Kornimate/medical-research-clean huggingface dataset:
external control, observational, retrospective study comparing pralsetinib to best available therapy in patients with ret-fusion positive nsclc

Conditions: RET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Diseases; Head and Neck Neoplasms; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Metastatic Non Small Cell Lung Cancer

Summary: this is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with ret-fusion positive advanced nsclc.


Eligibility criteria:
inclusion criteria: * must have a diagnosis of locally advanced (non-resectable) or metastatic ret-fusion positive nsclc * must have received at least one line of systemic therapy for locally advanced (non-resectable) or metastatic ret-fusion positive nsclc, which may include regimens containing: * chemotherapy, e.g., regimens containing platinum doublet-based therapy (carboplatin, cisplatin) * chemotherapy in combination with other drugs will be assessed, e.g., in combination with pemetrexed, immune checkpoint inhibitors (pembrolizumab), bevacizumab * ramucirumab in combination with docetaxel * immune checkpoint inhibitors, e.g., pembrolizumab, nivolumab, and atezolizumab * mkis, e.g., cabozantinib, alectinib, vandetanib, sunitinib, and nintedanib * must be aged ≥18 years of age at the initiation of first systemic line of therapy * must have availabile of performance status (e.g., eastern cooperative oncology group \[ecog\] score or karnofsky score) * must have an index date at least 3 months prior to the start of data collection (in order to include patients with at least 3 months of follow-up after index date), unless date of death occurred less than three months from index date * must have an approved waiver of informed consent or signed informed consent for participation in the retrospective chart review study, as applicable exclusion criteria: * known primary driver alteration other than ret (e.g., targetable mutation in egfr, alk, ros1, or braf) * history of other malignancy, other than non-melanoma skin cancer, within 1 year prior to initiation of first systemic therapy * received pralsetinib as the first line of systemic therapy for ret-fusion positive nsclc, or prior to initiation of first systemic therapy
18f-fdg metabolism imaging monitoring non-small cell lung cancer curative effect of chemotherapy multicenter clinical study

Conditions: Non-small-cell Lung Cancer

Summary: the subject is going to use 18f-fdg pet/ct to assess different genetic nsclc metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18f-fdg pet/ct in nsclc treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

non-small-cell lung cancer (nsclc) is the first leading cause of cancer death in the world. systemic chemotherapy has contributed to the only choice for more than 50% nsclc patients. the genetic abnormalities lead to different therapy response to the same chemotherapy scheme in nsclc patients. at present, early assessment and prediction is the key for optimize nsclc therapy. 18f-fdg pet/ct is a noninvasive cell metabolism reaction molecular imaging technology which can assess cancer glucose metabolism sensitively and react cancer proliferation to some degree. hence 18f-fdg pet/ct may be used to assess nsclc therapy response noninvasively. it is a reliable method to individualize nsclc treatment clinically by define the appropriate metabolism response cut-off values and assess time points of 18f-fdg pet/ct in predicting different genetic nsclc patients.the subject is going to use 18f-fdg pet/ct to assess different genetic nsclc metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18f-fdg pet/ct in nsclc treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Eligibility criteria:
inclusion criteria: * pathological biopsy for nsclc; stage iii-iv; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year; exclusion criteria: * with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years

Keywords: non-small-cell lung cancer 18f-fdg pet/ct treatment response assessment
first in human study of uct-03-008 in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of uct-03-008 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * advanced solid tumor * measurable disease, per recist v1.1 * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * has not recovered \[recovery is defined as nci ctcae, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of uct-03-008 * progressive or symptomatic brain metastases * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * history of significant cardiac disease * history or current evidence/risk of retinopathy * history of myelodysplastic syndrome (mds) or aml * history of another cancer within 3 years before day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. a history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (dcis) of the breast and prostate cancer with a gleason score less than or equal to 6, are also not excluded * if female, is pregnant or breastfeeding
sentinel lymph node biopsy with hybrid technique in breast cancer

