Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial of de-intensified therapy in human papilloma virus (hpv) associated oropharyngeal squamous cell carcinoma

Conditions: OPSCC; Oropharyngeal Squamous Cell Carcinoma (SCC); HPV Associated Cancers

Summary: hpv-associated oropharyngeal squamous cell carcinoma (opscc) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. the treatments for opscc, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. these side effects can lower patients' quality of life and make it difficult for them to eat and speak normally. this study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with hpv-positive opscc. by doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.


Eligibility criteria:
inclusion criteria: * histologically confirmed or suspected hpv associated squamous cell carcinoma of the oropharynx. * p16 immunohistochemistry is the surrogate marker for hpv positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (a negative result excludes the patient from the trial) * in the case of equivocal p16, high risk hpv (hr hpv), in-situ hybridization (ish) / polymerase chain reaction (pcr) may be performed to determine hpv positivity * ajcc tnm 7th edition stage t1-t3, n0-n2b (or ajcc tnm 8th edition stage t1-t3 n0-n1) disease. * staging will be based on cross sectional imaging investigations and clinical exam. * patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study. * multidisciplinary team decision to treat with primary transoral resection and neck dissection. * patients considered fit for surgery and adjuvant therapy. * aged 18 or over. * written informed consent provided. exclusion criteria: * hpv negative squamous cell carcinomas of the head and neck * t4 and/or t1-t3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins. * ajcc tnm 7th edition n2c-n3 nodal disease (or ajcc tnm 8th edition n2-n3 nodal disease) or high likelihood of gross extranodal extension. * patients for whom transoral surgery and neck dissection is not considered the primary treatment modality. * distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. ct thorax and upper abdomen or pet ct. * women who are pregnant or breastfeeding * prior history of radiation to head and neck

Keywords: radiation de-intensify
a study of [68ga]ga-nota-rg2 pet imaging in the diagnosis of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the aim of this study was to establish and optimize the imaging method of \[68ga\]ga-nota-rg2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma patients 1. age between 18 and 65 years old, gender is not limited. 2. patients with suspicious intrahepatic spaces detected by mr and considered to be hepatocellular carcinoma with afp\>200 ug/l who have not undergone surgery. 3. patients with hepatocellular carcinoma confirmed by puncture pathology 4. written informed consent must be signed by the subject or his/her legal guardian or caregiver. 5. willingness and ability to cooperate with all programs of the study. exclusion criteria: * subjects meeting any of the following criteria will be excluded from the study: 1. patients receiving anti-tumor therapy prior to the pet/ct scan. 2. suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases. 3. alternative subjects with conditions that contraindicate pet/ct scanning. this includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias. 4. within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 msv. 5. alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month 6. the alternate subject has any clinical condition that, in the opinion of the sponsor of this study, may cause or has the potential to cause harm from this agent.

Keywords: hepatocellular carcinoma positron-emission tomography
characterization of radiolabeled tracer uptake pattern in noninfected transcatheter aortic valves.

Conditions: Infective Endocarditis

Summary: therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18f-fdg) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (tavr).

diagnostic accuracy of infective endocarditis (ie) is commonly challenging. current clinical guidelines recommend the use of the modified duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of ie. thus, recent works have demonstrated that 18f-fdg pet/ct and radiolabeled leucocyte spect/ct may improve the detection of silent endocardial lesions. the sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. it is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. however, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. the hypothesis is that patients undergoing transcatheter aortic valve replacement (tavr) show a radiolabeled tracer (18f-fdg) uptake around the prosthesis despite the absence of ie. moreover, the uptake pattern might vary between different platforms. therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after tavr. this will be a pilot study including 30 patients after tavr procedure.

Eligibility criteria:
inclusion criteria: * patients \>18-year-old undergoing tavr procedure with edwards sapien 3 and core valve evolut r devices. * informed written consent exclusion criteria: * inability to provide signed informed consent. * patients with definitive or possible ie according to modified duke criteria and current clinical guidelines for the management of ie. * any contraindication for 18f-fdg pet/ct. * any condition making it unlikely the patient will be able to complete the protocol procedures and follow-up visits.

Keywords: transcatheter aortic valve replacement infective endocarditis radionuclide imaging radiolabeled tracer uptake pattern
pf-06741086 multiple dose study in severe hemophilia

Conditions: Hemophilia A or B

Summary: this study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of pf-06741086 in subjects with severe hemophilia.


