Kornimate/medical-research-clean huggingface dataset:
safety study of preservon-treated bone implants for cervical fusion in the treatment of cervical radiculopathy or myelopathy

Conditions: Cervical Radiculopathy; Myelopathy

Summary: the purpose of this study is to compare the safety and efficacy of preservon(tm) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy. patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. at 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. patients will complete questionnaires and x-rays taken at each visit. the degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. the x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.


Eligibility criteria:
inclusion criteria: * patient is skeletally mature * patient has confirmed radiculopathy or myelopathy * pain unresponsive to non-operative treatment * radicular pain in either or both upper extremities * neurological deficit in distribution of nerve root from c3/4 to c6/7 * patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused * patient agrees to comply with protocol * patient can provide voluntary informed consent and follow-up information exclusion criteria: * patient has previous cervical spine surgery * patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level * patient has clinically compromised vertebral body structure * patient has multi-level fixed/ankylosed cervical spine * patient has signs of significant instability at level to be treated or adjacent level * patient has history of metabolic bone disease * patient is taking chronic oral/iv corticosteroid therapy or medications that potentially interfere with bone/soft tissue healing * patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, or any other condition that interferes with self-assessment of pain, function, or quality of life * patient has opll at any level * patient has active infection, local or systemic * patient is pregnant or considering pregnancy (x-ray requirements) * patient is participating in another investigational study * patient belongs to vulnerable population

Keywords: cervical fusion anterior cervical discectomy and fusion acdf
ondansetron plus dexamethasone with or without metoclopramide as antiemetic prophylaxis after receiving cisplatin

Conditions: Cancer

Summary: the objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Eligibility criteria:
inclusion criteria: * schedule to receive first cycle of cisplatin \> 50 mg/m\^2 * pathologically or histologically confirmed solid cancer * more than 18 years old * creatinine clearance more than 50 ml/min * aminotransferase less than 2 times of upper normal limit exclusion criteria: * pregnant woman * patients with episode of vomiting within 24 hours prior to chemotherapy session * gut obstruction * brain metastasis * abdominal or pelvic irradiation * no history of allergy to study drugs

Keywords: chemotherapy induced nausea and vomiting, metoclopramide
phase 2 study evaluating rapcabtagene autoleucel in participants with severe active gpa or mpa

Conditions: ANCA Associated Vasculitis (AAV)

Summary: the purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa)

this is a phase 2, randomized, assessor-blinded active controlled study. this study comprises two cohorts: * a lead-in cohort enrolling participants to receive rapcabtagene autoleucel * a randomized cohort with participants receiving either rapcabtagene autoleucel or comparator. after end of study (eos), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (ltfu) period lasting up to 15 years after rapcabtagene autoleucel infusion. this ltfu will be described in a separate study protocol.

Eligibility criteria:
key inclusion criteria: 1. men and women, aged ≥18 and ≤ 75 years with a diagnosis of gpa or mpa according to the american college of rheumatology/ european league against rheumatism 2022 (acr/eular 2022) classification criteria 2. positive test for anca-autoantibodies 3. gpa and mpa participants with severe active disease key exclusion criteria: 1. any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-cd19 car-t therapy and further participation in the study 2. hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol 3. other systemic autoimmune diseases requiring therapy 4. any medical conditions that are not related to gpa/mpa that would jeopardize the ability of the participant to tolerate cd19 car-t cell therapy 5. inadequate organ function

Keywords: chimeric antigen receptor-t (car-t) rapcabtagene autoleucel anti-neutrophil cytoplasmic antibody (anca) anca-associated vasculitis/vasculitides (aav) granulomatosis with polyangiitis (gpa) microscopic polyangiitis (mpa)
endometriosis pelvic pain interdisciplinary cohort data registry

Conditions: Endometriosis

Summary: the purpose of this data registry is to prospectively collect data from patients referred to an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and endometriosis.

the bc women's centre for pelvic pain and endometriosis is the tertiary referral centre for endometriosis/pelvic pain in british columbia, canada. the centre offers a unique interdisciplinary approach including minimally invasive surgery, hormonal and other medical therapy, pain education, physiotherapy, and cbt/mindfulness. after informed consent, patients prospectively consent to data collection in the online registry. the registry consists of patient intake questionnaires (including validated measures), physical and ultrasound examination, review of medical records, surgical findings, and annual outcomes to 5 years. the online data registry is housed in the research electronic data capture (redcap) platform located at bc children's hospital.

