Kornimate/medical-research-clean huggingface dataset:
tolvaptan open-label pilot efficacy, tolerability, and safety study in autosomal dominant polycystic kidney disease (adpkd)

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: this study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (adpkd).

autosomal dominant polycystic kidney disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys. the accumulation of these cysts causes the kidneys to enlarge several times the normal size and leads to the eventual loss of renal function and ultimately results in renal failure in end-stage patients. this is a disease with life-threatening implications to those who have it, and their family members who may also be affected. aside from early anti-hypertensive control and dietary protein restriction, which are presumed to offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality. a rationale for use of tolvaptan in these genetic disorders has been proven, in principle, through use of a variety of animal models. in these models, tolvaptan is effective in halting or reversing the progression of this renal disease. the current study is being undertaken in order to evaluate whether tolvaptan, an oral vasopressin v2 receptor inhibitor, will maintain an adequate safety profile and show a potential clinical benefit by reducing total renal volume in the hopes of making an impact upon disease progression.

Eligibility criteria:
inclusion criteria: * prior participation in designated tolvaptan adpkd studies (156-04-248, 156-04-249). * able to give informed consent. exclusion criteria: * women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods. * in the opinion of the study investigator or sponsor may present a safety risk. * patients who are unlikely to adequately comply with study procedures. * patients who at day 1 have an estimated glomerular filtration rate (gfr) below 30 ml/min or who anticipate renal-replacement therapy within one year of study entry. * patients having contraindications to magnetic resonance imaging (mri) or gadolinium contrast will be eligible but will not be able to participate in mri. * patients taking a diuretic within 1 week of enrollment or likely to need diuretic therapy prior to month 2.
efficacy & safety study of nasalfent (fentanyl citrate nasal spray) for treatment of breakthrough cancer pain in patients taking regular opioids

Conditions: Cancer Pain

Summary: cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. nasalfent contains fentanyl in a patented drug delivery system called pecsys and is given via a simple nasal spray. this study will test the efficacy and safety of nasalfent in the treatment of breakthrough cancer pain.

current treatments for breakthrough cancer pain (btcp) work too slowly to meet the fast onset of most btcp episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. in addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. the nasal route is a common way to administer medication for example in the treatment of migraine or allergy. at any time during the study the patient may take their regular treatment for btcp should they so wish. this study will compare the time of onset and degree of pain relief of nasalfent to that of placebo. the safety of the two treatments groups (nasalfent, placebo) will also be examined.

Eligibility criteria:
inclusion criteria: * able and willing to give consent * women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception * diagnosis of cancer * taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain * experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication * able (or via caregiver)to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary * able to be up and about for 50% of the day or greater exclusion criteria: * intolerance to opioids or fentanyl * rapidly increasing/uncontrolled pain * pain that is not cancer related

Keywords: pain cancer
subretinal macugen® for neovascular age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to assess the efficacy of pegaptanib (macugen®) for neovascular (exudative) age-related macular degeneration (amd) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the amd was deemed ineffective.


Eligibility criteria:
inclusion criteria: * adults aged 50 years and older with neovascular amd proven by fa * patients who at baseline * have a bcva letter score in the study eye between 20/40 to 20/320 using an etdrs chart measured at 4 meters or snellen equivalent * have a cnv lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: * evidence that cnv extends under the geometric center of the foveal avascular zone. * previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given: * loss of visual acuity (2 or more snellen lines) in the previous 3 months defined as either or * ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months * ability of subject to understand character and individual consequences of clinical trial. * signed and dated informed consent of the subject must be available before start of any specific trial procedures. * women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry). exclusion criteria: * subjects presenting with any of the following criteria will not be included in the trial: * have a relevant ocular disease which may be associated with increased intraocular vegf levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion) * had previous vitrectomy surgery for whatsoever reason * are not pseudophakic * have a \>50% area of scarring of the whole cnv lesion size as seen in fa * arterial hypertension refractory to medical treatment * pregnancy and lactation. * history of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. * participation in other clinical trials during the present clinical trial or within the last 3 months. * medical or psychological condition that would not permit completion of the trial or signing of informed consent. * suspected or present ocular or periocular infection

Keywords: age-related macular degeneration subretinal injection pegaptanib macugen
intraosseous vs submucosal injection of dexamethasone

Conditions: Tooth, Impacted

Summary: thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. all surgeries were performed by one surgeon. postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7. swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper. early healing of periodontal soft tissue wound was assessed by using early wound healing score (ehs) which composed of 3 parameters: clinical signs of re-epithelization (csr), clinical signs of hemostasis (csh), and clinical signs of inflammation (csi) and were assessed on postoperative days 1, 7, and 14. mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.


