Kornimate/medical-research-clean huggingface dataset:
pots-cfs study: orthostatic intolerance in the context of pediatric me/cfs

Conditions: Chronic Fatigue Syndrome in Adolescence; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Summary: pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (me/cfs) compared to age-matched healthy controls (hc).

me/cfs is a complex disease. symptoms include orthostatic intolerance (oi) such as postural tachycardia syndrome (pots). pots in me/cfs can significantly impair everyday function and social participation. yet, data in affected adolescents are rare and inconsistent. this pilot-case-control study study aimed at characterizing oi in adolescents aged 14-17 years with me/cfs and age-adapted hc, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics. me/cfs was diagnosed according to the clinical canadian criteria (ccc 2003), criteria of the former institute of medicine (iom 2015), the diagnostic work sheet developed by rowe 2017, and/or the pediatric case suggested by jason 2006. questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. a standardized specific interview was performed to assess the medical history of oi (hoi). heart rate (hr) and blood pressure were evaluated every minute during a passive 10-min standing test (nasa lean test) in the morning with empty stomach and without morning medication. data were evaluated according to the pots criteria defined in 2019 at the national institutes of health expert consensus meeting and by the international classification of diseases (icd-11) (8d89.2). frequency and type of oi, including pots, were examined in both groups and outcomes compared to parameters from questionnaires. based on the results, novel standards for oi diagnostics were suggested.

Eligibility criteria:
inclusion criteria: 1. cases (me/cfs): - me/cfs diagnosed by the indicated clinical criteria 2. healthy controls * clinically healthy * no known underlying disease * no prescription medication (except contraception) exclusion criteria: * any contraindication for nasa lean test (cardiac failure, severe aortic stenosis, inability to stand) * pregnancy * breastfeeding.
gynemesh ps mesh post marketing clinical follow-up study

Conditions: Pelvic Organ Prolapse

Summary: the objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a gynemesh ps mesh.


Eligibility criteria:
inclusion criteria: subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse 2. gynemesh ps mesh was used as a bridging material according to the ifu. 3. able and willing to participate in follow-up 4. subject or authorized representative has signed the approved informed consent exclusion criteria subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. subjects \< 21 years of age at the time of informed consent 2. subjects who had transvaginal approach for surgery 3. had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Keywords: gynecare gynemesh® ps nonabsorbable prolene® soft mesh pop
ovarian tumor organotypic slices cultures for functional drug testing and therapy response prediction

Conditions: Ovarian Cancer

Summary: ex vivo organotypic tumor slice cultures (otsc) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. moreover, drug screening has been successfully performed on otsc in a clinically meaningful time window. for these reasons, we designed a study to assess the feasibility of establishing otsc in oc patients and the concordance between ex vivo sensitivity and in vivo treatment response. if proven effective and reliable, otsc could be introduced into clinical practice as empirical predictor of patients' response to platinum.

most patients with ovarian cancer (oc) present with advanced stage and severe symptoms. the standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. it is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. to date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting. among cancer models, ex vivo organotypic tumor slice cultures (otsc) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. moreover, drug screening has been successfully performed on otsc in a clinically meaningful time window. for these reasons, we designed a study to assess the feasibility of establishing otsc in oc patients and the concordance between ex vivo sensitivity and in vivo treatment response. if proven effective and reliable, otsc could be introduced into clinical practice as empirical predictor of patients' response to platinum.

Eligibility criteria:
inclusion criteria: 1. preoperative clinical, serological and radiologic suspicion of international federation of gynecology and obstetrics (figo) stage iiic or greater ovarian, fallopian tube, or primary peritoneal cancer; 2. age over 18 years; 3. estimated life expectancy of at least 4 weeks; 4. fagotti score (piv) \> 8 or patients not considered operable in the first place for any reasons; 5. histologic diagnoses of epithelial ovarian cancer at frozen section. exclusion criteria: 1. non- epithelial histology at frozen section; 2. patients enrolled in other clinical trials.
frequency and distribution of mixed falciparum-vivax infections in french guiana

Conditions: Malaria

Summary: malaria is still endemic in the interior of french guiana. mixed infections by 2 or more different malaria parasites lead to complex and potentially harmfull therapeutic problems. the aim of the study was to look at malaria smears between 2000 and 2008 and determine using pcr the frequency of mixed infections, and their distribution in the terrtory of french guiana. overall 10.75% of 400 smears showed mixed infection with p. falciparum and p. vivax. the maroni river where duffy negative populations live was largely devoid of vivax infections. these results suggest that mixed infections are frequent in french guiana except on the maroni river which leads to practical implications for clinicians facing a patient with clinical malaria.