Conditions: Breast Cancer

Summary: sentinel lymph node (sln) biopsy is the gold standard method to stage axilla in breast cancer. the aim of the study is to compare the efficiency of various methods to identify sln is breast cancer patients.

various markers has been used for sln biopsy including isosulfan blue (patent blue), indocyanine green (icg), radioisotope colloid (raic) and ultrasound (us) with several advantages and disadvantages. in this study investigators designed an algorithm using the combination of mapping with patent blue, icg, raic and us to compare the accurate identification of sln in breast cancer patients. the protocol is based on the hypothesis that identification rate of sln is increased with multiple agents. patent blue and icg provides visual guidance. the combination of dyes with sonographic and raic method have the potential to prevent obstacles and ensure better outcomes as an identification strategy. patent blue provides visual identification of the sln. icg fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. rai has several advantages, but disadvantages as well, like cost and invisibility. rai can only be detected and confirmed by means of sound and numerical value through gamma probe. all breast cancer patients underwent axillary ultrasound before slnb with different mapping combinations. the determination of abnormal axillary lymph node was followed by ultrasound-guided fna cytology of these nodes. the sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness \>2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). patients with negative results of fna would undergo slnb. lymphatic mapping was performed with abovementioned dyes and radioactive colloid. before the incising for slnb real time intraoperative us was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. in the slnb operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy * cn0 patients * in patients with abnormal axillary lymph nodes sonographically us-guided fna cytology of these nodes were performed and fna cytology negative patients planed to undergo slnb with different mapping techniques. exclusion criteria: * patients with neoadjuvant therapy * patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy * patients with pathologically proven axillary disease * patients with t4d tumor

Keywords: breast sentinel lymph node patent blue indocyanine green
a study for the identification of biomarker signatures for early detection of pulmonary hypertension (ph)

Conditions: Hypertension, Pulmonary

Summary: the primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (rna) in the blood samples associated with high risk of pulmonary hypertension (ph) to assist in the diagnosis of ph; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with ph by comparing the biomarker signatures to right heart catheterization (rhc) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (tte) in identifying participants with ph documented by rhc.


Eligibility criteria:
inclusion criteria: * having undergone an right heart catheterization (rhc) within 18 months (prevalent ph participants) or 6 months (prevalent non-ph participants) or have undergone or planned rhc within 6 weeks (incident participants). the results of the incident rhc (incident participants) or the most recent rhc (prevalent participants) will be used to classify the participant in one of the above study population categories * medically stable on the basis of physical examination, medical history and vital signs performed at screening. any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * must provide an informed consent form (icf) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid \[dna\]) sample for research (where local regulations permit). refusal to give consent for the optional (dna) research sample does not exclude a participant from participation in the study exclusion criteria: * participants requiring renal dialysis * history of lung or heart transplant (waiting list status or consideration of enlisting is allowed) * severe left ventricular dysfunction: left ventricular ejection function less then (\<) 35 percent (%)
study in adults with severe chronic rhinosinusitis with nasal polyposis treated with dupilumab in france

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Summary: this is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in france: patients' characteristics, disease characteristics, prior treatments for severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. as well as to assess the clinical outcome after initiation of dupilumab (dupixent®) and safety of the product during the two years of treatment


Eligibility criteria:
inclusion criteria: * patient aged \>= 18 years old at the time of the initiation of the treatment with dupilumab (dupixent®). * decision to initiate dupixent® prior to inclusion in the study, initiation of dupixent® for severe chronic rhinosinusitis with nasal polyposis (crswnp) maximum 3 months before inclusion. * informed consent and willingness to participate. exclusion criteria: * conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results. * patient participating in an interventional clinical trial with experimental product at inclusion.