Eligibility criteria:
inclusion criteria * patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the pell and gregory classification 1933) * healthy patient (american society of anesthesiologists class i status) * patient age range from 18 to 40 years old. * patient without any local inflammation or pathology. * patient who will able to understand verbal and written instructions. exclusion criteria * pregnant or breast-feeding women. * patient had anti-inflammatory drugs within 2 weeks before the procedure. * patient under radiotherapy or chemotherapy. * habits (heavy smoking and alcoholic). * allergy to drugs used in this study. * patient under anticoagulant or corticosteroid therapy.
a study comparing viscosupplementation and corticosteroid injections for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?

objectives primary i. to determine if patients' vas "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (mpa) versus patients who receive a single injection of hylan g-f 20 (synvisc one™) for treatment of knee oa. secondary i. to determine if differences in vas "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between mpa and ha patients. ii. to determine if differences in vas "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between mpa and ha patients. iii. to determine if differences in vas "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between mpa and ha patients. iii. to determine if differences in koos questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between mpa and ha patients. iv. to determine if differences in womac questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between mpa and ha patients. v. to determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between mpa and ha patients. vi. to track the number of patients who receive additional injections after 3 months following their index injection.

Eligibility criteria:
inclusion criteria: * clinical * 19-75 years of age (inclusive) * symptomatic oa (1 of the following: pain, stiffness, or swelling) * evidence of grade i, ii or iii oa on radiographic images according to kellgren-lawrence grading scale. exclusion criteria: * clinical * previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy) * intra-articular treatment within the last 3 months * ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity * inflamed knee or pronounced effusion * allergy to birds, eggs, avian proteins or known ha or corticosteroid * venous or lymphatic stasis * skin condition in the injection area * evidence of infection in the affected joint * history of crystalline arthropathy or inflammatory arthritis * pregnant or nursing * third party, medical legal or workers' compensation board * patient unable to understand english or unable to providing informed consent

Keywords: oa of knee osteoarthritis of knee viscosupplementation and osteoarthritis viscosupplementation and oa hyaluronic acid corticosteroid injection versus hyaluronic acid synvisc one and knee oa viscosupplementation and knee pain knee pain from oa
hemostatic powder versus clinical management for the treatment of upper gastrointestinal bleeding from tumor lesions

Conditions: Gastrointestinal Hemorrhage; Gastrointestinal Neoplasms

Summary: this study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper gi tract. half of participants will receive hemostatic powder and half will be submitted to standard treatment.

gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. several endoscopic hemostasis techniques have been tested, but results were disappointing. re-bleeding and mortality rates are still high. hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.

Eligibility criteria:
inclusion criteria: * any kind of malignancy * gastrointestinal bleeding in the last 48 hours * referred to emergency endoscopy exclusion criteria: * under 18 years old * bleeding from non malignant lesions * previous endoscopic treatment with another method done in the last 48h

Keywords: endoscopy, gastrointestinal
dm-boost para latinx: a diabetes mellitus program using behavioral economics to optimize outreach and self-management support with technology for latinx patients

Conditions: Diabetes Mellitus, Type 2

Summary: the specific aims of this project are to culturally adapt the dm-boost intervention for latinx patients, usability test 'dm-boost para latinx' to optimize cultural appropriateness and patient engagement and conduct a feasibility evaluation of dm-boost para latinx. these aims will be accomplished via a community-based participatory research approach in collaboration with clinical, community and patient partners. this project will inform subsequent proposals to evaluate implementation of dm-boost in the umass memorial health care system.


Eligibility criteria:
aims 1 and 2 patient inclusion criteria: * age \> 18 years * diagnosis of type 2 diabetes * identifies as hispanic/latinx * spanish language preference aims 1 and 2 patient exclusion criteria: * cognitive impairment * current prisoner * pregnant women aim 3 patient inclusion criteria: * age \> 18 years * diagnosis of type 2 diabetes * identifies as hispanic/latinx * spanish language preference aim 3 patient exclusion criteria: * cognitive impairment * current prisoner * pregnant women * completed dsmt in previous year
complement component 3c and tumor necrosis factor-α in patients with human papillomavirus-induced cutaneous warts

Conditions: Warts

Summary: the investigators explore the role of the complement pathway and t helper 1 immune response in clinical response to candida immunotherapy via complement component and tumor necrosis factor, respectively.