Eligibility criteria:
inclusion criteria: * all new and re-referred patients at the bc women's centre for pelvic pain and endometriosis. exclusion criteria: * patients at the bc women's centre for pelvic pain and endometriosis seen for reasons other than chronic pelvic pain and/ or endometriosis as well as patients who decline to complete the online questionnaire.

Keywords: endometriosis chronic pelvic pain dyspareunia
acceptability and feasibility of cognitive behavioral therapy for treatment-seeking (cbt-ts) with deaf individuals

Conditions: Mental Health Issue; Alcohol Use Disorder; Depression; Anxiety; Insomnia; Post Traumatic Stress Disorder

Summary: the current study aims to assess the acceptability and feasibility of an adapted version of cognitive behavioral therapy for treatment seeking (cbt-ts) for use with signing deaf adults. this is a stage 1a intervention refinement study consisting of a single-arm open pilot trial. thirty deaf adults with clinically significant symptoms of alcohol use disorder (aud), post-traumatic stress disorder (ptsd), depression, anxiety, and/or insomnia, who are not currently engaged in treatment will be recruited from across the united states. all subjects will complete a baseline assessment of their behavioral health symptoms, perceptions towards treatment, and intent to seek treatment prior to engaging in the adapted cbt-ts intervention. the primary clinical outcome, assessed at one-month follow-up, will be whether subjects scheduled professional treatment. secondary outcomes include changes in subjects' perceptions towards treatment, intentions to seek treatment, and symptom severity from baseline. during the one-month, follow-up assessment subjects will also complete a client satisfaction survey and open-ended questions to provide feedback about the cbt-ts intervention.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * self-identify as deaf or hard-of-hearing (any degree of hearing loss) * primary method of communication is asl or pse * positive screen for one or more behavioral health disorders including: aud (audit \> 16 and alcohol use in the past 30 days exceeds the limit for low-risk drinking established by the niaaa), ptsd (pcl-5 \> 31), depression (phq-9 \> 10), anxiety (gad-7 \> 10), or insomnia (isi \> 15) * no current behavioral health treatment per standardized self-report * access to video chat technology with internet and webcam. exclusion criteria: * unable to communicate with the researcher in asl or pse * current alcohol withdrawal necessitating medical evaluation * current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others) * unable to comprehend the nature of the study * currently receiving behavioral health treatment for their symptoms.
improving inpatient screening for hepatitis c

Conditions: Hepatitis C

Summary: this study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis c (hcv) screening.

the hepatitis c virus (hcv) is the leading cause of liver transplant and hepatocellular carcinoma in the united states, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. the centers for disease control and prevention (cdc) estimate that 75% of all chronic hcv infections in the united states are among adults born between 1945 and 1965. the cdc and us preventive services task force (usptf) therefore recommends birth cohort screening for all adults born in this time period. in 2016, the commonwealth of pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered hcv screening. in this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting hcv screening into the admission order set to improve screening rates.

Eligibility criteria:
inclusion criteria: * be admitted to the hospital of the university of pennsylvania (hup) or penn presbyterian medical center (ppmc) * born between 1945 and 1965 exclusion criteria: * patients will be excluded if they have already received hepatitis c screening or have been previously diagnosed with hepatitis c.