Eligibility criteria:
inclusion criteria: * severe hemophilia a or b (factor viii or factor ix activity ≤ 1%), including patients with inhibitors to factor viii or factor ix * episodic (on-demand) treatment regimen prior to screening * at least 6 acute bleeding episodes during the 6-month period prior to screening exclusion criteria: * known coronary artery, thrombotic, or ischemic disease * currently receiving treatment for acute bleeding episodes with apcc and cannot substitute treatment with rfviia

Keywords: hemophilia
expanded access to bezuclastinib to be coadministered with sunitinib for patients with gastrointestinal stromal tumors

Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

Summary: the purpose of this expanded access program (eap) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (gist) with no comparable or satisfactory alternative therapy options. the combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary kit mutations that commonly occur in gist.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent and commit to recommended eap assessments. * ≥18 years of age. * able to swallow tablets. * histologically confirmed locally advanced, metastatic, and/or unresectable gist. * intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable gist that resulted in disease progression. * meet clinically acceptable local laboratory results. exclusion criteria: * patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial. * prior or known intolerance to sunitinib. * patients who have previously participated in a bezuclastinib clinical trial. * patients with persistent \> grade 2 toxicities from prior therapy. * known pdgfr driving mutations or known sdh deficiency. * pregnant or currently breastfeeding. other protocol-defined criteria apply.

Keywords: solid tumors sunitinib bezuclastinib gastrointestinal stromal tumors
wash benefits child development follow up

Conditions: Child Development; Maternal Depression

Summary: the purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. this study is a follow-up assessment of the children and mothers enrolled in the wash-benefits bangladesh study.

globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. in low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. water, sanitation and hygiene (wash) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. a recent cluster-randomized controlled trial (crct) in bangladesh (wash-benefits, or wash-b, clinical trials.gov identifier: nct01590095), found that improvements in wash or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households. this follow-up study, funded by the bill \& melinda gates foundation, includes assessments of the children and caregivers originally enrolled in the wash benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. the original wash benefits intervention enrolled pregnant women between may 31, 2012, and july 7, 2013. the goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the wash benefits trial.

Eligibility criteria:
inclusion criteria: * enrolled in the wash-benefits bangladesh intervention exclusion criteria: * no exclusion criteria

Keywords: child development wash nutrition
combined repetitive transcranial magnetic stimulation and robot-assisted upper arm training in subacute stroke patients

Conditions: Stroke

Summary: this study was designed to establish the clinical evidence for effect of robot-assisted upper arm training and repetitive transcranial magnetic stimulation on upper limb function of subacute stroke patients. * purpose : to elucidate the effect of robot-assisted upper arm training and repetitive transcranial magnetic stimulation on upper limb function of stroke patients compared to conventional occupational therapy * subjects : total 99 patients with stroke whose upper limb functions are impaired * intervention : 4 weeks of therapy (5 days per week) * studies : upper limb functional assessment (fma, mft, wmft), computerized motion analysis * evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention


Eligibility criteria:
inclusion criteria: * upper fma 7-38 * hemiplegic patients within 6months after stroke onset * male or female, 20 years older exclusion criteria: * patients with cognitive impairment who are unable to comply with protocol-required procedure * quadriplegic or double hemiplegic patients * patients with musculoskeletal disease, peripheral nerve disease in upper extremity * patients with lower motor neuron disease * patients who cannot perform rtms * pregnant woman
a spinal functional magnetic resonance imagine (fmri) study of resting-state, motor task and acupoint stimulation

Conditions: Cerebral Infarction

Summary: the spinal cord is a very important part of the central nervous system. fmri can be applied to observe functional status of the human spinal cord. under different conditions, the investigators will see different types of fmri signals within the spinal cord. in resting state, the investigators might see active/inactive signals, too.


Eligibility criteria:
inclusion criteria (for healthy people): * chinese male residents * right handed * no history of psychological/psychotic problems * no history of important diseases exclusion criteria (for healthy people): * with factors which make subjects unsuitable to receive mr examination * history of important diseases inclusion criteria (for patients): * chinese male patients with ischemic stroke (ct/mri scan confirmed) * right handed * at least 1.5 months from onset of stroke * ability to follow complex commands exclusion criteria (for patients): * hemodynamic instability * history of dementia * inability to give consent because of impaired cognition or receptive aphasia * diseases in spine/spinal cord * with factors which make subjects unsuitable to receive mr examination

Keywords: fmri spinal cord human health cerebral infarction healthy
impact of ilm peeling in rrd/ i-peel

Conditions: Retinal Detachment

Summary: retinal detachment is associated with a substantial risk of re-detachment in 10-20% and to the formation of secondary epiretinal membranes in up to 15%. relevant postoperative vision loss is encountered in many instances, primarily in consequence of macular involvement, but also secondarily due to postoperative complications, namely the formation of an epiretinal membrane and proliferative vitreoretinopathy. these mechanical reasons of influence can potentially be prevented by ilm peeling during reattachment surgery. this, however, is not a generally accepted standard of care during primary routine vitrectomy. two groups suffering from primary retinal detachment will be compared: the first group will receive standard re-attachment vitrectomy surgery, whereas the second group will receive an identical vitrectomy surgery, but with additional ilm peeling. in this study, the investigators wish to assess the influence of ilm peeling on visual outcomes and postoperative complications over 12 months.