39 patients are enrolled in the study they suffer from chronic recurrent cutaneous warts patients receive candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions blood samples are withdrawn before and after intervention c3, c4, mbl, c3c and tnf alpha serum levels are measured

Eligibility criteria:
inclusion criteria: * chronic multiple cutaneous exclusion criteria: * hypersensitivity to candida antigen * fever * immunosuppressive disorders * previous wart therapy in the last month
correlation of fecal microbiome and its metabolites with outcome of radiotherapy in head and neck carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. in this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.

head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors. comrad-hnscc is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. the composition of gut microbiota will be analysed by ribosomal dna high-throughput amplicon sequencing of the dna isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples. the long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.

Eligibility criteria:
inclusion criteria: * signed written and voluntary informed consent. * patient must be willing and able to provide collection for stool specimen analyses at 2 time points. * age \> 18 years, male or female. * patient must be diagnosed with histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx). * patients must be eligible for curative-intent treatment with either radiotherapy or concurrent chemo-radiotherapy. * overall disease stage iii-iv based on 8th edition of american joint committee on cancer staging system. exclusion criteria: * receipt of induction chemotherapy. * presence of distant metastases. * any previous head and neck cancer. * any other known concurrent malignant disease. * any condition that, in the opinion of the investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.

Keywords: radiotherapy microbiome metabolites
feasibility and efficacy of physical literacy screening integration into pediatric clinical settings

Conditions: Pediatric ALL; Motility Disorder

Summary: the proposed research will be the first study to investigate the feasibility of incorporating physical literacy screening into primary care clinical settings, while determining the efficacy of integration on physical literacy. to investigate aim 1, feasibility, the research team will provide all children ages 6-11 presenting for well-child care by the participating pediatricians with physical literacy screening (pavsped) at point of entry for care. the child will complete the 5 yes/no screen and answers will be provided to the pediatrician for acknowledgement. to investigate aim 2, efficacy, participants will be randomized into a control group (standard of care) or an intervention group (patient education). the intervention group will receive the patient education document with their questionnaire, randomization will occur by the study team prior to subject visits. the patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/pt (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)). all participants will receive a 6-month follow-up email with the same 6 questions to assess if responses changed between the two groups.


Eligibility criteria:
inclusion criteria: * • children 6-11 years presenting for an annual well-child appointment at longwood pediatrics exclusion criteria: * • children with physical handicaps or other significant health problems that would preclude physical activity involvement.
gp chemotherapy in combination with tislelizumab and ociperlimab as first-line treatment in advanced btc

Conditions: Intrahepatic Cholangiocarcinoma

Summary: this is an open label, multi-center, phaseⅱstudy to evaluate the efficacy and safety of gp (gemcitabine/cisplatin) in combination with tislelizumab and ociperlimab as first-line treatment in participants with unresectable advanced biliary tract carcinoma (btc).

biliary tract carcinoma (btc) have insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. for patients with advanced btc, systemic therapy is currently the main choice, and gemcitabine/cisplatin (gp) is currently the "gold standard" for first-line treatment of advanced btc, but the efficacy is still unsatisfactory, and more and more clinical practice has found that gp-based combination therapy may have better efficacy. previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. this study is to explore the efficacy and safety of gp in combination with anti-pd1 antibody (tislelizumab) and anti-tigit antibody (ociperlimab) as first-line treatment in participants with unresectable advanced btc.

Eligibility criteria:
inclusion criteria: * • subjects with a histopathological or cytologically diagnosis of btc * the participants must be required to sign an informed consent * at least one measurable lesion (recist 1.1) * no previous systematic treatment for btc * child-pugh score, class a * ecog performance status 0 or 1 * adequate organ function * life expectancy of at least 3 months exclusion criteria: * • diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma * known history of serious allergy to any monoclonal antibody * known central nervous system metastases and/or leptomeningeal disease prior to treatment * portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment * any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * any active malignancy prior to the start of treatment * active or history of autoimmune disease * other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * pregnant or lactating women