Keywords: hepatitis c hcv screening nudge defaults
effect of pentoxifylline on cognitive impairment after ischemic stroke

Conditions: Cognitive Impairment

Summary: pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. the patients with cognitive impairment and non-dementia pscind after ischemic stroke were randomly divided into two groups. in addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic pscind. it is expected to explore the possible internal biological mechanism by using transcranial doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke.

pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function.

Eligibility criteria:
inclusion criteria: * han chinese, age 40-80 years old, male and female, right-handed; * the diagnosis is consistent with the expert consensus on the management of cognitive impairment after stroke 2021; * nihss score 1-15 points; * daily living ability scale (adl) ≥75 score; * the informed consent signed by the patient or his legal representative exclusion criteria: * can not cooperate with the examination (including neuropsychological tests and scale assessment); * there were memory disorders, dementia with lewy bodies and frontotemporal dementia before the onset of stroke events; * there were definite infectious diseases 2 weeks before admission; have a serious mental illness, previous history of cancer, alcohol or drug abuse; * use of drugs that may affect cognitive function, including sedatives, anti-anxiety drugs, hypnotics, nootropic drugs, and cholinoid drugs; * can not accept brain mri examination
multicenter, randomized placebo-controlled clinical trial to evaluate the effect of perioperative use of tranexamic acid on transfusion requirements and surgical bleeding in major spine surgery

Conditions: Spinal Fusion; Antifibrinolytic Agents; Hemorrhage; Blood Transfusion

Summary: current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery. objectives: to evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. to evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period. methods: multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. the main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old of both sexes * scheduled for complex spine surgery * asa i-iii * weighing more than 30 kg * body mass index \<30 kg/m2 * operated on in the participating hospitals * major spinal surgery * signed an informed consent form to be included in the study exclusion criteria: * a history of allergy or hypersensitivity to the agent used * receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents) * a history of frequent bleeding * plasma creatinine values \>1.5 mg/dl in the baseline analysis * platelet count less than 150,000/mm3 in the follow-up analysis * abnormal prothrombin time (inr \>1.5) or partial thromboplastin time (inr \>1.5) * a history of a thromboembolic episode before surgery * family history of thromboembolism * lack of consent to participate in the study * infectious disease, tumor or trauma of the spine as the reason for surgery * scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day

Keywords: spinal deformity correction surgical bleeding transfusion practice spinal fusion antifibrinolytic agents hemorrhage blood transfusion
surgery vs. casting for displaced articular radius fractures in elderly

Conditions: Radius Distal Fracture

Summary: objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.

rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. to ensure optimal functional outcome there is a tendency to operate. however, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated. study design: multi-center randomized controlled trial with a non-inferiority design. economic evaluation alongside a randomized controlled multi-center trial. study population: all consecutive patients aged between 65 years and older with displaced intra-articular (ao type c) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma. intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group). main study parameters: the primary outcome will be evaluated after 1 year with the patient-rated wrist evaluation score (prwe). secondary outcomes comprise other patient reported outcome measures (prom) including the disability of the arm, shoulder and hand (dash), quality of life (eq-5d) and pain catastrophizing scale (pcs). further outcome measurements comprise a costs evaluation questionnaire, range of motion (rom), grip strength, radiographic parameters and complications.

Eligibility criteria:
inclusion criteria: * \> 65 years at time of trauma * intra-articular distal radius fracture (ao type c\*) * one or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation): ≤15° inclination \ 15° dorsal tilt \>20° volar tilt intra-articular gap or step-off \>2 mm * \< 3 weeks post trauma * living independent * fit for surgery * mentally competent * dutch fluency and literacy * informed consent exclusion criteria: * open fractures * neurovascular damage * multiple-trauma patients (iss \>16) * other fractures in the injured extremity other than ulnar styloid process fractures

Keywords: elderly intra articular rct
zoledronic associated with hight hypofractionated radiotherapy dose in bone metastases vertebral prostate adenocarcinoma

Conditions: Prostate Adenocarcinoma

Summary: this study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 gy x 9) associated with zoledronic acid. the administration of zoledronic acid repeat dosages defined under the authorisation on the market. all patients receive a total dose of 27 gy divided into 3 fractions of 9 gy performed at least 48 hours apart each, for a treatment to j1, j3 and j5.


