Kornimate/medical-research-clean huggingface dataset:
online adaptive radiotherapy for postoperative treatment of endometrial and cervical cancer

Conditions: Uterine Cervical Neoplasm; Endometrial Neoplasms

Summary: online adaptive radiotherapy (oart) has demonstrated to be feasible to reduce planning target volume (ptv) margins for postoperative treatment of endometrial and cervical cancer. to explore the value of reduced margins in oart for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

this is an investigator-initiated efficacious, single-center, open-label clinical trial study. this study hypothesizes that the use of reduced ptv margins in oart for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. a dose of 45 or 50.4 gy is delivered to clinical target volume (ctv) with reduced margin oart. patients receive cisplatin based concurrent chemotherapy. the primary endpoint is acute toxicity. the first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (clinicaltrials.gov id: nct05682950).

Eligibility criteria:
inclusion criteria: 1. patients must be informed of the investigational nature of this study and give written informed consent before treatment. 2. postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (figo stage ivb). 3. pathological findings indicate risk factors and adjuvant radiotherapy are prescribe. 4. karnofsky score ≥ 70. 5. subjects aged ≥ 18 years and ≤ 70 years. 6. no evidence of para-aortic metastatic lymph nodes. 7. no contraindications to ct scanning. 8. subjects must be able to cooperate in completing the entire study. 9. adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/l, hemoglobin ≥ 80 g/l, platelet count ≥100\*10\^9/l. 10. normal liver and kidney function: creatinine (cr) \< 1.5 mg/dl, alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 2\*upper limit of normal (uln). exclusion criteria: 1. subjects who have received prior pelvic radiotherapy. 2. subjects with other primary malignancies. 3. subjects with contraindications to radiotherapy, as determined by the investigators. 4. any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance. 5. active infection with fever. 6. active inflammatory bowel disease.

Keywords: uterine cervical neoplasm endometrial neoplasms online adaptive radiotherapy adjuvant radiotherapy
study about contrast media

Conditions: Small Bowel Obstruction

Summary: patients hospitalized with adhesive small bowel obstruction (sbo) are randomized to 2 study groups at admission after signing an informed consent form. water-soluble contrast media (cm) will be administered after 4 or after 24 hours of nasogastric- tube decompression.

patients presenting with symptoms of small bowel obstruction (sbo) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice. if immediate surgery is needed- it will not be delayed if patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (cm) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression. contrast media challenge acquires radiographs (x-rays) to be taken after an interval (common practice) decided by the surgeon. if at any point patient needs surgery- it will not be delayed. the results are compared. the hypothesis is, that if cm is administered sooner- it will help sbo resolution

Eligibility criteria:
inclusion criteria: * patients 18 years or older * adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation * no peritonitis present, no need for an emergent surgery * patients sign an informed consent exclusion criteria: * patients younger than 18 yeas * patients with mechanical small bowel obstruction caused by incarcerated hernias * patients with mechanical small bowel obstruction caused by carcinomatosis * patients with paralytic small bowel obstruction * patients who have undergone surgery within 6 weeks * patients who do not want to be enrolled in the study
imaging non-brain electromagnetic activity in healthy adults using meg

Conditions: Chronic Pain

Summary: the primary purpose of this study is to determine the effectiveness of the magnetoencephalography (meg) instrument to record electrical activity from parts of the body other than the brain. this study will examine if electrical activity from parts of the body, other than the brain, can be imaged by the meg instrument. finding will contribute to studies of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which can be severe, yet there is no non-invasive way to image this abnormal activity. this is particularly relevant to deep muscle pain and back pain.


Eligibility criteria:
inclusion criteria: * healthy adults who are willing and able to provide informed consent. exclusion criteria: * subjects with characteristics incompatible with meg recordings as listed on the meg safety checklist (appendix a), * involuntary, uncontrolled tremor, * chronic pain. * pregnant women (based on self-report).

Keywords: magnetoencephalography whole-cortex meg system (with optional eeg)
a study of viral response to triple therapy in hepatitis c virus-infected participants with insulin resistance who failed dual therapy (mk-3034-113)

Conditions: Hepatitis C

Summary: this study is being done to find out if participants with insulin resistance and hepatitis c virus genotype 1 (hcv gt1) infections who failed dual therapy with peginterferon alfa (pegifn) + ribavirin (rbv) will benefit from the addition of boceprevir to pegifn + rbv (triple therapy).