Eligibility criteria:
inclusion criteria: * malaria diagnosis exclusion criteria: * no malaria
study of adg206 in subjects with advanced/metastatic solid tumors

Conditions: Advanced/Metastatic Solid Tumors

Summary: adg206 is an activatable prodrug form of a fully human monoclonal antibody (mab) of the immunoglobulin g1 (igg1) subclass that specifically targets cluster of differentiation 137 (cd137) (also known as 4-1bb) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.

this is a fih, phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of adg206 in subjects with advanced/metastatic malignancies. primary objective of the study: to assess safety and tolerability at increasing dose levels of adg206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status ≤1. * subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists. * at least 1 measurable lesion per response evaluation criteria in solid tumors version 1.1 (recist 1.1). * adequate organ function. * woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug. * male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception. exclusion criteria: * subjects within washout period of other anti-tumor therapies. . * history of prior malignancy other than the cancer under treatment in the study. * major trauma or major surgery within 4 weeks before the first dose of study drug. * serious nonhealing wound, ulcer, or bone fracture. * history of significant immune-mediated ae. * central nervous system (cns) disease involvement. * any evidence of underlying severe liver dysfunction. * prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation. * clinically significant cardiac disease with insufficient cardiac function. * evidence of active uncontrolled viral, bacterial, or systemic fungal infection. * known positive test result for human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids). * infection of hepatitis b virus (hbv), or hepatitis c virus (hcv) (unless the disease is clinically controlled) . * history or risk of autoimmune disease. * subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis. * any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent. * known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in adg206. * pregnant, lactating, or breastfeeding.
mechanisms of deep transcranial magnetic stimulation in enhancing cognitive-behavioral therapy for anorexia nervosa

Conditions: Feeding and Eating Disorders

Summary: the goal of this clinical trial is to learn if dtms targeting the acc can be used to rapidly and effectively treat an. a randomized controlled study design is adopted, in which patients with an are divided into the cbt+dtms treatment group and cbt+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether cbt combined with dtms is superior to single cbt treatment for an.

the investigators propose hypothesis that cbt improves an symptoms by modulating the "an-acc pathology network", and that high-frequency stimulation targeting the acc by dtms can synergize "an-acc pathology network" and enhance the efficacy of cbt. in order to verify this hypothesis, a randomized controlled study design is adopted, in which patients with an are divided into the cbt+dtms treatment group and cbt+pseudostimulation group by 1:1 randomization, followed by 6-week intervention and a half-year follow up, to clarify the near-term and long-term efficacy and safety of the dtms treatment. patients in both groups undergo fmri examinations, complete delay discounting task (ddt) and body image task before and after each treatment session. symptoms, psychometrics and side effect questionnaires are followed up at baseline, week 6 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). this study will provide a theoretical and practical basis for the innovative combined intervention method in patients with an, and to verify the "an-acc pathological network" pathomechanism of an at multiple levels.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * female, aged 18-35 years, right handedness. * above primary education. * meet the diagnostic criteria of an in dsm-v, and13.0 kg/m2 ≤ body mass index (bmi)\<18.5 kg/m2. * no systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment. * able to understand the nature of this study and sign an informed consent form. exclusion criteria: * diagnosed with a dsm-5 disease other than anorexia nervosa, or at high risk of suicide, strong impulsive behavior as well as anti-social behavior. * with severe physical or cognitive impairment. * not able to undergo mri. * considered unsuitable for enrollment in this clinical trial for other reasons.

Keywords: anorexia nervosa deep transcranial magnetic stimulation anterior cingulate cortex
effect of acid suppression with esomeprazole on vocal cord granulomas

Conditions: Larynx Disease

Summary: the purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (nexium) or placebo (inactive drug) on vocal cord granulomas.

vocal cord granulomas (vcg) are common structural lesions of vocal cords attributed to vocal abuse / misuse and recently to gastroesophageal reflux. vocal process granulomas are reactive/reparative process, in which an intact or ulcerated squamous epithelium is underlaid by granulation tissue or fibrosis (4, 5). ulualp et al (6) have reported a higher prevalence of pharyngeal acid reflux (par) events in patients with vocal cord lesions. in a case control study they showed that the prevalence of pharyngeal reflux, documented with 3 site pharyngoesophageal ph monitoring, is higher among patients with posterior laryngitis and vocal cord lesions than control (78% vs. 21%). most recently our cohort trial in over 80 patients with laryngeal findings suggestive of gerd suggested that vocal cord abnormalities such as granulomas may be more specific sign of gerd than any other (7). thus, there is reasonable scientific intrigue regarding this laryngeal finding and the causal role from gastroesophagopharyngeal acid reflux requiring better studies. however, no study has evaluated the potential causal association between gerd and vcgs.