Keywords: real world evidence (rwe) ent disease crswnp nasal polyp syndrome dupixent surgery
long-term safety of bcx9930 in participants with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this study is designed to provide continued access to bcx9930 for participants currently receiving treatment with bcx9930 in a biocryst-sponsored clinical study for paroxysmal nocturnal hemoglobinuria (pnh) who, in the opinion of the investigator, would benefit from continued treatment with bcx9930 and who do not have access to other treatment options.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female participants * are receiving treatment with bcx9930 in another clinical study of pnh and, in the opinion of the investigator, have benefited from treatment with bcx9930 and would benefit from continued treatment with bcx9930, and who do not have access to other treatment options exclusion criteria: * any clinically significant medical or psychiatric condition including alcohol or drug dependency that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant * an ongoing adverse event, including a laboratory abnormality, or other unacceptable toxicity that, in the judgment of the investigator, compromises the ability of the participant to continue study-specific procedures or it is considered not to be in the participant's best interest to continue or benefit-risk assessment is no longer in favor of the participant's continued treatment

Keywords: bcx9930 factor d inhibitor proximal complement inhibitor oral therapy paroxysmal nocturnal hemoglobinuria
dynamic neural mechanisms of brexanolone-induced antidepressant effects in postpartum depression

Conditions: Postpartum Depression

Summary: this is a feasibility study of performing repeated eeg recordings and assessment of affective states during open-label administration of brx to women with postpartum depression. study phases will include screening, enrollment, intervention, and follow-up. subjects will be screened for study eligibility criteria through clinical assessments and self-report. enrolled subjects will be admitted to the unc women's hospital, where five serial eeg recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour iv infusion of brx. follow-up procedures will include assessments of ppd and affective symptoms, as well as an exit interview with the study team. if feasibility outcomes are achieved, exploratory eeg analyses will be performed with amica (adaptive mixture independent component analysis), community detection, and microstate assessment. exploratory analyses of data collected by facial expression detection software (imotions affectiva) are also planned.


Eligibility criteria:
inclusion criteria: * signed informed consent. * documented proof of full covid-19 vaccination * ambulatory, female, aged 18-45 * ≤ 8 months postpartum * agrees to adhere to the study requirements. * onset of depression in 3rd trimester or within 4 weeks of delivery * meets dsm-v criteria for major depressive disorder with peripartum onset. * 17-item ham-d total score ≥20 at screening * stopped breastfeeding or agrees to temporarily stop for 7 days including 4 days of hospitalization and 3 days after * no new psychotropic drugs during screening and active treatment of study * stable use of any current psychotropic drugs for at least 28 days prior to enrollment, with stable dosage for at least 14 days prior to enrollment * must be on documented contraceptive. * must have a caregiver or family member with them to help care for the subject's child(ren) during the infusion and to be in the room with the subject if the child(ren) are present during the infusion exclusion criteria: * positive pregnancy test at screening or day 1 * pregnancy that resulted in a stillbirth, termination, or child that was placed for adoption. * renal impairment or failure, hepatic impairment or failure, or anemia * untreated or inadequately treated hypothyroidism or hyperthyroidism * known allergy to progesterone or allopregnanolone. * suicide attempt at this episode * medical history of schizophrenia, and/or schizoaffective disorder * current psychotic symptoms including delusions, hallucinations, or formal thought disorder. * concurrent substance abuse * exposure to another investigational medication or device within 30 days * has previously participated in any study employing brexanolone or sage-217. * subject is investigative site personnel, sponsor personnel, or an immediate member of their family. * has received electroconvulsive therapy during current episode. * history of seizure disorder * on anticonvulsant agents * on benzodiazepines
effect of saline lubrication on post-intubation complications

Conditions: Postoperative Sore Throat

Summary: the purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of postoperative sore throat (post) after general anesthesia with endotracheal intubation.