Eligibility criteria:
inclusion criteria: * quantifiable serum hepatitis c virus-ribonucleic acid (hcv-rna) * hepatitis c virus genotype 1 * homeostasis model of assessment - insulin resistance (homa ir) \> 2.5 in two determinations made 4 weeks apart (the first homa evaluation is able to be made 3 weeks before screening visit) * previous failure to achieve svr with pegifn plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs * no response, partial response, or relapse after previous therapy * compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis * if heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject) exclusion criteria: * coinfection with hcv genotypes other than hcv-gt1 * evidence of decompensated liver disease * history of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension * history or signs or symptoms or evidence of hepatocellular carcinoma (hcc) * history of organ transplant * coinfection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * severe psychiatric disease * inadequately controlled thyroid function * other important comorbidities (cardiovascular diseases, type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc) * substances abuse * alcohol intake \>20 grams/day for females and \>30 grams/day for males * history of severe adverse events during previous treatment with pegifn plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity
study of gx-i7 in combination with pembrolizumab in refractory or relapsed (r/r) tnbc subjects(gx-i7-ca-006/keynote-899)

Conditions: Triple Negative Breast Cancer

Summary: to evaluate the safety and tolerability of escalating doses gx-i7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (orr) in subjects with refractory or relapsed tnbc


Eligibility criteria:
key inclusion criteria: 1. triple negative must be defined as guidelines of american society of clinical oncology(asco)/ college of american pathologist(cap): estrogen receptor (er) \< 1% positive tumor nuclei, progesterone receptor (pr) \< 1% positive tumor nuclei, and negative for her2 by ihc 1+, 0 or negativity status confirmed by in situ hybridization (ish). 2. subject must have received anthracycline and taxane based chemotherapy for tnbc 3. has measurable disease as defined by recist 1.1 as assessed by the the local site investigator/radiology. 4. female subjects, age ≥ 19 years at the time of consent. key exclusion criteria: 1. known severe hypersensitivity (≥ grade 3) to pembrolizumab, pembrolizumab formulation excipients or gx-i7 formulation excipients or cyclophosphamide formulation. 2. has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent or with an agent directed to another co-inhibitory t-cell receptor (ie, ctla-4, ox-40, cd137) or has previously participated in a merck pembrolizumab (mk-3475) clinical trial.

Keywords: breast cancer tnbc
clinical management of neuropathic pain with ramelteon

Conditions: Neuropathic Pain

Summary: this proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. to date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. we propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon \[a melatonin (mt) 1/ mt2 receptor agonist\] on neuropathic pain. we hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

Eligibility criteria:
inclusion criteria: 1. subject will be between ages 18 to 65 years. 2. subject has not been on ramelteon for at least one month. 3. subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). this requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study. 4. subject has a vas pain score of 5 or above at the beginning of the study. 5. subject has had a neuropathic pain condition as listed above for at least three months. this requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation. 6. female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit. exclusion criteria: 1. subject has moderate to severe liver impairment. 2. subject has liver function tests (lft's) \>1.5x normal. 3. subject has a history of renal impairment. 4. subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen. 5. subject has a history of glaucoma. 6. subject has obstructive sleep apnea. 7. subject is taking medications for sleep disorders including insomnia. 8. subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse). 9. subject has a history of dementia or delirium. 10. subject has a history of falls. 11. subject is pregnant or lactating. 12. subject is using an illicit drug detected by a screening test. 13. subject is currently taking fluvoxamine. 14. subject has been taking ketoconazole in the past two weeks. 15. subject has known hypersensitivity to ramelteon. 16. subject has pending litigation related to his/her neuropathic pain condition. 17. subject has concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.

Keywords: pain neuropathic pain pain scores
trial of flexible bracing treatment of adolescents idiopathic scoliosis

Conditions: Scoliosis

Summary: scoliosis is the three-dimensional (3d) deformity of the spine and trunk. the majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. the progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at risser stage 0, 1 or 2. however, scoliosis braces are traditionally constructed based on the experience of orthotists. since 3d spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. ai and ml methods therefore constitute a new approach to address the difficulties in designing braces.

the designs of flexible brace include: an artificial hinge bone is used to stabilize the corrective components. corrective straps are attached to the artificial hinge to exert corrective forces onto the scoliotic spine. semi-rigid silicon pads with high conformability to the body are used to enhance the corrective forces. this study is a multi-disciplinary collaborative project with experts in computer science, orthopaedics, materials science, garment technology, engineering and biomechanics. a biomechanical computational model will be developed to recommend modifications to the flexible brace design. the effectiveness of the flexible braces will be evaluated through low-dose x-ray radiography at pre-, post-expert and post-ml designed treatment. a polynomial scoring system will be created to assess the therapeutic similarity of the ml-designed flexible brace to the expert-designed flexible brace based on an estimate of the corrective forces applied through the braces. reinforcement learning with scores based on estimated pressure force will guide ai training towards superior therapeutic designs.