Eligibility criteria:
inclusion criteria: patients with vocal cord granulomas exclusion criteria: * age \< 18 * pregnancy * use of proton pump inhibitor (ppi) within the last 30 days
study to determine the safety, tolerability and pharmacokinetics of uv-4b solution administered orally in healthy subjects

Conditions: Viral Infection

Summary: the objective is to evaluate the safety and tolerability of a single-ascending oral dose of uv-4b in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of uv-4b in healthy subjects.

the causative agent of dengue fever is dengue virus (denv), a member of the flavivirus genus. there are four denv serotypes. infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million denv infections per year distributed over 100 countries. recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

Eligibility criteria:
inclusion criteria: * healthy subjects * women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period * men: using barrier contraception measures during the study period exclusion criteria: * health conditions * taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)

Keywords: dengue arbovirus infections flaviviridae infections flavivirus infections hemorrhagic fevers, viral rna virus infections virus diseases pharmaceutical solutions pharmacologic actions therapeutic uses
the effect of combined cryotherapy and immunotherapy on systemic t cell changes and clinical outcomes in metastatic non-small cell lung cancer

Conditions: Lung Cancer Stage IV

Summary: lung cancer remains one of the most commonly diagnosed oncological diseases worldwide and the first in terms of mortality. although immune checkpoint inhibitors form the backbone of current metastatic non-small cell lung cancer treatments, there is still no ideal predictive marker for its efficacy and patients still achieve suboptimal results in overall response and survival. while immune checkpoint inhibitors are known to shift systemic anti-tumor immune response from suppression to stimulation in some patients, the investigators hypothesize that this effect can be further enhanced by cryotherapy, especially in "cold" tumors. if proven successful, cryotherapy in combination with immunotherapy, could potentiate a more powerful immune response compared to systemic therapy alone, improve overall response rate, patients' survival without disease progression, and overall survival. the investigators, therefore, aim to use combined local tumor cryotherapy, combined with immune checkpoint inhibitor therapy to induce and evaluate systemic anti-tumor t lymphocyte response and achieve improved non-small cell lung cancer patient outcomes than with immunotherapy alone.


Eligibility criteria:
inclusion criteria: * patients with eastern cooperative oncology group (ecog) performance score 0 - 1; * patients with histologically confirmed metastatic non-small cell lung cancer and pd-l1 expression on tumor cells was evaluated; * ct examination shows measurable tumor formations according to the recist 1.1 criteria; * primary lung tumor or metastasis accessible to flexible bronchoscopy; * patients may have received surgery, adjuvant or neoadjuvant chemotherapy prior to the study if it was completed at least 12 months before relapse; * patients informed about the purpose and course of the study and provided a written consent to participate. exclusion criteria: * patients who refused to participate in the clinical trial and did not sign the informed consent form; * men and women under the age of 18, pregnant women; * patients belonging to a vulnerable social group; * high risk of general anesthesia, defined as american society of anesthesiologists (asa) class 4 - 6; * documented allergy to medications used during general and local anesthesia, systemic cancer treatment; * patients previously treated with immune checkpoint inhibitors; * egfr mutations or alk translocations have been identified in patients; * patients with previously diagnosed autoimmune diseases, active viral hepatitis, uncontrolled human immunodeficiency virus (hiv) infection or untreated tuberculosis; * patients treated with immunosuppressive drugs, systemic corticosteroids, with equivalent doses of prednisolone exceeding 10 mg/day; * patients with an increased risk of bleeding during an interventional procedure; * acute untreated conditions that would make it impossible to perform an interventional lung procedure.

Keywords: pulmonology oncology immunotherapy cryotherapy
study of perennial allergic rhinitis in pediatrics

Conditions: Rhinitis, Allergic, Perennial

Summary: to verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (tnss) over the total treatment period from the score of the baseline assessment period


Eligibility criteria:
inclusion criteria: * children with perennial allergic rhinitis. * giving informed consent. * children with a positive response to specific ige antibody test. * children assessed as positive in the nasal eosinophil count. * children whose severity score of nasal symptom is 4 or higher. exclusion criteria: * have spastic disease such as epilepsy * have a history of drug hypersensitivity * are pregnant, lactating or possibly pregnant female children * are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods * have vasomotor rhinitis and eosinophilic rhinitis * have asthma that requires the treatment with corticosteroid * have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs * have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation * have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment * have received surgical treatment for reduction and modulation of nasal mucosa * redintegration therapy of nasal cavity to improve the degree of nasal airway * surgical operation to improve rhinorrhea.

Keywords: allergic pediatric rhinitis perennial
assessing the clinical effectiveness of serum biomarkers in the diagnosis of metastatic uveal melanoma

Conditions: Uveal Melanoma

Summary: uveal melanoma is the most common primary intraocular tumor in adults. the local treatment is effective, but patients still die of metastatic disease. it has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients. many serum biomarkers are employed in oncology. it makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma. the investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.


Eligibility criteria:
inclusion criteria: * diagnosis of uveal melanoma exclusion criteria: * refusal to participate in the study

Keywords: uveal melanoma metastatic uveal melanoma