Eligibility criteria:
inclusion criteria: * patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation exclusion criteria: * history of gastroesophageal reflux disease (gerd) * congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies * previous airway surgery; increased risk of aspiration * coagulation disorders * previous history of difficult intubation or conditions with expected difficult airway including mallampati classification ≥ 3 or thyromental distance \< 6.5 cm * using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy * symptoms of sore throat or upper respiratory tract infection * expected to place nasogastric tube during perioperative period * requiring nasotracheal intubation
beta testing of a new assessment in huntington's disease (hd)

Conditions: Huntington Disease

Summary: huntington's disease (hd) is an inherited neurodegenerative disease for which there are no existing disease-modifying treatments. repair-hd is an eu fp7 consortium that aims to establish all the preclinical requirements for transplantation of stem cell-derived neurons in hd in order to replace those lost to the disease process. these requirements include the generation of new clinical assessments for detailed monitoring of patients with hd who have undergone cell replacement therapy. this protocol describes the beta testing of a new clinical assessment battery: core assessment protocol for intrastriatal transplantation in hd version 2 (capit-hd beta / capit-hd2). capit-hd beta represents a substantial revision of a previous capit-hd battery published over 20 years ago, which is in need of updating in order to accommodate knowledge from clinical transplant studies over this time and to take advantage of technological advances in patient assessment. hd is a complex disorder in which there is relentless deterioration of motor, cognitive and behavioural functions, usually from mid-life onwards. the original capit battery aimed to capture elements of change in all three domains, but was based predominantly on subjective semi-quantitative assessment tools that have poor inter-rater reliability. moreover, a number of deficits, such as impairments in social cognition, were not recognised when the original capit-hd battery was constructed, so we have developed novel assessments of these deficits, some of which are included in capit-hd beta. the beta testing will take place in established hd clinical centres in cardiff, manchester, paris, and munster by teams of researchers who are experienced in leading clinic research in hd. patients with early to moderate hd will be assessed at baseline, and at one and twelve months later, to assess the reliability and sensitivity of the capit-hd beta battery. arrangements for data storage and analysis are in place.


Eligibility criteria:
1. patients inclusion criteria * must be confirmed to carry the hd gene through genetic testing (cag ≥ 36) * must be 18 years or above * stage i or ii disease (tfc staging) exclusion criteria * the inability to approve consent * any comorbid condition that has the potential to confound the results of the study 2. controls inclusion criteria - must be 18 years or above exclusion criteria * the inability to approve consent * any comorbid condition that has the potential to confound the results of the study

Keywords: beta testing assessment battery hd
innovative toilet seat test for patients with symptoms of constipation and/or emptying disorders

Conditions: Constipation

Summary: emptying disorders are of the most common causes of constipation. an adjustable toilet seat was designed by " shva-nach" ltd company, and is designed to facilitate the angle sitting position. its efficacy will be evaluated in the current study, on 50 volunteers who suffer from constipation and meet the rome 3 criteria for constipation.

emptying disorders are of the most common causes of constipation. laxatives are usually unsuccessful. behavioral therapy such as anorectal biofeedback , have a limited success in most hospitals in this country. toilet seat that lifts the legs and brings us into a sitting position closer to squatting (which is the desired physiological position) can relieve these patients in the emptying process. the company " shva-nach" ltd. and its design team designed a seat at an angle slightly elevated and a toilet stool customized to the personal anatomy of each subject. the purpose of the study: evaluating efficacy elevated toilet seat with a support of a brackets stool making emptying easier in patients with constipation and difficulty in emptying. methods: an open, randomized, crossover study in use of a toilet seat and comparing it to a standard seat.

Eligibility criteria:
inclusion criteria: 1. patients suffering from constipation and meet the criteria of rome 3. no sub - distribution by emptying disorders or decreased stool frequency 2. age group 18-80 years 3. study population may include patients suffering from metabolic diseases such as diabetes mellitus, hypothyroidism and hypercalcemia. 4. patients who understand the goals of the research and collaborate exclusion criteria: 1. patients who do not understand the goals of the research and / or unable to cooperate. 2. women with known pregnancy - second trimester and up 3. patients with obesity - bmi\> 35 and / or weight over 120 kg 4. neurological diseases - dementia, parkinson's disease, cva, multiple sclerosis, muscular dystrophy, spinal cord injury 5. disabled patients on wheelchairs. 6. patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon. 7. minors and no judgment

Keywords: constipation