Eligibility criteria:
inclusion criteria: * teenagers diagnosed with adolescent idiopathic scoliosis * cobb's angle between 20 to 45 degrees * immature skeletons (risser grade 0-2) * types of scoliosis are classified by the lenke classification system * have received rigid brace treatment exclusion criteria: * contraindications for x-ray exposure * diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * history of previous surgical treatment for ais * contraindications for pulmonary and/ or exercise tests * psychiatric disorders * recent trauma * recent traumatic (emotional) event

Keywords: flexible brace
transforming health and resilience in vulnerable environments: mental health, psychosocial support, and climate-smart farming in nakivale

Conditions: Psychological Distress; Malnutrition, Child; Dietary Deficiency; Mental Health; Malnutrition

Summary: the study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. it is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in nakivale refugee settlement in uganda. the mothers will be randomly assigned to one of three groups: * control group: mothers will receive enhanced usual care (euc). * hgi group: mothers will receive the home gardening intervention, consisting of training and supplies for home gardening. * hgi/sh+ group: mothers will receive both the home gardening intervention and the self-help plus mental health intervention. the main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the euc control group. it also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. the study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). additionally, the study will assess children's well-being and functioning. children will also be asked to carry out gamified tasks designed to measure their cognitive development.


Eligibility criteria:
inclusion criteria (mothers): * psychological distress (score 5 or above on k-6) * ability to speak and understand kiswahili * have a child aged 36-59 months * availability of plot of land for farming * access of water for farming * written informed consent to enter the study exclusion criteria (mothers): * imminent risk of suicide * observable signs of psychosis * manic behaviors * intellectual disability inclusion criteria (children): * age 36-59 months * written parental consent to enter the study * assent to enter the study exclusion criteria (children): * intellectual disability * not living with mother

Keywords: self-help plus home gardening intervention uganda refugee nakivale mental health child development food security climate change adaptation climate smart agriculture farming intervention
fosamprenavir versus other protease inhibitors

Conditions: Infection, Human Immunodeficiency Virus I

Summary: this study was designed to evaluate and compare safety, tolerability of subjects who successfully suppress hiv-1 on their first pi regimen to those who switch to fosamprenavir. this is a 48-week study, where subjects who were assigned to be in their original pi-group have the option of switching to fosamprenavir on week 24. prior to being assigned their treatment group, subjects had to be suppressed for at least three months. all subjects also take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.


Eligibility criteria:
inclusion criteria: * be on your first protease inhibitor (pi) containing regimen, and the regimen must consist of a pi +/- ritonavir and 2 nucleoside/nucleotide reverse transcriptase inhibitors (n\[t\]rtis). * have a plasma hiv-1 rna level (viral load) at screening of less than 400 copies/ml, for at least 3 months prior to screening and at screening while on your current regimen of a pi +/- ritonavir + 2 n(t)rtis. * females must not be pregnant or breastfeeding or plan to become pregnant during the study. * females of child-bearing potential must agree to use one of the approved methods of birth control. exclusion criteria: * not able to follow the medication schedules and attend the study visits for the entire length of the study. * have any other illnesses, laboratory test results, medication use, allergies, or medical conditions that would make it unsafe for the subject to participate in this study. * currently be enrolled in any other research studies that could affect the subject''''s hiv-1 rna levels.

Keywords: fosamprenavir lexiva non-inferiority safety tolerability
swog-9507, fenretinide in treating patients with neoplasia of the mouth

Conditions: Head and Neck Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. the use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth. purpose: phase ii trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.

objectives: i. evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia. ii. assess the toxicity of fenretinide in these patients. outline: patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses. after 6 courses, patients receive a post-treatment biopsy. patients exhibiting disease progression or unacceptable toxicities are removed from the study. patients are followed at 3 and 6 months. projected accrual: a total of 51 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven oral mucosal intraepithelial neoplasia stage ii: moderate dysplasia, keratosis with atypia stage iii: severe keratinizing or nonkeratinizing dysplasia no myelodysplastic syndrome no retinopathies patient characteristics: see general eligibility criteria prior concurrent therapy: biologic therapy: no concurrent biologic therapy chemotherapy: no concurrent chemotherapy endocrine therapy: no concurrent endocrine therapy radiotherapy: no concurrent radiotherapy surgery: prior surgical ablation of prior dysplastic sites allowed other: at least 2 months since prior therapy toxicities patient characteristics-- age: not specified performance status: swog 0-1 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study

Keywords: lip and oral cavity cancer