Eligibility criteria:
inclusion criteria: adenocarcinoma of the prostate metastatic age\> 18 years3. * life expectancy\> 12 months; * performance index status \<3 psa ≥ 4 ng / ml zoledronic acid treatment in progress as recommended by the authority for the marketing creatinine clearance above 30 ml / min lack of maintenance causing disabling pain not lying down long (30 minutes) no history of radiotherapy to the region to be irradiated absence of neurological signs compression distance between the metastasis and spinal cord ≥ 5 mm absence of metastases unstable metastatic epidural spinal cord compression or may require surgery before radiotherapy exclusion criteria: * concomitant treatment with a drug testing, participation in another clinical trial within \<30 days * presence of central system nervous desease (symptoms or progressive), patient with a severe neurological disease, current manifestations of peripheral neuropathy\> grade 2 nci-ctc v4 existence of another severe pulmonary disease, liver or kidney, digestive likely to be exacerbated by treatment, * untreated with zoledronic acid * treatment with a bisphosphonate other than zoledronic acid * clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or to any excipients in the formulation of zometa. * creatinine clearance below 30 ml / min * history of another primary cancer (except basal cell skin cancer) * or demented patient with altered mental status who can not obtain informed consent. / persons deprived of liberty or under guardianship * pain not resulting in maintaining the prolonged supine position (30 minutes) * psa below 4 ng / ml * history of radiotherapy in localized tumor site * distance between the metastasis and spinal cord \<5 mm * monitoring impossible because of psychological, sociological or because of geographical distance.

Keywords: patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.
89zr-trastuzumab pet/ct in subjects with previously treated her2-positive solid tumors scheduled to receive treatment with mt-5111

Conditions: HER2-positive Solid Tumor; HER-2 Positive Cancer

Summary: this is an open-label, single center, pilot study to assess the feasibility of baseline 89zr-trastuzumab pet/ct to predict response to treatment with monotherapy mt-5111


Eligibility criteria:
inclusion criteria: * must meet eligibility criteria and be registered to receive treatment under protocol mt-5111_001 (wu hrpo # 201907092). * must have at least one measurable lesion by recist 1.1 during the dose expansion phase of mt-5111_001. osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included. * must have standard of care 18f-fdg-pet/ct within 90 days before administration of 89zr-trastuzumab or be willing to undergo 18f-fdg pet/ct scan for research purposes. * able to undergo pet/ct imaging * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * hepatic only disease * pregnant or breastfeeding.
characterization of immunosuppressive signing of cervical cancer

Conditions: Cervical Cancer

Summary: infection with human papillomavirus high-risk human (hr-hpv) is the main factor of risk of cancer of the cervix. recent studies show that cancers linked to infection with hr-hpv are associated with immunosuppression and lack of t cell response such mechanisms would promote progression to cancer and progression of it . various factors such as an increase of regulatory t cells, the presence of myeloid cells and suppressor of defects in the signaling pathway toll like receptor (tlr) may have a key role in these immunosuppression mechanisms. at this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. the results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer. the aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.


Eligibility criteria:
inclusion criteria: * the women presenting for initial therapeutic management of cervical cancer * elderly patients over 18 years * patients beneficiary of a social security scheme * pregnant women can not participate in this study * women known to be hiv positive will not participate in this study exclusion criteria: * patients with a recurrence of a treaty cervical cancer * patients with a history of pelvic radiotherapy * patients unable to receive informed about the progress and objectives of the study * patients not receiving a social security scheme * patients who have not signed informed consent * immunocompromised patients and pregnant women