nrti taken twice daily.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. hiv-1 infected patients. 3. patients on haart therapy including efavirenz and two nrtis in a twice-daily regimen for 6 months at least. 4. patients with an undetectable hiv-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). 5. subject able to follow the treatment period. 6. signature of the informed consent. 7. women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study. exclusion criteria: 1. hepatic tests \> 5 times above normality. 2. pregnancy or breastfeeding 3. presence of opportunistic infections and/or recent tumours (\< 6 months). 4. suspected or documented resistance to any of the investigational drugs. 5. known allergic hypersensitivity to any of the investigational drugs or any similar drug. 6. subjects with abusive consumption of alcohol or illegal drugs. 7. patients participating in another clinical trial.

Keywords: antiviral efficacy tolerability immunologic response virologic response hiv
comparative effects of nebivolol and carvedilol on diastolic function in the elderly heart failure patients

Conditions: Heart Failure

Summary: heart failure (hf) is a common and disabling condition in the elderly. randomized clinical trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves the outcomes of patients with hf. however, limited data have been available on the treatment of hf with preserved ejection fraction (ef) in the elderly. no study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating hf in old age patients with preserved ef.

this trial is a prospective, randomized, open-label, active controlled study designed to investigate effects of nebivolol and carvedilol on diastolic function of the left ventricle (lv) in the elderly hf patients with preserved ef. patients will be included in the study if they had lvef ≥ 40%, nyha functional class i, ii or iii, and clinical stability without hospital admission for hf in the preceding 3 months.

Eligibility criteria:
inclusion criteria: * more than 70 years * ef ≥ 40% exclusion criteria: * contraindication to the study drug
study evaluating bapineuzumab in alzheimer disease subjects

Conditions: Alzheimer Disease

Summary: the study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate alzheimer disease. subjects will be in the study for six months and will receive subcutaneous injections once per week.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer disease according to national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria * mini-mental state examination (mmse) score 16-26 exclusion criteria: * magnetic resonance imaging (mri) showing other brain abnormalities * other diagnosed neurological or psychiatric disorders

Keywords: antibody immunotherapy