Kornimate/medical-research-clean huggingface dataset:
feasibility trial in men with hormone sensitive oligometastatic prostate cancer

Conditions: Hormone Sensitive Oligometastatic Prostate Cancer

Summary: patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.

investigators propose to do a randomized feasibility trial comparing rp vs rt to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. sbrt will be used to treat all of the metastases, and this will be combined with an intermittent adt approach. adding systemic chemotherapy will be allowed. given the past difficulties of randomizing patients between rp and rt in localized prostate cancer studies (like spirit), investigators feel a small feasibility project is the first step. in the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. if patients do not accept their assigned randomization (ie they prefer rp even though they are randomized to rt, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.

Eligibility criteria:
inclusion criteria: * able to provide informed consent. * histologic confirmation of prostate adenocarcinoma. * stage iv disease with ≤ 5 metastases outside of the pelvis. * ≤ 3 metastases in any one organ system. * ecog performance 0-1. * all metastatic tumours amenable to sbrt. * patient eligible for either rp or rt to the prostate. exclusion criteria: * castration resistant prostate cancer. * previous rp or rt to prostate. * inability to treat all metastases with sbrt. * prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
biomechanical changes in women with post-partum pelvic girdle pain: an observational case-control study

Conditions: Postpartum Pain

Summary: research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (pgp), both perinatally and postnatally. researchers also report an association between temporomandibular joint disorder (tmd) and changes in lumbopelvic alignment. there are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (pgp), both perinatally and postnatally. researchers also report an association between temporomandibular joint disorder (tmd) and changes in lumbopelvic alignment. there are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

Eligibility criteria:
inclusion criteria: - the age of the participants will be ranged from 20 to 40 years. their body mass index will be ranged from 20 to 25 kg/m2. they will have regular menstrual cycle. they will not receive any hormonal therapy or taking any regular drugs exclusion criteria: * bone disease. discogenic state with radiculopathy or not. systemic disease of musculoskeletal system. any sensory problems. previous vertebral fractures. major spinal structural abnormality. major jaw abnormality. any jaw orthotics or prosthesis. missing teeth.

Keywords: pelvic girdle pain, lumbopelvic angles, pelvic parameters, and temporomandibular joint disorders.
molecular analysis of patients with neuromuscular disease

Conditions: Neuromuscular; Disorder, Hereditary; Duchenne/Becker Muscular Dystrophy; Limb-girdle Muscular Dystrophy

Summary: the purpose of this study is to identify new genes responsible for neuromuscular disorders and study muscle tissue of patient with known neuromuscular disease, as well as their family members. we are interested in recruiting many types of neuromuscular disease including; duchenne muscular dystrophy (dmd), becker muscular dystrophy (bmd), and limb-girdle muscle dystrophy (lgmd). there are still many patients diagnosed with muscular dystrophy with no causative gene implicated in their disease. using molecular genetics to unravel basis of these neuromuscular disorders will lead to more accurate diagnosis/prognosis of these disorders which will lead to potential therapies.

we are looking to discover new disease genes responsible for the neuromuscular diseases found in our participants and their families. our research lab has a long history of identifying novel genes responsible for various forms of neuromuscular disease including; dmd gene, the sarcoglycans, obscurin, and filamin. each discovery has resulted in advances in our ability to develop diagnostic tests which benefit patients and their families by providing accurate diagnosis, presymptomatic and/or prenatal testing. genotype-phenotype correlation studies have increased our understanding of the natural history of these rare disorders benefiting patients through better prognostic determinations by clinicians. biochemical and pathological analysis of muscle biopsy samples in patients with known and unknown types of neuromuscular disease has led to new insights into disease pathophysiology, which we hope will aid in finding new treatments.

Eligibility criteria:
the samples used in this study will be derived from individuals at risk for, or suffering from, neuromuscular disease, generally resulting in clinical weakness of one or more muscle groups and their family members. inclusion criteria: 1. having a clinical and/or pathological diagnosis of a muscular dystrophy 2. being the first degree relative of someone with such a diagnosis 3. having had a muscle biopsy if diagnosed with a neuromuscular disease 4. willingness to provide a skin biopsy for research only exclusion criteria: 1. not having a neuromuscular diagnosis in you or a family member 2. not wishing to participate 3. being incapable of giving consent and not having a legal guardian willing or able to do so

Keywords: neuromuscular disease muscle weakness muscle atrophy
investigation on the sustained effect of anthocyanins on endothelial function in postmenopausal women

Conditions: Post-menopausal Women

Summary: anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. the investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (fmd) in young male volunteers. there were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. a large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. the formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.


