Kornimate/medical-research-clean huggingface dataset:
evaluation of the diagnostic efficacy and safety of [123i]nav5001 as an imaging agent to aid in the diagnosis of parkinsonian syndromes

Conditions: Parkinson's Syndrome

Summary: this is a phase 3, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of \[123i\]nav5001 spect imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation * age ≥ 40 years * have had upper extremity tremor for \< 3 years duration, regardless of presumed diagnosis or etiology * have a updrs part iii score upon entry of ≤ 16 exclusion criteria: * any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator * structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke) * any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator * any clinically significant abnormal electrocardiogram (ecg) results obtained at screening and as determined by the investigator * any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the diagnostic and statistical manual of the american psychiatric association, fourth edition, revised (dsm-iv-tr \[american psychiatric association, 1994\]) * positive urine drug screen for opiates, cocaine, or amphetamines at screening * positive pregnancy test before imaging * participation in an investigational drug or device clinical trial within 30 days before the date of informed consent * previous scan with any dat imaging agent (e.g. \[123i\]nav5001, altropane, datscan, dopascan) * any exposure to radiopharmaceuticals within 30 days before the date of informed consent * breast-feeding * inability to lie supine for 1 hour * any thyroid disease other than adequately treated hypothyroidism * known sensitivity or allergy to iodine or iodine containing products * treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.

Keywords: parkinson's disease
prospective sinonasal cancer multi-institution study

Conditions: Sinonasal Carcinoma

Summary: this is a multi-institution prospective study of patients with sinonasal malignancies. the goal of this study is to learn more about the course of sinonasal cancer, treatment outcomes, and patient quality of life. in addition, central mutational and genomic analysis of tumor tissue will be evaluated.


Eligibility criteria:
inclusion criteria: * subjects between the ages of 30 days (non-inclusive) and 99 years (inclusive) * patients with a diagnosis of sinonasal cancer * patients undergoing treatment at mayo clinic exclusion criteria: * healthy individuals * unwilling to sign the informed consent
clinical evaluation of polycation-based new dental desensitizer on dentin hypersensitivity

Conditions: Dentin Sensitivity

Summary: evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy.

this is a randomized, single-blind and controlled study to include 40 patients with dentin sensitivity. the study will be a randomized controlled trial with split mouth control, with two quadrants of the same patient as test and control groups, the test group being the group using the new desensitizer and the control group being the group with the clinically used desensitizer (gruma desensitizer). improvement in dentin sensitivity symptoms was the primary outcome indicator observed. dentin sensitivity was assessed by evaluating the reduction in dentin sensitivity vas scores at immediately, 1 month, 3 months, and 6 months points after the desensitization treatment, and by evaluating the subjects' self-reported relief of sensitivity. safety was assessed by evaluating appliance defects and adverse events at the immediately,1-, 3-, and 6-months points after the desensitization treatment.

Eligibility criteria:
inclusion criteria: * dentin hypersensitivity, with vas score≥4 points and the normal pulp viability * dentin-sensitive tooth in at least 2 different quadrants of the mouth (neck enamel dentin exposure or maxillofacial abrasion within the middle layer of dentin). * in good overall health * participants informed consent. exclusion criteria: * gastroesophageal reflux * dental caries, wedge defects, crowns or large fillings. * received dentin sensitivity desensitization treatment or used desensitization mouthwash within 1 month. * received systematic periodontal therapy or periodontal surgery within 3 months, ongoing orthodontic treatment, and medical treatment, including long-term use of anti-inflammatory, analgesic, and psychotropic medications. * pregnancy or breastfeeding. * participated in other clinical trials in the past 3 months.

Keywords: dentin sensitivity tooth desensitizer
a safety and efficacy study of amdoxovir in hiv-1 treatment-experienced subjects

Conditions: Human Immunodeficiency Virus Infection

Summary: this study is an open-label extension of rfsp-amdx-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. this study will examine the safety and efficacy of the investigational hiv drug, amdoxovir (300 mg and 500 mg bid doses; n = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.


Eligibility criteria:
inclusion criteria: * must have completed study rfsp-amdx-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study rfsp-amdx-2012. * must have maintained ≥ 1.0 log10 copies/ml from baseline at week 12 in study rfsp-amdx-2010. * must not have had any serious adverse experience since enrollment in study rfsp-amdx-2010, whether or not considered to be study drug-related. exclusion criteria: * subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion. * subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents. * subjects who require medications that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events. * known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations. * women who are pregnant or breastfeeding.