Eligibility criteria:
inclusion criteria: * primary rhegmatogenous retinal detachment * of legal age (18 years or older) * in case of bilateral retinal detachment, only the first-affected eye will be included exclusion criteria: * pre-existing functional and morphological changes to the macula, hindering visual recovery (amblyopia, trauma, macular degeneration) * advanced retinal detachment with pvr stage c2 or more * eyes pre-operated within six months prior to the development of rd * state after any vitreoretinal surgery * state after complicated cataract surgery, including aphakia and anterior chamber lens implantation * patients with increased risk profiles * myopia magna (≥7 diopters) * advanced diabetic retinopathy * any chronic ocular or systemic inflammatory disease * any other proliferative systemic disease or condition associated with impaired wound healing

Keywords: retinal detachment ilm-peeling
fluoroglutamine pet/ct in imaging patients with malignant tumor

Conditions: Cancer; Metastatic Cancer; Metastatic Brain Cancer

Summary: this clinical trial studies positron emission tomography (pet) imaging utilizing 18f-(2s,4r)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. \[18f\]fluoroglutamine pet may provide additional information that help diagnose and stage cancer patients.


Eligibility criteria:
inclusion criteria: * age between 18-79; * the patient must be able to give informed consent; * patients can finish pet/ct scan without tranquilizers; * patients with pathology-proven cancer or a tumor highly suspected to be malignant ; * lesions can be measured and assessed at the recist 1.1 standard; * no chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18f-fdg and the 4-\[18f\]fluoroglutamine pet/ct. exclusion criteria: * pregnant or lactating patients; * inability or refusal to have at least one peripheral intravenous line for intravenous access; * from assays obtained \ 1.5\*uln,ast/alt \>2.5 \* uln, albumin\ 2.5 x uln if alp\> 2.5 x uln, creatinine\>1.5\*uln or creatinine clearance \<60ml/min； * patients with a history of allergic reaction to this drugs or its analogues； * patients with poor compliance; * acute major illness
clinical trial of pegylated interferon α-2b via nebulization for treatment of hand, foot, and mouth disease .

Conditions: HFMD

Summary: this is a multicenter clinical trial investigating the safety and efficacy of inhaled peginterferon α-2b at different doses, in combination with supportive care, for the treatment of patients with hand, foot, and mouth disease (hfmd) of ordinary type. the trial aims to enroll 90 patients with hfmd. eligible subjects will be randomly assigned to receive either supportive care + peginterferon α-2b mcg or supportive care + peginterferon α-2b 90 mcg, administered on days 1 and 3. the study period includes a 3-day screening phase and a 5-7 day inpatient visit period. the results of this trial will be used to evaluate safety and efficacy.


Eligibility criteria:
inclusion criteria: -1. age: 1 year of age ≤ age ≤ 6 years of age. 2.gender: both male and female. 3.clinical symptoms/signs: manifesting as common type hfmd (stage 1, rash stage), with fever or rash symptoms first occurring within 72 hours prior to the signing of the informed consent form. 4.informed consent: guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign). exclusion criteria: * (1) severe or critical hfmd presentation at enrollment 1. manifesting as severe hfmd (stage 2, neurological involvement phase) 2. manifesting as critical hfmd (stage 3 or 4, cardiopulmonary failure phase) with any of: brainstem encephalitis, encephalomyelitis, or meningitis,neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,shock or circulatory collapse. 3. concurrent multi-organ failure requiring icu monitoring (2) allergy history and treatment history 1. received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use 2. received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use 3. known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation 4. use of other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to screening, or current participation in medical device trials (3) medical history 1. congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases 2. active hbv, hcv, hiv, or treponema pallidum infection 3. history of malignant tumors (current or prior) 4. history of epilepsy, neurological/psychiatric disorders, or relevant family history (4) clinical parameters: resting respiratory rate \>40 breaths/min,heart rate \>160 bpm (5) other considerations: any condition deemed by investigators to render participation medically inadvisable

Keywords: peginterferon α-2b injection hfmd
chemotherapy combined with adebrelimab and mecapegfilgrastim in neoadjuvant treatment of potentially resectable btc

Conditions: Biliary Tract Neoplasms

Summary: the purpose of this study is to assess the safety and efficacy of gemcitabine/cisplatin combined with adebrelimab and mecapegfilgrastim in neoadjuvant treatment of potentially resectable biliary tract neoplasms.

after being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be receive gemcitabine/cisplatin combined with adebrelimab and mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

Eligibility criteria:
inclusion criteria: * male or female * age ≥ 18 years，≤ 75 years * patients with untreated resectable locally advanced biliary tract cancer (btc) who are difficult to directly resecte surgically * ability to provide written informed consent prior to participation in any study-related procedure * eastern cooperative oncology group (ecog) performance status 0-1 * at least one, not previously irradiated, measurable lesion according to recist (version 1.1). * adequate organ function exclusion criteria: * diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma * known history of a serious allergy to any monoclonal antibody * 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
swan: study on the tolerance and efficacy of a new anti-regurgitation formula (pc-2016-01)

Conditions: Gastroesophageal Reflux

Summary: the aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation


Eligibility criteria:
inclusion criteria: * infants : * aged ≤ 5 months old * fully formula fed * with at least 5 episodes of regurgitation per day, for at least a week exclusion criteria: * breast fed infants * infants presenting symptoms of a complicated gastroesophageal reflux * infants presenting intestinal disorders