Eligibility criteria:
inclusion criteria: * post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis * \> 50 years exclusion criteria: * cardiovascular disease * acute inflammation * cardiac arrhythmia * renal failure * heart failure (nyha ii-iv) * diabetes mellitus * c-reactive protein \> 0.5 mg/dl * malignant disease * hypotension (≤100 / 60 mm hg)

Keywords: anthocyanins post-menopausal women endothelial function vascular function
study of respiratory gated proton beam radiotherapy for inoperable pancreas carcinoma

Conditions: Pancreatic Cancer

Summary: the only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. so far, the use of 5-fluorouracil (5-fu) was the traditional method of chemotherapy. however, these days, oral anti-cancer medicine, capecitabine(xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-fu). furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(xeloda®) with radiation therapy was proved to be very effective and safe. proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation and which can minimize the exposure to normal tissues. the purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.


Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the pancreas or a serum ca19-9 level higher than normal limits and an pancreas cancer-compatible radiological features in one or more in ct/mri/pet scans * unresectable disease base on institutional standard criteria of unresectability or recurrent disease following radical surgery. there is no evidence of metastatic disease in the major viscera and no peritoneal seeding * patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation * all malignant disease must be encompassable within a single irradiation field (15x15cm maximum) * all patients must have radiographically assessable disease * no previous irradiation to the planned field * age of ≥ 18 years * performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score * required entry labortory parameters: * wbc count ≥ 2,000/mm3 * hemoglobin level ≥ 7.5 g/dl * platelet count ≥ 100,000/mm3 * total bilirubin ≤ 2.0 mg/dl (patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreased ≤ 2.0 mg/dl prior to study entry) * creatinine ≤ 3.0 mg/dl * oral intake (including j-tube feeding) of ≥ 1,500 calories/day should be maintained. exclusion criteria: * there is evidence of metastasis in the major viscera or peritoneal seeding. * age of \< 18 years * previous history of rt adjacent to planned field * poor performance status of 3 to 4 on the eastern cooperative oncology group (ecog) score * pregnant or breast feeding status * previous history uncontrolled other malignancies within 2 years
long-term safety of pf-00345439 (oxycodone)

Conditions: Pain

Summary: long-term safety of pf-00345439 (oxycodone) in patients with moderate to severe chronic low back pain or osteoarthritis

this study will evaluate: (a) the long-term safety of pti-821 during a 12-month period; and (b) the long-term efficacy of pti-821 by assessing pain intensity (pi), the quality of analgesia, and the global assessment of study medication.

Eligibility criteria:
inclusion criteria: * males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the baseline visit or persistent moderate to severe low back pain for at least six months while regularly taking one or more of the following types of oral analgesic medication(s) prior to the baseline visit. * patient agrees to refrain from taking any opioid medications other than study drug during the study period. patients must agree to report all non-opioid analgesic medications taken. * females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or iud). if practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the baseline visit. exclusion criteria: * patient has a positive urine drug screen at the baseline visit. * patient currently is on an opioid regimen with a daily opioid dose equivalent of oxycodone \> 160 mg. * patient has major surgery planned during the proposed study period.

Keywords: safety pf-00345439 remoxy pti-821
study comparing tigecycline and imipenem/cilastatin in chinese subjects with complicated intra-abdominal infections

Conditions: Abdominal Abscess

Summary: the primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of chinese subjects with complicated intra-abdominal infections. \


Eligibility criteria:
inclusion criteria: · hospitalized male or female subjects over 18 years of age exclusion criteria: · subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.

Keywords: peritonitis community-acquired infections cross infection
contrast enhanced ultrasound with lumason in detecting liver cancer in participants with cirrhosis

Conditions: Cirrhosis

Summary: this early phase i trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (lumason) works in detecting liver cancer in participants with cirrhosis. contrast enhanced-ultrasounds use contrast agents, such as lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. contrast enhanced ultrasound with lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.

primary objectives: i. determine the accuracy of contrast enhanced ultrasound (ceus) utilizing contrast agent sulfur hexafluoride lipid-type a microspheres compared to b-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (hcc), in cirrhotic ultrasound (us) patients. secondary objectives: i. determine the concordance of ceus vs. contrast enhanced magnetic resonance imaging (ce-mri) liver imaging reporting and data systems (li-rads). outline: within 30 days of routine mri, participants undergo non-contrast ultrasound of the abdomen. participants then receive lumason intravenously (iv) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.

Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent * diagnosis of cirrhosis based on one or more of the following: histology, us, computed tomography (ct) or mri showing cirrhosis, +/- lesions seen on ce-mri exclusion criteria: * history of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in lumason * pregnant patients-excluded by history * pediatric patients, as pediatric cirrhosis is uncommon
hem1036 phase 2 study in low anterior resection syndrome

Conditions: LARS - Low Anterior Resection Syndrome

Summary: double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of hem1036 in the treatment of subjects with lars

the study will be conducted as a double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of hem1036 in the treatment of subjects with lars. subjects will be males and females ≥18 and ≤75 years of age with lars. subjects must have a lars score of \>20 at the screening visit after sphincter preserving rectal resection surgery for the curative treatment of diagnosed rectal cancer.

