Kornimate/medical-research-clean huggingface dataset:
effect of spironolactone in treating chronic non-resolutive central serous chorioretinitis

Conditions: Central Serous Chorioretinitis

Summary: the objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (cscr) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients. cscr is a major cause of visual loss in the young population. it is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. the exact causes of the disease remain unknown but a choroidopathy has been suggested. moreover, corticotherapy and stress are known risk factors of cscr. our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow. the investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of cscr. criteria of efficacy endpoint: reduction of subretinal fluid ≥ 40 microns secondary endpoint: visual acuity gain ≥ 15 edtrs letters

this is a prospective placebo controlled cross over study including 16 patients

Eligibility criteria:
inclusion criteria: * patient between 18 and 60 years * cscr affecting the macula and non-resolutive for at least 3 months * patients having given and signed informed consent * vital prognosis non engaged for the next 6 months. exclusion criteria: * other ocular pathology * neovascularization, * diabetes * uveitis * ocular surgery in the last 3 months * allergy to fluorescein or indocyanine green * pregnancy or no contraception * renal or liver insufficiency * kaliemia ≥ 5.5 mmol/l criteria of efficacy

Keywords: retina
a research study looking at how the medicine nnc0385-0434 works in the body of healthy japanese men

Conditions: Healthy Volunteers; Atherosclerotic Cardiovascular Disease

Summary: the aim of this study is to look at how the study medicine works in the body and how it is removed from the body. we are testing the study medicine to make a medicine that can help people lower their cholesterol level. participants will either get 1. nnc0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg. 2. placebo (a dummy medicine which looks like the study medicine but without any medicine). which treatment participants get is decided by chance. nnc0385-0434 is a new medicine and has not been approved by the health authorities (centre for drug evaluation). participants will get 1 tablet per day for 10 days. the tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days. participants will have 7 clinic visits. one of these visits will be a 13-day, 12-night stay (v2) and the rest will be 1-day visits (v1 and v3 to v7). at all visits, except the information visit, participants will have blood drawn along with other clinical checks. participants will be asked about their health, medical history and habits including mental health.


Eligibility criteria:
inclusion criteria: * body weight greater than or equal to 54.0 kg. * body mass index (bmi) between 20.0 and 34.9 kg/m\^2 (both inclusive). exclusion criteria: * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator. * any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
diagnostic of transient lower esophageal sphincter relaxation with combined impedance and high resolution manometry in patients with gerd

Conditions: Gastroesophageal Reflux Disease

Summary: the aim of this study is to establish and validate high resolution manometry (hrm) criteria for the definition of transient lower esophageal sphincter relaxations (tlesrs) in gastroesophageal reflux disease (gerd) patients.

tlesrs represent the main mechanism of all types of reflux events. inhibition of transient lower esophageal sphincter relaxations (tlesrs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. hrm is the gold standard for detecting and characterizing tlesr, and could be considered as part of the pharmacological evaluation of new drugs targeting tlesrs. hrm criteria for the objective definition of tlesrs in gerd patients have to be established, as it has been done in healthy patients subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Eligibility criteria:
inclusion criteria: * patients 18 to 75 years old * gerd documented by : * typical reflux symptoms (heartburn, regurgitations) completely responsive to ppi therapy * and/or erosive esophagitis or barrett's esophagus at endoscopy * and/or positive ph 24h monitoring (acid exposure time \> 5% or positive symptom association indices) * possibility of easily positioned transnasal catheter * patients covered by social security * subjects must provide written, free and informed consent exclusion criteria: * pregnant or lactating women * history of digestive or thoracic surgery (except appendicectomy) * patients unable to stop ppi therapy for 7 days * subjects unable to provide written consent, including adult under guardianship and emergency situation * simultaneous participation in another study

Keywords: gerd tlesr impedance manometry
sleeping quality and chronic ocular diseases

Conditions: Sleep Disorder

Summary: to assess the impact of sleep quality on chronic eyes diseases

in this study 3 questionnaires will be distributed to outpatients attending the routine examinations : the pittsburgh, the berlin and the epworth tests these questionnaires, once completed, will then be collected to be then transformed into digital files for the appropriate statistical evaluations and the drafting of the results and conclusions.

