Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of vdphl01 in males with aga

Conditions: Androgenetic Alopecia; AGA; Male Pattern Baldness

Summary: this study will evaluate the safety and efficacy of vdphl01 in male subjects with androgenetic alopecia (aga). aga (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. vdphl01 8.5 mg tablet is an investigational oral drug to treat male pattern baldness. this multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).


Eligibility criteria:
inclusion criteria: * subject is male aged 18-65 years old; * subject has a clinical diagnosis of mild to moderate aga; * subject is in good general health and has adequate renal and hepatic function; * subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study; * subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in english; * subject is willing and able to swallow study drug whole; * subject agrees to have a micro dot tattoo placed on their scalp; * subject agrees to have this area photographed at study visits as indicated in the protocol. exclusion criteria: * subject has uncontrolled blood pressure or orthostatic hypotension; * subject has symptoms or history of certain heart or thyroid conditions; * subject has a history of or active hair loss due to conditions/diseases other than aga; * subject has a current or recent history of dietary or weight changes, including use of glp-1 agonists; * subject has been diagnosed with covid-19 within 16 weeks of screening; * subject has had previous radiation of the scalp; * use of any of the following treatments within the indicated washout period before screening: * subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening * subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening * subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening * subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening * subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening * subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening * subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study; * subject has any other condition that, in the investigator's opinion, interfere with the study

Keywords: hair loss male hair loss
effort to narrow the gap between in accordance with guidelines and consent to treat chb population in east of china

Conditions: Chronic Hepatitis b

Summary: china has the world's largest burden of hepatitis b virus (hbv) infection and will be a major contributor towards the global elimination of hepatitis b disease by 2030. one of the main issues in the management of patients with chronic hbv infection (chb) is to maximize the individuals who need the treatment engaged and retained in care. however, our investigation revealed that 21.1% patients were treatment eligible but not treated based on chinese 2019 chb treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to aasld 2018 hepatitis b guidance in a real-life cohort study. to maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat chb population in east of china.


Eligibility criteria:
inclusion criteria: 1. positive hbv surface antigen (hbsag) for 6 months or more; 2. elevated alt levels (\>1×uln) and detectable hbv dna; 3. treatment-naïve; 4. willing to attend this study and able to provide the written informed consent. exclusion criteria: 1. co-infection with other viral hepatitis and human immunodeficiency virus; 2. concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease; 3. patients with liver cirrhosis; 4. coexistence of hepatocellular carcinoma and other malignant tumor; 5. underwent liver transplantation before the enrollment; 6. severe cardiac, renal, respiratory, hematological, or psychiatric illness.

Keywords: chronic hepatitis b antiviral treatment
pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy

Conditions: Pain, Postoperative; Post-Craniotomy Headache

Summary: a majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. as a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. for the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. however, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. as is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. thus, investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia; * american society of anesthesiologists (asa) physical status of i or ii; * participates required to fix their head in a head clamp intraoperatively; * participates with an anticipated fully recovery within 2 hours postoperatively. exclusion criteria: * history of craniotomy; * expected delayed extubation or no plan to extubate; * participants who cannot use a patient-controlled analgesia (pca) device; * participants who cannot understand the instructions of a numeral rating scale (nrs) 35 before surgery; * extreme body mass index (bmi) (\ 35); * allergy to opioids, dexamethasone or ropivacaine; * history of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects; * history of psychiatric disorders, uncontrolled epilepsy or chronic headache; * pregnant or at breastfeeding; * symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes; * preoperative glasgow coma scale\< 15; * suspicion of intracranial hypertension; * peri-incisional infection; * participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Keywords: postoperative pain post-craniotomy headache dexamethasone ropivacaine pre-emptive scalp infiltration
confirmation of ventilation and intubation by determination with ultrasonography

Conditions: Critical Illness; Mechanical Ventilation

Summary: chest radiography is the gold standard for confirming tracheal intubation. bedside ultrasound can be a useful alternative. the investigators are conducting a multi-center, observational study from january 2019 to may 2020 (covid-us study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

endotracheal intubation is an important aspect of managing critically ill patients. chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. the objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.