Keywords: amdoxovir zidovudine hiv haart antiretroviral
stroke team remote evaluation using a digital observation camera- long term outcomes(stroke doc-lto)

Conditions: Telemedicine Evaluation vs Telephone Evaluation

Summary: specific aim: the specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the stroke doc ("stroke doc trial (nct00283868)") telemedicine clinical trial. aim 1: aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (stroke doc trial ("stroke doc trial (nct00283868)"); now completed). stroke doc-lto will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.

specific aim: the specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the stroke doc ("stroke doc trial (nct00283868)") telemedicine clinical trial. aim 1: aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (stroke doc trial ("stroke doc trial (nct00283868)"); now completed). stroke doc-lto will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations. specific protocol information: the protocol will contact these patients by telephone. one of 5 stroke center team members will contact the patient, using strict telephone scripted language (approved by the irb) and ask questions regarding 1. current functional status 2. death 3. hemorrhage 4. recurrent stroke 5. disposition for 3 time periods (6 months after index event, 12 months after index event, and "current" time of contact.

Eligibility criteria:
inclusion criteria are: 1. male or female subjects, age \> 18 years. 2. prior enrollment into the stroke doc ("stroke doc trial (nct00283868)") clinical research trial. exclusion criteria are: 1. male or female subjects, age \< 18 years. 2. patients not previously enrolled into the stroke doc ("stroke doc trial (nct00283868)") clinical research trial.

Keywords: telemedicine telephone outcomes
cryosurgery in treating patients with liver cancer or liver metastases

Conditions: Liver Cancer; Metastatic Cancer

Summary: rationale: cryosurgery kills cancer cells by freezing them during surgery. purpose: phase i/ii trial to study the effectiveness of cryosurgery in treating patients with unresectable primary liver cancer or liver metastases.

objectives: i. assess the safety and efficacy of liquid nitrogen necrosis of liver lesions using a commercially available intraoperative cryosurgical system, with placement of the cryoprobe and subsequent monitoring by high-resolution ultrasound. ii. use this technique on selected patients with surgically unresectable metastatic or primary liver cancer whose disease appears confined to the liver and who are potentially curable if all tumor in the liver can be destroyed. iii. quantitate the quality and duration of survival, identify recurrence of hepatic malignant disease, and identify any morbidity from the procedure. outline: cryosurgery. liquid nitrogen freezing of tumor using a cryoprobe placed and maintained under ultrasound guidance. projected accrual: 50 patients will be treated.

Eligibility criteria:
disease characteristics: biopsy-proven metastatic or primary malignant disease of the liver no extrahepatic regional or distant metastases no primary tumors commonly associated with local spread or metastases to other sites, e.g.: gastric cancer pancreatic cancer breast cancer lung cancer liver lesions considered unresectable because of location in relation to major vascular structures or involvement of multiple hepatic segments tumor extent and location such that cryosurgery expected to destroy all tumor and render patient disease-free tumor volume no greater than 50% of total hepatic volume on ct no more than 12 lesions patient characteristics: age: over 21 other: overall health permitting safe laparotomy blood/body fluid analyses and imaging/exams for tumor measurement within 1 month prior to registration prior concurrent therapy: prior liver resection, radiotherapy, or chemotherapy allowed

Keywords: localized unresectable adult primary liver cancer recurrent adult primary liver cancer liver metastases
to evaluate the safety and efficacy of remsima™ in patients with crohn's disease (cd) or ulcerative colitis (uc)

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: an observational, prospective cohort study to evaluate the safety and efficacy of remsima™ in patients with crohn's disease (cd) or ulcerative colitis (uc)

this is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of remsima™ in patients with ibd, who have active crohn's disease (cd), fistulizing crohn's disease (cd), or ulcerative colitis (uc). patients will be included in this registry who are receiving treatment with 5 mg/kg of remsima™ by iv infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. if a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. patients will undergo safety and efficacy assessments in accordance with routine medical practice. the decision to treat with remsimatm will be independent of the decision to enroll the patient in this registry.

Eligibility criteria:
inclusion criteria: * adult patients with moderate to severe active cd * children and adolescent patients, aged 6 to 17 years old with severe active cd * adult patients with fistulizing active cd * adult patients with moderate to severe active uc * female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of remsima™. * patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records. exclusion criteria: * patients with a history of hypersensitivity to infliximab * patients with a current or past history of chronic infection * patients with current diagnosis of tuberculosis (tb) or severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or previously diagnosed with tb or severe or chronic infection, without sufficient documentation of complete resolution following treatment. * recent exposure to persons with active tb, or a positive test result for latent tb (determined by a positive interferon-γ release assay \[igra\] test, with a negative chest x-ray) at screening * patients with moderate or severe heart failure (nyha class iii/iv).
feasibility 3d perfusion ultrasound for liver cancer sabr planning and response evaluation

Conditions: Liver Cancer; Liver Tumor; Hepatocellular Carcinoma; Liver Carcinoma

Summary: the purpose of this study is to prospectively analyze the value of 3d ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

primary objective: the primary objectives of this prospective pilot study is to: 1. determine the feasibility and reproducibility of 3d contrast enhanced ultrasound imaging in liver cancer patients undergoing stereotactic ablative radiotherapy and 2. evaluate whether there are treatment induced early changes in imaging metrics derived from 3d contrast enhanced ultrasound. this study will provide valuable insight as to the potential of baseline and/or early post-treatment 3d ultrasound perfusion characteristics (measurements of blood-flow) of primary and metastatic liver tumors to predict tumor response to stereotactic ablative radiotherapy. the investigators' underlying goal is to assess whether early perfusion changes at 1-7 days after sabr initiation can be used as a non-invasive early biomarker for treatment response assessment. secondary objectives: evaluate the feasibility of contrast-enhanced ultrasound-to-ct fusion by assisting three-dimensional (3d) perfusion ultrasound (us) imaging with optical and electromagnetic tracking of the ultrasound probe on patients with liver cancer that will undergo ct for treatment planning and/or response evaluation.

Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign the written informed consent document * patient with primary liver tumor or metastasis scheduled for stereotactic ablative radiotherapy (sabr) * patient is at least 18 years of age. no gender/race-ethnic restrictions. * performance status (ecog) between 0-3 * history and physical done within 4 weeks of enrollment. exclusion criteria: * patient has previously been enrolled in and completed this study. * known right to left cardiac shunt, bidirectional or transient. * patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. * history of hypersensitivity to the contrast agent perflutren * history of pulmonary hypertension * patients who are pregnant or are trying to become pregnant

Keywords: liver cancer hepatocellular carcinoma liver imaging stereotactic ablative radiotherapy sabr
prospective genomics initiative on multiple synchronous lung cancer (pgi-mslc)

Conditions: Multiple Synchronous Lung Cancers (MSLCs)

Summary: this prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (mslc) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for mslc patients.

* to initiate a prospective registry of mslc patients with high-quality clinical samples and detailed medical data. * to define the clonal relationship, genomic landscape and potential driver alterations of mslc using whole-genome sequencing. * to determine the intrapatient and intratumor genetic heterogeneity of mslc. * to correlate molecular features with clinical parameters and patient outcome. * to serve as a continuous infrastructure for a large variety of research purposes including: a. diagnostic research b. prognostic research c. biological research d. interventional trial design testing new therapies in mslc.

Eligibility criteria:
inclusion criteria: * age 18 years or older * confirmed diagnosis of multiple synchronous lung cancers (mslcs) without metastatic disease * signed informed consent exclusion criteria: * medical or psychiatric condition that would preclude informed consent * history of known high-risk infections * with metastatic tumors except lung
study to assess pharmacodynamics of rm-131 in patients with diabetic gastroparesis

Conditions: Diabetes Mellitus Type 1 and 2; Diabetes Mellitus Complications; Gastroparesis; Gastrointestinal Motility Disorder

Summary: the purpose of this study is to evaluate the pharmacodynamic (pd) and pharmacokinetic (pk) profile and the safety and tolerability of rm-131 in patients with diabetes mellitus and delayed gastric emptying.


Eligibility criteria:
key inclusion criteria: * able to provide written informed consent prior to any study procedures. * diagnosis of type 1 or 2 diabetic gastroparesis. * controlled type 1 or 2 diabetes mellitus (hba1c \<10.1%). * stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to period 1 (daily adjustments of insulin doses are permitted). * body mass index of 18-40 kg/m². key exclusion criteria: * unable or unwilling to provide informed consent or to comply with study procedures. * history of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (note: history of diagnostic endoscopy is not exclusionary). * acute or chronic illness or history of illness, which in the opinion of the investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, class iii or iv congestive heart failure, poor renal or hepatic function, etc. * any clinically significant abnormalities on screening laboratories as determined by the investigator. * abnormal 12-lead electrocardiogram (ecg), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the investigator. * poor venous access or inability to tolerate venipuncture. * acute gi illness within 48 hours of period 1. * positive pregnancy test. * participation in a clinical study within the 30 days prior to dosing in the present study. * any other reason, which in the opinion of the investigator, would confound proper interpretation of the study.

Keywords: diabetes mellitus type 1 and 2 delayed gastric emptying gastroparesis gastrointestinal motility disorder
skin-to-skin contact time and maternal psychology

Conditions: Skin to Skin Contact

Summary: the aim of this study was to determine the effect of postpartum skin-to-skin contact time on fear of childbirth, birth trauma and maternal attachment.

this is a single-blind, randomized controlled trial. data were collected from 110 women who gave birth in the gynecology clinic of a public hospital in southern turkey between september 2021 and february 2022. participants who met the inclusion criteria were informed about the purpose of the study and skin-to-skin contact, informed consent was obtained from those who agreed to participate, and the women were divided into groups according to a 1:1 computer-based randomization program. data were collected at the time of consent to the study, within the first hour after birth, 24 hours after birth, 4 weeks postpartum, and 4 months postpartum. collected by the first author. the consort directive was followed in the planning, implementation and writing of the research.

Eligibility criteria:
inclusion criteria * must be able to a normal term vaginal delivery, * native language is turkish, * have single fetus * must be able to skin to skin contact wit her baby exclusion criteria * cesarean section, * complications, * psychological or psychiatric disorder,