Eligibility criteria:
inclusion criteria: * patients with macular degeneration or glaucoma or * healthy volunteers exclusion criteria: - patients with other ocular disorders
treatment of chronic pain with cannabidiol (cbd) and delta-9-tetrahydrocannabinol (thc)

Conditions: Chronic Pain, Widespread

Summary: this is a study comparing the effects of delta-9-tetrahydrocannabinol (thc) versus cannabidiol (cbd) versus a placebo on chronic non-cancer pain.

the overall aim of this study is to examine the effects of delta-9-tetrahydrocannabinol (thc) and cannabidiol (cbd) on chronic pain symptoms, specifically we will examine the effects of different doses of thc/cbd on symptoms of chronic pain and life functioning. participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high thc/low cbd, low thc/high cbd, or placebo. in addition to receiving thc/cbd/placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. these measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of cbd/thc or placebo. a secondary objective will be to examine the association between clinical and neurocognitive variables and use of cbd/thc, including the potential side effects of thc/cbd. other secondary objectives include the use of magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs), acquired before and after final administration with cbd/thc or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. imaging analyses will focus on regional brain changes before and after administration of thc/cbd/placebo.

Eligibility criteria:
inclusion criteria: 1. age between 18-50 yrs. 2. history of cannabis use. 3. chronic musculoskeletal and joint pain for at least 3 months or longer. 4. participants must live within a 60 mile radius of salt lake city, utah to be eligible. exclusion criteria: 1. current or past neurological illness. 2. substance abuse or dependence within the prior 60 days. 3. contraindication to brain mri. 4. type i and type ii diabetes. 5. unstable medical conditions. 6. consumption of more than 2 drinks of alcohol per night. 7. current pregnancy or planning to become pregnant or breastfeeding 8. history of seizures or head trauma 9. active or history of major mental illness 10. lft results 3 times greater than the upper limit of normal at screening. 11. participants may be excluded if the pi feels they do not meet safety criteria.
dexamethasone infusion in community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

community-acquired pneumonia (cap) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. it is the leading cause of community-acquired infection requiring icu admission.1 especially elderly patients may have a severe illness with a high morbidity and mortality rate. in pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. however, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. on icu, early treatment with corticosteroids to attenuate systemic inflammation is widespread. at the same time, outside the icu little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with cap. hypothetically, early initiated administration of corticosteroids in the course of a cap can lower systemic and pulmonary inflammation. this may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Eligibility criteria:
inclusion criteria: patients aged 18 to 100 years with a community-acquired pneumonia. criteria to determine a community-acquired pneumonia: * chest radiograph showing new opacities * in combination with two of the following findings: * cough * production of sputum * temp \>38,0 °c or \<36,0 °c * audible abnormalities by chest examination compatible with pneumonia * leukocytosis (\>10.000 cells/mm3), leftward shift (\>10%) or leukopenia (\<4000 cells/mm3) * crp \> 15 mg/dl (three times upper limit of normal) exclusion criteria: * o the following groups are excluded: * immunocompromised patients: * patients with a known congenital or achieved immunodeficiency. * patients who received chemotherapy less than 6 weeks ago. * patients who received corticosteroids in the last 6 weeks. * patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine) * patients with copd who are on systemic corticosteroids for copd. * patients who require icu treatment.

Keywords: pneumonia dexamethasone community-acquired pneumonia
epidemiological factors and optimization of conservative approaches to precancerous lesions of female reproductive organs

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia (CIN); Risk Factors; Conservative Management

Summary: the primary aim of this study is to develop a recommended clinical practice guideline for managing women with hpv hr positivity and cervical lesions. additionally, in collaboration with the bioptic laboratory, the study will analyze the integration of hpv hr testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for hpv hr-positive women. research objectives: * evaluate spontaneous regression/progression over two years based on hpv hr genotyping (three groups - according to alinity: high, intermediate, and low risk). * assess spontaneous regression/progression over two years based on hpv hr genotyping and viral load in hpv-vaccinated vs. non-vaccinated patients. * evaluate spontaneous regression/progression over two years based on methylation results. * assess spontaneous regression/progression over two years based on cintec results.


Eligibility criteria:
inclusion criteria: * informed consent * cervical biopsy - hg lesion * age: 18-46 years * colposcopicaly visible transformation zone * hpv: unvaccinated * cytology all except ais, adenocarcinoma, squamous cell carcinoma, agc neo exclusion criteria: * cytology ais, agc neo, adenocarcinoma, squamous cell carcinoma * immunosuppression * active autoimmune disease * history of cervical cryodestruction * hpv vaccinated prior to start of the study

Keywords: cervical intraepithelial neoplasia (cin) conservative management precancerous cervical lesions
phase ii trial evaluating elimination of radiation therapy

Conditions: Cancer of the Larynx

Summary: the purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. in this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue


Eligibility criteria:
inclusion criteria: * patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx . * treated with surgical resection with one (or both) side(s) of the neck pathologically n0. * indication for radiation therapy at the primary site or neck consisting of any of the below characteristics: * close margin (\<= 0.5 cm) * positive margin * perineural invasion * lymphovascular space invasion * metastatic disease in more than one lymph node * metastatic disease in more than one lymph node group * extracapsular extension in any lymph node * constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion. * age \>= 18. * patients must sign study specific, institutional review board (irb)-approved consent form. exclusion criteria: * previous head and neck cancer other than non melanoma skin cancer. * previous head and neck surgery. * female patients who are pregnant or nursing.
a cohort study of ischemic cerebrovascular disease

Conditions: Ischaemic Stroke

Summary: this study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. by integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of ischemic stroke. 2. age ≥ 18 years. 3. signed informed consent form. exclusion criteria: 1. patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures. 2. patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes. 3. agitated patients who cannot cooperate with imaging examinations. 4. pregnant or lactating patients, as well as those planning to become pregnant within 90 days. 5. patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days. 6. patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.
gastrectomy plus prophylactic cholecystectomy in gastric cancer surgery

Conditions: Gastric Cancer

Summary: the patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

the incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. this higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. however, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing standard gastric surgery for cancer exclusion criteria: * gallbladder disease

Keywords: gastric cancer, surgery, prophylactic cholecystectomy
gzmb-pet/ct to evaluate neoadjuvant therapy efficacy in breast cancer

Conditions: Breast Cancer Invasive

Summary: to explore the efficacy of 68ga-gzmb pet/ct in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal suvmax threshold of 68ga-gzmb pet/ct for predicting pathological complete response (pcr), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.


Eligibility criteria:
inclusion criteria: * age 16-65 * histologically confirmed unilateral primary invasive breast cancer * tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy * complete clinical and histo-pathological information * ecog 0-1 within 10 days from the beginning of the study * normal bone marrow reserve: white blood cell count ≥ 3.0×10\^9/l, neutrophil count ≥ 1.5×10\^9/l, hemoglobin level ≥ 90g/l; platelet count (plt) ≥ 80×10\^9/l; normal liver and kidney function: blood aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal, total bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance rate \> 50ml/min. * the patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form exclusion criteria: * bilateral or metastatic (stage iv) breast cancer * there has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer * severe systemic infection or other uncontrolled diseases * patients with psychiatric disorders or those unable to comply with treatment due to other reasons * known allergy or intolerance to the drug or its excipients * having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past * patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial. * patients deemed unsuitable for participation in this study by the investigator.

Keywords: breast cancer granzyme b pet/ct neoadjuvant treatment pcr
stopping cavities study: diammine silver fluoride

Conditions: Dental Caries

Summary: this study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

phase iii rct with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. subjects are 200 preschool children in good general health with untreated tooth decay. intervention is topical application of the study drug to the open cavity. primary outcome is caries activity at 14-21 days.

Eligibility criteria:
inclusion criteria: * nyvad criteria 3 * active carious lesion exclusion criteria: * allergy to silver * stomatitis or oral ulcerative condition * weight less than 15 kg

Keywords: silver diamine fluoride diammine silver fluoride children
different dietary patterns

Conditions: Diet, Healthy; Endotoxemia

Summary: the aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.


Eligibility criteria:
inclusion criteria: * bmi between 18.5 kg/m² und 24.9 kg/m² exclusion criteria: * chronic inflammatory diseases * metabolic diseases * viral or bacterial infections in the last 3 weeks * allergic reactions in the last 3 weeks * intake of anti-inflammatory drugs * malignant diseases * pregnancy and lactation * smoking * alcohol consumption \> 10 g/d for women and \> 20 g/d for men * drug consumption * vegetarian or vegan diet * food intolerances
an observational study to assess real-world use of upadacitinib tablets in adolescent and adult participants with moderate to severe atopic dermatitis in china

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a skin condition that may cause a rash and itching due to inflammation of the skin. upadacitinib is an approved drug for treating ad. approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in china. participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. participants will be followed up for approximately 12 months. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * adolescents (body weight \>= 40 kg at the baseline visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment. * clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * upa treatment is indicated for ad and prescribed as per chinese label / smpc. * the decision to prescribe upa is made prior to and independent of study participation. * the participant should not be treated with upa prior to this study. * participants who are willing and able to participate in the collection of patient-reported data, including epros and ediary via apps. * the participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted. exclusion criteria: * the participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation). * any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.

Keywords: upadacitinib rinvoq