Eligibility criteria:
inclusion criteria: * adult patients (\> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care exclusion criteria: * recent neck or chest surgery * cervical spine immobilization * lack of availability of operators or equipment for performing the ultrasound protocol

Keywords: intubation bedside ultrasound point-of-care ultrasound
real-world data on stage iii nsclc patients treated with durvalumab after chemoradiotherapy in asia area (pacific aa)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: first real-world data on unresectable stage iii nsclc patients treated with durvalumab after chemoradiotherapy in asia area

study design: the study is an observational review of medical records of patients diagnosed with unresectable stage iii nsclc in taiwan, participating in an early access program (eap). physicians having treated patients in the eap will be asked to recruit these patients to have their data abstracted from their medical records. data will only be collected from routine clinical care. data source(s): centre staff will extract de-identified data from patient's medical charts. all collected data will be retrospective at time of extractions. study population: patients diagnosed with an unresectable stage iii nsclc, having not progressed after a crt and who have received at least one dose of durvalumab following the crt within the eap will be the target population. exposure(s): clinical characteristics, details of treatments (previous therapies, subsequent therapies), durvalumab exposure and serious aesis primary outcome(s): pfs and os. sample size estimations: a target of 140 patients is estimated in the study.

Eligibility criteria:
inclusion criteria: 1. written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures 2. adult of age ≥ 20 years at time of study entry 3. patients must have been enrolled in one of the pacific durvalumab eaps exclusion criteria: 1. patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the eap).
interpretable machine learning models for prognosis in gastric cancer patients

Conditions: Stomach Neoplasms; Gastrectomy; Machine Learning

Summary: this multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

this multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer. the study included patients who underwent radical gastrectomy for primary gastric or gastroesophageal junction cancer across multiple institutions in china. the primary objective was to create a machine learning-based model to predict postoperative outcomes following gastrectomy, using readily available clinical and pathological parameters. the main outcome of interest was early recurrence within 2 years after surgery, which significantly impacts overall prognosis. the study employed various machine learning algorithms to develop prediction models, which were then compared and validated. model performance was assessed through measures such as area under the receiver operating characteristic curve (auc), calibration, and brier score. the shapley additive explanations (shap) method was used to interpret the model and rank feature importance. this research aims to provide clinicians with a tool for identifying patients at higher risk of poor postoperative outcomes who may benefit from more intensive post-operative monitoring and early intervention strategies, potentially improving prognosis for gastric cancer patients.

Eligibility criteria:
inclusion criteria: * patients diagnosed with primary gastric or gastroesophageal junction cancer * underwent radical gastrectomy * complete clinical and pathological data available exclusion criteria: * presence of distant metastases before surgery * non-adenocarcinoma histology * incomplete follow-up data

Keywords: machine learning prognosis stomach neoplasms gastrectomy
interest of virtual reality in the management of anxiety and pain related to post-cardiac surgery care

Conditions: Surgery, Cardiac

Summary: this study compares virtual reality versus nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.

after cardiac surgery, the mediastinal and pleural drains are usually removed the second postoperative day, in the absence of complications. this procedure, realized by nurses, is a source of anxiety and pain for patients. nitrous oxide (kalinox®) is commonly used to manage many situations of anxiety, including the removal of mediastinal and/or pleural drains, and has shown a greater effect than placebo in this indication. virtual reality (vr) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. by distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care. this randomized monocentric trial compares vr versus kalinox® administration for the management of anxiety and pain related to post-cardiac surgery care, especially mediastinal and/or pleural drain removal.

Eligibility criteria:
inclusion criteria: * extubated after cardiac surgery * sinus rhythm * consent for participation * affiliation to the social security system exclusion criteria: * pacemaker * visual acuity making impossible the use of virtual reality * intolerance to morphine * contraindication to kalinox® * pregnant or breastfeeding women * patients under protection of the adults (guardianship, curators or safeguard of justice) * communication difficulties or neuropsychiatric disorder

Keywords: pain anxiety mediastinal drain removal
escitalopram in patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with generalized anxiety disorder (gad), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

the study will be performed in russia, as an open-label, uncontrolled, one arm trial. the patients will receive escitalopram for 8 weeks. start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national summary of products characteristics (spc).

Eligibility criteria:
inclusion criteria: * the patient suffers from gad, diagnosed according to icd-10 (international classification of diseases) * the patient meets criteria as set out in the national spc for escitalopram * the patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs exclusion criteria: * the patient has/has had an alcohol or drug abuse-related disorder, as defined in icd-10 * the patient has contraindications to escitalopram * the patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram * the patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance * the patient is pregnant or breast-feeding * the patient, if a woman of childbearing potential, is not using adequate contraception

Keywords: generalized anxiety disorder gad antidepressant anxiolytic
identification of correlations between reaction to biotine and autoimmune diseases

Conditions: Autoimmune Disease

Summary: working hypothesis and aims: biotin is conjugated covalently to several proteins and use as a co-factor. conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. in this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied: a. assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease. b. assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker. methods: a. patient recruitment. gathering participant's medical record and blood samples. b. records of clinical and biochemical measures. c. serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. d. controlled test for repeatedly injected mice with biotinilated self-antibodies. level of anti-biotin will be tested and their influence on the mouse. e. determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease. expected results :serum biotin-protein levels and anti biotin antibodies levels are increased in patients with active autoimmune liver diseases. importance: the proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease. probable implications to medicine: identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.