Eligibility criteria:
inclusion criteria: 1. male and female subjects ≥18 and ≤75 years old. 2. diagnosed with rectal cancer and undergone sphincter preserving rectal resection surgery. 3. completed curative treatment (rectal resection, systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, radiotherapy, and stomy repairment) ≥6 months prior to screening. 4. current lars with a lars score \>20 at screening. 5. an eastern cooperative oncology group score 0 or 1 at screening. 6. no evidence of anastomotic leakage or severe stenosis. 7. capable of returning to study site for all study visits according to requirement of protocol and willing to comply with the policy, procedure, and restriction of the study. 8. capable of actively communicating with the investigator/study personnel and completing the study related documents. 9. body mass index is at least 18 kg/m2 but no more than 35 kg/m2. exclusion criteria: 1. history of: abdominoperineal resection surgery, hartmann operation, colostomy, transanal irrigation therapy for lars within 2 weeks prior to screening, secondary operation with stoma, etc. 2. not completed stomy repairment done at rectal resection surgery. 3. history of allergic or adverse responses to ip or milk, yeast, soy. 4. on systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiotherapy at the time of screening. 5. any antibiotic use within 4 weeks before the first dose of the ip. 6. is currently participating or has participated in another study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of the ip. 7. tested positive for hiv antigen, hepatitis b, c at screening 8. past or current alcohol or drug abuse history

Keywords: lars - low anterior resection syndrome probiotics colorectal cancer
treatment of tk2 deficiency with thymidine and deoxycytidine

Conditions: Mitochondrial DNA Depletion Syndrome 2 Myopathic Type; Thymidine Kinase 2 Deficiency

Summary: patients with confirmed mitochondrial dna depletion syndrome 2 (thymidine kinase 2 \[tk2\] deficiency) have reduced levels of nucleotides (deoxythymidine monophosphate and deoxycytidine monophosphate) for mitochondrial dna synthesis. this results in mitochondrial dna depletion syndrome (i.e less number of functional mitochondrial dna). patients with confirmed tk2 deficiency will be treated with open label deoxythymidine (dthd) and deoxycytidine (dcyt), which are nucleotide precursors, with the expectation that the cells could make additional mitochondrial dna. this in turn may help reduce the clinical symptoms.

mitochondrial are responsible for the production of cellular energy. mitochondria contain dna which is the encoding system ( "recipe") for making the proteins that allow the mitochondria to function. reduced amount of mitochondrial dna, caused by genetic mutations in certain genes, mitochondrial dna depletion syndrome. this can result in symptoms; such as fatigue, weakness, and deficiencies in various body systems. tk2 deficiency is considered a mitochondrial depletion syndrome. patients with tk2 deficiency have weakness and walking difficulty. they also have depleted levels of chemicals (phosphorylated deoxythymidine and deoxycytidine) used to make mitochondrial dna. based on previous studies with a similar compound, patients reported more energy and better motor skills. eligible patients include those with genetic mutations in the tk2 gene who are willing to attend several outpatient visits, and have motor skills testing, neurological exam by doctor, and blood samples.

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of tk2 deficiency * deemed by principle investigator to be symptomatic with tk2 deficiency * single gene disease; absence of polygenic disease * hematocrit within normal range for age group * patient or patient's guardian able to consent and comply with protocol requirements * presence of caregiver to ensure study compliance (if needed) * abstention from use of all pill-form dietary supplements and non-prescribed medications (except as allowed by the investigator) * abstention from use of other investigational medications or other medications according to the study investigator exclusion criteria: * clinical history of bleeding or abnormal prothrombin time (pt)/partial thromboplastin time (ptt) * hepatic insufficiency with liver function tests (lfts) greater than two times normal * renal insufficiency requiring dialysis * any other concurrent inborn errors of metabolism * severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis

Keywords: thymidine deoxycytidine
act-based nursing intervention for ovarian cancer patients: a pilot study

Conditions: Ovarian Neoplasm ; Psychological Distress

Summary: the purpose of this study is to evaluate the feasiblity and effectiveness of an acceptance and commitment therapy (act)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. data will be collected at baseline (prior to the act session), on day 8 (after one week of self-monitoring), and at 5 weeks. primary outcome is psychological flexibility.

this study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an act-based nursing intervention for distress management in patients with ovarian cancer. a total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. paticipants will receive a one-time act-based nursing intervention lasting approximately 60 minutes. the researcher will coordinate schedules with participants to deliver the act-based nursing intervention using zoom, a video conferencing platform which minimizes time and location constraints. before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session. following the single-session intervention, the researcher will send a daily google form link to participants for seven consecutive days. participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.

Eligibility criteria:
inclusion criteria: * adult (19 ≤ age ≤ 75). * ovarian cancer patients with figo stage 2-3. * those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years. exclusion criteria: * patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions. * patients with history of cancer recurrence.

Keywords: ovarian neoplasms psychological distress acceptand and commitment therapy (act) nursing intervention