Eligibility criteria:
inclusion criteria: * freely given informed consent * autoimmune disease exclusion criteria:
cs-101 in patients with β-thalassemia

Conditions: Beta-Thalassemia

Summary: the goal of this open label, single-arm clinical study is to learn about the safety and efficacy of cs-101 in treating β-thalassemia.

cs-101 is an autologous cd34+ cell suspension, edited by in vitro base editing technology, which modifies the bcl11a binding site in hbg promoter, so that it loses the ability to bind to bcl11a, which can re-induce the production of γ-globin chain and increase the concentration of fetal hemoglobin(hbf) in the blood, compensating for the function of missing adult hemoglobin hba to achieve clinical cure. the therapy addresses two major challenges in the current treatment of the disease: lack of matching donors and graft-versus-host diseases in allogeneic hematopoietic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * 6 to 35 years old(inclusive) male or female subjects at the time of informed consenting diagnosis of β-thalassemia, genotypes include but are not limited to β+β0，βeβ0，β0β0, etc history of at least≥8 units/year of packed rbc transfusions in the prior 12 months prior to the screening period generally in good condition, karnofsky performance score≥60 points for subjects≥16 years old at the time of autologous hematopoietic stem cell collection, or lansky play-performance score≥60 points for subjects under 16 years old, or equivalent clinical evaluation as the investigator site's common practice exclusion criteria: * treatment with other investigational medications or other experimental interventions 30 days prior to signing informed consent or within 6 half-lives of the drug, whichever is longer. subjects who have received or are receiving thalidomide and/or luspatercept, when their drug-drug interaction on the efficacy and safety of cs-101 cannot be ruled out, unless at least there are 3 test results showing the total hemoglobin level before transfusion is below 9g/dl in the past 6 months before screening. previously received allogeneic hematopoietic stem cell transplantation or gene(edited) therapy. subjects have available related fully matching donors and are eligible and prepared for allogeneic hematopoietic stem cell transplantation. those with active infections, including but not limited to: hiv, hepatitis b, hepatitis c, cytomegalovirus, epstein-barr virus and treponema pallidum test positive, or known tuberculosis, parasitic infection, etc. who are judged by the investigator to be unsuitable to participate in this study. echocardiography results with ejection fraction below 45%. advanced liver disease, defined as： aspartate aminotransferase (ast), alanine aminotransferase (alt) \>3 × upper limit of normal (uln) or: baseline international normalized ratio (inr) \>1.5 × uln. mri during the screening period showed heavy iron overload and is judged by the investigator to be unable to participate in the study.
a study to assess the safety, pharmacokinetics, and anti-tumor activity of oral hp518 in patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the overall objective of this phase 1 study is to evaluate the safety, pk, and anti-tumor activity of 12 weeks of daily oral dosing with hp518 after selecting the rp2d of hp518 based on assessments of multiple dose escalation in patients with progressive mcrpc.

this first in human dose escalation and expansion study of hp518 in patients with mcrpc is being conducted not only to evaluate the safety and tolerability of orally administered hp518, but also to provide necessary information for efficacy analysis in future studies.

Eligibility criteria:
inclusion criteria: 1. has histologically confirmed adenocarcinoma of the prostate. 2. has metastatic disease at study entry documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by ct/mri. 3. has disease progression while receiving any adt, androgen biosynthesis inhibitors, or second-generation ar inhibitors. 4. must have recovered from toxicities related to any prior treatments 5. ongoing adt with lhrh agonist/antagonist therapy or history of bilateral orchiectomy. 6. ecog performance status score of 0 to 1. exclusion criteria: 1. has received more than 1 line of chemotherapy for prostate cancer. 2. use of enzalutamide, and/or other second-generation ar inhibitors and/or abiraterone as follows: * received any agent within 4 weeks prior to the start of study drug. * discontinued agent without evidence of radiographic or psa progression. 3. has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177lu-psma-617, radium 223, parp inhibitor) within 4 weeks prior to the first dose of hp518. 4. has gastrointestinal disorder affecting absorption (e.g., gastrectomy). 5. has significant cardiovascular disease. 6. use of an investigational agent, without evidence of radiographic or psa progression, within 4 weeks prior to the first dose of hp518 or a period required by local regulation, whichever is longer.